U.S. GOVERNMENT PUBLISHING OFFICE

32–361 WASHINGTON : 2019

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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

JEFF DUNCAN, South Carolina 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

(III) 

SUBCOMMITTEE ON HEALTH

MICHAEL C. BURGESS, TEXAS

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

JOE BARTON, Texas 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MARSHA BLACKBURN, Tennessee 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

ANNA G. ESHOO, California 

DIANA DEGETTE, Colorado 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(V) 

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 

Page

VI 

Burgess documents—Continued 

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 

(1) 

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. 

2 

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 devVerDate Nov 24 2008 08:45 Feb 06, 2019 Jkt 037690 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-126 CHRIS
3 

astating 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. 

4 

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. 

5 

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. 

6 

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. 

7 

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:] 

8 

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. 

9 

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 paVerDate Nov 24 2008 08:45 Feb 06, 2019 Jkt 037690 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-126 CHRIS
10 

tient 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:] 

11 

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 

12 

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 

13 

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. 

14 

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:] 


32361.001
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32361.002

Our nation's health care 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. Part 2 regulations restrict providers' ability to access critical 

suhstance abuse treatment information, which results in poor and, in some cases, tragic outcomes 

for patients. The story of jessica "jessie" Grubb, who passed away from an overdose in March 2016, 

demonstrates the consequences of providers not having access to a patient's full health history. 

jessie, who was in substance use recovery, went in for routine surgery. Providers were informed by 

her parents that she should not be given opioids except under strict supervision. However, upon 

discharge jessie was prescribed 50 oxycodone pills, and the hospital pharmacy filled the 

prescription he cause her substance use disorder treatment history was not in her medical record. 

That night, she died as the result of an overdose. jessie's father, David, said at the time "she went 

home with, in essence, a loaded gun." 

Doctors can't treat a whole patient with half a medical record and patients have a right to the best 

medical care available. I, along with Representative Mullin, have authored the bipartisan Overdose 

Prevention and Patient Safety Act, H.R. 3545, to prevent tragedies like jessie's and will align Part 2 

regulations with the existing patient confidentiality protections under HIPAA. 

Our bipartisan legislation would treat medical records generated at a substance use treatment 

facility that relate to "treatment, payment, or health care operations" in the exact same manner as 

all other medical records, removing the stigma that has for so long segregated those records from 

the rest of the health care system. Stigma around substance use disorders unfortunately still exists, 

and it should not be the major reason preventing care coordination for patients with a chronic 

illness. At the current time, persons with substance use disorders are the only subset of health care 

patients whose records are treated differently, and as a result, may not receive coordinated care. 
16 


32361.003

Stigma is also associated with mental health and HIV /AIDs; but both mental health and l!IV /AIDs 

patients fall under the protections of the HIP A/\ privacy law. Care is improving for both of those 

populations, thanks to the increased access to public health data and open lines of communications 

that reduce unnecessary public discrimination. 

For Americans who are in recovery, our legislation maintains and strengthens existing Part 2 

protections that prevent the disclosure of substance abuse treatment records in a manner that 

might lead to prosecution, discrimination, or loss of employment, housing, or child custody. For 

example, currently it is illegal to share an individual's substance use treatment record with an 

employer, law enforcement, or a landlord. That wouldn't change under H.R. 3545. Furthermore, 

llR. 3545 will require automatic dismissal of criminal proceedings based upon a substance use 

treatment record that was improperly obtained using the process currently set forth under Part 2. 

Finally, current penalties for improperly disclosing or sharing confidential patient information 

under Part 2 range from $500 to $5,000. Our legislation would increase the penalty range to $100 

to $1.5 million, providing the stronger enforcement standards currently in place under HIPAA 

As our health care delivery system moves towards more robust, integrated care models, every 

member of a patient's treatment team needs to understand a patient's full medical history, 

including substance use disorder history. Current Part 2 regulations stand as a hindrance to whole· 

person care and must be changed to ensure all patients, regardless of diagnosis, have access to safe, 

effective, high-quality treatment and care. 

Thank you for the opportunity to share the importance of the Overdose Prevention and Patient 

Safety Act, H.R. 354, with you.llook forward to continuing to engage with Members of the 

Subcommittee as you consider these important issues. 

3 
17 

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. 

18 

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. 

19 

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:] 

20 


32361.004

Dustin James McKee 

U.S. House Energy & Commerce Health Subcommittee 

Testimony Re: HR 3545 

The Overdose Prevention and Safety Act 

May 8'", 2018 

Chairman Burgess, Vice Chair Guthrie, Ranking Member Greene and members of the Energy and 

Commerce Subcommittee on Health, thank you for this opportunity to testify before you today 

regarding HR 3545, the Overdose Prevention and Safety Act. 

As you know, our nation is in the midst of a public health crisis. Opiates are killing more and more 

people each year. In 2016, my home state of Ohio had the second highest opiate overdose death rate in 

the nation. According to the Centers for Disease Control and Prevention, 10,383 people have died from 

opiate overdoes since 2014. 

One of the people who died of an opiate overdose in 2014 was my big brother, Brandon Johnathan 

McKee. He was 36. He was the father of three sons, ages 4, 11 and 16 at the time of his death. 

Brandon's death was preventable. However, in part because of the antiquated provisions contained 

within 42 CFR Part 2, the medical professionals that prescribed him opiate based pain medications were 

not able to identify him as a high risk individual with a history of substance use disorders, substance use 

treatment, and countless relapses. 

Brandon struggled with addiction for most of his adult life. When he was 17, he fell while attempting a 

trick on his skateboard and dislocated his shoulder. His ex-wife recalls him frequently saying that the 

opiate based pain medication he was given intravenously in the emergency department gave him the 

best sensation that he had ever experienced in his life. It seems as though that incident was the 

beginning of a long and ultimately unsuccessful battle with substance use and addiction. 

Brandon was a talented salesman. By age 21, he was making a six figure salary as a sales manager at a 

car dealership in Mansfield, Ohio. However, despite his career success, his addictions constantly 

plagued him. Even after receiving two courses of residential substance use treatment, and ongoing 

outpatient treatment, his substance use led to several eventual job losses, multiple DUI's, family strife, 

and an eventual divorce. 

After his divorce, Brandon moved into my mother's basement in Wooster, Ohio. He was 35 at the time. 

Although he was trying to get sober and going to meetings, he relapsed one night. He took his truck to 

the bar after taking some mixture of tranquilizers and alcohol. He drank until the tavern closed, and 

then tried to drive his truck home. That night, he passed out behind the wheel and crashed into a large 

post, shattering several vertebrae in his back. 

After the accident he was taken to Wooster Community Hospital and was eventually transported to 

Cleveland Metro Hospital where he would have back surgery to repair his spine. Because of 42 CFR Part 

2, his orthopedic surgeon had no way of knowing that Brandon had a serious opiate related substance 

use disorder. Brandon did not sign a waiver, nor would he ever sign such a waiver if he had a chance to 

get a long-term prescription for opiate pain killers. These medications made him feel perfect, and he 

couldn't resist such an opportunity. 
21 


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After the surgery, his surgeon gave him a prescription for a high dose opiate-based pain medication, 

with multiple refills. Four months later, he fell down and broke the titanium screws in his back. This 

second accident required a second surgery. Due to 42 CFR Part 2, the surgeon was once again unable to 

see that Brandon was an addict with a long history of substance use disorder treatment. Unsurprisingly, 

this lack of care coordination led to yet another prescription for a high dose opiate-based pain 

medication with multiple refills. 

After Brandon's pain medication prescriptions were used up, he turned to street heroin. However, until 

his fatal overdose, none of us knew that he was an intravenous drug user. He was going to work every 

day, selling car,s and living in his own apartment. 

Three days before he died, he called me. He finally admitted to me, and only me, that he was struggling 

with narcotics. He never told me he was addicted to heroin, he was too ashamed to say so. However, 

he said he'd been taking opiate based pain pills, and had been off of them for a week and a half. 

He was crying. He told me he had made it through the "dope sickness" of withdraw, and would be 

attending an NA meeting that evening. Ironically, during our conversation, the battery in his phone 

was drained and his phone cut off before the conversation was finished. The last words he said to me 

was "I'm going to go to that meeting brother, I promise", and then the phone shut off. 

Three days later, he died of a heroin overdose, alone in his apartment. He was found curled up in the 

fetal position. It was May 10'h, 2014. 

Mr. Chairman, as Brandon's tragic story demonstrates, 42 CFR Part 2 "rs a significant barrier to integrating 

physical and behavioral health. It is also a major patient safety issue. We at the National Alliance on 

Mental Illness (NAMI) feel strongly that this barrier to integration and source bad outcomes (for both 

physical and behavioral health) needs to be updated and brought into the 21" Century. 

Individuals diagnosed with a mental health conditions are at much greater risk of abusing substances 

and falling into the grip of addiction. Additionally, we know that siloed treatment for mental illness and 

addiction is ineffective and leads to negative outcomes in both an individual's mental health and 

substance use condition. In many instances, it also creates an even greater risk that individuals will 

experience poorly managed co-morbid, chronic medical conditions. This is a major contributing factor 

to the high rates of early mortality for individuals livinl> with mental illness. Numerous studies have 

found that life expectancy for adults with mental illness may be as much as 25 years less than the 

general population. 

Integrating care across not only mental health and substance use care, but also with primary and 

specialty medical care, is effective at improving clinical outcomes. It also lowers overall costs across 

public programs, such as Medicare and Medicaid, and private programs like employer-provided health 

insurance. However, integration cannot be achieved without the sharing of treatment records among 

providers. 42 CFR Part 2 remains a significant barrier to the sharing of clinical data and the proper 

coordination of care. These burdensome consent requirements that are not aligned with HIPAA further 
22 


32361.006

stigmatize mental illness and substance abuse as separate from the rest of the health care system. 

Parity is necessary across the health care system to ensure that behavioral health records are managed 

the same as all patient data. 2018 marks the lOth anniversary of this Committee passing the Paul 

Wellstone and Pete Domenici Mental Health Parity and Addition Equity Act (MHPAEA). This was a huge 

victory for Americans living with mental illness and substance use disorders. At the same time, we will 

never achieve full parity until we live by the same rules and standards as the rest of health care. This is 

especially the case with the sharing of critical health information and the integration of care for the 

whole patient. 

I would further emphasize that HR 3545 takes a very narrow targeted approach that simply aligns 42 CFR 

Part 2 with HIPAA for the purposes of sharing information for "treatment, payment and health care 

operations" or TPO. This legislation in no way places treatment records at risk of being shared outside 

of the context of health care TPO, that is to landlords, employers, law enforcement or civil litigation. In 

fact, the current draft strengthens existing penalties for inappropriate or illegal disclosure of behavioral 

health treatment records. 

With bipartisan support, this Committee has embraced alternative payment models (APMs) and is 

moving our nation's health care system toward paying for "value over volume." As long as behavioral 

health records remain subject to separate rules that prevent the sharing of data for treatment, payment 

and health care operations, mental health and substance use will again be left behind the rest of the 

health care system. As you advance addiction treatment legislation this spring, I urge you to include the 

provisions that are in HR 3545 in any bill that is produced by the Committee. This is an important 

opportunity to improve coordination of care and produce better outcomes for people with mental 

health and substance use conditions. 

Separate is never equal. It is time to align 42 CFR Part 2 with HIPAA and move us toward the goal oftrue 

health care integration. 

The members of this subcommittee, along with their colleagues in the One Hundred Fifteenth United 

States Congress have an opportunity to prevent deaths like these. By passing HR 3545 and removing the 

antiquated barriers to care integration that exist today because of 42 CFR Part 2, physicians with high 

risk patients like Brandon can be fully informed so they can medically manage the hazards associated 

with prescribing opiate-based pain medications to people with a history of addiction treatment. 

I urge you to make the common sense policy changes in HR 3545 by passing this legislation. The lives of 

your constituents may actually depend on it. 

Thank you again forth is opportunity to testify. I would be happy to answer any questions that the 

committee has at this time. 
23 

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. 

24 

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:] 

25 


32361.007

House Energy and Commerce Committee, Health Subcommittee hearing -

"Improving the Coordination and Quality of Substance Use Disorder Treatment" 

May 8, 2018 

Statement by 

Patty McCarthy Metcalf 

Executive Director of Faces & Voices of Recovery 

First, I would like to thank the Committee for hosting this important hearing and for inviting me 

to testify on "Improving the Coordination and quality of Substance Use Disorder Treatment." 

My written and oral testimony are the results of my personal experience as a person in substance 

use disorder recovery and well as my professional experience as the Executive Director of Faces 

& Voices of Recovery. 

ABOUT ME: 

My name is Patty McCarthy Metcalf. I am a woman in long term recovery from alcohol and 

drug addiction. For me, that means that I haven't used alcohol or other drugs in over 28 years. 

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. 

I have personal lived experience with substance use disorder ("SUD") treatment. As a teen and 

young adult, I went to residential treatment three times. The third time, I had just turned 18 

years old and was admitted to inpatient treatment for alcohol use disorder and cocaine use. If 

today I was trying to start college, starting my career, or even buying life insurance, it's likely I 

wouldn't be telling you this for fear of stigma and discrimination. 

840 First !::itreet NE 3'" Floor • Washmgton, DC 20002 

202.737.0690 • Fax: 202.737.0695 

www.facesandvoicesofrecovery.org 
26 


32361.008

In fact, if I had a drug-related felony and wanted to apply for federal financial aid to go to 

college or if I wanted to get a license to cut hair, I could be ineligible based on my past history 

even though I am in long term recovery. The point is that stigma and discrimination are still 

barriers for millions of people in or seeking recovery from substance use disorders. 

ABOUT FACES & VOICES OF RECOVERY: 

Faces & Voices of Recovery is a national recovery advocacy organization based in Washington, 

D.C. Since 2001, we have been dedicated to unifying around key priorities- to gain needed 

resources for recovery and to end stigma and discrimination against people in recovery. We are 

working to eliminate barriers to recovery for every American and every family, and to help 

today' s children and future generations, who often arc the biggest winners in the process of 

recovery. 

The Association of Recovery Community Organizations ("ARCO") at Faces & Voices of 

Recovery is comprised of over I 00 organizations across the nation with hundreds of thousands of 

individuals engaged in their programs and participating in recovery support services. By 

organizing and speaking out together, we support and give hope to individuals who are still 

struggling with addiction and to those who have found the power oflong-tcrm recovery. 

As an organized voice protecting the rights of individuals with substance use disorders, we are 

adamantly opposed to the dismantling of our critically important 42 CFR Part 2 ("Part 2") 

confidentiality protections. We do not want our highly sensitive, personal information shared for 

purposes of treatment, payment, health care operations or for any other purpose beyond current 

the rule without our express written consent or Part 2 's other safeguards. 

PATIENT PRIVACY: 

The advocacy efforts to eliminate 42 CFR Part 2 have largely been driven by coalitions of 

hospital associations, insurers, treatment agencies, software vendors and pharmaceutical 

840 First Street NE 3'' Floor • Washington, DC 20002 

202.737.0690 • Fax: 202.737.0695 

www. facesandvoicesofrecovery. org 
27 


32361.009

companies, without representation of patient advocacy groups or people in recovery from alcohol 

and other drug addiction. Faces & Voices of Recovery agrees with the Congress who enacted 

Part 2 in the 1970s that weakening privacy regulations will discourage individuals who need 

SUD treatment from seeking it. In fact, we believe that the interaction between a SUD 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. We also 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. We believe that resources 

targeted towards educating the medical field on the current Part 2 protections and to increase 

understanding of substance use conditions would go far to improve care without eliminating our 

rights. 

An essential element of treatment and recovery includes strength-based approaches that are 

patient-centered and empower the person to choose who to share their information with and 

when. Most often the treatment provider encourages their clients to provide a written consent to 

share information with their primary care physician. lfthe client is reluctant to do this, they have 

an opportunity to weigh the benefits and discuss options. In addition, through the updated 2017 

Part 2 regulations, patients can now choose to disclose their SUD treatment records in a 

simplified consent form to their other treating providers in electronic health networks, integrated 

care systems, as well a~ treating provider entities (e.g., hospitals, and mental health and other 

outpatient health centers). 

Shared decision-making and whole person care require the participation of the patient. A system 

that denies patient autonomy and dignity will discourage people from seeking help for a 

substance use condition. An integrated, recovery-oriented system of care would not seek to keep 

persons with substance use conditions from being a partner in their own care. The dismantling 

of 42 CFR Part 2 is the antithesis of the principle of patient-centered, integrated care, and is 

840 First Street NE 3rd Floor • Washington, DC 20002 

202.737.0690 • Fax: 202.737.0695 

www.facesandvoicesofrecovery.org 
28 


32361.010

largely being pursued by groups who hold their own business interests ahead of the rights and 

interests of our community. 

UNrNTENDED CONSEQUENCES: 

Federal confidentiality regulations are intended to protect the right to privacy for individuals 

with all substance use disorders, not just those with opioid use disorders. An estimated 16 

million people in the United States have an alcohol use disorder ("AUD"), according to the 

National Institute on Alcohol Abuse and Alcoholism. Research has repeatedly shown that people 

with AUDs experience stigmatization (by the public as well as ti·om health professionals) more 

severely than people with other mental disorders. A high perceived stigma in persons diagnosed 

with an AUD has been shown to reduce the probability of using health care services and thereby 

contributes to a decreased likelihood of treatment seeking. Research also indicates that worries 

about privacy keep people from seeking treatment. (Source: NIAAA, Alcohol Alert, Number 81: 

Exploring Treatment Options for Alcohol Use Disorders.) 

Making changes to minimize 42 CFR Patt 2's protections will have long lasting effects for a 

wide range of individuals and family members. For example, my daughter participated in 

counseling (at a Part 2 program) as a requirement of a diversion program for a possession of malt 

beverage charge (underage drinking). Without privacy protections, this information would be 

automatically prominently dis played on her medical record and could negatively impact her for 

the rest of her life. Had the counseling been related to illicit drug use, the harm could be 

devastating to her future. As a proud parent, I am happy to report that my daughter graduated 

college with a 4.0 GPA last week. As another example, a truck driver with a commercial 

driver's license may participate in counseling and driving under the influence ("DUI") classes at 

the advice of his or her attorney after a first DUI offense. !fa medical screening is a requirement 

for employment, as it is for many professions, the physician could potentially disclose his or her 

substance usc disorder treatment history. 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. 

840 First Street NE 3'' Floor • Washington, DC 20002 

202.737.0690 ·Fax: 202.737.0695 

www. facesandvoicesofrecovery. org 
29 


32361.011

Unlike most other medical illnesses, substance use disorders often have criminal and civil legal 

consequences. Part 2 provides safeguards for patients against potentially disastrous results of 

unauthorized disclosure. Unlike individuals with other illnesses or disabilities, SUD patients arc 

vulnerable to arrest, prosecution, and incarceration. Additionally, many people with SUD (who 

arc currently using illegal drugs) arc not protected by federal or state civil rights laws that protect 

people with disabilities from employment, housing and other types of discrimination. Loosened 

confidentiality protections for SUD patient records can not only discourage patients from seeking 

treatment, but also subjects them to the risk of experiencing severe negative consequences and 

discrimination. 

SUD patients may be hesitant to reveal they have been discriminated against. Someone using 

illegal drugs would have to reveal this fact, as well as the activities associated with the use of the 

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 ifthey did, in most 

cases individuals would not do so as by the very act of trying to assert their rights would 

acknowledge drug use and addiction in a way that would open them up to prosecution and 

discrimination. 

The assertion that 42 CFR Part 2 is a barrier to health care is patently false. Part 2 simply 

requires that a patient decide if they want to share their personal information with another party. 

That's all it docs. It is not a barrier, because it includes the patient in determining what risk the 

patient is willing to assume when their personal information is being shared with others. Part 2 as 

it stands today is a key clement of integrated care in the most fundamental way. It upholds the 

autonomy and dignity of the patient by allowing the person with the substance use condition to 

decide who gets to get their information. We cannot integrate care by excluding the patient from 

the ability to make choices about what happens to their information. This is paternalistic and 

misguided. 

840 First Street NE 3'' Floor • Washington, DC 20002 

202.737.0690 • Fax: 202.737.0695 

www.facesandvoicesofrecovery.org 
30 


32361.012

There are protections that people would lose ifHIPAA becomes the standard for substance use 

information. Law enforcement authorities could seize patient records with subpoenas and general 

court orders and use them to prosecute people in addiction treatment programs. The Health 

Insurance Portability and Accountability Act ("HIPAA") does not provide significant protections 

against information in substance use disorder ("SUD") records being routinely seized to 

investigate and prosecute patients in substance use treatment. Under the federal substance use 

disorder confidentiality regulation, Part 2treatment programs are prevented from releasing 

patients' SUD information to law enforcement authorities, and judicial or administrative bodies, 

without a special court order. 

CONCLUSION: 

Beyond the significant harm that this proposed legislation (H.R. 3545) would do in our 

communities, it is entirely unnecessary. It is deeply disturbing to us that organizations who 

ostensibly support recovery and patient autonomy are supporting the elimination of these rights 

for our community. Others appear to be signing on for financial gain, convenience, other 

unknown purposes. 

There is far too much at stake here to those of us depending on these protections in order that we 

may heal and realize our potential as productive citizens of this great nation. Congress was wise 

in its adoption of these important protections in the early 1970's when they passed the law. They 

recognized at that time that these protections were necessary as they were facing a heroin 

epidemic and they understood that they were important in order to allow people to seek help for 

their substance use conditions without fear of their information going out father than necessary. 

As recently as last year, the regulations have been updated to reflect our changing health care 

system while ensuring our ability to consent to share it. We believe that many medical providers 

are unaware of these changes. The current Part 2 protections should be given an opportunity to 

work instead of pursuing these efforts to eliminate our rights. 

840 First Street NE 3'' Floor • Washington, DC 20002 

202.737.0690 • Fax: 202.737.0695 

www. facesandvoicesofrecovery. org 
31 


32361.013

While it is true that there are many parallels between substance use conditions and other medical 

conditions, by its very nature, substance use conditions may involve use of illicit substances 

which is an illegal activity. The recognition of this fact led to the very protections that this bill 

seeks to dismantle. These protections are as critical as they were 40 years ago and must be 

maintained to ensure that individuals and families will seek help. 

Many of us have made it clear that we would not have gone to substance use disorder treatment 

or accepted these services if we thought that our information would have been shared with other 

entities without our permission or knowledge. We would not have put our careers, reputations, 

or families at risk of stigma and discrimination if we were not assured that information about our 

substance use disorder was safe and would only be shared with our consent. 

At a time when the opioid overdose crisis claims 144 lives every day, barriers to achieving a life 

free from the effects of harmful drug use must not be erected. Barriers to recovery hurt not only 

the individual, but that individual's family, community and the larger society as well. 

As a person in long-term recovery, as a parent, and on behalf of the recovery community. I look 

forward to working with you and the Members on this Committee to advance meaningful 

legislation while protecting patient privacy. Thank you for the opportunity to testify today and 

for your commitment to addressing such an important issue that impacts millions of American 

families every day. 

CONTACT INFORMATION: 

Patty McCarthy Metcalf, M.S. 

Executive Director 

Faces & Voices of Recovery 

pmccarthy@facesandvoicesofrecovery.org 

1.202. 73 7. 0692 

840 First Street NE 3" Floor • Washington. DC 20002 

202.737.0690 • Fax: 202.737.0695 

www.facesandvoicesofrecovery.org 
32 

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. 

33 

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:] 

34 


32361.014

Testimony of Jeremiah Gardner, MA, LADC, Hazcldcn Betty Ford Foundation 

Before the House Energy and Commerce Committee Subcommittee on Health 

On H.R. 3545- May 8, 2018 

Summary: I\fr. Chairman, thank you Ycry much for inYiting n1c to participate in this itnportant hearing. 

t~1Tl grateful to you and the ?vfcmbcrs of the Subco1nmittcc for your leadership in addressing the opioid 

addiction crisis, and for the opportunity to testify in support of H.R. 35·15. 

~'fy natne is Jeremiah Gardner, and I an1 a person in long-tcnn recovery. For me~ that means I haYcn't 

used alcohol or other drugs in almost 12 years and have been able to build a life, family and career defined 

hy scn~ice, community~ purpose and gratitude. I'm also the son of a wonderful wotnan whose life ended 

three years ago due to her opioid usc disorder one of the hundreds of thousands of Americans lost to 

O\~crdosc in recent years. I am a recovery adYocatc in rr.ty community and nationally. I also haYe a master's 

degree in addiction studies and am licensed as a counsdor in ?\linnesota. In addition, I work as a 

communic,tions professional for the Halelden Betty Ford Foundation, a nonproftt that has been fighting 

for patients and their rights for decades. 

li.R. 3545 would be a key step in gi'·ing those with opioid usc disorder greater access to the lifesaving 

health care they need. The bill would reform the outdated and onerous 42 CFR Part 2 ("Part 2") privacy 

regulations, which ha\T become a barrier to access and patient safety and deprive patients of the full 

benefits of modern health care scrdces. Part 2 regulations, enacted in the 1 070s, are applied neither fairly 

nor uniformlr, applying only to a small subset of addiction treatment providers. They ha'T never been 

enforced and actually perpetuate the very stignu that causes discrimination, rather than prcn~iding any real 

extra protection against it. By aligning Part 2 with the Health Insurance Portability and 1\ccountability 1\ct 

("I IIPAAn) for ''trcattnent," "paytncnt," and "operations" putposes thus allowing the usc and disclosure 

of patient information when needed to facilitate optimal care and protect patient safety H.R 35-15 will 

continue Congress's effort to bring much-needed parity between care for addiction and care for physical 

health conditions. The bill will enable <lddiction care to become more fully integrated '\Vithin the broader 

health care syste1n so patients have rnultiplc access points and can get support for this chronic condi1ion 

beyond the acute care stage. 1\t the same time, it will strengthen Part 2's protections against discrimination 

and other potential abuses of information in criminal and ci'·il courts. l'or all of those reasons, I LR. 3545 

is an essential piece of the federal opioid response. 

\V'hilc this testimony is professionally informed, I \.vill focus primarily on my personal experiences as a 

patient, a person and advocate in recovery, and a son who lost his mon1 to addiction. 
35 


32361.015

Gardner Testimony 1 Pag:::: 2 of 1 

Testimony (Cont.): !'or whatever reason, Sept. 25, 2006, was my turning point. \'<ihen I woke up in a 

hotel at 10 a.m. that Monday late for work, sick, tired, and crying- I made the fateful decision to stop 

fighting the reality of my substance usc disorder and ask for help. I called a friend and within se1:eral hours 

\vas adtnittcd to a treatment center. \\/c didn't once talk about privacy that day; it wasn't the slightest factor 

in n1y help-seeking decision. I did, however, make son1c calls before I was driven to the treatment center. 

called my boss first. I figured it would be hard to skip work- or in my case, multiple weeks of work 

\vithout explaining. It didn't eycn cross n1y tnind to keep it a secret. I don't even know ho\v that \vould 

l,;n·e been possible. 1 also called some fellow volunteer.s to let them know I wouldn't be at an upcoming 

community event. ;\nell called tny girlfriend to let her know, too. And then I got the help I needed at a 

small, nonprofit facility subject to Part 2. 

\\'hat sort of message do you think I internalized when 1 was asked to sign multiple consents at multiple 

times during n1y care? It wasn't that my provider or the systcn1 cared deeply about tnc or was trying to 

protect n1c. Ins lead~ 1 was getting the subtle, stigmatizing tnessagc that my illness tnay den1and 

extraordinary secrecy. Before, I hadn't been under the impression that I needed to or could keep n1y 

treattncnt a secret. In fact, gctt:ing help had sccn1cd like a good thing. To be sure, nobody wants to go to 

the hospital, clinic ot an addiction treatment center. And there's some confusion and frustration around 

not being able to get healthy on one's o\vn, born of ignorance about the disease. But I hadn't planned to 

feel shame for getting help. I can tell you I had also intuitively expected that anyone working 'vith the 

facility would know about me, and that anyone \1.:ith 1TIY insurance company who needed to know \vould, 

too. \\'hy would 1 expect anything differently? J\nd yet, the unusual culture of secrecy seemed 

disconnected to the other idea I was learning- which that I had a health condition, rather than a 

problem of will or morals. 
36 


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Cmdner Testimony j P3ge J ot 7 

It's true, of course, that many of u::; feel guilt and shame O\'Cr the behaYiors that were the syrnptoms of our 

health condition. But the idea that getting help and getting well might be a secret we want to keep is an 

idea that was planted in me. Vltimatcly, I chose to be as open as I \vould about any other illness to be 

authentic and not establish dual identities- because it felt intuitinly like the healthy choice. 

Now, had I lost a job after I got back to work because of my treatment, that would haye been terrible. It 

also would have been clearly discriminatory, actionable and wrongheaded. Yes, discrinlinaiion happens, 

and we must prosecute it to the full extent of the law. Ilut if we want to take that next step as a culture, 

and create an ctwiromncnt that produces less discrin1ination and addresses addiction n1orc openly, \VC 

have to change the la\\'S and institutions that unintentionally \'alidatc stigma. \\'c cannot fight 

discrinllnation \Vith stigma. And we cannot treat addiction as a health condition unless \VC do just thatactually treat it like a health condition. 1 t's time for our law to reflect the cultural change we want and need 

to sec. LiYes depend on it. 

Even if I had tried to keep my illness a secret, Part 2 would not have protected any more than HIP"'u\ 

against my employer finding out about my treatment. lf that information got to my employer without my 

consent, it '\VOnld have constituted a fiiPAA Yiolation. Indeed, if you examine the privacy breach scenarios 

tnost often cited by tho~c concerned about this bill, they are viobtion;o; already :lddressed by HlP JL\. 

It may be true that the more health care and insurance company employees who touch my record, the 

greater chance there is smncone tnay violate I IIPA1\. I '"111 stipulate that, conceptually. Bur is that a 

widespread problcrn in the real world? For-profit addiction treatment centers are not subject to Part 2. Is 

I I lPP A failing their patients? 1 don't think so. Arc we seeing more privacy ''iolations at the Department of 

Veterans ;\ffairs, where patient record regulations are already aligned with J-!IPAA? Not that I'm aware of. 
37 


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Gardner Testimony j Page 4 of 7 

Congress decided that Part 2 provides no extra protection for our veterans, sen.ricc tncn and '\vomen, and 

their fan1ilies \Vhen you cxen1ptcd the VA from the burdens of Part 2last year. 'l'hat lcgishtion was passed 

'\Vithout controversy, and the harms warned of by those concerned about fLR. 354-5 ha\"e not manifested. 

If I IIPAA is sufficient to protect the privacy of out veterans and service members seeking treatment for 

substance usc disorders, why would it not be for ch--ilians? 

1-IIPAA provides sufficient protection, and its violations are rigorously enforced, unlike Part 2 Yiolations, 

which have never been enforced by a single court- 1nostly because Part 2 dolations are almost ahvays a 

I IIP.r\A ,~iolation, too. It's no surprise the health care systetn, as an ecosystem, is attuned and geared 

toward !-liP ;\A compliance. ;\nd yet, think of the coordinated care and patient safety we sacrifice for Part 

2's illusion of extra protection. 

Just three short years ago, my stepfather found my mother dead on her bed at home, leading to the worst 

phone call of my life. I am the oldest of ft,·e kids; she also had seven grandkids and, like a lot of moms, 

"\vas a towering presence for our entire family. But, in an in:::tant, she was gone. Just 59 years old. 

Prescription opioids - \vhich she once described as the "monkey on her back" had finally becon1c 

something 1nuch \\'Orsc. 

l\[y mom had started taking prescribed opioids about 20 years earlier for pain, at the onset of what \:Vould 

come to be known as our national opioid crisis. Like so tnany, tny n10111 never got off the pills. Eventually, 

she was taking 400 tng of morphine a day, as prescribed. \\.re kids '\Vcre 111ostly unaware. I3ut I did learn in 

the early-90s, prior to ~ liPJ\<\ that tny mon1 \\rent to addiction treatment for '\vhat I understood to be 

alcohol problems. I didn't really know or comprehend what having a problem meant at the time, and 

honestly~ it \vas son1cthing- that sort of came and went for our fan1ily. 
38 


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Gnrdner Test~rnvny 1 Page 5 of 7 

But, all the ·while, tny n1other\ opioid journey continued unabated, I won't pretend to know all the details, 

but r can't imagine a scenario where her doctors knew 2bout her prior addiction treatment, even though it 

was a significant fact in her health history, l\'fy 1nom's pain never got better, by the \Vay- only \Vorsc, And 

longtin1e opioid usc eventually contributed to other ailn1ents, deteriorating tncntal health and additional 

medications. It "\Vas a vicious cycle of problems, more n1c<.licat.ion, and more problems to justify more 

medication. Not to mention, more doctors. And, until she opened up to 111e about this painful history 

during those final rnonths of her life, my mother's battle \\ras fought 111ostly internally, quietly and secretly. 

Tn the end, she had a con1plex combination of opioid use disorder, chronic pain, acute pain, depression, 

anxiety, arthritis and other physical conditions, an assorttncnt of social stresses, and because she relied so 

much on pills for so long- a deficit of healthy coping rncchani:;ms. I ler pain, as iris \Vith so tnany chronic 

pain p<Hicnts, was profound 1nanifesting itself, like addiction does, physically, mentally, emotionally, 

socially and spiritually. 

\\

7

hat my mon1 needed \Vas 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 

\Vork together. Instead, they kept prescribing deadly amounts and combinations of drugs to someone \Vith 

the disease of substance use disorde-r. At the very end, \vhilc her ptimary doctor -..vas on v:-~.cation, a fill-in 

prescribed her fentanyl patches to hdp with the pain that follnwcd f\'-ro knee surgeries and \vas 

complicated by the chronic pain and poor health she had dc\Tloped mTr her 20 years of opioid usc. I\!y 

mom misused the fentanyl patches along with Vicodin and anxiety medications, and it killed her just a 

couple of rooms away from her husband and 13-ycar-old grandson. 

Now, I can't tell you exactly where Part 2 and I liP 1\A fit into my mom's story. !lull can say unequivocally 

that my mom had a severe substance use disorder and did not get anything close to the coordinated care 
39 


32361.019

Gardner Testimony 1 Page f of 7 

she necUcd. Instead she got subpar care. Could she have been more forthconUng and actively coordinated 

her care herself? Yes. But as a professional in this fidd, and someone ·with lhTed experience, I can tell you 

that's an impossible expectation of someone who is in actiYc addiction- sotnconc \vhose brain is not 

functioning properly. In reality, there's no way my mon1 would have volunteered information that \vould 

have prc\Tntcd her from getting pills for her pain even rhough she knew the pills were a problem. That 

irrationality, indeed, is the very nature of addiction and Ls all the more unUcrstandable in a health care 

system that tnay haYc been prone to just take away her pills; rather than get her the critical care she needed. 

Addiction is a disease that h<~s been neglected and marginali7cd for generations. It's tin1e to bring the full 

weight of our healthc"e system to bear against 1\merica's longstanding addiction crisis, which the opioid 

epidemic has tragically revealed to the masses. Mainstream health care is finally at the table, no longer 

av'oiding this illness and the people who have it, but seeking to treat it on par with other conditions and 

physical ailments. It's time for primary health care and specialized care providers like 1-Iazclden Betty Ford 

to \vork together to address this public health crisis. Part 2 gets in the way \Vith cumbersome regulations 

and lcaYcs baked into our law the idea that addiction ·warrants extraordinary secrecy~ which perpetuates the 

\'Cry stigtna \VC continue to work so hard to stnash. 

1 have the utmost respect for the folks who have expressed concern for this bill. But please don't think 

they rcp1·cscnt the entirety of the patient community or that patients arc unifie-d against this change. I talk 

to re;ll people every day who arc in recovery or still struggling. lviy organization works on the ground day~ 

in-and-day-out, helping thousands of people a year. \X-'c'rc in the trenches on this, and I'm telling you, 

when patients arc in the help-seeking tnodc, they generally just want to know: Ca!l)'OII belp? And bou; can I 

payjorthi.r?This bill addresses the questions patients and their families care about most. 
40 


32361.020

Gar·dner Testrmony I Pa~1e 7 of 7 

1\forc and more people arc rccoycring out loud, and saying "no" to secrecy and shame. There is even now 

a certain kind of stigma against those who stigmatize people \Vith addiction. 1n other \vords, we've made 

good progress, and aligning Part 2 with HIPAA "111 continue that progress in an important way. 

This bipartisan bill is about priorities and the future of addiction treatment in the United States. If you 

believe patient safety is the most important priority, I urge you to \'Ote for I l.R. 3545. And if the future 

you envision is one with less stign1a; open, routine con'-~ersations about addiction and addiction care; and 

more people getting the best possible help on par with other health conditions, I also urge you to pass this 

important legislation. 

Because I work for the I Iazelden Bettv Ford Foundation, the largest nonprofit prodder of substance usc 

treatment, education and pre\Tention ser1lices in the world) I also have submitted, as supplemental tniltcrial, 

a letter from our CEO and Chief Medical Officer, further highlighting our organizational insights on this 

bilL 

\\'e have ?ttri,Tcd at a pivotal point in the history of addiction trcattncnt and recovery. Part 2) once \~a]uablc 

in the absence of HIP 1\:\, is now impeding progress toward the kind of coordinated care that \c1ll better 

pj·otect and ensure patient safety. 1\faintaining unnecessary harriers to care dw·ing the nation's ·worst 

addiction crisis ever would be a tnissc:d opportunity and potentially gran· mistake. 

Thanks again for the opportunity to share my vie,vs. I look forward to ans\vering your questions. 
41 

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. 

42 

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:] 

43 


32361.021

Testimony of H. Westley Clark, MD, JD, MPH 

Dean's Executive Professor ofPublic Health 

Santa Clara University 

Santa Clara, California 

Before the Health Subcommittee 

of the House Energy and Commerce Committee 

May 8, 2018 

My name is Dr. H. Westley Clark. I am a psychiatrist, addiction medicine specialist and a 

professor. I retired from Federal service after proving clinical care to our nation's veterans for 

14years and after directing the Center for Substance Abuse Treatment in the Substance Abuse 

and Mental Health Services Administration for 16 years. 

I am currently teaching undergraduates about substances of misuse to undergraduates at Santa 

Clara University, recognizing that the young men and women of this Nation are both at risk for 

substance misuse and have the potential to changing the cultural dynamic which puts their age 

cohort at greatest risk for misuse and overdose. 

I am here to advocate for maintaining the integrity of 42 USC 290dd-2 and to keeping those 

federal regulations that protect individuals with substance usc disorders who would be 

discouraged from seeking substance usc disorder treatment, because they would be subject to 

discrimination and legal consequences in the event that their information is improperly used or 

disclosed. 

There are two contemporary phenomenon that I would cite as a prelude to the substance of my 

testimony: ( 1) the Facebook/Cambridgc Analytica issue, and (2) the NIH All of Us longitudinal 

research project. 

Without venturing into the web of politics associated with the Faccbook/Cambridge Analytica 

issue, it was clear from the general discourse and dialogue about the misuse of information that 

surfaced from that chain of events, that privacy and confidentiality were important to people, that 

their sensitive information disclosed without their consent represented a violation of autonomy 

and sense of self. It was also clear that those violated were not happy about the situation. 

That the information was subsequently used for predictive analytics, according to media 

accounts, for the purpose of int1uencing those whose information had been compromised 

showed the potential for abuse. Keep in mind that this was not a case of data security, but a case 

of breach of confidentiality and apparent invasion of privacy. 

1 
44 


32361.022

I turn next to the NIH All of Us protocol. The NIH is seeking I million people to volunteer for an 

ambitious study that will last l 0 or more years. The objective of this study is to build a research 

resource composed of participant-provided information (PPI), including environmental, 

physiologic, and health data and biospecimens from l million or more research participants. 

The NIH Study will include all data available in the participants Electronic Health Records, 

including demographics, visits, diagnoses, procedures, medications, laboratory visits, vital signs, 

and physician notes. In addition, the NIH notes that the pertinent information may include data 

about mental health, substance use, or H!V status. 

However, what is interesting about the All of Us Study protocol and relevant to this hearing is 

that participants will be given the option of providing consent to release information from their 

electronic health records. In other words, patients will be asked to consent to the usc of data from 

their EI-!Rs. While this is a research protocol and falls under the aegis of research consent and 

disclosure, the fact remains that consent is a requirement and that the right to refuse consent is 

respected. The fact that the the All of Us study anticipates using additional data from Social 

Security Death Master Files. pharmacy system data, and health registry data makes consent all 

the more important, as aspects of study participants health lives will be examined. This research 

will also provide information about the willingness of participants to consent to have their 

electronic health information used. Furthermore, formal consent is required because academic 

scientists, commercial organizations, and interested citizen scientists will be able to request 

access to the participants' data; thus, the array of inquiring entities will not be given automatic 

access to this data. 

The All of Us protocol 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 social determinants, about what people eat, how much they sleep, if they are obese 

or live in a food desert, or whether they arc lonely.' Thus, the medical record becomes a 

comprehensive dossier on the individual ripe for use or misuse. The hope, of course, is that in 

coming decades adequate resources will be available to address the convergence of social 

determinants and health. In the meantime, it has yet to be determined that the necessary linkages 

and interoperabilities can be fostered to actually benefit the patient rather than simply integrating 

all that is known about an individual using the health record as the portal. 

Privacy, confidentiality, and the consent arc important.to Americans, and something that should 

be respected. If the two vignettes I've 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 protections of 42 USC 290dd-2 and 42 CFR part 2 to a 

population that that is more vulnerable than those on Face book or those who agree to participate 

in the All of Us Study. 

As you well know, we are in the midst of the worse opioid epidemic that this nation has ever 

seen. And, at the same time, less than 10% of people who need treatment seek treatment. 

Instead of recognizing that we need to reassure those in need of treatment that they can trust the 

2 
45 


32361.023

treatment community to use the information they disclose, many are calling for severely 

weakening 42 USC 290dd-2 and 42 CFR Part 2 .. 

It is argued that the opioid epidemic justifies modifying 42 CFR Part 2 to address the opioid 

overdose deaths and the misuse of opioids. 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. 

Data from the National Survey on Drug Use and Health reveals that 65 million Americans 12 

and Older admit to binge drinking in the past month. Of these, 16 million admit to being heavy 

drinkers. We should also be aware that 24 million people admit to being past month users of 

marijuana. n 

These numbers alone suggest the magnitude of the issues we are confronting today, as they 

exceed the 3.4 million people who admit to past month use of pain relievers and the 475,000 who 

admit to past month users of heroin. 

The critical question today is how do we get the 28.6 million Americans who are current illegal 

drug users and the 65 million people who are binge drinkers to discuss their substance use with 

the medical community? 

"[Wjhat should we do about the opioid crisis? First, we must be realistic about who is 

getting in trouble with opioid pain medications. Contrary to popular belief, it is rarely the 

people for whom they arc prescribed. Most lives do not come undone, let alone end in 

overdose, after analgesia for a broken leg or a trip to the dentist. There is a subset of 

patients who are vulnerable to abusing their medication-those with substance usc 

histories or with mental health problems. Ideally, they should inform physicians of their 

history, and, in turn, their doctors should elicit such information from them."'" 

Although the use of alcohol is legal for those over the age of21, the medical community should 

also communicate with their patients about alcohol use. However, as for all psychoactive 

substances, communications between clinician and patient require trust. Trust is not possible if 

the function of disclosure is the release of sensitive information into a virtual data storm sewer 

It is often argued that substance use should be treated like HIV, the flu, diabetes or bypertension 

and therefore should be treated like those conditions. Those who make this argument blind 

themselves to the reality that many substances of misuse arc illegal, and that disclosure of such 

information can give rise to harm to the individual affected. 

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 and 

discrimination, the loss of privacy and the loss of autonomy.'v Medical records can also be used 

to incriminate a person and subject that person arrest, prosecution, and incarceration. 

It is irresponsible to ignore the real harms to which a person with a history of substance use 

could be subject. It is also irresponsible to ignore the implication that modern electronic health 

information has for privacy and confidentiality. ]1. is sometimes said that computers have eidetic 

3 
46 


32361.024

memories----they don't forget. Thus, people in recovery from alcohol and drug use who have 

long since stopped using are still at risk for discrimination and stigma. 

The case is ofien made that the health care delivery systems need to know about the substance 

usc history of a patient. You don't hear why providers can't simply ask patients themselves 

about their substance use histories. You hear that it is too confusing for clinicians to know about 

42 CFR Part 2 and to apply the rules Yet, these same clinicians and health care systems spend 

quite a bit of time learning about and executing reimbursement rules, licensing rules, 

administrative rules, quality standard rules, and all the other rules that arc necessary to get paid 

for the services delivered to the very people whose agency and dignity are now deemed too 

inconvenient to respect.. 

Furthermore, there are those in the health care delivery system, including those involved with 

insurance and reimbursement who are looking for data to inform predictive analytics to 

anticipate those might be at risk for substance use disorders in order to actuarially determine 

what course of prospective action should be taken to address those with such possibilities. 

Just last week, the USA Today ran a front page article on the evolving image of marijuana, 

noting that 24 million Americans said that they used marijuana in the past 30 days, 90% for socalled recreational purposes and I 0% for medical reasons.v Clearly, clinicians should want to 

know why the estimated 2.4 million medical marijuana users choose to use that psychoactive 

substance to cope with their medical problems. Yet, even though, an estimated 30 states 

recognize some form of medical marijuana, it remains a Schedule I drug and, thus, not legal 

under the federal Controlled Substances Act. While marijuana does not carry the morbidity and 

mortality profile ofthc opioids, we should want patients to willingly disclose their use ofihis 

substance to their health care providers without fear of social or legal repercussions. 

I rarely hear or read about concem about the harm to the patient. Instead, I hear concern for the 

convenience of the delivery system, a concern that creates an adversarial relationship between 

patient and practitioner rather than respect for and trust from the patient. What appears to 

underlie the argument for administrative efficiency and systems needs is distrust of the patient, if 

not contempt for the patient. 

Now is the time to welcome people with substance use disorders into the health care delivery 

system, not with the demand that such individuals concede their agency, dignity and privacy to 

the administrative convenience of the health care delivery system, but with the old adage of 

"First, do no harm." 

Distrust and Contempt for people with substance use disorders has led to distortions and 

misinterpretation of 42 CFR Part 2. Emergency room clinicians argue that a patient with an 

opioid use disorder comes into the ED following an overdose and is unresponsive, 42 CFR part 2 

keeps them from getting lifesaving information. Not true, 42 CFR Part 2 allows those 

emergency room clinicians to access Part 2 protected information kept either by a health 

information exchange or a substance use disorder treatment program in order to treat the patient 

in the emergency status. 

4 
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32361.025

I ntcrnists may argue that it is critical not to prescribe an opioid to an opioid dependent patient 

who is on methadone. However, they don't establish that asking the patient about their 

methadone treatment is ineffective. Fmihermore, they don't establish that checking the PDMP is 

ineffective. Ifthe PDMP is ineffective, they don't argue for improving PDMPs by making them 

real time and regional. 

Family members, concerned about the welfare of their opioid dependent adult relatives, are not 

precluded from getting information when an unconscious adult is brought into the ER following 

an opioid overdose. Emergency room clinicians under this situation arc not prohibited from 

sharing information with those concerned family members. 

It is argued that 42 CFR Part 2 perpetuates the stigma of addiction. This disingenuous argument 

ignores the laws, regulations, policies and social view about addiction and substance usc 

disorders. It is not illegal to be depressed. It is not illegal to have diabetes. It is not illegal to 

have a broken leg. It is illegal to usc heroin. It is illegal to usc marijuana. People with untreated 

or active diabetes arc protected by the Americans with Disabilities Act. People with untreated or 

active substance usc are not. There are no signs posted at the employment office of employers 

declaring that the workplace is a hypertension free workplace and that all new applicants will 

have their blood pressure checked; there are no signs saying that anyone with evidence of 

hypertension shall be denied employment. 

The Department of Health and Human Services has already moved to accommodate the 

modernization of 42 CFR Part 2 through two rounds of rulemaking, including a 2017 Final Rule 

and a 2018 Final Rule. However, the EHR community and a number of health systems remain 

restless, impatient and intolerant of those with substance use disorders, suggesting that 

information sharing is more important than the people about whom that information is shared. 

Thus, the regulatory efforts to allow patient to provide a general disclosure for substance use 

disorder information, to offer some flexibility in transmitting substance use data electronically, 

and to clarify the circumstances in which providers can disclose patient information to 

contractors and subcontractors for payment and healthcare operations is not enough. The critics 

of 42 CFR seck to expose those with substance usc disorders who seek treatment, making the 

exercise of treatment a dangerous proposition. 

Patient Attitudes toward Treatment 

We spend millions of dollars collecting information about the substance usc patterns of people in 

the US. Perhaps we should be concerned about the reality that 89% of people, who meet criteria 

for needing substance usc disorder treatment, did not receive such treatment."' 

Of the 28.6 million people who misused illicit drugs and the 65 million people who were binge 

drinkers in the past month, only 3.8 million people received treatment in the past year. Of 

course, mere use does not equate with dependence or needing treatment. However, NSDUH data 

indicate that over 20 million people 12 or older met criteria for a substance use disorder in the 

past year in 2016, with 2.1 million meeting criteria for an opioid use disorder. 

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What is equally interesting is that of the people who met criteria for needing treatment and did 

not receive treatment, 95.5% perceived no need for treatment. In short I 8.7 million people 

needed but did not receive treatment; of these, 17.9 million perceived no need for treatment. 

Now comes the critics of 42 erR Part 2, under the flag of bringing integrated treatment to those 

in need, claiming that it is 42 CrR Part 2 that operates as a barrier to effective and efficient 

treatment of opioid use disorders, claiming that there is no need for special concerns about 

substance use disorders, today, never mentioning how they will explain to those actually seeking 

treatment and those in need of treatment the ramifications of attenuating 42 CFR Part 2. 

Changing 42 CFR J>art 2 and the Response of Suhstanee Users 

It is important to recognize that 42 CFR Part 2 does not apply to most clinicians or most clinical 

settings. In fact, 42 erR Part 2 only applies to programs that hold themselves out "as providing, 

and provides, alcohol or drug abuse diagnosis treatment, referral for treatment or prevention." 

Of course, 42 CFR Part 2 governs substance use disorder patient records for those patients who 

receive, diagnosis, referral or treatment from (a) an identified unit of a general medical facility 

that holds itself out as providing, and provides alcohol or drug use disorder diagnosis. treatment 

or referral for treatment or (b) medical personnel or other staff in the general medical care 

facility whose primary function is to provide those services. 

So, it is the patient records of a substance use disorder program (which includes the substance 

use patient records clinicians who hold themselves out as treating people with substance use 

disorders in even in non-specialty settings), that are controlled by 42 CFR Part 2. This creates a 

responsibility for the substance usc disorder program to explain to the patient the meaning of 

confidentiality as it applies to information disclosed to the treatment program. 

For the millions of people whose substance use docs not meet criteria for protection under 42 

CFR Part 2, HIPAA may control. However. IIIPAA only controls those health care providers, 

such a doctors, clinics, psychologists, dentists, chiropractors, nursing homes, or pharmacists that 

transmit any information in an electronic form in connection with a transaction for which DHHS 

has adopted a standard. HIPAA's covered entity standard also applies to health plans and health 

care clearinghouses. As broad as this covered entity standard is, it docs not cover the substance 

use disorder treatment landscape. 

Those seeking changes in 42 USC §290-dd may be attempting to reshape the SUD treatment 

landscape and to increase the medicalization of SUD treatment. According to data collected by 

the Substance Abuse and Mental Health Services Administration, private non-profit organizations 

operated 53 percent of all facilities in its data base and were treating 49 percent of all clients; in 

addition, private for-profit organizations operated 35 percent of all facilities and were treating 39 

percent of all clients. While the focus on opioids is indeed impm1ant, the reality is that opioids are 

not the primary substance treated by SUD treatment facilities. The medium number of clients treated 

6 
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by non-opioid treating programs in 2016 was 34. In fact, looking at Opioid treatment programs 

cet1ified by SAMHSA for the provision of medication-assisted therapy with methadone and/or 

buprenorphine, only 8 to 9 percent of all facilities between 2006 and 2016 fit this category. 

Nevertheless, it is true that the proportion of all clients receiving methadone from any of the over 

14,000 programs in the SAMHSA data base ranged from 23% to 30% in period 2006 to 2016; a large 

minority of patients in SUD treatment, but still a minority of patients. 

The dominant forms of therapy provided in SUD treatment are behavioral, not medication 

oriented. Such treatments as generic substance abuse counseling, relapse prevention, cognitive 

behavioral therapy, motivational interviewing, anger management, trauma related counseling, 

12-step facilitation, dialectical behavioral therapy, rational emotive therapy and other behavioral 

interventions are the norm. 

Fut1hermore, while 89 percent of the over 14,000 SUD facilities accepted cash or self-payment, only 

68% accepted private health insurance, 62% accepted Medicaid and only 34% accepted Medicare. 

However, with the advent of the Patient Protection and Affordable Care Act and parity laws, there is 

a push to increase reimbursement opportunities by some. Thus, eliminating the protections of 42 

CFR part 2 from current spectrum of SUD treatment facilities, larger, more technology savvy 

treatment programs would be able to exet1 greater inllucnce in the SUD treatment market, 

consolidate business practices and decrease competition. Whether better care would be enhanced is a 

matter for time to tell. Whether costs would actually rise over time with decreased completion would 

also be a matter for observation. The ethical question remains, should the privacy of the vulnerable 

be sacrificed in the service of market dynamics? 

We must keep in mind that that HIPAA regulations allow for unconsented disclosure of patient 

information for, among other things, health care operations. 

Healthcarc operations include: 

Underwriting, enrollment, premium rating, and other activities related to the creation, 

renewal, or replacement of a contract of health insurance or health benefits, and ceding, 

securing, or placing a contract for reinsurance of risk relating to claims for health care 

(including stop-loss insurance and excess of loss insurance) 

Reviewing the competence or qualifications of health care professionals, evaluating 

practitioner and provider performance, health plan performance, conducting training 

programs in which students, trainees, or practitioners in areas of health care learn under 

supervision to practice or improve their skills as health care providers, training of nonhealth care professionals, accreditation, certification, licensing, or credentialing activities; 

Business planning and development, such as conducting cost-management and planningrelated analyses related to managing and operating the entity, including formulary 

development and administration, development or improvement of methods of payment or 

coverage pol icics 

7 
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32361.028

Business management and general administrative activities of the entity, including, but 

not limited to: 

(i) Management activities relating to implementation of and compliance with the 

requirements ofthis subchapter; 

(ii) Customer service, including the provision of data analyses for policy holders, plan 

sponsors, or other customers, provided that protected health information is not disclosed 

to such policy holder, plan sponsor, or customer. 

(iii) Resolution of internal grievances; 

(iv) The sale, transfer, merger, or consolidation of all or part of the covered entity with 

another covered entity, or an entity that following such activity will become a covered 

entity and due diligence related to such activity; and 

(v) Consistent with the applicable requirements of§ 164.514, creating de-identified health 

information or a limited data set, and fundraising for the benefit of the covered entity. 

Do non-42 CFR Part 2 covered providers explain the width and depth of the health care 

operations provision under HIPAA? Would patients exempted from 42 CFR Part 2 protections 

feel that disclosing histories of substance use is wise under HIPAA, even if experimental or rare 

use of psychoactive substances is involved? Would a patient experiencing a co-occurring 

disorder of trust and substance use feel comforted knowing that her personal information could 

be disclosed to the broad spectrum of entities covered under the healthcare operations rubric, 

especially in small communities? Much of the literature favoring weakening 42 CFR Part 2 or 

aligning it much more substantively docs not discuss this perspective. Ignoring the autonomy of 

the patient seems to be the prevalent view, diminishing the identity and integrity of the patient is 

the net effect. 

We can learn a lot about the use and misuse of private information from the Face book/ Analytica 

problem . There, from 50 to 87 million people reportedly had their private data used for political 

and financial gain without their knowledge or consent. While the spiral of events started out 

apparently innocently enough, the proprietary interests in predictive analytics apparently 

overcame whatever promises and safeguards in place. Given the spectrum of exceptions that are 

inherent in HIPAA 's hospital operations category and given the interest of electronic health 

record vendors and data brokers in predictive analytics, I believe that HIPAA is an inadequate 

safeguard for those seeking substance usc disorder treatment. . 

Moving from HIPAA into those programs whose records arc controlled by 42 CFR Pati 2, it is 

clear that those with moderate to severe substance use disorders requiring treatment already do 

not believe that treatment is warranted. How are we going to encourage them to participate in 

treatment when we propose to broadcast their personal information through networks of 

uncertainty entities with uncertain purpose? 

Unfortunately, there are more serious consequences to voiding the patient's right to consent to 

the disclosure of sensitive information. The unconscntcd disclosure of sensitive information 

8 
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resulting in harm to the patient could easily give rise to suicide, relapse to substance usc or 

overdose; these arc tragic events that we should be avoiding rather than pretending that the 

agency and dignity of the patient have no value and can be compromised for the convenience of 

EHR vendors, data miners and health care operations, Furthermore, we should recognize that 

many in substance usc disorder treatment arc at risk for depression, anxiety and other psychiatric 

disorders, any of which would be made worse by a breach of trust by substance use disorder 

treatment programs and the health care delivery system. 

The loss of privacy due to unconsented disclosure itself is a harm, perhaps not of the magnitude 

of the loss of a job or of child custody, but a harm nevertheless. Patients have a legitimate 

liberty interest in their autonomy, in the right to make decisions about their lives. 

Blaming the Vulnerable 

The Health Information Technology for Economic and Clinical Health Act (HITEC!I Act) was 

enacted under Title XIJI of the American Recovery and Reinvestment Act of2009"'. It provided 

billions of dollars of incentives to an array of primary care hospitals and to physicians to adopt 

electronic health records and to promote the exchange of health information. However, that 

same act essentially ignored the behavioral health community; as a result, there were no 

incentives available for substance use disorder treatment programs to adopt electronic health 

records. In addition, there were no incentives to the electronic health record industry to develop 

software and protocols specific to the behavioral health community and the sensitive information 

generated by behavioral health providers, information of little use to most primary care 

providers. 

At the time of the unfolding of the HITECII Act, I was the Health Information Technology 

Strategic Initiative Lead for SA\1HSA. My team and I met with a number of software vendors 

in an effort to address the unique needs of the behavioral health community and to compensate 

for the omission of behavioral health from the promulgated incentives provided to general 

medicine. We met with little success. 

In order to compensate for excluding behavior health from the incentives, standards, and designs 

for the evolving EHR systems, information exchanges, and the growing recognition that 

comprehensive health care required addressing behavioral health, efforts were mounted to 

promote the fiction that behavioral health patient information contained nothing unique and 

distinct from the general health care environment. 

The notion that all health care information is equivalent runs counter to the historical status 

recognized in the psychotherapist-patient privilege which was justified on the grounds that some 

personal health information was more sensitive than others. Discussions of mental health, 

substance use, and sexual health are inhibited unless the patient has certain reassurances that 

highly sensitive personal health information would remain between themselves and their health 

care providers. Indeed, "the prevailing legal default and ethical norm in Western nations both 

9 
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32361.030

strongly favor the preservation of patient confidence in the absence of compelling grounds to act 

otherwise."v 111 

As Shenoy and Appel point out, the behavioral health record "often combines data related to the 

patient's present symptoms, with a descriptive narrative of the patient's life experience, 

including sensitive details of psychological trauma, domestic violence, incarceration, sexual 

encounters, and substance abuse. Much of this information is of great value to a therapist, but 

not always of clinical use to many other medical providers. The stigma attached to mental 

healthcare among some individuals and in certain cultural communities even leads some patients 

to avoid using their insurance for psychiatric care in order to protect their privacy."" 

While I was at SAMHSA, we recognized the continued sensitivity of behavioral health 

information, especially for substance use in particular. As a result, we developed an open source 

code base through a contract that would provide an inexpensive software application for the 

behavioral health community.' Unfortunately, due to complaints of unfair competition we 

discontinued our efforts. 

The HITECll Act with its focus on meaningful use and information exchange did not change the 

unique character of behavioral health information. As a result, we developed Consent2Share, an 

open-source data segmentation platform that could be incorporated into existing electronic health 

records to allow patients to be able to consent to the disclosure of highly sensitive patient 

information. xi 

Consent2Share was developed evolved within the Data Segmentation for Privacy (DS4P) 

initiative within ONC's Standards and lnteroperability (S&l) Framework to improve the 

interopcrability of the plethora of EHRs containing sensitive information that must be protected. 

The DS4P initiative met its two goals, which were to: Demonstrate how standards can be 

used to support current privacy policies, including 42 CFR Part 2, for sharing sensitive health 

information across organizational boundaries; and develop standards that will enable sensitive 

electronic health information to flow more freely to authorized users while improving the ability 

of health IT systems to implement current privacy protection requirements for certain 

Types of health care data, such as substance use disorder patient records. 

Unfortunately, the EI-IR vendor community felt no need to support data segmentation, dismissing 

the importance of privacy and confidentiality to patients. Furthermore, health information 

exchanges chose to ignore the importance of privacy and confidentiality to the patients by 

choosing not to embrace the utility of data segmentation and patient choice. Naturally, without 

data segmentation and consent management capacities, substance abuse treatment programs 

operating under 42 CFR Part 2 requirements have diminished capacities to share information 

with integrated treatment models that ignore patient choice. 

In short, SAMHSA was able to demonstrate that patient choice could be respected without 

compromising the agility and flexibility of required tor integrated information exchange. 

10 
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However, for matters of mere convenience and low market demand, most EHR vendors and 

health information exchanges chose to support the less expensive and ethically problematic 

position of eviscerating 42 CFR Part 2 .. 

Economic Disparities, HIPAA, and Confidentiality 

What is remarkable about the industry and provider objections to having patients weigh in on 

whether their private medical information should be disclosed is the loophole in HIPAA that 

allows rich people or middle income people to have the right to restrict certain disclosures of 

protected health information to a health plan where the individual pays out of pocket in full for 

the health care or service rcceivedXIi. Health care providers, under HIPAA, are required to 

include such a statement in the notice of privacy practices provided to the patient. Thus, if a 

patient is rich and can pay for their own treatment in full, including substance usc disorder 

treatment or if they are middle class and can mortgage their home to pay for their treatment in 

full, they can avoid disclosing the fact that they are in substance use disorder treatment to their 

health plan. What is amazing is that providers who arc committed to doing no harm are willing 

to sacrifice poor whites, poor blacks, poor Hispanics, poor Native Americans, poor Alaskan 

Natives, poor Hawaiians, and poor Asians in the service of a fiction of needing highly sensitive 

personal information without a patient's consent when they could most likely receive that 

information simply by asking the patient. In situations where a patient refuses consent to disclose 

sensitive information to entities outside of the treatment situation, that should be the patient's 

prerogative. 

Given the well documented harm that can happen to a person who is an admitted substance 

users, it should not be EHR vendors or health systems or substance use disorder treatment 

providers that should decide what sensitive information should be disclosed outside of a 

substance use treatment process. Financial ability should not be the deciding factor on whether a 

person retains a modicum of control over their personal information. 

Increased Liability for Substance Use Disorder Treatment Programs 

Substance Usc Disorder treatment programs have a duty to inform patients about the limits of 

confidentiality. Given the spectrum of entities under the rubric of healthcarc operations, it would 

be difficult for a substance use disorder treatment program to accomplish this with any degree of 

effectiveness; this would expose the covered program to liability. 

Given that the potential harms from inappropriate disclosure of sensitive information garnered 

during substance usc disorder treatment is real, the disclosure of that information may give rise 

to legal claims including lawsuits for some form of negligence. Unfortunately, since substance 

abuse treatment programs will be the entities releasing information under the proposed modified 

42 CFR Part 2, undoubtedly they will bear the brunt of the legal burden. Increased liability 

insurance, legal costs, and impaired reputations will ensue. After all. once sensitive information 

is released into the entity that releases that information has no control over its distribution. The 

11 
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32361.032

question would become should substance abuse treatment program that released the information 

have known that it contained information that could be used to the detriment of their current or 

past patient. 

Substance usc disorder treatment programs caught up in lawsuits may have to withdraw from the 

treatment marketplace. Treatment programs that close under the weight of malpractice claims 

will only diminish the number of available treatment slots. The cost of care will also increase as 

treatment programs have to compensate for thee increased administrative costs of doing 

business. 

Conclusion: 

We cannot adequately address the current opioid epidemic if we remove the protections that 42 

cfr part 2 and its authorizing legislation, 42 USC § 290dd-2, offers. We cannot treat those 

experiencing substance use disorders with contempt. by weakening the protections that they 

currently have. We cannot treat those who experience substance usc disorders as a means to an 

ends, attempting to compensate for the lack of public investment in electronic health records for 

the behavioral health treatment communities following the HITECH Act's focus on primary 

care. 

Efforts to balance the health information technology requirements of integrated systems while 

preserving a patient experiencing a substance use disorder's right to consent to the disclosure of 

their substance use treatment history and sensitive matters subsumed under that history have 

been thwarted by the EHR industry and by health information exchanges. The claim that it would 

cost too much is overshadowed by the existence of open source strategies that could accomplish 

the necessary consent management strategies and by the inherent right of a person to determine 

what happens to sensitive information. 

We have contemporary examples of data misuse and data appropriation. The most immediate 

and germane is the Faccbook/Cambridge Analytica experience. We also have an example of an 

effmi to enlist the cooperation and consent of those who participate in efforts to personalize 

medicine and to collect data on willing participants in the All of Us NIH project; by respecting 

the consent of its participants, the NIH hopes to engage I million people for a longitudinal study. 

While the All of Us project may yield strategies to support a comprehensive health record on 

individuals, it is not clear whether the public will be willing to have comprehensive dossiers of 

their lives hanging in the electronic cloud for the use of those who gain access. The I 0 year time 

line for this research should provide interested parties critical information about the acceptability 

of comprehensive health records and the utility of predictive analytics that uses information that 

goes beyond traditional health related data. However, it is premature to adopt such strategies, 

and certainly inappropriate to use vulnerable populations such as those with substance use 

disorders as the pilot target groups to vet such strategies. 

12 
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32361.033

Unlike the All of Us project, Congress is being asked to conduct a grand experiment, with those 

who present for substance usc disorder treatment functioning as unwitting test subjects and with 

no suitable IRB or patient advocate, In this experiment, the presumption is that despite laws, 

regulations, customs and attitudes to the contrary, no harm will come to those currently protected 

by 42 USC 290dd-2 with its removal., The burden of this presumption falls not on those with 

assets and not on those with resources to negotiate, arbitrate or litigate, but on the vulnerable. 

Congress is being asked to alter the substance use disorder treatment landscape to favor 

economic models of care that favor corporate entities over local entities, that benefit regional 

providers over local providers and that decrease competition rather than increasing competition. 

Again, by sacrificing the informational and decisional privacy of those with SUDs, aggressive 

market practices would be encouraged without having protected the very objects of those 

practices. 

Thus, despite the chorus ofEHR and data vendors, health systems administrators, SUD treatment 

providers and others who convince themselves that it is appropriate to impose unnecessary risks 

of harm on those with substance usc disorders seeking treatment, Congress should not abandon 

the commitment to encourage those in need of treatment to seck treatment by stripping away the 

limited protections offered under 42 USC g 290dd-2. 

i Bernie Monegain, "Epic CEO Judy Faulkner is standing behind switch from EHRs to 'CHRs"', 

HealthiTNews, October 6, 2017, http://www.healthcareitnews.com/news/cpic-cco-judy-faulknerstanding-bchind-switch-ehrs-chrs, accessed May 5, 2018 

"Source: SAMHSA, Center for Behavioral Health Statistics and Quality. National Survey on 

Drug Usc and Health, 2016. 

Sate!, Sally, "The Myth of the Roots of the Opioid Crisis", Politico Magazine, February 21, 

20 18,ttps://www.politico.com/magazine/story/20 18/02/21 /the-myth-of-thc-roots-of-the-opioidcrisis-217034, accessed 02/24/2018 

lv Lopez, Karla & Reid, Deborah, "Discrimination Against Patients with Substance Usc Disorder 

Remains Prevalent and Harmful: The Case for 42 CFR Part 2, ·• Health Affairs Blog, April 113, 

2017, DOl: 10.1377/hblog20170413.059618, accessed 02/25/2018 

v Hughes, Trevor, "The Evolving image of pot" USA Today, 05/03/2018, 36(162), Pages 1A and 

2A 

'

1 Source: SAMHSA, Center for Bchavioralllcalth Statistics and Quality, National Survey on 

Drug Usc and Health, 2015 and 2016. 

v" The American Recovery and Reinvestment Act of2009, Public Law 111-5). 

,;, Shenoy, A and Appel, JM. "Safeguarding Confidentiality in Electronic Health Record", 

Cambridge Quarterly of Healthcare Ethics (20 17), 26, 337-341. 

IX Ibid 

13 
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' http://www. f eisystems.com/whot -we-do/learn-about -wits/why -choose-wits-2/ 

'' Department of Health and Human Services: 42 CFR Part 2: Confidentiality of substance use 

disorder patient records; proposed rule. Federal Register 81:6988-7024,2016. 

x" Department of Health and Human Services;, 45 CFR Parts 160 and 164: Modifications to the 

H!PAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health 

Information Technology for Economic and Clinical Health Act and the Genetic Information 

Nondiscrimination Act; Other Modifications to the HJPAA Rules. Federal Register 78 (17: 5566-

5702 

14 
57 

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 

58 

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:] 

59 


32361.035

Testimony of Gerald (Jud) E. DeLoss 

Greensfelder Hemker & Gale P.C. 

Chicago, IL 

Before the House Energy & Commerce Committee 

Health Subcommittee 

Improving the Coordination and Quality ~~{'Substance Use Disorder Treatment 

May 8, 2018 

My name is Gerald (Jud) E. DeLoss and I am a partner with the law firm of Grccnsfelder, 

Hemker & Gale, P.C. in Chicago, Illinois. I am a health law attorney that focuses on health 

information privacy and confidentiality and behavioral health law. I have extensive experience 

with HIPAA and 42 C.F .R. Part 2 (Part 2). I have previously served as the Chair of the Health 

Information & Technology Practice Group of the American Health Lawyers Association 

(AHLA) and Chair of the Behavioral Health Task Force of the AllLA. I represent several 

substance use disorder (SUD) treatment programs covered by Part 2 and other behavioral health 

provider clients including Lake County, NICASA, North Central Behavioral Health Systems, 

Stepping Stones Treatment Center, and TASC. I am here today on behalf of Netsmart 

Technologies, a technology partner to behavioral health, substance use treatment, and post-acute 

providers nationwide. 

I am here today to explain the existing protections under the Health Insurance Portability and 

Accountability Act of 1996 and the Privacy and Security Regulations promulgated thereunder 

(jointly "HIPAA") and Part 2 and the protections that would remain in place following 
60 


32361.036

enactment of HR 3545 and HR 3545 as amended. I believe there have been misstatements of the 

law and the protections they provide. My testimony is intended to provide a correct summary of 

the law and clear up any misunderstandings of the substantial protections in place for the privacy 

of SUD patient records. 

Limited Impact of HR 3545 on Part 2 

At the outset it is important to note that the Bill only modifies uses and disclosures of Part 2 

SUD patient information for purposes of "treatment", '·payment", and "health care operations", 

each as defined under HIPAA. The Bill does not reduce or remove Part 2 protections against 

disclosures to employers, landlords. life insurance companies, or in response to subpoenas or 

discovery requests. Those disclosures arc not "TPO" (Treatment, payment, and health care 

Qperations) as defined by HIPAA. Those disclosures would still be governed by, and protected 

by, Part 2. 

Furthermore, the amended Bill only allows for disclosure "[t]o a covered entity by a covered 

entity, or to a covered entity by a [Part 2] program" for purposes of TPO. Under HR 3545, as 

amended, the only disclosures authorized for TPO would be to covered entities. which under 

HIPAA only include certain health care providers, health plans, and health care clearinghouses. 

Disclosures to third parties that are not considered HIPAA covered entities would not be 

allowed. Employers, landlords, life insurance companies, marketers, and the courts are not 

covered entities. Disclosure to those entities or individuals would not be allowed under the 

amended Bill. 

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32361.037

The definition of "treatment"' under HIPAA would allow for the disclosure of health information 

to a covered entity or a health care provider. Under HR 3545 as amended, health information 

cannot be disclosed to a health care provider. The disclosure of health information is only 

permitted to a covered entity. The definition of "payment" under HIPAA would allow for 

disclosures to third parties for reimbursement and payment-related purposes. Under HR 3545 as 

amended, health information cannot be disclosed to third parties unless they arc HlPAA covered 

entities. The definition of "health care operations" encompasses many functions and allows for 

sharing of health information to a variety of third parties. Under HR 3545 as amended. health 

information cannot be disclosed to third parties only covered entities. Because health 

information may only be disclosed to covered entities under f-IR 3545 as amended, there is no 

ability for the information to be shared or re-disclosed by a Part 2 program or covered entity to 

any other recipient unless the recipient is a covered entity. Covered entities would be bound by 

HR 3545 as amended, by HlPAA, and could not disclose or re-disclosc the health infonnation to 

any other third party, except for other covered entities. 

HR 3545 as amended would also not expressly allow for disclosures to or by HIPAA business 

associates, which arc third parties that carry out distinct operations and tasks for covered entities. 

Disclosures are only permitted to a covered entity. Part 2 allows for disclosures necessary for 

operations or similar purposes to contractors or agents of the Part 2 program, which arc defined 

as qualified service organizationsi Any such disclosures to the qualified service organizations 

would need to be carried out utilizing a qualified service organization agreement (QSOA) 

pursuant to Part 2. 

I 42 CPR § 2.1 I. 

3 
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32361.038

The proponents of maintaining the old Part 2 configuration argue that the Bill will open the 

floodgates and "eviscerate" the protections available under the law. However, they fail to 

mention two critical items. First, the Bill only allows for uses and disclosures for treatment, 

payment, and health care operations purposes as defined under H!PAA. These types of uses and 

disclosures are typical in the health care world. For example, when a patient is being admitted to 

treatment, a Part 2 program will require consent to share information with the patient's insurance 

company to coordinate benefits and ensure reimbursement. Part 2 provides that a program need 

not admit a patient until assurances of reimbursement are in place. These types of disclosures 

are limited, purposeful, and necessary for our health care system to operate. Second, those 

disclosures relating to life and disability insurance, family law and custody disputes remain 

unchanged and under the Bill will still require patient consent or a court order. 

Legal Protections Provided by lllPAA 

In addition to the limitations on disclosures set forth in HR 3545, HIPAA provides stringent 

protections against the usc of health information by employers, for child custody detem1inations, 

and by law enforcement. Like Part 2, HIPAA generally prohibits the disclosure of health 

information to third parties without patient authorization or court order. The arguments advanced 

by those who support continuing the existing regulations do not take into consideration the 

stringent legal protections already available under HIPAA and the robust enforcement of HIPAA 

that dwarfs the little to no enforcement that has been undertaken with respect to Part 2. 

4 
63 


32361.039

Minimum Necessary Protections under Hll'AA 

Under HIPAA, disclosures of health information for payment and operations purposes must 

utilize the minimum amount of health information that is required in order for the parties to 

process and pay for claims or engage in the opcration. 2 Further, providers are required by 

HIPAA to develop and implement policies and procedures that appropriately limit the use and 

disclosure of health information to the minimum necessary to accomplish the intended purpose, 

such as obtaining payment from a health insurer for services rendered.3 These minimum 

necessary requirements arc in place to limit the amount and type of information shared for nontreatment contexts, reducing the likelihood and impact of any breach or loss of data. 

Employment Protections under HIPAA and ADA 

As explained above, the disclosure of health information to an employer would not be considered 

part of TPO. Any disclosure to an employer under H!PAA would be governed by specific 

regulations that generally prohibit the disclosure of health information to an employer without an 

authorization or court order. Under HIPAA, the health care provider must provide the health care 

service to the individual at the request of his or her employer or as a member of the employer's 

workforce. The health care service provided must be for medical surveillance of the workplace 

or an evaluation to determine whether the individual has a work-related injury. Further, the 

employer must have a duty under the Occupational Safety and Health Administration (OSHA), 

the Mine Safety and Health Administration (MSHA), or the requirements of a similar State law, 

to keep records on such information.4 Even in that limited situation, the employer must request 

2 45 erR§§ 164.506(c) and 164.502(b). 

'45 erR§ l64.514(d)(3). 4 45 CFR § 164.512(b)(l). 

5 
64 


32361.040

the evaluation, and the hcalthcare provider must provide advance written notice to the paticnt.5 In 

addition, employers who sponsor group health plans are prohibited from using or disclosing 

health information for employment-related decisions or any other benefit decision 6 

Generally, under the Americans with Disabilities Act (''ADA"), an employee whose poor 

performance or conduct is attributable to an SUD may be entitled to a reasonable 

accommodation and the employer cannot discriminate against the employee based upon the 

SUD, which is considered a disability. The ADA will not allow for an employee to engage in the 

use of substances while at work, if the employer prohibited such illegal use. As a result, an 

employer does not violate the ADA by uniformly enforcing its rules prohibiting employees from 

illegally using drugs on the job or in the workplace 7 However, "'qualified individuals'' under the 

ADA include those individuals: 

Who have been successfully rehabilitated and who are no longer currently engaged in the 

illegal usc of drugs 8 

Who arc currently participating in a rehabilitation program and arc no longer currently 

engaging in the illegal use of drugs 9 

Who arc regarded, erroneously, as currently illegally using drugs 10 

An individual su!Tcring from an SUD may be protected under the ADA because the addiction 

may be considered a substantially limiting impairment. 11 

5 !d. 

6 45 CFR § 164.504(f)(2)(ii)(C). In addition, the group health plan documents must restrict uses or disclosures to 

those specifically permitted under 45 CFR § !64.504(1). See 45 CFR § 164.504(1)(1). 7 EEOC Technical Assistance \1anual on the ADA§ 8.3. 8 42 U.S.C. § l2ll4(b) (1994). 0 42 U .S.C. § 12114(b) ( 1994). A "rehabilitation program" may include inpatient, outpatient, or employee assistance 

programs, or recognized self-help programs such as Narcotics Anonymous. EEOC Technical Assistance Manual on 

the ADA§ 8.5. 10 42 u.s.c. § 12114(b). 

6 
65 


32361.041

HIPAA and ADA Protections for Housing 

Part 2 does not allow for the disclosure of SUD treatment inf(mnation to a landlord or housing 

agency without patient consent or a court order. HR 3545 would not alter those protections. 

HIP A/\ generally does not allow for the disclosure of health information to a landlord or housing 

agency without patient authorization or a court order. However, HIPAA would allow for the 

disclosure of limited types of health information to a landlord or housing agency only if it were a 

necessary part of the patient's treatment- such as supportive housing. 

Generally, under the ADA, a landlord or agency would not be able to discriminate against an 

individual with a disability and would be required to provide reasonable accommodations for 

him or her in housing. If an individual is su!Tering from an SUD, the ADA protections would 

generally apply and prohibit such discrimination as explained in the section on Employment 

Protections under HIP AA, set forth above. 

HIPAA Protections in Legal Proceedings 

Disclosures of patient information where the covered entity is not a party arc not considered part 

of treatment. payment. and health care operations and would not be permitted under HR 3545. 

The Bill as amended also dramatically increases the protections for SUD information in any 

criminal prosecution or civil action. Under the HR 3545, a court order or patient consent would 

be required before: 

Entering the information into evidence in a civil or criminal proceeding 

forming the part of the record or taken into account in a proceeding before a Federal 

agency 

11 See EEOC Technical Assistance Manual on the ADA§ 8.5. 

7 
66 


32361.042

• Being used to conduct an investigation of a plaintiff 

Being used in any application for a warrant 

HIP/1.A also imposes specific requirements for the use or disclosure of health information in 

legal proceedings, including child custody and family court cases. Where a covered entity is a 

patty to a legal proceeding, such as a plaintiff or defendant, the covered entity may usc or 

disclose health information for purposes of the litigation as pm1 of its health care operations. 12 

Where the covered entity is not a party- such as when the patient is involved in legal action with 

a different party, health information may only be produced in court pursuant to an order by the 

court or patient authorization. Under HIPAA, health information can only be produced during 

discovery pursuant to a court order, patient authorization or in accordance with other privacy 

protections. All subpoenas for records must be accompanied by notice to the patient with 

opportunity to object, or proof that the litigant sought a Qualified Protective Order. 13 

HIPAA Protections Relating to Law Enforcement 

Disclosures to law enforcement are not considered part ofTPO, and HR 3545 would not alter the 

current Part 2 protections and prohibitions in place against those disclosures. In addition, the vast 

majority of disclosures to law enforcement under HIPAA require patient authorization, a crime, 

emergency, threat to public health/safety, or court involvement. Similar to Part 2, generally 

under HIPAA a disclosure to law enforcement requires patient authorization (in limited 

circumstances) or a cow1 order. HIPAA only permits the following limited disclosures to law 

enforcement: 

12 45 CFR § 164.50!. 13 45 CFR § 164.512(e). 

8 
67 


32361.043

By an employee of a provider about the identity of a suspect who had engaged in a 

criminal act against the employee. Only limited demographic and related information 

may be disclosed for this purpose. 14 

To report abuse. neglect or domestic violence 1

S, similar to Part 2's allowance for 

reporting of child abuse. 16 

Where required by law, in limited situations such as reporting gunshot wounds or other 

injuries. 17 

• Under a grand jury subpoena, 18 or for an administrative request, civil or investigative 

demand or similar process, provided the information sought is relevant and material; 

specific and limited in scope, and de-identified information could not reasonably be 

utilizcd 19 

Certain identifying information to identify or locate a suspect, fugitive, material witness 

or missing person.20 

If the patient is a victim, then after consent or in the event of an emergency, to law 

enforcement to assist the victim (but never to be used against the paticnt) 21 

When the patient has died and the death may have been the result of criminal activity. 22 

In the event of a crime on the premises (virtually identical to Part 2's exception for a 

crime on program prcmises) 23 

14 45 CFR § 164.5020)(2). 15 45 CFR §§ 164.512(b)(l) and 164.512(c). 16 42 CFR § 2.12(c)(6). 17 45 CFR § 164.512(1)(1). 18 45 CFR § 164.512(1)(1). 1

"45 CFR§ 164.512(1)(1). 20 45 CFR § 164.512(1)(2). 21 45 CFR § 164.512(1)(3). 22 45 CFR § 164.512(1)(4). 

"45 CFR § 164.512(1)(5). 

9 
68 


32361.044

In an emergency not on the premises, where the emergency medical provider needs to 

disclose the information to alert law enforcement of a crime.24 

• To avert a serious threat to health or safety of the patient or others ("Duty to Warn" 

exception) 25 

In limited circumstances where necessary to apprehend an individual participating in a 

violent crime or who has escaped from prison26 

• To provide healthcare to inmates and those in custody27 

Part 2 Limits the Sharing of SUD Treatment Information - Even Within the Same 

Organization 

A major flaw in the current Part 2 regulations is the prohibition on re-disclosing SUD treatment 

information without another consent, court order, or exception under the regulations. Under the 

newly-created general designation process promulgated under the Final Part 2 regulations, a 

patient may consent to share his or her information with an intermediary, such as a health 

information exchange (HIE), accountable care organization (ACO), or other integrated care 

setting which may then share the information with all members of the integrated care model that 

possess a treating provider relationship with the patient.28 However, a recipient of SUD 

treatment information within an HIE or ACO with a treating provider relationship would not be 

able to re-disclosc that information to another participant in the same HIE or ACO without 

additional patient consent, rendering the new process unusable in practice. 

45 CFR § 164.512(1)(6). 

45 CrR § 164.512UJ. 

45 CFR §§ 164.5120)(1), (2). 27 45 CFR § 164.512(k)(5). See generally, 

http://www.hhgov/ocr/privacy/him=m/faq/disclosut:~s for law enfQrs;.ement purposes/505~html. 

28 42 CFR § 2.3l(a)(4)(iii)(l3). 

10 
69 


32361.045

First, the Substance Abuse and Mental Health Services Administration (SAMHSA) has issued 

guidance that establishes that "treating providers" in an HIE, ACO, or other integrated care 

setting cannot directly share SUD treatment information directly with other treating providers 

inside or outside the integrated setting?9 

Under prior versions of Part 2 (pre-20 17), an organization with mental health and SUD treatment 

facilities and clinicians could address the legal restrictions on sharing SUD information by using 

a qualified service organization agreement (QSOA) between the Part 2 program and the mental 

health department to share Part 2 information without client consent. The sharing of information 

would be allowed because it was considered to be for medical services provided by the mental 

health department to the Part 2 program, consistent with the terms of Part 2 and the QSOA 

provisions. 

The Final Part 2 Rule changes the section addressing QSOAs to no longer allow for disclosures 

for medical purposes. This revision removes the ability of an organization to utilize a QSOA to 

efficiently share Part 2 information between a SUD department and other departments which are 

not covered by Part 2 but are part of the same organization. Under the existing Part 2 regulations, 

a program would need to obtain individual patient consent for it to share patient information 

within the same organization that is treating the patient for other conditions - both mental and 

physical. 

29 82 Fed. Reg. 6052. 6081 (January 18, 20 17). 

11 
70 


32361.046

Patient and Program Choice 

The adoption of the HIPAA standards for TPO would not mandate that Part 2 programs disclose 

SUD treatment information to third parties. In fact, under HJPAA, a covered entity may impose 

additional and more stringent protections of health information, above and beyond what IllPAA 

requires. It is widely-known that HIPAA only mandates disclosures in two situations: ( 1) to the 

patient or individual who is the subject of the information and has requested access; and (2) to 

the Office for Civil Rights, Department of Health and Human Services (OCR) in response to an 

investigation or enforcement action (Note that in this latter situation, HR 3545 as amended 

would prohibit a disclosure to OCR as it would not be a disclosure to a covered entity). A Part 2 

program would not have to disclose patient information without consent if it chose to continue to 

require it. As is the case today, Part 2 programs would still have the ability under law to control 

who receives that information and how with strict penalties still in place for non-compliance. 

Opponents of the Bill argue that if HR 3545 is adopted, Pa1i 2 programs would freely share 

patient data without limitation and without due consideration for confidentiality. This view 

assumes that Part 2 programs will engage in dishonest and unethical acts with patient 

information and that to date, they have only acted with honesty and integrity because Part 2 

prevented them from deviating. Having dealt with Part 2 programs and clinicians, I know that 

nothing could be further from the truth and that Part 2 providers are honest, trustworthy, and act 

with integrity. 

HIPAA provides substantial protections for health information. The adoption of HIPAA 

standards relating only to disclosures to covered entities for TPO will allow for patient choice. 

Whether and to what extent a patient desires to share any health information, pmiieularly SUD 

12 
71 


32361.047

treatment information, is a decision that should lie with the patient and not with the Part 2 

program, the Substance Abuse and Mental Health Services Administration (SAMHSA) or the 

hcalthcarc system. 

Today, a patient cannot share their SUD treatment information freely in an HIE or ACO because 

consent and re-disclosure requirements imposed under Part 2 are too restrictive. Part 2 now 

contains a consent process that allows an intermediary, such as an HIE or ACO, to share 

information with those participants that have a treating provider relationship with the patient30 

However, that consent process under Part 2 does not allow participants with a treating provider 

relationship to share the SUD treatment information with each other directly, and does not allow 

participants with a treating provider relationship to share SUD treatment information with 

another hcalthcare provider, such as the patient's primary care physician, if that physician is not 

a participant in the HIE or ACO. This artificial barrier prevents fully-integrated healthcare for 

patients wishing to include their SUD treatment infonnalion. 

Any person, whether suffering from mental illness, diabetes, a SUD or multiple co-occurring 

conditions, should be able to share his or her health information with their healthcare providers, 

regardless of diagnosis, if they so desire. If someone does not wish to share their data, they 

should have a clear option to either opt-out or not opt-in to sharing that information. 

Under HfPAA, a patient can request a restriction on usc or disclosure of health information for 

TPO. The covered entity would determine whether it can and will accept the restriction and once 

30 42 CFR § 2.31 (a)(4)(iii)(B)(3). 

13 
72 


32361.048

it agrees, the information must be maintained in accordance with that restriction. 31 The covered 

entity does not need to accept the restriction unless the patient pays for an item or service out of 

pocket and requests that the provider not share information about that treatment or service with 

his or her health insurer, in which case the provider must not disclose it to the insurcr32 

The ability to share the information for treatment, payment and healthcare operations under HR 

3545 does not mean that Part 2 programs will be sharing SUD information without due concern 

for patient confidentiality. The Bill will allow for Part 2 programs and their patients to decide 

whether to share SUD treatment information. 

Currently under Pmi 2. all programs, including those in integrated care settings HIEs, ACOs 

and Integrated Health Homes- arc required to segment out SUD treatment information from the 

health record to prevent its disclosure to other treating providers not in the same integrated care 

setting. Data segmentation is complex and expensive to implement. While some EHR providers, 

including Nets mart, can segment data, most EHR and HIE providers would need to modify their 

systems to do so. The cost of modifying all these systems would be significant- well beyond the 

amount estimated by SAMHSA. Even if mandated from the Federal level, we estimate that a 

robust system capable of supporting this type of segmented data would not be available for 7-10 

more years. In the meantime, most providers and HIEs do not have the resources to modify their 

systems to support it. 

" 45 CFR § 164.522. 

45 CFR § l64.522(a)(1). 

14 
73 


32361.049

Breach Protections 

The 13ill as amended would apply the breach notification requirements of HIPAA to all Part 2 

programs. The breach notification provisions will provide additional compliance and 

enforcement opportunities to ensure patient information is protected. 

Under HIPAA, a covered entity must notify OCR if it discovers a breach of unsecured protected 

health information. 33 If a breach of unsecured protected health information affects 500 or more 

individuals, a covered entity must notify OCR of the breach without unreasonable delay and in 

no case later than 60 calendar days from the discovery of the breach. 34 If a breach of unsecured 

protected hea!Lh information affects fewer than 500 individuals, a covered entity must notify 

OCR of the breach within 60 days of the end of the calendar year in which the breach was 

discovered. 35 

Covered entities must notify individuals following the discovery of a breach. The individual 

notifications must be provided promptly and no later than 60 days following the discovery of a 

breach. The notice must include a brief description of the breach, a description of the types of 

information that were involved in the breach, the steps affected individuals should take to protect 

themselves from potential harm, a brief description of what the covered entity is doing to 

investigate the breach, mitigate the harm, and prevent further breaches, as well as contact 

information for the covered entity. 36 

l.l 45 C.F.R. § I 64.408. 34 Id. 

JS Jd. 36 ld. 

15 
74 


32361.050

These protections will be incorporated into Part 2 under the Bill as amended. The notification 

requirements of HIPAA already provide more protections and assurance of compliance than 

existing Part 2 requirements. 

HIPAA Enforcement 

Since the compliance date of the Privacy Rule in April 2003, the Department of Health and 

Human Services Office for Civil Rights (OCR) has received over 173,426 HIPAA complaints 

and has initiated over 871 compliance rcvicws. 37 OCR has resolved ninety-seven percent of these 

cases (168,780) 38 

OCR has investigated and resolved over 25,695 cases by requiring changes in privacy practices 

and corrective actions by, or providing technical assistance to, HIPAA covered entities and their 

business associates. Corrective actions obtained by OCR from these entities have resulted in 

change that is systemic and that affects all the individuals they serve. OCR has successfully 

enforced the HIPAA Rules by applying corrective measures in all cases where an investigation 

indicates noncompliance by the covered entity or their business associate. To date, OCR has 

settled or imposed a civil money penalty in 53 cases resulting in a total dollar amount of 

$75,229,182.00. 39 

OCR has aggressively audited, investigated, penalized, and enforced the privacy and security 

requirements under HIP A/\. 

_~ 7 https :// www .hhs .gov /h ipaa/for-professionals/ comp 1 ia nee-enforcement/data/enforcement-high I ights/i nd ex. htm I, 

last accessed 5/3/18. 

38 ld. 

3" I d. 

16 
75 


32361.051

As of this writing, the author is unaware of a single substantive enforcement action taken under 

Part 2. Although the Final Part 2 Rule will increase enforcement opportunities, historically it 

has been HIP AA that has been enforced more stringently and more effectively than Part 2. 

Conclusion 

I !R 3545 as amended will allow for the legitimate sharing of health information for specific 

treatment, payment, and health care operations purposes. The sharing of the information will 

only be with covered entities those individuals and organizations that are bound by HIPAA and 

must have policies and procedures in place, training for their workforce, and agreements that 

protect the use or disclosure of all health information. Those entities could only re-disclose SUD 

information to another covered entity. The substantial protections and new rights and 

antidiscrimination provisions in l-IR 3545 as amended address the concerns raised by opponents 

and futiher the goal of effective, timely, and quality integrated care. 

17 
76 

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? 

77 

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. 

78 

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 

79 

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. 

80 

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 

81 

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 physiVerDate Nov 24 2008 08:45 Feb 06, 2019 Jkt 037690 PO 00000 Frm 00087 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-126 CHRIS
82 

cian 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. 

83 

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. 

84 

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. 

85 

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. 

86 

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. 

87 

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 neg- ligible 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. 

88 

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. 

89 

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 

90 

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, heartwrenching 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? 

91 

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 gradVerDate Nov 24 2008 08:45 Feb 06, 2019 Jkt 037690 PO 00000 Frm 00097 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-126 CHRIS
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uates, 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. 

93 

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? 

94 

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. 

95 

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? 

96 

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 

97 

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? 

98 

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 paVerDate Nov 24 2008 08:45 Feb 06, 2019 Jkt 037690 PO 00000 Frm 00104 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-126 CHRIS
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tient 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—— 

100 

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. 

101 

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 medicationassisted 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, 

102 

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. 

103 

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. 

104 

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. 

105 

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 

106 

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 inVerDate Nov 24 2008 08:45 Feb 06, 2019 Jkt 037690 PO 00000 Frm 00112 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-126 CHRIS
107 

dividual, 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? 

108 

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 

109 

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 

110 

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? 

111 

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 

112 

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:] 

113 


32361.052

Aprilll, 2018 

The Honorable Greg Walden 

Oregon@ Association 

of Hospitals and Health Systems 

Chair, Energy and Commerce Committee 

U.S. House of Representatives 

Washington, DC 20515 

Dear Representative Walden, 

On behalf of the 62 members of the Oregon Association of Hospitals and Health Systems, I am writing to 

applaud your efforts to move the bipartisan package of bills aimed at addressing the opioid epidemic. 

The Energy and Commerce package includes a number of measures that take important steps toward 

addressing the opioid epidemic in Oregon and other states. 

We are especially supportive of one aspect of the committee's work: modernizing outdated substance 

use disorder privacy policies. Specifically, OAHHS strongly supports aligning the privacy regulations in 42 

CFR Part 2 with the Health Insurance Portability and Accountability Act (HIPAA) for the purposes of 

treatment, payment and health care operations. 

Coordinating care for patients in treatment for substance use disorder is fundamental to successful 

treatment. However, the requirements of 42 CFR Part 2 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. 

We urge the Committee to adopt legislation that would fully align the 42 CFR Part 2 regulations with the 

HIPAA rules. Applying the same requirements for all patient information- whether behavioral or 

medical- would facilitate appropriate information sharing needed for clinical care coordination and 

population health improvement, while safeguarding patient information from unwarranted disclosure. 

As always, please don't hesitate to contact us if you would like additional information on this issue. 

Thank you for your consideration. 

Respectfully, 

1 ,~A 1/h.L!/~ 

Andy Van Pelt 

Executive Vice President 

Oregon Association of Hospitals & Health Systems 

4000 Kruse Way Place, Bldg. 2, Suite 100 

lake Oswego, Oregon 97035 

503-636·2204 
114 


32361.246

MS HEALTH HOME 

Information Resource Center 

BRIEF- JANUARY 2015 

Designing Medicaid Health Homes for Individuals with 

Opioid Dependency: Considerations for States 

By Kathy Moses and Julie Klebonis; Center tor Health Care Strategies 

Over the last decade, increasing rates of opioid 

dependency have become a concern for public health 

officials, state Medicaid agencies, and the federal 

government. Increased health care service usc and 

higher costs of care have resulted from the significant 

morbidity and mortality associated with illegal opioid 

usc. In 20 t 0, roughly 600,000 people in the United 

States used heroin 1 and 12 million used prescription 

painkillers, including oxycodone and morphine, for 

nonmedical reasons 2 In 2009, nearly half a million 

emergency department visits were due to people 

misusing or abusing prescription painkillers. In that 

same year, health insurers spent S24 billion on 

treatment for substance use disorders, of which 

Medicaid accounted for 21 percent of all spending. 3 

Individuals who are opioid dependent often have 

complex social, physical, or behavioral health 

comorbiditics. For example, six out of l 0 people with 

a substance usc disorder also suffer from another form 

of mental illncss4 and could benefit from increased 

care management. 

According to a recent informational bulletin from the 

Center for Medicaid and CHIP Services, states can 

incorporate Medication Assisted Therapy (MAT), an 

evidence-based practice to address opioid usc~ into 

efforts to address substance usc disorders. 5 Clinical 

guidelines recommend that MAT be offered in 

combination with behavioral health therapies. 6 

Moreover, to ensure that treatment is coordinated with 

other needed physical and behavioral health services, 

many state Medicaid agencies arc seeking new 

mechanisms to promote integrated care for 

individuals with opioid dependency. 

The Medicaid health home state plan option offers 

states one such mechanism. As of December 2014, 

three states----Maryland, Rhode Island, and 

Vermont--have approved state plan amendments 

(SPAs) to implement Medicaid health home models 

targeting opioid dependence 7 This brief, made 

• Julie Klebonis is a former employee of the Center for Health Care Strategies. 

possible by the Centers for Medicare & Medicaid 

Services (CMS), shares insights from these three 

states and outlines key considerations for states in 

designing an opioid dependence-focused health home. 

Comparison of Approved Opioid Health 

Home Models 

Common features across the opioid treatment health 

home models in Maryland, Rl10de Island, and 

V crmont include: (I) statewide implementation; (2) 

Opioid Treatment Programs (OTPs)8 as a designated 

provider; and (3) definitions of eligible populations 

(Exhibit 1 ). While some program aspects are similar, 

CMS provides the flexibility for states to tailor 

programs~within defined requirements and subject 

to federal approval-to meet the needs of 

beneficiaries and local providers. Variations across 

the three state opioid health home models include: 

This brief was developed for the Centers for Medicare & Medicaid Services by the Center for Health Care Strategies and 

Mathematica Policy Research. For more information or technical assistance in developing health homes, visit 

http://www.medicaid.gov. 
115 


32361.247

Health home provider structure. Each 

state has defined providers differently. 

Vem1ont's health home model, for example, 

refers to its designated providers as '~Hubs 

and Spokes." Hubs are designated providers 

(OTP programs) that serve clinically 

complex members and dispense methadone 

and buprenorphinc in an addictions treatment 

center. Spokes refer to a team of health care 

professionals (Office Based Opioid 

Treatment [OBOT]) that is comprised of 

physicians licensed to prescribe 

buprcnorphinc; nurses; and clinician case 

managers. (For more information, sec 

sidebar Spotlight on Vermont's Health Home 

Model page 5.) 

Type of enrollment, States must determine 

if eligible Medicaid beneficiaries will be 

assigned into the health home with the ability 

to opt~out, or if beneficiaries must opt~in. 

Most health home models, including Rhode 

Island and Vermont, auto-assign 

beneficiaries, but allow them to opt-out at 

any time or select among other qualified 

health homes. Maryland uses the opt-in 

approach and built beneficiary consent into 

the opt-in process, ensuring the opportunity 

to secure the necessary member consent to 

share critical health care information. 

Team of health home providers. Each 

state defines the health home team 

differently in terms of: (1) required staff 

positions; (2) education or training 

requirements; and (3) the ratio of members to 

full-time equivalent staff. Rhode Island 

created a shared statewide administrativelevel coordinator role to oversee health home 

Medication Assisted Therapy 

implementation at all agencies and act as the 

liaison to the state agencies supporting health 

homes. The coordinator strategizcs with 

teams to encourage member participation, 

identifies potential community partners, 

addresses implementation challenges, and 

assists in outcomes evaluation. In Rhode 

Island, this position is viewed as a trusted 

advisor to the site-specific health home 

teams, as well as an excellent resource to the 

state for ensuring fidelity to the health home 

model. A key component to this staffing 

approach is that the state is responsible for 

hiring the shared administrative coordinator, 

but funding for the position is shared across 

all health home sites. 

Approach to payment. Whereas all three 

states include some form of bundled 

payment for health home services, there are 

three slight variations in payment models: 

(I) Maryland's per member per month 

(PMPM) payment is coupled with a one-time 

payment for initial intake assessment; (2) 

Rhode Island uses a weekly bundled 

payment with the rate based on whether the 

member is enrolled in fee~ for-service or 

managed care; and (3) Vermont has a 

monthly bundled rate for Hub providers and 

a monthly capacity payment for Spoke 

nurses and clinician case managers. The 

average monthly payment across these three 

models ranges from approximately $l 00 to 

$350 depending on the team's cost for 

providing the service, staffing ratios, and 

what services are included in the rate. 

Mel:!icationA~sjsted 'rt•erapy,(MAT) ~ses medicati~n (m<>thad0ne, buprenorphine or naltrexone) in ~~njun~tio~ with 

cci~nseling an<:! behaviorafiherapies .. r.AAT is available in two different provider seltings: Opioid' Treatml)nt 

P:ro.grams {OTP~) br 0ffice. eased Opioid Treatm~nl(OBOT) se!tfngs. OTPs are speciaU)i.llcen~ei!lreatmE~nt 

programs where patients receive dispensed m.ethadone .on a dl>ity schedule, !lupHlnorphin(l or. na!tr";xor1e therapy, 

which less rigorous dosing schedule, lsalsoavailable through an OTP. 90BOT settings refer to .oo(tified 

general medical practices who are also authoriZed to prescribe buprenorphine' or nallrel(One. 

Designing Medicaid Health Homes for Individuals with Opioid Dependency: Considerations lor States 
116 


32361.248

Exhibit 1: Features of Approved Medicaid Health Home Models for Opioid Dependency 

Feature 1 State 

1.~11iylan'd ::1 vermonr > . . . .. . . . . . 

! Effective Oat~ J O~tober 2013 

___ \ ..... , .. , ~ , f' :: _,\ ... \ ... ···'"-"'' :~~· .:.·· .. ::·.~ ... :> •.. : ... ~,~:._ ... ;·: .• >.L ... ~ -~- ··- I July2013 1 July 2013, expanded January 2014 

~-····· ; Ge-;,graJ;hi~ -l·- Statewide 1 Statewide j- Statewide 

Location i ·------·~-----···-·- .... L- ·-·--·-· .. ----·--·--···-··--··--···-~·-···· +·············--·······-........... .. i Medicaid recipients with opioid I Opioid-dependent Medicaid 

i use disorder and the risk of : recipients currently receiving or I 

Medicaid recipients with opioid 

dependence and the risk of developing 1 developing another chronic ! who meet criteria for MAT 

j condition; or one or more I another substance use disorder and 

1 co-occurring menta! health condition 

l serious and persistent mental 

i illness (SPMI) 

.. l .. opt:i~-;,~~~~~;;;e;;i 

I ~·- )'' ~- -- ~----·~-·---·~--·--~~--

! Auto-assignment, with opt-out 

I - L 

I 4,553 (4,038 with SPMI and ... •

1

' 4,436 (2,464 in Hubs, 1,972 in Spokes) i 515 with opioid use disorder) l 

·r --O"~signat~d -~rovider must b~"- ll Hub: Designated provider must be a 

i one of the following: (1} an regional specialty OTP 

! opioid treatment program ! ' (OTP); and, for the SPMI 1 Spoke: Team of health care 

: population, either (2) ! professionals set in OBOT programs 1 Psychiatric Rehabilitation 1 

1 Program; or (3) Mobile 1 1 . 

Provid.;;;;-~T~;;~:i~~~ilC:~~~~~;r-·j"'Fi;;;;;;~~[d;~~;;;;;t,12~;t~~id;f·Fl~~H-;;b~~~~,;;~-127 'spoke ~----l ' -------·~-~~~site~-~-~·~--~~~-·-~~cations~~·~-- 1 ~ovi~:~~~~~-~~~-: rKey Health i Health home director, nurse I Supervising physician, -rHub; Registered nurse and master's 

j Home Team 1 care manager, physician, or i. registered nurse, health home 1

1

1evell1censed clinician case manager, 

1 nurse practitioner consultant, I team coordinator, case and program director employed by the 

and administrative support 1 manager I hospital liaison and Hub 

staffb 1 pharmacist. Also, three shared 1 i P?Sit~ons acro.s~ hea.lth home I Spoke: Registered nurse and clinician i Sites .. (1) a~mm!stratlve le~el . j case manager employed by Blueprint 

, coordmator, (2) HIT co~r~mator, I Community Health Teamd 

l and (3) health home trammg [ 

] coordinatorc . 

! $87.52 for fee-for~se~ic;--~~ I H~b; Monthly bundled rate per member 

l members and $52.52 for 1 of$493.37. Note: only 30% of the rate 

' managed care members ! is health~home specific, thus only 30% 

structured as a weekly, bundled i of the Hub payment is matched at 90% 

rate per member j of the federal financial participation I rate, or approximately $148 PMPM . 

.J __ Sp."J<e: $163.75 PMPM _I"'Ymer11_ ____ . 

a As ofDecember2014. 

b Staffing based on a ratio of 125 enrollees per team that equates to slightly more than 1.25 FTEs. 

c Staffing based on a ratio of 125 enrollees per team of 4.35 FTEs. 

d Staffing based on 100 enrollees per team of 2 FTEs. 

Designing Medicaid Health Homes for Individuals with Opiold Dependency: Considerations for States 
117 


32361.249

Considerations for Developing Opioid 

Health Homes 

Interviews with representatives from Maryland, 

Rhode Island, and Vermont provide additional 

recommendations for the development of opioid 

dependency-focused health home models. These 

include: 

I. Leverage the requirements of OTPs to 

encompass key health home components. 

OTPs, given their responsibility to provide daily 

doses of methadone to members, have a "captive 

audience" that is enviable in Medicaid health 

homes. Thus, the typically challenging task of 

identifying and engaging members is not an issue 

in OTP settings. This opportunity in OTPs for 

daily member contact with medical and other 

clinical professionals supports health home goals 

of ongoing care management, care coordination, 

and consumer engagement. 

2. Invest in multi-agency collaboration to 

develop opioid treatment health homes. 

Overwhelmingly, states cited internal 

collaboration with other state agencies, such as 

the Office of Mental Health and the Office of 

Alcohol and Substance Abuse, as paramount to 

the success of their opioid health home delivery 

models. This collaboration requires a significant 

amount of internal stakeholder engagement to 

bridge differences in priorities and practices 

between Medicaid and sister state agencies. 

Vermont's Medicaid agency identified the need 

for internal collaboration as a key success factor 

both in the design and implementation phases of 

its health home. The design of its opioid health 

home was a result of collaboration between the 

Department of Health's Division of Alcohol and 

Drug Abuse Programs (ADAP), the Department 

of Vermont Health Access (DVHA) (Vermont's 

Medicaid program), and Vermont's Blueprint for 

Health (Blueprint)-the state's health care reform 

initiative. 

In building the health home model, the state 

leveraged ADAP's existing relationships with 

established providers as well as existing provider 

education mechanisms. The Blueprint for Health, 

part ofDVHA, coordinates the overall 

administration of the health home effort as well 

as the PCMH initiatives that are building blocks 

to the opioid treatment health home model. 

Blueprint community health teams (CHTs) are 

being used to provide the additional care 

management services to Hub and Spoke health 

homes. Pulling from multiple agencies, Vermont 

built on each state agency's strongest attributes to 

develop a health home model that meets both the 

goals of the state and the needs ofthc individuals 

it serves. 

3. Support providers in transforming into 

effective opioid treatment health homes, 

Offering support and education to providers is 

vital to the success of health homes for 

individuals with opioid dependency. The three 

Designing Medicaid Health Homes for Individuals with Opioid Dependency: Considerations for States 
118 


32361.250

states' approved SPAs include a variety of health 

home provider education approaches that can be 

repeated as new providers come on board or staff 

turns over. In the three approved SPAs, state 

options for fostering provider education included: 

Maryland used a series of webinars and 

regional meetings to support information 

sharing and problem solving among OTP 

health home teams. The state is also 

performing outreach to foster linkages with 

community providers that may collaborate 

with health homes. 

Rhode Island built its education activities 

upon experience from earlier health home 

models and substance abuse programs. The 

state supplemented general health home 

education activities by adding training on 

health literacy, motivational interviewing, 

and emotional trauma in order to enhance 

provision of care management and care 

coordination activities. In addition, Rhode 

Island is also planning to provide the Whole 

Health Action Management (WHAM) 

training programll developed by the 

SAMHSA-HRSA Center for Integrated 

Health Solutions to its peer workforce in 

order to strengthen their ability to support 

opioid-focused health homes. 

Vermont's ADAP and the Blueprint for 

Health are sponsoring learning collaboratives 

and trainings to support OTPs and OBOTs in 

transitioning to Hub and Spoke health 

homes. Regional OBOT collaboratives and 

statewide Hub and Spoke learning 

collaboratives are designed to: (I) provide 

education on best practices in eare 

management for individuals with opioid 

dependence; (2) report on quality measures; 

and (3) share health home quality 

improvement efforts (e.g., Plan, Do, Study, 

Act cycles). The state provides continuing 

education credits to providers participating in 

the regional collaboratives. 

Designing Medicaid Health Homes for Individuals with Opioid Dependency: Considerations for States 
119 


32361.251

4. Encourage information sharing between 

providers. 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. Federal regulations 

(i.e., 42 CFR Part 2) were established to protect 

the privacy of individuals with alcohol and 

substance use disorders by limiting who can 

access information regarding treatment. 12 

Because 42 CFR Part 2 applies to any entity 

receiving federal assistance that provides an 

alcohol or substance abuse diagnosis, treatment, 

or referral to treatment, OTPs are included under 

this provision. 

As more states are moving toward an integrated 

health care delivery approach, 42 CFR Part 2 poses 

unique challenges for information sharing. States 

pursuing an opioid dependency health home program 

may consider training opportunities that: (1) ensure 

that health home team members understand privacy 

laws and what information can be shared between 

providers absent a signed release; (2) encourage the 

use of 42 CFR Part 2-compliant release forms; and (3) 

encourage enhanced support to beneficiaries on the 

benefits of sharing substance use information with 

other providers, including how the information will be 

used in their health home treatment plans. 

Conclusion 

The Medicaid health home option in the ACA affords 

states considerable opportunity to customize health 

home services to the unique competencies of 

providers and needs of beneficiaries. Such 

considerations arc critical for all aspects of program 

design-ranging from how the population is 

identified to how providers arc qualified and services 

delivered and reimbursed. 

As more states pursue health homes, additional 

customization for specific target populations, 

including individuals with opioid dependence, may be 

expected. The considerations used to shape the opioid 

dependency health home programs in Maryland, 

Rhode Island, and V crrnont offer helpful guideposts 

for the development of health home programs in other 

states, including models that target substance usc 

disorder more broadly. Based on the experiences of 

these three states, health homes should be considered 

as an integral model for addressing opioid usc 

disorders in the Medicaid program. 

Designing Medicaid Health Homes for Individuals with Opioid Dependency: Considerations for States 
120 


32361.252

Endnotes 

1 P. Muhuri, J. Gfroerer, and M.C. Davies. Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States. 

SAMHSA CBHSQ Data Review, August 2013. Available at: http:ffv.ww.samhsa.gov/data/2k13/DataReview/DR006/nonmedical-pain-reHeveruse-20 13.pdf. 2 Centers for Disease Control and Prevention. Prescription Drug Overdose in the United States: Fact Sheet. Available at: 

http:l/www.cdc.gov/homeandrecreationalsafety/overdose/facts.html. 

3 Substance Abuse and Mental Health Services Administration. National Expenditures for Mental Health Services 

and Substance Abuse Treatment, 1986-2009. HHS Publication No. SMA-13-4740. Rockvl!le, MD: Substance 

Abuse and Mental Health Services Administration, 2013. 4 National institute on Drug Abuse. Drug Facts: Comorbidity: Addiction and Other Mental Disorders. Available at 

http:/~.drugabuse.gov/publications/topics·in-brief/comorbid-druq·abuse-menta!-illness. 

5 CMCS Informational Bulletin: Medication Assisted Treatment for Substance Use Disorders; July 11, 2014. Available at: 

http://www.medlcaid.gov/Federal·Po!icy·Guidance/downloads/CIB-07-11-2014.pdf. 

6 !bid. 

7 A state plan is an agreement between a state and the federal government that describes how the state administers its Medicaid program. In 

it, the state assures that it will abide by federal rules to claim federal matching funds. States submit a state plan amendment (SPA) to the 

Centers for Medicare & Medicaid Services {CMS) if they wish to make changes it their Medicaid programs. For more information see: 

http://www.medicakl.goy/State-Resource-Center/Medicaid·State-Plan--Amendments/Medicaid-State-Pian-Amendments.htmL 

9 Healthcare Brief: Medication Assisted Treatment for Opioid Addiction. Office of National Drug Control Policy. Available at: 

http://v.ww.whltehouse.gov/sites/defauiUfiles/ondcp/recoverv/medication assisted treatment 9-21-20121.pdf. 9 Center for Substance Abuse Treatment. Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. 

Treatment Improvement Protocol (TIP) Series 43, HHS Publication No. (SMA) 12-4214. Rockville, MD: Substance Abuse and Mental Health 

SeJVices Administration, 2005. 10 Health Home Information Resource Center. Health Home State Plan Amendment Matrix. Available at http://www.medicaid.gov/State~ 

Resource~Center/Medicaid-State--T echnicai-Assistance/Health-Homes-Technicai-Assistance/Hea!th-Home-lnformation-ResourceCenter.htm!· Maryland Health Home SPA, available at http://www.medicaid.govfState-Resource-Center/Medicaid-State-Technlcal-

. hode Island Health Home SPA, available at 

omes~Technlcalme SPA, available at: http:/fwww.medicaid.goy/State-ResourceCenter/Medicaid-State-Plan-Amendments/DownloadsNTNT-13-001.pdf. 

11 See http://'NWW.integration.samhsa.gov/health-wel!ness/wham for more information about SAMHSA's Whole Health Action Management 

peer support training program, 12 American Society of Addiction Medicine {ASAM) MagazJne. Confused by Confidentlallty? A Primer on 42 CFR Part 2, August 15. 2013, 

Available at http:/lwww.asam.ora/magazine/read/artic!e/2013/08/15/confused-by-confidentiality-a-primer-on-42-cfr-part-2. 

Designing Medicaid Health Homes for Individuals with Opioid Dependency: Considerations for States 

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consent requirements that discriminate against and endanger people with 

a substance use disorder (SUD) or history of SUD treatment. 

People with diabetes, asthma, HIV, cancer or a history of heart attack can 

easily share their health information with doctors. They can also take full 

advantage of electronic health information exchanges (HIEs) that reduce 

the risk of potentially deadly medication errors among care teams. 

Why should it be any different for a person with a history of SUD? Why are 

brain diseases excluded from a comprehensive, collaborative approach to 

care? 

The ultimate goal of consent should be to give people the power to share 

their own health data with healthcare providers, if they so desire. This 

power of consent should apply regardless of whether a person has a SUD, mental illness, cancer, diabetes or multiple conditions. 

Likewise, if a person does not wish to share her health data, she should 

have the clear option to either opt-out or not opt-in to sharing that 

information. 

Current feder'!.Lfl:_rivacy regulations (42 CFR Part 2), which only apply to 

people with a SUD, place restrictions on sharing your own health data with 

a history of SUD. Such regulation puts a burden on patients, their treating 

providers, and Health information exchange (HIEs), making it operationally 

expensive- and with today's existing HIE technology- extremely costly, 

to transfer and manage SUD data. 

This makes it very easy for HIEs to just say no, we will not accept your SUD 

data- thereby denying a person with SUD who wants to share data the 

same access to care as a person with cancer or diabetes. In this case, the 

regulations are discriminatory, preventing people with a SUD from benefiting from coordinated, integrated care, and increasing the chance 

of inappropriate opioid prescribing. 

Imagine you are scheduled for outpatient surgery at a local surgery 

center. You sign a consent form for your SUD treatment program to share 

information about your addiction to OxyContin with the surgery center. 

The surgery center makes a note in your health record, but your surgeon, 

tough for Comey and .. 

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Former FBl agent: If 

Mueller is to preserve ... 

Stormy Daniels makes 

the Steele dossier look ... 

Juan Williams: GOP has 

sold its soul on Russia 

People 'Nith addiction tssues should be able to control their own health data I TheHrll 

who is employed at a separate clinic, isn't permitted to see that part of 

your health record and prescribes OxyContin for your pain. 

Incidents like this happen every day across the nation, and raise several 

major concerns: 

Incomplete health record information 

Despite recent updates to regulations by the Substance Abuse and Mental 

Health Services Administration (SAMHSA), there are still significant 

complexities in one's ability to consent to release SUD treatment 

information to treating providers. This data gap prevents doctors and 

others from seeing a full picture of their patient's health, substantially 

increasing the risk of treatment and prescribing errors. 

Discrimination and lack of parity 

Addiction is a disease, not a mind set or a moral failing. Outdated Part 2 

regulations are aiding and abetting discrimination against people with a 

SUD. 

Technology limitations 

Some integrated healthcare delivery systems, such as HIEs, Medicaid 

Health Homes and Medicare Accountable Care Organizations (ACOs) 

won't accept a patient's data (who has a history of SUD treatment) 

because they lack the technology or financial resources to comply with 

current consent and data segmentation requirements. Ironically, these 

entities were designed to provide "whole-person" care that addresses a 

full spectrum of co-occurring brain and body health conditions, including 

addiction treatment. 

What's the answer? 

We are seeing some movement in the right direction. There are 

indications that SAMHSA may reopen the rulemaking process for further input. Reps. Markwayne Mullin {R·Okla.) and Earl Blumenauer {D-Ore.) have 

introduced the bipartisan Overdose Prevention and Patient Safety Act in 

the U.S. House. A bipartisan companion bill, the Protecting Jessica 

Grubb's Legacy Act (The Legacy Act}, has been introduced in the U.S. 

Senate by Sens Joe Manchin (D·W.Va.) and Shelley Moore Capito (R-W.Va). 

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3/21/2018 People W1th addiction issues should be able to control the1r own health data I TheHill 

These bills more closely align 42 CFR Part 2 regulations with H!PAA, 

helping to ensure that all clinicians involved in a person's care get the full 

picture of their health. The bills also strengthen protections and 

prohibitions against disclosures of SUD information for criminal justice 

purposes- a legitimate concern of patient advocacy groups. 

Most recently, during the fourth meeting of the President's Commission 

on Combating Drug Addiction and the Opioid Crisis, leaders from the 

nation's top insurance companies, as well as Commission members, 

overwhelmingly called for immediate 42 CFR Part 2 reform to stop the 

horrific cycle of preventable and unnecessary deaths in this country. 

Recently, SAMHSA published a final rule that now allows for greater 

flexibility in the sharing of SUD treatment information by third parties for 

payment and hea!thcare operations. The final rule specifically excluded 

treatment. diagnosis and referral for treatment from the new, more 

flexible provisions. 

Ironically, it's now easier for a person's SUD-related health information to 

be shared by payers, health plans and other entities for billing, payment, 

claims management and collections- than with the person's own 

healthcare providers for fully-informed diagnosis and treatment. The 

exclusion of treatment from the list of permissible activities for disclosure 

prevents people with an SUD from benefiting from coordinated, 

integrated care and exacerbates the stigma often associated with SUDs. 

While HIPAA provides substantia! protections for health information, it 

also provides something that Part 2 regulations cannot: patient choice. 

The decision to share critical health information should lie with the 

individual, not the Part 2 program, SAMHSA or the hea!thcare system. 

Patrick J. Kennedy is the founder of The Kennedy Forum and former 

democratic congressman from Rhode Island. He is also a former member of the President's Commission on Combating Drug Addiction and the 

Opioid Crisis. Kevin Scalia is the executive vice president of Netsmart. 

TAGS SHElLEY MOORE CAPITO MARKWAYNEMULLIN EARL BLUMENAUER JOE MANCHIN 

SKAR.G: 

http:llthehlll.comfopinion/healthcaref368563-people-with-addiction-issues-shou!d-be-able-to-control-their-own-health 

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3/21/2018 People With addiction issues should be able to control their ovm health data jlheH11! 

THE HIU 1625 K STREET, NW SUITE 900 WASHINGTON DC20006I202·628·8500 TELI202·628·8503 FA)( 

THE CONTENTS OF THIS SITE ARE ©2018 CAPITOl HilL PUBliSHING CORP., A SUBSIOIARY OF NEWS COMMUNICATIONS, INC. 

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Electronically submitted via PrivacyRegulations@samhsa.hhs.gov 

Feb.28,2018 

Elinore F. McCance-Katz, M.D., Ph.D. 

Assistant Secretary for Mental Health and Substance Use 

Substance Abuse and Mental Health Services Administration 

U.S. Department of Health and Human Services 

Attn. Mitchell Berger 

5600 Fishers Lane, Room 18E89C 

Rockville, MD 208S2 

Magellan HEAlTH 

Re: Confidentiality of Substance Use Disorder Patient Records; Notice of Public Meeting {Docket 

no. 2018-00150) 

Dear Assistant Secretary McCance-Katz: 

Magellan Health, Inc. (Magellan) appreciates the opportunity to respond to the Notice of Public Meeting 

published by the Substance Abuse and Mental Health Services Administration (SAMHSA) in the Jan. 9, 

2018 Federal Register concerning confidentiality of substance use disorder (SUD) patient records 

regulations, 42 C.F.R. Part 2 (Part 2 regulations), as noted in Section 11002 of the 21st Century Cures Act 

of 2016. We further appreciate the opportunity to have attended the Jan. 31, 20181istening session and 

have incorporated herein the oral remarks made by Teresa Berman, Magellan's senior vice president 

and Deputy Compliance Officer, as requested in the course of that session. 

Headquartered in Scottsdale, Ariz., Magellan helps millions of Americans live healthier, more vibrant 

lives. We are committed to connecting behavioral, physical, pharmacy, and social needs with highimpact, evidence-based clinical and community support programs to ensure the care and services 

provided to the members we serve1 are individualized, coordinated, fully integrated, and cost effective. 

Magellan develops and supports innovative ways of accessing better health by combining advanced 

analytics, agile technology, and clinical excellence, while remaining focused on the critical personal 

relationships necessary to achieve a healthy, vibrant life. 

In addition to Ms. Berman's remarks, our response to the Notice also includes Magellan's experience 

with Part 2; how Part 2 affects patient care and health outcomes; and recommendations for regulatory 

action for SAMHSA to consider related to the following, as described further on Pages 5-6: 

Aligning Part 2 with the Health Insurance Portability and Accountability Act (HIPAA) of 1996, 

Relaxing the stringency of the consent requirements to permit a consent form be executed for 

HIPAA-Iike purposes, and 

1. Included here also are individuals we serve whom t~re members of our customers' health plans. 

One Columbus Center, 283 Constitution Drive, Suite 100, Virginia Beach, VA 23461 Office 317.387.4141 

Government Affairs 
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32361.059

Magellan HEALTH 

Indicating the permissability (in response to the opioid crisis) of coordinating SUD care between 

providers and with providers and clinicians working within managed care entities. 

I. Magellan Health's Experience with 42 C.F.R. Part 2 

Much of what Magellan does on behalf of our members and our customers necessitates disclosing 

patient-identifying information within the healthcare system, interfacing and interacting with providers 

while protecting the privacy concerns of members with mental health conditions and, often, cooccurring SUDs receiving treatment. Indeed, the Journal of the American Medical Association found 50 

percent of individuals living with serious mental illness (SMI) also have a substance use disorder2 Of 

those, more than half (53 percent) are a drug-related use disorder, such as opioid use disorder. As a 

result of Part 2's restrictions, these members' access to whole-person, fully integrated healthcare can 

be hampered when providers are prevented from accessing all relevant information necessary to 

appropriately support individuals' health care needs. 

As an experienced specialty healthcare organization, Magellan provides a tailored spectrum of mental 

health and substance use disorder treatment and services and Employee Assistance Programs for health 

plans, employers, and various military and government agencies and public healthcare programs, 

including to active-duty service members and their families, the Medicare Advantage and state Medicaid 

programs, and individuals dually eligible for Medicare and Medicaid. Magellan also contracts with more 

than 80,000 credentialed behavioral health providers nationwide and provides behavioral healthcare 

services to approximately 1.6 million public-sector members through a range of innovative state 

programs, including the nation's first Medicaid specialty health plan for individuals living with SMI, 

Magellan Complete Care of Florida. Our subsidiary, Magellan Healthcare, contracts with health plans 

nationwide and some state Medicaid programs (including Florida, as noted) in order to perform case 

management and care coordination, utilization review, utilization management, and/or claims 

adjudication functions on their behalf, and thus has significant direct experience with the impact of the 

requirements under 42 C.F.R. Part 2. As a contractor and subcontractor, Magellan Healthcare is 

expected to perform case management and care coordination and related functions on behalf of its 

customers for its customers' members, including those living with a SUD. 

In addition, our subsidiary, Magellan Rx Management, is a full-service pharmacy benefit manager that 

expands beyond traditional core services to help our customers and members solve complex pharmacy 

challenges, including through the use oftargeted clinical programs, comprehensive member and 

provider engagement strategies, advanced analytics, and expert specialty pharmacy management 

capabilities. Accordingly, much of what Magellan does on behalf of our customers and membersincluding members living with SUDs- necessitates disclosing Part 2-covered, patient-identifying 

information within the healthcare system, including interfacing and interacting with providers, while 

protecting the privacy concerns of individuals living with SUDs receiving treatment and services. 

2. Darret A Regier, MD, MPH; Mary E. Farmer, MD, MPH; DonaldS. Rae, MS; eta!., "Comorbidity of Menta! Disorders With Alcohol and Other 

Drug Abuse: Results From the Epidemiologic Catchment Area (ECA) Study," Journal of the American Medical Association (1990) 264, no. 

19:2511-2518. doi :10.1001/Jama.1990.03 450190043026. 

Page 2 

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Magellan HEAlTH 

For our members and our customers, as well as our customer's members, Magellan performs case 

management, care coordination, discharge planning, utilization review, claims adjudication, and other 

related functions, affording us significant direct experience with the impact of Part 2. This extensive 

experience informs our perspective on confidentiality and disclosure of substance use disorder patient 

records, and our response to the Notice. 

II. How 42 C.F.R. Part 2 Affects Patient Care and Health Outcomes 

The vast majority of today's integrated care models rely on HIPAA-permissible disclosures and 

information sharing to support care coordination-that is, without the need for the individual's written 

consent to share relevant treatment details, provider by provider. Magellan believes it is critical for 

health plans to be able to assist their members' recovery and relapse prevention by sharing valuable 

substance use disorder information with members' providers when arranging for pre-authorization, 

referrals, step-down services, residential treatment, and other care coordination activities without the 

need to obtain written consent for each individual provider. 

The same is true for the modern electronic infrastructure for information exchange. In an era of 

electronic medical records (EMRs), having incomplete records available for providers-because 

substance use disorder information cannot be included without individualized consent-disallows 

providers from supporting their patients holistically. In facln some case, providers may believe the EMR 

(to which they have access) reflects the individual's full medical record. In such situations, a provider 

may, for example, prescribe opiates for back pain for a member with prior history of opioid misuse, 

which could lead to relapse. Access to complete medical information is critical for providers to ensure 

members' access to care is appropriate to their needs and clinical histories. 

While having to obtain any written consent is a barrier to achieving care coordination, the ability to 

obtain a more broad consent would certainly permit member information to more easily be shared 

for care coordination and treatment purposes. It would also make it easier to include information in 

EMR systems noting whether the consent was constrained to individual providers. Consents having to 

list individual providers often have to be obtained over and over again as members move through the 

system of care, leading to delays or barriers in coordinating a member's care. These hurdles are 

extremely problematic for health plan entities who are responsible for coordinating the care received by 

their members to make certain it is optimally suited for each member; any change of provider by the 

member necessitates a new written consent. In the event a member changes their primary care 

provider, or switches psychiatrists, or begins a new course of treatment with a cardiologist-all of whom 

need to know about the member's substance use disorder treatment history to ensure patient safety 

and proper treatment approaches a new written consent must be obtained. Doing so is not always 

easy, particularly if the member is in denial about their SUD; is unable to effectively understand or 

communicate due to their condition; or has other co-occurring conditions (such as SMI) which stymie 

the consent-collection process. 

The national opioid crisis is not being addressed nearly as effectively as it could be given the 

limitations posed by Part 2 on effectively coordinating care. For example, when a health plan is 

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Magellan HEAlTH 

coordinating a member's discharge from an inpatient detox facility and attempting to locate an 

appropriate outpatient therapist in the community, the health plan is prohibited from informing the 

outpatient therapist that their new patient has a SUD diagnosis and was discharged from detox, and 

must hope that either the: 

Detox facility notifies the therapist of the treatment directly (although they too would first need 

to obtain written consent to do so as well). 

Therapist asks the member about any SUD history (and that the member responds truthfully), 

or 

Member is forthcoming enough to inform the therapist proactively. 

If none of these occur, the therapist's treatment plan will not address the crux of the member's 

healthcare needs- their substance use disorder- potentially leaving the member at greater risk of 

relapse, re-admission, or worse. 

Similarly, when a detox facility calls the member's health plan for pre-authorization, the health plan is 

prohibited from advising the facility that this member could have been in detox multiple times in the 

past year and- as a result- may need their treatment approach adjusted accordingly to improve the 

member's quality of care and overall outcome. A member with a SUD may not provide the health plan 

with written consent and may not share his or her treatment history with the facility, leaving the facility 

in the position of being unaware of this critical information and providing treatment or treatment 

recommendations in the dark. 

Other effects on patient care and health outcomes Magellan has encountered in attempting to manage 

the behavioral healthcare and services of members in compliance with Part 2 include: 

Page 4 

Due to the need to exclude SUD data from the information sharing necessary to successfully 

coordinate a patient's care, the regulations result in fragmentation in treatment, less than 

optimal patient assessments, and treatment plans often created in a vacuum because the 

complete clinical picture is not available to the current provider, which can lead to adverse 

drug reactions, accidental overdose, inappropriate diagnosis, and ineffective treatment which 

targets the incorrect condition. 

The need to single out specific patient written consent for each individual provider prior to 

any disclosure of SUD information slows the treatment process considerably, creates great 

inefficiencies, and may actually result in reinforcement of stigma associated with SUD 

treatment and services instead of overcoming it. 

The inability to share substance use patient information between providers without the 

express, written consent of the patient has created perceived liability situations for many 

physicians and other clinicians to the point that they may opt to refuse to treat any patient 

with a suspected history of substance use, particularly in primary care, which is most 

unfortunate since primary care providers often are in the most advantageous position to screen 

Magellan Health, "Confidentiality of Substance Use Disorder Patient Records; Not1ce of Pub he Meeting {Docket no. 2018~00150)"' (Feb. 28, 2018) 
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Magellan HEAlTH 

for and treat substance use disorders. 

Denial is an important dynamic in substance use disorders. Individuals living with a SUD may 

inadvertently rely on denial and not appreciate their own chronic health condition, allowing him 

or her to hide their condition from clinicians who are attempting to ensure appropriate 

treatment and services. Without an easier, more effective way to facilitate transfer of SUD 

information between providers and health plans, the clinician is left naive concerning the 

patient's true healthcare condition, and the SUD diagnosis can go unaddressed and 

untreated, further feeding into this difficult, unintended pattern. 

In our experience, we have seen multiple member situations and dynamics adversely impacted by Part 2 

(as we note above). In further response to the listening session, we would like to share the story of one 

of our members, and how their care and health outcomes were affected by Part 2: 

An adult member was brought to the emergency department by relatives concerned by 

their loved one's depression and suicidal statements. The member received a complete 

evaluation, including a physical examination and a psychiatric evaluation. Records from a 

previous psychiatric hospitalization were obtained from another facility in the community 

without patient written consent, as permitted by HIPAA. 

Three days after admission, the patient experienced a grand mal seizure; it was only then 

the member shared several years of barbiturate misuse. The member shared they had not 

wanted the hospital's treatment team to know about this, and thus had denied any history 

of substance use to staff. 

At the previous admission to the other psychiatric facility, the member had been 

forthcoming about the barbiturate misuse, and had received appropriate detox treatment; 

however, since a release specifically for SUD information had not been signed by the 

member, pages of their medical record concerning this previous SUD history had been 

omitted when the facility provided the patient's records to the emergency department. 

Since the emergency department's treatment team was deprived of this knowledge, the 

hospital's inability to correctly diagnose and treat their patient led to a serious adverse 

incident for this member. 

Ill. Recommended Regulatory Action for SAMHSA to Consider 

While we appreciate recent efforts to revisit the regulations, Magellan continues to urge SAMHSA to 

update Part 2 to align with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 by 

adopting a care coordination exception to the consent requirement. While HIPAA permits such 

information sharing for treatment and healthcare operations, Part 2 does not-presenting an 

unnecessary and sometimes even insurmountable barrier and marginalizing this crucial tool for 

individuals living with SUDs. This meaningful change would retain sufficient protection and 

confidentiality of individuals' substance use disorder records while also bringing Part 2 into the modern 

era. Part 2 was created before HIPAA existed and these stringent requirements are incompatible with 

contemporary advancements in care coordination and electronic information sharing which can 

Page 5 

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Magellan HEAlTH 

currently be afforded to all health plan members, except those with substance use disorders. 

Alternatively, while SAMHSA may be constrained somewhat by 42 U.S.C. §290dd-2, Magellan believes 

there is some latitude afforded both in relaxing the stringency of the consent requirements in 42 

U.S.C. §290dd-2 (1) and in the exception in section (2) for disclosures "to medical personnel to the 

extent necessary to meet a bona fide medical emergency." 42 U.S.C. §290dd-2(1) notes the content of 

records "may be disclosed in accordance with the prior written consent of the patient with respect to 

whom such records are maintained, but only to such extent, under such circumstances, and for such 

purposes as may be allowed under regulations prescribed pursuant to subsection (g)." The regulations 

could be modified to permit a consent form to be executed that allows for the use of the member's 

information for treatment, payment and healthcare operations- including care coordination- rather 

than the current requirements to obtain consents specific to each and every provider who is involved in 

the member's care in order to coordinate all the various treatments and services the member receives. 

We also believe that, given the significant opioid crisis in our country, which has been declared a public 

health emergency', SAMHSA could indicate in regulation that the coordination of substance use 

disorder care between providers and with providers and clinicians working at managed care entities 

and pharmacies would be permissible in response to addressing a bona fide medical emergency. 

To ensure individuals with substance use disorders receive the full benefits of integrated care, Magellan 

respectfully requests that SAMHSA consider pursuing the proposals discussed above, including either 

permitting coordination of care without an authorization, or, in the alternative, permitting a member to 

sign one consent authorizing their information to be used for treatment and healthcare operations 

purposes, including care coordination, without the burden of naming individual providers. 

Magellan would be glad to answer questions or provide further information. Please contact Brian Coyne, 

vice president of federal affairs, at (804) 548-0248 or bcoyne@magellanhealth.com; or, Claire Wulf 

Winiarek, vice president of public policy, at (860) 507-1918 or cwulfwiniarek@magellanhealth.com. 

Thank you for the opportunity to share our experience and recommendations on this important issue. 

Sincerely, 

Meredith A. Delk, Ph.D., MSW 

Senior Vice President, Government Affairs 

3. Office of the Secretary, U.S. Department of Health and Human Services, "Determination that a Public Health Emergency Exists" {Oct. :26, 

2017}, https:/fwww.hhs.gov/sites/default/files/opioid%20PHE%20Dedaration-no-sig.pdf. 

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March 8, 2018 

The Honorable Greg Walden 

Chairman 

U.S. House of Representatives 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Frank Pallone 

Ranking Member 

U.S. House of Representatives 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Chairman Walden and Ranking Member Pallone: 

The Healthcare Leadership Council (HLC) is writing to you to urge passage of H.R. 3545, the 

"Overdose Prevention and Patient Safety (OPPS) Act", to enable the appropriate exchange of 

necessary information among medical professionals who are treating individuals with substance 

use disorders, including opioid abuse. While HLC commends the U.S. Substance Abuse and 

Mental Health Service Administration's (SAMHSA's) ruling to amend 42 C.F.R. Part 2 to better 

align Part 2 regulations within the Health Insurance Portability and Accountability Act (HIPAA) to 

integrate behavioral and physical health care, we believe this ruling does not go far enough to 

help increase access to relevant health information among patients, payers and providers while 

concurrently protecting patient privacy. 

HLC is a coalition of chief executives from all disciplines within American health care. It is the 

exclusive forum for the nation's health care leaders to jointly develop policies, plans, and 

programs to achieve their vision of a 21st century health system that makes affordable, highquality care accessible to all Americans. Members of HLC- hospitals, academic health 

centers, health plans, pharmaceutical companies, medical device manufacturers, laboratories, 

biotech firms, health product distributors, pharmacies, post-acute care providers, and 

information technology companies- advocate for measures to increase the quality and 

efficiency of health care through a patient-centered approach. Through this diversity, we develop 

a nuanced perspective on the impact of any legislation or regulation affecting the privacy and 

security of health consumers. We believe access to timely and accurate patient information 

leads to both improvements in quality and safety and the development of new lifesaving and lifeenhancing medical interventions. 

Current federal regulations governing the confidentiality of drug and alcohol treatment and 

prevention records (42.C.F.R. Part 2 (Part 2)) preclude the Centers for Medicare and Medicaid 

Services (CMS) from disclosing medical information to healthcare providers for care 

coordination, including those engaged in accountable care organizations and bundled payment 

organizations. These regulations currently require complex and multiple patient consents for the 

use and disclosure of patients' substance use records that go beyond the sufficiently strong 

patient confidentiality protections that were subsequently put in place by HIPAA. 
133 


32361.065

Electronic health records and value-based payment models such as Accountable Care 

Organizations (ACOs), Health Information Exchanges (HIEs), Medicaid Health Homes, and 

related Medicare and Medicaid integrated care programs were designed to create a more 

holistic, patient-centered approach to healthcare where providers work together to coordinate 

across their traditional silos and in some cases are held jointly accountable for the quality, 

outcomes, and cost of that care. Critical to making these new models work for patients is having 

access to the individuals' health records, including those related to substance use disorders. 

CMS provides participating providers of Medicare AGO and bundled payment organizations with 

monthly Medicare Parts A, B and D claims under data use agreements that include criminal 

penalties for misuse. Yet, due to outdated laws mentioned above, CMS is forced to remove all 

claims where substance use disorder is a primary or secondary diagnosis. Patient safety is also 

threatened with the potential pharmaceutical contra indications that could occur without access 

to the full medical record. Without this critical information, providers are prevented from 

understanding the full extent of their patients' medical needs. 

We commend SAMHSA's recent rulemaking efforts, and understand the agency has probably 

gone as far as possible in regards to attempts to modernize the Part 2 Rule. To sufficiently 

address the need for further reform, Representatives Markwayne Mullin (R-OK) and Earl 

Blumenauer (D-OR) have introduced H.R. 3545 to ensure healthcare providers have access to 

the full medical record, including information on substance use disorders, to effectively and 

safely treat patients suffering from substance use disorders while guaranteeing the privacy and 

security of substance use medical records. In particular, H.R. 3545 would reinforce and expand 

existing prohibitions on the use of these records in criminal proceedings. 

We urge the Committee to consider H.R. 3545 to amend 42 CFR Part 2 and align with HIPAA's 

treatment, health care operations, and payment policy as one of several potential solutions 

Congress passes to help with the opioid crisis. Thank you for your attention to this important 

matter. Should you have any questions, please contact Tina Grande at 202.449.3433 or 

tgrande@hlc.org. 

Sincerely, 

Mary R. Grealy 

President 

cc: U.S. House of Representatives 
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32361.066

MAR 1 9 2018 

The Honorable Markwayne Mullin 

1113 Longworth House Office Building 

Washington, DC 20515 

Dear Representative Mullin: 

Thank you for your correspondence about the revised Confidentiality of Substance Use Disorder 

Patient Records Final Rule (42 CFR Part 2 or Part 2) and its impact on data-sharing by Medicare 

and Medicaid programs. Your letter states that the "Centers for Medicare and Medicaid Services 

(CMS) is forced to remove all claims where substance use disorder is a primary or secondary 

diagnosis," from data shared with A COs, bundled payrnent organizations, and others. You also 

indicate that sharing of information in electronic health records (EHRs) is critical to the success 

of these new payment models. You suggest that Part 2 is inconsistent with the Health Insurance 

Portability and Accountability Act (HIPAA) requirements. 

The Substance Abuse and Mental Health Services Administration (SAMHSA) is encouraged to 

se(! Congress examine the benefits of aligning Part 2 with HIPAA. Patient privacy is, of course, 

critical but so too is patient access to safe, effective, and coordinated treatment. To facilitate this 

most efficiently, healthcare providers must have secure access to patient information, including 

substance use disorder information, in order to provide integrated and effective care. The 

practice of requiring substance use disorder information to be any more private than information 

regarding other chronic illnesses such as cancer or heart disease may in itself be stigmatizing. 

Patients with substance use disorders seeking treatment for any condition have a right to 

healthcare providers who are fully equipped with the information needed to provide the highest 

quality care available. 

As you note, SAMHSA has taken the steps within our purview to address some of these 

concerns; however, Congressional action is needed to fully address the issue. The steps 

SAMHSA has taken include the following: 

• SAMHSA 's revisions in January 2018 (83 f'R 239) permit additional sharing by lawful 

holders, including Medicare and Medicaid entities, with contractors, subcontractors, and 

legal representatives for payment and health care operational purposes consistent with 

those listed in HIPAA's Privacy Rule, as long as initial patient consent is obtained. 

• SAMHSA's 2017 final rule (82 FR 6052) notes that entities may ask patients to consent 

to use of a general designation to share their Part 2 records with all of their current or 

future treating providers. The preamble to the rule specifically states that "an ACO, 

pursuant to a (patient's use of the] general designation, may disclose information 

Behavioral Health is Essential To Health ~ Prevention Works • Treatment is Effective .. People Recover 
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Page 2 The Honorable Markwaync Mullin 

described in the "Amount and Kind" section of a consent form ( ... J to "all my entity 

treating providers." The tina! rule also makes it clear that A COs may share information 

in accordance with Part 2 to cany out audit and evaluation activities (§2.53). 

Additionally, SAMHSA recently held listening sessions related to Part 2, as required by the 21 "

1 

Century Cures Act (Section II 002). The vast majority of those who spoke at the listening 

session expressed their support for further aligning Part 2 and HIPAA and acknowledged that to 

achieve many of their goals, Congress would need to take action on bills such as yours. 

HI-IS and SAMHSA appreciate your attention to this issue and stand ready to provide any 

technical assistance you may request on this very significant matter. If you or your staff have 

any questions, please feel free to contact Brian Altman. Acting Legislative Director, at (240) 

276-2009, This response has also been sent to Representative Blumcnauer. 

Sincerely, 

~~ Elinore F. McCance-Katz, M.D., Ph.D. 

Assistant Secretary for Mental Health and 

Substance Use 

Behavioral Health is Essential To Health • Prevention Works • Treatment is Effective • People Recover 
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Statement for the Record 

Committee on Energy and Commerce 

Subcommittee on Health 

Combating the Opioid Crisis: Prevention and Public Health Solutions 

March 21-22, 2018 

Thank you for your work regarding the nation's opioid crisis. America's Essential Hospitals 

appreciates your committee's dedication in its response to this public health threat, which affects 

all communities nationwide. Belowt we outline the unique role essential hospitals play in 

addressing the opioid crisisj share issues that impact our hospitals, and comment on several hills 

before your committee. 

America's Essential Hospitals is the leading association and champion for hospitals and health 

systems dedicated to providing high-quality care to all people. Filling a vital role in their 

communities, our 325 member hospitals provide a disproportionate share of the nation's 

uncompensated care and devote about half their inpatient and outpatient care to Medicaid or 

uninsured patients. Through their integrated health systems, members of America's Essential 

Hospitals offer primary care through quaternal)' care, including trauma care, outpatient care in 

ambulatory clinics, public health services, mental health and substance abuse services, and 

wraparound service-B vital to disadvantaged patient,<;, More than a third ofpatient..c:; at essential 

hospitals are racial or ethnic minorities who rely on the culturally and linguistically competent 

care that only our members can provide. 

A...c::; pillars of their communities and trusted providers for al1 1 essential hospitals have seen 

firsthand how opioid use disorders have affected individuals and their surrounding communities. 

Essential hospitals lead in efforts to improve population health and continue to develop 

innovative programs lo prevent opioid misuse among the most vulnerable populations, and they 

provide treatment to all who need it. As you contiuue to develop policies to combat the crisis, we 

urge the committee to consider the unique role essential hospitals play in prevention of opioid 

misuse, as well as response and recovery for individuals stn1ggling with opioid use disorders. 

Essential Hospitals Response to Opioid Crisis Essential hospitals play a unique and significant role iu the opioid crisis. Hospitals are a main 

care provider for people experiencing opioid-related health problems, like infection or overdose, 

associated with substance misuse. As a result, hospitals have an enonnous role to play in the 

prevention and treatment of this widespread problem. Essential hospitals have partnered with 

pharmacies, public health departments, law enforcement, emergency medical services, and other 

community providers to combat the crisis. 

For example, an essential hospital in Massachusetts has been a national leader in fighting the 

opioid crisis. The hospital runs the largest primary care office-ba.."\ed opioid treatment program 

in New England. The program wa.-; the first of its kind in the nation and ha.<> been replicated in 

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35 states. lt employs a collaborative care model using nur;:;e care managers to provide 

medication-assisted treatrnent (MAT) to individualc; with opiokl use disorder. The program ha.c; 

been tailored 1o meet the nef'ds of other patient populations, including a<lolesccnts and pregnant 

women. In addition, this hospita1 created one of the first emergency department (ED)- and 

urg0nt care-based oploid treatment programs in the country, and its inpatient addiction consult 

_c;cnrice has reduced ED visits for participants by :30 percent. In partnership with the state health 

department, the hospital has pioneered naloxone distribution programs with law enforcement 

and other first responders and overdose bystandns. 1 

Evidenrc-based treatment prognuns, which can exist vdthin or outc;idc a hospital system, are a 

key component of combating opioid use. One of the most commonly used treatment models-

:fv1AT-uses counseling in combination ·with drugs, such as methadone and huprenorphine, to 

prevent. \l,;ithdrawal, suppre."ls cravings, and support recovClJ'· MAT has proved successful in 

decrea.:::ing mortality, decreasing risk of infection, improving social functioning, and increasing 

retention in rehabilitation programs. But there are htrge gaps between MAT capacity and 

demand. To meet this need, some health systems arc developing their o\vn infrastructure and 

care teams--which inclnde physicians, licensed therapists, counselors, and/or recovery 

specia1ists-to treat opioid misn.'ie. 2 Essential hospitals arc deploying protocols that."lercen for 

opioid use, provide MAT as ncccssmy, and pair patients with addiction counselors. 

Additionally, c.:::sentia1 hospitals are deploying targeted improvement efforts to address opioid 

prescribing patterns and align incentive.::: that promote quality of care. For example, several 

essential hospitals have implemented new guidelines for prescribing opioids, particularly in the 

ED. These hospitals urge providers tn first provide non-opioid options-ibuprofen and 

acetaminophen, for example-and then to explore alternative pain management, such a.<> 

localized nerve-blocking methods. Hospitals engage physicians, pharmacists, an<l nurses to 

ensure all staff are committed to providing non-opioid regimens befOre prescribing stronger 

medications. Initial evaluations show that such policies reduced by nearly 50 percent the 

number of opioids prescribed to trauma patients.:.~ 

Essential Hospitals Face Challenges 

42CFR Part2 

Although esst>ntial hospitals han~ deployed innovative approaehC's to treat patients with opioid 

and substance use disorders, they continue to face challenges. \Vhen patients visit doctors an<l 

hospitals, most assume providers have a complete medica] history and an awareness of 

addictions or substance usc that need to be factored into treatment and prescribing. But that is 

not always the case, due to an antiquated rcgn1ation~4,2 CFR Part 2 (Part 2).4 This regulation 

limits access to an<l use of patients' substance use records for cert<lin substance use treatment 

programs. Obtaining multiple eonsents front the patient is challenging and creates barriers to 

whole-person, integrated approaches to can". As a result, many providers often learn of addiction 

problems only afl.er an adverse event or an overdose. Pnrt 2 regulations also might lead to a 

physician treating a patient and writing prescriptions for opioid pain mcdi~ation for that 

individual without kno\ving the person has a suhstanre use disorder. Separation of a patient's 

addiction record from the rest of that pcrson"s medical record creates several proh1ems and 

2 
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impedes patients· ability to receive safe, effective, high-quality substance use treatment and 

coordinated care. 

It is crucial that Part 2 is better aligned with the l Tealth Insurance Portability and Accountability 

Act (IIIPAA) so that health care providers ran provide comprehcnsi\'e and coordinated 

substance usc treatment and Olre. The Substance Abuse and Mental Health Services 

Administration (SAMHSA) recrntly released a fina} ntle that tilkes some steps to moderni7.c Part 

2, but it docs not go far enough. 5 L.awmakcrs must act to modify Part 2 and bring substance usc 

records into the 21st century, a11owing for appropriate levels of accrss for pro ... iders to have a 

complete picture of their patients. However, just aligning Part 2 for treatment purposes is an 

in:mfficlent approach. Such an approach i'i inconsi.'itcnt with HIP /\A language on treatment, 

payment and health care operations, as care coordination activities are not considered a part of a 

patient's treatment. For Medicaid prov;dcrs engaging in whole-person care management, it is 

ditricnlt to separate treatment from payment and health care operations. Also, only alig11ing Part 

2 with I-ITPAA for treatment activities could preclude a robust prescription drug monitoring 

program. VVithout all information about a patient availahlc, it vvill be challenging to flag patients 

engaging in drug-seeking behaviors. 

IMD Exclusion 

::\-fedicaid does not provide reimbursement for inpatient treatment in an instituLion for mrnlal 

disease (IMD) with more than 16 beds. As states con.'iidcr various approaches to romhat the 

opioid crisis, this IMD e.-...:cltL'iion has hampered r.omprehensive treatment. approaches. The 

Centers for Medicare & Medicaid Services (C:!'viS) has encouraged states to pursue innovations 

and strategirs to address the opioid epidemir through Medicaid Section 1115 waiver 

demonstrations. In aN ovcm her 2017 update to states, CMS outlined a streamlined approach to 

accelerate states' ability to respond to the crisis.6 Sevf'fal states, sueh as \Vest Virginia, Maryland, 

and Virginia1 have used this approach to 11tart comprehensive, eYidcnce-hased prevention and 

treatment programs for Medicaid beneficiaries. 

Additional Challenges 

The Medicaid program cover.s MAT services as an optional benefit for states under the Medicaid 

statute, which has caused available services to vary widely across states.' This limits providers as 

they identify and employ the best treatment options for their patients 

Essential hospitals also far.e the additional challenge of a \vorkforcc shortage for substance use 

disorder and beh(lviora1 health professionals. There has been a .'ihortage of addiction specialists 

for decades, and the opioid epidemic only has increased demancf.1

l SArvfHSA recognized the 

serious workforce shortages for behavioral health profes/'iionals and funded several programs and 

initiatives to com hat the issue. E.•:;sential hospitals operate on slim marf;ins that migbt hinder 

them from offrring competitive compen11ation pRcl\ages to attract needed snbstance use disorder 

and behavioral health professionals. Not only do they have financial constraints, many e.'isential 

hospitals fmd themselves either in extremely competitive nrhan markets or in less desirable 

geographic areas. 

"82 Fhleral Register 6052, 1

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7 il1cdicaid and CHIP 
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Last, essential hospitals lack adequate reimbursement for integrated care. Overall care delivery is 

transforming across the health crt.re industry, shifting from frag.1nentatlon and care siloes to a 

more intcgraled and c-ollaborative system. In responding to the opioid crisis, essential hospitals 

recognize the complexity and importance of treating beha-vioral health issues, particularly as tlwy 

relate to improving care for our nation's most vulnerable patients. Essential hospitals across the 

United States have dedicated substantial resources to developing innovative programs to 

improve care coordination among primary care, inpatient, hcha"Viora1 health, and communitybased services for indhidua]s 'vith behavioral health disorders. For example, an essential 

hospital in \\'ashington slate began a heha"ioral hca1th integration program that incorporates 

behavioral health care managers and psychiatric eonsultants nt 14 primary care clinics:9 Primary 

care physicians in the clinics conduct rouLine screening for hehavioral health disorders among 

patients, determine whether further assessment and diagnosis hy behavioral health specialists is 

required, and, when necessary, prmidc warm handoffs to care coordinators within the same 

facility. As providers of care to vulnerable populations, essential hospitals are uniquely 

pm;itioned to implement this kind of care. But funding shortfalls and reimbursement slructures 

pose consistent and significant obstacles to integration. 

Legislative Proposals 

Prescription Drug i\'lonitoring Programs and H.R. _,to enhance and improve state-run 

prescription drug monitoring programs, 

Prescription drug monitoring programs (PDMPs) are state-lcve1 interventions to improve opioid 

prescribing and inform clinical practice by tracking the prescribing and dispensing of controlled 

prescription drugs. Some statr-s have implemented polices that require physicians to check a 

state PD!YlP to assess a patient's ri.'ik of :mbstancc use disorders or nonmedical use of controlled 

substances as part of the discharge planning and medication n~conciliation process. The 

leg·ishtive proposal before the comrnittee yvould seek to 1m prove PDW1Ps by anthorizing the 

Centers f()r Disease Control and Prevention to conduct certain surveillance activities to improve 

data collection and integration in physirian clinical workflow. 

\Vc support the goal of reducing prescription drug abuse by increasing provider awareness of atrisk patients. However, the challenges a_<;sociated with PDMPs~inrluding issues with health IT 

intPropcrahility, timely data transmission, and privacy and security-make this tool an 

unsatisfactory option for now. Further, the quality ofPDMP data must he validated lwfore its 

use in the context of a federal program, such a.'i Medicaid. For example, PDMPs do not include 

data on physiC'irtn specialty or patient dlagnosis, 'vhich can make it diffir.ult to distinguish 

legitimate use, .snr:b a.<; higher doses for cancer pain management, from inappropriate w.;e, sm:h 

a.<; use In pediatrics. Additionally, platforms differ by state, creating a lack of uniformity in 

accessing PDMP data, More work is needed to mitigate issues of cross-::;tate PDMP data accesse.g., al1ow prcscrlhcrs and dispen.'iers to obtain patients' prescription records from aC'ross state 

lines to pro\ide a more complete in-state and out-of-state medication history for at-risk patients. 

Contimwd state-lcYel cva.Ination ofPDNIPs is needed to identl~y and evaluate promising 

practices and to build synergies nece.ssary for application at Lhe federal1eve1. \Ve hope the 

committee will consider these concerns. 

H.R. 5197, Alternatives to Opioids in the Emergency Department Act 

4 
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\Ve supporl1cgislation that \Vould encourage alternatives for opioid use in hospital EDs. 

Specifically, '\.Ve are encouraged. by consideration of H.R. 5197, the Alternatives to Opioids 

(ALTO) in the Emergenc.y Department Act. This legislation would allow hospitals to rein in 

oploid prescrihing by assessing lhe use of alternate medication options for pain management. 

This prolocol is currently underway at St. Joseph's Health, an essential hospital in Paterson, Ne\v 

Jersey, and. is an effective tool to combat opioid addiction. 

II.R .. lll02, Suhstancc Use Disorder Workforce l~oan Repayment Act 

Ilealth care v.rorkforcc shortages pr~sent .'iignificant challengeR. Substance use disorder (SUD) 

treatment profe-ssionals arc critical in lhc fight against opioid addiction, and creating incentives 

for health care and other social service professionnls to treat individuals w·ith SUDs will help to 

strengthen the workforce in an area with severe needs. Given the financial burden often placed 

on students training in health-related. fields, f-I.R. 5102, the Substance Usc Disorder \Vorkforee 

LDan Repayment Act, will take a step in the right direction to f'ncourage health professionals to 

work directly on .SUD treatment. By offering student loan repayment for these professionals, 

essential hospitals, who often treat some of the most significant opioid addiction ca,<;es, will have 

greater access to trained SUD profe.<>sionals and can expand. their work already underway to fight 

opioid addiction. 

H.R. 5261, Treatment, Education, and Community Help lo Combat Addiction Act 

America's Essential Hospitals supports IT.R. fi261, the Treatment, Education, and Community 

HPlp to Combat Addiction Act, which would. support learning institutions that specialize in SUD 

treatment education to improve how health professiona-ls are taught about SUD and pain 

management for patients. This bill \vould help address gaps in educational programs provided to 

physicians at essential hospitals to ensure SUD paticnL'i receive the most comprehensive care for 

their exposure to opioids. 

H.R. _,Poison Center Network Enhancement Act 

The Poison Center Network Enhancement Act would reauthorize the national network of poison 

control centers, which offer free, confidential, expert medica] advice and. serve as primary 

resources for poisoning information. Essential hospitals frequently work in tandem with poison 

control centers to <'!ddress public health ernergcncles, including opioid exposures. Specifically, 

these centers help lessen the hurd en on EDs through in-home treatment for opioid exposures. 

Reauthorizing thi.'l network would allow for broader communication between the 

centers to improye care for those exposed to opioids before they enter hospital systems. 

Discussion Draft ofH.R. _,A Rill to Support the Peer Support Specialist 'Vorkforce 

We support including language to improve the peer support specialist workforce. This provision 

would. expand Department of IIealt.h and Human Sen ices grants to peer support speciaHst 

organizations providing recovery services. Peer support specialists are indiYiduals recm·ering 

from a subs lance use disorder (SUD) \vho have received formal training on how to support and 

mentor other individuals new to the rceovery proce~'is. Peer support has been a succes.'iful tool to 

support ind.ividuaJs ne,vly diagnosed. with a disease or disorder. Essential hospitals have 

successfully used multidisciplinary approaches to the treatment of individuals with SUDs, and 

peer snpport sp<:>cialists can be a critlcal tool to an individuals' recovel)·. 

We appreciate your consideralion of these provisions and look fonv<1rd to working 'vith yon to 

improve the legislati,·e package to pffectively eonntcr this ongoing crisis. 
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OFFICERS 

130AR0 OF DIRECTORS 

Oirector>-at-large 

Regional Directors 

Ex·Officio 

FOUNDING PRESIDENT 

American Society of 

Addiction Medicine 

March 21, 2018 

The Honorable Michael Burgess 

Chairman 

Health Subcommittee 

House Committee on Energy 

and Commerce 

U.S. House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Gene Green 

Ranking Member 

House Subcommittee 

House Committee on Energy and 

Commerce 

U.S. House of Representatives 

2322A Rayburn House Office Building 

Washington, DC 20515 

Re: 201B Substance Use Disorder Treatment, Prevention, and Recovery 

Package 

Dear Chairman Burgess and Ranking Member Green, 

On behalf of the American Society of Addiction Medicine (ASAM), the 

nation's oldest and largest medical specialty society representing more 

than 5,100 physicians and allied health professionals who specialize in 

the prevention and treatment of addiction, we are writing to offer 

legislative comments and recommendations as the House Energy and 

Commerce Subcommittee on Health works on a comprehensive, 

legislative response to our nation's opioid overdose and addiction crisis. 

As you know, the cost of substance misuse, and untreated and 

ineffectively treated addiction in the United States is staggering, both in 

economic terms and in terms of human lives lost During the twelvemonth period ending January 2017, the Centers for Disease Control and 

Prevention estimates there were approximately 64,000 drug overdose 

deaths-' Recently, the White House Council of Economic Advisers 

announced that the cost of the opioid crisis, alone, approached $504 

billion in 2015." And while opioid·related overdose deaths may 

dominate national headlines, the associated costs are a fraction of the 

total societal cost of substance misuse and addiction. Each year alcohol 

misuse leads to approximately 88,000 deaths in America."i Cigarette 

smoking contributes to another 480,000." These costs, however, could 

be dramatically reduced by utilizing effective substance misuse 

prevention practices and programs and by addressing untreated, and 

ineffectively treated, addiction in this country. 

Given these alarming statistics, we appreciate your leadership regarding 

the possible passage of legislation aimed at addressing our country's 

crisis of addiction involving opioid use. President Donald J. Trump's 

direction to declare the opioid epidemic a nationwide public health 
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emergency on October 26, 2017 was a historic first step, but turning the tide on the current 

crisis and preventing future crises related to substance misuse and addiction require a new 

approach to the delivery of substance use prevention, addiction treatment, and recovery support 

services. Considering all the lives we have lost and all the lives we still risk losing, the time for 

transformational change is now. Thus, ASAM respectfully offers these comments for your 

consideration as you embark on the hard work that lies ahead. 

Advancing Cutting-Edge (ACE) Research Act (H.R. 5002/S. 2046) 

The ACE Research Act would facilitate additional research into treatments for public health 

epidemics such as the opioid addiction crisis by providing the National Institutes of Health (NIH) 

with new tools and flexibility to approve high-impact, cutting-edge research. Patients with 

addiction and patients with chronic pain, like all patients, should have available to them a robust 

and varied array of treatment options, as no one treatment modality is appropriate or 

therapeutic for everyone. We support research and the development of non-addictive pain 

treatment options and additional therapies to treat addiction. These new treatments could not 

only help save lives but help prevent addiction from taking hold in the first place. ASAM 

supports the ACE Research Act and recommends that Congress incorporate it into a future 

legislative package to address the opioid addiction epidemic. 

The Addiction Treatment Access Improvement Act (H.R. 3692/S. 2317) I Amendment in the 

Nature of a Substitute to H.R. 3692 

To make a meaningful and sustainable impact on the current opioid overdose epidemic, it is 

imperative that we build a robust treatment workforce. There are simply too few physicians and 

other clinicians with the requisite knowledge to meet the needs of the estimated 20.1 million 

Americans suffering from untreated substance use disorders. The Addiction Treatment Access 

Improvement Act makes great strides in doing so by codifying the Final Rule issued by the 

Department of Health and Human Services (HHS) in July 2016 that raised the DATA 2000 

patient limit for certain physicians to 275 patients, eliminating the sunset date for nurse 

practitioners' (NPs) and physician assistants' (PAs) prescribing authority for buprenorphine, and 

expanding the definition of 'qualifying practitioner' to include nurse anesthetists, clinical nurse 

specialists, and nurse midwives. 

These changes would increase the number of the clinicians to meet the needs of patients who 

are seeking treatment for their addiction but are unable to find a practitioner who can treat 

them. It is essential that we increase the treatment workforce, and we urge Congress to include 

these provisions (or the provisions in the substitute amendment that would also shorten the 

timeframe to reach the 100-patient limit in certain circumstances) in any legislative package 

moving forward. 

Substance Use Disorder Workforce loan Repayment Act (H.R. 5102/S. 2524) 

In addition to expanding and codifying the eligibility of existing treatment providers, it is 

imperative that our country make strategic investments to incentivize clinicians to work in 

programs and practices that specialize in the treatment of addiction. To accomplish this goal, the 

Substance Use Disorder Workforce Loan Repayment Act helps clinicians who pursue full-time 

substance use disorder treatment jobs in high-need geographic areas repay their student loans. 

Many parts of the United States, and particularly rural areas, suffer from a lack of treatment 

providers. ASAM supports the goals of this bill and its efforts to incentivize clinicians to work in 
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substance use disorder treatment programs in these high-need areas and urges Congress to 

include it in any future legislative package to address the opioid epidemic. 

The Reinforcing Evidence-Based Standards Under Law in Treating Substance Abuse (RESULTS) 

Act (H.R. 5272) 

ASAM is pleased that the House Energy and Commerce Subcommittee on Health is holding a 

hearing that includes the RESULTS Act of 2018. The RESULTS Act would require grant, loan, and 

other recipients of funds from the Department of Health and Human Services for a mental health 

or substance use disorder prevention or treatment program to use evidence-based practices. We 

also support research and the development of new and innovative treatments for substance use 

disorders that will contribute to the body of knowledge that is needed for emergent or innovative 

programs and activities to become evidence-based. 

There are many misconceptions about the disease of addiction, and we need a culture change in 

this country to drive patients to the treatment options that have been proven to be effective at 

reducing relapse and overdose deaths and supporting patients in remission and recovery. When 

it comes to opioid addiction, the most effective treatment options we have involve the use of 

medications in combination with specific psychosocial interventions to support remission and 

recovery. When we say, "Treatment works," we're not referring to every approach that claims to 

be treatment. We are physicians and other clinicians who specialize in the treatment of addiction. 

We're referring to those interventions that have scientific evidence to support their effectiveness. 

The RESULTS Act would raise the clinical standard to a level that we demand from all other 

forms of medicine-to use clinical methods and practices based on evidence-and ASAM is 

proud to support that goal. 

Preventing Overdoses While in Emergency Rooms Act (H.R. 5176) 

With the rise in the use of potent synthetic opioids such as fentanyl and carfentanil, the rates of 

opioid overdoses and emergency department visits due to opioid overdose have increased 

significantly. Data from CDC's Enhanced State Opioid Overdose Surveillance (ESOOS) program 

showed opioid overdose rates increased an average of 35% in the 16 states reporting from July 

2016 through September 2017. Eight states reported substantial increases (25% or greater) in 

opioid overdose emergency department visits.v 

People who are admitted to a hospital for a drug overdose and discharged without treatment are 

at elevated risk to relapse and overdose again. H.R. 5176, the Preventing Overdoses While in 

Emergency Rooms Act, works to prevent that from happening by authorizing the Secretary of 

the Department of Health and Human Services to create grants for health care sites with 

emergency departments to develop protocols for discharging patients who have presented with 

a drug overdose and enhance the integration and coordination of care and treatment options for 

individuals with substance use disorders after discharge. 

Addiction is a chronic brain disease and evidence shows that treatment is effective at achieving 

and sustaining remission and recovery. It is past due that we stop discharging patients from 

emergency rooms without treating their addiction. ASAM is proud to support the Preventing 

Overdoses While in Emergency Rooms Act and urges Congress to include it in any legislative 

package to address the needs of patients who have overdosed. 
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The Comprehensive Opioid Recovery Centers Act of 2018 (H.R. 5327) 

Treatment of the disease of addiction. without also addressing associated social externalities 

such as homelessness. will result in poorer outcomes. The Comprehensive Opioid Recovery 

Center Act would help to fill this gap in wrap-around care and services, by creating competitive 

grants to entities to establish or operate comprehensive opioid recovery centers. This policy 

would accomplish the two-fold objective of increasing access to treatment and ensuring that the 

treatment is comprehensive - offering a full continuum of clinical, vocational, and educational 

services to meet the needs of patients. In addition, the grants would prioritize entities in a state 

or Indian country with high per capita drug overdose mortality rates, so the resources are 

focused in areas that need it most. 

As you consider this legislation, ASAM offers these additional comments: 

Selected centers should be required to ensure that intake and ongoing evaluations meet 

the clinical needs of patients, including by offering assessments for services and level of 

care recommendations through independent, research-validated verification processes 

for reviewing patient placement in addiction treatment settings: 

Independent program evaluators should be required to evaluate program effectiveness; 

and 

Selected centers should be required to report on a set of pre-identified performance 

measures. 

ASAM applauds this legislation which would make great strides in increasing access to 

comprehensive treatment and urges Congress to include it in any upcoming legislative package 

to address the opioid epidemic. 

The Treatment, Education, and Community Help to Combat Addiction Act of 2018 (H.R. 5261) 

This legislation would amend the Public Health Service Act to provide for regional centers of 

excellence to enhance and improve how health professionals are educated in pain management 

and substance use disorder through development, evaluation, and distribution of evidencebased curriculum for health care professional schools. ASAM has recommended for years that 

medical, nursing, dental, pharmacy and other clinical schools increase curriculum time devoted to 

addiction screening and treatment, safe prescribing and pain management. We would also 

encourage you to consider supporting future proposals which would establish an additional 

pathway for physicians who have had comprehensive training in medical school treating and 

managing opiate-dependent patients to apply for a DATA 2000 waiver. 

We welcome this legislation and urge Congress to include it in any upcoming legislative package 

to address the opioid epidemic. 

Confidentiality and 42 CFR Part 2 

The federal regulations governing the confidentiality of drug and alcohol treatment and 

prevention records, 42 CFR Part 2 (Part 2), set requirements limiting the use and disclosure of 
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patients' substance use records from certain substance use treatment programs. Obtaining 

multiple consents from the patient is challenging and creates barriers to whole-person, 

integrated approaches to care, which are part of our current health care framework. Part 2 

regulations may lead to a physician treating a patient and writing prescriptions for opioid pain 

medication for that individual without knowing the person has a substance use disorder. 

Separation of a patient's addiction record from the rest of that person's medical record creates 

several problems and hinders patients from receiving safe, effective, high-quality substance use 

treatment and coordinated care. 

The advent of integrated health systems and electronic medical records has improved the safety, 

quality, and coordination of care for patients with any other health condition. Part 2 

requirements prevent patients with addiction from sharing in these benefits, even though 

electronic exchanges of other health information are governed by strict privacy and security 

standards set by the Health Insurance Portability and Accountability Act (HIPAA) and the Health 

Information Technology for Economic and Clinical Health (HITECH) Act. 

ASAM holds patients' privacy rights in the highest regards but recognizes the barriers that Part 2 

currently presents to coordinated, safe, and high-quality medical care cause significant harm, and 

that thoughtful changes to the law are necessary to mitigate this harm while protecting patients' 

privacy. Thus, we support changes that would align Part 2 with HIPAA's consent requirements 

for the purposes of treatment, payment, and healthcare operations. Such a change would allow 

for the sharing of patients' addiction treatment records within the healthcare system under 

HIPAA's well-established and modern privacy and security protections, while leaving in place 

Part 2's prohibition on disclosure of records outside the healthcare system. Moreover, we also 

welcome changes that would strengthen protections against the use of addiction treatment 

records in criminal proceedings, a further improvement to Part 2 that we see as essential to 

protect patients in treatment for substance use disorder. 

CARA 2.0 Act of 2018 (H.R. 5311/S. 2456) 

We appreciate the leadership of all the CARA 2.0 Act sponsors in filing this major legislative 

package aimed at addressing the opioid addiction crisis in our country. With that, we would like 

to respectfully provide comments and recommendations to you on provisions of the CARA 2.0 

legislation for your consideration. 

Section 3. Three Day Limit on Opioid for Acute Pain. 

We appreciate the desire to help reverse the exponential increases in opioid misuse, addiction, 

and death by limiting initial prescriptions for opioids to three days or less while exempting 

certain conditions such as chronic pain care and pain being treated as part of palliative care. 

While this goal is important, a "hard" three-day limit in federal statute is inconsistent with 

evidence-based guidelines such as the 2016 CDC Guideline for Prescribing Opioids for Chronic 

Pain (the "CDC Guideline"). 

According to Recommendation 6 of the CDC Guideline, "[w]hen opioids are used for acute pain, 

clinicians should prescribe the lowest effective dose of immediate-release opioids and should 

prescribe no greater quantity than needed for the expected duration of pain severe enough to 

require opioids. Three days or less will often be sufficient; more than seven days will rarely be 

needed."v' Further, the applicable CDC Guideline narrative reads as follows: 
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Experts thought, based on clinical experience regarding anticipated duration of pain 

severe enough to require an opioid, that in most cases of acute pain not related to 

surgery or trauma, a ~3 days' supply of opioids will be sufficient ... Some experts 

thought that because some types of acute pain might require more than 3 days of opioid 

treatment, it would be appropriate to recommend a range of ~3-5 days or ~3-7 days 

when opioids are needed. Some experts thought that a range including 7 days was too 

long given the expected course of severe acute pain for most acute pain syndromes seen 

in primary care.vii 

Considering the foregoing, we highlight three observations for your consideration. First, unlike 

the CDC Guideline, Section 3 of CARA 2.0 is not limited to primary care prescribers. Second, 

patients with acute pain related to surgery or trauma and for whom three days or less can be 

insufficient, may have to incur financial costs and bear logistical burdens to obtain additional 

medically-appropriate opioid medication. Further, such a 3-day limitation would inevitably and 

disproportionately impact patients with lower incomes and patients living in rural areas located 

many miles from their prescribers. Third, violating a federal statute can carry significant legal 

ramifications for prescribers trying to treat acute pain appropriately as compared to deviating 

from a voluntary guideline, such as the CDC Guideline. Therefore, ASAM strongly recommends 

that any statutory acute pain limitation passed by Congress incorporate more flexibility for 

prescribers to meet the medical needs of all their patients and should more closely align with the 

recommendations of the CDC Guideline. 

Section 4. First Responder Training. 

This section would provide funds primarily to make naloxone available to first responders to 

train and provide resources for carrying and administering naloxone. While we know state and 

local governments would certainly welcome federal assistance for naloxone training and 

distribution given the increasing cost of naloxone in this country, we urge you to consider 

enacting policy interventions which would allow the federal government to bulk purchase 

naloxone at discounted prices to increase access to this life-saving medication. Our nation's 

Vaccines for Children Program may be an existing model Congress could rapidly replicate to 

increase naloxone access for first responders, public health departments, and community 

organizations.'::: Such a program, coupled with investments aimed at enhancing the Centers of 

Disease Control and Prevention's surveillance capabilities for identifying overdose clusters and 

infectious disease outbreaks, could go a long way in preventing the spread of infectious diseases 

and death. 

Section 6. Building Communities of Recovery. 

ASAM supports additional investments in recovery support services for people trying to achieve 

long-term remission and recovery from the disease of addiction. However, we strongly caution 

against any statutory language which states that addiction recovery support services can be "in 

lieu of addiction treatment." Nearly 90% of Americans with addiction do not receive treatment 

and 80% of individuals with opioid addiction are not treated.:'' As many families know all too 

well, remission and recovery from addiction involving opioid use is often only preceded by 

evidence-based medical treatment. To put it simply, there is no remission or recovery if you are 

dead. 

Therefore, our nation must come to terms with the difficult reality in which we find ourselves: 

the current addiction treatment gap will never be closed with the current addiction treatment 
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workforce. While we want you to support additional investments in recovery support services, 

we urge you also to prioritize federal funding for Accreditation Council for Graduate Medical 

Education (ACGME)· accredited addiction medicine and addiction psychiatry fellowship 

positions and a loan repayment program for students who enter the substance use disorder 

treatment workforce.'' Additionally, please consider revising the Public Health Service (PHS) Act 

to include addiction medicine specialists in the definition of "behavioral and mental health 

professionals" within the National Health Service Corps. 

Section 7. Medication-Assisted Treatment for Recovery from Addiction. 

ASAM applauds the efforts in Section 7 of CARA 2.0 that would expand access to medicationassisted treatment for remission and recovery from addiction. As previously noted, it is 

imperative that we build a robust treatment workforce, and this section would make great 

strides in doing so by eliminating the sunset date for nurse practitioners' (NPs) and physician 

assistants' (PAs) prescribing authority under DATA 2000 and expanding the definition of 

'qualifying practitioner' to include nurse anesthetists, clinical nurse specialists, and nurse 

midwives. This section would also give individual states the option to waive the limit on the 

number of patients a physician can treat so long as the state directs its applicable state 

regulatory body to adopt evidence-based prescribing guidelines for the use of medication to 

treat addiction involving opioid use, such as ASAM National Practice Guideline for the Use of 

Medications in the Treatment of Addiction Involving Opioid Use. This policy change would help 

accomplish the two-fold objective of increasing access to and the quality of the prescribing 

medications for the treatment of addiction involving opioid use. 

We also welcome the opportunity to work with you and the CARA 2.0 sponsors to improve the 

innovative "Offer 2 Types of Medication-Assisted Treatment" minimum requirement in Section 

7(d) of CARA 2.0. For example, we would recommend that such minimum, two-medication 

requirement for medications to treat opioid use disorder only apply to residential treatment 

providers, prisons, and jails'" that receive federal funds for a program or activity offering 

addiction treatment to people with opioid use disorder, especially if a residential provider is 

receiving Medicaid funding due to a waiver or repeal of the Institutes for Mental Diseases (I MD) 

Exclusion within the Medicaid program. We would want to avoid any policy intervention which 

could result in an unintended consequence of decreasing access to life-saving medications 

prescribed by individual prescribers treating patients whose health care is federally-subsidized. 

Section 13. Require the Use of Prescription Drug Monitoring Programs (PDMP). 

ASAM believes that prescription drug monitoring programs (PDMPs) are an important tool to 

inform safe prescribing. From 2014 to 2016, there was a 121 percent increase in the number of 

queries by health professionals to state POMP databases.''" As a result, we applaud the creative 

policy innovations outlined in this section - namely that prescribers or their designees be 

required to query the POMP upon initial prescription of a controlled medication and quarterly 

thereafter if treatment continues. Further, requiring proactive reports, increased timeliness of 

data entry, and de-identified data sets for research and evaluation are also welcomed policy 

changes. However, requiring state agencies to provide reports to law enforcement agencies and 

licensing boards "describing any prescribing practitioner that repeatedly fall [sic] outside of 

expected norms or standard practices for the prescribing practitioner's field" is troubling as it 

could have an unintended chilling effect on appropriate prescribing, particularly with respect to 

disclosures to law enforcement outside of a court-supervised process. POMP information 

should be considered what it is: personal health information, and, therefore, should be protected 

from release like other personal health information. 
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In addition, we would be remiss not to urge you to fund research and evaluation programs that 

study best practices for integrating PDMPs into EHRs and clinician workflow in a meaningful, 

user-friendly manner. While PDMPs now exist in almost every state and practitioners are 

increasing their use of them, the lack of integration with electronic health records continues to 

inhibit the effective use of these clinical support tools. Further, in addition to improving and 

integrating these programs, ASAM recommends that Congress urge the Department of Health 

and Human Services to support the development of training for primary care providers to know 

how to engage a patient whose POMP report indicates he or she may be inappropriately 

accessing controlled substances. Without such training, many clinicians might simply dismiss 

patients from their practice without an assessment for substance use disorder or referral to 

treatment, if indicated. These clinicians are missing an important opportunity to engage patients 

in treatment and should be equipped to use the POMP report as a conversation-starter with 

patients at risk of addiction or overdose death. 

Telemedicine 

As stated in a testimony on behalf of ASAM before the House Energy and Commerce 

Subcommittee on Health, telemedicine provides significant opportunities to reach more patients 

in urban and rural communities. However, the current restrictions on internet prescribing under 

the Ryan Haight Act and the seven, specific "practice of telemedicine" exceptions it provides for 

are of limited utility for expanding access to treatment with buprenorphine for addiction 

involving opioid use via telemedicine. As you know, the Ryan Haight Act generally requires an 

"in-person medical evaluation" in the physical presence of the prescribing clinician for the 

prescription to be considered valid. 

The "practice of telemedicine" exceptions to this requirement provide for circumstances in 

which the patient is being treated by, and physically located in, a DEA-registered hospital or 

clinic, or in which the patient is being treated by and in the physical presence of another DEAregistered practitioner. It generally does not allow for circumstances in which a patient may have 

received a medical evaluation by another qualified practitioner but is not physically present in a 

DEA-registered hospital or clinic or with another DEA-registered practitioner. While The ASA/V1's 

Standards of Care';v and The ASA/V1 National Practice Guideline for the Use of Medications in the 

Treatment of Addiction Involving Opioid Use'v make it clear that patients presenting for treatment 

of addiction involving opioid use should receive a physical examination by a qualified and 

appropriately licensed health care professional as part of a comprehensive assessment process, 

they specifically allow for this examination to be conducted by a healthcare professional other 

than the prescriber, as long as the prescriber "ensure[s] that a current physical examination is 

contained within the patient medical record before a patient is started on a new medication for 

the treatment of his/her addiction." 

ASAM recommends that Congress pass legislation to revise the Ryan Haight Act to include an 

additional exception to the requirement for an in-person physical exam by the prescribing 

clinician to allow for a current physical exam to be conducted by another appropriately licensed 

health care professional and documented in the patient's medical record. Additionally, ASAM 

recommends limiting this exception to the in-person physical exam requirement for patients who 

will be treated with buprenorphine for opioid addiction only to those physicians who hold 

"additional certification" or who practice in a "qualified practice setting" per the definitions in the 

2016 SAMSHA rule that raised the DATA-2000 prescribing limit. 
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Additional Recommendations 

On March 8, 2018, the Senate HELP Committee held a hearing titled "The Opioid Crisis: 

Leadership and Innovation in the States." Hearing participants discussed recommendations from 

Governors across the U.S. expressed at the National Governors Association annual winter 

meeting. Toward the conclusion of that hearing, Chairman Alexander highlighted the problem of 

an "unevenness" in addiction treatment program quality across the country. We would be 

honored to have the opportunity to meet with Congressional leaders to discuss, in greater detail, 

possible federal action that could start incentivizing states to continue building out an addiction 

treatment infrastructure that can consistently deliver quality care for people suffering with 

addiction. 

We know well that as the field of addiction treatment works to integrate more fully with 

traditional medical care, it is imperative that it "catch up" with other medical specialties in terms 

of clinical guideline development and quality measurement. Federal efforts to promote highquality addiction treatment could include support for the following: 

• Development and dissemination of clinical practice guidelines for addiction treatment, 

such as the ASAM National Practice Guideline for the_Use Qf Meqications in the Treatment of 

Addiction Involving Opioid Use and of science-based patient guides, such as the Opioid 

Addiction Treatment: A Guide for Patients, Families and Friends, that include information on 

assessment, treatment overview (including treatment plans, patient participation, and 

counseling), and all the medications available to treatment opioid use and overdose: 

• Establishment and maintenance of addiction treatment programs that ensure intake and 

ongoing evaluations meet the clinical needs of patients by offering assessments for all 

substance use disorder services and level of care recommendations through an 

independent, research-validated verification process for reviewing patient placement in 

addiction treatment settings: and 

• Implementation of, and related technical assistance for, nationally-recognized and 

research-validated treatment center certification programs that can provide patients, 

families, and payers with a reliable indicator that providers are delivering a certain level 

of care. 

Efforts such as these are critically needed to help improve the overall quality of addiction 

treatment provided in our nation and assure those who are seeking and paying for treatment 

that they are receiving medically appropriate and high-quality care. 
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Thank you for the opportunity to make recommendations and offer additional tools that may be 

helpful to combat this public health emergency. We look forward to working with you to build 

upon the progress already made and help lay the foundation for a future in which long-term 

remission and recovery from addiction is not only possible, but probable. If you have any 

questions or concerns, please contact Kelly Corredor, ASAM's Director of Advocacy and 

Government Relations, at kcorredor@asam.org or at 301-547-4111. 

Sincerely, 

Kelly J. Clark, MD, MBA, DFASAM 

President, American Society of Addiction Medicine 

cc: The Honorable Greg Walden 

The Honorable Frank Pallone 

'Provisional Counts of Drug Overdose Deaths, as of 8/612017; 

https :/ lwww. cd c.gov Inch s I data /he a I th _poI icy I monthly-drug-overdose-death-estimates. pdf 

;; White House: Opioid Crisis Cost US Economy $504 Billion in 2015; https:llwww.voanews.comla/us-opioidcrisis-white-house-report/4126121.html. [Accessed on 2017 November 27]. 

;,; Stahre, M., Roeber, J., Kanny, D., Brewer, R. D., & Zhang, X. (2014). Contribution of excessive alcohol 

consumption to deaths and years of potential life lost in the United States. Preventing Chronic Disease, 

11(E109). 

iv U.S. Department of Health and Human Services. The Health Consequences of Smoking-50 Years of 

Progress: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, 

Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health 

Promotion, Office on Smoking and Health, 2014 [accessed 2017 Nov 29], 

v Centers for Disease Control and Prevention. CDC Vital Signs, March 2018. 

https://www.cdc.gov/vitalsiqns/pdf/2018-03-vitalsigns.pdf. Updated March 6, 2018. Accessed March 15, 

2018. 

vi Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United 

States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1-49. DOl: 

http:/ ldx.doi.orgl10.155851mmwr.rr6501e1 

vii !d. 

v>ii Vaccines for Children (VPC) Program. Retrieved from 

https: llwww. cdc.gov Iva ccines/ p rograms/vfc lin dex. htm I 

"Legal Action Center. (2015). Confronting an Epidemic: The Case for eliminating Barriers to Medication Assisted 

Treatment of Heroin and Opioid Addiction. Washington, D.C: Legal Action Center. Available at http://lac.org/wpco ntg nt/u ploa dsil 014/0 7 /LI\C-T h_g:c9 se-f or-E I i rn i n_agr>g:Q_a_r_rje rs-to-Med i cat io n,Ass iste d-Treat me rlL!lQ£ 

x Saloner PhD, Karthikeyan MPP. Changes in Substance Abuse Treatment Use Among Individuals with Opioid Use 

Disorders in the U nrted States, 2004-2013. The Journal of the American Medical Association. 2015;314(14):1515-

1517 

x; By way of further background, in 2016, addiction medicine was recognized as an American Board of 

Medical Specialties (ABMS) subspecialty under the American Board of Preventive Medicine (ABPM). The 

first ABMS addiction medicine board exam was offered in October 2017. While the board exam will be 

open to any American physician with a primary ABMS board certification until 2022, after that time, 

physicians will need to complete a year-long fellowship program to be qualified to sit for the exam. In five 

short years, the number of accredited and funded addiction medicine fellowship programs and slots will be 

the limiting factor in determining how many addiction medicine specialists can receive board certification. 
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It is critical that all stakeholders work to maximize funded addiction medicine fellowship opportunities 

before their number begins to limit qualified examinees. 

'"Green TC, Clarke J, Brinkley-Rubinstein L, Marshall BDL, Alexander-Scott N, Boss R, Rich JD. Post 

incarceration Fatal Overdoses After Implementing Medications for Addiction Treatment in a Statewide 

Correctional System. JAMA Psychiatry. Published online February 14, 2018. 

doi:10.1001/jamapsychiatry.2017.4614. 

xiil Based on AMA survey and responses from 44 state POMP administrators. https:/ /www.amaass n. org/ sites I default/ files/ media- browser I public/ p hys icia n s/ patient -ca rei opioid -task-force-progressreport. pdf 

'

1

' American Society of Addiction Medicine. The ASAM Standards of Care for the Addiction Specialist 

Physician. 2014. Available at: https:/ /www.asam.org/docs/default-source/practice-support/qualityimprovement/asam-standards-of-care.pdf?sfvrsn=338068c2 10 

"Kampman K and Jarvis M. American Society of Addiction Medicine (ASAM) National Practice Guideline 

for the Use of Medications in the Treatment of Addiction Involving Opioid Use. J Addict Med 2015;9: 1-

10. 
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Board of Directors 

Lynda Zeller 

President 

Michigan 

Wayne Lindstrom, Ph.D. 

Vice President 

New Mexico 

Valerie Mielke, M.S.W. 

Secretary 

New Jersey 

Terri White, M.S.W. 

Treasurer 

Oklahoma 

Tracy J. Plouck 

Past President 

Ohio 

Vacant 

At~Large Member 

Doug Thomas, M.S.W, 

LC.s.w. 

At-Large Member 

Utah 

Sheri Dawson, R.N. 

Mid-Western Regional 

Representative 

Nebraska 

Barbara Bazron, Ph.D. 

Northeastern Regional 

Representative 

Maryland 

John Bryant 

Southern Regional 

Representative 

Florida 

Thomas Betlach 

Western Regional 

Representative 

Arizona 

Brian Hepburn, M.D. 

Executive Director 

NASMHPD 

National Association of State Mental Health Program Directors 66 Canal Center Plaza, Suite 302:, Alexandria, VA 22314 (703) 739-9333 Fax (703) 548-9517 

April 6, 2018 

The Honorable Greg Walden 

Chairman 

House Energy and Commerce 

l 04 Hart 2185 Rayburn HOB 

Washington, DC 20515 

The Honorable Frank Pallone 

Ranking Member 

House Energy and Commerce 

23 7 Cannon HOB 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

The National Association of State Mental Health Program Directors writes to seek 

your support for the inclusion, within the Energy and Commerce package of 

legislation designed to fight the U.S. opioid epidemic, of legislation that would 

align the statute underlying the 42 CFR Part 2 regulations with the disclosure 

provisions of the Health Insurance Portability and Accountability Act (HIPAA). 

NASMHPD is the organization representing the state executives responsible for the 

$41 billion public mental health service delivery systems serving 7.5 million 

people annually in 50 states, 4 territories, and the District of Columbia. 

Information-sharing among health care providers treating a patient being treated for 

substance use disorders is limited under current law because of the restrictions 

outlined under 42 CFR Part 2 and its underlying statute, 42 U.S.C. § 290dd-2 

against the disclosure of records containing diagnosis, treatment, and referral 

information without specific patient consent. 

That statute, enacted in the 1970s, well before HIPAA, and its regulations prohibit 

the sharing of treatment information-including pharmaceutical treatment 

involving the use of opioids or opioid antagonists-among treating providers 

absent specific patient consent. The inability of a patienfs other treating providers 

to access that information automatically) if the substance use disorder patient has 

not thought or agreed to bring his or her other providers into the treatment loop, 

raises the risk of adverse prescription reactions) addiction regression, and even 

opioid overdose. It also prevents the integration of care so crucial for patients who 

so often have co-occurring substance use, mental, and medical disorders and 

conditions. 

While the Substance Abuse and Mental Health Services Administration 

(SAMHSA) recently relaxed 42 CFR Part 2 to permit sharing for purposes of 

operations and payment, the agcney specifically prohibited sharing among 

providers. The agency's legal counsel advises that current law docs not permit it to 

relax restrictions on disclosures among providers. The conduits of any sharing that 

might be permitted, the Health Information Exchanges, remain reluctant to share 

substance use diagnosis, treatment, and referral information on their networks, 

even for the limited purposes permitted, because of ambiguity in what the relaxed 

regulations mean, the potential legal liability for mistaken disclosures, and the 

expense and technological difficulty in redacting substance use disorder 

information from patient information. 

H.R. 3545, as originally introduced by former Representative Tim Murphy and 

now sponsored by Representative Markwayne Mullin, would have maintained the 

existing statutory prohibition against the use of the subject records to initiate or 
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l'\ASMI !J>D Li.:tlCr on Inclusion or H.R. 3545 in Lm:rg; and Commerce Op10id Legislation 

substantiate any criminal charges against a patient or to conduct any investigation of a patient, except 

under court order. Use of those records in criminal proceedings have to be excluded from evidence, and 

proceedings <:lutomatical\y dismissed where the records were offered into evidence. 

In response to concerns expressed by some attorney advocates for individuals with substance use 

disorders, the amended version of H.R. 3545 offered by Representative Mullin in the Energy and 

Commerce Health Subcommittee would significantly expand the existing prohibition against use in 

crimina! proceedings to also ban the usc of substance use disorder patient treatment information without a 

court order to initiate or substantiate any civil or administrative charges, claims, or allegations against a 

patient, or to conduct any investigation of a patient 

The amended bill also requires the exclusion from evidence of any substance use disorder treatment record 

in any proposed or actual actions or proceedings relating to such criminal, civil, or administrative charges, 

claims, allegations or investigations that has been used or disclosed to initiate or substantiate any criminal 

or civil charges, claims, or allegations against a patient or to conduct any investigation of a patient. In 

addition, absent good cause shown, the use of those records would result in the automatic dismissal of any 

actions or proceedings for which the content of the record was offered. 

The legislation also responds to the expressed fears of the same attorney advocates by specifically 

restating the prohibitions against discrimination already prohibited under the existing Americans with 

Disabilities Act to protect individuals in treatment fOr substance use disorders prohibiting discrimination 

in (i) admission or treatment for health care; (ii) hiring or terms of employment; (iii) the sale or rental of 

housing: or (iv) access to Federal, State, or local courts. 

In summary, the amended bill would facilitate the integration of care and patient safety for individuals 

treated for substance usc disorders, while also increasing the protections against stigma, discrimination, 

and prosecution, and the usc of those records in criminal, civil, and administrative actions. Enabling 

treating providers to share substance usc disorder treatment records would not only help to integrate care 

for individuals most likely to have co-occurring medicaL mental, and substance use conditions and 

disorders, but would also serve to avoid adverse prescription reactions and substance usc and opioid 

overdoses. 

As such, H.R. 3545 constitutes a critically necessary tool in any Congressional toolkit to com hat th~ U.S. 

opioid crisis. We urge strongly that it be included in the final Energy and Commerce legislative package. 

Please feel free to reach out to !ll£ by email or by phone at 703-682-5181 or to NASMHPD's Director oC 

Policy and Communications, ~a11 Yael Go;:\!Q!l, by email or by phone at 703-682-7552 with any 

questions regarding this letter. 

Sincerely, 

l3rian Hepburn, M.D. 

Executive Director 

National Association of State Mental Health Program Directors (NASMHPD) 

cc: Kristen Shatynski 

Waverly Gordon 

Pamela CJreenberg 
154 


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Jt American Association on Health & Disability 

110 N. Washington Street Suite 328-J Rockville, MD 20850 

T. 301-545-6140 F. 301-545-6144 www.aahd.us 

AMiD Dedicated to better health for people with disabilities through 

health promotion and wellness 

April 7, 2018 

Re: HR 3545- Overdose Prevention and Patient Safety Act 

The Honorable Greg Walden 

Chainnan 

House Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington. DC 20515 

Kristen.shatynski(ii'mail.housc.gov 

Caleb.gruff(aimail.housc.gov 

The Honorable Frank Pallone . .Jr. 

Ranking Member 

House Committee on Energy and Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

'J!.averlygQIQgn@mail.housc.gov 

Tiffany. gu a rase i or(l,m ui I. house .gov. 

Dear Representatives Walden and Palone: 

The American Association on Health and Disability (AAHD) (www.aahd.us) is a national nonprofit organization of public health professionals, both practitioners and academics, with a 

primary concern for persons with disabilities. The AAHD mission is to advance health 

promotion and wellness initiatives for persons with disabilities. 

AAIID is a member of the Partnership To Amend 42 CFR l'art 2. Medical records privacy 

provisions should be aligned with and fully support integrated whole-person health care. The 

focus should be on maximizing the health of individuals, consistent with precise patientconsumer~cnrol!ce consent and shared decision-making. Knowledge of all medications currently 

used by a patient-consumer-enrollee and particularly avoidance of counter-indicated medications 

should be an important component of individualized whole-person health. 
155 


32361.087

Thus, AAIID supports passage of HR 3545, consistent with the approach of the Partnership To 

Amend 42 CFR Part 2. 

Thank you tor your consideration. If you have any questions please contact Clarke Ross at 

clarkeross I O({t'comcast.net. 

Sincerely, 

'- ' ~ \-? ,.-1.-0 

E. Clarke Ross, D.P.A. 

Public Policy Director 

American Association on Health and Disability 

clarkcross I Q@£9mca§!.net 

Cell: 301-821-5410 

Roberta S. Carlin, MS, JD 

Executive Director 

American Association on Health and Disability 

II 0 N. Washington Street, Suite 328J 

Rockville. MD 20850 

301-545-6140 ext. 206 

301 545-6144 (fax) 

rgarlin@aahd.us 

cc. tavlor.fllttlel2l)!nail.hous~ 

Kristcn..:donheffllcr(Wmail.house.gov 
156 


32361.088

C®nnmt 

National Alliance on Mental Illness 

April 9, 2018 

The Honorable Greg Walden 

Chairman 

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, DC 20515 

The Honorable Frank Pallone 

Ranking Member 

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

On behalf of the National Alliance on Mental Illness (NAMI), I am writing to offer our strong 

support for the Overdose Prevention and Safety Act (HR 3545). As the nation's largest 

organintion representing people living with mental illness and their families, NAMl is pleased 

to support this important legislation to advance the pursuit of integrating care and improving 

outcomes in behavioral health care. 

NAMI believes that 42 CFR Part 2 remains an outdated and antiquated barrier to coordinated 

care, particularly for individuals with co-occurring mental illness and a substance use disorder. 

As you both know, individuals diagnosed with a mental health conditions are at much greater 

risk of abusing substances and falling into the grip of addiction. Additionally, we know that 

siloed treatment for mental illness and addiction is ineffective and leads to negative outcomes in 

both an individual's mental health and substance use condition. In many instances, it also creates 

an even greater risk that individuals will experience poorly managed co-morbid, chronic medical 

conditions. This is a major contributing tirctor to the high rates of early mortality for individuals 

living with mental illness. Numerous studies have found that life expectancy for adults with 

mental illness may be as much as 25 years less than the general population. 

Integrating care across not only mental health and substance use care, but also with primary and 

specialty medical care, is effective at improving clinical outcomes. It also lowers overall costs 

across public programs, such as Medicare and Medicaid, and private programs like employerprovided health insurance. However, integration cannot be achieved without the sharing of 

treatment records among providers. 42 CFR l'alt 2 remains a significant barrier to the sharing of 

clinical data and the proper coordination of care. These burdensome consent requirements that 

arc not aligned with HIPAA further stigmatize mental illness and substance abuse as separate 

ti·om the rest of the health care system. Parity is necessary across the health care system to ensure 

that behavioral health records are managed the same as all patient data. 

With bipartisan support, the Energy and Commerce Committee has embraced alternative 

payment models (APMs) and is moving our nation's health care system toward paying for "value 

over volume." As long as behavioral health records remain subject to separate rules that prevent 

NAMI. 3803 North Fairfax Drive, Suite 100. Arlington, VA 22203-1701 

(703) 524· 7600 • www. nami.org 
157 


32361.089

the sharing of data for treatment, payment and health care operations, mental health and 

substance usc will again be !eli behind the rest of the health care system. As you advance 

addiction treatment legislation this spring, NAMl urges you to include the provisions that are in 

HR 3545 in any bill that is produced by the Committee. This is an important oppo11unity to 

improve coordination of care and produce better outcomes for people with mental health and 

substance usc conditions. 

Separate is never equal. It is time to align 42 CFR Part 2 with IIIPAA and move us toward the 

goal of true health care integration. Thank you for your leadership on this important issue. 

Sincerely, 

~7~~· 

Mary Gilibcrti, J.D. 

Chief Executive Officer 

NAMI, National Alliance on Mental Illness 

2 
158 


32361.090

American 

~ Hospital 

Association. 

AprillO, 2018 

The Honorable Greg Walden 

Chairman 

Energy and Commerce Committee 

United States House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 20515 

0Cll10111Stree~NW 

Two CityCenter, Suite 400 

Washington, DC 200!1-4956 (202) 638-1100 Phone 

W\MN.aha.org 

The Honorable Frank Pallone, Jr. 

Ranking Member 

Energy and Commerce Committee 

United States House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, 

and our clinician partners- including more than 270,000 affiliated physicians, 2 million nurses and 

other caregivers- the American Hospital Association (AHA) thanks you for your leadership in 

addressing the nation's opioid epidemic. As you begin to craft comprehensive legislation in the 

Energy and Commerce Committee, we write to reiterate our strong support of H.R. 3545, the 

Overdose Prevention and Patient Safety (OPPS) Act, which would align 42 CFR Part 2 with the 

Health Insurance Portability and Accountability Act for the purposes of treatment, payment and 

health care operations. 

Clinicians treating patients for any condition need access to their complete medical histories, 

including information related to any substance use disorder (SUD), to ensure their patients' safety, 

and delivery of the highest quality care. Partitioning a patient's record to keep SUD diagnoses and 

treatments hidden from the clinicians entrusted to care for the patient, as required by 42 CFR Part 2, 

is dangerous for the patient, problematic for providers and contributes to the stigmatization of 

mental and behavioral health conditions. 

Too many patients who suffer from an SUD have stories of how a well-intentioned emergency room 

physician or other clinician nearly prescribed them an opioid or another drug that would have 

endangered their life or sobriety. Such incidents occur because current law prevents some clinicians 

from accessing information on the patient's SUD and treatment plan unless the patient has given 

consent. 

Clinicians in our hospitals and health systems must go to extraordinary lengths to comply with the 

requirements of 42 CFR Part 2. For example, we have heard concerns from obstetricians who 

specialize in treating pregnant women with SUD diagnoses and other clinicians who treat both the 

physical and SUD diagnoses of patients. To ensure compliance with 42 CFR, Part 2, as currently 
159 


32361.091

The Honorable Greg Walden 

The Honorable Frank Pallone, Jr. 

April 10, 2018 

Page 2 of2 

written, they must maintain two separate computers and two separate medical records. This adds 

burden and expense, but without benefit. 

Recent revisions made by the Substance Abuse and Mental Health Services Administration 

(SAMHSA) to the Part 2 regulations are not a significant improvement over the previous 

requirements, and do little to eliminate the regulation's barriers that impede the robust sharing of 

patient information necessary for effective clinical integration and quality improvement. Complete 

alignment of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) 

privacy rule will therefore require statutory changes. 

The importance of coordinated care for patients in treatment for opioid use disorder cannot be 

overstated, and 42 CFR Part 2, enacted more than 40 years ago, is a major barrier to such care. 

Congress must amend this law, which impedes the sharing of critical patient information that is 

necessary to deliver the most effective and efficient care. Applying the same requirements to all 

patient information whether behavioral or medical would support the appropriate information 

sharing essential for clinical care coordination and population health improvement, while 

safeguarding patient information from unwarranted disclosure. H.R. 3545 would achieve these 

goals and we, therefore, urge the Committee to report this important legislation as introduced. 

If you have questions or would like further information, please contact Priscilla A. Ross, Senior 

Associate Director, Federal Relations, at pross@aha.org or (202) 626-2677. 

Sincerely, 

~asP. 

~~ .. ~ ickels 

Executive ice President 

cc: Members of the Committee on Energy and Commerce 
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I 

Academy of 

P Managed Care 

j Pharmacy* 

April 10,2018 

The Honorable Greg Walden 

Chairman 

House Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Frank Pallone, Jr. 

Ranking Member 

House Committee on Energy and Commerce 

2322A Rayburn House Office Building 

Washington, DC 2015 

RE: H.R. 3545- "Overdose Prevention and Patient Safety Act" 

Dear Chairman Walden and Ranking Member Pallone: 

The Academy of Managed Care Pharmacy (AMCP) is writing in strong support of 

H.R. Jj45 -the "Overdose Prevention and Patient Safety Act". As you know, ILR. 3545 has bipartisan support 

and was introduced by Reps. Markwaync Mullin (R-OK), Earl Blumenauer (R-OR), Jim Renacci (R-OH), 

Buddy Carter (R-GA) and Pat Meehan (R-PA). Under your leadership the Energy and Commerce Committee 

continues its bipartisan efforts to address the opioid epidemic. We applaud your efforts and are especially 

supportive of your approach to the problem because you acknowledge that it must be addressed on many fronts. 

To that end, H.R. 3545 is designed to addresses the issue of patient substance abuse disorder records by 

bringing those records under the protection of the Health Insurance Portability and Accountability Act (HIPPA). 

AMCP is the nation's leading professional association dedicated to increasing patient access to affordable 

medicines, improving health outcomes and ensuring the wise use ofheallh care dollars. Through evidence- and 

value-based strategies and practices, the Academy's 8,000 pharmacists, physicians, nurses and other 

practitioners manage medication therapies for the 270 million Americans served by health plans, pharmacy 

benefit management firms, emerging care models and government. AMCP is also a member of the Partnership 

to Amend 42 CFR Part 2, a coalition of more than 40 organizations representing stakeholders across the health 

care spectrum committed to aligning Part 2 with the Health Insurance Portability and Accountability Act 

(HIPAA) to allow appropriate access to patient information that is essential for providing whole-person care. 

The restrictions implemented by 42 CFR Part 2, under authority granted by a law passed more than 40 years 

ago, limit the ability of health care providers to implement treatment protocols designed to provide "wholeperson'' care which includes the use of multi-disciplinary health care provider teams to diagnose and treat 

patients. Pharmacists, as medication experts, are integral members of those provider teams. However, 

pharmacists, doctors, nurses and other health care providers do not have complete access to addiction treatment 

records. Access to a patient's complete medical record is critical to patient treatment, safety, and recovery. 

Of equal concern for patient safety and treatment, is the multitude of unintended consequences of drug to drug 

interactions, adverse reactions, and even death. Opioids obtained legally, such as those containing oxycodonc, 

and those obtained illegally, such as heroin, may have significant side effects when used with other legal!y 

prescrihed medications. I fa person with an addiction has taken an opioid either legally or illegally and then 

675 North W~Shtngton Street I Suite 220 I Alexandria, VA 22314 j 703 684 2600 I ~amcparg 
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receives an addilional dose of another opioid. an individual may either experience impairment in their ability to 

breathe, known as respiratory depression, coma, or even death. 

As you know, the opioid epidemic is an ongoing crisis for many patients, their families, the health care system 

and every state has their "number" of known deaths from overdoses and the mounting toll faced by those 

suffering from addiction and financial losses resulting from it By integrating those substance abuse disorder 

records into a patient's medical records under HIPAA critical information would be available for treatment, 

payment and operations, yet safeguards and legal protections are also present to assure patients of privacy. 

We urge you to support H.R. 3545 as one of the ways to stem the tide of this deadly and costly epidemic. We 

must continue to work together and if we can provide additional information, please do not hesitate to contact 

me at 703-684-2600 or at scantrell@amcp.org. 

Sincerely, 

Susan A. Cantrell, RPh, CAE 

Chief Executive Officer 
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Avera 

April10, 2018 

The Honorable Greg Walden 

Chairman 

House Energy & Commerce Committee 

2125 Rayburn HOB 

Washington, DC 20515 

The Honorable Frank Pallone 

Ranking Member 

3900 W. Avera Drive 

Sioux Falls, SO 57108·5721 

(605) 322-4700 

Fax: (605) 322·4799 

www.avera.org 

House Energy & Commerce Committee 

2322A Rayburn HOB 

Washington DC 20515 

On behalf of Avera Health, a Catholic sponsored health system serving patients in eastern South Dakota and 

the surrounding states, I am writing in strong support of the Overdose Prevention and Patient Safety Act (H.R. 

3545), As the country continues to struggle with how to address the opioid problem, Avera's hospitals and 

physicians need access to public health data and the patient's full medical record in order to assist in fighting 

this epidemic. Under current law (42 CFR Part 2) a patient suffering from a substance use disorder is in control 

of their medical record, unlike every other disease covered by HIPAA, This separate privacy rule is hindering 

our ability to treat and coordinate care for those suffering from substance use disorder. 

As Congress works on the opioid package, which will likely include many proposals such as expanding the 

utilization of medication assisted treatments, expanding and improving continuing medical education on 

opioid prescribing, and possibly more funding for states to tackle the crisis, Avera urges the Energy and 

Commerce Committee to include H.R. 3545, which would align 42 CFR Part 2 with HIPAA so that medical 

providers can see the full medical record and safely treat patients suffering from addictions, 

Sincerely, 

Deb Fischer-Clemens, BSN, RN, MHA 

Senior Vice President of Public Policy 

Sponsored by the Benedictine 

and Presentation Sisters 
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Aprilll, 2018 

The Honorable Greg Walden 

Chair 

Committee on Energy & Commerce 

US House of Representatives 

Washington, DC 20515 

RE: Overdose Prevention and Safety Act {HR 3545) 

Dear Chair Walden and Ranking Member Pallone: 

The Honorable Frank Pallone 

Ranking Member 

Committee on Energy & Commerce 

US House of Representatives 

Washington, DC 20515 

On behalf of OCHIN, Inc., the largest federally·funded Health Center Controlled Network (HCCN) in the 

nation headquartered in Portland, Oregon,! am writing this letter to convey our strong support of HR 

3545 known as the "Overdose Prevention and Safety Act," OCHIN ls a collaborative of health care 

organizations that are working together to provide integrated care for our nation's most vulnerable 

patients. We provide technology and telehealth, training, research, analytics, consultation, advocacy, 

and other wrap-around support services to nearly 800 clinic locations nationwide. 

OCHIN believes integrated care ls a priority for not only our network of federally-qualified health 

centers, public health systems and other safety net clinics, but it is also a key component of ensuring 

cost-effective, safe, and truly holistic care for all patients served throughout the country. As you are 

aware, 42 CFR Part 2 (Confidentiality of Substance Use Disorder Patient Records) has served a vital role 

in supporting individuals as they engage in recovery from drugs and alcohol; however, it was 

constructed in an era that predated modern technology. The authors and supporters could not even 

begin to conceive of how patient care would evolve in the following decades. Today, we know that 

integrated primary, behavioral, dental and other health care is essential for delivering safe, effective, 

responsible, and affordable care. It is time that these outdated rules are updated to reflect the 

technology and processes that are foundational to coordinating treatment and other services, including 

the exchange of records via health information technology. Unfortunately, 42 CFR Part 2 continues to 

serve as a barrier to coordinated and safe care. Physicians, counselors, therapists, pharmacists, and 

others need to be able to easily share information about their shared patients in seamless manner. 

OCHIN is extremely encouraged by the bi-partisan support that the Energy and Commerce Committee 

has already received in its promotion of alternative payment models and other key activities. Aligning 42 

CFR Part 2 with the federal HIPAA and HITECH rules is a next logical step in achieving streamlined, 

integrated care that is safe and effective, while supporting value-based pay. As you are evaluating your 

support for addictions treatment, we urge you to In dude the provisions that are in HR 3545 in any bill 

that 1s produced by the Committee. 

OCHlN strongly supports the adoption of HR 3545 and aligning and streamlining care for our members. 

Thank you for your leadership on this very important issue. 

Respectfully, 

c...kuu:~ Stu& ~~-nn~fe~oH VP, Government Relations and Public Affairs, OCHIN 

1881 SW Naito Parkway, Portland, OR 97201 ! t: 503.943.2500 ! f: 503.943.2501 ! www.ochln.org 

Page lofl 
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APCMA 

"Co 

April 11, 2018 
165 


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APCMA 

Introduction 

PCMA appreciates this opportunity to submit a statement for the record for the hearing, 

"Combating the Opioid Crisis: Improving the Ability of Medicare and Medicaid to Provide 

Care for Patients." PCMA is the national association representing America's pharmacy 

benefit managers (PBMs), which administer prescription drug plans for more than 266 

million' Americans with health coverage provided th employers, health 

insurers, labor unions, Medicare, Medicaid, SCHIP, Employees Health 

Benefits Program (FEHBP). America's PBMs majority of the nation's 

4.5 billion annual prescriptions." 

We appreciate the Health Subcommittee' 

ongoing efforts to address the nation's o 

the Committee's efforts to limit Medicare b 

specific pharmacy or prescriber. bills u 

committee's prior work. 

crisis. Given their role 

and h the software systems 

, and adjudicate claims, PBMs can 

nd pharmacies, are getting a 

nrr•m•enrlArl by the Centers for Disease 

a longer days' supply than necessary. 

improve and physicians move to ePBMs and prescribers will have almost complete 

here, and when prescriptions for controlled 

Where the law will allow it, PBMs also will be 

able to use coverage s to address opioid prescriptions exceeding the 

CDC-recommended days' supply or morphine-equivalent dosage. PBMs already can 

lock in patients at risk to an appropriate pharmacy or pharmacy chain for their controlled 

substances in most state Medicaid programs and the commercial insurance market, and 

because of congressional action in CARA, next year will start a similar program in 

Medicare Part D. 

2 
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There are significant additional steps policymakers can take to help private sector 

efforts to reduce opioid abuse. 

Common-Sense Policl£ Solutions to Curb the Opioid Crisis 

While the factors driving America's opioid crisis are complex and do not lend 

themselves to easy solutions, targeted policy changes can help curb prescription opioid 

abuse and diversion. Below we suggest a number of to curb the crisis. 

Mandatory Electronic Prescribing for 

that using federal program payment policy to 

prescribing) for controlled substances cou 

prescribing has been shown to d 

and after the DEA allowed e-prescribing 

followed. Currently all states permit EPCS, 

passed laws requiring its use, 

EPCS mandatoryiv 

have 

payments to require 

The PBM industry 

H.R. 3528, the "Every 

these goals and urge the 

one very similar to it. We would 

leadership on this important 

Members Joe Kennedy, Paul 

and Diana DeGette. 

savings and decreases opioid use. One 

that after implementing EPCS, it reduced opioid 

(from 60,000/month to 31 ,000/month).v The switch 

savings. Across the health system savings averaged 

thus far added up to ongoing cost savings of $5.1 M 

from EPCS tools.v' Similarly, one New York hospital examined its emergency 

department prescription volume for opioids from before and after New York State 

adopted an EPCS mandate. The hospital reported a decrease of 53% of prescribed 

opiates, seeing decreases in all15 common emergency diagnoses studied. vii 
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APCMA 

Further, e-prescribing platforms typically provide physicians a patient's medication 

history, which informs physicians of prescriptions that other prescribers have written and 

pharmacies have dispensed, even ones for which patients have paid cash. This can be 

especially important for controlled substances, where patients may engage in doctor 

shopping to find one or more doctors to write a prescription for a dangerously addictive 

drug. 

According to a recent study by Visante and Point of 

with access to comprehensive medication history 

prescribers and pharmacies rose to optimal 

annual savings of up to $53 billion, based o 

o $18 billion to $37 billion in redu 

opioid abuse; 

o $7 billion to $14 billion saved 

treatment costs, 

costs; and 

rs, if the use of EPCS 

ationally and its use by 

history were required for 

and pharmacies rose to optimal 

of more than $2 billion annually, 

to Medicare beneficiaries of: 

health care costs, decreased 

uctivity gains, and reduced criminal justice 

greater efficiencies in physician offices and 

convenience for consumers. viii 

Improve and Integrate State PDMPs and Require Prescriber Check: As described 

above, PDMPs can be an important tool to help identify and prevent prescription drug 

abuse. A key problem keeping PDMPs from operating optimally is that state PDMPs 

vary as to who may use a POMP or receive its data. States also vary with respect to the 

agencies operating PDMPs and some fund their PDMPs adequately while others devote 

few resources. While there are efforts to make PDMPs interoperable across state lines, 

4 
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APCMA 

at present many are not Some state PDMPs have up-to-date data, while in others the 

data lags by months. The differences in data access, material support, and 

administration can make it difficult to make the best and timely use of POMP data. 

The Subcommittee could use federal health program payment policy to encourage 

POMP data be updated in a timely manner, be interoperable across state lines, and 

easily accessible to prescribers and pharmacies. Req the use of, and integrating 

EPCS with, POMPs may be particularly helpful in this . Additionally, prescribers 

should be required to check state POMP database opioids, at least 

until EPCS is widely adopted and supplies simila 

Suspension of Claims in Part D Where 

Misuse: In Medicare Parts A and B, 

payment of claims upon a credible 

Medicare Part D. Part 0 plans 

they can do little more than 

the suspected fraud. To close 

suspend payment of suspect 

a Part 0 plan sponsor 

have the latitude investigated further. 

questionable opioid prescribing 

_,,, . .,,,.far outside the norm, 

same report also found over 22,000 

r shopping (i.e., they received high 

and pharmacies).x Allowing Part D plan 

investigation would limit fraudulent transactions 

seek to commit fraud from filing fraudulent claims in 

In the specific case of the Part D stand-alone plans, the Bipartisan Budget Act of 2018 

(BBA) allows them access to their enrollees' Part A and Part B Medicare data as of 

2020. If the implementation of this provision could be accelerated to occur in 2019, it 

could allow Part D plan sponsors to better detect potential opioid fraud and misuse 

sooner. Additionally, policymakers should make it clear that that the use of Part A and 
169 


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APCMA 

Part 8 data to detect and ameliorate opioid fraud and misuse should not be interpreted 

as making "coverage determinations" as otherwise restricted in the BBA. 

Reconsider Limits on Use of Medicare Parts A and B Data by Medicare Part 0 

Plans: In the recent two-year budget deal, Congress included language that made 

Medicare Part A and Part 8 data available to Part D plans, but forbade Part D plans 

from using the data in any way to inform coverage s. As a result, plans will be 

unable to use data gleaned from a beneficiary's in outpatient record to help 

guide patient-specific decisions on step therapy Indeed, given the 

constraints, it is uncertain what the utility of the d and many Part D plans 

likely will not request the information. We ubcommittee reconsider 

the new statutory limit on how Medicare A by Part D plans. 

Electronic Prior Authorization: PCMA 

authorization that reduce physicians' ad 

National Council for 

just as easily abused as any other 

deepening of the crisis despite wide 

magic bullet to stop opioid abuse. 

of existing non-ADF generics in favor 

exooer\SI\Ie formulations will dramatically raise 

abuse. PCMA welcomed FDA Commissioner 

that FDA will be "taking a flexible, adaptive approach 

of ADF opioids. "xi 

Public policy that promotes ADF-only opioids assumes that all patients who use opioids 

are drug abusers, and, moreover, ignores research showing that a large percentage of 

those abusing opioids ingest the drug. While technological innovations such as ADF 

have been developed to prevent opioid medications such as OxyContin from being 

crushed, dissolved, chewed, or cut, this does not prevent abuse and potential overdose 

6 
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APCMA 

because an individual can still ingest opioids as intended and in increasing amounts, 

whether they are ADF opioids or non-ADF opioids. 

The Institute for Clinical and Economic Review (ICER) recently released a report 

examining the evidence on abuse-deterrent opioidsxii ICER rated the net health benefits 

of the ADF formulation of OxyContin and found no compelling evidence it was better 

than non-abuse-deterrent opioids, for producing lower rates of opioid abuse!iii Despite 

the fact that the evidence for abuse reduction isn't the pharmaceutical 

industry persists in advocating for their mandatory they are far more 

expensive than generic opioids,xiv and therefore for the drugmakers. 

Align Substance Abuse Treatment 

Care Coordination: To help facilitate 

substance abuse, we encourage the 

records privacy policies with the 

(HIPAA) privacy rule. Under 

Part 2, addiction treatment p 

patients in order to share any 

exception being for ' 

health care provid 

health care 

Conclusion 

abuse 

ity Act 

at42 CFR 

· ct to a minimum 

are given a notice explaining how 

multiple consents from a patient, 

creates barriers to integrated 

for patients. The separate and 

se-disorder patient history creates virtual 

It also perpetuates the unnecessary division 

and may serve to perpetuate stigma in the 

records (EHRs), integrated health care, and 

We thank the Subcommittee for this opportunity to share our views on how commonsense policy proposals can help curb America's opioid crisis. PCMA stands ready to 

work with the Subcommittee, the full Committee, and all Members of Congress to 

address the overuse of opioids. 

7 
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APCMA 

Feb 04, 2016 

·A Review of 2016 and Outlook to 

v" 0, Danovich et aL 

, J, Chacko, J. Greenstein, 

of Oplolds 

8 
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32361.104

April10, 2018 

The Honorable Greg Walden 

House Committee on Energy & Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Michael Burgess 

Subcommittee on Health 

House Committee on Energy & Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Frank Pallone, Jr. 

House Committee on Energy & Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

The Honorable Gene Green 

Subcommittee on Health 

House Committee on Energy & Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Walden, Ranking Member Pallone, Chairman Burgess and Ranking Member Green: 

Thank you for your ongoing efforts to fight the opioid crisis. Addiction became personal for me and my 

family when I lost my son Brian to the disease on October 20, 2011. In the months that followed, it 

haunted me knowing how many families were being shattered every day by this disease. Shortly 

thereafter, I founded Shatterproof, the first national nonprofit organization dedicated to attacking 

addiction from all perspectives and sparing other families from the devastation my family has suffered. 

Unlike most other chronic medical illnesses, substance use disorders (SUDs) have always carried a 

negative connotation. Years of misconstruing addiction heavily fueled our country's public health crisis 

and have left the quality of treatment SUDs decades behind other chronic illnesses. 

As a result, the epidemic continues to worsen according to recent data from the Centers for Disease 

Control (CDC), with an estimated 30 percent increase for emergency department visits due to suspected 

opioid overdoses from July 2016 through September 2017. In 2016, opioid overdoses took the lives of 

over 42,000 people. 

While Congress has acted on the crisis with the Comprehensive Addiction and Recover Act (CARA) and 

21" Century Cures Act, and most recently provided nearly $4 billion in funding through the Fiscal Year 

2018 Omnibus, there is more that can and should be done. Today, we respectfully submit the following 

recommendations and endorsements of legislation currently under consideration by the Committee, 

many of which would not require additional or new funding: 

Prevention and Intervention 

Provider Training Requirements. H.R. 2063, the Opioid PACE Act introduced by Rep. Brad Schneider (DIL-10), would help to improve provider training on SUD issues by requiring training as a condition of 

obtaining and renewing a controlled substance registration with the Drug Enforcement Administration 

(DEA). It is critical that those who prescribe opioids have the proper training to do so, and therefore 

Shatterproof also strongly recommends the following additions to the bill: 
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32361.105

1) Include language to ensure that the Department of Health Human Services (HHS) may only 

establish or support training modules that adhere to the Centers for Disease Control (CDC) 

Guideline for Prescribing Opioids for Chronic Pain. 

2) Add a requirement that any provider obtaining or renewing a DEA registration number also be 

required to complete the Drug Addiction Treatment Act (DATA) 2000 waiver application process 

which would save many lives by increasing the number of qualified providers that are eligible to 

prescribe buprenorphine to treat opioid addiction. 

Improving the Effectiveness of Prescription Drug Monitoring Programs (PDMPs). While we know 

legislation on this issue is still under development, Shatterproof strongly recommends that states do not 

receive any PDMP funding after August 1, 2019, unless and until the following PDMP standards have 

been met: 

1) Mandatory query of the PDMP for schedule II, Ill and IV at first prescribing event and at least 

every 90 days thereafter; 

2) Require input of dispensation information into the PDMP within 24 hours; 

3) PDMP must include the most recent 12 months of prescription history (at a minimum); 

4) Allow Medicare, Medicaid, health plans and pharmacy benefit managers to request access to 

state PDMP information; and 

5) Require interstate PDMP data sharing with adjoining states (at a minimum). 

The five preceding best practices have all been recommended in numerous white papers, and not 

including them in the final opioid package would be a lost opportunity to save countless American lives. 

Shatterproof also recommends that PDMP funding should incentivize i) Integration of PDMP information 

into Electronic Heath Records (EHR) and Pharmacy Dispensation Systems (PDS) and ii) Inclusion of data 

analytics and substance use disorder tools in the PDMP; both of these would be very beneficial to 

clinicians in helping their patients. 

Prescribing limitations. Shatterproof supports limiting prescriptions for controlled substances to three 

days for acute pain, with sensible exceptions for situations like chronic care and hospice. H.R. 5311, the 

CARA 2.0 Act introduced by Reps. Marsha Blackburn (R-TN-07) and Tim Ryan (D-OH-13) includes a threeday limit. We also support providing the Food and Drug Administration (FDA) with the authority to 

require unit dose packaging and/or safe disposal packaging. Limiting the pill count for acute pain 

prescriptions is critical to preventing more patients from becoming addicted in the first place. 

Treatment 

Evidence-Based Treatment. H.R. 5272, the Reinforcing Evidence-Based Standards Under Law in Treating 

Substance Abuse (RESULTS) Act introduced by Reps. Steve Stivers (R-OH-1S) and Eliot Engel (D-NY-16), 

would require applicants for mental health or substance use disorder funding to demonstrate to HHS 

that the prevention or treatment activities are evidence-based. It is a fact that a large part of federal 

funding goes to prevention and treatment that is based on outdated methods, rather than going to 

prevention and treatment programs that utilize the research that has proven to save American lives. 
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This requirement would make significant progress towards incentivizing evidence-based approaches, 

while including a sensible exception for innovative programs. 

Health Information Technology for Behavioral Health Providers. H.R. 3331, the Improving Access to 

Behavioral Health Information Technology Act introduced by Reps. Lynn Jenkins (R-KS-02) and Doris 

Matsui (D-CA-06) would provide long overdue incentive payments to behavioral health providers for 

adopting certified EHR technology, via a Center for Medicare and Medicaid Innovation (CMMI) 

demonstration. As you know, behavioral health providers were left out of the HITECH Act funding in 

2009 for incentives to adopt electronic health records. Research has proven that one of the most 

important factors in successful treatment is coordination of care among the various professionals 

treating a patient. It is only right and morally just that these providers are able to adopt health IT to 

ensure care coordination with other provider types, just like any other disease. 

Changes to 42 CFR Part 2. Rep. Markwayne Mullin's (R-OK-02) amendment in the nature of a substitute 

to H.R. 3545, the Overdose Prevention and Patient Safety Act, strikes the right balance between 

allowing SUD records to be shared for the purposes of treatment in accordance with the Health 

Insurance Portability and Accountability Act (HIPAA), while also providing protections for discrimination 

or unauthorized disclosure. As stated above, one of the most important factors in successful treatment 

is coordination of care among the various professionals treating a patient. This can be accomplished 

most effectively through the use of EHRs; however in order to be effective, the EHRs need ail relevant 

patient information including SUD records. This amendment will allow for the inclusion of this vital 

information in the EHR which will save lives by improving care coordination and also provide stronger 

HIPAA protections forthis sensitive patient information. In addition, this also supports the important 

goal of ending the shame and stigma for American afflicted with this disease. 

Workforce Capacity. H.R. 5102, the Substance Use Disorder Workforce Loan Repayment Program 

introduced by Reps. Katherine Clark (D-MA-05) and Hal Rogers (R-KY-05). would allow for student loan 

forgiveness up to $250,000 for those who offertheir training and talent in a SUD position. We 

desperately need more qualified health professionals in SUD professions and this student loan 

repayment incentive would go a long way toward meeting that need. 

Another bill that would assist with improving workforce capacity is H.R. 3692, the Addiction Treatment 

Access Improvement Act introduced by Reps. Paul Tonka (D-NY-20) and Ben Ray Lujan (D-NM-03). This 

bill would make permanent the provisions from CARA to allow nurse practitioners and physicians 

assistants to prescribe buprenorphine, while also expanding on the eligible provider types to include 

clinical nurse specialists, certified nurse midwives and certified registered nurse anesthetists. It would 

also codify current regulations that allow certain providers to treat up to 275 patients with 

buprenorphine. The more qualified health providers who are able to prescribe buprenorphine, the more 

American lives that will be saved. 

Naloxone Training and Funding. H.R. 992, the Opioid Abuse Prevention and Treatment Act introduced 

by Rep. Bill Foster (D-IL-11) would provide funding fortraining on how to safely administer naloxone. 

Shatterproof also recommends providing additional funding or other means to make it possible for 

every American at risk of an overdose caused by opioids and everyone in a position to save their lives to 

access naloxone. If naloxone is administered in time, it can save lives and give our loved ones a second 

chance. 
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Enforcement of the Mental Health and Addiction Equity Act of 2008. H.R. 4778, the Behavioral Health 

Coverage Transparency Act introduced by Rep. Joseph Kennedy (D-MA-04) would require health plans to 

disclose additional information to better assess how the law is being implemented. The bill would also 

require a minimum of 12 random audits per year to ensure the law is being implemented and enforced. 

We must ensure this law is being implemented fully to make treatment available to those who are 

dealing with addiction. 

Best Practices for Post-Overdose Care. H.R. 5176, the Preventing Overdoses While in Emergency Rooms 

Act introduced by Reps. David McKinley (R-WV-01) and Mike Doyle (D-PA-14), would create a pilot 

program with 20 health care facilities to develop best practices for emergency departments as they 

discharge patients who have had an overdose. With opioid overdoses increasing, improving postoverdose care with proven best practices is crucial to helping a patient get a second chance. 

There are many other smart initiatives being considered by this and other Committees to address the 

opioid crisis, but I strongly encourage you to include the proposals outlined above in any final package. 

These will make a lasting and meaningful impact on the opioid epidemic in the near-term and for years 

to come. 

Every morning, I wake up thinking of the Serenity Prayer. The serenity to accept what I cannot change, 

and the courage to change the things we can. Our society must find the serenity to accept the lives that 

have already been lost, but waste no time in working together across party lines to find "the courage to 

change the things we can" and save countless lives. If there is anything that Shatterproof can do to assist 

in your efforts, please do not hesitate to call on us. 

Gary Mendell 

Founder & CEO, Shatterproof 

www.shatterproof.org 

gmendell@shatterproof.org 
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Trinity Health 

April10, 2018 

The Honorable Greg Walden 

Chairman 

Committee on Energy & Commerce 

The Honorable Michael Burgess, MD 

Chairman 

Subcommittee on Health 

The Honorable Frank Pallone, Jr. 

Ranking Member 

Committee on Energy & Commerce 

The Honorable Gene Green 

Ranking Member 

Subcommittee on Health 

Re: Trinity Health Comments on Combatting the Opioid Crisis 

Dear Chairmen Walden and Burgess and Ranking Members Pallone and Green, 

Trinity Health appreciates the work of this Committee on ways in which it can address the 

devastating impact of the opioid crisis. Our following recommendations reflect a strong interest in 

public policies that support better health, better care and lower costs to ensure affordable, high 

quality, and people-centered care for all. We also believe that reverence- honoring the sacredness 

and dignity of every person- is inherently necessary to reducing opioid harm. 

We strongly believe that health systems and hospitals must play a critical role in addressing opioid 

use and misuse. Trinity Health is committed to developing and implementing important opioid 

utilization reduction strategies, ensuring comprehensive education and awareness programs, 

engaging in robust advocacy, and measuring impact to ensure continuous improvement for all 

populations that we serve. Committed to putting the people and communities we serve at the center 

of every behavior, action and decision, Trinity Health is broadly collaborating-through our Opioid 

Utilization Reduction (OUR) initiative-for the system-wide development, evaluation and 

dissemination of evidence-based tools and protocols for optimizing care and reducing opioid harm. 

Trinity Health is one of the largest multi-institutional Catholic health care delivery systems in the 

nation, serving diverse communities that include more than 30 million people across 22 states. 

Trinity Health includes 93 hospitals as well as 109 continuing care locations that include PACE, 

senior living facilities, and home care and hospice services. Our continuing care programs provide 

nearly 2.5 million visits annually. Committed to those who are poor and underserved, Trinity Health 

returns $1.1 billion to our communities annually in the form of charity care and other community 

benefit programs. We have 35 teaching hospitals with Graduate Medical Education (GME) programs 

providing training for 2,095 residents and fellows in 184 specialty and subspecialty programs. We 

employ approximately 131,000 colleagues, including more than 7,500 employed physicians and 

clinicians, and have more than 15,000 physicians and advanced practice professionals committed to 

22 Clinically Integrated Networks that are accountable for 1.3 million lives across the country. 

If you have any questions on our comments that follow, please feel free to contact me at 

wellstk@trinity-health.org or 734-343-0824. We look forward to working with you as the Committee 

advances a legislative package on these issues. 

Sincerely, 

Tanya K. Wells 

Vice President, Public Policy & Federal Advocacy 

Sponsored by Catholic Health Ministries 1 20555 Victor Parkway • Livonia, Ml48152 • 734-343-1000 • trinity-health.org 
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Trinity Health is committed to partnering with all stakeholders to address opioid use through 

prevention, intervention, treatment, and recovery initiatives. As we work to address the country's 

culture of pain, we must also recognize that a patient's experience of pain depends on many factors 

including comorbidities, stress levels, and social supports. Trinity Health strongly believes that 

altering the course of opioid and substance use disorders must include the following imperatives that 

encompass prevention, intervention, treatment and recovery: 

Building awareness, education and engagement across all stakeholders including patients, 

providers, pharmacists, families and communities. Broad community education is critical. 

Ensuring resources and coordinated, comprehensive solutions across local, state and federal 

levels of government. 

Supporting a whole-person approach to meet the full range of an individual's physical, 

behavioral and social support needs in an integrated fashion and recognizing that each of 

these dimensions impacts a patient's experience of pain as well as his/her health and 

wellness. 

Enhancing prevention through communication, transparency and accountability among all 

stakeholders. 

Breaking down barriers to effective treatment and recovery including reducing stigma and 

ensuring appropriate insurance coverage. 

While many state legislatures have enacted targeted measures to address the opioid crisis, a 

coordinated nationwide strategy that prioritizes appropriation of federal funding for programs 

to support the opioid efforts of state and local governments, hospitals, and community-based 

organizations is required. Ensuring that federal and state mitigation measures and provider 

education requirements or initiatives are as consistent as possible across all states to avoid 

duplication, confusion, and undue burden on providers is of critical importance. 

SUPPORT WHOLE-PERSON CARE 

Comprehensive Coverage 

It is of critical importance that Congress ensure comprehensive insurance coverage is 

maintained for all vulnerable populations, including through Medicaid. Comprehensive 

coverage is especially important to opioid and substance use disorder prevention and treatment. 

42 CFR Part 2 

Congress is urged to align confidentiality requirements for sharing a patient's substance use disorder 

records (known as 42 CFR Part 2) with the requirements in the Health Insurance Portability and 

Accountability Act (HIPAA) so that opioid and substance use disorders can be treated like other 

medical conditions, improving patient safety and continuity of care. Aligning the confidentiality of 

substance use records with HIPAA requirements- thereby granting health care providers 

access to information to diagnose and effectively treat patients who use opioids and other 

controlled substances- will better ensure integrated care across providers and settings. As a 

result of these antiquated regulations, opioid and substance use disorder diagnosis and treatment 

information gets locked away from other providers and care managers, fueling bifurcation, limiting 

care coordination, and creating safety risks for beneficiaries. Specifically, we urge Congress to 

include the Jessica Grubbs Legacy Act (S.1850)/the Overdose Prevention and Patient Safety 

Act (H.R. 3545) in any opioid-related package. 

Access to Non-Opioid and Non-Pharmacological Alternative Approaches to Pain 

Management 

Across Trinity Health's continuum of care providers, we daily hear of struggles associated with 

coverage and access to non-opioid and non-pharmacological alternative approaches to pain 

management. Meaningful coverage- from both Centers for Medicare and Medicaid Services 

(CMS) and third-party payers- to non-opioid and non-pharmacologic alternatives is one of 

the most important long-term strategies policy makers can address to combat the opioid 

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crisis facing our nation. The Food and Drug Administration (FDA) also has an important role in 

supporting research into these alternatives and speeding alternatives and approvals to market. More 

comprehensive utilization of these modalities have great potential to reduce opioid use and improve 

patient functionality and outcomes. 

As an example of non-opioid alternatives, Lyrica (pregabalin) is an extremely valuable medication in 

treating numerous neuropathic pain syndromes but has only been approved for minimal indications, 

such as fibromyalgia. This non-opioid medication is extremely effective for treating several 

neuropathic pain syndromes, but it is very difficult for a patient to garner approval for its use. 

Additionally, utilizing procedures- for example injections such as epidural steroids that can be used 

to treat acute exacerbations of radicular pain- is another critical example to reducing opioid use in 

patients. Coverage for these procedures, however, are increasingly being denied. Nonpharmacological alternatives- such as physical therapy and cognitive behavioral therapy- as well 

as complementary approaches- such as acupuncture and chiropractic therapy- are also critical. 

More comprehensive utilization of these alternative approaches is paramount to minimizing the risk 

that people develop opioid or other substance use disorders. Ensuring access to and low or no 

co-payments for non-opioid and non-pharmacological pain management modalities could 

reduce opioid misuse and improve patient functionality and outcomes. 

Current CMS reimbursement policies, as well as those from other health insurance payers, create 

barriers to the adoption of these alternative strategies. This is a significant barrier in clinicians being 

able to consistently and more broadly embrace utilization of these alternative and complementary 

pain management approaches. We strongly urge that a broader range of pain management and 

treatment services- including alternatives to opioids, physical therapy, cognitive behavioral 

therapy, acupuncture, and chiropractic therapy- be adequately reimbursed by payers, 

including Medicare and Medicaid. Specifically, CMS should review and modify rate-setting 

policies that discourage the use of non-opioid treatments for pain. 

Supporting a Team-Based Workforce 

A critical component of ensuring that all individuals receive the best, evidence-based prevention, 

screening, and assessment is an effective workforce. We urge Congress to ensure CMS provides 

appropriate reimbursement and financial incentives for supporting a collaborative, teambased environment that includes psychiatrists, addiction medicine specialists, advance 

practice clinicians (e.g., PAs, NPs), psychologists, social workers, nurses, care coordinators, 

community health workers (CHWs), and peer-to-peer support specialists. Allowing these 

individuals to practice at the highest level of their education, training and licensure is also important. 

Mental Health Parity 

The Mental Health Parity and Addiction Equity Act of 2008 built on the Mental Health Parity Act of 

1996 by requiring that coverage provide the same level of benefits for substance use and mental 

health as it does for other medical care. While parity is a requirement, enforcement remains a 

challenge. Parity regulations must be adequately and uniformly enforced for these policies to 

be effective and to ensure evidence-based, coordinated care is received for those with opioid 

and substance use disorders. CMS has an important role in this imperative. We also urge the 

Committee to examine additional ways to ensure all beneficiaries of federal health programs 

are benefiting from mental health parity and treated equitably relative to commercial and 

managed care plans. 

OVERPRESCRIBING AND DATA TRACKING 

Prescribing Guidelines and Requirements 

It is critical that policymakers acknowledge and recognize the importance of ensuring that the 

pendulum not swing too far in the other direction as we collectively work to reduce opioid misuse and 

abuse. We strongly urge that public policies intended to reduce inappropriate use of opioids 

do not simultaneously create access barriers to pain management for patients for whom 

opioids are medically indicated and who are benefiting from such treatment. 

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While Trinity Health supports and, as discussed later in these comments, is widely 

disseminating the Centers for Disease Control (CDC) Guidelines for Prescribing Opioids for 

Chronic Pain, it is important that these clinical guidelines not be narrowly interpreted into 

overly restrictive policy and across-the-board requirements that could result in numerous 

negative, unintended consequences. For example, the CDC states: "This guideline provides 

recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of 

active cancer treatment, palliative care, and end-of-life care." Trinity Health strongly urges that 

public policies to address inappropriate opioid use should always include exceptions for 

hospice care, cancer diagnoses, end-of-life care, and palliative care. Many institutions and 

payers are establishing dose and time limits for all patients, irrespective oftheir underlying 

diagnosis, context or goals. Again, public policies must not be so overly restrictive that it inhibits 

clinical decision-making on the needs and circumstances of individual patients. 

We also have significant concerns with the proposed 3-day limit on initial opioid prescriptions for 

acute pain in the CARA 2.0 package introduced in the Senate. A 3-day limit is overly restrictive 

public policy, as it inhibits clinical decision-making based on the needs and circumstances of 

individual patients and could cause significant harm for surgery patients in particular. Patients with 

legitimate pain needs could be left on a weekend, for example, without the availability of a clinician 

to provide additionally needed days of a prescription to treat their pain. Limiting the initial supply 

of an opioid prescription for acute pain to 7-days is a more reasonable approach to 

addressing the reservoir of unused prescription opioids, and less problematic for clinical 

decisions based on individual patient's circumstances and needs. The CDC states: "When 

opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediaterelease opioids and should prescribe no greater quantity than needed for the expected duration of 

pain severe enough to require opioids. Three days or less wi11 often be sufficient; more than seven 

days will rarely be needed." CDC's clinical guidelines acknowledge that three days is often sufficient 

but not always. Limiting to 3-days could also encourage prescribers to write second and third 

prescriptions to be used at a later date which could further exacerbate the problems surrounding 

opioid misuse and abuse. 

To ensure that the pendulum not swing too far in the other direction and create access barriers to 

pain management for patients for whom opioids are medically indicated, we would also support 

funding to improve the pain management evidence base. This could, for example, support a 

supplement to the CDC Guidelines that provides greater direction beyond the primary care audience 

for which these Guidelines were originally intended. 

Improving POMP Utility 

Prescription Drug Monitoring Programs or PDMPs hold great promise as demonstrated by the recent 

Health Affairs study, which found that both the number of opioid prescriptions and spending was 

significantly lower in states with a registration mandate or a registration and use mandate, compared 

to states without either. For example, opioid prescriptions declined 28 percent in Massachusetts 

from 2015 to 2017 with 97 percent of health care providers registered with their awareness tool 

that's getting an average of 125,000 searches a week. And the Ohio database processed more than 

24 million queries from physicians and other health professionals in 2016 while the number of 

opioids dispensed to Ohio patients decreased 20 percent since 2013. 

However, it is critical that policy makers address inadequate databases and ensure crossstate information exchange. This is particularly important for providers that practice near borders 

and have patients coming from a neighboring state to seek care. Additional investments should 

be made in innovative technology that advances interoperability and interstate data-sharing 

among PDMPs nationally. As a national health system operating in 22 states, we are proactively 

mapping out a system-wide strategy to ensure our electronic health records (EHRs) are able to 

capture states' POMP data to make the process as seamless as possible for providers. Ensuring 

cross-state exchange of information and active alert systems are critical next steps. We also urge 

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that these database efforts- including related requirements on providers- not be overly 

burdensome and are integrated into these existing databases, systems and workflow. 

COMMUNICATION AND EDUCATION 

Provider Education 

Trinity Health's OUR initiative has identified prescriber education as the most critical need for our 

hospitals and clinicians to be successful with reducing opioid utilization and related harm. While we 

support increased prescriber education initiatives, we also have concerns that the varying 

requirements coming from local, state and federal entities is quickly becoming confusing. Ensuring 

that government mitigation measures- including provider education requirements- are not 

duplicative in nature and are as consistent as possible across all states is critically important 

to avoiding confusion and undue burden on providers. 

Trinity Health strongly believes that providing prescribers with resources and education about 

national guidelines for safe and appropriate opioid prescribing is the foundation for opioid utilization 

reduction education. We support wide dissemination of the CDC Guidelines. Additionally, across the 

entire Trinity Health system, two critical prescriber education platforms are being rolled out -first is 

the SCOPE of Pain for basic overview training and secondly is the Center to Advance Palliative Care 

(CAPC) for pain management competency based training. Supporting advancement of responsible, 

evidence-based opioid prescribing and counseling through pain management education, safe 

prescribing training, and addiction training for all prescribers and dispensers throughout medical 

schooling and beyond is critical to policymaking. Additionally, Trinity Health has developed -and 

integrated into our electronic health record (EHR)- the attached, two-page opioid discharge 

education piece for patients. If the Department of Health and Human Services (HHS), including 

Medicare and Medicaid, were directed to coordinate the development of a national curriculum 

and standard of care for opioid prescribers, we strongly urge that all of the above referenced 

educational resources be utilized. We also urge that the Committee prioritize education 

requirements that are as consistent as possible across all states to avoid duplication, 

confusion, and undue burden on providers. 

TREATMENT 

Coverage and Access to Treatment 

Breaking down barriers to effective prevention, screening and treatment is critical, and any opioid 

reduction strategy must be accompanied by increases in access to treatment. According to the 

National Institute on Drug Abuse (NIDA), every dollar invested in addiction treatment yields a return 

of up to $7 in reduced drug-related crime and criminal justice costs. When health care savings are 

included, the return on investment can exceed $12. CMS must ensure meaningful insurance 

coverage of and access to evidence-based medication-assisted treatment (MAT) for opioid 

use disorder. This includes limiting prior authorization requirements and ensuring there are 

no lifetime limits and no arbitrarily low dose and time limits for treatment of these patients in 

order to effectively improve patient outcomes. Significant access challenges also result from 

having too few providers certified to prescribe these medications, such as Buprenorphine, as well as 

the costs of these medications often prohibiting access as well. Congress should appropriate 

funding to expand MAT training and provide financial incentives for prescribers willing to 

secure waivers to prescribe Buprenorphine. 

The impact of opioid use disorders impacts all age groups and demographics. Eliminating the 

restriction on Medicaid payments for inpatient treatment at large residential facilities (i.e., the 

Institutions for Mental Diseases (I MD) exclusion) is important to expanding treatment for 

those covered by Medicaid. For those covered by Medicare, it's important that Methadone 

treatment be covered not just in the inpatient setting but in the outpatient setting as well. 

ATTACHMENT TO THESE COMMENTS: Trinity Health's Patient Discharge Instructions on Opioids 

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What You Should Know About Opioid Medicine 

What is an Opioid? 

Opioid medications are used to treat moderate to severe pain. Morphine, Oxycodone (Percocet®), 

llydromorphone (Dilaudid®) and Hydrocodone (Norco®) are some types ofopioids. 

How do Opioids work? 

Opioids reduce the pain signals sent to your brain, \Vhich decrease your feelings of pain. Opioids may 

reduce your pain) but may not take all the pain away. 

What are the risks from taking opioids? 

Prescription opiolds carry serious risks of physical dependence! addiction and overdose, with long term use. If 

)'OU take too much of an opioid it can cause sudden death. 

Other risks include but are not limited to: 

Physical dependence means you have symptoms of withdrawal when a medication is stopped. 

Addiction is a brain disease. Medications change the structure of the brain and how the brain works. 

These brain changes may be long lasting and can lead to harmful behaviors. 

Overdose means you took too much medication. Opioid overdose can result in de::~th. 

J\<take sure you rl'ad all of the medication sheet you received w·ith your prescription. 

Call 911 right a'''ay if you have any of these signs of overdose: 

Pale or bluish skin color 

Trouble breathing 

Severe confusion; not knowing where you arc 

Your heart is beating slower than normal 

You see or hear things that are not real 

Tell the people you live with that you are taking a medicine that can stop your breathing. Ask them to watch for 

slow, shallow, or trouble breathing. Tell them to call 911 right away if you have trouble breathing or they 

cannot '"'ake you up. 

What you need to know while taking Oploid medication: 

Do Not take more medication, or higher doses than prescribed, as you may stop breathing or pass out. 

Do not take opioids mon• often or in higber doses than prescribed. Call your doctor if your pain is not 

controlled. 

Do Not drink alcohol (beer, wine or liquor) while taking this medication, as you may stop breathing or pass 

out. 

Do Not take sleeping pills (like zolpidem (Ambien®) or temazepam (Restoril®) or anti-anxiety medication 

(like a!prazolam (Xanax®), diazepam (Valium®), and lorazepam (Ativan ®)while taking this medication, 

as you may stop breathing or pass out. 

Do Not crush or alter opioid medication or take it in ways not prescribed by your doc. tor 

Do not drive or do tasks that require you to be alert after taking this medication. 

If you arc pregnant, talk to your dortor. Opioids may harm your pregnancy or baby. 

What are the side effects from taking oploids? 

The most common side effects are: 

Hard stools (Constipation) 

Upset stomach, throwing up and dry mouth 

Feeling sleepy 

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Feeling more pain 

Confusion 

Depression, low mood, feeling sad or nervous 

Itching and sweating 

Trouble passing urine 

Willi become addicted to opioid medication? 

Addiction is not common when this medication is used for a short time. But, when opioid medications are 

misused addiction is possible. Talk with your doctor about how to switch to using only non-opioid pain 

treatment. Please talk to your doctor about your concerns about addiction. 

How do I safely store and dispose of my opioids? 

Storage: 

Keep your medications secure. 

Keep your medications, including any medication patches, out of reach of others (this includes children, 

friends, family and pets). 

Keep your opioids, and all medications, in the pill bottle from the pharmacy. Keep the lid closed. 

Disposal: 

Safely throw out unused opioids: Contact your local pharmacy for how to throw out unused opioid 

medications or find your local medicine take-back site ( http://disposemymeds.org/) 

Follow these steps if you can't find a medicine take-hack site to throw out expired, unused or unwanted 

medicines: 

o Step #1: Mix medicine with used coffee grounds, dirt, or kitty litter. 

o Step #2: Put medicines in a sealed plastic bag. 

o Step #3: Place plastic bag in the trash. 

o Step 114: Take prescription bottle and scratch out personal information, then recycle or throw 

away. 

Throw out patch medications by folding them in half with the sticky sides together, and then flushing 

them down a toilet. Do not place them in the household trash where children or pets can find them. 

It is against the law to share or sell yom· opioid medication. 

What else can I use to treat my pain? 

Non-opioid pain medications (such as Tylenol®, Motrin®, and Aleve®) may also help with your pain. If 

your doctor approves, these medications may be used with an opioid medication ordered fOr you. Nonopioid pain medications also have risks and side effects; please ask your doctor if these medications are safe 

for you. 

Many opioid medications also have acetaminophen (Tyle-nol®) in it. Ve-r)' bad, and sometime-s deadly, 

liver proble-ms can happen with too much acetaminophen use. 

What are other ways to help ease your pain? 

Heat or icc 

Stretching 

A pillow under the painful area 

Massage 

Talking to someone about how your thoughts and feelings affect your pain 

Listening to music 

Talk to your doctor to make sure these actions arc safe for you. 

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~ ABHW 

Association for Behavioral 

Health and Well ness 

Advancing benefits and services 

tn mental health, substance use 

and b12havior change. 

April11,2018 

The Honorable Greg Walden, Chairman 

House Committee on Energy & Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

The Honorable Frank Pallone, Ranking Member 

House Committee on Energy & Commerce 

2322A Rayburn House Oftice Building 

Washington, DC 20515 

On behalr of the Association for Behavioral Health and Wellncss (AIJHW) I am writing to express our support for 

H.R. 3545, the Overdose Prevention and Patient Safety Act (OPPS Act), sponsored by Representatives Mullin and 

B!umcnauer, and to strongly encourage inclusion of the OPPS Act in the opioid package that your committee is 

currently developing. 

!\81·1\V is the leading association working to raise awareness) reduce stigma, and advance federal policy to improve 

mental health and addiction care. Our members include top regional and national health plans that collectively care 

f(Jr approximately 175 million people. 

II.R. 3545 would align 42 CFR Part 2 (Part 2) with the llealth Insurance Portability and Accountability Act 

(HIPAA) for the purposes of health care treatment, payment, and operations (TPO) and strengthen protections 

against the use of substance use disorder records in criminal proceedings. Part 2 is an outdated 1970s federal 

regulation governing the confidentiality of drug and alcohol treatment and prevention records and it needs to be 

reformed. Pmi 2 sets requirements limiting the use and disclosure of patients' substance use disorder (SUD) records 

!rom rederally assisted entities or individuals that hold themselves out as providing, and do provide, alcohol or drug 

use diagnosis, treatment, or referral for treatment This can prohibit health plans, and others. from sharing this 

information with the health care providers on the front line caring for patients suffering from opioid and other 

substance use disorders. ABHW members say Part 2 is one of the biggest- if not the biggest- barriers w fighting 

the opioid crisis. 

Obtaining multiple consents from the patient is challenging and obstructs \vhole-person, integrated approaches to 

care, \Vhich are part of our current health care framework. Part 2 regulations may lead to a doctor treating a patient 

and writing prescriptions for opioid pain medication for that individual without knowing the person has an opioid 

use disorder. Without written consent from the patient ABI-IW member companies have had cases where the health 

plan cannot speuk to the patient's primary care provider and other specialists ahout the patient's SUD, even if that 

provider is prescribing opioids to the patient. 

For example, one health plan notes that it found over 200 members had been to emergency departments (EDs) over 

seven times in a six-month period. The health plan wanted to share this information through an automatic tCed to 

the respective providers so they could take action in helping these members. HO\vever, because the information 

may have included whether or not a member was categorized as having a SUD, the plan was not able to provide the 

feed. This \Vas especially troubling, since in reviewing the data, the health plan also found that some members \Vere 

!325 G Street, NW, Suite 500, W;;1shington. DC 20005 I Tel202.449.7660 : Fax 202.449.7659 i www.abhw.org 
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attempting to obtain opioids from several different EDs. Unfortunately. because of Part 2, the health plan was not 

able to inform the provider that it appeared their patient may be misusing opioids. 

The Substance Abuse and Mental Health Services Administration (SAMHSA) released two final rules on Part 2 

in the past year. Both rules take small steps to modernize Part2, but they do not go far enough. Legislative action 

is also necessary in order to modify Part 2 and bring substance use records into the 21st Century. Aligning Part 2 

requirements with! IIPAA allow the usc and disclosure of patient information for TPO and improve patient care 

by ensuring that providers and organizations with a direct treatment relationship with a patient have access to his 

or her complete medical record. Without access to a complete record, providers cannot properly treat the whole 

person and may, unknO\vingly, endanger a person's recovery and his or her liCe. 

Harmonization of Part 2 with HIPAA would also increase care coordination and integration among treating 

providers and other entities in communities across the nation. We support provisions that preclude Part 2 

information from being disclosed for non-treatment purposes to law enforcement, employers, landlords, divorce 

attorneys! or others seeking to use the information against the patient. We do not want consumers to be made 

vulnerable as a result of seeking treatment for a substance use disorder. Ho\vever, disclosures of substance use 

disorder records for treatment, payment, and health care operations should be allowed. Separation of substance 

use fi·om the rest of medicine increases the stigma around the disease and hinders patients from receiving safe, 

effective, high quality substance usc treatment and integrated care. 

Thank you for your leadership in addressing the opioid crisis. ABHW appreciates the opportunity to express our 

supp011 for li.R. 3545 and we look forward to continuing this dialogue and working with you to end the overdoses 

and deaths that are ravaging our country. Please feel free to contact me at (202) 449-7660 to discuss these issues 

further. 

Sincerely, 

Pamela Greenberg, MPP 

President and CEO 

1325 G Street. NW, Suite SOO, Washington, DC 20005 I Tel202A49.7660 i Fax 202.449.7659 ! www.abhw.org 
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Mental Health America • 

84Stage4 

April 11, 2018 

The Honorable Greg Walden 

Chairman 

House Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

The Honorable Frank Pallone, Jr. 

Ranking Member 

House Committee on Energy and Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

Mental Health America (MHA) applauds the House Energy & Commerce Committee for its attention to 

the nation's opioid epidemic, and writes to urge the inclusion ofH.R. 3545, the Overdose Prevention and 

Patient Safety Act, in any final package passed by the Committee. 

MHA- founded in 1909- is the nation's leading community-based nonprofit dedicated to addressing the 

needs of those living with mental illness and to promoting the overall mental health of all Americans. Our 

work is driven by our commitment to promote mental health as a critical part of overall wellness, 

including prevention services for all, early identification and intervention for those at risk, integrated care, 

services, and supports for those who need it, with recovery as the goal. 

Based on over a century of experience, MHA believes that individuals have a right to control the 

disclosure and dissemination of their protected health information (PHI). We also believe strongly that 

separate authorizations perpetuate stigma and lead, perhaps unintentionally, to discrimination and lack of 

parity in care without giving the individual any more control over their information. They also constitute 

a significant barrier to integrating treatment. H.R. 3545, the Overdose Prevention and Patient Safety Act 

would allow for a single authorization for sharing integrated health information while enhancing 

protections against discrimination as a result of improper disclosures. 

The Health Insurance Portability and Accountability Act (HIPAA) requires an individual to sign a form 

allowing their health care provider to disclose their health information to others, such as other providers 

or family members. For substance use information, 42 CFR Pt II, an archaic regulation dating back to 

1970, requires an individual to sign a separate form in addition to the HIPAA form to allow disclosure of 

their substance use information. Federal law does not say explicitly that a separate authorization is 

required for mental health information, but providers often interpret the law regarding substance use to 

include all other behavioral health information as well. In the absence of statutory clarity, SAMHSA has 

been unable to conform the two rules. 

Separate authorizations contribute to discrimination in care. When an individual goes in for substance use 

treatment and receives a special authorization form, it implies that they should be wary of disclosure and 

that they might be doing something others could view negatively. Separate authorizations also complicate 

the coordination and integration of treatment, because often the behavioral health information does not 

get transmitted along with other health information. Providers understand that you cannot treat a whole 

Mental Health America, 500 Montgomery Street, Suite 820, Alexandria VA 22314 703-684-7722 
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person with half a health record, and overwhelmingly support action to address this deficiency. We agree. 

When a special authorization is required for behavioral health information, a provider receiving a record 

with no behavioral health information in it cannot know whether the person has no behavioral health 

records, whether they have declined to share them, or whether they were never even asked. This at best 

contributes to confusion and at worst to poor quality or even dangerous care. 

On the other side, MHA has found no evidence that additional formalities actually accomplish the privacy 

goals of legal advocacy organizations, or guarantee protections beyond those that are inherent in the 

Americans with Disabilities Act, also enacted after 42 CFR Pt. 2. H.R. 3545 would allow for a single 

authorization to be used, giving individuals full control over their health information, while promising 

better integrated care. Individuals will still decide when and to whom to disclose their own PHI, with 

additional protections from H.R. 3545 for wrongful disclosures. 

MHA thanks the House Energy & Commerce Committee's consideration of including H.R. 3545 in the 

final package, and looks forward to continuing to work with the Committee to address addiction and 

overdose. Please do not hesitate to contact Nathaniel Z. Counts, J.D., Senior Policy Director of MHA, at 

ncounts@mentalhealthamerica.net for follow-up or questions. 

Sincerely, 

Paul Gionfriddo 

President and CEO 

Mental Health America, SOO Montgomery Street, Suite 820, Alexandria VA 22314 703-684-7722 
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Aprilll, 2018 

The Honorable Lamar Alexander 

Chairman 

Committee on Health, Education, 

Labor, and Pensions 

U.S. Senate 

Washington, DC 20510 

The Honorable Greg Walden 

Chairman 

Energy and Commerce Committee 

US. House of Representatives 

Washington, DC 20510 

The Honorable Patty Murray 

Ranking Member 

Committee on Health, Education, 

Labor, and Pensions 

US. Senate 

Washington, DC 20510 

The Honorable Frank Pallone 

Ranking Member 

Energy and Commerce Committee 

U.S. House of Representatives 

Washington, DC 20510 

Dear Chairman Hatch, Ranking Member Wyden, Chairman Walden, and Ranking Member 

Pallone: 

On behalf of the nation's Medicaid Directors, we are writing to request your consideration of 

statutory modifications to the rules governing the disclosure of substance usc disorder (SUD) 

patient history and information. Spedficallyr Medicaid Directors seek alignment of 42 CFR Part 

2 rules with the privacy protections under the Health Insurance Portability and Accountability 

Act (HIPAA}, and believe this alignment will support the care coordination and integration 

Jctivities that are critical to addressing the ongoing opioid crisis. 

The National Association of Medicaid Directors (NAMD) is a bipartisan, nonprofit, professional 

organization representing leaders of state Medicaid agencies across the country. Our members 

drive major innovations in health care while overseeing Medicaid, which provides a vital health 

care safety net for more than 72 million Americans. The Medicaid program is one of the primary 

payers of behavioral health services in the nlltion. 

The Part 2 statute is outdated and does not reflect current SUD treatment best practices, clinical 

understanding of addiction, or contemporary hcalthcare opemtions. YVhile the Substance Abuse 

444 North Capitol Street, Suite 524 • Washington, DC 20001 • Phone: 202.403.8620 • W'WW.medlcaiddirectors.otg 
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NAMD 

National Association of 

Med!caid Directors 

and Mental Health Services Administration (SAMHSA), the agency responsible for 

administering Part 2, has worked to modernize Part 2 regulations- and in doing so has 

acknowledged Medicaid auditing authority and the role of managed care entities in today's 

healthcare landscape- we continue to view Part 2 as creating serious barriers to effective SUD 

treatment. These barriers ultimately derive from the statutory misalignment between Part 2 and 

HIPAA. 

Part 2 statute and SAMHSA regulations create more stringent privacy protections for patient 

SUD data than for other sensitive health data protected by modern HIP AA rules. Specifically, 

Part 2 requires patient consent each time a new provider would need access to the patient's 

SUD medical records, rather than HIPAA's generalized consent. 

The lack of alignment between Part 2 and HIP AA creates challenges across the healthcare 

system, from state Medicaid agencies to managed care plans and down to individual provider 

practices. SAMHSA's most recent rulemaking earlier this year still explicitly prohibits 

disclosure of Part 2 data for purposes of diagnosing, treating, or referring patients to SUD 

treatment (including care coordination and case management) without patient consent. This 

prohibition inhibits the integration of SUD care into primary care and other care models, places 

unnecessary administrative costs on states, plans, and providers, and can result in patient harm 

or death due to lack of full access to relevant SUD data. 

Additionally, evidence shows significant comorbidities for individuals with SUD. For example, 

in FY 2011, 51% of Medicaid beneficiaries with SUD also had a mental health condition, nearly 

13% had asthma, and over 10% had diabetes 1 As this data predates the option for states to 

expand Medicaid to 138% of the federal poverty level, these figures are likely higher today, 

further emphasizing the need for integrating SUD services into the full continuum of physical 

and behavioral health care. 

We recognize the serious consequences that stem from illegal and unauthorized disclosure of 

SUD data. NAMD supports the prohibition on using SUD data to initiate or substantiate 

criminal, civil, or administrative proceedings against individuals with SUD. Statutory changes 

should facilitate appropriate data sharing across integrated care teams to support effective 

treatment and continue to assure patients that they will not face adverse action for seeking 

treatment. We believe the HIP AA construct, which protects other sensitive health information, 

is an appropriate vehicle for achieving these goals. 

1 Government Accountability Office, 11Medicaid: A Small Share of Enrollees Consistently Accounted for a Large 

Share of Expenditures." May 2015. https://www.gao.gov/assets/680/670112.pdf. 

Page 2 of3 
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,,~~!-? ~ Medicaid Directors 

Thank you for your consideration of these comments. Please do not hesitate to reach out to 

NAMD for additional information on these requests. 

Sincerely, 

Judy Mohr Peterson 

Med-QUEST Division Administrator 

State of Hawaii 

President, N AMD 

Page 3 of 3 

Kate McEvoy 

State Medicaid Director 

State of Connecticut 

Vice President, NAMD 
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'-A-HiM A American Health Information 

Management Assodationi!!' 

April12, 2018 

The Honorable Greg Walden 

Chairman 

House Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

233 N. Mich1gan Ave ,21H F\ 

Chicago, ll 60601·5600 

phone» (312) 233·1100 

fax » (312) 233·1 090 

web » www.ahima.org 

The Honorable Frank Pallone, Jr. 

Ranking Member 

House Committee on Energy and Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

On behalf of 103,000 health information management professionals, the American Health Information 

Management Association (AHIMA) wishes to express support for H.R. 3545, the Overdose Prevention 

and Patient Safety (OPPS) Act. The legislation seeks to align the 42 CFR Part 2 regulation with the Health 

Insurance Portability and Accountability Act (HIPAA) for purposes of health care treatment, payment and 

operations. 

AHIMA's credentialed and certified health information management (HIM) members can be found in 

more than 40 different employer settings in 120 different job functions-consistently ensuring that 

health information is accurate, timely, complete, and available to patients and providers. The Part 2 

regulation presents an operational challenge for HIM professionals working in designated Part 2 

programs. HIM professionals working in such programs are often forced to work with paper records.ln 

instances where a Part 2 program may have an electronic health record (EHR), data segmentation 

functionality is often not available. Lacking such functionality, HIM professionals must keep a patient's 

addiction records separate from the rest of the patient's medical record-resulting in the creation of 

two separate medical records. Because such information is kept separate, providers are often unaware 

of the risks to their patient from multiple drug interactions and co-existing medical problems even 

though substance use disorders can have a cascading effect on an individual's health and must be 

carefully managed and coordinated. 

The Part 2 regulation is also an impediment to HIM professionals working in states with integrated care 

delivery models that encourage information sharing to support care coordination and integration of 

patient care. Despite the fact that state law may encourage information sharing (including substance 

abuse treatment information), the Part 2 regulation often limits the sharing of both mental health and 

substance abuse treatment information for purposes of care coordination. in turn, this compromises the 

intent of integrated care by putting individuals with substance use disorders at a disadvantage over 

other patients because providers have an incomplete picture of their patient thereby hindering a 

clinician's ability to deliver informed, coordinated care-the foundation of integrated care delivery 

models. 

A major tenet of the HIPAA Privacy Rule is to ensure that "protections for patient privacy are 

implemented in a manner that maximizes the effectiveness of such protections while not compromising 

either the availability or the quality of medical care." 1 AHIMA believes that the same justification should 

1 67 FR 53181. 
191 


32361.123

hold true for patients receiving substance use disorder treatment in a Part 2 program. Access to an 

individual's medical record, including addiction records, for purposes of healthcare treatment, payment 

or operations will help ensure that providers have the information necessary to provide safe, effective, 

high-quality treatment and care. 

We appreciate your leadership on this issue and look forward to working with you and other Members 

of Congress to advance H.R. 3545. 

Sincerely, 

Dr. Wy\ecia Wiggs Harris, PhD, CAE 

Chief Executive Officer 

AHIMA 
192 


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April23, 2018 

The Honorable Greg Walden 

Chairman 

House Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Frank Pallone, Jr. 

Ranking Member 

House Committee on Energy and Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

lllucCross BlucSblcld 

Assoclatlon 

An Association or Independent Blue C:rms nnd RlucShi(!ld Plon~> 

l3!0GStrcct,N.W. 

Washington, D.C. 20005 

202.626.4780 

Fax 202.626.4833 

RE: Passage of H.R. 3545, the "Overdose Prevention and Patient Safety (OPPS) Act" to 

Amend 42 C.F .R. Part 2 and align the Federal Privacy Regulation of Protected Health 

Information 

Dear Chairman Walden and Ranking Member Pallone: 

The Blue Cross and Blue Shield Association (BCBSA) is writing to you in support of the 

passage of H.R. 3545, the "Overdose Prevention and Patient Safety (OPPS) Act." This 

important legislation would enable the appropriate exchange of information necessary to ensure 

those suffering opioid use disorders (OUD) and substance use disorders (SUD) obtain safe and 

effective treatment, gain their most applicable financing and receive their deserved assistance in 

the form of care management and other health care operations. 

BCBSA is a national federation of 36 independent, community-based and locally operated Blue 

Cross and Blue Shield Plans that collectively provide health care coverage for one in three 

Americans. For more than 80 years, Blue Cross and Blue Shield companies have offered quality 

health insurance coverage in all markets across America- serving those who purchase 

coverage on their own as well as those who obtain coverage through an employer, Medicare, 

and Medicaid. Today, Blue Plans are also working with qualified 42 C.F.R. Part 2 treatment 

programs to ensure that their members with OUD and SUD are provided the care and support 

to achieve successful health outcomes. 

BCBSA commends the efforts of the Substance Abuse and Mental Health Services 

Administration (SAMHSA) to better align the regulations governing the confidentiality of drug 

and alcohol treatment and prevention records (42.C.F.R. Part 2 (Part 2)) with the Health 

Insurance Portability and Accountability Act's (HIPAA) Privacy Regulations. However, 

SAMHSA's efforts do not go far enough to enable the needed access to relevant health 

information among patients, payers and providers and balance the protection of individual 

privacy with individuals' expectations of care. 

Current Part 2 federal regulations preclude the disclosure of medical information to healthcare 

providers for care coordination, including those engaged in alternative payment models. These 

regulations currently require complex and multiple patient consents for the use and disclosure of 

patients' substance use records that go beyond the sufficiently strong patient confidentiality 

protections that were put in place by HIPAA. For example, a health plan or provider should be 
193 


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permitted to inform a treatment facility that the individual being admitted was recently released 

from a different treatment entity's care- information vital to patient safety and quality outcomes. 

We are aware that aligning the Part 2 regulations with HIPAA for the purpose of treatment only 

is under consideration. But treatment purposes cannot be separated from payment and health 

care operations. For payers, treatment, payment, and operations all are interrelated-and the 

following examples help illustrate future challenges if the alignment is for treatment only: 

Medicaid requires whole-person care management. Payers could not participate in certain 

prescription monitoring activities without the potential to share information for treatment, 

payment, and operations. For example, health plans that want to be active in identifying 

members who are engaging in drug-seeking behavior or providers who are inappropriately 

prescribing addictive drugs would not be able to send warning letters to the members' 

primary care physicians and other providers to alert them to the inappropriate prescription 

activity. 

Health plans might be prevented from partaking in normal customer service activities, like 

parents calling in about their minor children's authorizations and claims, or family members 

or friends helping a patient with the financial end of things (claims issues, appeals, 

questions about coverage). 

Health plans may be blocked from offering significant support to providers in their networks 

to assist and to help the providers coordinate the patient's entire care. Health plan case 

management programs, and longer-term data collection, are important pieces of a person's 

OUDISUD history and support for them and their family when they are not directly engaged 

in a program. Most of the time, a patient is at home, with family and friends, and health 

plans' case management programs offer the supports necessary to assist and to help the 

providers coordinate all the patient's care. 

SAMHSA has acknowledged that the agency has done as much as it can though regulatory 

efforts under the limitation of the current statutes. Legislative action is necessary in order to 

modify Part 2 and bring OUD and SUD access regulations to a configuration that supports the 

21st Century healthcare approaches and stem the current plague of substance use disorders. 

BCBSA urges the Committee to include H.R. 3545 to amend 42 CFR Part 2 and align 

SAMHSA's OUD and SUD regulations with HIPAA's treatment, healthcare operations, and 

payment policy as Congress passes legislation addressing the opioid crisis. 

Sincerely, 

Justine Handelman 

Senior Vice President, 

Office of Policy and Representation 

Cc: Kristen Shatynski 

Caleb Graff 

Waverly Gordon 

Tiffany Guarascio 

Taylor Hittle 

Kristen Donheffner 
194 


32361.126

Association for Community 

Affiliated Plans 

April 24, 2018 

The Honorable Michael Burgess, MD, Chairman 

Health Subcommittee 

House Energy and Commerce Committee 

Rayburn House Office Building 

Washington, DC 20515 

Chairman Burgess and Ranking Member Green: 

115515m Street, N.W., Suite 600 1 Washington, DC 20005 

Tel. 202204.7508 1 Fax 202.204.7517 1 'NWW.communityplans.net 

John Lovelace, Chairman 1 Margaret A. Murray, Chief Executive Officer 

The Honorable Gene Green, Ranking Member 

Health Subcommittee 

House Energy and Commerce Committee 

Rayburn House Office Building 

Washington, DC 20515 

On behalf of the Association for Community Affiliated Plans (ACAP), I am writing to express our gratitude 

and support for the House Energy and Commerce Health Subcommittee's commitment to move a 

comprehensive slate of bills to address America's devastating opioid crisis. ACAP particularly applauds 

the Committee's bipartisan recognition of the important role that the Medicaid program has in 

addressing the opioid epidemic and we look forward to working with members of the Committee and 

the Administration, as well as the states, to maximize Medicaid's potential to address the opioid crisis. 

ACAP represents 61 member plans in 29 states serving more than 20 million Americans receiving 

coverage through Medicaid, CHIP, Medicare Advantage D-SNPs, and the Health Insurance Marketplaces. 

While ACAP supports a comprehensive approach to addressing the opioid issue in America, we want to 

specifically voice our support for several pieces of common-sense legislation that represent policy 

priorities for America's safety net health plans. We urge the Committee to ensure these bills are part of 

any legislative effort that moves through the legislative process. ACAP particularly urges the members 

of the Subcommittee to support the following: 

H.R.___..J Require Medicaid Programs to Report on All Core Behavioral Health Measures, to 

require state Medicaid programs to report on the 11 behavioral health measures that are 

included in CMS's 2018 Core Set of Adult Health Care Quality Measures for Medicaid. This 

legislation is vita! to help federal and state policymakers better understand how state Medicaid 

programs are addressing the opioid crisis and to provide opportunities to share best practices in 

this area. ACAP has long advocated for state reporting of the Medicaid core quality measures, 

we applaud the Subcommittee forth is legislation and urge its passage; and 

H.R. 3545, the Overdose Prevention and Patient Safety Act, to align the use of substance use 

disorder (SUD) treatment records with the Health Insurance Portability and Accountability Act 

(HIPAA) fort he purposes of treatment, payment, and healthcare operations. Safety Net Health 

Plans strongly support the protection of patient privacy and confidentiality. However current 

federal law and regulation {42 CFR Part 2) creates bureaucratic hurdles to the treatment of and 

care coordination for health plan members suffering from SUD, including those receiving 

coverage in Medicare, Medicaid, and through the health insurance exchanges. This legislation 

will protect patient confidentiality while improving the ability of health plan providers to provide 

vita! health care services to plan members and we urge its support by the Subcommittee. 
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Association for Community 

Affiliated Plans 

1155 15tn Street, N.W., Suite 600 1 Washington, DC 20005 

Tel. 202.204.7508 ! Fax 202.204.7517 1 'NW'W.communityp!ans.net 

John Lovelace, Chairman ! Margaret A. Murray, Chief Executive Officer 

ACAP recognizes and applauds the Subcommittee's efforts to provide a comprehensive solution to 

America's substance abuse epidemic and we stand prepared to work with the bipartisan members of 

this Committee to ensure these bills become law. 

Please do not hesitate to contact me or Jenny Babcock, Vice President for Medicaid Policy & Director of 

Strategic Operations, if ACAP can be of any assistance to you. 

Sincerely, 

(sf 

Margaret A. Murray 

Chief Executive Officer 

Cc: Members, House Energy and Commerce Committee 
196 


32361.128

April15, 2018 

Chairman Michael C. Burgess, M.D. 

Energy & Commerce Health Subcommittee 

United States House of Representatives 

2336 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Burgess: 

~ Hazelden Betty Ford /\<'J'"\')~,_',/J.CV 

Thank you for your continued leadership on the federal response to the opioid crisis. We are writing to 

express strong support for the Overdose Prevention and Patient Safety Act, H.R. 3545, in its 

original bipartisan form and to urge against the adoption of the "Amendment in the Nature of a 

Substitute" drafted by the bill's sponsor, Rep. Markwayne Mullin. 

We deeply appreciate Rep. Mullin's leadership on this bill but believe his substitute proposal would fail 

to solve the significant problems the original legislation set out to address. The original, on the other 

hand, would be an essential piece of any opioid response package produced by the House this session. 

As background, the Hazelden Betty Ford Foundation is the largest nonprofit provider of substance use 

treatment, education and prevention services in the world. We have provided leadership in the field of 

addiction treatment for nearly 70 years. In 2017 alone, our organization touched the lives of more than 

21,000 people affected by addiction and other co-occurring medical and mental health conditions. We 

have 17 sites nationwide, serving children, adolescents, adults, families, schools and communities, and 

all of our treatment facilities are licensed or certified and have achieved accreditation by The Joint 

Commission. 

To address the opioid overdose epidemic and the underlying addiction crisis in this country, we need 

your help to closely i11tegrate addiction care within the broader health care system so patients have 

multiple access points and can get support for this chronic condition beyond the acute care stage. The 

original H.R. 3545 reforms the outdated 42 CFR Part 2 ("Part 2") privacy regulations, which have 

become a barrier to access and deprive patients of the full benefits of modern health care services. 

That's why we support this bill to align the Part 2 requirements with those of the Health Insurance 

Portability and Accountability 1\ct ("HIPJ'u\"), which apply to all health care providers and allow the 

use and disclosure of patient information when needed to facilitate optimal care. 

Part 2 is outdated and onerous 

Part 2 is a 45-year-old law that was created a quarter century before HIPAA specifically to protect the 

privacy of patients who sought care within the vcty young and largely un-professionalized addiction 

treatment industry of that time. \Vhen HIPAA was enacted in 1996, Part 2 was left in place, despite 

providing little to no extra privacy protections beyond those HIPAi\ began providing for all patients 

regarding all health conditions, and despite addiction care integrating more and more over time witb tbc 

rest of health care. 

Generally speaking, Part 2 requires many specific, written consents by the patient for his or her 

substance usc-related health records to be shared among doctors, hospitals, specialty care providers like 
197 


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the Hazelden Betty Ford Foundation, insurers and others who may support the patient's care. HIPP A, 

on the other hand, allows for streamlined blanket consents that better facilitate needed information 

sharing. Both laws provide protections for privacy violations, and the federal government regularly 

prosecutes HTPAA violators. But not a single enforcement case has ever arisen from Part 2, partly 

because full compliance is a practical impossibility that often poses risks to patient care, and also 

because legitimate infringements on patient privacy are already well covered by HIP AA. 

Part 2 is not fairly and uniformly applied 

2 

It's also important to note that, unlike HIPAA, Part 2's unnecessary privacy regulations do not apply to 

all health care providers who serve patients seeking care for substance use disorder. Generally, Part 2 

2!2!)c applies to the patients of nonprofit specialty treatment providers and those that treat the poor and 

elderly through public insurance. Most for-profit treatment providers are not subject to the Part 2 

regulations; nor are most primary care providers and independent mental health professionals, who 

increasingly are part of the care continuum for people with a substance use disorder; and nor is the 

Veterans Administration. As a result, thousands of patients receive treatment services at non-Part 2 

providers throughout the country, and their information is protected by HIP AA and state law. The 

good news is that HIP AA is meeting the needs of those patients just fine, without the barriers that Part 

2 poses for patients of Part 2 facilities. 

Part 2 is largely unnecessary 

Opponents of l-LR. 3545 have testified it would create a framework by which, for example, a father in 

recovery could be denied visitation with his children because he was in addiction treatment, a mother 

could be threatened with eviction from a she.lter because she was being treated with prescribed 

methadone for her opioid addiction, or a young man receiving worker's compensation could be cleared 

for work by a doctor but forbidden from returning due to the discovery of a previous treatment for 

addiction. The fact is that none of those scenarios plays out differently under HIP AA v. Part 2. All 

would involve disclosures made by the patients themselves, not providers -who would be equally 

bound under either law. Remedies in each of these situations would be best pursued under 

discrimination laws. 

\Vhat is needed for substance use patients is legal protection from discrimination, not laws that impede 

information-sharing for legitimate treatment, payment and operational purposes. The idea that Part 2 

provides extra protection against discrimination is, practically speaking, an illusion. While some have 

testified that harmonizing privacy laws would discourage people from seeking treatment, neither the 

law itself nor our experience as a frontline treatment provider supports that assertion. 

Part 2 compromises care 

In the end, Part 2's costly, onerous rules don't add meaningful protections for patients and, in fact, 

compromise care by forcing hospitals and doctor's offices to keep records from Part 2 providers on 

paper or in separate systems from all of the other electronic patient data maintained by their HIPAAcompliant systems. The result of the dual systems is that addiction treatment data are often not shared 

among doctors. This means doctors may not know if their patients have a history of drug or alcohol 

misuse or even if they've gotten treatment, and hospitals and doctors in integrated care models can miss 

crucial information to prevent misdiagnosis and harmful medical interactions for the patient. This 

separation of the data also makes it difficult for addiction treatment providers to participate in some 

integrated care models, for which they have to share their patient data. The reality is that the health care 

system is designed around HIPAA, and now that addiction care is integrating with mainstream 

medicine to serve patients better, Part 2 poses a dangerous disconnect. The dual policies are simply 

incompatible ·with health care today. 
198 


32361.130

i\s it is, we arc faced every day with balancing the impossible requirements of Part 2 with a sacred 

commitment to our patients, whose care is compromised by the letter of this outdated law. 

3 

One example: A recently discharged, hard-of-hearing patient used a relay service interpreter to 

contact us, a call we cannot legally take without a signed release from the patient for that 

interpreter. This type of scenario forces us to choose between two risks: breaking the law to 

help the patient, or abiding by the law and risking patient harm? It's an easy decision in the end, 

but a double-jeopardy with which we shouldn't even be confronted. 

Another example: A patient was prescribed suboxone during residential treatment and 

returned to his home state. As part of his discharge plan, he was to engage a physician to 

continue his care. He delayed engaging a physician in his home area, which necessitated a call to 

the treatment center physician with a request to send his prescription to the local 

pharmacy. The patient was unable to immediately execute and deliver a written consent to the 

local pharmacy, however, meaning our physician at the treatment center could not legally call in 

the prescription refill or consult with the pharmacist. 

Anything less than full alignment with HIPAA is problematic 

Rep. Mullin's drafted amendment would dial back the scope of his original proposal hy aligning Part 2 

with HIPlv\ only for treatment purposes but not for payment or operations purposes. Unfortunately, 

this further bifurcation of health care records only complicates compliance further and keeps the 

requirement that dual systems be maintained. It also will hurt patients. 

Part 2, as it relates to payment, creates access and quality care barriers, starting with patients' first call 

for help to determine if they have benefits and if the insurer will issue the necessary preauthorization. 

These barriers continue through the adjudication of the claim through the insurer as well·as the peer 

review and utilizatioo review processes, and on to any eventual applicatioo for disability benefits. The 

more patients are confronted by barriers like this, the less likely they are to follow through with their 

intent to access and complete treatment In serving thousands of patients every year, we know financial 

impact is ooe of the most important factors for them and can be a barrier to access. 

Part 2, in fact, requires specific written consent for each person who touches a record within the 

insurance payment process, and each provider staff member who needs to touch the record as part of 

day-to-day operations. The average patient at the I-lazelden Betty Ford Foundation, for example, is 

asked to sign about a dozen releases during the course of his or her care. Imagine people who have a 

heart attack being asked to provide consents to every person in the emergency room, hospital, 

insurance paymeot pipeline, and in their health care history who may have ioformation pcrtineot to 

optimal care. It's unreasonable and an impossible requirement for Part 2 providers to meet in many 

cases, but still a federal criminal law. So, responsible organizations like ours do everything we can to 

comply, at great frustration, expense and harm to care. 

Part 2 is a frustration to many patients, not a benefit. Payrnent alone takes, on average, three to five 

consents. Haviog to revisit those conversations throughout the treatment process is a barrier betweeo 

patients and their care, and often takes an emotional toll on patients. Worse, if mistakes are made at any 

point, or if anything changes in the process of insurance review, providers often cannot make even the 

simplest changes without the patient's express coosent. And if providers are unable to locate the patient 

in a timely manner-due to the complicated logistics of obtaining written consents from patients not 

physically on site, a barrier that docs not exist for the rest of healthcare or for non-Part 2 treatment 

providers-bills end up becoming the patient's responsibility, the stress of which can significantly 

impact recovery in a negative way. Under HIPAA, on the other hand, presenting your insurance card at 

the outset provides consent for the whole payment process, a much more patient-friendly policy. 
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4 

Part 2 institutionalizes stigma 

Repeated consents also send patients the signal that the illness for which they're getting care is one that 

requires unusual secrecy. In that way, Part 2 institutionalizes and exacerbates the very stigma it purports 

to protect against. \V'e have fought for decades to have addiction viewed and treated as a healthcare 

condition, and yet Part 2 validates-even if unintentionally so-the stigmatized view that it is instead a 

moral failing, worthy of hiding. 

Part 2 also needs to be aligned with HIP lv\ for operations purposes. Part 2 programs need to be able 

to utilize patient information for administrative, regulatory financial, and quality programs. It is 

impossible for a Part 2 program to obtain consent for every activity and person within the organization 

that may need to touch patient information for operations activities like fulfilling our licensing and 

accreditation requirements and performing quality assurance. Some specific examples of operationsrelated needs include (but are not limited to) utilizing patient information to: examine the most effective 

treatment options; improve documentation; defend the organization or its partners in a legal dispute; 

conduct training programs for students~ trainees or practicing clinicians; review the competence or 

qualifications of our multi-disciplinary team of professionals; and evaluate clinical performance. 

Alignment supports "parity" 

By aligning Part 2 with HIP AA for "treatment," "payment," and "operations" purposes, the original 

I I.R. 3545 would continue Congress's effort to bring much-needed parity between care for addiction 

and care for physical health conditions. At the same time, the bill would actually strengthen Part 2's 

protections against discrimination and other potential abuses of information in criminal and civil courts; 

we know how important this is because we get subpoenas every day for patient records, which our 

Legal Department fights strenuously. 

\V'hen Part 2 was enacted in the 1970s, there was no insurance coverage for addiction treatment, few 

states regulated facilities or providers who delivered services, and there were no other federal or state 

privacy regulations of comparable scope. However, much has changed in the decades since. Thanks to 

the 2008 Mental Health Parity and Addiction Equity Act, millions of Americans are now able to utilize 

their insurance benefits. Many states also now regulate facilities and providers, and providers are subject 

to federal regulations as well- most notably, HIPAA. It's time to bring about the regulatory changes 

necessary for providers to meet the needs of our patients. 

It is critical that the original H.R. 3545 be preserved to align Part 2 with HIPAA for "treatment," 

"payment," and "operations" and included in any opioiJ package enacted by this Congress. 

We have led the way in advocating for the rights of people with addiction for decades. In this case, the 

concerns of those opposed to the original bill are not supported by facts or our frontline experience. 

\\1 e feel strongly that maintaining unnecessary barriers to care during the nation's worst addiction crisis 

ever would be a missed opportunity and potentially grave mistake. 

Thank you very much for your consideration and leadership on this important topic. 

Sincerely, 

/I l (} 

~,W, 1 ;-} A,I I i> j11f11,- ;j/ /?lL..~.t<-. 

Mark Mishek 

President and Chief Executive Officer 

Hazelden Betty Ford Foundation 

Marvin D. Seppala, MD 

Chief Medical Officer 

Hazelden Betty ford Foundation 
200 


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April16, 2018 

The Honorable Greg Walden, Chairman 

House Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Frank Pallone, Jr., Ranking Member 

House Committee on Energy and Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

Cc: 

Rc: Support for alignment of Part 2 with HIPAA for purposes of TPO 

Dear Chairman Walden and Ranking Member Pallone, 

Kristen Shatynski 

Caleb Graff 

Waverly Gordon 

Tiffany Guarascio 

We are very encouraged by Congress's dedication to reversing the opioid epidemic. Centerstone is 

grateful for all the efforts Congress has made, particularly in the past year, to find ways to better treat patients 

with substance use disorders. Specifically, Centerstone thanks you for all your work in drafting dozens of 

legislative proposals to become part of a larger CARA 2.0 package, We appreciate the Committee's continued 

leadership in working toward well-vetted, high-quality solutions to our nation's opioid challenge, Once again, 

we reiterate our support for a legislative vehicle to align Part 2 with H!PAA for the purposes of treatment, 

payment, and healthcare operations (TPO). 

The Confidentiality of Substance Use Disorder Patient Records rule- 42 CFR Part 2 is a stringent rule 

that prevents providers from systematically treating OUD/SUD patients in reliance on complete and accurate 

patient histories. In moving towards more robust integrated care models where every member of a 

patient's treatment team needs to understand a patient's full medicaVSUD history, Part 2 stands as a 

hindrance to whole-person care. Part 2 has never been applied universally: only federally assisted alcohol and 

drug abuse programs providing SUD diagnosis or treatment are subject to the stringent Confidentiality of 

Substance Use Disorder Patient Records rule- 42 CFR Part 2. 1

•

2 Part 2 prevents these federally funded 

providers from accessing a patient's full substance use history witbout the patient's prior written consent In 

contrast, non-federally assisted providers throughout the country are governed only by HIPAA. Re-disclosurcs 

of protected patient information occasionally cited by patient privacy groups are currently illegaL Thus, 

improper re-disclosures of information are not a reflection of a weak privacy law, but rather, are a reflection of 

improper on-the-ground practice, which can be challenged in court, Thus, we urge lawmakers to align 42 CFR 

Part 2 with HIPAA for the purposes of treatment, payment, and health care operations. Common sense 

legislation like The Overdose and Patient Safetv Act (H.R. 3545), would align Part 2 with HIPAA for the 

purposes of treatment, payment, and health care operations. The Amendment in the Nature of a Substitute to 

H.R. 3545 has strengthened language regarding penalties for improper re-disclosures. Centerstone supports that 

added language, but stresses the need for the statutory alignment to be for purposes of treatment, payment, and 

healtheare operations, and not solely for the purposes of treatment (as in the AINS). 

1 https·//W\VW samhsa gov!sJtes/default/files/faqs-applying-confidentiality-regulations-to-hie.pdf 2 http· I /www.jhcon nect. org/\\'P·Contcntfup loads/20 13/09/42 -CFR-Part-2-final. pdf 
201 


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Substance use disorders can have complicated ripple effects on a patient's health that need to be 

carefully identified and coordinated.' The current outdated rule poses a serious safety threat to persons with 

substance use disorders due to risks from multiple drug interactions and co-existing medical problems. To 

illustrate this, an example from a Centerstone Indiana patient follows: 

A young man was referred to Centerstone from a surgeon who had concerns about depression in his 

patient. The referred individual had complex medical needs due to an injury. Upon initial referral, it appeared as 

though the young man had some mental health concerns that were being treated with an anti-depressant and a 

benzodiazepine, as prescribed by the surgeon. When assessing the young man at our community mental health 

center for mental health and addiction services, we developed serious concerns about the possibility of 

overlapping addictive disorders including opiate, benzodiazepine, and alcohol addiction, in addition to a 

depressive disorder. Due to the severity and combination of drugs the man was using, there were major safety 

concerns. The young man's support system was shallow- he was not from the area and had no friends or family 

that lived locally. He had concerns about signing releases of information for any of his family that lived out of 

town or for any other health care provider because he feared he would no longer be able to hide his addiction 

from them, or obtain medication from other providers to support his addiction. Due to the complexity of his 

medical condition, he was able to easily obtain both opiates and benzodiazepines from separate medical 

providers. Being honest about his addiction would have resulted in him no longer having access to the 

drugs that were being legally prescribed to him- ones that were threatening his wellbeing and posing 

high levels of lethal risk of overdose. 

After consulting with psychiatric staff, we determined he was in need of an additional psychiatric 

assessment before potentially starting him on Suboxone to aid in staving off his addiction to opiates. The fear 

remained, though, that he would continue to access bcnzodiazepines, which, if combined with Suboxone, could 

be dangerous. As part of the terms of his Suboxone treatment, he had to agree to sign releases of information to 

his other medical providers so that his psychiatrist could inform them of his full condition, which, if ignored, 

could be more lethal than any of the other complex conditions he was being treated for. After several months, 

the young man agreed to be more open about his opioid use, and agreed to involve more and more individuals in 

his care by signing additional releases of information. Shortly after he signed a release for his mother, he had a 

significant relapse. Thanks to the ability to correspond with his mother, the treatment team intervened to get him 

immediate medical attention and follow-up inpatient treatment that led to a longer term residential placement. If 

the young man had not signed the ROis for his mother or his other health care providers, his providers would 

have been extremely limited in how to proactively respond to his needs. Without an ability to share the young 

man's full medical history, he would have been at high risk o£ death. 

SAMHSA recently released two final rules which take some steps to modernize Part 2, but they do not 

go far enough. Legislative action through The Overdose and Patient Safety Act (H.R. 3545) is necessary to 

modify Part 2 to the full TPO extent. We hope you will consider examples like these in finalizing a CARA 2.0 

package to make care safer for all those who seek it. Thank you for your continued attention to these matters. 

Sincerely, 

David C. Guth, Jr. 

Chief Executive Officer 

Centerstone 

1 http.//Viww.helpendoploidcrisis org/ 
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32361.134

PREMIER 

April20, 20!8 

HlANSFORM!NG 

HfALTHCA>.IE TOGt;;THER' 

The Honorable Greg Walden 

Chairman 

House Energy & Commerce Committee 

2125 Rayburn HOB 

Washington, DC 205!5 

The Honorable Frank Pallone, Jr. 

Ranking Member 

House Energy & Commerce Committee 

2322A Rayburn HOB 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

On behalf of the 3,900 hospitals, hundreds of thousands of clinicians and 150,000 other provider 

organizations in the Premier hcalthcarc alliance, we thank you for your leadership in finding 

solutions to address the opioid crisis that is plaguing our communities. We believe critical steps are 

needed to equip patients, healthcare providers, payers and others in our communities to better deal 

with the challenges that this epidemic presents and the Committee's role has been instrumental in 

developing legislation to accomplish this. 

As you mark-up your opioid package, we would like to highlight why it is important to include H.R. 

3545, the Overdose Protection and Patient Safety Act, introduced by Representatives Markwayne 

Mullin and Earl Blumenaucr, which would align 42 CFR Part 2 (Part 2) with HIPAA's treatment, 

payment and operation protections. Part 2 was enacted more than 20 years before HIPAA and 40 

years prior to the utilization of electronic health care records. When Part 2 was first enacted 

it played an intricate role in protecting the paper medical record from improper usc or seizure by 

law enforcement for those suffering from substance usc disorder. 

While these protections were important in the 1970's, Congress went on to enact I IIPAA in 1996, 

which provides strong protections for every medical condition (i.e. mental health, HIV/A!Ds, 

STD's, llcp. C) with the exception of conditions related to substance use covered by Part 2. The 

enactment of the 2!'1 Century Cures Act then put in motion the transition from paper medical 

records to interoperable electronic medical records with the aim of connecting our silocd health care 

system to allow true integrated delivery models that could improve patient safety, quality and 

outcomes and reduce costs to ensure the longevity of Medicare and Medicaid. Today, many 

integrated health care providers, such as accountable care organizations, are using electronic health 

records to better coordinate care for patients among all participating health care providers, including 

for the purpose of medication reconciliation at the time of diagnosis and treatment. 

Premier believes changing Part 2 to align with the HIPAA standard of care for treatment, payment 

and healthcare operations is essential to ensuring many of the proposals being considered by the 

13034 Ballantyne Corporate Place T 704 3570022 444 North Capotol Street, NW T :m2.3930860 PREHIERINC.COJo4 

Charlotte. NC 28:277 F 704.3576611 Su1te 625. Wash>ngton, DC 20001 F 202.393.6499 
203 


32361.135

House Energy & Commerce Committee 

April 20, 2018 

Page 2 of3 

Energy & Commerce Committee can achieve their intended goals. The opponents of H.R. 3545 

cannot provide specific examples how H.R. 3545 would legally allow employers or landlords to 

access an individual's medical record, as they claim could occur. The bill's co-sponsors have heard 

them loud and clear and have added protections for substance use data to the bill that go beyond 

HIPAA's current robust protections. That said, they continue to argue that data breaches happen, 

but this can be said of any industry in the country, not just healthcare. 

The Premier healthcare alliance is committed to helping healthcarc providers with their ongoing 

efforts to reduce adverse drug events, dependence and addiction. Our members are always driving 

toward continuous improvement and toward finding solutions to this national problem. We are at a 

point in which the opioid I heroin/ fentanyl crisis is moving in the wrong direction, evidenced by 

the latest CDC reports that show emergency department visits are up 30 percent for overdoses. We 

are committed to protecting patients' privacy and believe that can be achieved by aligning Part 2 

with HlPAA protections. Under current law the penalty for misusing or sharing information covered 

under Part 2 is $50 (some argue this may have expired) and only enforceable by the Department of 

Justice. If Part 2 is aligned with HIPAA, the penalties would range from $150,000 to $1.5 million, 

providing a much stronger recourse if any wrong doing occurs. 

First, if we are to effectively care for Medicaid beneficiaries suffering from substance use 

disorders, wouldn't it be prudent to allow the states to receive much needed public health data to 

ensure they can identify problem areas in their state and allocate the proper resources to address 

them? Last year, Virginia's Secretary of Homeland Security and Public Health Brian Moran's 

written testimony highlighted the need to amend and align Part 2 with HIP A A. He also clearly 

noted the state of Virginia was flying blind on how to address the deadly opioid crisis. 

Second, effective utilization of state prescription drug monitoring programs will require making 

changes to Part 2. Currently, patients covered under Part 2 will not have their prescriptions reported 

into the state Prescription Drug Monitoring Program (POMP). This presents many challenges, 

especially in regards to preventing patients from doctor shopping for prescriptions, or identifying 

bad actors in the medical community. 

Finally, if we are to expand access to medication assisted treatments for more individuals, 

shouldn't we ensure that the healthcare community has access to the full medical record? Do we 

really think it is safe to say that every Part 2 patient is openly and willingly sharing their full 

medical record with all of their health care providers? As you know, buprenorphine and drugs 

similar in nature contraindicate with many other drugs patients may be taking. In order to prevent 

unnecessary adverse events and ensure the best care is being delivered and medications are being 

safely prescribed, shouldn't the medical community be able to fully reconcile a patient's drug 

history? 

13034 Ga!!anty11e Corporute Place T 704 .357.0022 444 North Cnpitol Street NW, T 202.393 OS60 PREMIERINC.COM 

CMrlotte, NC 20277 F 70<1.357.6611 Suite 62S, Wa~hmgton, DC 20001 F 202.393 6499 
204 


32361.136

House Energy & Commerce Committee 

April 20, 2018 

Page 3 of3 

We would welcome the opportunity to share more information about our work to address the 

opioids epidemic and explore ways in which we can help tackle the problem within the Medicare 

program. 

Sincerely, 

Blair Childs 

Senior vice president, Public Affairs 

Premier healthcarc alliance 

13034 8all:mtyne Corporate Place T 704 357.0022 

Charlotte.NC28277 F 704.357.6611 

444 North Cap•tol Str€!1!t, N.W T 202.393.0860 PREHIERINC.COM 

Swte625.Wi!Shlllgton.DC 20001 F 202.393.6499 
205 


32361.137

April 6, 2018 

The Honorable Greg Walden 

Chair, Energy and Commerce Committee 

U.S. House of Representatives 

Washington, D.C. 20515 

RE: Overdose Prevention and Safety Act 

The Honorable Frank Pallone 

Ranking Member, Energy and Commerce Committee 

U.S. House of Representatives 

Washington, D.C. 20515 

Dear Chairman Walden and Ranking Member Pallone, 

On behalf of the Catholic Health Association of the United States (CHA), the national leadership 

organization of more than 2,000 Catholic health care systems, hospitals, long-term care facilities, 

sponsors, and related organizations, I am contacting you regarding the opioid crisis affecting far 

too many of our nation's communities. We have heard from our health systems, hospitals and 

clinics across the nation how this crisis is affecting their ability to provide health care, and we are 

pleased to see the variety of legislative solutions being considered in the hearings held by the 

Energy & Commerce Health Subcommittee. 

As the Committee continues consideration oflegislation, we wish to express our strong 

support for the Overdose Prevention and Safety Act as originally introduced (H.R. 3545). 

This legislation would align current regulations for substance use disorder (SUD) records 

with existing patient protections for treatment, payment and health care operations, so that 

SUD and other medical records would be treated in the exact same way. We also support 

adding provisions to the legislation to ensure even stronger protections for patient privacy and 

anti-discrimination, as well as appropriate penalties for violations of these protections. 

Catholic health providers recognize that each human life is sacred and possesses inalienable 

worth, and that health care is essential to promoting and protecting the inherent dignity of every 

individual. We also recognize that supportive and readily available substance use disorder (SUD) 

treatments are essential facets of holistic, person-centered and effective health care. The first 

principle in our Vision for U.S. Health Care affirms our call to pay special attention to those 

most likely to lack access to health care, many of whom are in desperate need of SUD services. 

This commitment is why the Catholic health ministry strongly supports efforts to increase access 

to these services and ensure that they become fully integrated into our health care system. 

CHA supports H.R. 3545, the Overdose Prevention and Safety Act, as an important tool for 

achieving that integration. Most importantly, H.R. 3545 as originally introduced would 

allow "use or disclosure" of the content of records to carry out SUD treatment, payment or 

health care operations as defined under current HIPAA regulations. These three pieces of a 

1875 Eye Street NW, Ste. 1000 Washington, DC 20006 phone 202.296.3993 fax 202.296.3997 www.chausa.org 
206 


32361.138

patient's record are inseparable in existing electronic health records (EHRs). They enable 

the essential flow of patient information among providers that is critical to the timely and 

effective delivery of health care and critical to patient safety and quality. That is not 

possible when having to maintain and access two separate sets of records for the same 

patient. For health providers, the alignment with HIP AA for SUD treatment as well as 

payment and health care operations is essential to providing whole-person care. Full 

coordination of physical care and SUD treatment, including medical records, is also necessary to 

minimize the risk of relapse or future addiction among patients. And it is a key component for 

licensing requirements, accreditation standards and maintaining best practices to ensure that 

those requiring SUD treatment receive the most effective care possible. 

We understand from our member organizations treating substance use disorders that the current 

system, with separate charts and records for SUD patients, has made the provision of care 

unnecessarily burdensome and curtailed their ability to expand options for care and treatment 

even as the opioid epidemic continues. The full alignment of SUD records with HIP AA across 

treatment, health care operations and payment settings, as originally provided for in H.R. 

3545, is essential to their work, mission and patient safety. 

Thank you again for your attention to the urgent matter of opioid and other substance use 

disorders. We know that you share the goal of our Catholic health ministry in providing the best 

possible care and treatment for those who need it, and we look forward to working with you on 

legislative solutions that can meet the current challenges. 

Sincerely, 

Michael Rodgers 

Senior Vice President, Advocacy & Public Policy 

1875 Eye Street NW, Ste. 1000 Washington, DC 20006 phone 202.296.3993 fax 202.296.3997 www.chausa.org 
207 


32361.139

Apri123, 2018 

The Honorable Greg Walden 

Chairman 

House Committee on Energy and 

Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Frank Pallone, Jr. 

Ranking Member 

House Committee on Energy and 

Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

Re: HR 3545- The Overdose Prevention and Patient Safety (OPPS) Act 

Dear Congressmen Walden and Pallone: 

The College of Healthcare Information Management Executives (CHIME) is pleased to 

support HR 3545, the Overdose Prevention and Patient Safety (OPPS) Act The legislation 

would be integral in managing opiold addiction records through seeking to align 42 CFR 

Part 2 regulation with the Health Insurance Portability and Accountability Act (HIPAA) for 

the purposes of payment, treatment and health care operations. 

CHIME is an executive organization dedicated to serving chief information officers (CIOs), 

chief medica! information officers (CMIOs), chief nursing information officers (CN!Os) and 

other senior healthcare IT leaders. With more than 2,500 members in 51 countries and over 

150 healthcare IT business partners, CHIME provides a highly interactive, trusted 

environment enabling senior professional and industry leaders to collaborate; exchange 

best practices; address professional development needs; and advocate the effective use of 

information management to improve the health and healthcare in the communities they 

serve. 

Recently, in the face of the almost 45,000 lives lost in 2016 to opioid addiction and 

overdose CHIME's Opioid Task Force is undertaking several initiatives aimed at curbing 

the pattern of addiction including reviewing the impact of technology and data driven 

solutions. 

When a provider is caring for a patient's health, it is essential that they have a complete 

medical history with all relevant information that will help them make clinical decisions to 

the best of their ability_ To ensure the highest quality of care possible, information 

pertaining to substance use disorder (SUD) is pertinent. However, as it currently stands as 

required by 42 CFR Part 2, SUD treatment and diagnoses are kept confidential tram providers which can be extremely problematic when a clinician is attempting to treat 

someone but doesn't know their prior addiction history. Our members strongly support 

synchronizing these consent policies and reducing the burdens imposed by these two 

different sets of rules and facilitating consent for the purposes of treatment, payment and 

healthcare operations pursuant to HIPAA. 
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32361.140

Oftentimes, someone is prescribed an opioid for pain because the physician doesn't have 

any knowledge of problematic substance abuse history. !f they had been able to access 

this information, they would often have been able to keep those vulnerable for misuse safe 

from the harm of the highly addictive painkiller. HR 3545 would align 42 CFR Part 2 with 

HIPAA which would allow the sharing of patient information with clinicians treating the 

patient, so they can make the most informed decisions possible. By allowing this, the 

information would still be safeguarded under the rules of HIPAA while giving clinicians 

electronic access to a broader picture of a patient's health: therefore, resulting in a better 

care experience for the patient. 

We appreciate your continued interest and leadership on this subject. We stand ready to 

work with you and your colleagues toward the passage of this important legislation, which 

would help clinicians treat those patients struggling with addiction. Should you have any 

questions about our position or require additional information, please contact us at 

policy@chimecentral.org. 

Sincerely, 

Russell Branzell, FCHIME, CHCIO 

CEO & President, CHIME 

Cletis Earle, Chair, CHIME Board of Trustees 

Vice President and CIO Information 

Technology Kaleida Health 
209 


32361.141

PARTNERSHIP TO AMEND 42 CFR PART 2 

A COALITION OF OVER 40 1/EALUI CARE STAKEHOLDERS COMMITTED TO ALIGNING 

42 CFR PART 2 (PART 2) WITH HIPAA TO ALLOW APPROPRIATE ACCESS TO PATIENT 

INFORMATION THAT IS ESSENTIAL FOil PROVIDING WHOLE-PERSON CARE. 

April 23, 2018 

The Honorable Greg Walden, Chairman 

House Committee on Energy & Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Frank Pallone, Ranking Member 

House Committee on Energy & Commerce 

2322A Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

On behalf of the Partnership to Amend 42 CFR Part 2. the undersigned organizations thank you for holding 

many hearings on the opioid crisis and putting forth thoughtful legislation to address this epidemic. The Committee 

on Energy and Commerce hearings have covered many challenges facing states and communities, 

~atients, providers, and payors across the country. 

As you mark-up your opioid package, we would like to highlight the importance of including 1-I.R. 3545, the 

Overdose Protection and Patient Safety (OPPS) Act, sponsored by Representatives Markwaync Mullin and Earl 

Hlumenauer. The OPPS Act would align 42 CFR Part 2 (Part 2) with the Health Insurance Portability ami 

Accountability Act (HIPAA) for the purposes of health care treatment. payment and operations (TPO). 

Part 2 was enacted more than 20 years before HIPAA and 40 years prior to the utilization of electronic health care 

records. While different treatment of substance use disorder (SUD) records were important in the 1970's, Congress 

went on 10 enact HIPAA in 1996, V·ihich allo\vs for the sharing of medical records without an authorization for 

TP(), Ready access to treatment and efficient payment for health care are essential to the effective operation of our 

health care system. Additionally, certain health care operations, such as administrative, financial, and quality 

improvement activities, are essential to support treatment and payment. Aligning Part 2 wilh H"IPAA for purposes 

of treatment alone \VOu!d not allow for care coordination, payment to providers, or fraud and ahusc detection 

\Vithout ;m authorization. I IJPAA applies to every single illne-ss, including other stigmatized diseases like mental 

health, HlV/AIDS, and SUD. However, because HIPAA sets the "floor" or minimum protections for health 

information, the overly~stringent restrictions imposed under Part 2 supersede lllPAA and prevent alignment with 

all other health care conditions. 

The members of the coalition are committed to quality care and protecting patients' privacy and believe that can be 

achieved by aligning Part 2 with HIPAA for the purposes ofTPO. H.R, 3545 maintains all of the protections 

against the use of SUD records outside ofTPO, including in criminal proceedings or investigations~ currently in 

Part 2 and in fact, strengthens them. For example, it currently is not, and is not under H.R. 3545, legal to share an 

individual's SUD record with an employer, law enforcement, or a landlord. Further. H.R. 3545 will require the 

automatic dismissal of any criminal proceeding or investigation based upon a SUD record that was not properly 

obtained using the longstanding com1 order process set forth under Part 2. Additionally, under current law the 

penalty for misusing or sharing information covered under Part 2 is from $500 to $5,000. If Part 2 is aligned with 

HIPAA, the penalties will range from $100 to $1.5 million, providing a much stronger recourse if any wrongdoing 

occurs. 
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32361.142

We believe changing Part 2 to align with the I IIPAA standard of care for TPO is essential in order to integrate care, 

stop opioid prescriptions from getting into the hands orindividuals with a SUD, and to ensure many of the 

proposals being considered by the Committee on Energy and Commerce can achieve their intended goals. 

Sincerely, 

Academy of Managed Care Pharmacy (AMCP) 

American Association on Health and Disability 

American Health Information Management Association (AHlMA) 

American Hospital Association 

American Psychiatric Association 

American Society of Addiction Medicine 

American Society of Anesthesiologists 

/\mcrica1

S Health Insurance Plans 

AMGA 

Association for Ambulatory Behavioral Hcalthcare 

Association for Behavioral Health and Well ness 

Association for Community Aftiliated Plans 

Catholic Health Association of the U.S. 

Centcrstone 

Global Allinnce for Behavioral Health and Social Justice 

Hnzelden Betty Ford Foundation 

Health IT Now 

Healthcare Leadership Council 

lnfoMC 

Mental Health America 

National Alliance on Mental Illness 

National Association for Behavioral Hcalthcare 

National Association of A COs 

~ational Association of State Mental Health Program Directors CNASMIIPD) 

Netsmart 

OCHIN 

Otsuka America Pharmaccuticnl, Inc. 

Premier 

The Joint Commission 
211 


32361.143

February 20, 2018 

The Honorable Greg Walden 

Chairman 

U.S. House of Representatives 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Frank Pallone 

Ranking Member 

Attachment 6 

U.S. House of Representatives 

CommiHee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Chairman Walden and Ranking Member Pallone, 

The Confidentiality Coalition is writing to you to urge passage of H.R. 3545, the Overdose 

Prevention and Patient Safety (OPPS) Act, to enable the appropriate e~change of necessary 

information among medical professionals who are treating individuals with substance use 

disorders, including opioid abuse. While the Confidentiality Coalition commends the U.S. 

Substance Abuse and Mental Health Service Adminlstratlon's (SAMHSA's) ruling to amend 42 

C.F.R. Part 2 to better align Part 2 regulations within the Health Insurance Portability and 

Accountability Act (HlPAA) to integrate behavioral and physical heallhcare, we believe this 

ruling does not go far enough to help increase access to relevant health information among 

patients, payers and providers while concurrently protecting patient privacy. 

The Confidentiality Coalition is a broad group of organizations spanning all sectors of healthcare 

working to ensure that policies are implemented to appropriately balance the protection of 

confidential health information with the efficient and interoperable systems needed to provide 

high quality healthcare. Access to timely and accurate patient information leads to both 

improvements in quality and safety and the development of new lifesaving and life-enhancing 

medical interventions. 

The Confidentiality Coalition is comprised of hospitals, medical teaching colleges, health plans, 

pharmacies, pharmaceutical companies, medical device manufacturers, vendors of electronic 

health records, biotech firms, employers, health product distributors, pharmacy benefit 

managers, health information and research organizations, clinical laboratories, and others. 

Through this diversity, we develop a nuanced perspective on the impact of any legislation or 

regulation affecting the privacy and security of health consumers. 

Current federal regulations governing the confidentiality of drug and alcohol treatment and 

prevention records (42.C.F.R. Part 2 (Part 2)) preclude the Centers for Medicare & Medicaid 

Services {CMS) from disclosing medical inlomnalion to healthcare providers for care 

coordination, including those engaged in accountable care organizations and bundled payment 

organizations. These regulations currently require complex and multiple patient consents for the 

use and disclosure of patients' substance use records that go beyond the sufficiently strong 

patient confidentiality protections that were subsequently put in place by HIPAA. 
212 


32361.144

Electronic health records and value-based payment models such as Accountable Care 

Organizations {ACOs), Health Information Exchanges (HIEs), Medicaid Health Homes and 

related Medicare and Medicaid integrated care programs were designed to create a more 

holistic, patient-centered approach to healthcare where providers work together to coordinate 

across their traditional silos and in some cases are held jointly accountable for the quality, 

outcomes and cost of that care. Critical to making these new models work for patients is having 

access to the individuals' health records, including those related to substance use disorders. 

CMS provides participating providers of Medicare ACO and bundled payment organizations with 

monthly Medicare Parts A, Band D claims under data use agreements that include criminal 

penalties lor misuse. Yet, due to outdated laws mentioned above, CMS is forced to remove a// 

claims where substance use disorder is a primary or secondary diagnosis. Patient safely is also 

threatened with the potential pharmaceutical contraindications that could occur without access 

to the lull medical record. Without this critical information, providers are prevented from 

understanding the full extent of their patients' medical needs. 

We commend SAMHSA's recent rule making efforts, and understand the agency has probably 

gone as far as possible in regards to attempts to modernize the Part 2 Rule. To sufficiently 

address the need lor further reform, Representatives Markwayne Mullin and Earl Blumenauer 

have Introduced H. A. 3545 to ehsure healthcare providers have access to the full medical 

record, Including information on substance use disorders, to effectively and safely treat patients 

suffering from substance use disorders while guaranteeing the privacy and security of 

substance use medical records. In particular, H.R. 3545 would reinforce and expand existing 

prohibitions on the use of these records in criminal proceedings. 

We urge the Committee to consider H.R. 3545 to amend 42 CFR Part 2 and align with HIPAA's 

treatment, healthcare operations and payment policy as one of several potential solutions 

Congress passes to help with the opioid crisis. Thank you for your attention to this Important 

matter. 

Sincerely, 

Tina Grande 

Tina Grande 

Healthcare Leadership Council on behalf of the Confidentiality Coalition 

cc: U.S. House of Representatives 
213 


32361.145

naxwqfyt naxws'Kayam' 

PORT GAMBLE S'KLALLAM TRIBE 

Statement for the Record of the Port Gamble S'Kiallam Tribe 

Before the House Energy and Commerce Subcommittee on Health 

For the Hearing Record for 

"Combating the Opioid Crisis: Improving the Ability of Medicare 

and Medicaid to Provide Care for Patients" 

Aprillt, 2018 

The Port Gamble S'Klallam Tribe provides these comments for the record for the 

Committee's hearing held on April II and 12, 2018, entitled, "Combating the Opioid 

Crisis: Improving the Ability of Medicare and Medicaid to Provide Care for Patients." 

These comments communicate the impacts of the opioid epidemic on our Tribe, our 

response, and what we need from Congress in order to ctTectively confront this issue. We 

arc proud of the steps our Tribe has taken towards formulating and implementing a multifaceted, comprehensive approach to respond to the opioid epidemic in our community, 

and we are pleased to share our experiences with the Committee. We look forward to 

fut1her opportunities for discussion on this important topic and invite the Committee to 

contact us with any follow up questions. 

I. About the Tribe, our Health Care System and Relevant Programs 

The Port Gamble S'Klallam Tribe is a federally recognized. self-governing tribe with I 00 

percent of its reservation lands in trust. We arc located on the not1hern tip of the Kitsap 

Peninsula in Kitsap County Washington. The Tribe's Reservation is home to about twothirds of the Tribe's 1,200 enrolled members. The Tribe is the only Indian health care 

provider of both primary and behavioral health services in Kitsap County, and proudly 

provides culturally appropriate health care to our members and approximately 800 other 

American Indians and Alaska Natives (AI/ AN) and community members living on our 

Reservation. 

The United States has a trust responsibility to provide health care to our tribal members, 

as recognized in our treaty and reflected in numerous statutes. In 1976, Congress 

amended the Social Security Act to recognize the Federal Government's commitment to 

honoring tribal sovereignty, upholding the trust responsibility, and recognizing our 

government-to-government relationship by authorizing Medicare and Medicaid 

reimbursement for services provided in the Indian Health Service (IHS) and tribally 

operated health care facilities. The Centers for Medicare and Medicaid Services (CMS) 

plays an essential role in fulfilling the Federal Government's trust responsibility to Tribes 

by ensuring access to and the quality of critical healthcarc programs and services to 

AI! AN communities. 
214 


32361.146

Medicaid funds represent !3% of total IHS funding, and provides coverage for 34% of 

non-elderly All ANs and over half of All AN children, but that only amounts to a fraction 

of one percent of total Medicaid funding. Over 44% of patients at the PGST clinic are 

Medicaid eligible and 28% remain uninsured. Over half of om uninsured patients are 

tribal members. Medicaid payments represent approximately 20% of our funding in 

health services. 

Medicaid reimbursements arc essential to filling the gap created by chronic underfunding 

of IHS, and are a critical source of funding for self-governance tribes like ours. Our IHS 

funding alone would not allow us to provide comprehensive primary care services. Our 

third-party revenue allowed us to hire additional medical staff and support staff, as well 

as nurse case management and funding for the essential prevention work. 

The Tribe joined the Tribal Self-Governance Project, a consortium of self-governing 

Indian Tribes, in 1990 and has directly provided health services to its members for over 

20 years. We fund our health services though a compact with the II-IS under the Indian 

Self: Determination and Education Assistance Act, and operate and manage our entire 

health system on om Reservation. 

Our health system includes primary care, dental, mental health and substance abuse 

services. We provide our primary care services out of our outpatient primary care health 

clinic, which is staffed with 2 physicians, a physician assistant, and 4 registered nurses. 

Our dental building is next door and includes 2 dentists, 1 dental health aide therapist, 

and a dental hygienist. Our behavioral health clinic is approximately two miles away. It 

includes 1 physician, 1 Advanced Registered Nurse Practitioner (ARNP), 4 substance 

abuse counselors, 5 mental health counselors and 2 prevention specialists. It provides 

outpatient substance abuse treatment, relapse prevention, group, individual and family 

mental health counseling, psychiatric evaluation and medication management, and 

Medication Assisted Treatment ("MAT'). Over 98 percent of our behavioral health 

clients are also served by our primary care clinic. Community Health Representatives 

and transporters fill an essential role for both clinics, providing clinical linkages to the 

community and transportation services. 

In addition, relevant to the opioid issue, our Tribe operates a police department, which 

consists of nine officers and places a strong emphasis on community-oriented policing for 

all residents and visitors. We also operate a Tribal Court with jurisdiction over criminal, 

civil and juvenile matters. Appeals are heard by our three-judge Co uti of Appeals. 

Our Children & Family Services Department includes our Behavioral Health Division 

and the Community Services Division and works to enhance the quality of life of our 

Tribal members and their families through a culturally sensitive approach that encourages 

living a healthy lifestyle and promotes self-sufficiency. The Port Gamble S'Klallam 

Tribe operates all eligible programs under Title IV of the Social Security Act; Temporary 

Assistance to Needy Families (TANF) Part A, Child and Family Services (Part 8), Child 

Support (Pati D), and lastly, Foster Care and Adoption Assistance (Pati E). 

2 
215 


32361.147

II. Impacts of the Opioid Crisis on the Trihe 

In Washington State, the Native American overdose rate is more than twice as high as 

that of white Washingtonians. 1 The data shows that AI/AN in Washington State die of 

drug overdoses at a rate of 34.4 per l 00,000 people, more than twice the rate of the next 

highest group (15.1 for Pacific Islanders), and almost three times that of whites at 12.4 

and African Americans at 12.3. Other rates are 1.1 per I 00,000 for Latinos, and 1.2 for 

Asian Americans.2 For every opioid overdose death, there are l 0 treatment admissions 

for abuse, 32 emergency room visits, 130 people who are addicted to opioids, and 825 

nonmedical users of opioids. 3 

Further, misuse of prescribed opioids frequently leads to abuse of other drugs such as 

heroin. According to the National Institute of Drug Abuse, 21 to 29 percent of patients 

prescribed opioids for chronic pain misuse them, and 4 to 6 percent who misuse 

prescription opioids transition to heroin. About 80 percent of people who use heroin first 

misused prescription opioids. The death rate for heroin overdoses among Native 

Americans has also skyrocketed, rising 236 percent from 20 l 0 to 2014. 4 That exponential 

increase is the result of and now a part ofthe prescription opioid crisis. 

The CDC reports that American Indians/Alaska Natives had the highest national drug 

overdose death rates of any race in 2015, and a 519% increase in the number of nonmetropolitan overdose deaths from 1999-2015.5 Alarmingly, approximately 1 in I 0 

American Indian youths ages 12 or older used prescription opioids for nonmedical 

purposes in 2012, double the rate for non-Hispanic white youth." 

These statistics reflect the heartbreaking reality on the Port Gamble S'Klallam 

Reservation as we struggle to confront the devastation caused by opioids flooding our 

community. We have had numerous overdoses and deaths in our community as a result of 

the opioid crisis, and not only from the vast supply of such drugs coming into our 

community through the black market. It has been estimated that approximately 60% of 

1 Austin Jenkins, lnslee Wants Washington State to Declare Opioid 'Public Health Crisis,' KUOW.org (Jan 

12. 201 &), available at http://kuow.org/post/inslee-wants-washington-state-declare-opioid-public-healthcrisis. 

2 Washington Department of Health Death Certificate Data. 3 National Institute on Drug Abuse. Opioid Abuse Crisis. Available at https://www.drugabuse.gov/drugsabuse/opioidsiopioid-overdose-crisis (last accessed March 8, 20 18). 4 Dan Nolan and Chris Amico, How Bad is the Opioid Epidemic?, PBS.org (Feb. 23, 20 16), available at 

https:i/www.pbs.org/wgbh/frontline/article/how-bad-is-the-opioid-epidemic/ (last accessed Feb. 27, 20 18). 5 CDC Morbidity and Mortality Weekly Repot1 (MMWR), available at 

https://www.cdc.gov/mmwr/volumes/66/ss/ss6619a l.htmos cid~ss6619a 1 w (last accessed March 8, 

2018). 

6 National Congress of American Indians. R~flectin!!, on a Crisis Curbing Opioid Abuse in Communities 

(Oct. 2016), available at http://www.ncai.org/policy-research-center/research-datalprcpublications/Opioid_Bricf.pdf (last accessed Feb. 27, 20 18). 

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the opioids that are abused come, directly or indirectly, through the standard, "lawful" 

channels of distribution.7 

On our Reservation, the deaths include members who were prescribed opioids as pain 

medication and accidentally overdosed. In the recent past, the Tribe experienced an 

overdose by a young mother and the death of a toddler, just two years old, who got into 

his parents' opioid medication. We have grieving children, parents, grandparents, and 

great-grandparents who have lost family due to this scourge. Every r:1mily on our 

Reservation has been impacted by this epidemic. 

At a government level, these impacts cut across all departments, complicating funding 

priorities and creating competition for scarce resources. Our Health, Behavioral Health, 

Children & family Services, and Housing Departments, as well as our courts, law 

enforcement, and administration, all have a role to play in responding to this crisis. 

One specific example of the impacts we face involves dependency cases that the Tribe 

files to ensure a child's safety and well-being. One of the key roles of our Children & 

Family Services Department is to keep children with their families. However, when the 

Department is dealing with children who arc removed from a home due to abuse and 

neglect, they need to find alternative care for those children. We have both relative 

placements and 20 Tribal licensed foster homes. As a result of the opioid crisis, the 

Department has seen a substantial increase in dependency cases. Ninety-eight percent of 

all dependency cases are now the result of drug use. In the first eight weeks of 2018, the 

Tribe filed four new dependency cases, three of which were related to parent(s) opioid 

abuse. This already surpasses the total new cases filed in 2017. These new cases are in 

addition to the open dependency cases that the Tribe has already filed. The increased 

number of dependency cases due to opioid abuse or overdose has overwhelmed our 

capacity. Opioid abuse impacts the whole family. Our Tribal member grandparents are 

often raising their grandchildren. In addition to this role, they often struggle to help their 

own child who is suffering from addiction. 

The increased number of dependency proceedings burden existing child welfare services 

staff and resources, and require additional hires. Every child who comes into the Tribe's 

care and custody needs an array of intervention and services, including mental health 

counseling, medical services, substitute care, and housing. The parents who survive need 

treatment and counseling as well. Children who are exposed to opioids in utero suffer 

from opioid withdrawal and Neonatal Abstinence Syndrome, and often bear scars that will 

last a lifetime. These infants are immediately transferred to a neonatal intensive care unit 

for a period of days, weeks, or even months. frequently requiring emergency evacuation 

for care to save the infant's life. Such emergency transportation costs the Tribe thousands 

of dollars for each occurrence. 

7 As we have alleged in our lawsuit (discussed below), the practices that the defendant manufacturers and 

distributors have engaged in by moving massive amounts of prescription opioids into our community are in 

fact unlawful. 

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The crisis has forced the Tribe to staff new positions at great expense, including additional 

substance abuse counselors to deal with the substantial increase in opioid addiction, a 

nurse specializing in substance abuse disorders for case management related to the opioid 

epidemic, and physicians to provide Medication Assisted Treatment with drugs such as 

naltrcxone for opioid addiction and abuse. 

The Tribe has provided naloxone HCI, also knovm as "Narcan", a nasally administered 

overdose reversal drug. and the training to use it, to all law enforcement personnel. Due to 

their work in the field in our Tribal community, those officers regularly encounter 

individuals suffering from opioid overdose symptoms who can only be assisted and saved 

from death by timely administration ofNarcan. The Tribe provides Narcan and training in 

its use to other members of our community, because the need for such emergency 

treatment is severe. Approximately 120 Tribal members have been provided with Narcan 

and trained on how to administer the drug. These steps are necessary, but they also cost 

money, which affects our Tribe's budget and priorities for budget spending. 

In terms of housing, the Tribe receives federal funding under the Native American 

Housing Assistance and Self-Determination Act (NAHASDA) to develop and operate 

affordable housing for low-income Indian families. Due to the substantial increase in 

opioid abuse, the Tribe has seen a parallel increase in evictions of Tribal members and 

other Indian families (since NAHASDA requires all leases to have language authorizing 

eviction for "drug-related criminal activity''). When those families are evicted from the 

Tribe's housing they generally become homeless, and as a result they are then in even 

greater need of social, medical, and child welfare services from the Tribe. 

The opioid crisis is overwhelming to our law enforcement and social services programs 

as they are not pn:sently resourccd sufficiently to meet the needs arising from the opioid 

epidemic. We are working as hard and as efficiently as we can with the resources we 

have, but additional resources in terms of funding, personnel and authorities are needed 

to combat the myriad problems the opioid crisis causes. 

This epidemic is a complex issue, and there is no quick and easy fix for resolving the 

problem. Rather, we need a multifaceted, comprehensive approach with tactics that 

work. Our Tribe has been working to implement such an approach but we need your help. 

III. What Port Gamble S'Kiallam Tribe is Doing to Combat the Crisis 

The Tribe has shown leadership in its aggressive and comprehensive response to the 

opioid epidemic through our cross-governmental Tribal Healing Opioid Response 

program, collaboration with Washington State, through participation in the Three County 

Coordinated Opioid Response Project (3CCORPS), and, most recently, like many other 

state and tribal governments, by seeking to cut the flow of opioids into our community 

and seek compensation for the devastation caused by the crisis by filing a lawsuit against 

the manufacturers and distributors of these drugs for their role in creating this crisis. 

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A. THOR- Tribal Healing Opioid Response 

The Tribe convened two Tribal town hall meetings last year to share the local impacts of 

the opioid crisis and determine a path forward. The extraordinary attendance at these 

community events demonstrated the intense and widespread impact of the crisis. Our 

Tribal Council then met with Kitsap County officials to discuss a response to the opioid 

crisis. The Tribe recognized that the crisis affects all our members and Tribal agencies 

and requires a cross-government response. These efforts led to the creation of our Tribal 

llealing Opioid Response (T! !OR), a project led by the Tribe's Behavioral Health and 

Health Services Departments. THOR is now the heart of our opioid response on our 

Reservation. 

THOR has three main goals, and Depatiments across the Tribe-not just health-related 

entities-are responsible for achieving them. These three main goals and the associated 

strategies are: 

(1) preventing opioid misuse and abuse by changing prescription practices, raising 

awareness of the danger of overdose, youth prevention programs, safe storage 

and disposal education, and drug supply reduction; 

(2) expanding access to opioid usc disorder treatment by training health providers 

to recognize disorder symptoms, increasing access to treatment, applying 

treatment practices in the criminal justice system, implementing syringe 

exchange and overdose prevention/treatment training, and reducing instances 

of opioid withdrawal in newborns; and 

(3) preventing deaths from overdose by educating the Tribal community in how to 

recognize and respond to an overdose, and expanding access to overdose 

reversal medication. 

Since January 2017, the Tribe has convened monthly THOR workgroup meetings 

composed ofTribal Council Members, Department Directors, staff, and other community 

members to implement the THOR goals. The workgroup is responsible for developing, 

reviewing and updating the Tribe's local response plan. It reviews the statewide opioid 

response plan and other best practices, identifies appropriate strategies, and assigns tasks 

and responsibilities to workgroup members. 

Significantly, our Tribe took note of the November 2016 Surgeon General's Report on 

Alcohol, Drugs and Health which identified prevention as key to the fight against abuse 

and addiction. We pulled strategies from this report and put them into practice in our 

effort to get ahead of potential addictions by creating a Prevention Team. Our Prevention 

Team is responsible for numerous programs that focus on youth and using evidencedbased approaches to keep youth active in the community. The youth services program 

offers extended hours, a safe space, and education about substance abuse and suicide 

prevention 6 days a week. Through our Chi-e-chec Tribal Coalition, we collaborate with 

adults in the community and provide substance abuse education and prevention activities 

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to adults and families. Chi-e-chee can be translated to "the workers or the do-ers." The 

coalition has been active for over 20 years and is identifying and implementing events 

and activities around issues that are significant to our community. 

The Tribe provides education to the community, focusing on pain treatment with 

exercise, mental health and non-opioid medications. Our ultimate goal through this effort 

is to significantly reduce the number of opioid prescriptions. Town hall meetings arc 

held qum1erly to help educate the community on current issues/topics that are significant 

to the community and are well attended. 

THOR assigns specific responsibilities to each of the Tribe's departments to reach the 

THOR goals. 8 For prevention, the Health Department is responsible for promoting best 

practices in prescribing and promoting safe storage and disposal of prescriptions; the 

Behavioral Health Department is responsible for awareness programs; Chi-e-chec is 

responsible for preventing misuse in youth; and the Police Dcpat1ment is responsible for 

attempting to interdict and decrease the supply of illegal opioids. For treatment, the 

Health and Behavioral Health Departments, along with the Police Department, train 

providers to recognize abuse, and the Behavioral Health Department, Health Department 

and Re-Entry Program work together to increase access to treatment and offer syringe 

and needle exchange. To prevent overdose deaths, Chi-e-chee, Human Resources, 

Behavioral Health and Health work together to educate the entire community to 

recognize and respond to overdoses, including through the administration of naloxone. 

As a tribal government, we are focused on providing culturally appropriate treatment to 

our members suffering from opioid addiction and the host of health and mental health 

issues that come with it. These include programs such as our well ness activities, talking 

circles, and group therapy. The Healing of the Canoe Project is a collaborative project 

among the Port Gamble S 'Kia!lam Tribe, the Suquamish Tribe, and the Alcohol and 

Drug Abuse Institute at the University of Washington. Its central mission is to develop a 

life skills curriculum for tribal youth that includes drug abuse materials. The Project has 

made its curriculum available and has trained a total of 350 attendees from 46 Tribes and 

14 tribal organizations in how to adapt and implement the curriculum. 

One of central reasons why our TI-IOR program is so effective is because the Tribe is not 

only a health care provider for our community, we are also a government with the ability 

to coordinate with State, County, and regional groups. Our clinics, Police Department and 

social services departments have the ability to quickly work through bureaucracy for 

cross departmental collaboration, providing better services to both Tribal members and 

the community as a whole. 

'Tribal Healing Opioid Response Program, 

https:l/www. nihb.org/ docs/1203 JO 171Tuesday%20Sessions/THOR %20Presentation.pdf (last accessed 

March 11, 2018). 

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B. Collaboration with Washington State and Accountable Communities of 

Health (ACH) 

Washington State has a Section 1115 waiver under the Social Security Act which funds 

experimentaL pilot, or demonstration projects that are found by the United States 

Secretary of Health and Human Services to be likely to assist in promoting the objectives 

of the Medicaid program. These demonstration projects provide states additional 

flexibility to design and improve their programs with an eye toward evaluating statespecific policy approaches to better serve Medicaid populations. Through its Section 

1115 waiver authority, Washington State has created Accountable Communities of 

Health, which bring together leaders from multiple health sectors around the state with a 

common interest in improving health and health equity. ACHs seek to align resources 

and activities to support wellness and a system that delivers care for the whole person. 

ACHs are also working to shift health care reimbursement strategies away from a system 

that pays for volume of service to one that rewards quality and outcomes. 

Through the Section 1115 waiver and the creation of these ACHs, the Tribe has been able 

to form partnerships that were not otherwise easily accessible or workable. Now, on the 

opioid issue, specitically, the Tribe has multiple partners at different levels with whom it 

can and has been coordinating to develop and implement a variety of tactics to address 

the many issues arising from the epidemic. The Tribe collaborates with Washington State 

on the Washington State Opioid Response Plan and, on the regional level, the Olympic 

Community of Health (OCH) which is implementing the Three County Coordinated 

Opioid Response Project (3CCORPS). 

C. Olympic Community of Health and 3CCORPS 

OCH is an Accountable Community of Health whose objectives are to improve patient 

care, reduce the cost of health care and improve the health of the population in Clallam, 

Jefferson and Kitsap Counties. Each of the seven Tribal Nations within the three county 

region, including our Tribe, is represented on the OCH Board of Directors. 

3CCORPS. OCT-I' s specific opioid response, was launched in September of 2016 and 

convened an opioid summit in January 2017. It was not long before this summit that one 

of our Tribal members died due to missing a dose of naltrexone. This tragedy spurred 

momentum for our Tribe's active opioid response. 

3CCORPS is currently in the implementation phase of its opioid response plan. 

Addressing the opioid epidemic is a required project in the Medicaid Transformation 

Project (MTP) of the OCH. 3CCORPS' foundations are the same 3 goals and strategies 

that the Tribe has adopted and adapted as our own opioid response plan. They also align 

with the statewide plan. The alignment of goals and strategies allows for quick 

duplication of evidence-based strategies and the ability to coordinate within the broader 

regional and state level, and also facilitates evaluation and data collection efforts. 

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3CCORPS is our work on the regional level with the OCH. Other groups that participate 

in 3CCORPS are independent clinics, police departments, and social service agencies that 

serve many different communities. 

D. Litigation to Curtail Oversupply of Opioids and to Obtain Compensation for 

Damages 

On March 5, 2018, the Port Gamble S'Klallam Tribe. along with the Suquamish Tribe 

and the Jamestown S'Klallam Tribe, filed a complaint in federal district court naming 

various opioid manufacturers and distributors, including Purdue Pharma LP, McKesson 

Corp., Cardinal Health Jnc., AmerisourceBergen Corp. and others. Our complaint alleges 

that these companies spread false and misleading information about the safety of opioids, 

negligently created an illicit market for opioids, and failed to control the flow of opioids 

to our Tribal members. The complaint details the same devastating impacts that we report 

to you today, and asks the court to find that the defendants broke the law though fraud, 

negligence, public nuisance, violation of Washington State consumer protection laws, 

other laws, and racketeering. Through the lawsuit, we seek compensation for the cost of 

responding to and treating opioid-related addiction and punitive damages. We are also 

seeking injunctive relief to stop these defendants from continuing these devastating 

actions. In tiling this lawsuit, we join over 400 other plaintiffs across the country, 9 

including state and tribal governments, in seeking to hold these companies accountable 

for the devastation caused by the opioid crisis. 

IV. Lessons Learned and Strategies All Tribes Can Choose to Put in Place 

A. Cross-Government Coordination 

Through THOR and our 3CCORPS program with the OCH, we have learned many 

lessons in the fight against opioid addiction and efforts to treat those affected. At the 

forefront, we learned that coordination and communication across our government is key 

as well as ensuring that all of our Departments pitch in to the effort however they can. 

As the opioid epidemic affects all facets of our community, we have taken an "all-handson-deck" approach as a government. As explained above. we draw on any and all of our 

Departments that can help so that we can attack the crisis from many angles. Our 

monthly THOR workgroup meetings have been key to synchronizing our programs and 

generating action items to address the opioid problems in our community. 

B. Culturally Appropriate Care 

Recognizing that traditional healing practices, cultural beliefs regarding approaches to 

treatment, and differences in interpersonal communication contribute to significant 

variances in effectively meeting the healthcare needs of All AN, cultural competency is 

an inherent part of who we are, who we serve and what we do. 

9 "Can This Judge Solve the Opioid Crisis?", New York Times, March 5, 2018, available online at 

https://www.nvtimes.com/2018/03/05ihealth/opioid-crisis-judge-lawsuits.html, (last accessed March 8, 

2018). 

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C. Abuse Prevention 

Prevention is the cornerstone for any opioid response, as the Surgeon General's Report 

on Alcohol, Drugs and Health (November 20 16) states. We realize that availability of 

resources is different in different parts of Indian Country. Y ct, there are strategies that 

any Tribe can put into place in its fight against the opioid epidemic. Our Tribe has a 

"toolkit" which we share with other Tribes in their opioid fight. We are happy to share 

our "toolkit" with any Tribe who would like access to it. Our "toolkit" includes: 

(!) Our Pain Agreement used in the clinic for clients with opioid prescriptions 

for chronic pain; 

(2) Our Narcan Standing Orders & Policy- provides Narcan to any Tribal 

member or household that requests it, and to any patient with an active opioid 

prescription; and 

(3) Our Good Samaritan Tribal Code- provides liability protection for those who 

act in good faith and seek medical assistance for any person who is 

experiencing a drug-related overdose. 

Collaborating with federal agencies has been very helpful in our Tribe's fight against the 

epidemic. We suggest that Tribes regularly call upon their regional federal agency 

of1icials from lHS, SAMHSA, HRSA, BlA, DOJ, and others. These agencies have 

resources, technical assistance and connections that they can share. Further, Tribes may 

find that partncring with their neighboring governments on this particular issue yields a 

variety of benefits. Accessing additional resources is always a benefit, whether they arc 

financial resources or non-financial resources such as experience, expertise and technical 

assistance. Brainstorming and sharing ideas with federal agencies and neighboring 

governments with mutual interest in stemming the opioid crisis can lead to innovation 

and cooperation. 

Our Tribe has benefited from having close collaboration with federal agencies at the 

regional level. The Acting Regional Director of the Department of Health and Human 

Services (HHS), and the Regional Director of the Substance Abuse and Mental Health 

Services Administration (SAMHSA), have both visited the Tribe recently, participating 

in robust discussions on opioid prevention. As a specific example, our SAMHSA 

discussion helped clarify 42 CFR Part 2 updates and requirements. 

V. Barriers and Needs to More Effectively Fight the Opioid Crisis 

A. Funding Needs 

There are several barriers that Tribes face in their efforts to overcome the opioid 

epidemic. We have run into several. 

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1. Adequate Funding and Direct Funding 

Adequate funding to combat this behemoth opioid crisis is, of course, a major barrier. 

Getting funding out to Tribes for their on-the-ground work is an issue not only in the 

amounts, but also in the manner in which such monies flow to Tribes. We strongly 

encourage Congress to not only work on increasing available funding, but to also provide 

direct funding to Tribes and ensure that any additional funds for opioid crisis response do 

not decrease services in other areas. 

We truly appreciate Congress's inclusion of authorization for $6 billion over 2 years for 

opioid efforts in the recently passed Bipartisan Budget Act of2018. We ask the 

Committee to advocate for full funding of the authorization and ensure that these funds 

go directly to tribal governments for them to spend in their own communities. Such 

funds should not be passed through the States. Direct funding of tribal programs is 

important as it ensures that funds are available to tribal governments like ours that have 

culturally appropriate programs and mechanisms in place for fighting the opioid 

epidemic. 

An important bill that includes the requested direct funding mechanism isS. 2270, the 

Mitigating the Methamphetamine Epidemic and Promoting Tribal Health Act. This bill, 

introduced by Senator Daines, a member of this Committee, would make Tribes and 

tribal organizations eligible for direct funding under the 21st Century Cures Act, which 

provides an allocation to states for opioid prevention and response. S. 2270 would allow 

such allocation to also be used for prevention and response for other substances, such as 

mcthamphetamines, if they arc having a substantial impact on the state or Tribe. 

2. Full Funding of IHS Budget 

Additionally, we ask you to work toward providing sufficient funding to the IHS for 

opioid treatment and prevention. The FY20 19 Budget Request provides $I 0 billion in 

new resources across HHS to combat the opioid epidemic and address serious mental 

illness. As part ofthis effort, the Budget Request includes an initial allocation of$150 

million to IHS to provide multi-year competitive grants based on need for opioid abuse 

prevention, treatment, and recovery support in Indian Country. 10 

The Public Health Service Commissioned Corps plays a vital role in providing direct 

patient care throughout the ll!S, and also has a direct role in the work of Tribes 

combating the opioid crisis. Any restructuring of the Corps should be done in close 

collaboration and consultation with Tribes. 

The FY 2019 Budget Request eliminated both Community Health Representatives and 

Health Education from the IHS budget. These two line items support the front line work 

of Tribes and the H-IS on both the opioid crisis and daily operations and patient care. 

10 2019 Budget in Brief https://www.hhs.gov/sites/default/files/fy.20 19-budget-in-brief.pdf. As of the 

preparation oftbis Statement for the Record, HHS has not released its detailed FY 2019 Budget 

Justification, including for IHS. 

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They need to be restored. 

3. Full Funding of Contract Support Costs 

The FY 2019 Budget Request fully funds Contract Support Costs at an estimated $822 

million and continues the usc of an indefinite appropriation, which allows IHS to 

guarantee full funding of this program. Funding for Contract Support Costs supports the 

costs incurred by Tribes for activities that are necessary for administering health care 

service programs under self-determination contracts and self-governance compacts. 11 

This is an important funding mechanism for self-governing Tribes like ours to administer 

our opioid prevention and treatment programs. 

B. Barriers Beyond Funding 

I. Regulatory Hurdles 

There arc several barriers in the fight against the opioid crisis that arc beyond funding. 

One such barrier relates to funding, but is an administrative limit on accessing already 

available funding. The Health Resources and Services Administration (HRSA) has 

behavioral health integration funding available, but it is restricted to rural locations. 

Kitsap County does not qualify as "rural" and so the Tribe is ineligible for these grants. 

We recently raised this issue to HRSA, and received assurances that this issue would be 

addressed. However, it would be helpful for members of Congress to encourage HRSA to 

reconsider the rural restriction and develop a mechanism for channeling such monies to 

Tribes. This could be through revising the definition of"rural" to include Tribes 

regardless of location or "geographic trait" of its reservation. 

2. Barriers to Medication Assisted Treatment 

We also want to point out certain other barriers to our efforts to combat the opioid crisis. 

Current regulations impose onerous training and waiver requirements for providers of 

Medication Assisted Treatment (MAT) prescribing drugs such as buprenorphine, even 

though no such limitation exists on providers prescribing opioids. This creates barriers to 

accessing MAT. Medicaid dollars used to fund transportation to opioid services could be 

reduced significantly ifbuprenorphinc, an opioid addiction treatment drug also known as 

Suboxone, was easier to access at primary care facilities. Those saved funds could be 

used for prevention or treatment. In addition, nurse care management as an adjunct to 

MAT has been shown to be successful and is an evidence-based practice in treating 

opioid addiction. We need to expand Tribes' access to this treatment. 

3. Phvsician Access to Medical Records 

Federal regulations at 42 CFR Part 2, related to the privacy of substance abuse treatment 

records, currently prevent the Tribe's primary care and mental health providers from 

accessing patient records from dependency providers so the whole person can be treated. 

II /d. 

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This lack of access is a barrier to coordinated, safe, and high-quality medical care and can 

cause significant harm. Part 2 regulations may lead to a doctor treating a patient and 

writing prescriptions for opioid pain medication for that individual without knowing the 

person has a substance use disorder. The President's Commission on Combatting Drug 

Addiction and the Opioid Crisis specifically mentioned the need to update 42 CFR Part 

2.12 

In August 2017, Congressmen Tim Murphy and Earl Blumcnauer introduced bipartisan 

legislation that would help align 42 CFR Part 2 with IIIPAA rules, ensuring that 

substance use disorder patients can receive proper care while their data remains secure. 

The Overdose Prevention and Patient Safety (OPPS) Act (HR 3545) allows access by 

doctors to patients' full medical records with all the safeguards of HIPAA, but also 

makes use of such information in criminal investigations unlawful. The Tribe joins others 

such as the Partnership to Amend 42 CFR Part 2, a coalition of over 20 health care 

stakeholders including the American Hospital Association, in support of HR 3545. 

4. The Lack of Co-location of Health Services on Our Reservation 

The Tribe is actively working to align substance use disorder treatment with primary care 

to address a person's overall health, rather than treating it as a substance misuse or a 

physical health condition alone or in isolation. As stated, our Health Facility and Dental 

Facility arc nearby each other, but our Mental Health Facility and Rehabilitation Facility 

arc some distance away. This causes extra administrative burden and expense of 

resources. Co-locating these services would improve behavioral health integration, but a 

new integrated facility for all health services would cost over $8 million dollars. We 

suspect other Tribes face similar problems with respect to the lack of co-location of 

services. We look to Congress for innovative ideas, perhaps through its infrastructure 

package, for facilitating the construction of co-located health care facilities on tribal 

lands. 

5. The Need to Modernize the IHS's Health Information System. 

This issue impacts the ability of Tribes to confront the opioid epidemic. Barriers to 

integration within the health information system arc being addressed at significant cost to 

the Tribe as we left the Indian Health Service RPMS system tor direct patient care 

documentation years ago, although we continued to utilize that system for Purchased & 

Referred Care (PRC). The system we usc, NextGen. is adequate for primary care, but has 

limitations for mental health and substance abuse. This has impacted our behavioral 

health integration work. 

The Veteran· s Administration announcement that it will pursue a contract with Cerner (a 

supplier of health information technology) as a replacement for the RPMS Parent system 

may provide an opportunity for both IHS and Tribes. IHS needs to ensure that the 

"The President's Commission On Combating Drug Addiction and The Opioid Crisis, at 121-122 (Nov. l, 

20 17) available at https:i/www.whitehouse.gov/sites/whitehousc.gov/files/imagcs/FinaiReport_Draf\_ll 

l-2017.pdf 

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replacement of RPMS will include options for non-RPMS tribes and pathways for cost 

saving programs such as the VA Consolidated Mail Outpatient Pharmacy Service 

(CMOPS). 

6. The Need for Pilot Projects for Residential Post-Treatment Facilities on Tribal 

Lands. 

Our Tribe is particularly interested in initiating a pilot program for residential posttreatment facilities. We would like to provide treatment and support past the prevailing 

28-day model, utilizing evidenced-based practices with a robust evaluation component. 

We have partnerships with Oxford House and Habitat for Humanity to construct and 

operate such facilities, and we are well positioned to start such a pilot program. We ask 

Congress to suppoti the establishment of a pilot program by an agency such as 

SAMHSA, HUD, or IHS to fund residential post-treatment facilities on reservations to be 

operated by Tribes for their members and families. 

7. Lack of Easy Access to Methadone Clinics 

Our Tribal Members must travel to Tacoma or the greater Seattle area to a methadone 

t:1cility to receive such treatment. We are working with OCH to obtain a methadone 

facility in Kitsap County to save our Members the burden and cost of traveling so far for 

that treatment. We ask Congress to consider ways it can facilitate the construction and 

operation of these facilities in locations accessible to tribal and rural communities like 

ours. Kitsap County, where we are located, has a restriction limiting service to one 

methadone clinic in the county. This limitation hampers our ability to provide expanded 

services in the future. 

C. Beneficial Opioid Legislation 

We have shown leadership by implementing an aggressive and comprehensive approach 

for responding to the opioid epidemic in our community. However, we still need the help 

of this Committee, Congress, and Federal agencies to continue our effective efforts to 

respond to the opioid crisis. We support several pieces of legislation introduced in the 

Senate with the hope that Congress will enact them and aid our efforts in combating the 

crisis. 

The Opioid Crisis Response Act, a draft package bill in the Senate, is good legislation that 

will significantly advance the United States' efforts to combat opioid issues. The Port 

Gamble S'Klallam Tribe generally supports T11e Opioid Crisis Response Act; however, 

we recommend that the Congress clarify eligibility standards for the new grant program 

for comprehensive opioid recovery centers and add the necessary language to the bill to 

ensure that Tribes and their communities will have adequate opioid recovery centers to 

meet the needs of their members. Furthermore, we respectfully request that Congress 

include the Indian Country-specific legislation (discussed below) in The Opioid Crisis 

Response Act, or a similar package bill in the House, to make sure that the unique needs 

of Tribes are addressed in this comprehensive effort. 

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S. 2270, the Miligating the Methamphetamine Epidemic and Promoting Tribal Health Act 

(the "Mitigating METH Act"). This bill, introduced by Committee Member Senator 

Daines, would make tribes and tribal organizations eligible for direct funding (no setaside) under the 21st Century Cures Act, which provides funding for prevention and 

response to opioids, or other substances-such as methamphctamines-ifthcy are having 

a substantial impact on the state or tribe. The bill would increase the allocation of$500 

million to $525 million. The Port Gamble S'Kiallam Tribe supports S. 2270 because it 

gives us access to direct funding and important resources for combatting the crisis, in 

recognition of the government-to-government relationship we have with the Federal 

government. 

S. 2437, the Opioid Response Enhancement Act. This bill, introduced by Senator 

Baldwin, would also make tribes and tribal organizations eligible for funding under the 

21st Century Cures Act but through a 10% tribal set-aside. LikeS. 2270, tribes and states 

could use this funding for prevention and response to other substances threatening public 

health-such as mcthamphctamines. Additionally, the bill requires the Substance Abuse 

and Mental Health Services Administration (SAMHSA) to provide technical assistance to 

both states and tribes for grant applications, formulating outreach and support efforts, and 

collecting data. The Port Gamble S'Kiallam Tribe supports S. 2437 because it has 

targeted funding for Indian Country. where Native families and communities feel the 

disparate impacts of the crisis hardest. 

We support direct funding as authorized in both S. 2270 and S. 2437. Adequate direct 

funding means reliable resources and flexibility for our Tribe to continue implementing 

our culturally appropriate, multi-faceted, comprehensive approach to abating the opioid 

epidemic sweeping the community. Additionally, adequate direct funding allows us to 

plan long term for infrastructure development, program enrichment, and service 

enhancements necessary for the well-being of our members and local community. We are 

encouraged by the Sponsors' recognition of the importance for direct funding. However, 

we note that S. 2437 provides significant increases in funding for a longer period of time. 

This additional funding is needed and could be put to use by Indian Country to carry out 

impotiant opioid response activities. Furthermore. we recommend that the Opioid Crisis 

Response Act be amended to fund opioid response activities through a direct funding 

mechanism to Tribes instead of grants. 

S. 2440. the Comprehensive Addiction, Recove1y, Education and Safety (CARE')) Act. 

This bill introduced by Committee Member Senator Cantwell-our Senator-would 

provide law enforcement with more tools to hold drug companies accountable for 

ensuring that their drugs do not enter the illicit drug market. Specifically, the bill 

increases civil and criminal penalties on companies that fail to keep proper records or 

report suspicious opioid distribution practices. Additionally, the bill authorizes funding 

for the Drug Enforcement Agency (DEi\) to investigate suspect drug companies and drug 

trafficking organizations. The PGST supports S. 2440 because it aligns with our goals in 

our federal lawsuit to hold drug companies responsible for failing to track orders and for 

creating an illicit market for their drugs. W c also note that the Senator's consultation with 

15 
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our Tribe for receiving early input about this bill could serve as a model for tribal 

consultation when developing legislation. Our Tribe supports S. 2440. 

S. 2545. the Native Behavioral Health Access Improvement Act of2018. Recently 

introduced by Committee Member Senator Smith, this bill aims to help combat the opioid 

epidemic by creating the Special Behavioral Health Program for Indians (SBHPl): a grant 

program modeled after the Special Diabetes Program for Indians (SDPI) and 

administered by the IHS, in coordination with SAMHSA. The SBHPJ would provide 

IHS, tribes and tribal organizations, and urban Indian health programs with access to 

much-needed resources for addressing mental health needs and substance use disorders, 

specifically providing $150 million in annual mandatory funding from fY 201 S to FY 

2022. The grants would give tribes needed flexibility to provide tribally driven, 

culturally appropriate behavioral health care to meet the specific needs of their 

communities. The bill also provides that IHS, in coordination with SAHMSA, would 

create a technical assistance center responsible for developing grant-reporting standards 

in consultation with tribal grantees. 

Our Tribe has operated a robust SDPI program for many years and is confident that its 

use as a model for the SBHP! will be a success. However, we caution against providing 

Tribes resources through another program funded in the form of grants. As we know 

from our SDPI experience, grant reporting requirements take away from clinical time and 

the self-governance model would allow for more administrative efficiency. Additionally, 

competitive funding pits struggling tribes and local governments against each other for 

access to limited resources when we should be working together. One of the reasons why 

our THOR program is so effective is that our Tribe has good relationships with State, 

County, and regional groups to coordinate on response strategies. The Port Gamble 

S'Klallam Tribe generally supports S. 2545; however, as an alternative to grant funding, 

we recommend that self-governance tribes-such as our Tribe-be able to receive 

funding through their self-governance compacts. 

VI. Conclusion 

The crisis has ripped the fabric of our community. The loss (through death or addiction) 

of parents, children, brothers and sisters, uncles and aunts, nieces and nephews, and 

cousins to this crisis has been devastating. and will impact the Port Gamble S' Klallam 

Tribe for generations. We are doing what we can to fight it, and we want to work with 

you to eradicate this crisis once and for all. lt will be through your dedication and that of 

your colleagues to ensure that sufficient resources and authorities are available to tribal 

governments, as well as to the federal, state and local governments, to stop this scourge 

on om Nation and communities which takes such a heavy toll on our children and 

families. 

We look forward to working with the Committee to make sure the necessary tactics are 

implemented to combat the opioid crisis. Our THOR program is an example of one such 

tactic. We invite you to visit our Tribe to learn more about it and other actions we are 

taking to do our part in the opioid light. 

16 
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32361.161

Medicaid reimbursements are a critical source of funding for self-governance tribes like 

ours and play an essential role in fulfilling the Federal Government's trust responsibility 

to Tribes. Our Tribe respectfully requests that the unique challenges facing Indian 

Country be considered and addressed in any legislation this Committee puts forward in 

its efforts to improve the role of Medicaid in combating the opioid crisis. 

Thank you again for your work and for the opportunity to submit this Statement for the 

Record. If you have any questions or would like to discuss this Statement for the Record. 

please contact our Tribal Chairman, Jeromy Sullivan. 

17 
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AMERICAN 

PSYCHIATRIC 

ASSOCIATION 

Board of TrustGeS 

2017-2018 

8PJ[\'J Schwa:il,M.D. 

v.~mnB.Pena,~r.~D 

Assembly 

2017-2018 

Jarnes(lkb)R. 8atl<::sor1, ~1.D 

Adrninistration 

SJullevm,N.DHNYA 

April 25, 2018 

Rep. Michael Burgess Rep. Gene Green 

Chairman Ranking Member 

House E&C Committee House E&C Committee 

Health Subcommittee Health Subcommittee 

2336 Rayburn House Office Building 2470 Rayburn House Office Building 

Washington, DC 20515 Washington, DC 20515 

Dear Chairman Burgess and Ranking Member Green: 

On behalf of the American Psychiatric Association (APA), the national medical 

specialty association representing more than 37,800 psychiatric physicians, we 

write to offer comments on several of the opioid-related legislative proposals slated 

for consideration before the House Energy & Commerce Subcommittee on Health. 

The APA appreciates your leadership on this topic, and as physicians who treat 

patients with substance use disorders (SUDs), we share your continued concern 

regarding the opioid crisis' impact on patients, families, and communities. As the 

Subcommittee moves forward with opioid-related legislation, we offer the 

following comments for your consideration. 

Access to Medication Assisted Treatment (MAT) 

The American Psychiatric Association (APA) supports expanded coverage and access 

to MATfor patients with substance use disorders. MAT are proven to be an effective 

treatment for patients with an opioid use disorder, and most effective when 

combined with psychotherapy treatments. Thus, MAT should be prescribed as a 

comprehensive treatment plan that includes counseling and participation in social 

supports. As you know, Congress passed the Comprehensive Addiction and 

Recovery Act (CARA) in 2016, which expanded prescribing privileges for MAT to 

qualifying nurse practitioners (NPs) and physician assistants (PAs) until Oct. 1, 2021 

by amending the Drug Addiction Treatment Act (DATA). Given its recent 

implementation, this is an appropriate timeframe to better understand the impact 

of expanding prescribing authority to certain practitioners under the law. However, 

we are concerned with the expanded prescribing authority in H.R. 3692, the 

"Addiction Treatment Access Improvement Act." 
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As currently written, H.R. 3692 proposes not only to remove the demonstration date for NPs and 

PAs to prescribe, but to expand permanent prescribing authority to other practitioners including 

clinical nurse specialist, certified registered nurse anesthetist, and certified nurse midwife. This 

is a permanent expansion of practitioners who have never had prescribing authoritY for MAT. 

Consequently, we are concerned H.R. 3692 is fast-tracking prescribing authority to practitioners 

without understanding the current environment and the potential impact of the change. 

Moreover, we are concerned patients may not receive optimal care from an expanded list of 

practitioners, to include appropriate psychotherapy services, which is a vital component of the 

effectiveness of MAT for opioid addition. Therefore, we recommend the Committee n.ot expand 

prescription authority beyond the current law of NPs and PAs until more data Is available 

relating to the efficacy of the current prescribing authority and any potential unintended 

consequences. 

Enhancing Collaboration Amongst Providers 

The current patient treatment paradigm, particularly for patients with SUD, is moving towards a 

system built on effective colfaboration amongst multiple health care providers, each practicing 

in different specialties. However, while APA has always advocated for strong confidentiality 

protections of patient records, we are concerned that the regulations contained in 42 CFR Part 2 

(Part 2) represent a persistent barrier to meeting the whole health needs of patients with SUD. 

We were pleased to see the Subcommittee consider H.R. 3545, the "Overdose Prevention and 

Patient Safety (OPPS) Act." This Important legislation would allgn Part 2 with the Health Insurance 

Portability and Accountability Act (HIPAA) for the purposes of health care treatment, payment, 

and operations (TPO). The APA remains committed to the provision of quality care and protecting 

patients' privacy and asserts that this standard can be maintained while allowing for patients to 

benefit from new models of integrated care by aligning Part 2 with HIPAA for the purposes of 

TPO. H.R. 3545 retains, and in some instances strengthens, current protections against the use 

of SUD records outside of TPO, including in civil, criminal, and administrative proceedings or 

investigations. The APA has long supported this legislation and highlights the importance of 

ensuring that a treating physician has access to a patient's full medical record. 

Compartmentalizing various portions of a patient's record jeopardizes patient safety by 

undermining a physician's ability to provide whole patient care. These barriers also increase the 

chance of complications related to comorbid medical conditions and/or potentially lethal drug 

interactions. 
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In addition, preserving the division between SUD records and all other medical records covered 

by HIPAA only serves to maintain the perception of SUD as something other than a medical 

condition and impairs a system of effective collaboration amongst providers. Other conditions 

that carry stigmas-including HIV and mental illness-are nonetheless included in a patient's 

medical record and are covered by HIPAA's protections. We urge the Subcommittee to advance 

H.R. 3545. 

The Subcommittee is also considering Jessie's Law (H.R. 5009). If enacted, H.R. 5009 would 

require HHS to develop and disseminate voluntary best practices regarding the prominent display 

of a patient's SUD history in their records, but only as authorized under existing law. It does not 

contain the enhanced prohibitions against the use of SUD records in civil, criminal, and 

administrative proceedings, nor does it allow a provider to see a patient's entire addiction record. 

As such, H.R. 5009 does not resolve the underlying barriers to integrated care created by Part 

2. 

Supporting Research for Evidence-Based Treatments 

The APA supports the Committee's consideration of H.R. 5002, the "Advancing Cutting-Edge 

Research Act." If enacted, this legislation would provide the National institutes of Health {NIH) 

with the additional tools and flexibility to support innovative medical research to combat the 

opioid crisis. The APA supports research on alternatives to opioid analgesics as an important 

component for addressing the opiois crisis. It is also our hope that the development of nonaddictive pain treatment options will help mitigate the likelihood that a patient, particularly those 

with co-occuring depression or other mental health needs, will develop a concurrent substance 

use disorder. 

Enhancing the Workforce of Substance Use Disorder Providers 

Ensuring a robust mental and behavorial health workforce is a critical aspect of any efforts to 

address the opioid crisis. Unfortunately, there are simply too few clinicians with the requisite 

knowledge to meet the needs of the the estimated 20.1 million Americans suffering from 

untreated substance use disorders. 

To help meet these needs, we appreciate the Subcommittee's consideration of H.R. 5102, the 

"Substance Use Disorder Workforce Loan Repayment Act," which creates a new student loan 

repayment program to incentivize an array of health professionals to select career paths that 
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focus on mental health professional shortage areas. The APA supports H.R. S:ZQ2 and urges the 

Subcommittee to advance the bill. 

Reducing Barriers to Telemedicine 

Treatment of mental heath and substance use disorders via telepsychiatry demonstrates 

similar-and in some cases, superior-outcomes to in-person care, particularly amongst rural 

communities, certain cultural groups (such as Native American communities), and individuals 

with certain diagnoses. Telepsychiatry can also help to mitigate the stigma often associated with 

seeking treatment for substance use disorders and improve access to psychiatric services in a 

variety of treatment settings. 

The Ryan Haight Act generally prohibits the prescription of controlled substances via the Internet, 

but contains an exception that allows providers to obtain a special registration to prescribe 

controlled substal)ces via legitimate telemedicine platforms. Unfortunately, because the 

Attorney General has yet to promulgate regulations concerning this telemedicine registration 

provision, many telernedicine and telepsychiatry providers remain in a state of limbo with regard 

to their patients suffering from a SUD. Therefore, the APA supports H.R. 5483, the "Special 

Registration for Telemedicine Clarification Act," that sets a concrete timeline for the Attorney 

General to Issue these regulations, which represents a critical first step in expanding access to 

telemedicine. 

Futher, the APA supports the draft bi!l, "Improving Access to Remote Behavioral Health 

Treatment Act of 2018," which would help to clarify some, but not all, of the telemedicine 

exceptions to the Ryan Haight Act. Specifically, while the APA supports the expansion of DEA 

registration to community mental health centers and therefore allow for the administration of 

controlled substances through the practice of telemedicine into these centers, as detailed in the 

bill, it does not entirely help to mitigate the persisting issue of lack of access to psyciatrists in 

response to the epidemic. The APA believes that activating the special registration for 

telemedicine for individual practitioners-regardless of the originating site of the patientshould also be contemplated in such legislation. 

Mental Health Parity and CHIP 

Following Congress' 10-year reauthorization of the CHIP program, we commend the 

Subcommittee for its additional focus on H.R. 3192, the "CHIP Mental Health Parity Act." Access 

to mental health care remains a critical component of the CHIP program, as approximately 

850,000 CHIP beneficiaries experience serious behavioral or emotional disorders. Nearly half of 
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all diagnosable mental illnesses show symptoms by age 14, and begin by the age of 24. 

Without early intervention services via the CHIP program, these disorders can lead to tragic and 

costly consequences, such as substance abuse, school dropout, crime, and suicide. 

Unfortunately, ten years after the enactment of.the Mental Health Parity and Addiction Equity 

Act, providers of mental health and SUD services continue to experience disparities in 

reimbursement, while patients experience disparities in coverage for services. According to the 

2017 Milliman report entitled, "Impact of Mental Health Parity and Addiction Equity Act," private 

insurers in 46 states and the District of Columbia offered plans with higher reimbursement rates 

for primary care office visits than for behavioral health office visits, while patients seeking 

behavioral health services were four times more likely to receive treatment from out-of:network 

providers than those seeking medical or surgical services. 

CHIP programs are no exception to this phenomenon, and the existing statutory scheme leaves 

ambiguity as to whether all CHIP plans are subject to parity requirements under federal law. H.R. 

3192 clarifies that all CHIP plans are subject to mental health and substance use disorder parity 

laws, and the APA supports its passage. 

Medicaid Institutions for Mental Diseases (IMD) Exclusion 

We are supportive of the Committee's efforts to expand residential treatment at institutions of 

mental disease {!MD) for substance use disorder patients covered under Medicaid with a 

maintenance of effort on other mental health and substance use expenditures. However, we 

are concerned that the Committee's emphasis on treating patients dealing with substance use 

disorders excludes the needs of patients who need to access long-term mental health care. We 

recommend that the Committee expand coverage for both patients struggling with o mental 

illness and/or substance use disorders to receive treatment at an /MD. 

Prescription Drug Monitoring Programs 

The APA supports and appreciates the Committee's efforts to promote information sharing and 

data transparency efforts among state PDMPs. While we support the expansion of PDMPs and 

the availability of these programs to share information across state lines, it is important to 

recognize that PDMPs do not capture all prescription drugs that a patient is taking. If a provider 

doesn't realize this when they check the POMP, he or she may inadvertently prescribe contraindicated medication. We recommend PDMPs include a notice to providers that clearly states 
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the drugs excluded from the program (such (IS methadone), so they can better understand the 

limitations of the data collected by the .POMP. 

Mental Health Care and the Criminal Justice System 

The ongoing discussions concerning the opioid crisis are inevitably tied to issues related to the 

criminal justice system. According to the. Bureau of Justice Statistics, more than half of those in 

the criminal justice system suffer from a mental illness, while between one-half and threequarters of inmates suffer from a substance use disorder. According to a recent study, former 

inmates within a week post-release were over eight times more likely to die from an overdose 

than inmates within 90 days to a year following their release. 

The APA thanks the Subcommittee for recognizing this aspect of the opioid crisis via its 

consideration of H.R. 4005, the "Medicaid Reentry Act." Under current federal law, medical 

care-including care for the treatment of mental health and substance use disorders-provided 

in correctional facilities is categorically ineligible for reimbursement under the Medicaid 

program. If H.R, 4005 would allow inmates with SUD to receive evidence-based care 

within 30 days of their.release, thereby enhancing former inmates' ability to successfully re-enter 

their communities. The APA urges the Subcommittee the advance H.R. 4005. 

Thank you again for allowing us to offer our insights on this important legisl~tion, and we look 

forward to working with the Subcommittee on the development of lasting, impactful solutions. 

Our Federal Affairs team will follow up with Su!)committee staff on the legislation referenced in 

this letter, If you have any questions, please contact Megan Marcinko at mmarcinko@psych.org 

I 202.559.3898 or Mike Troubh at mtroubh@psych.org /202.559.3571. 

Sincerely, 

/ 

Saul Levin, MO, MPA, FRCP-E 

CEO and Medical Director 
236 


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April 25, 2018 

The Honorable Greg Walden 

Chairman 

House Energy & Commerce Committee 

2125 Rayburn HOB 

Washington, DC 20515 

Dear Chairman Walden and Ranking Member Pallone: 

PREMIER 

The Honorable Frank Pallone, Jr. 

Ranking Member 

House Energy & Commerce Committee 

2322A Rayburn HOB 

Washington, DC 20515 

The undersigned organizations representing accountable care organizations, physicians, hospitals and 

other hcalthcare practitioners strongly urge you to include H.R. 3545 in the Energy and Commerce 

Committee's opioid legislative package to ensure healthcare providers who arc engaged in 

population health initiatives have access to the medical records they need, including information on 

substance use disorders, to effectively and safely treat their patients. 

Current federal regulations governing the confidentiality of drug and alcohol treatment and 

prevention records ( 42.C.F.R. Pmt 2 (Part 2)) preclude the Centers for Medicare & Medicaid 

Services (CMS) from disclosing such information to accountable care organizations and bundled 

payment organizations. These regulations currently require complex and multiple patient consents for 

the use and disclosure of patients' substance use records that go beyond the sufficiently strong patient 

confidentiality protections that were subsequently put in place by the Health Insurance Portability 

and Accountability Act (HIPAA). Wbile originally intended to protect patients' privacy, Part 2 now 

serves to endanger their health. Recognizing the need to revise these laws, the Substance Abuse and 

Mental Health Services and Administration recently testified before your Committee and submitted a 

letter for the record supporting the intent ofH.R. 3545 to align Pa1t 2 to ensure healthcare providers 

have access to the full medical record. 

New delivery system models such as A COs and bundled payments were designed to create a more 

holistic, patient-centered approach to healthcare where providers work together to coordinate across 

their traditional silos and are held jointly accountable for the quality, outcomes and cost of that care. 

Critical to making these new models truly work for patients is having access to the individuals' 

health records, including those related to substance use. CMS provides participating providers of 

Medicare ACO and bundled payment organizations with monthly Medicare Parts A, B and D claims 

under data use agreements that include criminal penalties for misuse. Yet, due to outdated laws 

mentioned above, CMS is forced to remove all claims where substance use disorder is a primary or 

secondary diagnosis. According to a recent New England Journal of Medicine study, this effects 

roughly 4.5 percent of inpatient Medicare claims and 8 percent of Medicaid claims. Not only does 
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this pose an alarming patient safety threat in light of potential phannaceutical contraindications and 

prevent providers from understanding the full extent of their patients' medical needs, but it is a heavy 

and costly administrative burden on CMS, which must manually scrub Medicare claims before 

submitting to A COs and bundled payment organizations. 

We commend you for your leadership on looking at so many solutions to prevent dependency on 

opioids and related deaths, as well as promoting appropriate access. While these are all urgently 

needed policy changes and investments, a critical and vital piece to ensuring healthcare providers 

who are on the front-lines treating those with opioid or other substance use disorders is H.R. 3545, 

which would provide an unobstructed view of a patients' medical records. Accordingly, we call on 

Congress to ensure that the Medicare, Medicaid and CHIP data feeds sent to providers that are 

participating in alternative payment models such as Medicare A COs and bundled payment 

arrangements include all claims, including those where a substance use disorder is listed as a primary 

or secondary diagnosis. 

Sincerely, 

AMGA 

National Association of A COs 

Premier healthcarc alliance 
238 


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April19, 2018 

Representative Greg Walden, Chair 

U.S. House of Representatives 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

N A P W 

Representative Frank Pallone, Jr., Ranking Member 

u.s. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

Opposition to H.R. 3545 noverdose Prevention and Patient Safety Act" and Support 

for Preserving and Improving Medical Confidentiality for People Receiving Treatment 

for Substance Use Disorders 

Dear Chair Walden and Ranking Member Pallone: 

National Advocates for Pregnant Women (NAPW), a non-profit organization advocating for the 

health and rights of pregnant women, opposes H.R. 3545, the "Overdose Prevention and 

Patient Safety Act." H.R. 3545 would eliminate key confidentiality protections in the 

Confidentiality of Substance Use Disorder Records regulations, 42 C.F .R. Part 2 ("Part 2"). These 

privacy protections are essential to public health efforts to engage people in life-saving 

treatment for substance use disorder ("SUD"). Without these protections, people will be 

deterred from seeking this important health care and will have devastating health 

consequences. In fact, experience under the existing regulations demonstrate the need to both 

preserve and enhance the protections of Part 2. 

Alternative methods of protecting the privacy of patients with SUD- such as relying on HIPAA, 

relying on medical ethics guidelines, and relying on health care workers being trained and 

knowledgeable about SUD and what they may and may not report-simply do not work. 

NAPW's peer-reviewed research documented hundreds of cases in which women have been 

charged with crimes or otherwise punished (e.g. detained, jailed, forced into treatment that is 

not warranted) in relationship to pregnancy and alleged current or former drug use (including 
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prescribed medications)1

• Approximately 25% of the pregnant women subject to arrest for 

crimes including fetal assault, attempted feticide, chemical endangerment of a child, delivery of 

drugs to a minor via the umbilical cord, and criminal child abuse between 1973 and 2005 were 

initially reported to law enforcement by doctors and other health care providers, who made 

those disclosures despite their clear legal and ethical obligations to maintain patient privacy. 

Since 2005, there have been more than 800 new arrests and detentions2

, many based on 

reports from health care providers to police and other public officials. Such reports are not 

necessarily mandated by any law, violate principles of medical ethics and are contrary to the 

positions of every leading medical group addressing issues involving pregnant women and drug 

use. 

For example, health care providers in South Carolina played a primary role in reporting 

pregnant patients who tested positive for certain drugs to police. The U.S. Supreme Court 

eventually found these violations of patient privacy to be unconstitutional3

• Even so, similar 

violations of patient privacy, particularly of pregnant women, are all too common. 

• Since 2006, Alabama health care providers have reported hundreds of pregnant patients 

who come to them for medical help to law enforcement officials because of suspected 

drug use4

• 

• Jamie Lynn Russell went to an emergency room in Oklahoma in such debilitating pain 

that she was unable to move. Because her excruciating pain prevented her from lying 

down for an examination, hospital staff labeled her "noncompliant," and called the 

polir.P.. ThP. police discovered that she had two pain pills that weren't hers. Still in pain, 

she was released by the hospital as "fit to incarcerate," arrested for drug possession, 

and taken to jail, where she died two hours later from a ruptured ectopic pregnancl. 

Pregnant women's experiences when they have specifically sought drug treatment not only 

demonstrate the continued need for the confidentiality protections of Part 2 but also the need 

to strengthen it. 

• When Rachaellowe was pregnant in Wisconsin and sought help for her opioid 

dependency problem, hospital staff failed to ensure her confidentiality. Instead they 

reported her to state authorities. The result was to undermine medically appropriate 

interventions that were being put into place; she was, instead, taken into custody by 

1 https :/ /read.dukeupress.edu/jhppl/artic le/3 8/2/2 99/13 53 3 I Arrests-of-and-Farced-Interventionson-Pregnant 

2 https://thinkprogress.org/criminalization-pregnancy-us-43e474l bb514/ 3 Ferguson v. City of Charleston, 532 U.S. 67 (2001) 4 https :/ /www. propu bli ca. org/article/when -the-worn b-is-a-crime-scene 5 https:/ /rewire.news/article/20 13/0 1/14/dehumanizing-pregnant -women-leads-to-real-loss-life/ 

875 6~ Avenue, Suite !807, New York, New York 10001 

phone 212-255-9252 j fox 212-255-9253 

IJNationaiAdvocntesforPregnnntWomen 1 'I @NAPW 

www.advocatesforpregnantwomen.org 

2 
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police, locked in a mental hospital, put on dangerous medications, and left without 

prenatal care6

• 

• In New York, a pregnant woman's past treatment for alcoholism was released to state 

authorities in violation of federal confidentiality protections and used by a prosecutor to 

support criminal charges against her7

• 

• A Massachusetts public health department policy supports health care providers 

reporting pregnant women who are receiving SUD treatment- the treatment 

recommended and supported by the U.S. Substance Abuse and Mental Health Services 

Administration and the World Health Organization- to the state child welfare agencl. 

• NAPW recently learned of a South Dakota SUD treatment facility that routinely shares 

drug test results with law enforcement. Those results are then used to support criminal 

drug possession charges based on prior use. 

Every major medical and public health group in the United States, including the American 

Medical Association, the American College of Obstetricians and Gynecologists, and the 

American Academy of Pediatrics, supports measures that encourage people to get SUD 

treatment when needed and opposes measures such as reporting and punishment, precisely 

because they deter people from seeking help9

• 

For these reasons, NAPW opposes H.R. 3545 and instead supports legislative action that is 

critical to preserving patient confidentiality and coordinating care between various health care 

providers. Among these are: 

• The Senate's bipartisan "Opioid Crisis Response Act of 2018," providing model 

programs and materials for training health providers and compliance staff on the 

permitted uses and disclosures of substance use disorder information, and for 

training family members and patients on their rights to protect and obtain 

substance use disorder information. 

• H.R. 3331, providing needed incentive payments to SUD and behavioral health 

providers to obtain certified electronic health record technology. 

6 http:/ /journaltimcs.com/ncws/local/judgc-frces-addict-mom/article 0440a451-4146-565f-9808-

e65148658lle.html - 7 https://www.nyclu.org/en/press-releases/court-rules-new-york-state-child-endangering-lawmay ·not -be-used -punish-pregnant-0 8 http://www.mass.gov/eohhs/docs/dph/quality/hcq-circular-letters/2013/dhcq-1305586-senguidelines.pdf 

875 6" Avenue, Suite 1807, New York, New York 10001 

phone 212-255-92521 fax 212-255-9253 

11NationalAdvocatcsforPrcgnantWomen I~ @NAPW 

www.advocatesforpregnantwomen.org 

3 
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• Amending 42 U.S.C. §290dd-2 and Part 2 to provide a private right of action for 

patients whose SUD information has been improperly disclosed in violation of 

the federal drug treatment confidentiality law. 

• Amending 42 U.S.C. §290dd-2 and Part 2 to clarify that the reporting provision 

for suspected child abuse and neglect does not create a sex-discriminatory 

exception to confidentiality protections for pregnant women or new mothers. 

Patients in SUD treatment must retain the power to decide when and to whom their records 

are disclosed. 

Respectfully submitted, 

Lynn 

/&y2~ M. Paltrow, Executive Director 

Nancy Rosenbloom, Director of Legal Advocacy 

875 6~ Avenue, Suite 1807, New York, New York 10001 

phone 212-255-92521 fax 212-255-9253 

ll NationaiAdvocatesforPrcgnWltWomcn I'# @NAPW 

www.advocatesforprcgnantwomen.org 

4 
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National Association for Children of Addiction ... working to eliminate the adverse impact of alcohol and drug use on children and families 

May 8, 2018 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Oflice Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545 -"Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and Coordinate 

Care 

Dear Chairman Walden and Ranking Member Pallone: 

I am writing to express the National Association for Children of Addiction (NACoA)'s 

opposition to H.R. 3545, the "Overdose Prevention and Patient Safety Act.'' In the midst of the 

worst opioid epidemic in our nation's history, we must do everything possible to increase the 

number of people who seck treatment, but H.R. 3545 would do the opposite. By reducing 

privacy pt·otcctions for individuals receiving substance usc disorder ("SUD") treatment 

to allow disclosures and rc-disclosurcs of SlJD information without patient consent to a 

wide range of health care providers and plans and others with whom they work, H.R. 

3545 would discourage people from entering care out of fear that their treatment records 

will be used against them in many harmful ways. 

NACoA is the voice for the I in 4 children whose parents suffer from substance usc disorders. 

These children arc the unaddressed victims in the addiction epidemic that continues to sweep 

our country destroying families, costing jobs, increasing family violence, and reducing the 

children's opportunity for a safe and productive life each day addicted parents do not receive 

treatment and recovery support. This proposed legislation will delay parental help to get well 

and parental possibilities to obtain gainful employment in early recovery, thus stigmatizing and 

isolating vast numbers of children from a part of mainstream American opportunity. Fear of 

losing their children already helps to keep many parents from seeking treatment. li.R 3545 

exacerbates that problem. 

I 0920 Connecticut Avenue, Suite 100 • Kensington, MD 20895 

l~888-55-4COAS (2627) • Fax: 301~468~0987 • nacoaiL;)nacoa,org • www.nacoa,org 
243 


32361.175

SAMHSA's amendments to Part 2 in 2017 and 2018 have made it much easier 

to facilitate (with patient consent) the sharing of health information between 

SUD and other health care providers in electronic health information systems 

and coordinated care settings. Unfottunately, many in the health care system do 

not know what these rules allow, and many SUD treatment programs do not 

have adequate computer systems to enable them to maintain electronic health 

records. 

Patients in substance abuse disorder treatment should retain the power to decide 

when and to whom their records are disclosed, given the continued prevalence 

of discrimination in our society. An important consequence to preserving that 

power will be the likelihood that their children will have parents who enter and 

finish treatment and go on to recovery and obtain gainful employment to help 

support their families, thus giving their children an equal opportunity to 

succeed. 

For these reasons, we oppose H.R. 3545 and instead support the following bills that are critical 

to preserving patient confidentiality and coordinating care between various health providers: 

• The Senate's bipartisan "Opioid Crisis Response Act of2018:" Provides 

model programs and materials for training health providers and compliance staff 

on the permitted uses and disclosures of substance use disorder information, and 

training family members and patients on their rights to protect and obtain 

substance use disorder information. 

• H.R. 3331 Introduced by Representative Lynn Jenkins and co-sponsored 

by Representative Doris Matsui: Provides needed incentive payments to 

substance use disorder and behavioral health providers to obtain certified 

electronic health record technology. 

Thank you for considering the unintended consequences off I.R. 3545 to already vulnerable 

children. 

Sincerely, 

Sis Wenger 

President/CEO 
244 


32361.176

Opioid Treatment Association of Rhode Island (OT ARI) 

April 16, 2018 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and Support 

for other Legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

The Opioid Treatment Association of Rhode Island (OTARI) writes to express our opposition to 

H.R. 3545, the "Overdose Prevention and Patient Safety Act." In the midst of the worst opioid 

epidemic in our nation's history, we must do everything possible to increase the number of people 

who seek treatment, but H.R. 3545 would do the opposite. By reducing privacy protections 

for individuals receiving substance use disorder ("SUD") treatment to allow disclosures 

and re-disclosures of SUD information without patient consent to a wide range of health 

care providers and plans and others with whom they work, H.R. 3545 would discourage 

people from entering care out of fear that their treatment records will be used against 

them in many harmful ways. 

OTARI members provide treatment and recovery support services to over 5000 Rhode Islanders 

living with Opioid Use Disorder (OUD) using the three (3) Federally-approved medicationsmethadone, buprenorphine, injectable naltrexone. Additionally, our members provide treatment 

and support for other Substance Use Disorders (SUD). 

The heightened protections for substance use disorder records in the federal confidentiality law, 

42 U.S. C. § 290dd-2 and its regulations at 42 CFR Part 2 (collectively known as "Part 2"), are as 

critically important today as ever. They support care coordination while maintaining patient 

confidentiality to help ensure that people enter SUD treatment. 

Patients have relied, and still rely, on the current protections to assure their ability to enter in to, 

and receive treatment without the fear of JUdgement, recr·imination, and marginalization. Many 

continue to find it difficult to find work, housing, and compassionate medical care. Many, 

particularly those in Medication Assisted Treatment (MAT), have been "abandoned" by their 

medical provider, terminated from employment, and blamed for their illness. The changes 

proposed in H.R. 3545- "Overdose Prevention and Patient Safety Act" will expose every person 

receiving treatment and recovery support for the broad range of Substance Use Disorders (SUD), 

including but not limited to, MAT, general outpatient for alcohol and other drugs, residential and 

inpatient treatment. 
245 


32361.177

Opioid Treatment Association of Rhode Island (OT ARI) 

Page 2. 

Every person seeking and/or receiving treatment and recovery support will be required to live 

with the fear and anxiety of unauthorized disclosure of personal as well as treatment information. 

Many, who might be considering entering treatment may be so concerned about the loss of 

confidentiality, may choose to forego treatment rather than run the risk associated with these 

disclosures. As it is, there are enough barriers to treatment. In a time when we are doing our 

best to get people into life-saving treatment, these proposed changes only add another, 

unnecessary and life-threatening barrier to access, engagement, and recovery. 

other reasons for our opposition to this bill include the following: 

SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it much easier to 

facilitate (with patient consent) the sharing of health information between SUD and 

other health care providers in electronic health information systems and 

coordinated care settings. Unfortunately, many in the health care system do not 

know what these rules allow, and many SUD treatment programs do not have 

adequate computer systems to enable them to maintain electronic health records. 

Patients in substance abuse disorder treatment should retain the power to decide 

when and to whom their records are disclosed, given the continued prevalence of 

discrimination in our society. 

For these reasons, OTARI oppose H.R. 3545 and instead support the following bills that are 

critical to preserving patient confidentiality and coordinating care between various health 

providers: 

The Senate's bipartisan "Opioid Crisis Response Act of 2018:" Provides 

model programs and materials for training health providers and compliance staff on 

the permitted uses and disclosures of substance use disorder information, and 

training family members and patients on their rights to protect and obtain 

substance use disorder information. 

H.R. 3331 -Introduced by Representative Lynn Jenkins and co-sponsored 

by Representative Doris Matsui: Provides needed incentive payments to 

substance use disorder and behavioral health providers to obtain certified electronic 

health record technology. 

Thank you for your consideration. 

Sincerely, 

Michael Rizzi, Chair 

Opioid Treatment Association of Rhode Island 

doCOHAC·- Rl (F)• 
246 


32361.178

April19, 2018 

Ringgold Treatment Center LLC 

8292 Hwy 41 

Ringgold, GA 30736 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone. Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington. DC 20515 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and 

Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

Ringgold Treatment Center writes to express our opposition to H.R. 3545, the 

"Overdose Prevention and Patient Safety Act." In the midst of the worst opioid epidemic 

in our nation's history, we must do everything possible to increase the number of people 

who seek treatment, but H.R. 3545 would do the opposite. By reducing privacy 

protections for individuals receiving substance use disorder ("SUD") treatment to 

allow disclosures and re-disclosures of SUD information without patient consent 

to a wide range of health care providers and plans and others with whom they 

work, H.R. 3545 would discourage people from entering care out of fear that their 

treatment records will be used against them in many harmful ways. 

We are a medication-assisted treatment facility for the treatment of opioid use disorder. 

We see firsthand the dramatic changes that opioid addicted individuals are able to make 

in their lives when they participate in comprehensive MAT. But we fear that should H.R. 

1 
247 


32361.179

3545 pass, these individuals will not seek SUD treatment due to the limits on 

confidentiality. Below are reasons that we oppose this bill: 

• The heightened protections for substance use disorder records in the 

federal confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 

CFR Part 2 (collectively known as "Part 2"), are as critically important 

today as ever. They support care coordination while maintaining patient 

confidentiality to help ensure that people enter SUD treatment. 

SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it 

much easier to facilitate (with patient consent) the sharing of health 

information between SUD and other health care providers in electronic 

health information systems and coordinated care settings. Unfortunately, 

many in the health care system do not know what these rules allow, and 

many SUD treatment programs do not have adequate computer systems 

to enable them to maintain electronic health records. 

• Patients in substance abuse disorder treatment should retain the power to 

decide when and to whom their records are disclosed, given the continued 

prevalence of discrimination in our society. 

For these reasons, we oppose H.R. 3545 and instead support the following bills that are 

critical to preserving patient confidentiality and coordinating care between various health 

providers: 

• The Senate's bipartisan "Opioid Crisis Response Act of 2018:" 

Provides model programs and materials for training health providers and 

compliance staff on the permitted uses and disclosures of substance use 

disorder information, and training family members and patients on their 

rights to protect and obtain substance use disorder information. 

• H.R. 3331 -Introduced by Representative Lynn Jenkins and cosponsored by Representative Doris Matsui: Provides needed incentive 

payments to substance use disorder and behavioral health providers to 

obtain certified electronic health record technology. 

Thank you. 

Sincerely, 

Vanessa Ruehlmann 

Program Administrator 

Ringgold Treatment Center LLC 

2 
248 


32361.180

Victory Clinical Services 

CARF Accredited 

4218 Western Avenue 

South Bend, IN 46619 

Phone: (574) 233-1524 

Fax: (574) 233-1612 

Aprill7,2018 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

21 85 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and Support for Other 

Legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

We at Victory Clinical Services would like to express our opposition to H.R. 3545, the "Overdose 

Prevention and Patient Safety Act." In the midst ofthe worst opioid epidemic in our nation's history, we 

must do everything possible to increase the number of people who seek treatment, but H.R. 3545 would do 

the opposite. By reducing privacy protections for individuals receiving substance use disorder 

("SUD") treatment to allow disclosures and rc-disclosures of SUD information without patient 

consent to a wide range of health care providers and plans and others with whom they work, H.R. 

3545 would discourage people from entering care out of fear that their treatment records will be used 

against them in many harmful ways. 

As an accredited treatment provider for Opioid Use Disorder since 1996, we know and have experienced 

the stigma still present with opioid usc disorder and the evidence-based treatment options available to help 

save lives. Without the protection of confidentiality on treatment records, the trust that Victory Clinic is 

able to extend to potential patients -to get them off the street, out of crime, and into treatment -would be 

shattered. 
249 


32361.181

Furthermore, the heightened protections for substance usc disorder records in the federal 

confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 CFR Part 2 

(collectively known as "Part 2"), arc as critically important today as ever. They support 

care coordination while maintaining patient confidentiality to help ensure that people 

enter SUD treatment. 

SAMHSA's amendments to Part 2 in 2017 and 2018 have made it much easier to facilitate (with 

patient consent) the sharing of health information between SUD and other health care providers 

in electronic hea1th information systems and coordinated care settings. Unfortunately, many in 

the health care system do not know what these rules allow, and many SUD treatment programs 

do not have adequate computer systems to enable them to maintain electronic health records. 

For these reasons, Victory Clinical Services opposes H.R. 3545 and instead supports the 

following bills that arc critical to preserving patient confidentiality and coordinating care 

between various health providers: 

• The Senate's bipartisan HQpioid Crisis Response Act of 2018:" Provides 

model programs and materials for training health providers and compliance staff 

on the permitted uses and disclosures of substance use disorder information, and 

training family members and patients on their rights to protect and obtain 

substance use disorder infom1ation. 

H.R. 3331 Introdnced by Representative Lynn Jenkins and co-sponsored 

by Representative Doris Matsui: Provides needed incentive payments to 

substance use disorder and behavioral health providers to obtain certified 

electronic health record technology. 

Thank you for your attention to our input. 

Erin 

~ LaCourt, LAC, ccdp, carle, cadacii 

VCS Program Director 

AA TOD Delegate for Indiana 

Vice President Indiana Association for 

Treatment ofOpioid Dependence 

CC: Mark Parrino, AA TOD President 

David Blankenship, VCS Executive Director 
250 


32361.182

Jennifer Kolakowski 

CEO 

Paul E. Kelly 

CFO 

Unda Mosel 

coo 

Board of_pirectors 

Jude Ade 

President 

Joshua Dickinson 

Vice President 

Sandra Posca 

Treasurer 

Gerald Craig 

Secretary 

Patrick Schmincke 

Past President 

Jerry McCarthy 

Deborah Schlein 

Wayne Trudeau 

Thomas Walsh Jr. 

Advisorv Board 

Salvatore A. Maresca, 

Jr 

of Programs 

Aprill6,2018 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn llouse Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and Support for 

Other Legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

Recovery Network of Programs, Inc. writes to express its opposition to H.R. 3545, the 

"Overdose Prevention and Patient Safety Act." In the midst of the worst opioid epidemic in our 

nation's history, we must do everything possible to increase the number of people who seek 

treatment, but H.R. 3545 would do the opposite. By reducing privacy protections for 

individuals receiving substance use disorder e•sUD") treatment to allow disclosures and 

re-disclosures of SUD information without patient consent to a wide range of health care 

providers and plans and others with whom they work, H.R. 3545 would discourage people 

from entering care out of fear that their treatment records will be used against them in 

many harmful ways. 

Recovery Network of Programs strives to solve the most difficult social problems facing 

humanity in order to effect positive, lasting change. It is our mission to save the lives of those 

ensnared by the hands of addiction as well as individuals who live with mental health 

disorders. While we fight daily to eradicate the stigma surrounding those suffering from 

substance use disorders, the reality remains that most of our clients expect 100% confidentiality 

with regard to their treatment. Client confidentiality is of highest concern when engaging 

individuals in first time treatment as is protecting against the unfortunate but very real 

discrimination associated with those labeled as addicts. 

Helping people build better lives. since 1972 

Administrative Office • 2 Trap Falls Road, Suite 405 • Shelton, CT 06484 • (P) 203.929.1954 • (F) 203.929.1279 

www.Recovery-Programs.org An Affirmative Action/ Equal Opportunity Employer 
251 


32361.183

Furthermore, the heightened protections for substance use disorder records in the federal 

confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 CPR Part 2 (collectively 

known as "Part 2"), are as critically important today as ever. They support care coordination 

while maintaining patient confidentiality to help ensure that people enter SUD treatment. 

Moreover, SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it much easier to 

facilitate (with patient consent) the sharing of health information between SUD and other health 

care providers in electronic health information systems and coordinated care settings. 

Unfortunately, many in the health care system do not know what these rules allow, and many 

SUD treatment programs do not have adequate computer systems to enable them to maintain 

electronic health records. 

Finally. patients in substance abuse disorder treatment should retain the power to decide 

when and to whom their records are disclosed, given the continued prevalence of 

discrimination in our society. 

For these reasons, we oppose H.R. 3545 and instead support the following bills that arc critical 

to preserving patient confidentiality and coordinating care between various health providers: 

The Senate's bipartisan "Opioid Crisis Response Act of2018:" Provides model 

programs and materials for training health providers and compliance staff on the 

permitted uses and disclosures of substance use disorder information, and training 

family members and patients on their rights to protect and obtain substance use disorder 

information. 

H.R. 3331-lntroduccd by Representative Lynn Jenkins and eo-sponsored by 

Representative Doris Matsui: Provides needed incentive payments to substance use 

disorder and behavioral health providers to obtain certified electronic health record 

technology. 

Thank you. 

Sincerely, 

Jennifer Kolakowski, LCSW 

Chief Executive Officer 
252 


32361.184

April 17,2018 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545 -"Overdose Prevention and Patient Safety Act" and Support for 

Other Legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

The members of SCATOD, the South Carolina Association for the Treatment of Opioid 

Dependence, write to express our opposition to H.R. 3545, the "Overdose Prevention and Patient 

Safety Act." In the midst of the worst opioid epidemic in our nation's history, we must do 

everything possible to increase the number of people who seek treatment, but H.R. 3545 would do 

the opposite. By reducing privacy protectious for iudividuals receiving substance use 

disorder ("SUD") treatment to allow disclosures and re-disclosures of SUD information 

without patient consent to a wide range of health care providers and plans and others with 

whom they work, H.R. 3545 would discourage people from entering care out of fear that 

their treatment records will be used against them in many harmful ways. 

The South Carolina Association for the Treatment of Opioid Dependence (SCA TOD) represents 

20 Opioid Treatment Programs (OTPs) currently operating in the state of South Carolina. Our 

programs are on the front lines of treating opioid addiction in our state. We currently serve close 

to 7,000 individuals with an Opioid Use Disorder (OUD). 

Even with the growing awareness that substance use disorders are a disease, the unfortunate truth 

is that persons with a SUD are still actively discriminated against. This stigma and discrimination 

is heightened for individuals using Medication Assisted Treatments (MAT), such as treatment with 

methadone or buprenorphine (best known as Suboxone), to address their OUD. Every day in South 

Carolina we sec examples of discriminatory practices towards the persons we serve. Such as a 

patient getting dropped by his Primary Care Physician's office and cut off from needed 

medications for his medical conditions when the physician found out the patient is receiving 
253 


32361.185

methadone for an OUD. Or a baby being taken away from a new mother because she is on 

methadone for an OUD despite long-standing compliance with her treatment and abstinence from 

illegal drug-use. 

For these reasons we believe the following: 

Patients in substance abuse disorder treatment should retain the power to decide when 

and to whom their records are disclosed, given the continued prevalence of 

discrimination in our society. 

Patients who believe their information may be shared without their consent may not seek 

treatment. Removing the heightened protections for substance use disorder records in the 

federal confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 CFR Part 2 

(collectively known as "Part 2") will create barriers to persons seeking treatment. 

The regulations under 42 CFR Part 2 support care coordination while maintaining patient 

confidentiality to help ensure that people enter SUD treatment. 

SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it much easier to 

facilitate (with patient consent) the sharing of health information between SUD and other 

health care providers in electronic health information systems and coordinated care 

settings. Unfortunately, many in the health care system do not know what these rules 

allow, and many SUD treatment programs do not have adequate computer systems to 

enable them to maintain electronic health records. 

As such, we oppose H .R. 3545 and instead support the following bills that are critical to 

preserving patient confidentiality and coordinating care between various health providers: 

The Senate's bipartisan "Opioid Crisis Response Act of2018:" Provides 

model programs and materials for training health providers and compliance staff 

on the permitted uses and disclosures of substance use disorder information, and 

training family members and patients on their rights to protect and obtain 

substance use disorder information. 

H.R. 3331- Introduced by Representative Lynn .Jenkins and co-sponsored 

by Representative Doris Matsui: Provides needed incentive payments to 

substance use disorder and behavioral health providers to obtain certified 

electronic health record technology. 

Thank you. 

Christine Martin, LMFT, CACII 

President 

SCATOD- South Carolina Association for the Treatment ofOpioid Dependence 

2301 Cosgrove Avenue, Suite F 

North Charleston, SC 29405 
254 


32361.186

From: 

To! 

Subject: 

Date: 

Northen Parkway 

Gordon waverly 

Opposition to H.R. 3545 ·"Overdose Prevention and Patient Safety Act" and Support for Other legislatwe Proposals to Preserve Confidentiality and 

Coordinate Care 

sunday, AprlllS, 2018 12:44:53 PM 

Dear chairman walden and Ranking Member Pallone: 

On behalf of Northern Parkway Treatment Services, I'm writing to express our opposition to H.R. 3545, the 

"overdose Prevention and Patient Safety Act." In the midst of the worst opioid epidemic 

in our nation's history, we must do everything possible to increase the number of people 

who seek treatment, but H.R. 3545 would do the opposite. By reducing privacy protections 

for individuals receiving substance use disorder ("SUD") treatment to allow disclosures 

and re-disclosures of SUD information without patient consent to a wide range of health 

care providers and plans and others with whom they work, H.R. 3545 would discourage people 

from entering care out of fear that their treatment records will be used against them in 

many harmful ways. 

The heightened protections fof. substance use disorder records in the federal 

confidentiality law, 42 u.s.c. § 290dd-2 and its regulations at 42 CFR Part 2 

(collectively known as "Part 2"), are as critically important today as ever. They support: 

care coordination whi 1 e mai ntai ni ng patient confi denti a 1 i ty to he 1 p ensure that peop 1 e 

enter SUD treatment. 

SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it much easier to facilitate 

(with patient consent) the sharing of health information between SUD and other health care 

providers in electronic health information systems and coordinated care settings. 

Unfortunately, many in the health care system do not know what these rules allow. and many 

SUD treatment programs do not have adeQUate computer systems to enable them to maintain 

electronic health records. 

Patients in substance abuse disorder treatment should retain the power to decide when 

and to whom their records are disclosed, given the continued prevalence of discrimination 

in our society, 

For these reasons, we oppose H.R. 3545 and instead support the following bills that are 

critical to preserving patient confidentiality and coordinating care between various 

health providers: 

The Senate's bipartisan ''opioid Crisis Response Act of 2018:'' Provides model programs 

and materials for training health providers and compliance staff on the permitted uses and 

disclosures of substance use disorder information, and training family members and 

patients on their rights to protect and obtain substance use disorder information. 

H.R. 3331 Introduced by Representative Lynn Jenkins and co-sponsored by Representative 

Doris Matsui: Provides needed incentive payments to substance use disorder and behavioral 

health providers to obtain certified electronic health record technology. 

Thank you. 

Sincerely, 

Babak Imanocl, 0<0. 

Medical Director and President 

Northern Parkway Treatment Services, Inc. 

3007 E. Northern Parkway 

Baltimore, MD 21214 

Phone; 443~475~0737 

Fax: 410-220-0703 

URL· htWifwww nptreatmentservjces com! 

This email or facsimile transmission may contain CONFIDENTIAL. PRIVILEGED and or PROTECTED lNFORMA TION intended solely for the 

use nfthe individual or entity to whom it is addresses. If you arc not the intended recipient, please notify the sender by email or fax immediately. 

Please do no disseminate or copy and delete or destroy immediately, 
255 


32361.187

Tii(s inf0rffiatiorl his been disclosed to you from records pfot~d6d- bY Federaf co"ntident'iaiitY, Rules' (42CFR Part 2). Th9 fe.derat rules p;.O'hnJa"you frOifi"fficlking 

any further disclosure of thiS information unless further disclosure is expressly permitted by the written consent of the person to whim it pertains, or is other.vise 

permitted by 42 CFR Pan 2. A genera! authorization for the release of medica! or other information is NOT sufficient of ttlis purpose. The federal rules restrict 

any use of this information to criminally investlgate or prosecute any alcohol or drug abusing patient 

Virus~ free www avg com 
256 


32361.188

From: 

To: 

Subject: 

Date: 

Babak Imanoel 

Gordon Waverly 

Opposition to H,R, 3545 -"Overdose Prevention and Patient Safety Act" and Support for Other Legislative 

Proposals to Preserve Confidentiality and Coordinate Care 

Sunday, Aprii!S, 2018 12:40:26 PM 

Dear Chairman Walden : 

On behalf of Bll Health Services, I'm writing to express our opposition to ll.R. 3545, the ··Overdose Prevention and 

Patient Safety Act." Jn the midst orthe worst opioiJ epidemic in our nation's history. we must do everything 

possible to increase the number of people who seck treatment, butll.R. 3545 would do the opposite. By reducing 

privacy protections for individuals receiving substance usc disorder (·'SUD"') treatment to allow disclosurt>s and rc~ 

disclosures of SUD information without patient consent to a wide range or health care providers and plans and 

others vvith whom they work. I I.R. 3545 would discourage people from entering care out or fear that their treatment 

records will be used against them in many harmful ways. 

The heightened protections tor substance use disorder records in the federal conlidentiality law, 42 \J.S.C. § 

290dd-2 and its regulations at 42 CFR Part 2 (collectively known as .. Part2"), are as critically important today as 

ever, They support care coordination while maintaining patient conJIJentiaiity to help ensure that people enter SUD 

treatment 

SAMHSA 's amendments to Part 2 by in 2017 and 2018 have made it much easier to facilitate (with patient 

consent) the sharing of health information between SUD and other health care providers in electronic health 

information systems and coordinated care settings. Unfortunately, many in the health care system do not know what 

these rules allow. and many SUD treatment programs do not have adequate computer systems to enable them to 

maintain electronic health records. 

Patients in substance abuse disorder treatment should retain the power to decide when and to whom their 

records are Jisclosed. given the continued prevalence of Jiscrlmination in our society. 

For these reasons. we oppose H.R. 1545 and instead support the follO\Ying bills that are critical to preserving patient 

confidentiality and coordinating care belwcl'n various health providers: 

The Senate's bipartisan '"OpioiJ Crisis Response Act of20 18:'' Provides model programs and materials Cor 

training health proviJcrs and compliance st::tfTon the permitted uses and disclosures of substance usc disorder 

information, and training family members and patients on their rights to protect and obtain substance usc disorJcr 

inf'ormation. 

I I.R. 3331- IntroduccJ by Representative Lynn Jenkins and co~sponsorcd by Representative Doris Matsui: 

Provides needed incentive payments to substance usc disorJcr and behavioral health providers to obtain certified 

electronic health record technology. 

Thank you. 

Sincerely, 

Babak Imanoel. DO 

Medical Director and President 

BII Ilealth Services. Inc. 

450 E. Main Street 

Westminster, MD 21157 

Phone: 410-871-3005 

Fax: 443-293-8711 
257 


32361.189

TEMPLATE FOR COMMENTS OPPOSING HR 3545, "OVERDOSE PREVENTION 

AND PA T/ENT SAFETY ACT" 

0411512018 

Serenity Health, LLC 

780 W Bel Air Ave, Suite B 

Aberdeen, MD 21001 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and 

Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

Serenity Health writes to express our opposition to H.R. 3545, the "Overdose 

Prevention and Patient Safety Act." In the midst of the worst opioid epidemic in our 

nation's history, we must do everything possible to increase the number of people who 

seek treatment, but H.R. 3545 would do the opposite. By reducing privacy 

protections for individuals receiving substance use disorder ("SUD") treatment to 

allow disclosures and re-disclosures of SUD information without patient consent 

to a wide range of health care providers and plans and others with whom they 

work, H.R. 3545 would discourage people from entering care out of fear that their 

treatment records will be used against them in many harmful ways. 

Some time ago, we had a young lady in our methadone maintenance program that 

committed suicide. She had several admissions to other levels of care that were 

unsuccessful, so she entered the methadone maintenance program. She had turned 

her life around. She was in college, working full-time, owned her own car, was 

purchasing a house and was no longer using illicit substances. She had to complete 
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probation for crimes she had committed while she was actively using illicit drugs. Her 

mother did not know she was in methadone treatment She did not want her mother to 

know because her mother did not agree with methadone. The judge found out she was 

in the methadone maintenance program and disclosed it in a court hearing with her 

mother present The judge and her mother insisted that she "get off that stuff', and she 

complied only because of the pressure from both to do so. She began abusing illicit 

substances and participating in illegal activity to obtain those substances. The guilt and 

shame of returning to what she described as "a life of hell", lead her to write a suicide 

note and end her life. If her confidentiality had not been violated, she may have been 

the one writing this letter. As healthcare providers, we are trained and educated as to 

the best approach for releasing pertinent health information to assure safe and 

appropriate disclosure of protected information. 

• The heightened protections for substance use disorder records in the 

federal confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 

CFR Part 2 (collectively known as "Part 2"), are as critically important 

today as ever. They support care coordination while maintaining patient 

confidentiality to help ensure that people enter SUD treatment 

SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it 

much easier to facilitate (with patient consent) the sharing of health 

information between SUD and other health care providers in electronic 

health information systems and coordinated care settings. Unfortunately, 

many in the health care system do not know what these rules allow, and 

many SUD treatment programs do not have adequate computer systems 

to enable them to maintain electronic health records. 

• Patients in substance abuse disorder treatment should retain the power to 

decide when and to whom their records are disclosed, given the continued 

prevalence of discrimination in our society. 

For these reasons, Serenity Health opposes H.R. 3545 and instead support the 

following bills that are critical to preserving patient confidentiality and coordinating care 

between various health providers: 

• The Senate's bipartisan "Opioid Crisis Response Act of 2018:" 

Provides model programs and materials for training health providers and 

compliance staff on the permitted uses and disclosures of substance use 

disorder information, and training family members and patients on their 

rights to protect and obtain substance use disorder information. 

• H.R. 3331 -Introduced by Representative Lynn Jenkins and cosponsored by Representative Doris Matsui: Provides needed incentive 
259 


32361.191

payments to substance use disorder and behavioral health providers to 

obtain certified electronic health record technology. 

Thank you. 

Sincerely, 

;(/ax'7' 9 / ~, ,0.), )tt;3fi2, z:5J11I) 

Nancy J. Turner, RN, MBR, DMP 

CEO 

Serenity Health, LLC 

3 
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April23, 2018 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545 -"Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

On behalf of the eighty (80) member organizations of the KY Mental Health Coalition, I am 

writing to express our strong opposition to H.R. 3545, the "Overdose Prevention and Patient 

Safety Act." As you know, we are in the midst of the worst opioid epidemic in our nation's 

history. It is a time when we must do everything possible to increase the number of people who 

seek treatment for their addiction. Our grave concern is that H.R. 3545 would not only not 

encourage individuals to seek treatment, but would actually discourage them from doing so. 

H.R. 3545 would discourage people from entering care out of fear that their treatment 

records will be used against tb.em in many harmful ways. The bill would reduce privacy 

protections for individuals receiving substance use disorder ("SUD") treatment by allowing 

disclosures and re-disclosures of SUD information without patient consent to a wide range 

of health care providers, coverage plans and others. 

The Kentucky Mental Health Coalition (KMHC) includes every kind of behavioral health 

professional licensed in Kentucky, as well as public-sector and private-sector agencies and 

treatment facilities. Our membership also includes advocacy, consumer and family groups who 

are very clear that protection of personal information is a key requisite of seeking treatment for 

addictive disorders. 

ADVOCACY ACTION NETWORK 

1 20 SEARS AVENUE, SUITE 21 2 LOUISVILLE, KY 40207 

PHONE: (502) 836-4222 TOLL·FREE (877) 894.()222 FAX: (502) 894.()635 

WEBSITE: WWW.A!J.YQ<;:i\_Cl'_A5:;::nQ!:J.,lLEJ: 
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32361.193

• The heightened protections for substance use disorder records in the federal 

confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 CFR Part 2 

(collectively known as "Part 2"), are as critically important today as ever. They 

support care coordination while maintaining patient confidentiality to help ensure 

that people enter SUD treatment. 

• SAMHSA's amendments to Part2 by in 2017 and2018 have made it much easier 

to facilitate (with patient consent) the sharing of health information between SUD 

and other health care providers in electronic health information systems and 

coordinated care settings. Unfortunately, many in the health care system do not 

know what these rules allow, and many SUD treatment programs do not have 

adequate computer systems to enable them to maintain electronic health records. 

• Patients in substance abuse disorder treatment should retain the power to decide 

when and to whom their records are disclosed, given the continued prevalence of 

discrimination in our society. 

For these reasons, we oppose H.R. 3545 and instead support the following bills that are critical 

to preserving patient confidentiality and coordinating care among various health providers: 

The Senate's bipartisan "Opioid Crisis Response Act of 2018:" Provides 

model programs and materials for training health providers and compliance staff 

on the permitted uses and disclosures of substance use disorder information, and 

training family members and patients on their rights to protect and obtain 

substance use disorder information. 

• H.R. 3331 -Introduced by Representative Lynn Jenkins and co-sponsored 

by Representative Doris Matsui: Provides needed incentive payments to 

substance use disorder and behavioral health providers to obtain certified 

electronic health record technology. 

Thank you for your attention to this critically important issue. The lives of those with addictions 

depend on your actions. 

Sheila A. Schuster, Ph.D. 

Executive Director 

ADVOCACY ACTION NE1WORK 

120 SEARS AVENUE, SUITE 212 LOUISVILLE, KY 40207 

PHONE: (502) 836-4222 ToLL-FREE (877) 894-0222 FAX: (502) 894-0635 

WEBSITE: WWW.ADVru;:_;;~'[M:!!Q!'!"I':!E;I 
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COMMENTS OPPOSING H.R. 3545, "OVERDOSE PREVENT/ON AND PATIENT 

SAFETY ACT" 

Apri121, 2018 

Holly Broce, MHA, LCADC 

President of the KY Association for the Treatment of Opioid Dependence 

Pinnacle Treatment Centers Regional Director 

1 05 Eastside Drive 

Georgetown, KY 40324 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545 -"Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and 

Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

Pinnacle Treatment Centers is writing to express our opposition to H.R. 3545, the 

"Overdose Prevention and Patient Safety Act." In the midst of the worst opioid epidemic 

in our nation's history, we must do everything possible to increase the number of people 

who seek treatment, but H.R. 3545 would do the opposite. By reducing privacy 

protections for individuals receiving substance use disorder ("SUD") treatment to 

allow disclosures and re-disclosures of SUD information without patient consent 

to a wide range of health care providers and plans and others with whom they 

work, H.R. 3545 would discourage people from entering care out of fear that their 

treatment records will be used against them in many harmful ways. 

Working in the field of addiction since 1994, I have witnessed time and time 

again, patients being dropped from a medical practice or prematurely forced out 
263 


32361.195

of treatment by the criminal justice system. This action is a direct result of a lack 

of understanding of medication assisted treatment. Forcing patients out of a lifesaving treatment, sends them into withdrawal and puts them at greater risk of 

relapse and overdose. 

• The heightened protections for substance use disorder records in the 

federal confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 

CFR Part 2 (collectively known as "Part 2"), are as critically important 

today as ever. They support care coordination while maintaining patient 

confidentiality to help ensure that people enter SUD treatment. 

• SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it 

much easier to facilitate (with patient consent) the sharing of health 

information between SUD and other health care providers in electronic 

health information systems and coordinated care settings. Unfortunately, 

many in the health care system do not know what these rules allow, and 

many SUD treatment programs do not have adequate computer systems 

to enable them to maintain electronic health records. 

• Patients in substance abuse disorder treatment should retain the power to 

decide when and to whom their records are disclosed, given the continued 

prevalence of discrimination in our society. 

For these reasons, we oppose H.R. 3545 and instead support the following bills that are 

critical to preserving patient confidentiality and coordinating care between various health 

providers: 

• The Senate's bipartisan "Opioid Crisis Response Act of 2018:" 

Provides model programs and materials for training health providers and 

compliance staff on the permitted uses and disclosures of substance use 

disorder information, and training family members and patients on their 

rights to protect and obtain substance use disorder information. 

• H.R. 3331 -Introduced by Representative Lynn Jenkins and cosponsored by Representative Doris Matsui: Provides needed incentive 

payments to substance use disorder and behavioral health providers to 

obtain certified electronic health record technology. 

Thank you. 

Sincerely, 

Holly Broce, MHA, LCADC 

President KY Association for the Treatment of Opioid Dependence 

Regional Director, Pinnacle Treatment Centers 

2 
264 


32361.196

People Advocating Recovery is a statewide group of concerned individuals working to eliminate 

barriers to recovery from addiction. 

April 22, 2018 

PAR-People Advocating Recovery 

1425 Story Ave. 

Louisville, KY 40206 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn llouse Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545 -"Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

People Advocating Recovery is writing to express our opposition to H.R. 3545, the 

"Overdose Prevention and Patient Safety Act." In the midst of the worst opioid epidemic 

in our nation's history, we must do everything possible to increase the number of people 

who seek treatment, but H.R. 3545 would do the opposite. By reducing privacy 

protections for individuals receiving substance use disorder ("SUD") treatment to allow 

disclosures and re-disclosures of SUD information without patient consent to a wide 

range of health care providers and plans and others with whom they work, H.R. 3545 

would discourage people from entering care out of fear that their treatment records will 

be used against them in many harmful ways. 

PAR-People Advocating Recovery 

1425 Story Ave. 

Louisville, KY 40206 

502-552-8573 

www.peopleadvocatingrecovery.org 
265 


32361.197

My name is Mike Barry. I am the CEO of People Advocating Recovery representing over 

7000 people in recovery, their families, and friends in the state of Kentucky. 

Patients in substance abuse disorder treatment should retain the power to decide when 

and to whom their records are disclosed, given the continued prevalence of 

discrimination in our society. 

I and many others would have not gone into a treatment program had we thought our 

information would be shared with others without our knowledge or consent. This could 

have put our careers in jeopardy since so many people still regard this illness as a moral 

failure. 

For these reasons, we oppose H.R. 3545 and instead support the following bills that are 

critical to preserving patient confidentiality and coordinating care between various health 

providers: 

The Senate's bipartisan "Opioid Crisis Response Act of2018:" Provides model 

programs and materials for training health providers and compliance staff on the 

permitted uses and disclosures of substance use disorder information, and training family 

members and patients on their rights to protect and obtain substance use disorder 

information. 

H.R. 3331 Introduced by Representative Lynn Jenkins and co-sponsored by 

Representative Doris Matsui: Provides needed incentive payments to substance use 

disorder and behavioral health providers to obtain certified electronic health record 

technology. 

Thank you. 

Sincerely, 

4 

/~?;cr£(y(~ \..._,._-

Mike Barry 

CEO-People Advocating Recovery 

Kentucky 
266 


32361.198

1324 Motor Parkway Suite 102, Islandia NY 11749 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

April12, 2018 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and 

Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

[I am writing on behalf of the Long Island Recovery Association (LIRA) to express our 

strong opposition to H.R. 3545, the "Overdose Prevention and Patient Safety Act." In 

the midst of the worst opioid epidemic in our nation's history, we must do everything 

possible to increase the number of people who seek treatment, but H.R. 3545 would do 

the opposite. By reducing privacy protections for individuals receiving substance 

use disorder ("SUD") treatment to allow disclosures and re-disclosures of SUD 

information without patient consent to a wide range of health care providers and 

plans and others with whom they work, H.R. 3545 would discourage people from 

entering care out of fear that their treatment records will be used against them in 

many harmful ways. 

As an individual in long term recovery, when I first decided to go to treatment in 1988 

knowing that my presence and related details of my stay were protected provided me 
267 


32361.199

with a sense of comfort and ease that allowed me to follow through on that life altering 

commitment. Knowing I was able to focus on the task at hand without worrying that my 

employer and others may know about my medical condition was a big reason I was able 

to trust the process leading to a sustained life in recovery now approaching thirty years. 

Had the long standing full provisions of CFR 42 not been in place I am certain I would 

not have entered treatment at that time. I cannot emphasize enough my belief that that 

these proposed changes in this legislation, particularly as we face the opioid crisis the 

number one healthcare issue in America, would have widespread negative impact on 

individuals in need of treatment for substance use disorders. 

• The heightened protections for substance use disorder records in the 

federal confidentiality law, 42 U.S. C. § 290dd-2 and its regulations at 42 

CFR Part 2 (collectively known as "Part 2"), are as critically important 

today as ever; supporting care coordination and maintaining confidentiality 

to help ensure that people enter SUD treatment. 

• Patients in substance abuse disorder treatment should retain the power to 

decide when and to whom their records are disclosed, given the continued 

prevalence of discrimination in our society. 

For these reasons LIRA opposes H.R. 3545. We support the following bills that are 

critical to preserving patient confidentiality and care between various health providers: 

• The Senate's bipartisan "Opioid Crisis Response Act of 2018:" 

Provides model programs and materials for training health providers and 

compliance staff on the permitted uses and disclosures of substance use 

disorder information, and training family members and patients on their 

rights to protect and obtain substance use disorder information. 

• H.R. 3331 -Introduced by Representative Lynn Jenkins and cosponsored by Representative Doris Matsui: Provides needed incentive 

payments to substance use disorder and behavioral health providers to 

obtain certified electronic health record technology. 

Thank you for your consideration and anticipated support. 

Sincerely, 

Richard Buckman 

Immediate Past President 

Founding Member 
268 


32361.200

April13, 2018 

Faces & Voices of Recovery 

840 First Street NE Third Floor 

Washington, D 20002 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

ES 

I ES 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and Coordinate 

Care 

Dear Chairman Walden and Ranking Member Pallone: 

Faces & Voices of Recovery writes to express our opposition to H.R. 3545, the "Overdose 

Prevention and Patient Safety Act." In the midst of the worst opioid epidemic in our 

nation's history, we must do everything possible to increase the number of people who 

seek treatment, but H.R. 3545 would do the opposite. By reducing privacy protections 

for individuals receiving substance use disorder ("SUD") treatment to allow 

disclosures and re-disclosures of SUD information without patient consent to a 

wide range of health care providers and plans and others with whom they work, 

H.R. 3545 would discourage people from entering care out of fear that their 

treatment records will be used against them in many harmful ways. 

Faces & Voices of Recovery is dedicated to organizing and mobilizing the over 23 million 

Americans in recovery from addiction to alcohol and other drugs, our families, friends and 

allies into recovery community organizations and networks, to promote the right and 

840 First Street NE 3'd Floor • Washington, DC 20002 

202.737.0690 • Fax: 202.737.0695 

www. face sand voicesofrecovery. org 
269 


32361.201

FACES 

I ES 

resources to recover through advocacy, education and demonstrating the power and 

proof of long-term recovery. 

People in or in need of recovery from addiction to alcohol and other drugs face myriad 

forms of discrimination. Discrimination creates barriers to our full participation in 

community life. Faces & Voices of Recovery strives to eliminate all policies and practices 

that discriminate against people and their impacted families based solely on their recovery 

status. We are very aware of the consequences if the 42CFR Part 2 were to change and 

as such oppose this bill for the following reasons: 

• The heightened protections for substance use disorder records in the 

federal confidentiality law, 42 U.S.C. § 290dd-2 and its regulations at 42 

CFR Part 2 {collectively known as "Part 2"), are as critically important today 

as ever. They support care coordination while maintaining patient 

confidentiality to help ensure that people enter SUD treatment. 

• SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it much 

easier to facilitate {with patient consent) the sharing of health information 

between SUD and other health care providers in electronic health 

information systems and coordinated care settings. Unfortunately, many in 

the health care system do not know what these rules allow, and many SUD 

treatment programs do not have adequate computer systems to enable 

them to maintain electronic health records. 

Patients in substance abuse disorder treatment should retain the power to 

decide when and to whom their records are disclosed, given the continued 

prevalence of discrimination in our society. 

For these reasons, Faces & Voices of Recovery opposes H.R. 3545 and instead support 

the following bills that are critical to preserving patient confidentiality and coordinating 

care between various health providers: 

• The Senate's bipartisan "Opioid Crisis Response Act of 2018:" 

Provides model programs and materials for training health providers and 

compliance staff on the permitted uses and disclosures of substance use 

disorder information, and training family members and patients on their 

rights to protect and obtain substance use disorder information. 

• H.R. 3331 - Introduced by Representative Lynn Jenkins and cosponsored by Representative Doris Matsui: Provides needed incentive 

840 First Street NE 3'd Floor • Washington, DC 20002 

202.737.0690 • Fax: 202.737.0695 

www.facesandvoicesofrecovery.org 
270 


32361.202

ES 

I ES 

payments to substance use disorder and behavioral health providers to 

obtain certified electronic health record technology. 

Thank you. 

Sincerely, 

Patty McCarthy Metcalf 

Executive Director 

Faces & Voices of Recovery 

840 First Street NE Third Floor 

Washington, D 20002 

840 First Street NE 3rd Floor • Washington, DC 20002 

202.737.0690 • Fax: 202.737 0695 

www.facesandvoicesofrecovery.org 
271 


32361.203

March 20'\ 2018 

The Honorable Chairman Greg Walden, 

The Honorable Ranking Member Frank Pallone 

House Energy & Commerce Committee 

2125 Rayburn House Office Building 

Washington, D.C. 20515 

RE: Hearing on Combatting the Opioid Crisis: Prevention and Public Health Strategies -Amendment to HR 3545 

the Overdose Prevention and Patient Safety Act" 

The Honorable Chairman Walden & Ranking Member Pallone, 

Thank you for the opportunity to comment on the proposed Amendment to HR 3545, "the Overdose Prevention 

and Patient Safety Act." The agency I represent is the Pennsylvania Recovery Organizations- Alliance (PRO-A), the 

statewide recovery community organization of Pennsylvania founded in 1998. We represent thousands of 

recovering persons across the state of Pennsylvania. We are dedicated to ending stigma, providing public 

education about addiction, providing recovery opportunities and to expand access to drug and alcohol services. 

We continue to believe strongly that the existing federal confidentiality requirements for substance use 

conditions information established in 42 U.S.C § 290dd-2 and 42 CFR Part 2 ("Part 2"), as recently amended 

twice by SAMHSA, do not require further modifications that would diminish our patient privacy protections in 

order to achieve the important goal of facilitating the provision of integrated care between substance use 

disorder information and overall health care. 

We remain very concerned that applying the HIPAA Privacy Rule ("HIPAA") standard of allowing without our 

consent disclosures of our substance use condition records for treatment, payment, health operations or any 

purpose other than those currently enumerated in Part 2 will result in discrimination against and harm to people 

living with substance use conditions. The result will be to discourage individuals from seeking SUD treatment 

even as our number one goal needs to be to encouraging millions more Americans to enter treatment during the 

worst opioid epidemic in our nation's history. 

Section (C) (2) on page 4 of the amendment in the section titled "Use of Records in Criminal, Civil, or 

Administrative Investigations, Actions or Procedures" identifies a threshold of "absent good cause" for ruling out 

the use of our information in Criminal, Civil, or Administrative Investigations. This is an ambiguous standard at 

best and provides insufficient guidance. This will inevitably result in our own information disclosed by seeking 

help with a substance use condition to be used against us. This will have a chilling impact on the ability of our 

community to seek help without fear of prosecution. 
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32361.204

The Amendment would allow broad access to highly sensitive and personal information. It would be opened up 

to a vast array of individuals and entities well beyond the counselor treating the person in need and the 

immediate care provider who need it and can access it under current regulation with our consent. 

Additionally, as this information 11flows out" to business associates and contracted entities, control over what 

happens to it decreases while the likelihood of the information being misused or stolen through a breach 

increases. In instances in which a person has had their information used in a way that caused harm to them, it 

will become virtually impossible for the patient to determine who was responsible for improperly releasing their 

information. It is the proverbial wall with a gate open and a pot of gold within. 

Our information is that proverbial "pot of gold" and we are deeply concerned about broad dispersal of highly 

sensitive and personal drug and alcohol related information proposed by the amendment and the lack of clear 

accountabiiHy to us, the patients. It will create conditions favorable to those who would use our information to 

discriminate against us in a myriad of ways. This includes employment, housing, education and insurance 

coverage. We have faced the constant drumbeat of the weakening of our protections by business related 

groups who are perpetually advocating for further weakening and I or elimination of this critically important 

rule. If one does a go ogle search on medications like "Narcan" or "Buprenorphine" coupled with the term "Life 

Insurance" one will lind how information available within patient records are being used to deny life insurance 

to people. Turning on the news this week, one is confronted with how Cambridge Analytica used a research 

clause to gain information on people to use as Kompromat. Drug and Alcohol patient records would be a 

primary target of other such groups working to gain access to our highly sensitive information. Treatment will 

become unsafe to participate in. 

The sad reality is that there are compelling reasons for entities to obtain and use this information to 

discriminate against us for their own material gain. 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, in 

most cases individuals would not do so as by the very act of trying to assert their rights would acknowledge drug 

addiction in a way that would open them up to prosecution and discrimination. In that sense the Amendment 

has toothless penalties as due process will be un-obtainable by those so harmed. 

The Amendment endangers the fragile therapeutic alliance and may well reduce access to care as who gets our 

patient information becomes unknowable to the patient. It will be no longer possible for the person in care to 

determine who gets their information and how it will be used (or misused). Information could now go in a 

myriad of directions once entered into the medical data base. If the information is used to discriminate against 

us, it is also nearly impossible from the patient perspective to determine how such a violation occurred and who 

was responsible. 

Under this Amendment, as the treating clinician (I have nearly three decades of direct care experience) I would 

have to tell my clients that I have no idea who will get their patient information, or how it will be used. I will 

note that I am a person in long term, continuous recovery for over 31 years. Under this amendment, I would 

have not entered treatment or self-edited my disclosures in a way that would have undermined my own care. 

Without strict protections, I would not have gotten help, obtained an education and have had the opportunity 

to be a productive citizen. It is quite possible I would not have survived. This is not just my story, this is true for 

so very many of us in recovery. 

Please understand that there is much greater stigma around substance use conditions than other kinds of 

medical conditions, and the very acknowledgment of having a substance use condition can open us up to 

Web site: www.pro-a.org Twitter Feed: https://twitter.com/PARecoveryOrg 

Face book: www. face book. com /Pa RecoveryO rga n i zat ion A Ilia n ce I 
273 


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discrimination and in rna ny instances, place us in legal jeopardy. We will face a Hobson's choice when seeking 

help under the proposed amendment. 

We implore you to not further weaken our confidentiality rights. We are concerned that these proposed 

changes add many layers of legalese, complexity and ambiguity to the regulations and will serve only to create 

further confusion. It is worth noting that even with our simpler, current standard many direct care professionals 

do not understand that they can access all the clinical information they need with a properly executed consent. 

It is also worth noting that each revision of the standard has made it more complex and harder to understand, 

which is in and of itself a barrier to care for patients. Others seem to not want to bothered to honor our privacy 

rights. 

We believe that the patient should retain control over who gets this information and how it is used.lt is 

important to note that substance use conditions are almost always fatal without help, that few people can 

afford to pay out of pocket for care as a direct result of the condition and that treatment at times can be 

compulsory. The bottom line is that if information that can harm us is widely available, we are left with no real 

choices beyond avoiding care or risking the use of our information to discriminate against us after it flows to 

covered entities and beyond based on "absent probable cause" language, business, research allowances and 

many other ways. 

We believe that expanding access to our information opens it up to misuse and urge policymakers to protect us 

from the misuse of our information and to hold those who use it to discriminate against us accountable to 

protect our information. This is the standard that Congress strived for back in 1972, which we believe is just as 

relevant now: 

''The conferees wish to stress their conviction that the strictest adherence to the provisions of this section 

is absolutely essential to the success of all drug abuse prevention programs. Every patient ond former 

patient must be assured that his right to privacy will be protected. Without that assurance, fear of public 

disclosure of drug abuse or of records that will discourage thousands from seeking the treatment they 

must have if this tragic national problem is to be overcome." 

We staunchly believe that sharing of addiction and recovery information is an individual choice to be made by 

the individual who retains control over how it is used and honors the need to limit access to highly sensitive 

information- we think that this is fundamental to quality care and consistent with the original statutes and we 

ask that the original intent be honored. 

Respectfully Submitted, 

~-w~;t?---"--

William ~ ·---- Stauffer, LSW, CCS, CADC 

Executive Director 

Web site: www.pro-a.org Twitter Feed: https:l/twitter.com/PARecoveryOrg 

Facebook: www. facebook.com/Pa RecoveryOrganizationAIIia nee/ 
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Campaign to Protect Patient Privacy Rights 

March 21,2018 

VIA ELECTRONIC MAIL 

Representative Greg Walden 

Chairman of the U.S. House of Representatives 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member of the U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: U.S. House of Representatives, Energy and Commerce- Subcommittee on 

Health: "Combating the Opioid Crisis: Prevention and Public Health Solutions;" 

Amendment in the Nature of a Substitute to H.R. 3545- "Overdose Prevention 

and Patient Safety Act" 

Dear Chairman Walden and Ranking Member Pallone: 

We, the undersigned national, state, and local organizations strongly support 

maintaining the core protections of the federal substance use disorder patient 

confidentiality law ("42 U.S. C. § 290dd-2") and its regulations "42 CFR Part 2," (referred 

to collectively as "Part 2,") to effectively protect the confidentiality of patients' records. 

The Substance Abuse and Mental Health Service Administration ("SAMHSA") recently 

twice amended the patient privacy regulations in order to facilitate the objective of 

providing integrative care between substance use disorder ("SUD") and other health 

care information. 

We remain concerned that using a weaker HIPAA Privacy Rule standard of allowing 

disclosures of SUD information without patient consent for treatment, payment, health 

care operations, or other purposes other than those currently allowed by Part 2- will 

contribute to the existing level of discrimination and harm to people living with 

substance use disorders. This will only result in more people who need substance use 

disorder treatment, being discouraged and afraid to seek the health care they need 

during the nation's worst opioid crisis. 
275 


32361.207

We strongly support maintaining Part 2's core protections for SUD information, instead 

of those of a weaker HIPAA Privacy standard as described in the Amendment (in the 

Nature for a Substitute) for H.R. 3545 for the following reasons: 

1. The heightened privacy protections in Part 2 are as critical today as they 

were when they were they were enacted more than 40 years ago and 

must be preserved. 

2. In the midst of the worst opioid epidemic in our nation's history, we must 

do everything possible to increase- not decrease -the number of people 

who seek treatment. 

3. SUD is unique among medical conditions because of its criminal and civil 

consequences and the rampant discrimination people face. 

4. With so much at stake, patients in SUD treatment should retain the right to 

consent when and to whom their records are disclosed, as currently found 

in Part 2. 

5. Effective integration of SUD treatment with the rest of the health care 

system is critically important, and information exchange in accordance 

with confidentiality law and current technology is now possible. To 

facilitate that process, SAMHSA recently amended the Part 2 regulations 

to further promote the integration of confidential SUD information into 

general health records. 

We respectfully request that the House Energy and Commerce Committee maintain the 

current confidentiality protections of Part 2 to support individuals entering and staying in 

SUD treatment and recovery services. 

Sincerely, 

CAMPAIGN TO PROTECT PATIENT PRIVACY RIGHTS: 

A New PATH 

Addiction Haven 

Addictions Resource Center, Waukesha, WI (ARC, Inc.) 

Advocates for Recovery Colorado 

AIDS United 

Alane Club of Portland 

Alcohol & Addictions Resource Center, South Bend, IN 

American Association for the Treatment of Opioid Dependence (AATOD) 

American Group Psychotherapy Association 

2 
276 


32361.208

Apricity 

Arthur Schut Consulting LLC 

Atlantic Prevention Resources 

California Consortium of Addiction Programs & Professionals (CCAPP) 

Capital Area Project Vox-Lansing (MI)'s Voice of Recovery 

Center for Recovery and Wellness Resources 

CFC Loud N Clear Foundation 

Chicago Recovering Cornrnunities Coalition 

Colorado Behavioral Healthcare Council 

Cornrnunity Catalyst 

Connecticut Cornrnunity for Addiction Recovery (CCAR) 

Council on Addiction Recovery Services (CAReS), Inc.- Olean, NY 

Dar June Recovery Support Services & Cafe 

Davis Direction Foundation- The Zone 

Daystar Center 

Delphi Behavioral Health Group-Maryland House Detox 

Detroit Recovery Project 

The DOOR-DeKalb Open Opportunity for Recovery 

Drug and Alcohol Service Providers Organization of Pennsylvania 

Faces & Voices of Recovery 

Faces and Voices of Recovery (FAVOR)-Grand Strand-SC 

Faces and Voices of Recovery (FAVOR)-Greenville, SC 

Faces and Voices of Recovery (FAVOR)-Low Country: Charleston, SC 

Faces and Voices of Recovery (FAVOR)-Mississippi Recovery Advocacy Project 

Faces and Voices of Recovery (FAVOR)-Pee Dee, SC 

Faces and Voices of Recovery (FAVOR)-Tri-County: Rock Hill, SC 

Facing Addiction 

Fellowship Foundation Recovery Cornrnunity Organization 

Foundation for Recovery 

Friends of Recovery-New York 

Georgia Council on Substance Abuse 

3 
277 


32361.209

Greater Macomb Project Vox 

Harm Reduction Coalition 

Home of New Vision 

HOPE for New Hampshire Recovery 

Jackson Area Recovery Community-Jackson, Ml 

Latah Recovery Center 

Legal Action Center 

Lifehouse Recovery Connection 

Long Island Recovery Association (LIRA) 

Maine Alliance for Addiction Recovery 

Massachusetts Organization for Addiction Recovery 

Message Carriers of Pennsylvania 

Mid-Michigan Recovery Services (NCADD Mid-Michigan Affiliate) 

Minnesota Recovery Connection 

Missouri Recovery Network 

National Advocates for Pregnant Women 

National Alliance for Medication Assisted Recovery (NAMA Recovery) 

National Association for Children of Addiction (NACoA) 

National Association of County Behavioral Health and Developmental Disability 

Directors (NACBHDD) 

National Association for Rural Mental Health (NARMH) 

National Center on Domestic Violence, Trauma & Mental Health 

National Council on Alcoholism and Drug Dependence, Inc. (NCADD) 

National Council on Alcoholism and Drug Dependence-Central Mississippi Area, Inc. 

National Council on Alcoholism and Drug Dependence-Maryland 

National Council on Alcoholism and Drug Dependence-Phoenix 

National Council on Alcoholism and Drug Dependence-San Fernando Valley 

Navigating Recovery of the Lakes Region 

New Jersey Association of Mental Health and Addiction Agencies 

Northern Ohio Recovery Association 

Oklahoma Citizen Advocates for Recovery and Transformation Association (OCART A) 

4 
278 


32361.210

Overcoming Addiction Radio, Inc. 

Parent/Professional Advocacy League 

Peer Coach Academy Colorado 

Pennsylvania Recovery Organizations-Alliance (PRO-A) 

People Advocating Recovery (PAR) 

Pennsylvania Recovery Organization-Achieving Community Together (PRO-ACT) 

Portland Recovery Community Center 

Public Justice Center 

REAL-Michigan (Recovery, Education, Advocacy & Leadership) 

Recover Project/Western MA Training 

Recover Wyoming 

Recovery Alliance of Austin 

Recovery Allies of West Michigan 

Recovery Cafe 

Recovery Communities of North Carolina 

Recovery Community of Durham 

Recovery Consultants of Atlanta 

Recovery Epicenter Foundation, Inc. 

Recovery Force of Atlantic County 

Recovery is Happening 

Recovery Resource Council 

Recovery Organization of Support Specialist 

Revive Recovery, Inc. 

Rhode Island Cares About Recovery (RICARES) 

Rochester Community Recovery Center 

ROCovery Fitness 

Safe Harbor Recovery Center 

SMART Recovery (Self-Management and Recovery Training) 

S.O.S. Recovery Community Organization 

SpiritWorks Foundation 

Springs Recovery Connection 

5 
279 


32361.211

Tennessee Association of Alcohol, Drug & other Addiction Services (TAADAS) 

The Bridge Foundation 

The Courage Center 

The McShin Foundation 

The Ohana Center for Recovery 

The Serenity House of Flint 

The Phoenix 

The RASE Project 

The Recovery Channel 

Tia Hart Community Recovery Program 

Together Our Recovery Center Heals (T.O.R.C.H.), Inc. 

Treatment Trends, Inc. 

Trilogy Recovery Community 

U MARC (United Mental Health and Addictions Recovery Coalition) 

Utah Support Advocates for Recovery Awareness (USARA) 

Vermont Recovery Network 

Voices of Hope for Cecil County, MD 

Voices of Hope Lexington 

Voices of Recovery San Mateo County, CA 

WAI-IAM, Inc. and RISE Recovery Community 

Wisconsin Voices for Recovery 

Young People in Recovery 

6 
280 


32361.212

NATIONAl COUNCIL ON AlCOHOliSM 

AND DRUG DEPENDENCE OF THE 

SAN FERNANDO VALlEY 

March 21, 2018 

Representative Greg Walden 

Chairman of the U.S. House of Representatives 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member of the U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: U.S. House of Representatives, Energy and Commerce Subcommittee on Health: 

"Combating the Opioid Crisis: Prevention and Public Health Solutions;" 

Amendment in the Nature of a Substitute to H.R. 3545 -"Overdose Prevention and Patient 

Safety Act" 

Dear Chairman Walden and Ranking Member Pallone: 

As a professional alcohol and drug outpatient treatment program, we strongly support 

maintaining the core protections of the federal substance use disorder patient confidentiality law 

("42 U.S. C. § 29odd-2 '')and its regulations "42 CFR Part 2," (referred to collectively as "Part 2,") to 

effectively protect the confidentiality of patients' records. Maintaining Part 2's core protections 

for SUD information, instead of those of a weaker HIP AA Privacy standard as described in the 

Amendment (in the Nature for a Substitute} for H.R. 3545 for the following reasons: 

1. The heightened privacy protections in Part 2 are as critical today as they were 

when they were they were enacted more than 40 years ago, and must be preserved. 

2. Amid the worst opioid epidemic in our nation's history, we must do everything 

possible to increase not decrease - the number of people who seek treatment. 

6r66 Vesper Avenue. Van Nuys, California 91411 {818} 997-0414 
281 


32361.213

3· SUD is unique among medical conditions because of its criminal and civil 

consequences and the rampant discrimination people face. 

4- With so much at stake, patients in SUD treatment should retain the right to 

consent when and to whom their records are disclosed, as currently found in Part 

2. 

5· Effective integration of SUD treatment with the rest of the health care system is 

critically important, and information exchange in accordance with confidentiality 

law and current technology is now possible. To facilitate that process, SAMHSA 

recently amended the Part 2 regulations to further promote the integration of 

confidential SUD information into general health records. 

Like many other professionals in the field of addiction treatment and recovery, we are concerned 

that weakening the HIP AA Privacy Rule standard of allowing disclosures of SUD information 

without patient consent for treatment, payment, health care operations, or other purposes other 

than those currently allowed by Part 2 -will contribute to the existing level of discrimination and 

harm to individuals and their families suffering with substance use disorders. This will only result 

in more people who need substance use disorder treatment, being discouraged and afraid to seek 

the health care they need during the nation's worst opioid crisis. 

We respectfully request that the House Energy and Commerce Committee maintain the current 

confidentiality protections of Part 2 in order to support individuals entering and staying in SUD 

treatment and recovery services. 

cc: NCADD-SF\1 Board of Directors 

NCADD-SF\1 Management Committee 

6166 Vesper Avenue. Van Nuys, California 91411 {818} 997-0414 
282 


32361.214

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

April18, 2018 

RE: Privacy and confidentiality of the health data of survivors of domestic and intimate partner violence 

Dear Chairman Walden and Ranking Member Pallone: 

Futures Without Violence (FUTURES) writes today to support strong privacy and confidentiality protections 

for the health and behavioral health data/records of survivors of domestic and intimate partner violence 

(DV/IPV). As an organization that partners with providers and patients, we support a pragmatic approach to 

care coordination and data sharing that improves care, reduces costs, and protects women and families 

who experience DV/IPV. Because disclosure of confidential health information can be particularly 

dangerous for victims, it is imperative that survivors are fully informed about how their data is being used 

and shared-and that they have control over how, when and with whom. 

We are concerned that the changes to the data sharing permissions policies are being hurriedly considered 

as part of H.R. 3545, the "Overdose Prevention and Patient Safety Act," and do not meet the unique privacy 

and security needs of survivors of DV/IPV. Careful consideration is required. This is true for substance use 

and mental health records-and for all health data. 

Recent changes to privacy rules, including SAMHSA's amendments to 42CFR Part 2 in 2017 and 2018, have 

made it much easier to facilitate (with patient consent) the sharing of health information between SUD, 

mental health and other health care providers in electronic health information systems and coordinated 

care settings. Until these policies are fully implemented and the full impact of these changes is understood, 

we recommend no additional changes to the policy to ensure that survivors of DV/IPV-and all patientshave their health data protected. 

For survivors, keeping health data confidential is critical both for the immediate safety concerns, and also 

for survivors' trust of their providers. Survivors may be at risk of violent retaliation or reprisal if an abuser 

learns about the disclosure of abuse. There also may be legal consequences with an abuser using a 

survivor's history of mental health or substance use services against them in court or custody proceedings 

or threatening to do so as a means of coercive control. Survivors also will be less likely to disclose abuse and 
283 


32361.215

seek help if they do not believe their disclosure will be kept private. Survivors must understand who has 

access to their health data and who may be able to get access to that data, and they should retain the 

powerto decide when and to whom their records are disclosed. 

To that end, FUTURES recommends that future policymaking adhere to the following principles: 

Robust and informed patient consent 

Survivors may have very different needs with regards to their privacy. Some may be comfortable sharing 

health data with various health care providers and others may choose to exercise more control. The health 

care system-and all corresponding technology-must be responsive to these different needs and ensure 

that patients fully understand how their data is shared and be offered the ability to fully consent. 

Patient control of data 

Patients should be able to choose who can see their records and under what circumstances, and must be 

offered options to exercise control over these situations. They need to fully understand where their data 

may go and how their data may be accessed. They must be given the opportunity to opt into (or out of) 

sharing their health data-and they must be able to control what providers have access to their data and 

under what circumstances. Technology can support these decisions by allowing survivors to withhold 

certain information or to prohibit the sharing of certain information. They must be able to easily change 

privacy settings if their life circumstances change. 

Transparency 

Survivors must be able to know and be able to track who has accessed their data and when, or when data 

was shared with others. Providers may be given tools to help survivors protect their data, and the 

technology must support providers decisions, including education on what data might be sent to outside 

providers or for reimbursement, or what information might be printed on insurance billing notifications. 

Enforceable penalties 

There should be strong and enforceable penalties for violations of privacy and consent both in a clinical 

setting, and across information exchanges. Whether due to negligence or oversight, violations of privacy 

and consents should be penalized to the fullest extent of the law. The penalties should be strong enough to 

deter future cases, and they must be enforceable. 

We thank you for consideration of these recommendations and look forward to answering any questions or 

addressing any concerns. For additional information, please contact Kiersten Stewart in FUTURES' 

Washington, DC office at 202-595-7382. 

Sincerely, 

Est a Soler 

President and Founder 

Futures Without Violence 
284 


32361.216

May 2, 2018 

Sally A. Cart 

502 S. 12th Street 

Perkasie, Pa. 18944 

Representative Greg \Valdcn 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking 1\'lember 

U.S. House of Representatives 

Eneq~')' and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Oppo~ition to H.R. 3545 -"Overdose Prevention and Patient Saft~ty Act" and Support for Other 

Legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

I, as a parent of a son whom suffers with the disease of addiction, and as a representative of a nonprofit, Never 

Surtci1dcr Hope, write to express my opposition to H.R. 3545, the "Overdose Prevention and Patient Safety 

Act." In the midst of the worst opioid epidemic in our nation's history, we must do everything possible to 

increase the number of people who seek treatment, but H.R. 3545 would do the opposite. By reducing privacy 

protections for individuals receiving substance use disorder ("SUD')) treatment to allow disclosures and redisclosures of SUD information without patient consent to a wide range of health care providers and plans and 

others with whom they work, H.R. 3545 would discourage people from entering care out of fear that their 

treatment records will be used against them in many harmful ways. 

As I stated above, my son is my main motivation in writing to you today. The stigma attached to the disease 

of addiction can he ·witnc!:ised, not only in daily life, but also in those places where people who suffer the same, 

should feel safe and not judged by their past attempts at recovery or anything else for that matter .. 

Patients in substance abuse disorder treatment should retain the power to decide when and to whom their 

records are disclosed, given the continued pre\'alence of discrimination in out society. 

For these reasons, I oppose H.R. 3545 and instead support the follo\ving bills that are critical to preserving 

patient confidentiality and coordinating care between various health providers: 

·The Senate's bipartisan "Opioid Crisis Response Act of 2018:" Pro,'ides model programs and materials for 

training health providers and compliance staff on the permitted uses and disclosures of substance usc disorder 

information, and training family members and patients on the-ir rights to protect and obtain substance usc 

disorder information. 

H.R. 3331- Introduced by Representative Lynn Jenkins and co-sponsored by Representative Doris 

1\fatsui: Provides needed incentive payments to substance use disorder and behavioral health providers to 

obtain certified electronic health record technology. 

Thailk you. 

Sincerely, 

Sally A. Carr 
285 


32361.217

May 2, 2018 

Lauryn Wicks 

499 Wood crest Drive 

Mechanicsburg, Pennsylvania 17050 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545- "Overdose Prevention and Patient Safety Act" and Support for Other 

legislative Proposals to Preserve Confidentiality and Coordinate Care 

Dear Chairman Walden and Ranking Member Pallone: 

I write to express my opposition to H.R. 3545, the "Overdose Prevention and Patient Safety Act." In the 

midst ofthe worst opioid epidemic in our nation's history, we must do everything possible to increase 

the number of people who seek treatment, but H.R. 3545 would do the opposite. By reducing privacy 

protections for individuals receiving substance use disorder ("SUD") treatment to allow disclosures 

andre-disclosures of SUD information without patient consent to a wide range of health care 

providers and plans and others with whom they work, H.R. 3545 would discourage people from 

entering care out of fear that their treatment records will be used against them in many harmful 

ways. 

The heightened protections for substance use disorder records in the federal confidentiality law, 42 

U.S.C. § 290dd-2 and its regulations at 42 CFR Part 2 (collectively known as "Part 2"), are as critically 

important today as ever. They support care coordination while maintaining patient confidentiality to 

help ensure that people enter SUD treatment. 

SAMHSA's amendments to Part 2 by in 2017 and 2018 have made it much easier to facilitate 

(with patient consent) the sharing of health information between SUD and other health care 

providers in electronic health information systems and coordinated care settings. Unfortunately, 

many in the health care system do not know what these rules allow, and many SUD treatment 

programs do not have adequate computer systems to enable them to maintain electronic health 

records. 

Page 1 of 2 
286 


32361.218

Patients in substance abuse disorder treatment should retain the power to decide when and to 

whom their records are disclosed, given the continued prevalence of discrimination in our 

society. 

For these reasons, I oppose H.R. 3545 and instead support the following bills that are critical to 

preserving patient confidentiality and coordinating care between various health providers: 

The Senate's bipartisan "Opioid Crisis Response Act of 2018:" Provides model programs and 

materials for training health providers and compliance staff on the permitted uses and 

disclosures of substance use disorder information, and training family members and patients on 

their rights to protect and obtain substance use disorder information. 

H.R. 3331-lntroduced by Representative Lynn Jenkins and co-sponsored by Representative 

Doris Matsui: Provides needed incentive payments to substance use disorder and behavioral 

health providers to obtain certified electronic health record technology. 

Thank you. 

Sincerely, 

Lauryn Wicks 

National independent Family Recovery Advocate 

Page 2 of2 
287 


32361.219

National Association for Children of Addiction ... working to eliminate the adverse impact of alcohol and drug use on children and families 

May 8, 2018 

Representative Greg Walden 

Chairman 

Energy and Commerce Committee 

2185 Rayburn House Office Building 

Washington, DC 20515 

Representative Frank Pallone, Jr. 

Ranking Member 

U.S. House of Representatives 

Energy and Commerce Committee 

237 Cannon House Office Building 

Washington, DC 20515 

RE: Opposition to H.R. 3545 -"Overdose Prevention and Patient Safety Act" and 

Support for Other Legislative Proposals to Preserve Confidentiality and Coordinate 

Care 

Dear Chairman Walden and Ranking Member Pallone: 

1 am writing to express the National Association for Children of Addiction (NACoA)'s 

opposition to H.R. 3545, the "Overdose Prevention and Patient Safety Act.'' In the midst of the 

worst opioid epidemic in our nation's history, we must do everything possible to increase the 

number of people who seek treatment, but ll.R. 3545 would do the opposite. By reducing 

privacy protections for individuals receiving substance usc disorder ("SUD") treatment 

to allow disclosures and rc-disclosurcs of SUD information without patient consent to a 

wide range of health care providers and plans and others with whom they work, H.R. 

3545 would discourage people from entering care out of fear that their treatment records 

will be used against them in many hat'mful ways. 

NACoA is the voice for the I in 4 children whose parents suffer from substance use disorders. 

These children are the unaddressed victims in the addiction epidemic that continues to sweep 

our country destroying families, costing jobs, increasing family violence, and reducing the 

children's opportunity for a safe and productive life each day addicted parents do not receive 

treatment and recovery support. This proposed legislation will delay parental help to gel well 

and parental possibilities to obtain gainful employment in early recovery, thus stigmatizing and 

isolating vast numbers of children from a part of mainstream American opportunity. Fear of 

losing their children already helps to keep many parents from seeking treatment. H.R 3545 

exacerbates that problem. 

10910 Connecticut Avenue, Suite 100 • Kensington, t'v1D 20895 

1-888-55-.tCOAS {2627) • Fax: ~01-468-0987 •nacoaf~{:nacoa,org • \\W\v.nacoa,org 
288 


32361.220

SAMHSA's amendments to Part 2 in 2017 and 2018 have made it much easier 

to facilitate (with patient consent) the sharing of health information between 

SUD and other health care providers in electronic health information systems 

and coordinated care settings. Unfortunately, many in the health care system do 

not know what these rules allow, and many SUD treatment programs do not 

have adequate computer systems to enable them to maintain electronic health 

records. 

Patients in substance abuse disorder treatment should retain the power to decide 

when and to whom their records are disclosed, given the continued prevalence 

of discrimination in our society. An important consequence to preserving that 

power will be the likelihood that their children will have parents who enter and 

finish treatment and go on to recovery and obtain gainful employment to help 

support their families, thus giving their children an equal opportunity to 

succeed. 

For these reasons, we oppose H.R. 3545 and instead support the following bills that are critical 

to preserving patient confidentiality and coordinating care between various health providers: 

The Senate's bipartisan "Opioid Crisis Response Act of2018:" Provides 

model programs and materials for training health providers and compliance staff 

on the permitted uses and disclosures of substance use disorder information, and 

training family members and patients on their rights to protect and obtain 

substance use disorder information. 

• H.R. 3331- Introduced by Representative Lynn .Jenkins and co-sponsored 

by Representative Doris Matsui: Provides needed incentive payments to 

substance use disorder and behavioral health providers to obtain certified 

electronic health record technology. 

Thank you for considering the unintended consequences ofH.R. 3545 to already vulnerable 

children. 

Sincerely, 

Sis Wenger 

President/CEO 
289 


32361.221

GHEG WALDCN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSCY 

RANKlNG MEMBER 

~ongress of tbe mlntteb ~tateg 

j!)oulic of l\eprrlientatitlcli 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBUnN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515·-6115 

MRJority (20ZlZZ5-2927 

Mi,JOrity t202)2/5-·JG41 

May 24,2018 

Dr. H. Westley Clark 

Dean's Executive Professor, Public Health Program 

Santa Clara University 

Santa Clara, CA 

Dear Dr. Clark: 

Thank you for appearing before the Subcommittee on Health on May 8, 2018, to testify at 

the hearing entitled "Improving the Coordination and Quality of Substance Usc Disorder 

Treatment." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record 

remains open for ten business days to permit Members to submit additional questions for the 

record, which are attached. To facilitate the printing of the hearing record, please respond to 

these questions with a transmittal letter by the close of business on June 8, 2018. Your responses 

should be mailed to Kristen Shatynski, Professional Staff Member, Committee on Energy and 

Commerce, 2125 Rayburn House Office Building, Washington, DC 20515 and c-mailed in Word 

fom1at to Kristen.shatynski@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

ce: The Honorable Gene Green, Ranking Member, Subcommi1tee on Health 

Attachment 
290 


32361.222

May 30.2018 

Ms. Kristen Shatynski 

Professional Staff Member 

Committee on Energy and Commerce 

2125 Rayburn !-louse Oftlcc Building 

Washington, DC 20515-6115 

Ms. Kristen Shatynski 

~. 

··;~ Santa Clara 

University 

At the request of the Honorable Frank Pallone. Jr. and as a result of the Subcommittee on Health hearing 

on May 8, 2018, I was asked if I was aware of any legal cases involving 42 CFR Part 2 and/or 42 USC 

290c\d-2. Below you will find a partial list of cases involving 42 CFR Patt 2 and 42 USC 290dd-2 and/or 

predecessor citations. This information was acquired from Googlc Scholar using the search term "42 

USC 290-dd"; this information docs not represent all the case involving the indicated statute and/or the 

indicated regulation. By using Google Scholar, the details and the content of the cases can be verit!cd. 

The partial list below involves decision. memoranda, orders or direct reference to 42 USC 290dd-2 and/or 

42 CFR Patt 2 or predecessor citation. The Federal cases are arranged by Circuit. The state cases are 

arranged by State jurisdictions. 

1 hope that this answers Representative Pallone's question. 

Sincerely. 

H. Westley Clark, MD . .10, MPH 

Dean's Executive Professor of Public Health 

Public Health Program, Sanla Clara Universily 

500 El Camino Real, Santa Clara. CA 95053-0269 

408-554-5422 \WIW.scu.edu/cas/phs 
291 


32361.223

FEDERAL CASI'S INVOLVING 42 USC 290dd-2 and/or 42 CFR Part 2 

First Circuit 

18 F.2d 1005 (1987) 

L:rsula C. WHYTE, etc., et al., Plaintiffs, Appellees, 

v. 

CONCiECTICUT MUTUAL LIFE INSL:RANCE 

CO~IPANY, Defendant, Appellant. 

tJrsu!a C. WHYTE. a/kr'a Wendy Whyte, as Trustee 

of the S. \Villiam Whyte Revocable Trust, Plaintiff, 

Appellant 

\". 

CONNECTICUT MUTUAL LIFE INSURA\':CE 

COMPANY, Defendant, AppcHcc. 

Nos. 86~ \295_,_86-1296. 

United States Court of Appeals, first Circuit. 

Argued September 9, 1986. 

Decided May! I, 1987. 

825 F.2d 538 (1987) 

U;--.;JTED STATES of America, Appellee, 

v. 

Robert D. CRESTA, Defendant, Appellant. 

UNlTED STATES of America, Appellee, 

v. 

John J. GILLEN, Jr., Defendant, Appellant 

UT\ITED STATES of America, Appellee, 

v. 

Anthony GRA VALLES E. Defendant, Appellant. 

UNITED STATES of America, Appellee, 

Guido I~lPEMBA, Defendant, Appellant. 

U?\ITED STATES of America, Appellee, 

Gabriel CARVAJAL, Defendant, Appellant. 

t_;NJTED STATES of America, Appellee, 

Ernesto AGUDELO, Defendant, Appellant 

UNITED STATES of America, Appellee, 

v. 

RichardT, FORD, Defendant. Appellant. 

United States Court of Appeals. First Circuit 

Argued September 8. !986. 

Decided July 21. 1987. 

95 F.Supp.2d 49 (2000) 

Ui'\'ITED STATES of America, 

v. 

John Patrick I IUGHES, Defendant 

United States District Court, D. ~v1assachusctts. 

\>1ay 11, 2000. 

(2006) 

l:NITED STATES OF A\1ER!C A, 

v. 

CHRISTOPHER SMITH, Defendant. 

Q:iUJ~O. 5~71.JJ-JA\V. 

United States District Court, D. Miiine. 

January 6, 2006. 

(2007) 

Ul':ITED STATES OF AMERICA, Appellee, 

v. 

CHRISTOPHER SMITH, Defendant, Appellant. 

No. 06-2;1.'!1., 

United States Court of Appeals. First Circuit 

December 21, 2007. 

515 F.Jd 5 (2008) 

UNITED STATES of America, Appellee, 

v. 

MarkS. SIIINDER:VIAN, M.D .. Defendant, 

Appellant. 

""· 07-1 '69. United States Court of .Appeals, First Circuit. 

Heard :\ovember 7, 2007, 

Decided January 29, 2008 
292 


32361.224

(2011) 

Richard McEvoy, Shelagh McEvoy. Co~ 

administrators of the Estate of Kevin McEvoy, 

v. 

Hillsborough County eta!. 

fiv. NQ,__Q9-cv-:LlJ .. :5_M_,_ 

United States District Court, D. New Hampshire. 

May 5, 2011. 

Second Circuit 

899 F.Supp. 933 (1995) 

John DOE and Jane Doe, Plaintiffs, 

v. 

Naomi MARSH eta!.. Defendants. 

Court, 0:.D. New YorL 

70 F.Supp.2d 225 (1999) 

UNITED STATES of America, 

v. 

Thomas G. LONGO, Defendant 

.t:;.Q,_92Dldllil.S" 

L;nited States District Court, W.O. New York. 

August 5, ! 999. 

(2005) 

PORT WASHINGTON TEACHERS' 

ASSOCIATION, AMERICAN FEDERATION OF 

TEACHERS, LOCAL 2938, NYSUT, 

AFL-CIO, MARY ANNE CARIELLO, as President 

of the Po11 Washington Teachers' Association. and 

MICHELLE WElDEN, 

on bcba!fofthcmsc!ves and the female students of 

the Port \Vashington Union Free School, Plaintiffs, 

v. 

BOARD OF EDUCATION OF Tl IE PORT 

WASHINGTON UNION FREE SOIOOL 

DISTRICT: 

LA\:RA MOGUL, NANCY V. C'OWLES. MARK 

:V1ARCELLUS, DEAN NARDONE, DR. ROY 

NELSON, 

ROBERT SEIDEN, and LlA VID STROM, as 

members of the Board of Education of the Port 

Washington Cnion Free School District 

and in their individual capacities: and DR. 

GEOFFREY N. GORDON, 

as Superintendent of the Port Washington Union Free 

School District and in his individual capacity, 

Defendants. 

04-C'IV- Ll57 (TCPJ(\1J\V). 

United States District Court, E. D. !'\ew York. 

March 22, 2005. 

568 F. Supp. 2d 220 (2008) 

Luis SANABRIA, Plaintiff: 

v. 

Officer Steven MARTJ1'\S, Defendant. 

Civil No. 3:06cv647 (JJ!A1 Lnitcd States District Cou11, D. Connecticut. 

March 26, 2008, 

(2014) 

MILTON OMAR COLON ct al., Plaintiffs. 

v. 

METRO-NORTH COMMUTER RAILROAD 

COMPAXY ct aL, Defendants. 

Case No. 3:13CVJ25(.!AMl. 

Lnitcd States District Court. D. Connecticut. 

April J, 2014 . 

(2014). 

KEITI! RICHARDSON, Plaintiff, 

v. 

NEW YORK STATE OFFICE OF MENTAL 

HEALTH, 

CENTRAL NEW YORK PSYCHIATRIC CENTER 

et al., Defendants. 

i'i9c.iUJ ciY .. cL9QHQl,S1A TIJ.1 

United States District Court, N.D. New York. 

August -t 20 l t1. 

Third Circuit 

896 F.Supp. 179 (1994) 

John MUU IOLLAND and Pamela Mulholland 

v. 

DIETZ COMPANY and Entwistle Corporation, 

Civ. A. No. 94~3517. 

United Stutes District Court, E.D. Pennsylvania. 

Decemher 5. ! 994. 
293 


32361.225

933 F.Supp. 485 (1996) 

Clarence CARR, Plaintiff, 

v. 

ALLEGHENY HEALTH, EDUCATION A!\D 

RESEARCH FOU:'\DA TION 

and General Hospital, Defendants. 

95-523. 

United States District Court, WD. Pcnnsy!vani<L 

August 9, 1996. 

(2005) 

GONZALEZ, 

v. 

CITY OF HOBOKEN, ct als. 

Docket "\;o. 04-.:...C'V-3556 (\\'Ji\111 

United States District Court D. New Jersey. 

June 30, 2005 

(2009) 

KATIIRYJ\ MEGOC.CIELL, Plaintiff, 

v. 

INFOTECII SOI.CTIO!\S, 1!\C. t/d/b 1a A VYSION 

IT and/or 

A VYSIO:'i IIEAI.TI !CARE SERVICES, PA\IELA 

HC\;TER 

1\ND LEONARD TOKAR, Defendants 

Civil Action \:o. I :07-cv-O::'JJ9. 

t;nitcd States District Court, M.D. Pennsylvania. 

i'\ovembcr 18, 2009. 

(2010) 

.IIRI PIK. 

v. 

TilE U:'\IVERSITY OF PE:'iNSYLVAMA. ct a!. 

Civil Action ~o. 0~<::; !64. 

United States District Court, LD. Pennsylvania. 

October 7. 20 I 0. 

791 f.Supp.2d 383 (2011) 

David BE! IAR, \1.D.. Plaintiff 

v. 

PENNSYLVANIA DFPARTMENT OF 

TRA!\SPORTATION 

and Allen Bichler. Defendants. 

.[i-..:.i.t./u~tiQD 1\o. I :09~CV~~4~3., 

United States District 

March 31,2011 

Fourth Circuit 

955 F.2d 914 (1992) 

LJNITED STATES of America, Plaintiff-Appellee. 

v. 

SOUTHERN MANAGEMENT CORPORATION, 

Dcf end ant ~Appel I ant. 

\io. 90~2496. 

li~~;;-dSt;t~ Court of Appeals, Fourth Circuit. 

Argued July 31, 1991. 

Decided February 3, 1992. 

(2012) 

45. l.il\ITED STATES Of A\'!ERICA, 

v. 

GRACIE AELLOSI·MITCHELL 

Case No. R \VT I Ocr600. 

t.Jnitcd States District Court, D. Maryland. 

September 6, 2012. 

(2014) 

.IOH:'i VANNOY. Plaintiff, 

v. 

Tl IE FEDERAL RESERVE BANK OF 

RICHMOND, Defendant. 

~ctiOJl_tl\l: 3_:_L}~(V::72} 

United States District Court, E. D. Virginia, 

Richmond Division. 

June 10,2014. 

(2014) 

MICHAEL ALAN CROOKER, Petitioner 

v. 

Tl\10TIIY STE\VART, Respondent. 

Civil Action No. ELH-14-1539. 

United States District Court, D. Mal)·land. 

December 16, 2014. 

(2017). 

THOMAS SI:'\SEL, Plaintiff, 

v. 

JilT A CHI KOKI USA, I.TD., Defendant. 

fase :-..io. 7:16-c~dl04LJ.:I1. 

United States District Court, E. D. 'North Carolina. 

Southern Division. 

~vtay 31,2017 
294 


32361.226

(2017) 

MICHAEL J. MORGA~, Plaintiff, 

RICKY J. SPIVEY, in his individual and official 

capacities as a Wake County Sheriffs Deputy, 

CASEY L. MILLER. in his individual and official 

capacities as a Wake County Sherifl~s Deputy, 

JOSIIUA K. LEGA!':, in his individual and official 

capacities as a \Vake County Sheri ITs Deputy, 

DON"I\lE HARRISON, in his official capacity as 

Sheriff of Wake C'ounty. ~orth Carolina, 

THE OHIO CASUALTY INSURANCE 

COMPA?'\Y, individually, and as a subsequent 

subsidiary of 

LlOERTY MUTUAL 11\St:RANCE COviPANY. as 

SURETY. Defendants. 

No. 5:16-CV<l~S-{::1_. 

United States District Court, E. D. North Carolina, 

Western Division. 

December 8, 20\7. 

Fifth Circuit 

408 F.Supp.2d 295 (2006) 

UNITED STATES of America 

v. 

Diana ZA:V10RA. 

No. CR C-05-7-16~1. 

United States District Com1, S.D. Texas, Corpus 

Christi Division. 

January 10,2006. 

Sixth Circuit 

63 F.3d 467 ( 1995) 

Rick R. ELLISON. Plaintiff-Appellant, 

COCKE COUNTY. TEJ\il\ESSEE and David 

Kickliter, M.D., Defendants-Appellees. 

t;q,~ 94_-j_j_ZL_ 

United States Court of Appeals, Sixth Circuit. 

Submitted Apri\10, 1995. 

Decided August 24. 1995. 

88 F.Supp.2d 753 (2000) 

Gary \\'aync FANNON, Plaintiff, 

v. 

Kurt .IOHl\iSTON, Defendant. 

:{o"_(iv,211:_01

.:.720Q6:Pl Lnited States District Court. ED. :Ylichigan, 

Southern Division. 

March 24, 2000. 

(2011) 

SAMUEL JCITERSON, Plaintiff, 

v. 

FERRER, PO I ROT, AND \V Al\SBRot;C;H, ct al., 

Defendants. 

~~:l;!D:QI8, 

ljnited States District Court. M.D. Tennessee, 

!\ashville Division. 

July 25, 20 II. 

(2014) 

SAMUEL JEFFERSON, Plaintiff. 

v. 

FERRER, PO I ROT & WA:\SBROUGII, et al.. 

Defendants 

.[:ase "!'\o. 3_;JJl:..0754, 

United States District Court, M.D. Tennessee, 

~ashville Division. 

:vlarch 13.2014. 

(2015) 

CARL WATSON RICCHlJITE, Plaintiff, 

v. 

JOEY JOHNSON, et al., Defendants. 

~~.:.i!.A£ti0n i'-.;57_,_1: 14-CV-104-G~'?--.!::113B. 

l:nited States District Com1, WJJ. Kentucky. 

BO\vling Green Division. 

September 25. 20 15 

(2016). 

GARDEN CITY EviPLOYEES' RETIREMENT 

SYSTE~1, Plaintiff, 

CENTRAL STATES, SOUTHEAST SOUTHWEST 

AREAS PENSION FUND, 

Individually and on Behalf of All Others Similarly 

Situated, Lead Plaintiffs, 

OEVERLY KERN, on llchalf of Herself and Her 

Siblings, 
295 


32361.227

and as Administrator of the Estate of Donna Kern, 

Intervenors, 

V. 

PSYCHIATRIC SOL\JTIOJ\S. INC., et al., 

Defendants. 

No .. 1:09·Cy·008R2. 

United States District CoUJi, M.D. Tennessee, 

~ashville Division. 

September 20,2016. 

670 F.2d 702 ( 1982) 

Seventh Circuit 

Ll\ITED STATES of America, Plaintiff-Appellee, 

v. 

Alex J. RAI?'JERI, Defendant·Appe!lant. 

"'\Jo. 8J.J39,t 

United States Court of Appeals, Seventh Circuit. 

Argued September 15, 1981. 

Decided February 8, 1982. 

Rehearing and Rehearing Denied March 24, 1982 

854 F.Supp. 1380 (1994) 

In rc The AUGUST, 1993 REGULAR GRAND 

JCRY. (Hospital Subpoena). 

~'! [s~~Q,_~]-·63 .... ~]G!n.d)!l!Y)~1!b.P.<l~.t1~Q.~.KYI.$:41: 

Q:L 

United States Distrkt Court, S.D. Indiana, 

Indianapolis Division. 

\t·Jay 20, 1994. 

168 F.3d !036 (1999) 

Carlos 01APA, Plaintiff-Appellant, 

v. 

Jura ADAMS, et aL Defendants-Appellees. 

Court of Appeals, Seventh Circuit. 

Argued January 22, ! 999. 

Decided February 23, 1999. 

277 F.Jd 969 (2002) 

lJNITED STATES of America ex rei. Janet 

CllAl\DLER, Ph.D .. 

Plaintiff Appellant_ Cross-Appellee, 

v. 

COOK COUNTY. !LI.INOIS,W Dctendant-Appellee. 

Cross-Appellant. 

No.UJQ:±ll.Q,.Q.L:JJI_LO, 

United States Court of Appeals, Seventh Circuit. 

Argu~d September 5, 2001. 

Decided January 22, 2002. 

(2005) 

LISA M. llEARD, Plaintiff, 

vs. 

CITY OF CHICAGO, Defendant. 

0'9·_.Q1_U2:r!.-' 

lJnited States District Court, 0:.D. Illinois, Eastern 

Dh·ision. 

January 7, 2005. 

(2006) 

LORA L. STANLEY, et al., Plaintiffs, 

v. 

CARRIER MlLLS-STOl\EFORT SCHOOL 

DISTRICT NO.2, 

and RICHARD MORGAN, Defendants. 

Civil No. 05-4201-JPG. 

United States District Court, S.D. 1!\inois. 

December 1-l, 2006. 

(20 13) 

:VliRANDA COSGROVE and Cl IRiSTI:\A 

COSGROVE, Plaintiffs, 

v. 

RODNEY D. McCLURE, individually and as an 

agent and/or employee ofPIO~EER COACH, INC.; 

PIO~EER COACH, INC., a foreign corporation; 

PHILLIP L. CARTER, 

individually as an agent and/or employee of JEFfC'O 

LEASING CO., INC.: 

and JEFFCO LEASING CO., INC., a foreign 

Corporation. Defendants. 

Case ~o. 3: 13-cv-00580·DJ'H-DGW. 

United States District Court, S.D. lllinois. 

October 28, 2013. 
296 


32361.228

Eighth Circuit 

(2006) 

R. KOTESWARA RAO KCNDA and CHICAGO 

INSt:RANCE CO., Plaintiffs, 

ST. ANTHONY MEDICAL CENTER SELFINDENTCRED TRUST, et aL, Defendants. 

_c;_"'---L_Qii:_CV-01 87 CEJ. 

Lnitcd States District Court, E.D. Missouri, Eastern 

Division. 

August 22, 2006. 

(2017) 

VIADISON GIROCX by her Attorney-in-fact, 

JEt\NIFER GIROt:X, Plaintifl; 

TOMMI YOU>-;G BULL BEAR, E~H Director, 

City/County Alcohol and Drug Program, in her 

individual capacity; 

BRE"!\DA WOOD, Director City/County Alcohol 

and Drug Program, in her individual capacity; 

PENNINGTON COt:NTY Sl IE RIFF'S DEPVT'Y 

PALL STEVE:\'S, in his individual capacity; 

and PENNINGTON COUNTY STATE'S 

ATTORNEY SARAII E. MORR!SO:'>, in her 

individual c<~pacity, Defendants. 

,0!o. CIV_,.J.Q-5003-JLV. 

United States Di~trict Court, D. South Dakota, 

\\'estern Division. 

~-larch 22, 2017 

(2017) 

IN RE EMPLOYME>-;T RECORDS OF JOHN 

DOES EMPLOYED BY SHARPE HOLDI!'G, INC., 

No. 4:17\-JC238 RLW. 

United States District Court. E.D. :Vlissouri, Eastern 

Division. 

December 20,2017. 

Ninth Circuit 

879 I'.Supp. I 054 (1995) 

C:,HTED STATES of America, Plaintiff, 

v. 

Gary Lee S?\'0\\'DEN, Defendant. 

::,;p. CR 94:18:!'!'" Cnited States District Coutt, D. Oregon. 

Fobruary I 0, 1995. 

146 F.3d 680 (1998) 

Donald I IALVORSEN, Jr., Plaintiff-Appellant, 

v. 

La\vrence BAIRD; Jeffrey Kaer; City of Portland; 

Central City Concern; 

Dick Endo; Aaron Beedle; Jeff Mitchell; Joe Brown, 

De fcndants~Appel Ices. 

Donald I fALVORSE:\', k, Plaintiff-Appe!lcc, 

V, 

Lawrence BAIRD; Jeffrey Kaer; City of Portland; 

Aaron I3eedle; Dick Endo. Defendants, 

and 

Central City Concern; JcffMitchc!l; Joe Brown, 

Dcf end ants-a ppc ll ants. 

'Jos. 95-35677 95-.15705. 

United States Court of Appeals. Ninth Circuit. 

Aruued and Submitted ;-...:ovcmbcr 5, 1996. 

Dc~ided June 11, 1998. 

(2010) 

LISA LO\\'EN, as next friend and natural parent of 

minor B.L., Plnintil( 

VIA CHRISTl HOSPITALS WICHITA, INC. dlbla 

St francis Campus, 

and K!VHlERLY :VIOUK, M.D., and HENRY B. 

DOERI:\'G, \1.0., Defendants. 

Cn,".~o. !ll:J2_0_HUJK Cnitcd States District Court. D. Kansas. 

November 16. 20 I 0. 
297 


32361.229

(2013) 

MARIA D. Cl !A VEZ and REI"E C!li\ VEZ, 

individually and as the Successors-in-Interest of 

CHRIST! A~ C!li\ VEZ, Deceased, Plaintiff, 

v. 

COUC:TY OF KERN, TOMMY J. ROBBINS, 

JEREMY STORAR, AND DOES I TO I 00, 

Defendants. 

c~s' No,_U 2,c~Q.O±_LJO-J'-L 

Cnited Statt":s District Court, E.D. California. 

July 9, 2013. 

(2013) 

.DE!30RAH CAHILL, Plaintiff, 

FRANC:ISC AN HEALTH SYSTE:Vl, Defendant. 

O!s__eJ'd,o .. _CL~?-~1.2J3Ji)~ 

Cnitcd States District Court, W.D. Washington, 

racoma. 

December 16,2013. 

(20!4) 

KETE\1A ROSS, eta!., Plaintiffs,v. 

JAY li\SLEE. in his official capacity as Governor of 

Washington, eta!.. Defendants. 

)S_Q,.L 14c.C'.Y:I.LLJQ:IQft, 

United States District Court, E. D. Washington. 

August 4. 2014. 

(2016) 

ROBERT DeWAY:\E BOSLEY, JR., Plaintiff, 

v. 

M. VALASC'O, et al., Defendants. 

~~ase No. I: l..t-cv-OOO...J.9-iv1JS! PC). 

United States District Court, [ .0. California. 

January 8, 2016. 

(20!6) 

ROBERT DEWAY~E BOSLEY, JR. Plaintiff, 

v. 

M. VA LASCO. et al., Defendants. 

'"~'-"~'\!Q._LH:<CY:DP.o±2.,M.J s_cerl. United States District Court, E.D. California. 

:vi arch 25,2016 

(20!6) 

Lawrence~- Cherry, et aL, Plaintiffs. 

V. 

United States of America, Defendant. 

;;o. C:V-15-00236-PIIX-PGR. 

United States District Court, D. Arizona. 

August31,1.016. 

(20!6) 

CHARLES DES ROCHES, on his own behalf and on 

behalf of his beneficiary son, 

R.D., and all others similarly situated, and SYLVIA 

iv1EYER. on her own behalf<md all others similarly 

situated, Plaintiff, 

v. 

C AL!FORN!A PIIYSICIANS' SERVICE d/b/a 

BLUE SHIELD OF CALIFORNIA; 

HUMAN AFFAIRS 1:\TER~ATIO~AI. OF 

CAL!FOR~IA; and 

\-!AGELLAN IlEAL Til SERVICES OF 

CALIFOR'-:IA. INC.-EMPLOYER SERVICES, 

Defendant. 

Case No. 16-cv-02848-LHK. 

United States District Com1, N.D. California, San 

Jose Division. 

September 7. 2016. 

(20!6) 

ANTOINE DOUGLASS JOHNSON, Petitioner, 

V, 

FELICIA POI\'CE, Respondent. 

:\o. 2:!6-cv-!037 JAM AC P. 

United States District Court, E.D. California. 

December 16.2016. 

(2018) 

ESTATE OF SA~DRA VELA, deceased, by and 

through A0i~A\1ARIE MORE~O; 

ANI\AMARIE :V10RENO; and BER:\ADETTE 

ALVERADO, Plaintiff, 

COUNTY OF :VtONTEREY; SHERIFF STEVE 

BERi\AL, in his individual and official capacities; 

CO~vi!\.1ANDER JAMES BASS, in his individual 

and official capacities: SERGEANT ERlKA KAYE, 

in her individual capacity: 

SERGEA:\T CAROL WHITE, in her individual 

capacity: DEPUTY lJARBARA FULKERSON, in 

her individual capacity; 
298 


32361.230

DEPUTY K QCJ:\TERO, in her individual capacity; 

FORMER SHI'RIFF SCOTT 'diLLER, in his 

individual capacity; 

CALIFORNIA FORENSIC :VIED I CAL GROUP, 

TAYLOR FITHIAN, :VlD; ELUID GARCIA. MD, 

Defendants. 

Case No. 16-CV-02375 I3LF. 

United States District Court, N.D. California, San 

Jose Division. 

January 18, 2018. 

Tenth Circuit 

r.Jd 1414 (1998) 

l:NITED STATES of America, Plaintiff-Appellee, 

v. 

Frank Anthony OBERLE, Dcfendanh"'.ppellant. 

Court of Appeals, Tenth Circuit. 

.120 f.3d 1107 (2003) 

CENTER FOR LEGAL ADVOCACY, doing 

business as Legal Center for People with Disab!lities 

and Older People, also known as Legal Center, 

Colorado's Protection and Advocacy System, 

P & A System, Plaintiff-Appellant, 

v. 

Michael EARNEST, 7\tD., in his official capacity as 

\ledical Director of Quality Rcvie\v and 

Improvement; 

Patricia GnbO\v, M.D., in her official cape~city as 

.\1cdical Director and ChicfExccutive Officer; 

Denver Health and Hospital Authority, also knO\Yn as 

Dll!V\, doing business as Denver J lea!th T\:[edical 

Center, 

also known as DHMC. Defendants-Appellees. 

Court of Appeals. Tenth Circuit. 

February 25, 2003. 

'(2006) 

\-liKE BOHANNO?-i, Plaintiff, 

v. 

J.M. BAKER, D.O. Defendant 

Cast~ No. 06-1033-MLB. 

United States District Court D. Kansas, 

October 12, 2006. 

(2006) 

CAROL J. HULSE, 

SUBURBAN MOBILE HOME SUPPLY 

COMPA~Y. et al., Defendants. 

<;;~'-'-]'io. 06-1168-WED" 

United States District Com1, D. Kansas. 

October 12,2006. 

(2007) 

JERE:VlY BUSTA:VIANTE, Plaintiff, 

CENTRAL KANSAS MEDICAL CENTER, a 

Kansas Corporation, DefendanL 

Cl\l~J'.:<L.O.!/.:_L'LlQ:: WEB" 

United States District Com1, D. Kansas. 

~day 1, 2007. 

(2007) 

JEREMY BUSTAMA?-iTE, Plaintiff, 

v. 

CENTRAL KANSAS MEDICAL CENTER., a 

Kansas Corporation, Defendant 

Case No. 06-1336-\VEB, 

United States District Court, D. Kansas, 

\-lay II, 2007. 

(2007) 

LORI PRESCOTT, Plaintiff, 

v. 

TREGO COCNTY, KANSAS, BOARD OF 

COCNTY C0\1MISSIO:\ERS. 

RICHARD SCIINEIDER, and DENNIS WEAVER, 

Defendants. 

Case No. 07-CV-1008-JH1-D\VB. 

Unit~d States District Court, D. Kansas. 

May 16,2007. 
299 


32361.231

(2008) 

REBECCA SORTER, Plaintiff, 

V. 

RICARDO ALVARADO, Defendant. 

Case No. 07-1401-~llc.ll.cDWB~ 

U~i"kd:~t~~t~;[)"i~'tric! Comt, D. Kansas, Wichita. 

March 3, 2008 

(2008) 

AT WICHITA, KANSAS ROBERT \IILLFR. 

Plaintiff, 

v. 

F.F.V .. minor. and LARRY V. VASQUEZ, father, 

legal guardian, 

and next best friend, Defendants. 

Case No, 0~ 114-J'D1:1!.Y>Jl~ 

tJ;;ited Sllitcs District Court, D. Kansas. 

June l 0, 2008. 

(20 10) 

JENNIFER PRATT, Plaintiff, 

v. 

JOSEPH PETELI<". M.D. and DANIEL PALEY, 

M.D., Defendants. 

Case '\:o. 09~2252-('M~GLK 

u;lltcd States Dist;i~t Co~rt~ D. Kansas. 

h.:bruary 4, 2010. 

(2010). 

G!'ORGE SPRAGGINS, Plaintiff, 

v. 

SU\1/-;ER REGIONAL MEDICAL CENTER 

and DR. LARRY A:-.illERSON, Defendants. 

Case No. 10-2276-1\'ElliKGG. 

L'nitcd States District Court, D. Kansas. 

:\ovcmbcr 3, 20! 0. 

(2010) 

UNITED STATES Of A\1ERICA, ex rei. A'iA 

SANCHEZ-SMITH, 

A\1BER HAVERFIELD-CIIAT\VELL, and DANA 

WHITE. Plaintiffs, 

v. 

AHS TlJLSA REGIONAL MEDICAL CENTER, 

LLC, 

d!bia TULSA REGIO:\AL MEDICAL CE~TER, 

Defendant. 

10 

<"o. 0.1-CV-442-TC'K:U(:~ 

C~~;;d-S't~~-i)~t-ri.~t Court, >J.D. Oklahoma. 

~ovcmber 5, 2010. 

(20 10) 

754 F.Supp.2d 1270 (2010) 

UNITED STATES of America, ex rel. Ana 

SANCHEZ-S~IITH, 

Amber Haverficld.Chat\ve!l, and Dana White, 

Plaintiffs, 

v. 

Al!S TCLSA REGIONAL MEDICAL CENTER, 

LLC, 

d'b/a Tulsa Regional \icdical Ccnler, Defendant 

Case No. 05-C\'-442-TCK-PJC. 

United States District Court, '\!.D. Oklahoma. 

<"ovcmbcr I 0, 20 I 0. 

(2013) 

NICOLETTE UTTER. Administrator of the Estate of 

CHRISTOPHER CTTF.R, Plaintiff, 

v. 

DALLAS THOMPSON, ct al., Defendants. 

Case No. I !<:~360-KHV. 

United States District Court, D. Kansas. 

June 7. 2013 

(2014) 

SI!A WN GIEGERICH, Plaintiff, 

v. 

NATIONAL BEEF PACKING COMPA<"Y, LLC, 

Defendant 

Casl' ~o. 13-~392-JAR. 

United States District Court, D. Kansas. 

January 9, 2014. 

(2015). 

A<"THONY LOLl<" JIMENEZ, SR., Applicant, 

v. 

COLORADO DEPART.\.1ENT Of CORRECTIONS, 

RICK RAEMISCH (Exec. Dir.), 

CROWLEY COUNTY CORRECTIONAL 

fACILITY, MICHAEL ~11LLER (\Varden), 

and THE ATTOR>-:EY GENERAL OF Tl lE STATE 

OF COLORADO, Respondents. 

Civil Action ~o. 15~cv~O l OOG~GPG. 

United States District C\1urt, D. Colorado. 

July 8, 2015. 
300 


32361.232

(2015). 

CHARLES EVANS, Plaintiff, 

v. 

WILLIAM D. MAUCH, M.D., Defendnnt. 

Case No.2: 15-CV-091 00-CM. 

United States District Court, D. Kansas. 

August 26,2015. 

(2016) 

FRA:\KIE T. LYDEN, individually, and FRA:\KIE 

T. LYDE:\, 

as Special Administrator of the Estate of :vfichael 

Lyden, 

deceased, on behalf of the Heirs of\1ICHAEL 

LYDEN, deceased, Plaintiffs, 

v. 

HOGAN DEDICATED SERVICES, LLC, A 

Missouri corporation; 

I lOGAN TRA:-.ISPORTS, 1:\C., a Missouri 

Corporation; 

I lOG A:\ TRUCK LEASI:\G, INC., dba HOGA'i 

MOTOR LEASING, INC .. 

A ~·tissouri corporation 

and ~11CHAEL DANIELY, a Yiissouri resident, 

Defendants. 

~1"-~-~,_ 15_-_(V_-9_~~2_-CM.c. 

United States District Court, D. Kansas at Kansas 

City, Kansas. 

April4, 2016. 

(2017) 

MARK RATLEY, Plaintiff, 

U:\ITED STATES OF A 'VIE RICA, Defendant. 

Ca~s;_l\Q_o 11::t0;2±-f)J>f2, 

Lniled States District Comt, D. Kansas. 

July 20, 10 I 7. 

Eleventh Circuit 

951 F.2d 320 ( 1992) 

llill W. DOE, Plaintiff-Appellant. 

v. 

Anthony M. FRA"7\K, Postmaster General 

of the Cnited States of America, Defcnd<:~nt-Appellce. 

l'ill~MJ~ 

United States Court of Appeals, Eleventh Circuit 

January 24, 1992. 

11 

196 F.3d 1226 (1999) 

Raymond D. I liCKS, M.D., Plaintiff-Appellee, 

v. 

TALBOTT RECOVERY SYSTEM, 10:C. a.k.a. 

Talbott ~1arsb Recovery System or Talbott Marsh 

Recovery Center, 

Anchor Hospital, Barry H. Lubin, \·1.D .. G. Douglas 

Talbott. \1.0., Defendants-Appellants. 

:-;o. 98 . .:!\.~lL 

United States Court of Appeals, Eleventh Circult. 

November 22, 1999 

170 F.Supp.2d 1211 (200 l) 

Gary P. MOSIER. Plaintiff~ 

v. 

AMERICA'\ H0~1E PAT!E:\T, 1:\C., Defendant. 

No~~4;01CVII-\VS. 

Cnitcd States District Court, N.D. Florida. 

Tallahassee Division. 

>-.:ovember 1, 200! 

(2013) 

47. IN THE MATTER OF: WILLIAM ARTHUR 

ASHCRAFT. D.M.D. 

(.iyi_Lb£HmL~9_,_:?;J_3_:..~Y:-_QQJj~3: JY~·1A_, 

United States District Court, KD. Alabama, Southern 

Division. 

June 3. 2013. 

(2016) 

U'JITED STATES OF AMERICA, Plaintiff, 

XIULU RUA!\, M.D., Defendant. 

~ITmlunU~o.Jj_:QQ.(tl:8~CG~B, 

Cnited States District Court, S.D. Alabama. Southern 

Division. 

April 4, 2016. 
301 


32361.233

DC Circuit 

598 F.Supp. 126 (1984) 

George L. \VHITLOCK, P!aintift~ 

v. 

Raymond J. DO~OVAN and United States 

Department of Labor, Defendants. 

Civ. A. No. 83-3388. 

United States District Court. District of Columbia. 

~ovcmber 6, 1984. 

63 F.2d 103 (1988) 

Frederick D. JUDD, Appe!lunt 

v. 

James IL I31LLINGT00l, Librarian of Congress. 

No. 87-5380. 

United&;~ Court of Appeals, Distdct of Columbia 

Circuit 

Argued :'\ovember 15, 1988. 

Decided December 20, 1988. 

STATE CASES 

Involving 42 USC 290dd-2 and/or 

42 CFR Part 2 

ALABAMA 

773 So.2d 431 (2000) 

Ex parte Dr. Vv'aher L. ETHERTON. 

(Rc Tammy Reynolds Freeman v. Dr. Walter L. 

Et!w!1on). 

!981962. 

Supreme Court of Alabama. 

~viarch 17, 2000. 

Rehearing Denied June 9, 2000. 

156 So.3d 973 (2014) 

W.A.A. 

v. 

BOARD OF DEJ\:TAL EXAMINERS OF 

ALABAMA. 

Couti of Civil Appeals of Alabama. 

12 

ALASKA 

89 P.Jd 800 (2004) 

Diana BRYSON, Petitioner/Cross-Respondent, 

v. 

BANNER HEALTH SYSTEM dfbla Fairbanks 

Memoria! Hospital 

d/bla Family Recovery Center and Guy Patterson, 

Respondents/Cross-Petitioners. 

Nos. S-10653, S-10673. 

Surreme Court of Alaska. 

April 23, 2004. 

338 P.Jd 953 (2014) 

John W. PLETCHER IV, Appellant. 

v. 

STATE of Alaska, Appellee. 

No. A-11492. 

Cou11 of Appeals of Alaska. 

:-.iovcmber 21, 2014. 

157 Ariz. 41 (!987) 

754 P.2d 1145 

ARIZONA 

Harry A. DANIELSON, M.D., and Jane Doe 

Danielson, 

whose true name is Beverly Ann Danielson, husband 

and wife, Petitioners, 

SUPERIOR COURT OF lhe STATE OF ARIZONA, 

In and For the COlJNTY OF MARICOPA, 

Honorub!c John Foreman, a judge thereof~ 

Respondent Judge, Joyce LOPEZ and Richard Lopez, 

husband and wife, Real Parties in Interest "o. I CA-SA 200. 

Court of Appeals of Arizona, Division !. Department 

A. 

December 8. 1987. 

As Amended on Denial of Reconsideration \1arch 

14. 1988. 

Review Denied June 7, 1988, 
302 


32361.234

(20 12) 

STATE OF ARIZONA, Appellee, 

VICTOR PEREZ CANO, Appellant. 

Ciq~l-~'cH:!\Jl:Qi7l 

Court of Arpcals of Arizona, Division One, 

Department B (ALGUST). 

Filed September 20, 2012. 

290 P.3d 228 (2012) 

231 Ari1 .. 34 

STATE of Ari70na, Appellee. 

v. 

Teny Wayne TATLOW, Appellant. 

1'i_<U~,H'RI.L:0.52J" 

Court of Apreals of Arizona, Division 1, Department 

C. 

December 4, 2012 

OF ARIZO'!A, Appellee. 

v. 

OA VIO ALAN HOUSE, Appellant. 

biLl_Cll'R l2.:_Q}~ 

Court of Appeals of Arizona. Division One, 

Department C. 

filed January 17, 2013. 

ARKANSAS 

No Cases in Google Scholar Discovered 

CALIFORNIA CASE 

(2010) 

rvl!C'flAEL MARQUEZ. Petitioner, 

THE SUPERIOR COURT OF LOS A"iGELES 

COCNTY, Respondent; 

ESTATE OF PABLO GARCIA, ct al., Real Pa<iies 

in Interest. 

;-.;o. B2~_! 965. 

Court of Appeals of CalifOrnia, Second District, 

Division Seven. 

Filed May 18, 2010. 

13 

COLORADO 

668 P.2d 3 (198.1) 

Stephan D. CLARK, Petitioner. 

v. 

DISTRICT COlJRT, SECOND JUDICIAL 

DISTRICT. CITY 

AND COU"iTY Or DENVER; 

Daniel !3. Sparr. one of the judges the reo!; 

Estates of Sallas. Respondents. 

of Colorado, En Bane. 

1983 

944 P.2d 660 (1997) 

The PEOPLE of the State of Colorado Through the 

DENVER 

DEPARTMENT OF SOCIAL SERVICES. In the 

Interest of R.D.I-1. 

and P.H., Children, l)pon the Petition of the Denver 

County 

Department of Social Services. Petitioneh\ppcl!ee, 

and Concerning K.L.H., Respondent·;\ppellant. 

No. 96CAO I 06. 

Colorado Court of Appeals. Dlv.l!. 

~lay 29, 1997. 

Rehearing Denied June 26, 1997. 

Certiorari Denied October 20. 1997 

217 P.3d 84I (2008) 

The PEOPLE of the State of Colorado, PlaintiffAppellee. 

Anthony Lolin JIMENEZ, Defendant-Appellant 

~i,;UHC,~ 

Colorado Court of Appeals. Div. Vl. 

October 16,2008. 

Rehearing Denied December 31,2008. 

[SEE FEDERAL CASE ABOVE] 

3161'.3d4(2013) 

20 !3 CO,\ 44 

ADOLESCENT A"iD FAMILY 1'\iSTITUTE OF 

COLORADO, INC'., 

a Colorado eorporation, Plaintiff-Appellant and 

Cross-Appe!lee. 
303 


32361.235

COLORADO DEPARTME:"T OF HLJ\IAN 

SERVICES, DIVISION OF BEHAVIORAL 

IIEALTH, 

f1kia Alcohol and Drug Abuse Division, Defendant~ 

Aprellcc and Cross~ APpellant. 

£:Qill!_QfAJW~-al~~shJ.lCA~-~-86__c 

Colorado Court of/\ppea!s, Div.l!. 

Announced March 28,2013. 

CONNECTICUT 

203 Conn. 641 (1987) 

STATE OF CONNECTICCT 

V, 

JEFFREY ROLLINSON 

Supreme Cou11 of Connecticut. 

ArguoJ AprilS. 1987. 

Decision released June 2. 1987. 

223 Conn. 450 ( 1992) 

COi':>'iECTICCT STATE MEDICAL SOCIETY ET 

AL. 

v. 

COM\·IISSION ON HOSPITALS AND HEALTH 

CARE 

( 14456) 

Supreme Comt of Connecticut. 

Argued June I 0, 1992. 

Decision released August I L 1992, 

48 Conn. App. 563 (1998) 

l>'i RE :>!ARV!:>i :>1. Er AlJ.l'l 

Appellate C'oUJ1 of Connecticut. 

Argued November 7, 1997. 

Officially released May 5, 1998. 

54 Conn. App. 663 (1999) 

MICI-IAEL SKAKEL 

JONATHAN BENEDICT 

lAC 19160) 

Appellate Court of Connecticut. 

Argued 0.1ay 27, 1999. 

Oftlcial!y released August 5. 1999eJ 

14 

55 Conn. App. 336 ( 1999) 

I!' RE JA~1ES LL' 

(AC 17869) (AC 18155) 

Appellate Court of Connecticut. 

.Argued June 2, 1999. 

Officially released October 19, 1999. 

[Footnote 14] 

263 Conn. 390 (2003) 

STATE OF CON:\ECTICUT 

V, 

RANDY KIRSCH 

l'K_l§llli 

Supreme Court of Connecticut 

Argued February 20, 2003. 

Officially released May 6, 2003 

DELAWARE 

683 A.2d 1055 (1996) 

STATE of Delaware 

v. 

Rodney A. BRIGHT, Defendant. 

I.D. No. 941201239!. 

Superior Court of Delaware, New Castle County. 

Submitted: June 4, 1996. 

Decided: June 27. 1996. 

979 A.2d 1138 (2009) 

DIVISIO:>i OF FAMILY SERVICES, Petitioner. 

v. 

Ramona REDi'v1AN,ill John Littleton. Respondents. 

No. (1i07-0277Q, 

Family Court of Delaware. Sussex County. 

Submitted: February 6, 2009. 

Decided: April 15, 2009. 

980 A.2d I 045 (2009) 

DIVISION OF L\MILY SERVICES, Petitioner, 

v. 

A.I3., A.\V., Thresholds, Inc., Respondents. 

No. CS08-0243R. 

Family Court of Delaware, Sussex County. 

Submitted: December 8, 2008. 

DeciJed: June 25, 2009. 
304 


32361.236

FLORIDA 

599 So.2d 749 (1992) 

SERVICE MERCHANDISE CO\!PANY OF 

FLORIDA, INC., Appellant, 

v. 

John LARSEN, Appellee. 

Couti of Arpeal of florida. Fourth District. 

June J, 1992. 

842 So.2d 177 (2003) 

STATE of florida. Petitioner. 

v. 

CENTER FOR DRl'G-FREE LIVING, INC., 

Respondent 

No. 5[)02~3356. 

District Court of Appeal of Florida. Fifth District 

Mareh 7. 2003. 

Rehearing Denied April 17,2003 

897 So.2d 501 (2005) 

William N. NELSON, Appellant. 

v. 

LAl30R Fl0;DERS, Gallagher l3assett Services, Inc,. 

and Florida Department of Insurance, Division of 

Workers Compensation, Appellees. 

No. I DO.l-5 I 04. 

District Court of Appeal of florida, First District. 

February 28. 2005. 

974 So.2d 1164 (2008) 

STATE of Florida, Appellant, 

v. 

\.1cghan D. RCDY, Appellee. 

0.'o. ·!Q9.6_-::19£L District Court of Appeal of Florida, Fourth District. 

February :w. 2008. 

GEORGIA 

194 Ga. App. 805 (1990) 

392 S.E.2d 286 

AETNA CASCALTY & SURETY COMPANY 

v. 

RIDGEVIEW I~STJTl!TE, 1!\C. et al. 

A89AI .. U§, 

Court of Appeals of Georgia. 

Decided i\-'larch 12, 1990. 

15 

5 I I S.E.2d 25j (I 999) 

236 Ga. App. 132 

In the Interest of LJ 1., a child. 

of Georgia. 

521 S.E.2d 199 (1999) 

239 Ga. Apr. 203 

SLETTO et al. 

V, 

HOSPITAL AUTHORITY OF IIOUSTO~ 

couc;TY et al. 

717 S.E.2d 190 (2011) 

289 Ga. 881 

IJOWLJ~G 

v. 

The STATE. 

"!2,211:\JJ.I .. L'l 

Supreme Court of Georgia. 

October 17,2011. 

IIAWAII 

No Cases in Google Scholar Discovered 

IDAHO 

No Cases in Goog!e Scholar Discovered 

764N.E.2d I (2001) 

I 98 IIL2d 249 

261 III.Dec. 710 

M.A.K .. Appellee, 

ILLINOIS 

Rt.:SI·I·I'RESBYTERIAN-ST.-LUKE'S MEDICAL 

CENTER, 

d:b/a Rush Behavioral Health Center· ·Du Page, 

Appellant. 
305 


32361.237

:t{Q_, 905:U.,_ 

Supreme Court of Illinois. 

December 20. 200 I. 

851 N.E.2d 1243 (2006) 

221 111.2d 453 

James 1\'ISNIEWSKI, Appellee, 

v. 

Reverend Raymond KOW:\ACKl ct al.. Appellants. 

\o.LJ..QJ Q L[, ]OJQ I,t 

Supreme ('ourt of Illinois. 

June 2, 2006. 

INDIANA 

579N.E.2d 1342(1991) 

TERRE IIAC'l'E REGIONAL HOSPITAL, Inc. 

and Hospital Corporation of America, Appellants~ 

Defendants, 

v. 

Linda S. TRCEBLOOD, Appellee-Plaintiff. 

l'o. 61A0·1-9107-C:V-223.]1] 

Court of Appeals ofindiana. First District 

October22, 1991. 

Rehearing Denied January IJ, 1992. 

669 N.E.2d 192 ( 1996) 

"Jane DOE". Appellant· Respondent, 

v. 

DAVIESS C:Ol3NTY DIVISION OF C:HILDREi' 

AND FAMILY SERVICES, Appellee-Petitioner. 

No.IMOI-9511-JV-361. 

Com1 of Appeals of Indiana. 

July 29, i Q96. 

Transfer Denied October 29, 1996. 

694 N.E.2d 1212 (1998) 

William F. HURT, Appellant-Defendant, 

v. 

STATE of Indiana, Appcllee·PlaintifT. 

No. 82AOI-9705-CR-161. 

Court of Appeals of Indiana. 

May 29, 1998. 

TransfCr Denied July 8, 1998. 

16 

698 N.E.2d 381 (1998) 

Larry J. LEY, M.D., and Llrological Care, P.C .. 

Appellants-Defendants, 

v. 

Donovan BLOSE and Jean Blose, Appellees· 

Plaintiffs. 

i':!S?~--~9AQ2:·3ZQ_&.~.CY.: ~j J, Cou11 of Appeals of Indiana. 

August 25, 1998. 

761 N.E.2d 431 (200 I) 

Sandra C ARTFR, Appellant-Respondent, 

K'iOX COUNTY OFFICE OF FAMILY A'iD 

CHILDREN. Appellee·Petitioner. 

"\Jo .. :PA0:'-0 1 0-l-JV- 15 I. 

Court of Appeals oflndiana. 

November 28, 200 I. 

Publication Ordered January ! 4, 2002. 

832 N.E.2d 563 (2005) 

In the :vlatter of' the I~VOLU:--;TARY 

TER:VIINATION 

OF THE PARENT CHILD RELATIONSHIP OF 

A. H., L.H., C:.H., 

and J.I-1., Minor Children and Their :vlother Annette 

Johnston 

and Their Father, .lay f laney, 

Jay I laney, Appellant-Respondent, 

v. 

Adams County Office of Family and Children, 

Appellee-Petitioner. 

l':o. OIA05-0501-JV-33. 

Com1 of Appeals of indiana. 

August 10,2005. 

IOWA 

~o Cases in Googlc Scholar Discovered 

K,\NSAS 

272 Kan. 1366 (2002) 

39 PJd 47 

STATE OF KA'iSAS, Appellee, 

v. 

MICIIAEL L. JENKINS, Appellant. 

riP~.B.!i,HQ, 

Supreme Court of Kansas. 

Opinion liled February I. 2002. 
306 


32361.238

KE:\TLCKY 

-:\o Cases in Google Scholar Discovered 

LOUISIANA 

638 So2d 1182 (1994) 

Quelyndrcia JACKSON 

v. 

Daniel DE~DY, et aL 

2'-g,JJJ c:_\YJ)905. 

Cou!i of Appeal of Louisiana, First Circuit. 

June 24. 199..:1. 

696 So.2d 652 ( 1997) 

Barry LUGAR 

v. 

BATON ROLGE GENERAL MEDICAL CENTER. 

of Louisiana. First Circuit. 

*921 So.2d I 0 12 (2005) 

Sheri NEWC0\1ER 

v. 

AMERICAN HO~IE ASSURANCE COMPANY, et 

a!. 

No. '"'005-C'-1242. 

Court of Appeal of Louisiana, Fourth Circuit. 

December 14, 2005 

637 A.2d 1162 (1994) 

ST.t\.TEofMaine 

v. 

!\1AINE 

Ronald IV. BOOBAR, Jr. 

Supreme Judicial Court of Maine. 

Argued January 6, 1994. 

Decided \1arch I. !994. 

'VIARYLAND 

No lases in Goog!c Scholar Discovered 

17 

MASSAClluSETTS 

456 Mass. 1003 (2010) 

921 N.E.2d 536 

DWIGHT HIGHTOWER 

C0\1\10NWEALTIL 

SJC~I,D56], 

Supreme Judicial Com1 ofY1assachusetts 

464 Mass. 1013 (20 13) 

KAREN COL:SINEAU 

v. 

COMMO'i\VF.ALTH. 

SJC-11254. 

Supreme Judicial Court of Massachusetts. 

February 20, :20 13 

MICHIGA'i 

(2008) 

CAROL JODIS and JAN JODlSJ..!l as Next Friend of 

MIKA YLA GRANGER, a Minor, PlaintiffsAppellants, 

v. 

MICHELLE BRUBAKER. SUE FOWLE, MARY 

STUART, DAVE BABCOCK, l\:lJRSEA. VAN 

CAMP, 

DR. DF.IlRA LUSTY, DR. ALFRED DEDIAKO, 

DR. VERONICA DULA, and 

HILLSDALE COUNTY COMMlJNITY IlEAL Til 

CE-:\TER, Defendants~ Appellees, and 

ELIZAllETH WARNER and PHILLIP 

ilERKEMEIER. Appe!lants.l.,J 

~0. 2716"19. 

Court of Appeals of Michigan. 

Janunry 31, 2008. 

PEOPLE OF TilE STATE OF MICHIGAN, 

Plaintiff~ Appellee, 

DAVID CHRISTIAN DEJONGE, DefendantAppellant. 

No. 295168. 

Court of Appeals of Michigan. 

June 5.:201:2. 
307 


32361.239

:VIINNESOTA 

342 N.W.2d 128 (1984) 

STATE ofY1inncsota, Respondent. 

v. 

David Gerald A~DRJNG, Appellant. 

376 :\.W.2d 451 (1985) 

STATE of Minnesota, Respondent, 

v. 

Gerry Dean BROW'\:, Appellant. 

1'\o. Cl-85-589. 

Coutt of Appeals of Minnesota. 

November 5, 1985. 

Review Denied December \9, 1985 

383 N.\\'.2d 338 (1986) 

STATE of\.1inncsota, Respondent, 

v. 

Toby Lynn GCLLEKSON, Appellant. 

JioSS-85-1647. 

Court of Appeals of Minnesota. 

\'larch I I. 1986. 

Review Denied May 16. 1986. 

MISSISSIPPI 

No rases in Goog!e Scholar Discovered 

MISSOURI 

973 S. \\'.2d 183 ( 1998) 

STATE of Missouri ex reL CJ.V., Relator, 

v. 

The Honorable Michael T. JAMISO;...r, Judte, Circuit 

Com1, St. Louis County, Missouri. Respondent. 

No. 73917. 

\1issouri Court of Appeals, Eastern District Writ 

Division Two. 

July 31. 1998. 

18 

MOJ'>TANA 

682 P.2d 1365 (1984) 

STATE ofivtontana, Plaintiff and Appellant, 

v. 

Arthur Leroy \1.'\GNUSO~, Defendant and 

Respondent. 

~~~_}_:_1_6_;2_: 

Supreme Cowi of Montana. 

Submitted March 2, !984. 

Decided June 1?:, 1984. 

l'>EIJRASKA 

No Cases in Goog!e Scholar Discovered 

NEVADA 

~o Cases in Ooogle Scholar Discovered 

:\EW HAMPSHIRE 

~o Cases in Google Scholar Discovered 

NEW JERSEY 

239 N.J. Super. I J 9 ( 1989) 

570 A.2d 1047 

STATE OF NEW JERSEY, PLAINTIFF, 

v. 

ADAM MARRERO. DEFE:\DANT. 

Superior C'oun of New Jersey, Law Division 

(Criminal), Cumberland County. 

Decided ~ovember 9, !989, 

NEW MEXICO 

~o Cases in Google Scholar Discovered 
308 


32361.240

"EWYORK 

93 Misc.2d 479 (1978) 

In the tl.'latter of Doe Children, Alleged to be 

Neglected. A lie, Respondent_l.:l 

Family Court, Queens County. 

March 7. 1978 

57 ".Y.2d 399 (1982) 

In the !\'latter of John Short, Respondent-Appellant, 

v. 

Board ofManngcrs of the Nassau County Medical 

Center, Appellant-Respondent. 

Court of Appeals of the State of New York. 

Argued October 14. 1982. 

Decided ~ovember 18. 1982. 

147 \1isc.2d 669 (1990) 

Susan W ., Plaintiff, 

v. 

Ronald A .. Defendant. 

Supreme Court, Queens County. 

June 15. 1990 

149 \·lisc.2d 200 (1990) 

In th!.! Matter of the Guardianship of John D. 

Alexander, Jr., an Infant. 

In the Matter of The Estate of Beverly Clark, 

Deceased. 

Surrogate's Court, Bronx County. 

December 12, 1990 

171 A.D.2d624(1991) 

In the Matter of David C. Reynolds, Petitioner, 

v. 

Benjamin Ward, as Police Commissioner of The City 

ofNe\v York, et aL Respondents 

Division of the Supreme Court of the State 

York, First Depat1mcnt. 

March 28. 1991 

176 A.D.2d 391 (1991) 

In the Matter of Robert J. Shedrick. Appellant, 

Thomas A Coughlin. as Commissioner of 

Correctional Services, et a!., Respondents 

Appellate Division of the Supreme Court of the State 

ufNew York, Third Department. 

September !2, !991 

19 

180 A.D.2d 866 (1992) 

The People of the State of New York, Respondent. 

v. 

Mark Simon, Also Known a<:> Spook, Appellant 

Appellate Division of the Supreme Court of the State 

of New York, Third Department. 

February l3, 1992 

158 Misc.2d 788 (1993) 

602 N. Y .S.2d 70 

In the ~·latter ofW.H. and Another, Children Alleged 

to be Neglected. I-Ll L, Respondent ~ 

Family Court, Rockland County. 

July 28. 1993 

163 Misc.2d 373 (1993) 

621 N.Y.S.2d 428 

In the ~atter of Lister County Derartment of Social 

Services. on Behalf of Jane, 

a Child Alleged to be Neglected. Leslie B., 

Respondent 

Family Court. Ulster County. 

August 23, 1993 

207 A.D.2d 660 (1994) 

6 I G ".Y.S.2d 38 

Jade 0/apoleoni et aL, Respondents, 

v. 

L'nion Hospital of the IJmnx eta!., Defendants, and 

Sushila Gupta eta\., Appellants 

Appellate Division of the Supreme Court of the State 

of New York, First Department. 

September l, 1994 

165 \1isc.2d 736 (1995) 

630 ".Y.S.2d 850 

In the Matter of Brandon A. and Others, 

Children Alleged to be Permanently Neglected. 

Claritha P., Respondent (And Another Action.) 

Family Court, Monroe County. 

June 15, 1995 

240 A.D.2d 683 (1997) 

659i\.Y.S.2d 495 

The People of the State of?\'cv .. · York, Respondent, 

v. 

Anthony Rodriguez, Appellant 

Appellate Division of the Supreme Court of the State 

of New York. 

Second Department. 
309 


32361.241

173 Misc.2d 879 ( 1997) 

662 KY.S.2d 706 

John \Varhurton, Claimant, 

v. 

State nfNew York,IJJ Defendant. {Claim No. 94378-

A.) 

Court of Claims. 

August 7, !997 

259 A.D.2d 1047 (1999) 

689 ~.Y.S.2d 325 

THE PEOPLE Of THE STATE OF NEW YORK, 

Respondent, 

v. 

GUY LANE, Appellant. 

Appellate Division of the Supreme Court of the State 

of New York, fourth Depanment 

186 Vlisc.2d 266 (2000) 

710 N.Y.S.2d 864 

In the \·1atter of\1AXIMO ~vL, a Child Alleged to be 

Neglected. 

ELIZA11ETlf R., Respondent. 

Family Court, Kings County. 

June 24, :woo. 

281 A.D.2d 387 (2001) 

721 N.Y.S.2d 383 

JOHN DOE et al.. Appellants, 

v. 

JA'VIES /vi. I~MA~ CONSTRUCTION CORP., 

Defendant and Third-Party Plaintiff, et al., 

Defendants. . 

CATHEDRAL MARBLE A'!D GRA'JITE 

CCYviPA~Y, Third-Party Defendant-Respondent. 

HARTfORD INS CRANCE C0\1PANY, i';onparty 

Respondent. 

Appc!latc Division of the Supreme Court of the State 

of New York, Second Department. 

Decided March 5. 200 I 

188 Misc.2d 470 (200 I) 

729 K Y .S.:2d 348 

BRAD I!. ct a!., on Behalf of Themselves and All 

Others Similarly Situated, Plaintiffs, 

v. 

CITY Or NEW YORK et al., Defendants. 

Supreme C'ourt, Nc\.-Y York County. 

June 26.2001. 

20 

285 .>\.D.2d 462 (2001) 

727 N.Y.S.2d 338 

In the Matter of \1ARLENE D., a Person Alleged to 

be a Juvenile Delinquent, Appelhmt. 

Appellate Division of the Supreme Court of the State 

of ;-..;ew York, Second Department. 

5 Mise.3d 517 (2004) 

785 ~.Y.S.2d 292 

THE PEOPLE OF THE STATE OF NEW YORK, 

Plaintiff. 

v. 

PIERRE JOSEPH. Defendant. 

Supreme Court. Kings County. 

September 22, 2004. 

71 A.D.3cll400 (2010) 

898 N.Y.S.2d 742 

L.T., Appellant, 

TEVA PHAR:VIACEUTICALS l)SA, INC., et al., 

Defendants, and 

TilE HARVARD DRUG GROUP, L.L.C., 

Respondent. 

CA OQ-0~!1QQ, 

Appellate Division of the Supreme Court of~e\V 

York, Fourth Depmiment. 

Decided \1arch 19,:2010. 

2011 i';Y Slip Op 50102(C) 

IN TilE MATTER OF HAVYN-LEIY "A.," A 

CHILD t.:NDER THE AGE OF EIGHTEEN YEARS 

ALLEGED TO BE PERMANEi';TLY NEGLECTED 

BY \10RIANNA" B.," Respondent. 

D-xxxxx~xx 

f"amily C'ourt, C'linton County. 

Decided January 20,20\1. 

89 i\.D.3d I 544 (20 II) 

934 i';.Y.S.2d 278 

ln the Matter ofKENNCDJE M. and Another, 

Infants. 

ERIE COL'NTY DEPARTMENT OF SOCIAL 

SERVICES, Respondent. 

DOUGLAS .VI.. Appellant, et al., Respondent. 

CHARLI'.S D.! IALVORSEN. ESQ., Attomey for 

the Children, Appellant. 

C ALLQcQI169. 
310 


32361.242

90 A.D.3d 1224 (2011) 

934 N.Y.S.2d 578 

In the Matter ofSIMMO~S \·!ACI!l:-.:E TOOL 

CORPORATION, Appellant, 

ST. PETER'S HEALTII CARE SERVICES. 

Respondrnt, and JOH~' DOE, Respondent. 

ll~~.J1~ 

Appellate Division of the Supreme Court of >Jew 

York, Third Department. 

December 8, 2011. 

90 A.D.3d 1655 (201 I) 

936 N.Y.S.ld 825 

In the Matter of SHIRLEY A.S .. an Infant. 

ERIE COUNTY DEPARTMENT OF SOCIAL 

SERVICES, Respondent; DAVID A.S., Appellant. 

~:flF I 1-01027. 

Appe!!ate Division of the Supreme Court of New 

York. Fourth Depatimcnt. 

December 30, 20 J L 

NORTH CAROLINA 

1:-.: THE MATTER OF: G.O.C., \linor Child. 

~o. COAOG~ 140 

North Carolina Cout1 of Appeals 

Filed :'\!ovember 7, 2006 

This c<Jse not for publication 

NORTH DAKOTA 

36 I 0i. W.2d 232 (I 985) 

IIEARTVIEW FOl!NDATIO~. 

a corporation, and Sherman Sandbo, Petitioners, 

Y. 

Gerald G. GLASER, Judge of the District Court, 

South Central Judicial District, and Keith Conrad, 

Respondents. 

Civ. No. 10849. 

Supreme Court ofN011h Dakota. 

January 18, 1985. 

488 0i.W.2d 879 (1992) 

JANE H., Petitioner, 

v. 

The f Ionorablc Cynthia A. ROTHE, 

Judge of the District Cout1, Cass County, 

East Central Judicial District. Thomas L. Herzog, 

21 

Jerry J. Bald\vin, and Fargo Clinic, Ltd., a.k.a. 

\1eritCare, Respondents. 

Civ. 'Jo. 920101. 

Supreme Court ofNorth Dakota. 

August 21, 1992 

6JIN.W.2d 159(2001) 

2001 NO 137 

Interest of R.O., V.O. ami J.H. 

Keith BERGER, Director Grand Forks County Social 

Services. Petitioner and Appellee, 

y_ 

F.O., Respondent, and 

L.H., Respondent and Appellant 

Interest ofR.O., V.O., and J.H. 

Keith Berger, Director Grand Forks County Social 

Services, Pl'titioner and Appellee, 

Y. 

17.0., Respondent and Appellant, and 

L.l L Respondent. 

'lo<. 20000305. 2000Q,LQL 

Supreme Court of North Dakota. 

July 20, 2001. 

OHIO 

1 I Ohio Misc. 2d 1 (1983) 

PACHECO 

v. 

ORTIZ.l'l 

~0. 5-l-159. 

Court of Common Pleas of Cuyahoga County. 

Decided November .:1, 1983. 

I 54 Ohio App3d 30 I (2003) 

2003-0hio-4847 

The STATE of Ohio, Appellee, 

v. 

PCLASKl. Appellant. 

No. I 9790. 

Court of Appeals of Ohio, Second District, 

\1ontgomery County. 

Decided September 12,2003 
311 


32361.243

2005~0hio~4243 

State of Ohio, Plaintiff-Appellant, (Cross-Appellee), 

V, 

Brandon Johnson, Defendant-Appellee, (CrossAppellant). 

~o.,Jl:t1P.:239--' 

Coun of Appeals of Ohio, Tenth District. franklin 

County. 

Rendered on August 16. 2005 

5N.L3d 100(2013) 

20 1:1-0hio-5540 

Rebecca R. GE~TILE, Phtintiff-Appellant, 

V, 

David D. Dl ~CAN eta!., Dcfendants-Appe!kes. 

N1). !2,lf ..:.l on. Court of Appeals of Ohio, Tenth District, Franklin 

County. 

December 17. 20 13. 

14 C,:EJd 470 (2014) 

20 14-0hio-2508 

OHIO STATE DE:\TAL BOARD, PetitionerAppellee, 

HEALTliCARE VENTURE PARTNERS, LLC ct 

al., Respondents-Appellees, 

(Dr. J.\V .. lHJS, Appellant). 

'7\'o. l4AP-l65. 

Court or Appeals of Ohio, Tenth District. Franklin 

County. 

June 10, 2014. 

OKLAHOMA 

"No Cases in Googlc Scholar Dlscovt.'red 

993 P.2d 152 (1999) 

164 Or. App. 369 

OREGON 

In the Matter of Chelsea West. a Minor Child. 

STATE ex rcL JUVENILE DEPARTMENT OF 

MlJLTC,:OMAII COUNTY, Respondent 

V. 

Dion WEST, Appellant. 

19707-82066; C1\~~lO_Ql501 

Court or Appeals of Oregon. 

Argued and Submitted tv1ay 10, 1999. 

Decided December 15. 1999. 

22 

99 P.Jd 748 (2004) 

195 Or. App. 431 

William E. MITCHELL. Rcspondent-CrossM 

'"\ppe!!ant. 

V!T. HOOD MEADOWS OREG., Limited 

Partnership, an Oregon limited partnership; 

and Mt. I Iood Meadows Development Corp., an 

Oregon corporation. Appcllants~Cross-Respondcnts, 

ooll5:1li389. A 116li'!c 

Court of Appeals of Oregon. 

Argued and Submitted July 22,2003. 

Resubmitted July 14,2004. 

Decided October 6, 2004. 

283 P.Jd 930 

251 Or. App. 

STATE of Oregon, Plaintiff-Respondent, 

v. 

\Vil!iarn Delray TOLA~l), Defendant-Appellant. 

State Of Oregon, Plaintiff-Respondent, 

V. 

Larry Alan Fricano, Defendant-Appellant. 

07C51659, 07C51658· A 141030 (Control), Al411147. 

Court of Appeals of Oregon. 

Argued and Submitted June 9, 201 I 

Decided July 25,2012 

PE'i:\SYLVANIA 

No Cases in Google Scholar Discovered 

RHODE ISLAND 

044 A2d 309 ( 1994) 

In re CORY C 

\io. 93-690-Appea!. 

Supreme Court of Rhode Island. 

May 18, 1994. 
312 


32361.244

SOL'TH CAROLINA 

455 S.E.2d 693 ( 1995) 

Shirley ;>vtcMAKll\, Respondent, 

v. 

BRUCE HOSPITAL SYSTE\1. Petitioner. 

Supreme Court of South Carolina. 

Heard January 3. I 995. 

Decided February 27. 1995 

458 S.E.2d 439 (1995) 

John DOE, Appellant, 

v. 

NORTH GREENVILLE HOSPITAL, Respondent. 

Court of Appeals of South Carolina. 

Submitted April3, 1995. 

Decided \·lay 8, 1995. 

Rehearing Denied June 29, 1995. 

343 S.C. 471 (2000) 

540 S.E.2d 484 

MacKennon \V ATSON, a Minor, by his Guardian ad 

Litem, Susan WATSON, Respondent. 

v. 

Davit.! CHAPMAN, M.D., Appellant. and 

Susan \Vatson and Don Watson, Respondents, 

v. 

David Chapman, \1.0., Appellant. 

;'SQ.:.-d272. 

Court of Appeals of South Carolina. 

Heard November 8, 2000. 

Filed December 18, 2000. 

Rehearing Denied rebruary 12, 200 I 

SOUTH DAKOTA 

No Cases in Googlc Scholar Discovered 

23 

TE""ESSEE 

194 S.W.3d 457 (2005) 

\1orris :V!. DICKSON 

v. 

CITY OF MEMPHIS CIVIL SERVICE 

COMMISSIO". 

Court of Appeals of Tennessee, Western Section. at 

Jackson. 

August 23, 2005 Session. 

1'\ovember 2. 2005. 

Permission to Appeal Denied April 24, 2006 

(20IO) 

STATE OF TE"~ESSEE, 

v. 

JOH" COTE AND SARA! I COTE. 

In Re: DR. SANDRA ELKINS. 

~~f:200,I::Q.~83-CCA-R9-CD. 

Cout1 of Criminal Appeals of Tennessee, at 

Knoxville. 

August 25, 2009 Session. 

Filed September 28,2010. 

(2012) 

CITY OF \1E:V!PHIS CIVIL SERVICE 

CO:VIMISSION. 

v. 

STEVEN PAYTON. 

No. W2QlL:Q2iQ1::£0A::.!l.3-CV. 

Coun of Appeals of Tennessee, at Jackson. 

July 19,2012 Session. 

Filed November 7, 2012. 

TEXAS 

I42 S.W.3d 574 (2004) 

In the Interest ofK.C.P. and J.D.P., Children. 

N<;>. 06-04-00009-CV. 

Court of Appeals of Texas, Texarkana. 

Submitted July 28, 2004. 

Decid<.!d August 9, 2004. 

UTAH 

"\o Cases in Googlt Scholar Discovered 
313 

Æ 


32361.245

VER\10NT 

648 A.2d 652 ( 199~) 

ln rc B.\V., Juvenile. 

659 A.2d 1137 (1995) 

In re B.S., Juvenile. 

No. 94-0~6. 

Supreme Court of Vermont. 

\1arch 31. 1995. 

V!RGI'\IA 

No Cases in Googlc Scholar Discovered 

WASHINGTON 

9 PJd 840 (2000) 

STATE of Washington. Resrondent, 

v. 

llrenda Rochelle ANDERSO'\, Appellant. 

"\io. 4~90-6-l. 

Cou11 of Appeals of Washington, Division L 

August 7. 2000. 

Publication Ordered August 31, 2000. 

76 P.3d 280 (2003) 

118 Wash.App. 435 

STATE of \Vashington. Respondent, 

v. 

Scott Warren \VI-lEA T. Appellant. 

94 P.3d 407 (2004) 

STATE of\Vsshington, Respondent. 

V. 

Catherine Christine CASSlLL-SKIL TO~. Arpe!!ant. 

WEST VIRGINIA 

~o Cases in Goog!c Scholar Discovered 

W!SCO;.JSIN 

No Cases in Google Scholar Discovered 

WYOMING 

No Cases in Googlc Scholar Discovered 

WASHINGTON. D.C. 

672 A.2d 1032 (1995) 

In re Robert R. STO~E. Jr.. Respondent, 

A Member of the Bar of the District of Columbia 

December IS. 1995, 

24