H.Res. 949

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in opposition to H.R. 6082, the Overdose Prevention and Patient Safety Act. This legislation would greatly harm our efforts to combat the opioid epidemic. If we really want to turn the tide on this crisis, we must find ways to get more people into treatment for opioid use disorder.

In 2016, there were about 21 million Americans aged 12 or older in need of substance use disorder treatment, but only 4 million of those 21 million actually received treatment. That means 17 million people are going without the treatment they need. Failure to get individuals with opioid use disorder into treatment increases risk of fatal and nonfatal overdoses as people continue to seek out illicit opioids as part of their addiction. The increasing presence of fentanyl in our drug supply only heightens this concern.

Strategies that increase the number of people getting into and remaining in treatment are particularly important because, as these treatment statistics show, major challenges exist to getting people with substance use disorders to enter treatment in the first place. And this House should not--and I stress ``should not''--take any action that puts at risk people seeking treatment for any substance use disorder, but particularly opioid use disorders.

Unfortunately, this bill risks doing just that: reducing the number of people willing to come forward and remain

in treatment because they worry about the negative consequences that seeking treatment can have on their lives. And this is a very real concern.

This bill weakens privacy protections that must be in place for some people to feel comfortable about starting treatment for their substance use disorder. Ensuring strong privacy protections is critical to maintaining an individual's trust in the healthcare system and a willingness to obtain needed health services, and these protections are especially important where very sensitive information is concerned.

The information that may be included in the treatment records of a substance use disorder patient are particularly sensitive because disclosure of substance use disorder information can create tangible vulnerabilities that are not the same as other medical conditions. For example, you are not incarcerated for having a heart attack; you cannot legally be fired for having cancer; and you are not denied visitation to your children due to sleep apnea.

According to SAMHSA, the negative consequences that can result from the disclosure of an individual's substance use disorder treatment record can include loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration. These are real risks that keep people from getting treatment in the first place.

While I understand that the rollback of the existing privacy protections to the HIPAA standard would limit permissible disclosures without patient consent to healthcare organizations, this ignores the reality: It may be illegal for information to be disclosed outside these healthcare organizations, but we know, Mr. Speaker, that information does get out. Breaches do happen.

Remember the recent large-scale Aetna breach that disclosed some of its members' HIV status?

But there are also small-scale breaches that don't make the news that can have devastating consequences for patients trying to recover and get treatment. For example, a recent ProPublica investigation detailed instances where a healthcare organization's employee peeked at the record of a patient 61 times and posted details on Facebook, while another improperly shared a patient's health information with the patient's parole officer. Breaches such as this are very concerning and could occur more often as a result of this legislation.

While I appreciate the sponsor's efforts to alleviate these concerns, I do not believe the potential harm that could be caused by eliminating the patient consent requirement under existing law for treatment, payment, and healthcare operations can be remedied through the measures included in this bill. The inclusion of these provisions cannot compensate for the risk of stigma, discrimination, and negative health and life outcomes for individuals with opioid use disorder that could result from the weakening of the existing privacy protections, and that is why every substance use disorder patient group has come out in opposition to this bill.

According to the Campaign to Protect Patient Privacy Rights, a coalition of more than 100 organizations: ``Using the weaker HIPAA privacy rule standard of allowing disclosure of substance use disorder information without patient consent for treatment, payment, and healthcare operations will contribute to the existing level of discrimination and harm to people living with substance use disorders.''

The Campaign goes on to say: ``This will only result in more people who need substance use disorder treatment being discouraged and afraid to seek the healthcare they need during the Nation's worst opioid crisis.''

This is a risk we simply should not take, and yet the majority is bringing this bill to the floor today, despite the very real concerns of these experts. These groups uniquely understand what is at stake from this legislation because many of their members live with or are in fear of the negative consequences that result from the disclosure of substance use disorder diagnosis and treatment information.

In fact, the negative consequences that will result from the disclosure of someone's substance use disorder would solely affect that individual and their family. They will bear the burden if we get this wrong. They could be at risk of potentially losing custody of their child and their freedom by the increased risk of improper disclosure of their medical record if this bill becomes law.

These risks may simply just keep them from seeking potentially lifesaving treatment. That is why substance use disorder treatment providers have also raised concerns.

The South Carolina Association of Opioid Dependence explained: ``Even with the growing awareness that substance use disorders are a disease, the unfortunate truth is that persons with substance use disorder are still actively discriminated against . . . such as a baby being taken away from a new mother because she is on methadone for an opioid use disorder, despite longstanding compliance with her treatment and abstinence from illegal drug use.''

Another provider, Raise the Bottom Addiction Treatment, one of two medical-assisted treatment facilities in Idaho, explained that ``our patients come from every walk of life, including professionals and executives within our community. Their anonymity and privacy is of utmost importance because their careers, families, and livelihood often depend on it.

``Knowing that people may seek treatment without fear of backlash and discrimination is often a deciding factor when considering entering treatment.

``To undo this protection will deeply affect one's ability and willingness to seek help. . . . Not only can the members of our community not afford to lose their right to confidentiality, but we as a nation cannot afford to move backwards in our fight to combat this opiate crisis.''

So again, Mr. Speaker, these are the words of experts on the frontline fighting this epidemic. People who suffer from substance use disorder should be able to decide with whom to share their treatment records from programs and for what purposes. Those rights are taken away from them under this legislation, and I believe that is wrong.

As we face a tragic national drug abuse problem, the scale of which our country has never seen, I believe maintaining the heightened privacy protections under existing law remains vital to ensuring all individuals with substance use disorder can seek treatment for their substance use disorder with confidence that their right to privacy will be protected. To do otherwise at this time is just too great a risk, and I strongly urge my colleagues to listen to the experts on the subject and to vote ``no'' on this legislation.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Oregon (Mr. Blumenauer).

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, proponents of this legislation argue that taking away patients' privacy rights related to substance use disorder treatment records is okay because we would be applying the HIPAA standard that applies to other sensitive health conditions like HIV, but I strongly disagree.

Individuals with substance use disorder face risk because of their medical conditions that those with other medical conditions do not. According to SAMHSA, those negative consequences include loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrests, prosecution, and incarceration.

Unlike other medical conditions, including HIV, you can be incarcerated, legally fired, and denied visitation with your children due to your substance use disorder.

So let me paint this picture with a few examples.

A 20-year-old pregnant woman in Wisconsin voluntarily went to a hospital to seek treatment for addiction to the opiate OxyContin. Rather than providing treatment, the hospital called State authorities to report this woman. She was taken into custody and held for several weeks before a judge ordered her released.

Another example provided to the committee from a provider in Maryland explained:

Some time ago, we had a young lady in our methadone

maintenance program who committed suicide. She had turned her

life around. She was in college, working full time, owned her

own car, was purchasing a house, and was no longer using

illicit substances. She had to complete probation for her

crimes that she had committed while she was actively using

these drugs.

Her mother did not know she was in methadone treatment. She

did not want her mother to know because her mother did not

agree with methadone, and the judge found out she was in the

methadone maintenance program and disclosed it in a court

hearing with her mother present.

The judge and her mother insisted that she ``get off that

stuff,'' and she complied only because of the pressure from

both to do so.

She began abusing illicit substances and participating in

illegal activity to obtain those substances. The guilt and

shame of returning to what she described as a life of hell

led her to write a suicide note and end her life.

Experiences like this, in addition to stories of individuals with substance use disorder who have lost jobs, housing, and child custody because of their substance use disorder, are reasons that some individuals with substance use disorder fear coming forward to enter treatment due to the negative consequences that result. It is why more than 100 groups, including AIDS United, joined the campaign to protect patient privacy rights. They have joined together to fight to protect the heightened privacy protections that exist under existing law.

Further, unlike the proponents of this legislation contend, the existing law is not an anomaly. States like Florida have laws requiring written patient consent for the sharing of a patient's substance use disorder and mental health treatment records, while others like New York, Kentucky, and Texas have such requirements for the sharing of HIV records. Other States have such requirements for reproductive health treatment records.

Further, the existing law is consistent with the confidentiality protections applied to substance use disorder treatment records. In fact, the law governing the confidentiality of VA medical records, 38 U.S.C. 7332, is consistent with and broader than part 2. Unlike that law, the VA cannot share a patient's substance use disorder, HIV, or sickle cell anemia treatment records with another provider without written patient consent.

So, Mr. Speaker, I want to stress that I do believe that we can learn an important lesson from our response to HIV, particularly during the height of the AIDS epidemic. A critical part of this Nation's response to the AIDS epidemic was increasing the privacy protections applied to HIV medical records. Such action was taken because people were afraid to enter treatment for HIV/AIDS because of the negative consequences that could result.

In the midst of the opioid epidemic, this bill would result in doing just the opposite: lowering the privacy protections applied to substance use disorder medical records despite the fact that, like during the AIDS epidemic, some individuals with substance use disorder remain afraid to enter treatment because of the negative consequences that result. And in many cases, they only do so out of the part 2 assurances that they can control to whom and for what purposes their treatment record is shared.

The increased stigma, discrimination, and criminalization faced by people with substance use disorder support the maintenance of the heightened privacy protections under existing law, in my opinion. And for some individuals, it is these privacy protections that make them feel safe to enter and remain in treatment for their substance use disorder. I am afraid that by passing this bill we could be creating a barrier that will keep people from getting the treatment they need, and that is a risk I am simply not willing to take.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, some of the proponents of this bill also mentioned the opiate use disorder situations in emergency rooms as a justification for the legislation, but I just want to say, Mr. Speaker, I think it is important to note that the existing law includes an exception to the patient consent requirement. A provider can access a patient's substance use disorder treatment records in the case of an emergency as determined by the provider without patient consent.

Additionally, nothing in the existing law prevents any provider from asking their patient about their substance use disorder history before prescribing any opioid, especially in the midst of the opioid epidemic. Every provider should ask patients about their opioid use disorder history, and, therefore, under the existing law and every other privacy law, the doctor can learn of a patient's opiate use disorder history by simply asking the patient that.

That remains, in my opinion, the optimum way of learning a patient's medical history, because currently our electronic health records aren't interoperable in many cases. Those underlying interoperability issues that prevent information sharing, including the part 2 information in cases where a patient has agreed to share their information with providers, aren't going to be solved by this bill.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I mentioned earlier the various groups that are opposed to this legislation because of the privacy concerns, and I actually would like to read or go through some sections from this letter that was sent to Chairman Walden and me from over 100 groups, including the New Jersey Association of Mental Health and Addiction Agencies.

And they say, Mr. Speaker:

Dear Chairman Walden and Ranking Member Pallone:

We, the undersigned national, State, and local

organizations strongly support maintaining the core

protections of the Federal substance use disorder patient

confidentiality law and its regulations, referred to

collectively as part 2.

And they say:

We remain concerned that using a weaker HIPAA privacy rule

standard of allowing disclosure of substance use disorder

information without patient consent or other purposes will

contribute to the existing level of discrimination and harm

to people living with substance use disorders. This will only

result in more people who need substance use disorder

treatment being discouraged and afraid to seek the healthcare

they need during the Nation's worst opioid crisis.

We strongly support maintaining part 2's current core

protections for substance use disorder information instead of

those weaker HIPAA privacy standards for the following

reasons.

And there are five.

One, the heightened privacy protections in part 2 are as

critical today as they were when they were enacted more than

40 years ago and must be preserved.

Two, in the midst of the worst opioid epidemic in our

Nation's history, we must do everything possible to increase,

not decrease, the number of people who seek treatment.

Three, substance use disorder is unique among medical

conditions because of its criminal and civil consequences and

the rampant discrimination people face.

Four, with so much at stake, patients in substance use

disorder treatment should retain the right to consent when

and to whom their records are disclosed, as currently found

in part 2.

Five, effective integration of substance use disorder

treatment with the rest of the healthcare system is

critically important, and information exchange in accordance

with confidentiality law and current technology is now

possible. To facilitate that process, SAMHSA recently amended

the part 2 regulations to further promote the integration of

confidential substance use disorder information into general

health records.

They finally conclude, Mr. Speaker, by saying:

We respectfully request that the House Energy and Commerce

Committee maintain the current confidentiality protections of

part 2 to support individuals entering and staying in

substance use disorder treatment and recovery services.

Mr. Speaker, I include in the Record this letter from these patients.

Campaign To Protect Patient

Privacy Rights,

June 18, 2018.

Re Opposition to H.R. 6082--``Overdose Prevention and Patient

Safety Act''.

Representative Greg Walden,

Chairman of the U.S. House of Representatives Energy and

Commerce Committee, Washington, DC.

Representative Frank Pallone, Jr.,

Ranking Member of the U.S. House of Representatives Energy

and Commerce Committee, Washington, DC.

Dear Chairman Walden and Ranking Member Pallone: We, the

undersigned national, state, and local organizations strongly

support maintaining the core protections of the federal

substance use disorder patient confidentiality law (``42

U.S.C. 290dd-2'') and its regulations ``42 CFR Part 2,''

(referred to

collectively as ``Part 2'') to effectively protect the

confidentiality of patients' records. The Substance Abuse and

Mental Health Service Administration (``SAMHSA'') recently

amended Part 2's patient privacy regulations in 2017 and

2018, which accomplishes the bill's proposed objective of

providing coordinated care between substance use disorder

(``SUD'') and other health care information.

We remain concerned that using a weaker HIPAA Privacy Rule

standard of allowing disclosures of SUD information without

patient consent for treatment, payment, health care

operations, or other purposes other than those currently

allowed by Part 2--will contribute to the existing level of

discrimination and harm to people living with substance use

disorders. This will only result in more people who need

substance use disorder treatment, being discouraged and

afraid to seek the health care they need during the nation's

worst opioid crisis.

We strongly support maintaining Part 2's current core

protections for SUD information, instead of those of a weaker

HIPAA Privacy standard as described in H.R. 6082 for the

following reasons:

1. The heightened privacy protections in Part 2 are as

critical today as they were when they were they were enacted

more than 40 years ago, and must be preserved.

2. In the midst of the worst opioid epidemic in our

nation's history, we must do everything possible to

increase--not decrease--the number of people who seek

treatment.

3. SUD is unique among medical conditions because of its

criminal and civil consequences and the rampant

discrimination people face.

4. With so much at stake, patients in SUD treatment should

retain the right to consent when and to whom their records

are disclosed, as currently found in Part 2.

5. Effective integration of SUD treatment with the rest of

the health care system is critically important, and

information exchange in accordance with confidentiality law

and current technology is now possible. To facilitate that

process, SAMHSA recently amended the Part 2 regulations to

further promote the integration of confidential SUD

information into general health records.

We respectfully request that the House Energy and Commerce

Committee maintain the current confidentiality protections of

Part 2 to support individuals entering and staying in SUD

treatment and recovery services.

Sincerely,

Campaign to Protect Privacy Rights: A New PATH; Addiction

Haven; Addictions Resource Center, Waukesha, WI (ARC, Inc.);

Advocates for Recovery Colorado; AIDS United; Alano Club of

Portland; Alcohol & Addictions Resource Center, South

Bend, IN; American Association for the Treatment of Opioid

Dependence (AATOD); American Group Psychotherapy

Association; Apricity; Arthur Schut Consulting LLC;

Association of Persons Affected by Addiction; Atlantic

Prevention Resources; California Consortium of Addiction

Programs & Professionals (CCAPP); Capital Area Project

Vox--Lansing (MI)'s Voice of Recovery; Center for Recovery

and Wellness Resources; CFC Loud N Clear Foundation;

Chicago Recovering Communities Coalition; Colorado

Behavioral Healthcare Council; Communities for Recovery.

Community Catalyst; Connecticut Community for Addiction

Recovery (CCAR); Council on Addiction Recovery Services

(CAReS)-Orlean, NY; DarJune Recovery Support Services & Cafe;

Davis Direction Foundation--The Zone; Daystar Center; Delphi

Behavioral Health Group--Maryland House Detox; Detroit

Recovery Project; The DOOR--DeKalb Open Opportunity for

Recovery; Drug and Alcohol Service Providers Organization of

Pennsylvania; El Paso Alliance; Faces & Voices of Recovery;

Faces and Voices of Recovery (FAVOR)--Grand Strand-SC; Faces

and Voices of Recovery (FAVOR)--Greenville, SC; Faces and

Voices of Recovery (FAVOR)--Low Country: Charleston, SC;

Faces and Voices of Recovery (FAVOR)--Mississippi Recovery

Advocacy Project; Faces and Voices of Recovery (FAVOR)--Pee

Dee, SC; Faces and Voices of Recovery (FAVOR)--Tri-County:

Rock Hill, SC; Facing Addiction; Fellowship Foundation

Recovery Community Organization.

Foundation for Recovery; Friends of Recovery--New York;

Georgia Council on Substance Abuse; Greater Macomb Project

Vox; Harm Reduction Coalition; Home of New Vision; HOPE for

New Hampshire Recovery; Jackson Area Recovery Community--

Jackson, MI; Latah Recovery Center; Legal Action Center;

Lifehouse Recovery Connection; Long Island Recovery

Association (LIRA); Lotus Peer Recovery; Maine Alliance for

Addiction Recovery; Massachusetts Organization for Addiction

Recovery; Message Carriers of Pennsylvania; Mid-Michigan

Recovery Services (NCADD Mid-Michigan Affiliate); Minnesota

Recovery Connection; Missouri Recovery Network.

National Advocates for Pregnant Women; National Alliance

for Medication Assisted Recovery (NAMA Recovery); National

Association for Children of Addiction (NACoA); National

Association of County Behavioral Health and Developmental

Disability Directors (NACBHDD); National Association for

Rural Mental Health (NARMH); National Center on Domestic

Violence, Trauma & Mental Health; National Council on

Alcoholism and Drug Dependence, Inc. (NCADD); National

Council on Alcoholism and Drug Dependence--Central

Mississippi Area, Inc.; National Council on Alcoholism and

Drug Dependence--Maryland; National Council on Alcoholism

and Drug Dependence--Phoenix; National Council on

Alcoholism and Drug Dependence--San Fernando Valley;

Navigating Recovery of the Lakes Region; New Jersey

Association of Mental Health and Addiction Agencies;

Northern Ohio Recovery Association; Oklahoma Citizen

Advocates for Recovery and Transformation Association

(OCARTA); Overcoming Addiction Radio, Inc.; Parent/

Professional Advocacy League; Peer Coach Academy Colorado;

Pennsylvania Recovery Organizations--Alliance (PRO-A).

People Advocating Recovery (PAR); Pennsylvania Recovery

Organization--Achieving Community Together (PRO-ACT);

Portland Recovery Community Center; Public Justice Center;

REAL--Michigan (Recovery, Education, Advocacy & Leadership);

Recover Project/Western MA Training; Recover Wyoming;

RecoveryATX; Recovery Alliance of Austin; Recovery Allies of

West Michigan; Recovery Cafe; Recovery Communities of North

Carolina; Recovery Community of Durham; Recovery Consultants

of Atlanta; Recovery Epicenter Foundation, Inc.; Recovery

Force of Atlantic County; Recovery is Happening; Recovery

Resource Council; Recovery Organization of Support

Specialist.

Revive Recovery, Inc.; Rhode Island Cares About Recovery

(RICARES); Rochester Community Recovery Center; ROCovery

Fitness; Safe Harbor Recovery Center; SMART Recovery (Self-

Management and Recovery Training); S.O.S. Recovery Community

Organization; SpiritWorks Foundation; Springs Recovery

Connection; Tennessee Association of Alcohol, Drug & other

Addiction Services (TAADAS); The Bridge Foundation; The

Courage Center; The McShin Foundation; The Ohana Center for

Recovery; The Serenity House of Flint; The Phoenix; The RASE

Project; The Recovery Channel; Tia Hart Community Recovery

Program.

Together Our Recovery Center Heals (T.O.R.C.H.), Inc.;

Treatment Trends, Inc.; Trilogy Recovery Community; U MARC

(United Mental Health and Addictions Recovery Coalition);

Utah Support Advocates for Recovery Awareness (USARA);

Vermont Recovery Network; Voices of Hope for Cecil County,

MD; Voices of Hope Lexington; Voices of Recovery San Mateo

County, CA; WAI-IAM, Inc. and RISE Recovery Community;

Wisconsin Voices for Recovery; Young People in Recovery.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, I just want to say in conclusion today, that amidst the worst opioid epidemic our country has ever faced, I think it is really important that we not take any action that could result in any individual with an opiate use disorder not seeking or remaining in treatment for this life-threatening condition.

I understand the opinions on both sides, but I do think that if we don't protect the existing privacy and keep the current law with regard to privacy that we will see many individuals not seeking treatment or remaining in treatment. That is why I strongly oppose this bill, and I urge my colleagues to vote ``no.''

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I have a motion to recommit at the desk.

I am opposed to H.R. 6082.

Mr. Speaker, this is the final amendment to the bill which will not kill the bill or send it back to committee. If adopted, the bill will immediately proceed to final passage, as amended.

Mr. Speaker, this amendment would maintain the privacy rights provided to individuals with substance use disorder. Those patients would retain their right to determine with whom and for what purpose to share their substance use disorder treatment records from part 2 programs.

Rather than strip away patients' privacy rights, my amendment would incorporate section 509 from the bipartisan Alexander-Murray bill, S. 2680, the Opioid Crisis Response Act of 2018, that was reported out of the Senate HELP Committee on a bipartisan basis, and that was incorporated in the underlying legislation.

That provision requires the Secretary to support the development and dissemination of model training programs for substance use disorder treatment records under part 2. It would help ensure that more patients, families, and providers understand how information can be protected and shared under part 2.

My amendment would also help us to better understand the privacy needs of individuals with substance use disorder as well as how to balance those needs with the information needs of our health system to provide the highest quality care.

Specifically, my amendment would require the Secretary to conduct or support a study to better understand the patient experience with part 2 through the examination of information-sharing behaviors of individuals who obtain substance use disorder treatment at part 2 programs.

This study will provide critical insight into the central question under debate today: What is the appropriate level of privacy protections that should be applied to substance use disorder treatment records?

While there are a lot of opinions and persuasive evidence to support both sides of this debate, there is a lack of research on this issue generally or as it specifically relates to part 2. Such information will help us better understand the level of control individuals with substance use disorders need over their medical records to ensure their privacy concerns are not a barrier for such individuals accessing potentially lifesaving treatment.

It would also help us better understand what is the appropriate balance between the needs of these individuals regarding the privacy of their substance use disorder treatment information with the needs of a coordinated healthcare system to best serve its patients.

We know that today, under current law, some patients who receive substance use disorder treatment from part 2 programs choose not to share their treatment records with any provider outside of their substance use disorder treatment provider. On the other hand, there are others who choose to share with only a few of their nonsubstance use disorder treatment providers.

So I just believe it is critical we understand the reasons why such individuals have made these decisions as well as how the right to make such a decision affected their willingness to seek or remain in treatment.

This amendment is consistent with the recent recommendations from the Medicaid and CHIP Payment and Access Commission. As part of their June 2018 report to Congress, the commission stated that at this time the commission does not recommend alignment of part 2 and HIPAA. Instead, the commission recommends additional subregulatory guidance, education, and training on part 2.

As I have made clear, Mr. Speaker, I have concerns that the underlying bill would hurt our efforts to respond to the opioid epidemic and could increase the odds that fewer individuals with opiate use disorder enter and remain in treatment, a risk I believe too great to take during the worst drug abuse epidemic our country has ever faced.

However, I realize there is another side of this argument as advanced by the proponents of this bill, and we should not be concerned that this bill will affect the uptick of treatment, and, in fact, we should believe that this will only improve treatment.

Rather than undertake the 50-State experiment to see which side is right, we should support the thorough study of this issue before taking any action to weaken the privacy protections provided by part 2. In that way, we can determine the actual effect on taking away from individuals with substance use disorder the ability to decide how their treatment information is shared. That way we would have no doubt on both the intended and unintended consequences of eliminating the patient consent requirement for treatment, payment, and healthcare operation purposes as proposed by the underlying bill.

I think the stakes are too high to get this wrong. I urge my colleagues to support this amendment to increase the awareness of patients, families, and providers about how their treatment records are protected and can be shared under part 2 as well as to increase our understanding of the privacy needs of individuals with substance use disorders.

I yield back the balance of my time, Mr. Speaker.

Mr. Speaker, on that I demand the yeas and nays.

Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 949 and ask for its immediate consideration.

Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gentleman from Massachusetts (Mr. McGovern), pending which I yield myself such time as I may consume. During consideration of this resolution, all time yielded is for the purpose of debate only.

General Leave

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks.

Mr. Speaker, House Resolution 949 provides for the consideration of three important bills aimed at curbing the deadly opioid epidemic plaguing this country and providing Americans with the tools to overcome their addictions: H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT Act; H.R. 5797, the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act; and H.R. 6082, the Overdose Prevention and Patient Safety Act.

The three bills included in today's rule all seek to accomplish one goal: assist Americans struggling with opioid addiction in controlling their addictions and moving forward in achieving productive and healthy lives.

The rule provides for 1 hour of debate on H.R. 6, equally divided and controlled by the chair and ranking minority member of the Committee on Energy and Commerce. The rule makes in order eight amendments offered by both Republicans and Democrats. Further, the rule provides the minority with one motion to recommit with or without instructions.

The resolution also provides for a structured rule for H.R. 5797, allowing 1 hour of debate to be divided and controlled between the chair and ranking minority member of the Energy and Commerce Committee. The rule also provides for debate on an amendment by Mrs. Mimi Walters of California, an active member of the Energy and Commerce Committee. Finally, the rule provides the minority with the customary motion to recommit with or without instructions.

The final bill included in today's resolution, H.R. 6082, will also receive 1 hour of debate on the House floor, equally divided and controlled by the chair and ranking member of the Energy and Commerce Committee. As the Committee on Rules received no germane amendments to H.R. 6082, no amendments were made in order in today's rule. The minority does receive the customary motion to recommit with or without instructions.

The statistics that many of us have heard on numerous occasions--at our district townhalls, in opioid roundtables with stakeholders, constituent meetings in our offices, and in our committee hearings--are truly heartbreaking stories, with more than 115 people dying in the United States every day from an opioid overdose. That is five people per hour.

According to national reports, emergency room visits and opioid overdose deaths have more than quadrupled in the last 15 years, and a preliminary analysis indicates those numbers are to rise. The misuse of and addiction to opioids--including prescription pain medications, heroin, and synthetic opioids such as fentanyl--is, indeed, an urgent national crisis that continues to threaten our public health, social fabric, and economic welfare. Both community hospitals and local paramedics are frequently coming across people overdosing on an opioid drug or a drug laced with fentanyl.

The opioid epidemic has affected families not only in my district in north Texas, but in communities large and small from Maine to California. It has also impacted American employers and businesses due to lost productivity and difficulty finding qualified candidates for employment. President Trump is right to call this epidemic the ``crisis next door.''

The efforts of the Energy and Commerce Committee in the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act in the previous Congress were a good start, delivering critical funding and resources to communities hit most hard by the opioid epidemic. But there was much more we still could do.

To start this process, the Energy and Commerce Health Subcommittee, which I chair, held a Member Day last October, where more than 50 bipartisan Members of this body, both on and off the committee, shared their personal stories from their districts and offered their solutions. This was followed by a series of three legislative hearings with markups where nearly 60 bills were considered and advanced to the full Energy and Commerce Committee that acted on these bills shortly thereafter.

The culmination of the work from the Energy and Commerce Committee and other House committees has brought us to consider many of these policies over the course of the last 2 weeks on the House floor. It required an all-hands-on-deck approach, and I believe the American people will see that, by this week's end, we did, indeed, come together in a bipartisan fashion and worked to address this crisis.

Today's rule provides for consideration of three important bills that will expand treatment options, deliver lifesaving services, and make necessary public health reforms, including Medicare and Medicaid, to bolster prevention and recovery efforts.

First, H.R. 5797, the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act, the IMD CARE Act, allows State Medicaid programs to remove the institutions for mental diseases exclusion for beneficiaries aged 21 to 64 with an opioid use disorder for 5 years' time. The bill provides the continuum of care

by removing a barrier of care under current law, so Medicaid can cover up to a total of 30 days of care in an institute for mental disease during a 12-month period, and eligible enrollees can get the care that they actually need.

The IMD exclusion is one of the treatment barriers consistently identified by State Medicaid directors, health policy experts, and many provider groups. Currently, this exclusion under Medicaid significantly limits the circumstances under which Federal Medicaid matching funds are available for inpatient services or for outpatient treatments.

Unfortunately, this policy has barred individuals with an opioid use disorder and mental illness from accessing short-term, acute care in psychiatric hospitals, or receiving treatment in residential substance use disorder treatment facilities. A 2017 Medicaid and CHIP Payment and Access Commission report stated that the Medicaid IMD exclusion is one of the few examples in the Medicaid program where Federal financial participation cannot be used for medically necessary and otherwise covered services for a specific Medicaid population receiving treatment in a specific setting.

In the midst of the opioid crisis, States must leverage all available tools to combat this epidemic. Section 1115 demonstration waivers are an important tool, but, so far, less than half of the States have sought or received an appropriate waiver from the Centers for Medicare and Medicaid Services to help patients with substance use disorder.

The IMD CARE Act also allows States the option to use the State plan amendment process, which is generally faster than using waivers. Under this process, once a State plan amendment is submitted, the Centers for Medicare and Medicaid Services has 90 days to decide or the proposed change will automatically go into effect.

H.R. 5797 amends an outdated law that has been in effect since the enactment of the Medicaid program in 1965. Since that time, there have been advances in behavioral health, and there have been advances in addiction treatment services where more, improved treatment options now exist.

It is long overdue to revisit this policy so that State Medicaid programs can better meet patients' needs and physicians can determine the most appropriate setting for care based on an individual's treatment plan.

Next, H.R. 6082, the Overdose Prevention and Patient Safety Act, makes timely reforms to a privacy law that affects patient access to healthcare and creates barriers to treatment. Specifically, the bill updates the Public Health Service Act to permit substance use disorder records to be shared among covered entities and 42 CFR part 2 programs by aligning part 2 with the Health Insurance Portability and Accountability Act of 1996 for the purposes of treatment, payment, and healthcare operations.

As a physician, I believe 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 particular 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 possible care.

I certainly do understand and respect that patient privacy protection is paramount and should be held in 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, this bill increases protections for those seeking treatment by more severely penalizing those who share patient data to noncovered entities and non-part 2 programs than under the current statute, with certain exceptions.

Lastly, it requires the Secretary of Health and Human Services to, among other things, issue regulations prohibiting discrimination based on disclosed health data and requiring covered entities to provide written notice of privacy practices.

The issue of the stigma associated with substance use disorder has been a constant in many of the discussions members of the Energy and Commerce Committee and the stakeholders have had in both our offices and in our hearings.

This carefully crafted legislation seeks 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.

We should not continue to silo the substance use disorder treatment information of a select group of patients if we want to ensure that these patients are indeed receiving quality care. This information should be integrated into our medical records and comprehensive care models to prevent situations where physicians, not knowing a patient's substance use disorder, may prescribe medications that have significant drug interactions, or worse, may prescribe a controlled substance that makes 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 and, paradoxically, it is perpetuating that stigma.

Providing high quality healthcare is a team effort, but physicians leading the team must 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.

There is a reason why the Substance Abuse and Mental Health Services Administration and most of the health stakeholder community are asking for this change. Clearly, there is an issue here that must be addressed. H.R. 6082 achieves the goal and contributes to Congress' effort in trying to stem the current crisis.

Finally, Mr. Speaker, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, is a package of bills that reform Medicare, Medicaid, and other health provisions to further combat this crisis by advancing many critical initiatives.

As we all know, this opioid epidemic is in our hospitals, but it is also in our living rooms and on our streets. Our partners at Federal agencies must rise to the challenge and deliver vital resources for States and communities most devastated by the crisis. The SUPPORT for Patients and Communities Act will provide our Department of Health and Human Services, including the Centers for Medicare and Medicaid Services and the Food and Drug Administration, with the necessary tools to address this crisis.

Title I of H.R. 6 addresses the ways in which Medicaid can be used to increase access to quality care and management for individuals suffering from substance use disorders. Some of these changes in Medicaid reflect the success of our State Medicaid programs by implementing State successes at the Federal level.

Section 101 under title I will expand protection for at-risk youth by requiring State Medicaid programs to restore Medicaid coverage of a juvenile following their release from incarceration. The next section also allows former foster youth to maintain their Medicaid coverage across State lines until they turn 26 years of age. These are vulnerable populations of individuals that will greatly benefit from increased access to treatment.

Section 105 builds on the current State Medicaid drug utilization review, which saves money and promotes patient safety. This section will require State Medicaid programs to have safety edits in place for opioid refills, monitor concurrent prescribing of opioids and certain other drugs, and monitor antipsychotic prescribing for children.

Care for mothers suffering from substance use disorder and their babies who are born with neonatal abstinence syndrome is a growing problem in the face of this epidemic. Section 106 requires HHS to improve care for these infants with neonatal abstinence syndrome and their mothers. It also requires that the General Accountability Office study the gaps in Medicaid coverage for pregnant and postpartum women with substance use disorders.

Section 107 of the bill provides additional incentives for Medicaid health homes for patients with substance use disorder.

Mr. Speaker, these health homes will allow States to create a comprehensive person-centered system of care coordination for primary care, acute and behavioral healthcare, including mental health and substance use. As our healthcare system moves towards caring for the whole person, it is important that we enable our physicians and our payers to provide that comprehensive care.

The SUPPORT for Patients and Communities Act also enables better pain management for our Nation's Medicare beneficiaries, ranging from increased access to substance use disorder treatment, including through the use of telehealth, to modification of physician payment for certain nonopioid treatments in Ambulatory Surgery Centers.

Title II of the bill contains Medicare provisions that encourage the use of nonopioid analgesics where appropriate and also aims to decrease fraud and abuse regarding prescriptions by requiring e-prescribing for the coverage of Medicare Part D controlled substances.

H.R. 6 strives to provide support for at-risk beneficiaries who might fall victim to substance use disorder. Section 206 of the bill accelerates the development and the use of drug management programs for at-risk beneficiaries. While this program is currently voluntary, by plan year 2021, it will become a mandatory program.

Lastly, the bill expands Medicare coverage to include opioid treatment programs for the purpose of providing medication-assisted treatment. Opioid treatment programs are not currently Medicare providers, which forces Medicare beneficiaries who need medication- assisted treatment to pay out-of-pocket costs for those services. These efforts should provide improved access to treatment for Medicare beneficiaries who have substance use disorders while also incentivizing the use of opioid alternatives, which hopefully will prevent the development of substance use disorders.

Even though an estimated 46,000 Americans died from opioid overdoses from October 2016 to October 2017, there is a lack of innovation and a lack of investment in the development of nonaddictive pain and addiction treatment.

A bill that I introduced, H.R. 5806, the 21st Century Tools for Pain and Addiction Treatments, is included in section 301 on H.R. 6 and requires the Food and Drug Administration to hold at least one public meeting to address the challenges and the barriers of developing nonaddictive medical products intended to treat pain or addiction.

The Food and Drug Administration is also required to issue or update existing guidance documents to help address challenges to developing nonaddictive medical products to treat pain or addiction.

Mr. Speaker, I did work closely with the Food and Drug Administration to get the policy in this section correct and to ensure that it will clarify those pathways for products that, in fact, are so desperately needed by America's patients.

I have remaining concerns about the language in section 303 that will allow nonphysician providers to prescribe buprenorphine. While I understand and greatly appreciate the intent to increase access to medication-assisted treatment, as a physician, I also respect how complicated the treatment of patients suffering from substance use disorder may be.

The Hippocratic Oath, we all know, is to first, do no harm. Patient safety should be our highest priority.

This is a complex patient population, Mr. Speaker. On average, people with substance use disorder die 20 years sooner than other Americans.

Additionally, buprenorphine is a schedule III drug that can be misused and could exacerbate the underlying problem. I am unsure about expanding these authorities to additional nonphysician providers at the risk of making the problem worse. I have worked to strengthen the reporting requirements of this section of H.R. 6 and look forward to reviewing that report on this particular policy.

Taken together, H.R. 6, the SUPPORT for Patients and Communities Act, will improve access to care for individuals suffering from substance use disorder, provide our healthcare system with tools and resources that it needs to care for patients, and to help prevent future misuse of opioids.

Before I close, I would like to share a quote from President Trump. He said: ``Together, we will face this challenge as a national family with conviction, with unity, and with a commitment to love and support our neighbors in times of dire need. Working together, we will defeat this opioid epidemic.''

The number of bills and policies advanced on the House floor in the last 2 weeks illustrates our shared commitment, and I am confident that we will make significant progress in defeating this epidemic.

Mr. Speaker, I urge my colleagues to support today's rule and the three underlying bills that are critical to our Nation's effort to stem the opioid crisis.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Pennsylvania (Mr. Costello), a fellow member on the Committee of Energy and Commerce.

I yield the gentleman from Pennsylvania an additional 1 minute.

Mr. Speaker, I yield myself 1 minute.

I do want to remind everyone that 18 months ago, in the previous Congress, with the passage of the 21st Century Cures Act and the Comprehensive Addiction Recovery Act, CARA, $1 billion was made available for treating people with substance use disorder. That was then supplemented with the passage of the more recent appropriations bill last month--2 months ago, with $4 billion.

Unprecedented amounts of money have been made available in the last 18 months to combat this crisis.

And then, finally, it is very, very difficult to integrate care if you don't reform the 42 CFR part 2, which is before us today.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself 2 minutes.

Mr. Speaker, the good news is that all forms of medication-assisted treatment are required for 5 years under H.R. 6. So I look forward to the gentleman's support when we get to the vote, and I reserve the balance of my time.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, I don't need to remind anyone that the lie of the year for 2012 was: If you like your doctor, you can keep your doctor--words that will ring through this body probably for the rest of time.

I want to read from the Statement of Administration Policy, back to the business at hand, the rule on the three bills that we are considering today. This is the Statement of Administration Policy: ``Addressing the opioid crisis has been a top priority of the President since day one, and the administration welcomes legislation that complements its efforts to end the opioid crisis. The administration strongly supports House passage of bipartisan bills to protect patients enrolled in Medicare and Medicaid, create targeted programs for at-risk populations, expand access to medication-assisted treatment for opioid use disorders, and provide resources for States and communities struggling to deal with the scale of the opioid crisis.''

The statement goes on, and it concludes: ``These initiatives represent bold, evidence-based steps to prevent and treat opioid abuse, and will help save the lives of countless Americans. The administration commends the House on taking up these important bills. . . . The administration supports House passage of H.R. 5797, H.R. 6082, and H.R. 6. . . .''

Mr. Speaker, today's rule provides for the consideration of these three important pieces of legislation aimed at

addressing the opioid crisis affecting so many of our fellow Americans.

H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act; H.R. 5797, the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act; and H.R. 6082, the Overdose Prevention and Patient Safety Act, will all play a critical role in treating patients and providing Americans the tools to put the pieces of their lives back together again.

I commend Chairman Walden for his efforts on bringing so many Members of this body into the discussion and taking the many ideas offered by Members, incorporating them into the legislative products. The result of those efforts is a legislative trio that this entire body can be proud of, and this entire body can support.

I, therefore, urge my colleagues to support today's rule and the three underlying pieces of legislation.

The text of the material previously referred to by Mr. McGovern is as follows:

An Amendment to H. Res. 949 Offered by Mr. McGovern

At the end of the resolution, add the following new

sections:

Sec. 5. Immediately upon adoption of this resolution the

Speaker shall, pursuant to clause 2(b) of rule XVIII, declare

the House resolved into the Committee of the Whole House on

the state of the Union for consideration of the bill (H.R.

4501) to increase funding for the State response to the

opioid misuse crisis and to provide funding for research on

addiction and pain related to the substance misuse crisis.

The first reading of the bill shall be dispensed with. All

points of order against consideration of the bill are waived.

General debate shall be confined to the bill and shall not

exceed one hour equally divided and controlled by the chair

and ranking minority member of the Committee on Energy and

Commerce. After general debate the bill shall be considered

for amendment under the five-minute rule. All points of order

against provisions in the bill are waived. At the conclusion

of consideration of the bill for amendment the Committee

shall rise and report the bill to the House with such

amendments as may have been adopted. The previous question

shall be considered as ordered on the bill and amendments

thereto to final passage without intervening motion except

one motion to recommit with or without instructions. If the

Committee of the Whole rises and reports that it has come to

no resolution on the bill, then on the next legislative day

the House shall, immediately after the third daily order of

business under clause 1 of rule XIV, resolve into the

Committee of the Whole for further consideration of the bill.

Sec. 6. Clause 1(c) of rule XIX shall not apply to the

consideration of H.R. 4501.

The Vote on the Previous Question: What It Really Means

This vote, the vote on whether to order the previous

question on a special rule, is not merely a procedural vote.

A vote against ordering the previous question is a vote

against the Republican majority agenda and a vote to allow

the Democratic minority to offer an alternative plan. It is a

vote about what the House should be debating.

Mr. Clarence Cannon's Precedents of the House of

Representatives (VI, 308-311), describes the vote on the

previous question on the rule as ``a motion to direct or

control the consideration of the subject before the House

being made by the Member in charge.'' To defeat the previous

question is to give the opposition a chance to decide the

subject before the House. Cannon cites the Speaker's ruling

of January 13, 1920, to the effect that ``the refusal of the

House to sustain the demand for the previous question passes

the control of the resolution to the opposition'' in order to

offer an amendment. On March 15, 1909, a member of the

majority party offered a rule resolution. The House defeated

the previous question and a member of the opposition rose to

a parliamentary inquiry, asking who was entitled to

recognition. Speaker Joseph G. Cannon (R-Illinois) said:

``The previous question having been refused, the gentleman

from New York, Mr. Fitzgerald, who had asked the gentleman to

yield to him for an amendment, is entitled to the first

recognition.''

The Republican majority may say ``the vote on the previous

question is simply a vote on whether to proceed to an

immediate vote on adopting the resolution . . . [and] has no

substantive legislative or policy implications whatsoever.''

But that is not what they have always said. Listen to the

Republican Leadership Manual on the Legislative Process in

the United States House of Representatives, (6th edition,

page 135). Here's how the Republicans describe the previous

question vote in their own manual: ``Although it is generally

not possible to amend the rule because the majority Member

controlling the time will not yield for the purpose of

offering an amendment, the same result may be achieved by

voting down the previous question on the rule. . . . When the

motion for the previous question is defeated, control of the

time passes to the Member who led the opposition to ordering

the previous question. That Member, because he then controls

the time, may offer an amendment to the rule, or yield for

the purpose of amendment.''

In Deschler's Procedure in the U.S. House of

Representatives, the subchapter titled ``Amending Special

Rules'' states: ``a refusal to order the previous question on

such a rule [a special rule reported from the Committee on

Rules] opens the resolution to amendment and further

debate.'' (Chapter 21, section 21.2) Section 21.3 continues:

``Upon rejection of the motion for the previous question on a

resolution reported from the Committee on Rules, control

shifts to the Member leading the opposition to the previous

question, who may offer a proper amendment or motion and who

controls the time for debate thereon.''

Clearly, the vote on the previous question on a rule does

have substantive policy implications. It is one of the only

available tools for those who oppose the Republican

majority's agenda and allows those with alternative views the

opportunity to offer an alternative plan.

Mr. Speaker, I yield back the balance of my time, and I move the previous question on the resolution.

Mr. Chairman, I yield myself such time as I may consume.

Mr. Chairman, I rise in support of H.R. 6, the SUPPORT for Patients and Communities Act. This bill makes incremental changes to support those affected by the opioid crisis, but it is far from perfect.

H.R. 6 does not adequately deal with the magnitude of the crisis that this country is facing, and there are provisions that I did not support at the subcommittee or full committee markup, including provisions that most Democrats voted against. Nonetheless, I am pleased that Democrats were able to secure positive provisions in the final package that we are considering today.

Most notably, H.R. 6 includes provisions from a bill introduced by Representative Tonko and Representative Lujan that would extend access to evidence-based, medication-assisted treatment. Specifically, this section of the bill will allow advanced practice registered nurses, including midwives, to treat patients with buprenorphine for opiate use disorder for 5 years. The bill will also allow nurse practitioners and physician assistants to treat patients with buprenorphine permanently, and allow qualified providers to treat up to 100 patients instead of 30 patients in their first year.

This is a critical step forward in the expansion of treatment, one of the major challenges that we continue to face in the fight against this epidemic.

Mr. Chair, I commend Representative Tonko and Representative Lujan for their ongoing leadership in this area.

This bill also expands coverage through Medicare by adding methadone clinics to the Medicare program. Right now, methadone clinics are not Medicare providers. Seniors who want to get treatment from methadone clinics have to pay out of pocket. Adding methadone clinics will address an important coverage gap in the Medicare program and meaningfully expand access to treatment for opiate use disorders.

The bill also improves coverage for vulnerable populations in Medicaid, ensures coverage for former foster youth up to the age of 26 nationwide, and supports State efforts to ensure continuity of coverage for people with substance use disorders as they leave incarceration.

The bill will also provide funding to Medicaid substance use disorder health homes, give States money to expand the treatment capacity of Medicaid providers, and raise reimbursement rates. It also mandates coverage of Medicaid for all forms of medication-assisted treatment for 5 years.

The legislation also mandates comprehensive substance use disorder benefits in the Children's Health Insurance Program, better known as CHIP. I am also pleased that H.R. 3528, the Every Prescription Conveyed Securely Act, authored by Representative Clark of Massachusetts, is included in the bill. E-prescribing is an important tool that will reduce opiate diversion and prescription fraud.

Further, the bill gives the Secretary of HHS the authority to expand the use of telehealth services in Medicare for substance use disorder treatment to help reach more people across the country.

These were all important Democratic provisions and priorities that we worked hard to have included in the final package. I think these will all make a real difference in our fight against the opioid epidemic.

Having said that, Mr. Chairman, I still have concerns with some of the provisions included in this final negotiated bill and the process by which we arrived here. For instance, there are two Medicare bills that I opposed through the committee process that I am concerned may not have a meaningful impact on the opioid crisis.

H.R. 5804 would increase reimbursement for certain interventional pain injections in the ambulatory surgery setting under Medicare. I have seen no evidence that increasing reimbursement for these injections would have a meaningful impact on opioid prescribing. While it is important that Congress finds ways to promote nonopioid therapies that will reduce opioid prescribing, this legislation endorses and incentivizes interventions that may not be effective for a majority of the patients receiving them.

I also have some concerns about H.R. 5809, which would extend a temporary pass-through payment for nonopioid analgesics for postsurgical pain management from 3 to 5 years in Medicare. I do question if this bill will have a meaningful impact on the opioid crisis.

I am also disappointed that partisan legislation that would direct the FDA to issue guidance on how the agency will apply the criteria for accelerated approval and breakthrough therapy designation to nonaddictive pain and addiction treatment was included in this package. This legislation would set the precedent of having the FDA opine on how expedited programs may apply differently for therapeutic areas.

It requires the agency to host a public meeting to discuss this and other topics, but provides no resources for the agency to complete these tasks. This is not legislation that FDA asked for or highlighted as a priority in fighting the opioid crisis.

While they may now be comfortable with the changes that have been made to the bill, I am not comfortable with the policy.

Finally, Mr. Chairman, I think it is essential that we keep this opioid package in the context of a larger healthcare debate in Congress. As I have stated before, my Republican colleagues are interested in taking credit today for some policies that helped those affected by the crisis while at the same time actively threatening and sabotaging the very healthcare coverage that many of the same people rely on in the first place. The ongoing efforts by House Republicans and the Trump administration to repeal or sabotage the Affordable Care Act have only harmed those affected by this crisis.

Earlier this month, Republicans directly threatened the healthcare of people with opioid use disorder when the Trump administration asked a Federal court to strike down key patient protections in the Affordable Care Act. If successful, the Trump administration's action would eliminate protections that ensure more than 130 million Americans with preexisting conditions cannot be denied coverage. And guess what is considered to be a preexisting condition? Opioid use disorders and people with it.

Republicans also continue with their attempts to gut the Medicaid program, which is our most important weapon in the fight against this epidemic. Both the consumer protections of the ACA and Medicaid have saved countless lives that would have otherwise been destroyed by the opioid crisis. So it is nice that we are passing this bipartisan package today, but we should not forget the tremendous harm Republican policies would inflict elsewhere on the same people we seek to help with this opioid package.

Mr. Chair, I reserve the balance of my time.

Mr. Chairman, I yield 2 minutes to the gentlewoman from California (Ms. Eshoo).

Mr. Chairman, I yield the gentlewoman from California an additional 30 seconds.

Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Peters).

Mr. Chairman, I yield 2 minutes to the gentlewoman from Massachusetts (Ms. Clark).

Mr. Chairman, I yield 3 minutes to the gentleman from New York (Mr. Tonko).

Mr. Chairman, may I ask how much time I have remaining.

Mr. Chairman, I yield 2 minutes to the gentlewoman from California (Ms. Bass).

Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Cardenas).

Mr. Chairman, I want to enter into the Record my extended remarks regarding a provision included in H.R. 6 that does not enjoy bipartisan support.

Section 301 was passed out of the Energy and Commerce Committee on a party-line vote. Had a committee report been filed, I would have filed the dissenting views that I am now seeking to have added to the Record.

Mr. Chair, H.R. 5806, the 21st Century Tools for Pain and Addiction Treatment Act, would require the Food and Drug Administration (FDA) to hold a public meeting regarding the challenges and barriers of developing non-addictive pain and addiction treatments and to issue guidance regarding the eligibility of such treatments for either the Accelerated Approval Program or Breakthrough Therapy Designation. This legislation could undermine FDA's implementation of the Accelerated Approval and Breakthrough Therapy Designation programs and divert critical financial and personnel resources away from activities related to addressing the opioid crisis for purposes of incentivizing an industry that is already taking advantage of these programs. This legislation is a solution in search of a problem.

Opioid overdose death rates are now the leading cause of unintentional, non-traumatic deaths in the United States. According to the Centers for Disease Control and Prevention (CDC), overdose deaths from opioids have quadrupled in the last 20 years. Approximately 116 deaths per day occur from an opioid overdose resulting in over 42,000 deaths per year.

Of those deaths, 40 percent are due to a prescription opioid. Every day, over 1,000 individuals are treated in emergency departments for complications due to the misuse of opioids, and hospitalizations have increased by over 60 percent since 2005. It is within this context that there has been increasing interest in developing non-addictive treatments for pain and substance use disorders.

FDA, led by Commissioner Scott Gottlieb, has acknowledged that the agency has a role to play in addressing the opioid crisis, including ensuring that fewer individuals become addicted through medical use of these products. According to Commissioner Gottlieb, this includes ``helping support the development of new, safe and effective treatments for pain that don't carry all the same risks of addiction as opioid medicines.'' One of his first actions was the creation of the Opioid Policy Steering Committee (OPSC) that has been tasked with fostering the development of novel pain treatment therapies, and the advancement of non-addictive drugs and devices to treat pain was also included as one of the agency's priorities in FDA's 2018 Strategic Policy Roadmap.

Despite this, concerns have been raised from some pharmaceutical manufacturers that more could be done to help incentivize manufacturers to develop non-addictive treatments for pain and addiction. This included legislation that would direct FDA to issue guidance clarifying how and when the agency would provide accelerated approval and breakthrough therapy designation for medicines to treat pain or addiction. In addition, the proposal includes requiring a detailed annual report in which the agency would account for the number of requests received, granted, or denied for consideration under the expedited programs, the common reasons for granting or denying an application for expedited programs, timelines for drug development, timelines for product review, comparison of metrics among review divisions, common reasons for longer timelines for drug development and product review, as well as recommendations as to how the expedited programs could be better utilized. This legislation was subsequently released by Representative Burgess (R-TX) and was one of the bills noticed for a hearing on March 21, 2018. At this hearing, a representative from BIO testified that the legislation is needed to ``serve as a powerful signal to stakeholders and investors that treatment and therapies that improve and protect the lives of patients suffering from pain and addiction is a top public health priority.''

H.R. 5806, the 21st Century Tools for Pain and Addiction Treatment Act, was formally introduced on May 15, 2018, with Reps. Bucshon and Griffith joining as co-authors. As introduced, the legislation would direct FDA to hold at least one public meeting within one year of enactment to discuss the challenges and barriers of developing non- addictive medical products intended to treat pain or addiction, including the application of novel clinical trial designs and the use of real world evidence and patient experience, as well as the application of eligibility criteria for the Accelerated Approval program and the Breakthrough Therapy designation. In addition, the bill would also direct FDA to issue final guidance or update existing guidance regarding how the agency would apply eligibility criteria for the Accelerated Approval program and the Breakthrough Therapy designation to non-addictive medical products for pain or addiction, including considering the risk of addiction to controlled substances for pain when establishing unmet medical need, and considering whether pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition. The guidance must also cover the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain and how the endpoints would be evaluated for efficacy.

FDA has repeatedly noted that it is actively working with industry and other government partners to encourage the development of non- opioid treatments for pain and addiction. Both former FDA Commissioner Robert Califf and current FDA Commissioner Scott Gottlieb have stated that FDA will use all of the tools at the agency's disposal to move alternatives to opioids as expeditiously as possible. This is a commitment that Commissioner Gottlieb has continued to echo in testimony before the Energy and Commerce Committee (the Committee), specifically noting that ``This includes programs such as Fast Track and Breakthrough Therapy Designations that are intended to facilitate development and to expedite review of products that, for example, are intended to treat a serious condition for which there is an unmet medical need. As a part of these efforts, FDA is meeting with innovators who are pursuing non-opioid alternatives for the treatment of pain to provide guidance on their individual products.''

However, FDA's commitment to this development has not been limited to testimony before Congress or through meetings with industry. In the last five years, FDA has taken a number of actions to help with development of alternative pain and addiction treatments, including convening the Science Board to discuss issues related to challenges facing FDA in supporting the development of pain medications; issuing final guidance and hosting two public meetings regarding the development of opioids with abuse deterrent properties; and as mentioned previously, the advancement of non-addictive drugs and devices to treat pain was also included in FDA's 2018 Strategic Policy Roadmap. Further, the agency also participated in a public-private- partnership under the Critical Path initiative, the Analgesic Clinical Trial Translation, Innovations, Opportunities, and Networks (ACTTION). ACTTION is a collaboration among a broad range of national and international groups working to advance the science in non-opioid and non-addictive pain medications, and includes participation from academia, government agencies, pharmaceutical and device companies, professional organizations, and patient advocacy groups. The agency has also approved non-opioid medications for treatment of chronic pain, including gabapentin, pregabalin, milnacipran, and duloxetine, among others.

These actions are all in addition to the consultation and meetings offered by FDA to sponsors in this space in a one-on-one setting. FDA has committed, to discussion with individual sponsors related to questions about the development of non-opioid and non-addictive medical products for pain or addiction. No evidence has been provided by supporters of this legislation, or by the Majority, that has shown otherwise.

FDA has in place four pathways by which review and consideration of a drug can be expedited--Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track. These pathways provide the sponsor of certain drugs with access to assistance and streamlined review from the agency. At issue in H.R. 5806 is the application of Accelerated Approval and Breakthrough Therapy Designation.

Accelerated Approval, first established in 1992 and codified in 2012, allows drugs for serious conditions that meet an unmet medical need to be approved based on a surrogate endpoint. The use of a surrogate endpoint may predict the clinical benefit of a drug earlier, and FDA is able to require the manufacturers to conduct post-market confirmatory studies to verify the clinical benefit. The Breakthrough Therapy Designation, established in 2012, provides sponsors of drugs to treat a serious condition with preliminary evidence that they demonstrate substantial improvement over other available treatments with access to intensive guidance regarding their drug development program, more frequent meetings and communication with FDA, and rolling review. Both pathways are desirable from a manufacturer's perspective as it can allow products to come to market sooner. A recent study conducted by Friends of Cancer Research found that cancer drugs that received Breakthrough Therapy Designation received FDA approval nearly three months sooner than drugs that did not, and their development time was reduced by nearly two years.

The additional guidance, communication, and expedited review provided by these two programs does have an impact on both the financial and personnel resources of FDA. In fact, the Breakthrough Therapy Designation program received far more interest than originally projected, and given the access to FDA staff throughout the development and review process and has been described by the agency as posing a ``strain'' because the creation of the designation did not come with any additional resources. According to testimony from Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, over the first four years of the program the agency had received 492 requests for designation, and of those, granted 165 requests. As a result, industry and FDA negotiated to increase the number of staff dedicated to the Breakthrough Therapy Designation program by 36 full- time employees as part of the Prescription Drug User Fee Act reauthorization signed into law as a part of the Food and Drug Administration Reauthorization Act. While user fee resources may help to address the issues associated with the implementation of the Breakthrough Therapy Designation program, the Office of New Drugs within the Center for Drug Evaluation and Review (CDER) continues to be short-staffed with one estimate noting that the Office is 10 percent under the authorized staffing ceiling.

As previously mentioned, proponents of the legislation have argued it is necessary in order to help ``enable the utilization of Accelerated Approval and Breakthrough Therapy pathways'' for non-addictive pain and addiction treatments. ``Enactment and implementation of this legislation would provide FDA and the biopharmaceutical industry with a greater understanding of what is required to meet criteria for these expedited approval pathways and ensure processes intended to expedite development and approval meet the unique needs of

pain and addiction medicines,'' noted Ms. Cartier Esham, Executive Vice President, Emerging Companies Section and Senior Vice President, Science & Regulatory Affairs at BIO, in testimony before the Committee. Despite the claims of lack of clarity, there is evidence that industry has been taking advantage of both of these pathways currently.

Accordingly, in technical assistance provided by FDA the agency stated, ``We believe, however, that sponsors and potential sponsors of [non-opioid and non-addictive medical] products are already aware of these programs, and have been taking advantage of them. We also believe that to the extent there is a need for additional outreach on application of the expedited programs to these products, FDA has, and is committed to using, other means to accomplish this, such as public meetings . . . and discussion with individual sponsors.'' More than 60 percent of new molecular entities and biologics license applications approved in 2017 were eligible for one of the expedited programs--Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval. This includes products in the pain and addiction space. On Breakthrough Therapy Designation, there have been 19 requests for designation from drugs with pain indications since the program was created, three of those were granted, 14 were denied, and two were withdrawn. According to FDA, ``In general, if a drug meets the statutory criteria it will get the designation.'' In regard to Accelerated Approval, there has been one drug with an indication for pain; another product has received Fast Track designation. All evidence indicates that sponsors of non- opioid and non-addictive medical products for pain and addiction are receiving access to FDA and have been able to take advantage of the expedited programs if they meet the statutory criteria.

The opioid crisis has made everyone rethink how we treat pain and addiction in this country and there is broad agreement that this conversation should include examining alternatives to opioids that are non-addictive. Patients and providers deserve to have options other than opioids for pain and addiction. It is clear that FDA has prioritized this effort and has been assisting sponsors in their development. No evidence has been provided that demonstrates otherwise. H.R. 5806 is legislation in search of a problem.

A key provision of H.R. 5806 is directing FDA to issue, or update, guidance regarding how the agency will apply the Accelerated Approval and Breakthrough Therapy Designation program to non-addictive medical products for pain or addiction. This would include the circumstances under which FDA may apply eligibility criteria to these products, how FDA will consider the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need, and how FDA will consider pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening condition. Such an effort would be precedent-setting for the agency as it would be the first time the agency would do such a regulatory guidance for a product specific area.

In order to help drug sponsors make determinations about whether or not their products would be eligible for expedited programs pathways, as well as Fast Track and Priority Review, the agency issued comprehensive guidance outlining the requirements and features of each of the pathways in May 2014. As noted in the guidance, ``The purpose of this guidance for industry is to provide a single resource for information on FDA's policies and procedures for these four programs as well as threshold criteria generally applicable to concluding that a drug is a candidate for these expedited development and review programs.'' H.R. 5806 would move to change this by requiring the agency to issue new guidance for non-addictive pain or addiction treatments. According to technical assistance received from FDA:

Typically, FDA refrains from issuing product area-specific

guidance documents unless there is a need to address

scientific or clinical issues specific to those products. It

is not clear what scientific or clinical issues specific to

application of our expedited programs to non-opioid or non-

addictive medical products to treat pain or substance use

disorder would benefit from FDA guidance. To the extent

sponsors have questions about how FDA's expedited programs

apply to their specific products, such questions are better

addressed in our existing guidance on the use of expedited

programs in general and in meetings or other communications

between FDA and individual sponsors. These latter

interactions with FDA permit targeted, product-specific

discussion of a type that is typically not possible in

guidance--even product area-specific guidance.

By requiring the agency to issue such guidance, despite FDA's concerns, H.R. 5806 is now raising questions regarding whether or not the criteria for the expedited programs applies differently for each product area, and could expose the agency to a multitude of additional requests from other therapeutic areas for product area-specific guidance about the eligibility for these pathways.

In addition, H.R. 5806 would also require the agency to host at least one public meeting to examine challenges and barriers facing non- addictive medical products for pain and addiction, including application of novel clinical trial designs, use of real world evidence and patient experience data, as well as the eligibility criteria for Accelerated Approval and Breakthrough Therapy Designation. Public meetings and guidance require considerable staff time and financial resources, diverting time away from other activities such as meeting one-on-one with sponsors or responding to questions regarding submissions. This legislation does not provide any new resources for these activities, and would have been more appropriately discussed during consideration of the user fee reauthorization that could have accounted for the need for additional resources to implement these activities.

As FDA has noted, the agency grants access to the expedited programs if products meet the statutory requirements of such programs. Proponents have argued that legislation is necessary to incentivize industry to develop non-addictive pain and addiction treatments as well as to make sure that the expedited programs and processes ``meet the unique needs of pain and addiction medicines.'' This makes clear the legislation is not about greater clarity as supporters have argued, but is instead about re-interpreting the requirements of the expedited programs to ensure that non-addictive pain or addiction treatments will be eligible. H.R. 5806 as such could be used in the future for stakeholder to request the eligibility for the expedited programs be changed to guarantee that their products can receive Accelerated Approval and Breakthrough Therapy Designation should the guidance provided under this legislation not be suffice. This could have the effect of unintentionally weakening the benefits of Accelerated Approval and Breakthrough Therapy Designation pathway by expanding it to even more products, and put strain on FDA's resources by expanding such programs to products that were not planned for under the user fee reauthorizations. While we all want to bring alternatives to opioids to market sooner, we must seriously consider the implications of expanding FDA's expedited programs.

Finally, this is not legislation that FDA has asked for or highlighted as a priority in fighting the opioid crisis. While the agency has indicated that they are not opposing the legislation and believe the changes that have been made are helpful, this legislation can have real and serious implications for the drug approval process.

It is for all these reasons that Democrats unanimously opposed H.R. 5806.

Mr. Chair, I reserve the balance of my time.

Mr. Chair, I have no additional speakers, and I reserve the balance of my time.

Mr. Chair, I continue to reserve the balance of my time.

Mr. Chairman, I want to thank the staff who worked so hard on H.R. 6 and the opioid bills, in general. Democrats worked to make H.R. 6 a better bill, even though we have concerns about the overall impact of the opioid package.

Mr. Chair, I ask my colleagues to support the legislation, and I yield back the balance of my time.

Mr. Speaker, pursuant to House Resolution 949, I call up the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records, and ask for its immediate consideration in the House.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and insert extraneous material on H.R. 6082.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, over the course of the past several months, the Energy and Commerce's Subcommittee on Health held four legislative hearings on bills to address the opioid epidemic and reported 57 bills to the full committee. Of those 57 bills, only one received its own discrete hearing. That bill was H.R. 6082, the Overdose Prevention and Patient Safety Act, introduced by Representatives Mullin and Blumenauer.

As a physician, I believe it is vital that doctors have all of the appropriate information to determine the proper course of treatment for a patient, ensuring patient safety and privacy, as required by Federal regulation known as HIPAA. The Overdose Prevention and Patient Safety Act maintains the original intent of the 1970s statute behind 42 CFR part 2 by protecting patients and improving care coordination.

In fact, the bill increases protections for those seeking treatment by more severely penalizing those who illegally share patient data than under the current statute. Current part 2 law does not protect individuals from discrimination based on their treatment records and, to this date, there have been no criminal actions undertaken to enforce part 2.

This bill has a wide range of support from national and State organizations. Since the bill was introduced, the Energy and Commerce Committee has heard from over 100 organizations in its support.

Arguably, the most notable support for this legislation comes from the Substance Abuse and Mental Health Services Administration in the Department of Health and Human Services. Dr. Elinore McCance-Katz, the Assistant Secretary for Mental Health and Substance Use, wrote to Mr. Mullin in March, stating that SAMHSA ``is encouraged to see Congress examine the benefits of aligning part 2 with HIPAA. Patient privacy is, of course, critical but so too is patient access to safe, effective, and coordinated treatment.''

I agree with Dr. McCance-Katz that in order to ensure patient safety, physicians must have secure access to patient records, including substance use disorder information. When this information is not provided to healthcare professionals, they may end up prescribing medications that have dangerous drug interactions or may lead a patient who is in recovery to be inappropriately prescribed an opioid and fall back into addiction.

One particular complication driven by 42 CFR part 2 directly impacts the care for pregnant women and their infants. For women who are pregnant, part 2 does not allow redisclosure of substance use disorder medical documentation to the women's OB/GYN doctor, primary care physician, or health home without their written consent. This leads to fragmented care, which opens up the mother and her baby to potential harm.

Centerstone, one of the Nation's largest not-for-profit healthcare organizations, notes that ``mothers who continue to use during pregnancy and who do not wish to sign secondary releases to allow their care providers to treat them comprehensively put their unborn children at risk for addiction.''

Centerstone watches these women and their infants suffer right before their eyes, but, because of part 2, Centerstone cannot share the information to ensure that the mother and baby are getting proper care.

As an OB/GYN physician myself, I cannot imagine having this information withheld. Such a situation would leave me with the inability to treat the whole patient and ensure that the mother is healthy and her baby is not on a path for addiction.

In another situation, a patient was referred to a treatment center following an emergency room visit for an overdose. The patient was not able to give written consent to his providers due to acute intoxication. Due to a lack of written consent and 42 CFR part 2, the treatment facility could not communicate to the ER and learn about the patient's condition or confirm that the patient had, indeed, enrolled in a drug treatment center, further delaying critical care coordination.

There is clear evidence that part 2 is a massive roadblock to providing safe, quality, and coordinated care to individuals suffering from substance use disorder.

The issue of the stigma associated with substance use disorder has been a constant in all of the discussions that we have had, both in our offices and in our hearings. In April, we heard from numerous individuals who were parents of children who died from opioid overdoses. Some noted that their children were afraid to seek help from their families or from healthcare professionals because they were embarrassed or they felt stigmatized.

We should enable physicians to fully care for these patients suffering from substance use disorder as if they had any other disease. The Overdose Prevention and Patient Safety Act will do just that.

The first step in addressing a problem is admitting that it exists. I would like to pose a question to those who are arguing against this legislation:

If we continue to silo the substance use disorder treatment information of a select group of patients rather than integrating it into our medical records and comprehensive care models, how can we ensure that these patients are, in fact, receiving quality care? How can we really treat substance use disorder like all other complex health conditions?

H.R. 6082 ensures adequate patient data protection in accordance with Federal law, with HIPAA. There are provisions in the language that ensure that the data may only be used for purposes of treatment, payment, or healthcare operations. Substance use disorder data cannot be used in criminal, civil, or administrative investigations, actions, or proceedings without patient consent or a court order.

Additionally, the legislation explicitly prohibits discrimination against an individual on the basis of their patient needs. Currently, part 2 includes no antidiscrimination protections and no protections for individuals if there is a data breach or improper disclosure.

Think about that for a minute, Mr. Speaker. This was a 1970s-era law. There were not data breaches back in the 1970s. 42 CFR part 2 was never intended to protect a patient in the instance of a data breach.

Should any entity or individual share patient data under H.R. 6082, they, in fact, will be severely penalized.

There is a reason why SAMHSA and most of the healthcare stakeholder community is asking for this change. Clearly, there is an issue here that must be addressed. This opioid crisis is devastating our country. Passing the Overdose Prevention and Patient Safety Act will enable greater coordination among healthcare providers in providing quality, effective care for individuals across the country who are battling substance use disorder.

My thanks to Mr. Mullin on the Energy and Commerce Committee and to Mr. Blumenauer for introducing this legislation that is of utmost importance.

I urge strong support for the bill, and I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Oklahoma (Mr. Mullin), the principal sponsor of the bill and a valuable member of the Energy and Commerce Committee.

Mr. Speaker, I yield 5 minutes to the gentleman from Oregon (Mr. Walden), the chairman of the full committee.

Mr. Speaker, I yield myself 2 minutes for the purpose of response before I yield to Dr. Bucshon.

Mr. Speaker, the tragic story that was just related to us really only reinforces the need to change the statute behind 42 CFR part 2. There are some important facts missing from the description of the situation that occurred.

It appears evident that at least one or both of the parties involved, the judge, and/or the methadone maintenance program, violated existing regulations under both part 2 and HIPAA.

Under part 2, patient records may only be disclosed without patient consent if the disclosure is authorized by an appropriate order of a court of competent jurisdiction. There must be a showing of good cause in which the court must weigh the public interest and need for disclosure against the injury to the patient, the physician-patient relationship, and treatment services. Further, the court must impose appropriate safeguards against unauthorized disclosure.

It is not clear from the description provided in the letter how the judge found out about the patient's participation in a methadone maintenance program. If the information to the judge was provided without an appropriate court order, then the methadone maintenance program likely violated the requirements under part 2 to safeguard the patient's records from such disclosure. If the information was provided as a result of a court order, then it is possible that the judge violated his or her ethical obligations to appropriately weigh the need for the information and safeguard the information once received.

Under HIPAA, there is still an obligation for the parties seeking information to confirm that reasonable efforts have been made to ensure that the individual has been given notice of the request for personal health information and the opportunity to object or that reasonable efforts have been made to secure a qualified protective order. Compliance with either of these requirements appears to have been lacking in the situation described in the letter.

All of this suggests that part 2 currently is insufficient to protect patients in these situations. The legislation before us today does not decrease the protections against the use of the records in criminal proceedings that already exist under part 2, but HIPAA makes the protections stronger.

I yield 3 minutes to the gentleman from Indiana (Mr. Bucshon), a valuable member of our committee and our subcommittee that has heard the testimony on this legislation.

Mr. Speaker, I yield 3 minutes to the gentleman from Illinois (Mr. Shimkus), a valuable member of the Energy and Commerce Committee.

(Mr. SHIMKUS asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield an additional 30 seconds to the gentleman from Illinois.

Mr. Speaker, I yield myself 3 minutes.

Mr. Speaker, I would like to point out that there are over 100 groups in support of the Partnership to Amend 42 CFR part 2. A letter from that partnership says, in part:

We are pleased that the bill aligns part 2 with HIPAA's

consent requirements for the purposes of treatment, payment

and operations, which will allow for the appropriate sharing

of substance use disorder records, among covered entities, to

ensure persons with opioid use disorder and other substance

use disorders receive the integrated care that they need.

Additionally, as we do not want patients with substance use

disorders to be made vulnerable as a result of seeking

treatment for addiction, this legislation strengthens

protections and limits the number of institutions that have

access to their records.

I am not going to read all of the names on the list, but some of the notable ones are the National Alliance on Mental Illness, Mental Health America, Hazelden Betty Ford Foundation, National Governors Association, Healthcare Leadership Council, American Hospital Association, American Society of Addiction Medicine, Centerstone, New Jersey Hospitals, and National Association of Addiction Treatment Providers.

Mr. Speaker, I include in the Record the entire list of all of the groups in favor of the Partnership to Amend 42 CFR.

Partnership To Amend 42 CFR Part 2--A Coalition of Over 40 Health Care Stakeholders Committed To Aligning 42 CFR Part 2 (Part 2) With HIPAA To Allow Appropriate Access to Patient Information That Is Essential for

Providing Whole-Person Care

June 15, 2018.

Hon. Markwayne Mullin,

House of Representatives,

Washington, DC.

Hon. Earl Blumenauer,

House of Representatives,

Washington, DC.

Dear Representatives Mullin and Blumenauer: The undersigned

members of the Partnership to Amend 42 CFR Part 2

(Partnership) and additional stakeholder organizations

applaud your leadership on the issue of substance use

disorder privacy records. We strongly support the Overdose

Prevention and Patient Safety (OPPS) Act, H.R. 6082, which

will align 42 CFR Part 2 (Part 2) with the Health Insurance

Portability and Accountability Act (HIPAA) for the purposes

of health care treatment, payment, and operations (TPO). The

Partnership is pleased that the OPPS Act was voted out of the

Committee on Energy and Commerce with a bipartisan vote.

The Partnership is a coalition of more than 40

organizations representing stakeholders across the health

care spectrum committed to aligning Part 2 with HIPAA to

allow appropriate access to patient information that is

essential for providing whole-person care.

We are pleased that the bill aligns Part 2 with HIPAA's

consent requirements for the purposes of TPO, which will

allow for the appropriate sharing of substance use disorder

records, among covered entities, to ensure persons with

opioid use disorder and other substance use disorders receive

the integrated care they need. Additionally, as we do not

want patients with substance use disorders to be made

vulnerable as a result of seeking treatment for addiction,

this legislation strengthens protections and limits the

number of institutions that have access to patient records.

Thank you both for your leadership on this issue and we

look forward to working with you on helping to address the

opioid crisis by passing this important bipartisan

legislation on the floor of the U.S. House of

Representatives.

Sincerely,

Partnership to Amend 42 CFR Part 2 Members

Academy of Managed Care Pharmacy; American Association on

Health and Disability; American Health Information Management

Association; American Hospital Association; American

Psychiatric Association; American Society of Addiction

Medicine; American Society of Anesthesiologists; America's

Essential Hospitals; America's Health Insurance Plans; AMGA;

Association for Ambulatory Behavioral Healthcare; Association

for Behavioral Health and Wellness; Association for Community

Affiliated Plans; BlueCross BlueShield Association; Catholic

Health Association of the U.S.; Centerstone; Confidentiality

Coalition; Employee Assistance Professionals Association;

Global Alliance for Behavioral Health and Social Justice;

Hazelden Betty Ford Foundation.

Health IT Now; Healthcare Leadership Council; The Joint

Commission; InfoMC; Medicaid Health Plans of America; Mental

Health America; National Alliance on Mental Illness; National

Association for Behavioral Healthcare; National Association

of ACOs; National Association of Counties (NACo); National

Association of State Mental Health Program Directors

(NASMHPD); Netsmart; OCHIN; Otsuka; Pharmaceutical Care

Management Association; Premier Healthcare Alliance.

Additional Stakeholder Organizations

ACO Health Partners; Aetna; AMITA Health; Anthem, Inc.;

Ascension Health; Avera Health; Banner Health; Baptist

Healthcare System; Beacon Health Options; Bon Secours Health

System, Inc.; CareSource; Catholic Health Initiatives;

Centene Corporation; Change Healthcare; Cigna; College of

Healthcare Information Management Executives (CHIME).

Excellus BlueCross BlueShield; Franciscan Sisters of

Christian Charity Sponsored Ministries, Inc.; Greater New

York Hospital Association; Henry Ford Health System; Howe

Home Designers; Johns Hopkins Medicine; Kern Health

Systems; Leidos; Lycoming County; Magellan Health;

Marshfield Clinic Health System; Mental Health America of

Indiana; Mosaic Life Care; NAMI; NAMI DC; NAMI Delaware.

NAMI Greene County Tennessee; NAMI Helena; NAMI of Howard

County, MD; NAMI Jefferson County, Washington; NAMI Kaufman

County; NAMI Kershaw County; NAMI Lewistown; NAMI Lexington;

NAMI of the Pee Dee (South Carolina); NAMI Piedmont Tri-

County; NAMI Sarasota County; NAMI South Suburbs of Chicago;

NAMI Sussex, Inc.; NAMI Temple Area; NAMI Utah; NAMI Valley

of the Sun.

National Alliance on Mental Illness (NAMI) Texas; National

Association of Addiction Treatment Providers; New Directions

Behavioral Health; OPEN MINDS; Optum; PerformCare; Providence

St. Joseph Health; SCAN Health Plan; SSM Health; Texas Health

Resources; The Center for Health Affairs/Northeast Ohio

Hospital Opioid Consortium; The MetroHealth System; Trinity

Health; University of Tennessee Medical Center; Valley Health

System; Vizient; Wayne Meriwether.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, by continuing to segregate substance use disorder records means that we are willing to allow some patients to receive care that is potentially lower quality at a higher cost.

Treating patient substance use disorder in isolation from their medical and mental health conditions--which predominated care in the 1970s--is not the standard for good practice today. There is now overwhelming evidence that patients' substance use disorders cannot be treated in isolation from other healthcare conditions. In the 1970s when part 2 was written, this was not widely accepted, and treatment for addiction was largely separate from treatment for other illnesses.

Mr. Speaker, further, I would say that the problem here is we need to treat addiction just like any other medical illness and improve our outreach to patients who meet the criteria for treatment. Maintaining a decades old, ineffective confidentiality law simply is not going to do that.

I urge my colleagues to support the bill. It is a good bill supported by Mr. Mullin and Mr. Blumenauer.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I reserve a point of order against the motion.

Mr. Speaker, I withdraw my point of order.

Mr. Speaker, I claim the time in opposition to the motion.

Mr. Speaker, I urge a ``no'' vote on the motion to recommit as it will destroy the intent of the bill.

Eliminating the sharing of records for the purposes of treatment, payment, and healthcare operations completely negates the entire purpose of this initiative.

Aligning 42 CFR part 2 with HIPAA for purposes of treatment, payment, and healthcare operations is the entire purpose of the legislation.

Opponents of this bill have offered no evidence or findings to back up their claim that HIPAA is inadequate to protect sensitive data contained in substance use disorder treatment records.

HIPAA is currently functioning well in protecting sensitive patient information in a number of areas.

Real integration of behavioral health and primary care simply cannot happen until we align 42 CFR part 2 with HIPAA.

The opposition of H.R. 6082 is not based on protecting privacy. It is based on very specific distrust of the healthcare community to properly provide care to people with substance use disorder--the very people whom we are asking to help us with this.

Yet, the ranking member is strongly in favor of numerous bills that seek to expand access to evidence-based medication-assisted treatment, telehealth and integration with mainstream medicine--the very things that demand alignment with HIPAA. So the thinking, Mr. Speaker, to be kind, is incongruous.

Prohibiting the sharing of addiction medical records for treatment, payment, and healthcare operations makes it impossible to prescribe the latest substance use treatment medications safely.

Like most pharmaceuticals, buprenorphine and methadone have drug interactions and interact with other medicines. Adverse events from drug interactions can lead to emergency hospital visits, serious injuries, or death.

We must amend part 2 so we can safely prescribe medication-assisted treatment for patients. Put simply, standard clinical practices like medication reconciliation are not feasible under the current Federal law. For that reason, I urge my colleagues to vote ``no'' on the motion to recommit. Vote ``yes'' on the underlying motion.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

(Mr. McGOVERN asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I thank the gentleman from Texas (Mr. Burgess) for yielding me the customary 30 minutes.

Mr. Speaker, my Republican colleagues are rushing to congratulate themselves for finally addressing opioid addiction. But, Mr. Speaker, what took them so long? This is an epidemic that fueled more drug overdoses in America in 2016 than died in the Vietnam war. In fact, opioids now kill more people every year than breast cancer. 115 Americans are dying from them every single day.

These statistics aren't new. They have been staring the Republicans in the face for months. The public has been pushing this Congress to act. Democrats have been pushing measure after measure after measure to address opioid addiction, but the majority has used their restrictive amendment process to block them from even getting a vote on the House floor.

More than a dozen amendments dealing with opioids have been blocked by the majority from even getting a debate. One of these amendments had bipartisan support, but it was blocked all the same.

This from a Republican majority that has already turned this Congress into the most closed Congress in history. Let me say that again. These guys, my Republican colleagues, have presided over the most closed Congress in history. There have already been 86 completely closed rules during the 115th Congress, and it is only June.

That number is expected to grow later this week as the majority considers their partisan immigration bills under a closed process.

Mr. Speaker, as well-intentioned as these bills may be, we aren't considering them in a vacuum. And here is the deal: We are taking them up at a time when Republicans are continuing their crusade against the Affordable Care Act, a law that has helped millions of Americans suffering from substance use disorders.

The Trump administration is refusing to defend the ACA. And get this: its Justice Department recently asked in a legal filing for the courts to invalidate this law's protections for preexisting conditions.

Mr. Speaker, does the majority realize that substance use disorders are a preexisting condition?

If Republicans are successful, they will make the opioid crisis even worse. And it doesn't stop there. Some conservative groups are pushing the majority to try repealing the ACA completely again before the summer is out.

This, after Republicans came within a few votes of taking healthcare from 23 million Americans last year, including those suffering from opioid addiction.

These rightwing groups released their latest repeal plan yesterday, so the words from my Republican friends today ring particularly hollow.

Mr. Speaker, we all know that the best answer to an epidemic is to get as many people as possible into treatment and to provide them and their families the support that they need. And one of the most effective ways to accomplish

this is to expand Medicaid and expand treatment options for substance abuse through the ACA.

Last October, the Republicans made clear what they think of the hundreds of thousands of Americans suffering from opioid addiction and alcohol and drug abuse. They passed a budget that makes $1.3 trillion in cuts to healthcare, including a 30 percent cut to Medicaid.

Mr. Speaker, Republicans can't bemoan the opioid epidemic on one hand and vote time and time again to cut the very healthcare systems required to treat addiction.

Nor can you set up a biased, tiered system that grants access to treatment for opioid addiction at the expense of providing treatment for addiction and abuse of other substances, like key provisions in H.R. 5797. Not only is that inhumane and immoral, but it is also ineffective. It undermines the entire health system of treating substance abuse.

Mr. Speaker, many Democrats have joined the majority in supporting one of these bills, H.R. 6, the SUPPORT for Patients and Communities Act. It is a good bill. It would help Medicare and Medicaid better respond to substance use disorders. We are working with the majority here.

So, Mr. Speaker, why won't they work with us to defend the ACA, preserve protections for preexisting conditions, and expand Medicaid.

Now, I know asking Congressional Republicans to show some empathy right now is a tall order. This is the group that has furthered President Trump's spin on family separations at the border, a policy he can change unilaterally, right now if he wanted to. I mean, children are being ripped out of their parents' arms in tears and kept in cages, warehouses, and tent cities. It is appalling and it is un-American.

You don't have to take my word for it. Republicans, like First Lady Laura Bush and Senator John McCain, have spoken out against it. And a U.S. attorney in Texas made clear it was President Trump's policy choice alone. And get this: This is a U.S. attorney who the President himself appointed.

But change is possible. Congressional Republicans can see the error of their ways. They can reject these calls for repeal. They can stop sitting idly by as President Trump attacks the Affordable Care Act. And they can start standing up for the 133 million Americans with preexisting conditions. That includes those suffering from addiction.

They could stop giving the President cover when he falsely claims that Democrats caused the chaos at the border that he clearly caused.

Stop playing with people's lives. We are talking about their healthcare. We are talking about getting treatment for addiction. For God's sake, we are talking about taking children out of the arms of their mothers. This isn't a handful of cases, it is thousands of cases. It is outrageous.

It is time for the adults in Congress, men and women of conscience, to stand up for what is right, not only on the opioid crisis, but on so many other important issues facing this country. I hope the majority comes to its senses before it is too late.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

Just let me remind my colleagues again, because I think it is worth emphasizing, that no matter what we do in the next couple of days with these bills that are going to be before the House, they are rendered meaningless if the Republicans continue in their effort to cut Medicaid and to take away protections for people with preexisting conditions.

Substance use disorder is a preexisting condition and Republicans, working with the White House, are trying to eliminate that protection for people. I don't get it. It doesn't make sense. But we ought to make sure that we keep this debate in context and people know what is going on out there.

Mr. Speaker, I yield 6 minutes to the gentlewoman from California (Ms. Matsui).

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, again, none of what we are doing here today is going to matter if the Republicans and the Trump administration are successful in cutting Medicaid and in basically removing the guarantee that people who have preexisting conditions cannot be denied insurance.

I mean, if the Trump administration is successful, individuals with preexisting conditions all across the country, including individuals suffering from opioid use disorders, both in the individual and in the employer market, could face a denial of coverage or skyrocketing premiums beyond anything anybody could afford.

I don't get it. I don't understand the hypocrisy here. I know that the efforts here today are well intentioned and people are trying to do the right thing, but then you ruin it all when you gut the funding sources that help people deal with the treatment they need.

This has to stop.

I know some of my friends have ideological blinders on when it comes to anything that was passed during the Obama administration, but we have got to put the American people first, and this is a crisis that affects every single community in this country. If this administration is successful in what they are trying to do to undercut the ACA, then countless people will not have access to healthcare and will not have access to the treatment they need.

Mr. Speaker, our Nation is in the midst of a devastating opioid crisis that is spiraling out of control. Every day, more than 115 people in the United States die after overdosing on opioids, according to the National Institute on Drug Abuse. The Centers for Disease Control and Prevention has also found that opioids are responsible for 6 out of 10 overdose deaths in the United States.

The American people are in desperate need of strong action by Congress to stem the tide of the opioid scourge. We need serious public investment to quell this exploding crisis, not just legislation on the peripherals. We must direct resources to the States and local communities on the front lines of this devastating public health crisis where assistance is needed the most.

Mr. Speaker, I am going to ask my colleagues to defeat the previous question, and if we do, I will offer an amendment to bring up Representative Loebsack's legislation, H.R. 4501, the Combating the Opioid Epidemic Act. This bill would provide badly needed funding for State grants for the prevention, detection, surveillance, and treatment of opioid abuse.

Mr. Speaker, I ask unanimous consent to insert the text of my amendment in the Record, along with extraneous material, immediately prior to the vote on the previous question.

Mr. Speaker, I yield 3 minutes to the gentleman from California (Mr. Ruiz).

Mr. Speaker, I yield an additional 2 minutes to the gentleman from California.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, today, we are on the floor discussing the opioid crisis. This is an epidemic that is plaguing every community in the country, and it is killing 115 people every single day. It is heartbreaking, and, quite frankly, I am ashamed it is taking Congress so long to act.

I would again point out that anything we do in the next few days and anything we have done gets erased if the Republicans succeed in cutting Medicaid and if the President succeeds in basically eliminating protections for people with preexisting conditions.

But, Mr. Speaker, I think it is also important that people know there is a lot of stuff going on this week, and we are also awaiting word from the House Republicans when the Rules Committee will have an emergency meeting, I guess today, on two immigration bills that were posted after 9 p.m. last night.

These bills were drafted without any Democratic input, and from what we can tell, they are dangerous and they are certainly not a comprehensive solution to immigration reform. They harm children, and they leave many Dreamers behind.

This is not what our constituents want us to do. They want the President to do what he could easily do and stop separating children from their parents.

The President says that he wants Democrats to come to the table, but we never get invited to anything. I tried to go and see the President yesterday when the Republicans were meeting with him, but I was not allowed to go into the room.

I tried to shout at the President as he was walking by, but he was quickly escorted by. I wanted to show him the pictures on the border of these young children who are being taken away from their parents.

The President continues to spread mistruths about immigration and practically every other issue that is before this Congress and before this Nation, and it seems just to be getting worse.

There are such things as facts. There are such things as truth.

Yesterday, The Washington Post published an article, entitled: ``President Trump Seems to be Saying More and More Things That Aren't True.'' Well, I would like to take a few minutes to read this article, because these aren't my words, Mr. Speaker. They are the words of The Washington Post, specifically, Ashley Parker, who wrote the piece.

If the President is watching, I think it is helpful for me to read because I know he doesn't read, so maybe he can hear this.

``He's done it on Twitter. He's done it in the White House driveway. And he's done it in a speech to a business group.

``President Trump, a man already known for trafficking in mistruths and even outright lies--has been outdoing himself with falsehoods in recent days, repeating and amplifying bogus claims on several of the most pressing controversies facing his Presidency.

``Since Saturday, Trump has tweeted false or misleading information at least seven times on the topic of immigration and at least six times on a Justice Department inspector general report into the FBI's handling of its investigation into Hillary Clinton's private email server. That is more than a

dozen obfuscations on just two central topics--a figure that does not include falsehoods on other issues, whether in tweets or public remarks.

``The false claims come as the President--emboldened by fewer disciplinarians inside the West Wing--indulges in frequent Twitter screeds. A Washington Post analysis found that in June, Trump has been tweeting at the fastest rate of his Presidency so far, an average of 11.3 messages per day.

``Inside the White House, aides and advisers say they believe the media is unwilling to give Trump a fair shot and is knee-jerk ready to accuse him of lying, even in cases where the facts support his point.

``The President often seeks to paint a self-serving and self- affirming alternate reality for himself and his supporters. Disparaging the `fake news' media, Trump offers his own filter through which to view the world--offering a competing reality on issues including relationships forged (or broken) at the Group of Seven summit in Canada, the success of the Singapore summit with the North Koreans, and his administration's `zero tolerance' policy on illegal immigration.

`` `It's extraordinary how he is completely indifferent to the truth. There's just no relationship between his statements--anything he utters--and the actual truth of the matter,' said Thomas Murray, president emeritus of the Hastings Center, the founding institution in the field of bioethics. `As far as I can tell, the best way to understand anything he says is what will best serve his interests in the moment. It's irrespective to any version of the truth.'

``According to an analysis by The Post's Fact Checker through the end of May, Trump has made 3,251 false or misleading claims in 497 days, an average of 6.5 such claims per day of his Presidency.''

``And within the past week, Trump seems to have ramped up both the volume and the intensity of his false statements on two of the most prominent topics currently facing his administration: the hardline immigration policy that has led to the separation of thousands of children from their parents--which Trump erroneously blames on others-- and the 500-page inspector general report that he claims, incorrectly, exonerates him in special counsel Robert S. Mueller III's probe of Russian interference in the 2016 election.

``Bella DePaulo, a psychology researcher at the University of California Santa Barbara, said Trump's use of repetition is a particularly effective technique for convincing his supporters of the veracity of his false claims, in part because most people have a `truth bias' or an initial inclination to accept what others say as true.

`` `When liars repeat the same lie over and over again, they can get even more of an advantage, at least among those who want to believe them or are not all that motivated either way,' DePaulo said in an email. `So when people hear the same lies over and over again-- especially when they want to believe those lies--a kind of new reality can be created. What they've heard starts to seem like it is just obvious, and not something that needs to be questioned.'

``On immigration, Trump and many top administration officials have said that existing U.S. laws and court rulings have given them no choice but to separate families trying to cross illegally into the United States. But it is the administration's decision, announced in April, to prosecute all southern border crossings that has led to the separation of families.

``That hasn't stopped the President from blaming Democrats for his administration's decisions. `Democrats are the problem,' Trump wrote in one tweet. In another, he was even more blunt: `The Democrats are forcing the breakup of families at the border with their horrible and cruel legislative agenda. . . .' ''

Mr. Speaker, let me divert a little bit here. The truth is that the President caused this crisis, and it is not just me saying it and The Washington Post saying it. Listen to what some of the Republicans have said, Lindsey Graham said: ``President Trump could stop this policy with a phone call. I'll go tell him: If you don't like families being separated, you can tell DHS, `Stop doing it.' ''

Senator John McCain: ``The administration's current family separation policy is an affront to the decency of the American people, and contrary to principles and values upon which our Nation was founded. The administration has the power to rescind this policy. It should do so now.''

Senator Susan Collins, former First Lady Laura Bush--and I can go on and on and on--a whole bunch of Republicans now are all agreeing with us that the President is not telling us the truth.

So let me go back to the article: ``While Congress could pass a legislative fix, Republicans control both the House and the Senate-- making it disingenuous at best to finger the opposing party, as the President has repeatedly done.

``Speaking to the National Federation of Independent Business on Tuesday, Trump again falsely painted the humanitarian crisis as a binary choice. `We can either release all illegal immigrant families and minors who show up at the border from Central America, or we can arrest the adults for the Federal crime of illegal entry,' he said. `Those are the only two options.'

``On Twitter, the President twice in the past 4 days has singled out Germany as facing an increase in crime. `Crime in Germany is up 10 percent-plus (officials do not want to report these crimes) since migrants were accepted,' Trump wrote. `Others countries are even worse. Be smart, America.' ''

That is his tweet.

``In fact, the opposite is true. Reported crime in Germany was actually down by 10 percent last year and, according to German Interior Minister . . . the country's reported crime rate last year was actually at its lowest point in three decades.

``The President has also falsely claimed that the inspector general report `exonerated' him from Mueller's probe, when the report did not delve into the Russia investigation. When he made this argument Friday during an impromptu press gaggle in the White House driveway, a reporter pressed him on the falsehood.

`` `Sir, that has nothing to do with collusion,' the reporter said. `Why are you lying about it, sir?' ''

The bottom line, Mr. Speaker, is, we have a President who has a problem with the truth, and Congress needs to stand up and do the right thing. We need to speak the truth; we need to embrace the truth; and we need to solve some of the issues that are before the American people.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.