[Congressional Record Volume 164, Number 105 (Friday, June 22, 2018)]
[House]
[Pages H5511-H5561]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SUBSTANCE USE-DISORDER PREVENTION THAT PROMOTES OPIOID RECOVERY AND
TREATMENT FOR PATIENTS AND COMMUNITIES ACT
General Leave
Mr. WALDEN. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days to revise and extend their remarks and include
extraneous materials on H.R. 6.
The SPEAKER pro tempore (Mr. Carter of Georgia). Is there objection
to the request of the gentleman from Oregon?
There was no objection.
The SPEAKER pro tempore. Pursuant to House Resolution 949 and rule
XVIII, the Chair declares the House in the Committee of the Whole House
on the state of the Union for the consideration of the bill, H.R. 6.
The Chair appoints the gentleman from Nebraska (Mr. Bacon) to preside
over the Committee of the Whole.
{time} 0916
In the Committee of the Whole
Accordingly, the House resolved itself into the Committee of the
Whole House on the state of the Union for the consideration of the bill
(H.R. 6) to provide for opioid use disorder prevention, recovery, and
treatment, and for other purposes, with Mr. Bacon in the chair.
The Clerk read the title of the bill.
The CHAIR. Pursuant to the rule, the bill is considered read the
first time.
Pursuant to the order of the House of June 21, 2018, general debate
shall not exceed 1 hour, with 40 minutes equally divided and controlled
by the chair and ranking minority member of the Committee on Energy and
Commerce and 20 minutes equally divided and controlled by the chair and
ranking minority member of the Committee on Ways and Means.
The gentleman from Oregon (Mr. Walden) and the gentleman from New
Jersey (Mr. Pallone) each will control 20 minutes. The gentleman from
Texas (Mr. Brady) and the gentleman from Massachusetts (Mr. Neal) each
will control 10 minutes.
The Chair recognizes the gentleman Oregon.
Mr. WALDEN. Mr. Chairman, I yield myself such time as I may consume.
Mr. Chairman, I rise today in support of H.R. 6. This is the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act, or the SUPPORT for Patients
and Communities Act.
I was proud to introduce this bill with my bipartisan colleagues:
Energy and Commerce Committee ranking member, my friend from New
Jersey, Mr. Pallone; Ways and Means Committee Chairman Kevin Brady; and
Ways and Means Ranking Member Richard Neal.
These past 2 weeks, this House, the people's House, has dedicated
tremendous amounts of time and energy to send a simple message to
millions of Americans impacted by the opioid crisis. And that message
is: Help is on the way.
Not only are we passing legislation, dozens and dozens of bills that
will save lives, but also we want to leave no doubt in the minds of
those suffering from addiction that the United States House of
Representatives, Republicans and Democrats alike, stand with them
together.
For too long, embarrassment and stigma surrounded the disease of
addiction. It is time for that to change. If you are struggling with
addiction, if you are fighting that invisible battle, please know that
it is okay to seek help.
Opioid overdoses take the lives of more than 100 Americans each and
every day. In fact, Mr. Chairman, a thousand people in our country will
go to an emergency room in the next 24 hours, suffering an overdose
from opioids. We don't want those people to become part of that deadly
statistic.
You matter. You are worthwhile. And I pray that the various
legislation we vote on here today, and that we voted on throughout the
last 2 weeks, can help you begin your journey of recovery.
H.R. 6 includes several bills that went through regular order at the
Energy and Commerce and Ways and Means Committees, but the bill we will
vote on today also includes dozens of other pieces of legislation that
have recently passed the House, most unanimously or with very strong
bipartisan majorities.
You see, at a time when it seems we couldn't be more divided, it is
clear that striking back against addiction is something that transcends
politics and brings us together as a community, as a country, and as a
Congress.
Remember, this legislation is not the first action that this Congress
has taken to combat the opioid crisis, and I am sure it will not be the
last. I guarantee you that.
The Comprehensive Addiction Recovery Act and the 21st Century Cures
Act, both of which were signed into law nearly 2 years ago, and an
additional $4 billion in resources for States and communities that was
provided in the omnibus appropriations bill just a few
[[Page H5512]]
months ago, indicate we have been at this for awhile, and we will be at
this for a while longer.
Taken together, this is one of the most significant congressional
efforts against a drug crisis in our Nation's history. But we must
continue to legislate, evaluate, conduct oversight, and work together
to provide new solutions, so that we can rise to this ever-challenging
situation.
Today, we have an opportunity to continue our work to combat this
crisis, an opportunity to save lives, and we cannot let it pass. The
legislation before us will help advance treatment and recovery
initiatives, improve prevention and educational efforts, protect our
communities, and bolster our efforts to fight deadly synthetic drugs
like fentanyl.
We owe it to the families we have heard from. We owe it to our
friends. Our communities need this and our country needs this to lift
our people out of addiction and, together, win this fight.
Mr. Chair, I urge my colleagues to support H.R. 6, the SUPPORT for
Patients and Communities Act, and I reserve the balance of my time.
Mr. PALLONE. 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. WALDEN. Mr. Chairman, I yield 1 minute to the gentleman from
Kentucky (Mr. Guthrie), the vice chairman of the Subcommittee on
Health, a great leader on these issues and more.
Mr. GUTHRIE. Mr. Chair, I thank the gentleman for yielding, and I
rise in support of the SUPPORT for Patients and Communities Act.
Kentucky has been one of the hardest hit by our Nation's opioid
crisis, and I have heard from many Kentuckians
[[Page H5513]]
across the Second District about the devastating effects the opioid
crisis is having in the Commonwealth.
Parents have lost children to opioid use disorder. Employers are
having a hard time finding employees. And the opioid crisis has taken a
terrible toll on our communities.
Last Congress, I was proud to work with my colleagues as we crafted
the Comprehensive Addiction and Recovery Act. We also passed the 21st
Century Cures Act. We have come together to build on those two laws
with more legislation to address the ongoing opioid epidemic. Over the
past 2 weeks, we have passed more than 50 bills out of the House,
including my bill, the Comprehensive Opioid Recovery Centers Act.
Today, we vote on the SUPPORT for Patients and Communities Act, the
culmination of our work over the past year to combat the opioid crisis.
I urge my colleagues to support this important bill that will help
all Americans affected by this awful epidemic.
Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentlewoman from
California (Ms. Eshoo).
Ms. ESHOO. Mr. Chairman, I rise in support of H.R. 6, and I thank our
ranking member for yielding time to me.
There isn't any question that our country is in the midst of a
destructive opioid epidemic that claims 142 lives every day. This is a
national crisis, and it is our duty as Members of Congress to do
everything in our power to stem the tide of addiction and the
devastation that this epidemic is causing. It is claiming more lives
than were lost in the Vietnam war. They are staggering figures.
{time} 0930
H.R. 6 includes policies to expand the number and types of providers
who can administer medication such as buprenorphine and naloxone to
opioid-addicted patients, and it allows Medicare to pay for opioid
treatment programs. That is a very important addition in the
legislation. This will help people suffering from opioid use disorder
to get access to the critical treatment they need on the day this
legislation is signed into law.
H.R. 6 also creates a payment structure that incents rather than
discourages the use of nonopioid alternatives. I think this is a very
important provision in the legislation because it will help to decrease
the number of opioids prescribed and keep patients from becoming
addicted in the first place.
I want to point something out that I believe is deeply troubling, and
the ranking member did as well. The majority has repeatedly voted to
gut funding for the benefits offered by Medicaid, which is the single
largest payer of mental health services, providing health coverage to
27 percent of adults with a serious mental illness.
The majority has also consistently and repeatedly undermined the
Affordable Care Act, including refusing to defend the protections for
patients with preexisting conditions.
The CHAIR. The time of the gentlewoman has expired.
Mr. PALLONE. Mr. Chairman, I yield the gentlewoman from California an
additional 30 seconds.
Ms. ESHOO. Mr. Chairman, this is very serious because this would
provide critical access to treatment for substance abuse disorders. So
the majority gives with one hand and takes away with the other.
These policies will harm millions of vulnerable Americans and limit
our responsibility to respond and recover from this epidemic.
This is an important first step. We need to do more to address the
causes of the epidemic, stem the tide of addiction, expand meaningful
access, and pay for it so that we can help the very people who need the
most help.
Mr. WALDEN. Mr. Chairman, I yield 1 minute to the gentleman from West
Virginia (Mr. McKinley), who has been a fierce fighter to resolve this
issue in his State and our country.
Mr. McKINLEY. Mr. Chairman, I rise in support of H.R. 6. Over the
past 2 weeks, America has witnessed something impressive. Both parties
have come together, once again, to take action on one of the more
challenging issues of our time: the opioid epidemic.
But this health threat is not unique. In the past, Congress faced the
AIDS epidemic that claimed the lives of hundreds of thousands of
Americans, and stared down the Ebola nightmare. Congress responded
methodically and thoughtfully by investing massive resources into
medical research at the NIH and into treatment and prevention programs.
That is exactly what Congress is trying to do today. In this bill, we
are funding NIH to develop alternatives to opioids for pain management,
increasing treatment and prevention programs, and equipping our law
enforcement to stop dangerous drugs like fentanyl from coming into
America.
This bill is going to make a difference in the lives of millions of
Americans. Congress is building on the work that it started with CARA
and with the 21st Century Cures, but this isn't the end. It is vital to
continue working together.
Mr. Chair, I urge my colleagues to support H.R. 6.
Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from
California (Mr. Peters).
Mr. PETERS. Mr. Chairman, I thank the gentleman for yielding.
Mr. Chairman, I want to take a moment to say a special thank you to
Mr. Pallone and his committee staff for their tireless work to address
this crisis.
The opioid crisis has ravaged our Nation. It twice has been declared
a national public health emergency under Federal law. More than 100
people will die from an overdose just today.
That is why this bipartisan effort to address it is so important.
There is certainly work to be done, but I am happy that legislation
that I worked on with my colleague, Dr. Bucshon, is included in this
bill, and it aims to stop addiction where it frequently begins: after
surgery. Millions of Americans are prescribed opioids following routine
surgeries because they are cheap and accessible, and nearly 70 percent
of those pills go unused.
Our bill reverses the perverse incentive that put so many cheap pills
in people's hands in the first place. It allows innovators to receive
extra compensation for nonaddictive opioid alternatives if they can
show that their alternative therapies have substantial clinical
benefit.
In the short term, the policy reduces the incentive to simply use the
cheapest postsurgical pain treatment, which is typically an opioid. In
the long term, it will spur innovation by providing additional
compensation for the future development of nonaddictive alternatives.
That means as long as this crisis takes to solve, there will be an
incentive to continue to develop nonopioid alternatives.
Of course, access isn't enough. These treatments must also be
affordable. We will continue to work with CMS and FDA to ensure that
safer and more effective nonopioids are affordable for the people who
need them most. We must find better ways to treat this problem where it
starts.
Mr. Chairman, I urge my colleagues to support the bill.
Mr. WALDEN. Mr. Chairman, we were glad to work with Mr. Peters on his
legislation to make it bipartisan and get it across the line.
Mr. Chairman, I yield 1 minute to the gentleman from Florida (Mr.
Bilirakis).
Mr. BILIRAKIS. Mr. Chairman, I rise today in support of H.R. 6, the
SUPPORT for Patients and Communities Act, a bipartisan bill that will
aid our overall efforts to combat the opioid crisis.
I am proud that two provisions of mine are included in the final
package of the bill. These provisions would establish a mandatory drug
management program for at-risk beneficiaries in Medicaid and Medicare.
This bipartisan effort shows that we can do things when we put
partisan politics aside and work together.
I want to thank Chairman Walden for all of his hard work over the
past year as we crafted this bill. He led the charge, and I appreciate
it, Mr. Chairman, so much.
I also want to thank Congressman Ben Ray Lujan, my Democratic
colleague and friend. Five years ago we developed the first drug
management program in Medicare, and now we developed a drug management
program in Medicaid.
Mr. Chairman, I encourage my colleagues to support this bill.
Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentlewoman from
Massachusetts (Ms. Clark).
[[Page H5514]]
Ms. CLARK of Massachusetts. Mr. Chairman, I thank the ranking member
for yielding and for all his work on this issue and continuing to
underscore the need to actually fund access to healthcare so that we
can curb this horrible epidemic in a meaningful way.
One of the many factors that contributes to the opioid crisis is the
sheer volume of opioids in circulation. According to the CDC, over 214
million prescriptions were written for opioids in 2016, and we can see
that in our own Federal programs.
A 2016 study showed that one in three Medicare part D recipients
received opioids. That is almost 80 million prescriptions for a cost of
$4.1 billion. The sheer volume makes it hard to prevent abuse,
addiction, waste, and fraud. Almost 90,000 beneficiaries of Medicare
are at serious risk for abuse and overdose, receiving over 2\1/2\ times
the recommended dosing. This study eliminated anyone who is on hospice
care. Additionally, 70,000 recipients receive an extreme amount of
opioids. That is the equivalent of 24 Vicodin every single day.
That is why I, along with my colleague, Markwayne Mullin, have
introduced the Every Prescription Conveyed Securely Act. This bill will
require that every prescription written for a Medicare part D
beneficiary be prescribed electronically by 2021. We know this
technology will save lives by making it harder to forge prescriptions,
easier for doctors to know if a patient is doctor shopping, and be able
to prevent fraud and save the government money.
Mr. Chairman, this is a commonsense bill that can help fight the
opioid crisis. I am very grateful to Chairman Walden and the ranking
member for including it in this package.
Mr. WALDEN. Mr. Chairman, I want to thank Ms. Clark and Mr. Mullin
for bringing that issue to our attention. We were proud to work with
them to get it in the bill.
Mr. Chairman, I yield 1 minute to the gentleman from Indiana (Mr.
Bucshon), who is one of our doctors on the committee.
Mr. BUCSHON. Mr. Chairman, I rise today in support of H.R. 6, the
SUPPORT for Patients and Communities Act. This bill will help our
struggling communities combat the opioid epidemic ravaging our Nation
by focusing on providing care to those in need while addressing
prevention of opioid misuse and abuse.
I am proud that two pieces of legislation that I introduced are
included in H.R. 6 as sections 202 and 203. Section 202, which I worked
closely with Representative Peters on to introduce, would incentivize
development of nonopioid pain alternatives for postsurgical pain.
Section 203 would increase screening for chronic pain, address
possible nonopioid pain alternatives, and increase early detection of
opioid use disorder in seniors as they enter Medicare.
Mr. Chairman, I am proud to have worked with my colleagues on
solutions to this serious crisis, and I urge my colleagues to support
H.R. 6.
Mr. PALLONE. Mr. Chairman, I yield 3 minutes to the gentleman from
New York (Mr. Tonko).
Mr. TONKO. Mr. Chairman, I thank the gentleman from New Jersey for
yielding.
Mr. Chairman, I rise in support of H.R. 6, the SUPPORT for Patients
and Communities Act. The SUPPORT for Patients and Communities Act
incorporates legislation that I introduced along with my good friend
and colleague, Representative Ben Ray Lujan of New Mexico, which will
provide a meaningful expansion to addiction treatment across our
country, especially in rural areas, and for vulnerable populations like
pregnant and postpartum women and the 13,000 babies born on average
each year with neonatal abstinence syndrome.
Our legislation includes three main policy changes to expand access
to treatment. First, it eliminates the current sunset provision that
would prohibit nurse practitioners and physician assistants from
treating patients with addiction medicine after 2021.
By ending this sunset, we can provide certainty to our healthcare
community and encourage more NPs and PAs to become part of the
addiction treatment workforce.
Second, this legislation would expand the classes of practitioners
eligible to prescribe buprenorphine to other advanced practice nursing
professionals to include nurse midwives, clinical nurse specialists,
and certified nurse anesthetists.
This provision was included based on feedback that my office has
received from medical groups such as the American Society of Addiction
Medicine and the American College of Obstetricians and Gynecologists
who are on the front lines of this crisis who have made the case that
adding additional classes of highly skilled nurses can help more people
access treatment and find that important road to recovery.
In many rural areas, advanced practice nurses play an outsized role
in providing care, and this legislation will help expand addiction
treatment capacity in these rural areas where it is most needed.
In addition, these advanced practice nursing professionals are
already providing primary care for some of our most vulnerable
populations: pregnant and postpartum women. By allowing these skilled
providers to provide addiction treatment as well, we can bolster
continuity of care for our moms and for our babies.
Finally, our legislation would make a technical change that would
allow DATA 2000 waivered providers to treat up to 100 patients in their
first year if they possess additional credentialing or are practicing
in a qualified practice setting.
Taken together, these three changes will make a meaningful difference
in moving toward a system of treatment on demand for individuals
struggling with the disease of addiction.
To those who would say we need more data or we need to be cautious
about expanding access to treatment, I would respond that more and more
people are dying in our streets every day. We don't have time to drag
our feet any longer.
Finally, I want to thank Ranking Member Pallone, Chairman Walden, and
their staffs for the continued efforts on these provisions through many
months of back and forth. In a personal way and a very upfront way, let
me thank Representative Pallone, our ranking member, and his
outstanding staff for the intellect and the energy they poured into
this because it truly made this a better bill, and it is going to save
lives.
Mr. Chairman, I urge my colleagues to support H.R. 6.
Mr. WALDEN. It is now my great honor, Mr. Chairman, to yield 1 minute
to the gentleman from California (Mr. McCarthy), who is the majority
leader of the United States House of Representatives. He has been
extraordinarily helpful in our efforts to move this entire bipartisan
package forward to save lives and help people in addiction.
Mr. McCARTHY. Mr. Chairman, I thank the gentleman for yielding, and I
want to congratulate the gentleman for his work, his tireless effort,
and his passion for those who have been afflicted with the addiction
and have lost the battle.
Mr. Chairman, I rise today to urge the passage of H.R. 6 which
contains more than 50 opioid-related bills which we have considered in
the past 2 weeks.
We have in this body the opportunity nearly every day to approve
legislation of great consequence to millions of people. But rarely do
the consequences feel so immediate and so vital as they do for the
opioids package we are considering. That is because this legislation
has to do with the deadliest drug crisis in our Nation's history.
{time} 0945
The grim truth is this: More Americans have died from drug overdoses
since the turn of the century than died in the Civil War. Yes, you
heard that right. In less than two decades, more than 630,000 people
have died because of drugs. Half of those deaths had to do with
opioids. This death toll is the ``American carnage'' that President
Trump referred to in his inaugural address.
My hometown of Bakersfield has been devastated by illegal drugs,
mostly heroin and meth. In 2016 alone, 54 people in my county died of
an opioid overdose. This is a statistic made up of 54 stories of
unimaginable sadness. They are stories of happy families torn apart by
deceit, abuse, and death; stories of parents robbed of children,
children robbed of parents, and friends robbed of friends. My local
news talked
[[Page H5515]]
to one man in Bakersfield who has lost four friends to overdoses in the
past few years alone.
Of course, these tragic events are not confined to just my district;
they are happening everywhere across the country, coast to coast.
So I would like to tell you another story, this time from the other
side of the country. It is the story of Eamon Eric Callanan, age 28. He
did not live to see age 29.
Eamon came from a family with deep roots in Rochester, New York. One
of his great-grandfathers was a chief of police in Rochester. His
grandfather was a judge, and his parents are attorneys. They were the
very definition, in other words, of a law-abiding family. But in early
2012, a series of events took place that sent Eamon down a different
path and stole him from his family forever.
At age 25, Eamon hurt his back--a story that many in America have
seen--while he was on his job. He began taking opioid painkillers in
response to his pain. When the pills became too expensive, Eamon, like
many Americans, switched to heroin. Before long, the loyal, goofy kid
his family once knew was gone. Drugs had dampened the beautiful music
of his life and turned it into a sorrowful echo.
Eamon Eric Callanan died of a drug overdose on June 8, 2016. Last
Wednesday marked the 2-year anniversary of his funeral.
In many respects, Eamon's story is not unique. He was one of 169
people in his county--42,000 people in our country--to die of an opioid
overdose that year. Eamon was just one body in a grim tide of overdose
deaths.
So why am I telling you this story? I am telling it to remind you
that each one of those victims had a name and a life and friends and
family whom they loved and left behind.
One of those people Eamon loved and who loves him deeply in return is
actually sitting in this Chamber right now. Her name is Erin. She is
Eamon's sister and my press secretary. Erin was 24 days from her
wedding when she learned that she would never see her brother again and
that he would not be there to celebrate with her on one of the happiest
days of her life.
Let that be a lesson to all of us. There is no event so joyful, no
place so safe that it is untouched by the drug crisis--even a wedding
chapel, even here in the Halls of power, even in my office.
Mr. Chair, if we hope to defeat the deadliest drug crisis in history,
we will need the biggest response in history. Rest assured that the
response is already underway, led by this administration and this
Congress. We are wrapping up voting on more than 50 bills to help
millions of Americans affected by the opioid crisis. We are about to
vote on a package that contains almost all of those bills, H.R. 6.
Among others, it contains a bill by Congressman Mike Bishop that
will reduce the flow of Chinese fentanyl into our country by giving law
enforcement new tools to detect suspicious packages in the mail. It
includes a reform to the so-called IMD exclusion, an outdated
regulation that restricts Medicaid funding for large inpatient
treatment programs, programs with the potential to heal substance abuse
patients like Eamon.
Those are just two of the important bills that are part of this
package. It is no exaggeration to say that they can save lives and save
families from the immeasurable grief of losing a loved one to an
overdose.
Yes, I am confident these bills will help stem the tide of drug
abuse, but I will end on a note of caution.
If defeating the opioid crisis is left to government alone, then we
will surely fail. Healing the wounds of drug abuse will take more than
just this body can provide; it will take the commitment by every
citizen to fulfill our duties to one another.
We have all been touched by this tragedy, so we all have a part to
play in its resolution. That means supporting people near us who are
struggling with drug addiction. It means rebuilding families and towns
torn apart by isolation, addiction, distrust, and death. It means
supporting the many charities, ministries, and nonprofits that are
already healing the sick in our communities.
In Bakersfield, that means groups like The Mission, the Christian
charity where I volunteer. The Mission operates a faith-based addiction
recovery program that is changing lives, even knitting together
families that have come apart at the seams.
Because of The Mission, a husband and wife with five children
overcame their past of drug addiction and drug dealing, and they did it
together. Then they convinced their niece to get clean, too.
We need more stories like that. In the days ahead, this House has a
chance to do its part to ensure that more stories of abuse and despair
have their own happy ending. We will do this work for the healers and
protectors, for the suffering, and for all those like Eamon who are now
at rest.
Mr. PALLONE. Mr. Chairman, may I ask how much time I have remaining.
The CHAIR. The gentleman from New Jersey has 5 minutes remaining.
Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentlewoman from
California (Ms. Bass).
Ms. BASS. Mr. Chair, I rise today in support of H.R. 6 and the foster
youth who will benefit from its passage.
One of the most popular provisions of the Affordable Care Act allows
young adults to stay on their parents' health insurance until they turn
26. It is only fair that young adults who age out of foster care should
keep their coverage until they turn 26, too.
But when the ACA was implemented, the Department of Health and Human
Services gave States the option of covering young adults who aged out
of foster care in a different State. For example, if a young adult aged
out of the system at 18 and had coverage in California but then moved
to New York, New York would have the option to cover them under
Medicaid until they turned 26 or not.
This extended coverage was never supposed to be optional. After all,
former foster youth should have every opportunity to move freely
without the fear of losing lifesaving health insurance. This is why I
introduced the Health Insurance for Former Foster Youth Act.
Last month, over 100 former foster youth were on the Hill and
shadowed their Members of Congress. We celebrated that many of the
young adults had been accepted to college, some out of State. This bill
will ensure that when former foster youth age out of the system, they
can keep their healthcare coverage until 26, no matter where they live.
This is about fairness. Former foster youth should be treated the
same way we treat all young people.
I am grateful to my colleagues on both sides of the aisle for
including my bill in this bipartisan opioid package.
Just this week, The Hill reported the States hardest hit by the
opioid epidemic have seen the number of children in foster care or
State care increase dramatically.
Again, I thank my colleagues for working with me to clarify this law,
and I thank Chairman Walden and Ranking Member Pallone for their
leadership on this issue.
Mr. WALDEN. Mr. Chair, I thank my colleague from California for
bringing this issue to our attention and helping us help these kids who
need this assistance.
Mr. Chair, I yield 1 minute to the gentleman from Wisconsin (Mr.
Ryan), the Speaker of the United States House of Representatives.
Mr. RYAN of Wisconsin. Mr. Chair, I thank the gentleman for yielding.
Mr. Chair, I first want to start by thanking the chair and the
ranking member.
But for a moment, I would like to address another issue. I want to
pause to honor the life of Dr. Charles Krauthammer.
Dr. Krauthammer was a widely respected conservative thinker. He wrote
columns for which he won a Pulitzer Prize. Paralyzed since college, he
wrote the most vigorous commentary of our age. He was a Harvard-
educated psychiatrist and had the perfect training to analyze our
politics.
He passed away yesterday, leaving behind a family that loved him,
colleagues that admired him, and grateful friends and readers like
myself.
If I had to think about this, Charles was a good friend of mine. He
had a beautiful mind, and he had a wonderful, wonderful way about him.
Simply put, I loved this man. I loved his work. I would marvel over not
just what he said, but how he would say it.
[[Page H5516]]
He had a unique ability to take the issue of the moment and place it
perfectly in the context of bigger things. ``America is the only
country founded on an idea,'' he would say, and his vocation was the
defense of that idea.
As great as his intellect was, there was absolutely no arrogance
about him. Charles was good company, so gracious, so curious. Take any
topic and he had already thought through his argument, your argument,
and all the counterarguments before you even got started thinking. He
was always willing to enjoy the fight, but with good cheer--he enjoyed
it; he reveled in it; he excelled at it.
Charles used his immeasurable gifts to contribute to our civic
discourse--and he did it civilly--and we are all the better for it. We
will be wiser for what he has done for us. I only hope and pray that we
can try to emulate his spirit and his sense of wonder and civility.
The House and this Nation are in his debt. Our prayers are with his
family.
Mr. Chair, I rise to express my wholehearted support for H.R. 6.
Today, our Nation is fighting a grave opioid epidemic. It is a threat
to a generation of young people and the very fabric that holds our
communities together. But to me, this legislation is about hope.
I have had the honor of speaking with and knowing three brave
Wisconsin families who have dealt with this, families that I have
gotten to know over the course of time.
Kyle Pucek is a guy I know from Janesville. He had an ankle injury
treated with opioid medication, just like a lot of people have. He
developed a dependency and eventually turned to heroin. He is now
clean, and he works with nonprofits in Janesville to encourage others
to seek treatment. He is helping make sure people don't make the
mistakes he made. He is making a huge difference.
Michelle Jaskulski has two sons, former high school athletes, who
became addicted to heroin. They are in recovery. She understands the
loneliness that comes with being a mother in this situation. She
understands how isolating it can all feel. Now she advocates for more
resources to fight this epidemic and supports other families so that
they don't feel like they are facing this fight alone, like she did.
Jason Simcakoski was a marine who served our country. He went to a VA
hospital looking for help for his anxiety. He was overprescribed
opioids, and he lost his life. His family has made it their mission to
ensure that others do not experience the same fate.
This is the heart of America. After suffering such unspeakable pain,
these families overcame. Now they are making it their mission in life
to make sure others have a place to turn to and that others don't have
to go down the path they went.
Asking for help is not a sign of weakness; it is actually an act of
strength. We all have a role to play in this, and it begins with
reaching out, with listening, and with being there for one another. All
of our institutions at every level should emulate and encourage this
kind of fellowship. We should make sure to make clear that no one is
alone, that every life matters.
This bill has the perfect title: SUPPORT for Patients and Communities
Act. It is bipartisan. It is high time we do it. It is a very, very
strong and good step in the right direction. It will advance treatment
and recovery; it will improve prevention; it will give resources to
communities; and it will fight deadly drugs like fentanyl.
So I thank Chairman Walden and Chairman Brady. I also thank Mr.
Pallone and Mr. Neal. I thank all the members of the Energy and
Commerce Committee and the Ways and Means Committee.
Let's not stop here. Let's not stop until we have instilled hope in
all of those who may be struggling. Let's not stop until we have ended
this epidemic.
I urge the entire House to vote ``yes.''
{time} 1000
Mr. PALLONE. Mr. Chairman, I yield 2 minutes to the gentleman from
California (Mr. Cardenas).
Mr. CARDENAS. Mr. Chair, I thank the authors for all the hard work
coming to this moment to get this very important bill on the floor.
Mr. Chair, I rise today to say how glad I am that my bill, the At-
Risk Youth Medicaid Protection Act, has been included in today's opioid
package.
According to a June 2017 MACPAC report, the opioid epidemic
disproportionately affects Medicaid beneficiaries. Therefore, State
Medicaid programs are taking the lead in identifying and tailoring
strategies to prevent and treat opioid use disorder. Among those
affected are our most vulnerable American population, our youth.
Currently, most children who are covered by Medicaid and come into
contact with the criminal justice system end up having their enrollment
terminated by States. While some States are beginning to suspend
instead of terminate their enrollment, only a few States and the
District of Columbia suspend their enrollment for the exact duration of
the incarceration. This results in unnecessary, costly delays.
I say again: When somebody is terminated rather than suspended, this
results in an unnecessary, costly delay, delaying their coverage and
preventing them from receiving timely and much-needed health and mental
care upon the child's release.
The At-Risk Youth Medicaid Protection Act would require States to
automatically restore the child's Medicaid enrollment upon their
release. Further, States would be required to process applications for
medical assistance by or on behalf of the child and make access to
medical assistance for children under foster care consistent with the
Affordable Care Act by extending the age of eligibility to age 26.
Mr. Chairman, we owe it to the American people to do everything in
our power to decrease the already 64,000 families broken by this
epidemic and restore faith in our government system. While this package
covers many fronts, the inclusion of this commonsense bill, the At-Risk
Youth Medicaid Protection Act, extends the effort to attack this
epidemic from all angles, modifying the package's foundation.
Mr. WALDEN. Mr. Chairman, I want to thank my colleague from
California for working with us. We were happy to include his bill in
this compilation of legislation.
Mr. Chair, I yield 1 minute to the gentleman from Georgia (Mr.
Carter), our resident pharmacist in the United States Congress and on
the Energy and Commerce Committee.
Mr. CARTER of Georgia. Mr. Chair, I thank my colleagues for
introducing this critical legislation.
Since this committee began tackling the opioid epidemic, I have said
there are three major parts to the crisis: prevention, treatment, and
law enforcement. This legislation touches all three prongs of the
opioid crisis with a number of creative solutions, in addition to
providing offsets to ensure that solving a public health crisis does
not lead to a fiscal one.
I voted for many of these bills when they came before the committee
for mark up, and I want to offer my full support for this legislation.
Mr. PALLONE. 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.
[[Page H5517]]
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
[[Page H5518]]
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. WALDEN. Mr. Chair, I yield 1 minute to the gentleman from New
Jersey (Mr. Lance), who has been very, very involved in this effort.
Mr. LANCE. Mr. Chair, I rise today in support of this bipartisan
package, H.R. 6.
The Energy and Commerce Committee, under the leadership of Chairman
Walden, has again delivered for the American people on the pressing
public health challenges facing the Nation. From combating childhood
cancer, to improving mental health care, to fighting the scourge of
drug addiction, the Energy and Commerce Committee produces results.
The menace of drug abuse and addiction has manifested itself in
opiates. Every corner of this country has known the heartache of losing
a life from this terrible problem. Congress has acted before with
passage of the Comprehensive Addiction and Recovery Act, but CARA needs
reinforcement. H.R. 6 delivers more resources, treatment, and
mitigation tools to fight opiate addiction.
Included in this package is the Eliminating Opioid-Related Infectious
Diseases Act, legislation I have authored with my colleague on the
Energy and Commerce Committee, Congressman Joseph P. Kennedy III.
Infectious diseases compound and complicate the lifelong path toward
recovery from substance abuse, and threaten the lives and safety of the
loved ones of those addicted, especially children.
This is how Congress is supposed to work, both sides coming together
to confront a national crisis, going through the committee process with
bipartisan bills, and getting to the root of the country's challenges.
Mr. Chair, I urge a ``yes'' vote.
Mr. PALLONE. Mr. Chair, I have no additional speakers, and I reserve
the balance of my time.
[[Page H5519]]
Mr. WALDEN. Mr. Chairman, I yield 1 minute to the gentleman from
Michigan (Mr. Walberg), who has been very involved in this effort as
well.
Mr. WALBERG. Mr. Chairman, I am grateful for your leadership and for
the work my colleagues on the Energy and Commerce Committee are doing
to tackle the opioid crisis.
Mr. Chair, I rise today in support of H.R. 6, the SUPPORT for
Patients and Communities Act. Everywhere I go around Michigan, I hear
about the opioid crisis plaguing our State and country. It is a deeply
personal and painful issue for many of our friends and loved ones,
including the family of Jessie Grubb, whose life was cut short. Her
family grieves that a mistake was made that, because of our
legislation, hopefully, will never happen again.
Over the past 2 weeks, the House has considered more than 70 bills to
enhance treatment and recovery programs, increase prevention efforts,
protect communities, and fight the synthetic drug fentanyl. These
measures include two bipartisan bills I introduced with Congresswoman
Debbie Dingell. They have been incorporated into legislation we are
voting on today, including Jessie's Law.
This is an urgent crisis, and I urge the Senate to take swift action
and advance these solutions. There is not a moment to waste.
Mr. PALLONE. Mr. Chair, I continue to reserve the balance of my time.
Mr. WALDEN. Mr. Chairman, I yield 1 minute to the gentleman from
Georgia (Mr. Allen).
Mr. ALLEN. Mr. Chair, I rise today in support of H.R. 6, the SUPPORT
for Patients and Communities Act.
Mr. Chair, I want to thank Chairman Walden and the entire Energy and
Commerce Committee for their work on this important legislation. The
SUPPORT for Patients and Communities Act is yet another bipartisan
effort aimed at preventing further opioid abuse and assisting those
currently dealing with this addiction.
This legislation will strengthen our efforts to advance treatment and
recovery initiatives, improve prevention, protect our communities, and
bolster the fight against deadly illicit drugs.
We have made meaningful progress in our fight against the opioid
epidemic throughout the country by passing more than 50 bills in the
House, but our work is far from over.
No community is immune from this crisis. In 2016 alone, more than
1,300 Georgians lost their lives to opioid abuse. Many of them in my
community, my closest friends, have had to deal with this.
Our Senate colleagues should take note of this important work that we
have done here in the House over the past 2 weeks to combat the opioid
crisis, and I urge all of my colleagues to support H.R. 6.
Mr. PALLONE. 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. WALDEN. Mr. Chair, I yield myself the balance of my time.
Mr. Chair, I want to thank my colleagues on both sides of the aisle.
We have had individual Members come to the floor today from both
parties. Together, we have broken through what others might see as
dysfunction in Washington to achieve a comprehensive legislative
package that will provide treatment; save lives; stop illegal fentanyl
from coming into this country; and, in no small measure, move America
forward in a much better direction.
I want to share with you, Mr. Chair, a letter to the Speaker and to
Ms. Pelosi, urging us to support H.R. 6. It comes from not 1 or 2 but,
literally, 161 different groups that are very involved in the recovery
effort.
I want to share a couple of comments, Mr. Chairman: ``Substance use
disorder not only impacts the individual, but the family and community
as well. According to the Substance Abuse and Mental Health Services
Administration, approximately 9 million children across our Nation live
in a home with at least one parent who uses an illicit drug.
``Tragically,'' they write, ``children in these homes are at an
increased risk for depression, suicide, poverty, delinquency, anxiety,
homelessness, and substance use disorder. In addition, while our Nation
has made significant strides in both our understanding and response to
the drug crisis, it is clear that too many communities across our
Nation still have fragmented prevention, treatment, and recovery
infrastructures.''
Introduced by myself, Mr. Pallone, Mr. Neal, and Mr. Brady, they
write: ``The SUPPORT for Patients and Communities Act,'' this bill,
``would strengthen key Federal low-income assistance and senior health
insurance programs to better respond to our Nation's drug crisis. In
addition to serving as the vehicle that will advance many other
significant proposals already considered in the House, this legislation
will give critical Federal safety net programs more tools to prevent
and help treat substance use disorder.''
They write: ``We applaud the champions of H.R. 6 for treating
addiction like the disease that it is and for their bold leadership, in
their respective committees and on the House floor, to advance so many
innovative, bipartisan proposals that will have an immediate and
positive impact to address addiction. We respectfully urge the full
House to immediately consider and pass H.R. 6, which represents a
significant step toward building the comprehensive response needed in
our Nation so that fewer lives are lost to substance use disorder.''
Mr. Chair, this comes from the people who live this every day, who
help our neighbors, our friends, our families, and our American
citizens get the help they need to beat the disease of addiction and to
reclaim their lives, their families, and their future.
Mr. Chairman, I urge my colleagues to support passage of H.R. 6, and
I yield back the balance of my time.
Mr. BRADY of Texas. Mr. Chair, I yield myself such time as I may
consume.
Mr. Chair, the opioid crisis has impacted every community in America
and robbed countless individuals of their potential.
A recent poll found that more than 4 out of 10 Americans who are
young, in their 20s and 30s, personally know someone who has dealt with
opioid addiction. It is a staggering number, and it shows that this
crisis touches a huge part of our society.
All too often, we hear stories of loved ones exposed to opioids, and
then quickly addicted, from routine surgeries that may not have
required opioid treatment in the first place. This can be prevented.
That is why I rise today in support of H.R. 6, known as the SUPPORT for
Patients and Communities Act.
This bill, which incorporates legislation recently approved by the
Ways and Means Committee, addresses this crisis by putting in place
many commonsense measures to reduce the unnecessary prescription of
opioids and also to help those who have become addicted.
One important policy within H.R. 6, which has been championed by
Congressman Peter Roskam, who leads our Subcommittee on Health, will
prevent abuse by making sure folks are not able to game the system by
visiting multiple doctors' offices in order to receive an opioid. H.R.
6 ensures that patients have selected prescribers and selected
pharmacies that will be best able to address their needs.
Another important measure expands access to more forms of really
broad, holistic treatments for addiction through the use of medication-
assisted treatment. Americans who are struggling with addiction must be
able to find treatment that works for them.
{time} 1015
While we still have a long way to go to solve this crisis, this bill,
which is made up of many commonsense, Republican and Democrat
proposals, takes meaningful strides to help millions of Americans
recapture their lost hopes and dreams.
I thank Representatives Mike Bishop, Dave Reichert, Carlos Curbelo,
Peter Roskam, Erik Paulsen, and Jackie Walorski for their leadership on
this important issue. And I thank all of our committee members,
Republicans and Democrats, for their hard work on this important
legislation. I look forward to working with the Senate to ensure that
we send this important bill to the President's desk.
[[Page H5520]]
Mr. Chairman, I reserve the balance of my time.
Mr. NEAL. Mr. Chairman, I yield myself 4 minutes.
Mr. Chairman, I rise in support of H.R. 6.
It has become all too clear that the ongoing opioid epidemic has
gripped our Nation's families and communities. It crosses social
spectrums and is a public health, safety, and economic crisis as well.
In Massachusetts in 2016 there were 2,083 confirmed cases of opioid-
related overdose deaths. This is a 26 percent increase from 2015 and a
54 percent increase from 2014. In 2017 there was a small decrease, but
clearly there was still a strong need to address this devastating
trend.
This week, the House has considered opioid bills in committee and on
the floor, and some of these, in fact, will expand treatment options
for the care that is necessary.
However, a number of the Democratic priorities here, I think, really
provide real investment and opportunity. For example, it incorporates a
bill I introduced that would expand Medicare coverage for opioid
treatment programs. Currently, Medicare does not cover this sort of
treatment. This would give Medicare beneficiaries access to a broad
range of treatment options, leading to opportunities for lasting
recovery.
Although many think of opioid use disorders as a problem faced by
young people, many may be surprised to learn that it is rapidly growing
among our Medicare beneficiaries. Medicare part D spending on opioids
for treatment outpaces enrollment, growing 165 percent from 2006 to
2015. In 13 States, the over-65 population has the highest rate of
opioid-related inpatient stays.
H.R. 6 also expands coverage of medication-assisted treatments and
allows nurse practitioners and physician assistants to prescribe or
dispense certain opioid treatment drugs. The measure also provides
consistent Medicaid coverage for at-risk youth and expands Medicaid
coverage for foster youth until the age of 26.
These bills are pieces of a large, complex puzzle. We need to find
realistic solutions with long-term outcomes. Part of this approach is
to protect and strengthen Medicaid and the Affordable Care Act.
The ACA guarantees parity and nondiscrimination for people who need
substance use disorder treatment and mental health treatment. Thanks to
the ACA, millions of previously uninsured adults now have access to
health insurance and, I might add, the expansion of Medicaid.
There are many efforts here, I think, time and time again, to
dismantle the Medicare proposal, as well as cutting back on many of the
initiatives that we have proposed in the past. Instead of strengthening
and ensuring a sustainable future for the ACA and for Medicaid, some of
our colleagues want to cut them to pay for a $2.3 trillion tax plan.
Efforts to sabotage the ACA, coupled with premium hikes, slashing
preexisting condition protections, and increasing drug prices will lead
to more uncertainty.
Dismantling current health benefits would damage any progress that we
are making today with the opioid crisis. It would also increase
healthcare costs and lower coverage and quality of life for Americans
and their families.
I urge my colleagues to recognize that many families, who are
devastated by addiction, are going to need the opportunities that we
are embracing today.
The impact of the opioid crisis on the labor participation rates in
America should concern all of us. According to a recent report, the
economic burden from opioids was estimated at $95 billion.
The American people are facing two-pronged obstacle health
challenges. Uncertainty remains one of them. We want to make sure that
we don't sabotage the ACA. And part of the path forward today is
highlighted by the achievement we are all about to recognize.
Mr. Chairman, I reserve the balance of my time.
Mr. BRADY of Texas. Mr. Chairman, I am proud to yield 2 minutes to
the gentleman from Illinois (Mr. Roskam), the leader of the Health
Subcommittee.
Mr. ROSKAM. Mr. Chairman, I want to thank Chairman Brady for his
leadership on this.
I have done a lot of work over the past several months, as I know we
all have, of listening to my constituents in suburban Chicago, and here
is what I have heard: They want us to take a multifaceted approach.
One of the things that I am doing this morning is highlighting a
portion of this bill that Mr. Brady mentioned in his opening statement,
and that is a lock-in phenomenon.
Here is the story: The power of this molecule, when it gets into our
bodies, is breathtaking and is sobering. Here is one statistic that
should make us shudder: One-third of part D Medicare beneficiaries were
prescribed an opioid in 2016--one-third of Medicare part D
beneficiaries were prescribed an opioid in 2016. There is nothing good
that is going on with that.
So here is what we are trying to do: We are saying that we need to
resist pharmacy shopping. We need to resist doctor shopping. And we
need to make sure that people can be identified who have a
predisposition towards this addiction.
So what this bill does--what part of this bill does--is it says:
Medicare part D programs don't just have the option of requiring a
lock-in program, we are now locking in on lock-in. We are saying: You
have got to do this.
Unambiguously, it is a mandate, it is a good mandate, and it is
something that has been a long time coming. TRICARE uses this, and a
number of other distribution systems use it, but the time is ripe and
we have absolutely got to get this done. It is part of a holistic
approach that I think is really welcome.
Mr. Chairman, I congratulate and thank Mr. Levin, the ranking member;
Mr. Bilirakis; and Mr. Lujan, also who similarly worked on this
legislation. I am confident that in 10 years' time, our country, based
on the work that this House is doing now, is going to reflect back, and
it is going to say: America responded. We did it on a bipartisan basis.
And we are going to be having a better and different conversation.
Mr. NEAL. Mr. Chairman, I yield 4 minutes to the gentleman from
Illinois (Mr. Danny K. Davis).
Mr. DANNY K. DAVIS of Illinois. Mr. Chairman, I thank Mr. Neal for
yielding.
Mr. Chairman, I support H.R. 6 as a step to the puzzle to address
substance abuse. However, I think we need to expand this bill in an
important way as it moves forward.
To prevent opioid addiction, we must address the social and emotional
harm caused by trauma that often underlies opiate use.
Research demonstrates that exposure to four or more adverse childhood
experiences, such as neglect, experiencing a parent battling addiction,
witnessing violence, or observing domestic violence, makes an
individual 10 times more likely to misuse illicit narcotics. These
drugs serve as a coping response to traumatic life experiences.
The Senate's bipartisan Opioid Crisis Response Act included
provisions from my Trauma-Informed Care Act with Senator Durbin to help
improve the Federal response to trauma to help prevent opioid abuse.
These provisions would expand the workforce capacity to help children
exposed to trauma, they would improve our understanding of trauma by
improving Federal data and best practices, and they would increase
services for children exposed to trauma to help these young people
heal.
Our efforts to prevent the opioid crisis will be insufficient unless
we address the role of trauma in it, which is why 28 organizations
supported my effort to amend H.R. 6 to focus on trauma--organizations
like the Child Welfare League of America, the Jewish Child and Family
Services, the National Association of Social Workers, Partners for Our
Children with the University of Washington, and the YMCA USA--but my
amendment was not made in order.
The science is clear that trauma has devastating effects on a child's
healthy development well into adulthood. When children experience
traumatic events, stress alters the developing brain, which harms them
physically and mentally.
Mr. Chairman, I include in the Record this outline of the research by
[[Page H5521]]
the Society for Research in Child Development documenting the harm
caused by trauma and parental separation.
[From the Society for Research in Child Development, June 20, 2018]
Statement of the Evidence--The Science Is Clear: Separating Families
Has Long-Term Damaging Psychological and Health Consequences for
Children, Families, and Communities
After the United States Department of Justice announced the
``Zero olerance Policy for Criminal Illegal Entry,''
Immigration and Custom Enforcement (ICE--an arm of the
Department of Homeland Security) separated approximately
2,000 children from their parents in April and May 2018 as
they approached the U.S. border. Children and parents were
placed in separate facilities as they were being processed
and were not told when or how they would be reunited. This
policy and its consequences have raised significant concerns
among researchers, child welfare advocates, policy makers,
and the public, given the overwhelming scientific evidence
that separation between children and parents, except in cases
where there is evidence of maltreatment, is harmful to the
development of children, families, and communities. Family
separations occurring in the presence of other stressors,
such as detention or natural disaster, only adds to their
negative effects.
Evidence on Harmful Effects of Parent-Child Separation
The evidence that family separation is harmful dates back
to studies on the effects of parent-child separations on
children's well-being during World War II. This research
documented far reaching effects of these separations into
adulthood, including increased risk for mental health
problems, poor social functioning, insecure attachment,
disrupted stress reactivity, and mortality (Pesonen &
Raikkonen, 2012; Rusby & Tasker, 2009; Mitrani, Santiste-ban,
& Muir, 2004). Other research similarly documents the harmful
effects of parental separation on child wellbeing in a
variety of other child populations including children in
Romanian orphanages (Zeanah, Nelson, Fox, et al., 2003),
children in foster care (Flannery, Beauchamp, & Fisher, 2017)
and children of incarcerated parents (Geller, Garfinkel,
Cooper & Mincy, 2009; Miller, 2006). More recent work has
documented the increased mental health risk faced by both
parents and children when they are separated in the
immigration process (Suarez-Orozco, Bang, & Kim., 2011; Rusch
& Reyes, 2013). Parent-child separation has long-term effects
on child well-being, even if there is subsequent
reunification. After being separated, reunited children can
experience difficulty with emotional attachment to their
parents, self-esteem, and physical and psychological health
(Smith, Lalonde, & Johnson, 2004; Gubernskaya & Debry, 2017).
For some children, time does not appear to fully heal these
psychological wounds (Shonkoff et al., 2012).
Parents Buffer Children from Adverse Effects of Toxic Stress
Parental separation is considered a toxic stressor, an
experience that engages strong and prolonged activation of
the body's stress-management system (Bridgman, 2014) The
physiological and psychological toll of early life stress,
including parental separation, changes how the body responds
to stress in the long term, disrupting higher-order cognitive
and affective processes as well as negatively altering brain
structures and functioning (Lupien, McEwen, Gunnar, & Heim,
2009; Pechtel & Pizzagalli, 2011; Kumar et al., 2014). Such
stressors put children at greater risk for a multitude of
health and psychological impairments, including anxiety,
depression, post-traumatic stress disorder, lower IQ,
obesity, immune system functioning, physical growth, cancer,
heart and lung disease, stroke, and morbidity (Granqvist,
Sroufe, Dozier, Hesse, & Steele, 2017, Heim & Nemeroff, 2001;
Mamam, Antornadis, & Morris, 2014; Pechtel & Pizza-galli,
2011; Shirtdiff, Coe, & Pollak, 2009; Taylor, 2010).
Children depend on their primary caretakers to successfully
navigate stressful and traumatic events. Children's
physiological responses to stress can be significantly
reduced by access to their primary caretaker (Hostinar,
Sullivan, & Gunnar, 2013). The separation of the family unit
under extreme conditions of stress worsens the psychological
and physiological ramifications of that stressor on children,
especially younger children (Masten & Narayan, 2012).
Conversely, ongoing contact with primary caregivers under
conditions of stress can protect against risk (Rodriguez &
Margolin, 2015).
Child-Separation from Parents Impacts Children at All Ages
Much of the research on family separation has focused on
the impacts on children early in development. However,
puberty is also an especially vulnerable time of rapid change
(Doom & Gunnar, 2013). Stressors during adolescence can have
lasting impacts--the effects of which may not become evident
until adulthood--(Humphreys, Gleason, Drury, et al., 2015;
Lupien, McEwen, Gunnar, & Heim, 2009). Further, the effects
of traumatic experiences are cumulative; children and
adolescents who have already faced previous adversity are
particularly susceptible to long term further negative
consequences (Brown, Anda, & Tiemeier, et al, 2009,
MacKenzie, Bosk, & Zeanah, 2017) Thus, the research shows
that across infancy, childhood, and adolescence, child-family
separations can be related to negative outcomes across the
lifespan.
Impact of Border Family Separations on U.S. Citizens
There is also evidence that family separations harm U S.
citizens whose family members experience border detention or
deportation. Parental separation increases the risk for these
U.S. children's mental health problems such as anxiety,
depression, behavior problems, and symptoms of post-traumatic
stress disorder (Allen, Cisneros, & Tellez, 2015; Rojas-
Flores, Clements, Hwang Koo, & London, 2017; Zayas, Aguilar-
Gaxiola, Yoon, & Rey, 2015). U.S. citizens of Latino descent
also report heightened worries and concerns for their
families and their communities as a result of changes in
implementation of immigration policies such as the Deferred
Action for Childhood Arrivals (DACA) policy (Roche, Vaquera,
White, & Rivera, 2018). Moreover, countries with supportive
integration policies are more likely to have child
populations with better overall health and mental health
indicators than those with less supportive approaches (Marks,
McKenna, & Garcia Coll, 2018). Thus, there is evidence that
policies about parental separations can negatively affect
American citizens.
The Policy Implications are Clear
The scientific evidence is conclusive. Parent-child
separations lead to a host of long-term psychological,
social, and health problems that are not necessarily resolved
upon reunification. In particular, the disruption of
biological stress regulation mechanisms in the body induced
by the need to seek refugee or asylum status are further
taxed by the absence of parental support. The science is
clear: policies that separate immigrant families upon entry
to the U.S. have devastating and long-term developmental
consequences for children and their families.
Mr. DANNY K. DAVIS of Illinois. That is why the administration's
intentional infliction of trauma on children by separating children
from their parents is so cruel and inhumane. Causing intentional harm
to children is a human rights violation and is un-American. We must
stop this appalling policy immediately, reunite parents and children
without delay, and provide intensive services to help these families
heal.
Mr. BRADY of Texas. Mr. Chairman, I am proud to yield 2 minutes to
the gentleman from Michigan (Mr. Bishop), the leader of the STOP Act,
which prevents illegal smuggling of fentanyl into the United States.
Mr. BISHOP of Michigan. Mr. Chairman, I thank Chairman Brady for his
steadfast leadership in finding a solution to this crisis.
Mr. Chairman, I rise in strong support of H.R. 6, the SUPPORT for
Patients and Communities Act. I am pleased that we are voting on this
legislation today, which includes important reforms to Medicare and
Medicaid policies, to help combat the opioid crisis in our country.
Mr. Chairman, the opioid crisis has affected every segment of our
Nation's population. Every Member of this Chamber has a community in
crisis. Each and every day, 115 Americans die from opioid overdoses. We
are talking about valued members of our communities: mothers, fathers,
and, especially, so many young children who have left us way too early
because of the tragedy of opioids.
As I travel across my district in Michigan, I hear frequently from
constituents about this crisis at townhall meetings and roundtables I
have hosted. I have heard personal stories from constituents about the
devastating impact this crisis is having in southeast Michigan.
I have also been meeting with elected officials across the district
on this crisis, including firefighters, police officers, emergency
responders, and medical professionals. They all want me to do
something, do it urgently, and for Congress to be involved.
While there is no silver bullet to address this issue, I am pleased
that over the past several weeks the House has passed over 70 bills to
address the opioid crisis. It includes the legislation that I authored,
the STOP Act, to stop the flow of synthetic opioids into the country.
H.R. 6 will do more than that. It will expand the Medicare coverage
for opioid treatment services, like substance abuse counseling,
individual and group therapy, and medication-assisted treatment. These
reforms will empower our Americans to overcome addiction and once again
become productive members of our society.
Mr. Chairman, again, I thank Chairman Brady and Chairman Walden for
[[Page H5522]]
their leadership in crafting this legislation, and for their steadfast
leadership to address the opioid crisis.
Mr. NEAL. Mr. Chairman, I reserve the balance of my time.
Mr. BRADY of Texas. Mr. Chairman, I am proud to yield 2 minutes to
the gentleman from North Carolina (Mr. Holding).
Mr. HOLDING. Mr. Chairman, I would like to highlight the importance
of medication-assisted treatment in combating the opioid epidemic.
This epidemic has pervaded all populations, including our seniors.
Medicare beneficiaries have among the highest and fastest rate of
opioid use disorder, yet they do not currently have coverage for the
most effective treatment.
The SUPPORT Act, which will be before the House today, would change
that. This bill provides for a fully coordinated, bundled-care model
that will help patients through medication-assisted treatment, which
combines the use of medication with counseling, group therapy, and drug
testing.
Just this week, the NIH released a study that found delivering
medication-assisted treatment to patients following an opioid overdose
dropped the death rate by 59 percent.
The President's Commission on Combating Drug Addiction and the Opioid
Crisis also cited the value of medication-assisted treatment in
reducing overdoses and relapses while retaining patients in a treatment
program.
For example, a constituent named Jeff from North Carolina became
dependent on opioids after a difficult back surgery. He initially tried
to stop cold, but went into withdrawal and relapsed. Fortunately, Jeff
was able to receive treatment from the Goldsboro Comprehensive
Treatment Center where he went through counseling. His progress was
monitored, and monthly drug screens kept him accountable. He--Jeff--now
says that his life has changed 100 percent for the better.
{time} 1030
Every Member of this House has constituents just like Jeff who have
struggled with addiction but can regain their life with the right
treatment. While there is no silver bullet to this crisis, we need to
ensure patients and doctors have all options at their disposal to
combat the opioid epidemic.
Mr. NEAL. Mr. Chair, I reserve the balance of my time.
Mr. BRADY of Texas. Mr. Chair, I yield 1 minute to the gentlewoman
from Indiana (Mrs. Walorski), a leader on the opioid crisis.
Mrs. WALORSKI. Mr. Chair, I thank Chairman Brady for all of his work.
Mr. Chair, I rise today in support for the SUPPORT for Patients and
Communities Act. It includes my bill, the Dr. Todd Graham Pain
Management, Treatment, and Recovery Act, that passed the House earlier
this week.
H.R. 6 is also vital for equipping those on the front lines with
important treatment and recovery initiatives. This includes people in
my district like Erin LaCourt at Victory Clinical Services in South
Bend. Victory provides comprehensive treatment for individuals with
substance abuse disorders, but H.R. 6 will help them expand those
services to include seniors.
This bill will also help Justin Phillips, who founded Overdose
Lifeline, which is dedicated to helping those affected by addiction,
assist even more Hoosiers on their road to recovery.
Solving the opioid epidemic requires every one of us to work
together. I want to thank Erin, Justin, and all the other hardworking
Hoosiers in my district who deserve recognition and to let them know we
have noticed all their hard work.
Mr. Chair, I urge my colleagues to support this bill.
Mr. NEAL. Mr. Chairman, I yield myself the balance of my time.
Mr. Chairman, I want to close by thanking Chairman Kevin Brady and
acknowledging Chairman Walden and Ranking Member Pallone for their hard
work on what is really a good step forward.
As I said earlier in my remarks, this bill is not going to solve the
opioid crisis tomorrow, but it does include a number of important
provisions that will expand access to treatment and recovery options
for all Americans. This was a bipartisan piece of work in our
committee. I think we can be proud of it. We know many who need
treatment now cannot access it, and this bill will take significant
steps to change that.
I want to thank Jessica Shapiro and Karl Hagnauer from the House
Legislative Counsel for their hours of work in helping us to put
together H.R. 6; the staff of the Centers for Medicare and Medicaid
Office of Legislation, in particular Ira Burney and Jennifer Druckman;
and the staff of the Congressional Budget Office, including Rebecca Yip
and Lara Robillard.
Finally, I want to thank the Ways and Means Republican staffers led
by Emily Murry, the Energy and Commerce Democratic staff led by Tiffany
Guarascio, the Energy and Commerce Republican staff led by Josh Trent,
and my own Democratic staff at Ways and Means, which is always superb,
led by Amy Hall, Melanie Egorin, and Rachel Dolin.
A lot of hard work goes into this sort of legislation and a lot of
complexities have to be addressed during the process, and oftentimes
that is not the sort of information that finds its way to the public
light. But acknowledging here those people who helped to put this
together as well as the men and women of the committee, I think,
frequently is missed, and we want to do that so that they receive the,
I think, due praise that they are entitled to.
I hope that this, when matched with Senate provisions, will quickly
become law.
One of the things that unites every one of us in this Chamber is that
we all know somebody--a family member, somebody who lives down the
street, or a coworker--who has an opiate addiction. I think that
Congress taking this step today in this direction will provide some
sense of hope for those families and friends who find themselves, for a
variety of reasons, suffering from the pain economically and physically
that comes from opiate addictions.
I think, as we close here, this is a good day for the Ways and Means
Committee, Energy and Commerce Committee, and, I think, for the members
and the staffers whose work is reflected in this product.
Mr. Chair, I yield back the balance of my time.
Mr. BRADY of Texas. Mr. Chair, I yield myself the balance of my time.
Mr. Chair, I agree with Mr. Neal. Republicans and Democrats have come
together from the Ways and Means Committee and Energy and Commerce to
help millions of Americans through prevention of overprescribing,
education for patients and prescribers, and access to treatment. This
is a major step forward.
Mr. Chair, I urge Congress to pass this bill. I look forward to
getting it to the President's desk.
Mr. Chair, I yield back the balance of my time.
The Acting CHAIR (Mr. Poe of Texas). All time for general debate has
expired.
Pursuant to the rule, the bill shall be considered for amendment
under the 5-minute rule.
The amendment in the nature of a substitute consisting of the text of
Rules Committee Print 115-76, modified by Rules Committee Print 115-78
and the amendment printed in part A of House Report 115-766, shall be
considered as adopted. The bill, as amended, shall be considered as an
original bill for the purpose of further amendment under the 5-minute
rule and shall be considered as read.
The text of the bill, as amended, is as follows:
H.R. 6
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Substance
Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act'' or the ``SUPPORT
for Patients and Communities Act''.
(b) Table of Contents.--The table of contents for the Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 101. At-risk youth Medicaid protection.
Sec. 102. Health Insurance for Former Foster Youth.
Sec. 103. Demonstration project to increase substance use provider
capacity under the Medicaid program.
Sec. 104. Drug management program for at-risk beneficiaries.
Sec. 105. Medicaid drug review and utilization.
[[Page H5523]]
Sec. 106. Guidance to improve care for infants with neonatal abstinence
syndrome and their mothers; GAO study on gaps in Medicaid
coverage for pregnant and postpartum women with substance
use disorder.
Sec. 107. Medicaid health homes for opioid-use-disorder Medicaid
enrollees.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 201. Authority not to apply certain Medicare telehealth
requirements in the case of certain treatment of a
substance use disorder or co-occurring mental health
disorder.
Sec. 202. Encouraging the use of non-opioid analgesics for the
management of post-surgical pain.
Sec. 203. Requiring a review of current opioid prescriptions for
chronic pain and screening for opioid use disorder to be
included in the Welcome to Medicare initial preventive
physical examination.
Sec. 204. Modification of payment for certain outpatient surgical
services.
Sec. 205. Requiring e-prescribing for coverage of covered part D
controlled substances.
Sec. 206. Requiring prescription drug plan sponsors under Medicare to
establish drug management programs for at-risk
beneficiaries.
Sec. 207. Medicare coverage of certain services furnished by opioid
treatment programs.
TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS
Sec. 301. Clarifying FDA regulation of non-addictive pain and addiction
therapies.
Sec. 302. Surveillance and Testing of Opioids to Prevent Fentanyl
Deaths.
Sec. 303. Allowing for more flexibility with respect to medication-
assisted treatment for opioid use disorders.
TITLE IV--OFFSETS
Sec. 401. Promoting value in Medicaid managed care.
Sec. 402. Extending period of application of Medicare secondary payer
rules for individuals with end stage renal disease.
Sec. 403. Requiring reporting by group health plans of prescription
drug coverage information for purposes of identifying
primary payer situations under the Medicare program.
TITLE I--MEDICAID PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 101. AT-RISK YOUTH MEDICAID PROTECTION.
(a) In General.--Section 1902 of the Social Security Act
(42 U.S.C. 1396a) is amended--
(1) in subsection (a)--
(A) by striking ``and'' at the end of paragraph (82);
(B) by striking the period at the end of paragraph (83) and
inserting ``; and''; and
(C) by inserting after paragraph (83) the following new
paragraph:
``(84) provide that--
``(A) the State shall not terminate eligibility for medical
assistance under the State plan for an individual who is an
eligible juvenile (as defined in subsection (nn)(2)) because
the juvenile is an inmate of a public institution (as defined
in subsection (nn)(3)), but may suspend coverage during the
period the juvenile is such an inmate;
``(B) in the case of an individual who is an eligible
juvenile described in paragraph (2)(A) of subsection (nn),
the State shall, prior to the individual's release from such
a public institution, conduct a redetermination of
eligibility for such individual with respect to such medical
assistance (without requiring a new application from the
individual) and, if the State determines pursuant to such
redetermination that the individual continues to meet the
eligibility requirements for such medical assistance, the
State shall restore coverage for such medical assistance to
such an individual upon the individual's release from such
public institution; and
``(C) in the case of an individual who is an eligible
juvenile described in paragraph (2)(B) of subsection (nn),
the State shall process any application for medical
assistance submitted by, or on behalf of, such individual
such that the State makes a determination of eligibility for
such individual with respect to such medical assistance upon
release of such individual from such public institution.'';
and
(2) by adding at the end the following new subsection:
``(nn) Juvenile; Eligible Juvenile; Public Institution.--
For purposes of subsection (a)(84) and this subsection:
``(1) Juvenile.--The term `juvenile' means an individual
who is--
``(A) under 21 years of age; or
``(B) described in subsection (a)(10)(A)(i)(IX).
``(2) Eligible juvenile.--The term `eligible juvenile'
means a juvenile who is an inmate of a public institution and
who--
``(A) was determined eligible for medical assistance under
the State plan immediately before becoming an inmate of such
a public institution; or
``(B) is determined eligible for such medical assistance
while an inmate of a public institution.
``(3) Inmate of a public institution.--The term `inmate of
a public institution' has the meaning given such term for
purposes of applying the subdivision (A) following paragraph
(29) of section 1905(a), taking into account the exception in
such subdivision for a patient of a medical institution.''.
(b) No Change in Exclusion From Medical Assistance for
Inmates of Public Institutions.--Nothing in this section
shall be construed as changing the exclusion from medical
assistance under the subdivision (A) following paragraph (29)
of section 1905(a) of the Social Security Act (42 U.S.C.
1396d(a)), including any applicable restrictions on a State
submitting claims for Federal financial participation under
title XIX of such Act for such assistance.
(c) No Change in Continuity of Eligibility Before
Adjudication or Sentencing.--Nothing in this section shall be
construed to mandate, encourage, or suggest that a State
suspend or terminate coverage for individuals before they
have been adjudicated or sentenced.
(d) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by subsection (a) shall apply to eligibility
of juveniles who become inmates of public institutions on or
after the date that is 1 year after the date of the enactment
of this Act.
(2) Rule for changes requiring state legislation.--In the
case of a State plan for medical assistance under title XIX
of the Social Security Act which the Secretary of Health and
Human Services determines requires State legislation (other
than legislation appropriating funds) in order for the plan
to meet the additional requirements imposed by the amendments
made by subsection (a), the State plan shall not be regarded
as failing to comply with the requirements of such title
solely on the basis of its failure to meet these additional
requirements before the first day of the first calendar
quarter beginning after the close of the first regular
session of the State legislature that begins after the date
of the enactment of this Act. For purposes of the previous
sentence, in the case of a State that has a 2-year
legislative session, each year of such session shall be
deemed to be a separate regular session of the State
legislature.
SEC. 102. HEALTH INSURANCE FOR FORMER FOSTER YOUTH.
(a) Coverage Continuity for Former Foster Care Children up
to Age 26.--
(1) In general.--Section 1902(a)(10)(A)(i)(IX) of the
Social Security Act (42 U.S.C. 1396a(a)(10)(A)(i)(IX)) is
amended--
(A) in item (bb), by striking ``are not described in or
enrolled under'' and inserting ``are not described in and are
not enrolled under'';
(B) in item (cc), by striking ``responsibility of the
State'' and inserting ``responsibility of a State''; and
(C) in item (dd), by striking ``the State plan under this
title or under a waiver of the'' and inserting ``a State plan
under this title or under a waiver of such a''.
(2) Effective date.--The amendments made by this subsection
shall take effect with respect to foster youth who attain 18
years of age on or after January 1, 2023.
(b) Guidance.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall issue guidance to States, with respect to the
State Medicaid programs of such States--
(1) on best practices for--
(A) removing barriers and ensuring streamlined, timely
access to Medicaid coverage for former foster youth up to age
26; and
(B) conducting outreach and raising awareness among such
youth regarding Medicaid coverage options for such youth; and
(2) which shall include examples of States that have
successfully extended Medicaid coverage to former foster
youth up to age 26.
SEC. 103. DEMONSTRATION PROJECT TO INCREASE SUBSTANCE USE
PROVIDER CAPACITY UNDER THE MEDICAID PROGRAM.
Section 1903 of the Social Security Act (42 U.S.C. 1396b)
is amended by adding at the end the following new subsection:
``(aa) Demonstration Project to Increase Substance Use
Provider Capacity.--
``(1) In general.--Not later than the date that is 180 days
after the date of the enactment of this section, the
Secretary shall, in consultation, as appropriate, with the
Director of the Agency for Healthcare Research and Quality
and the Assistant Secretary for Mental Health and Substance
Use, conduct a 54-month demonstration project for the purpose
described in paragraph (2) under which the Secretary shall--
``(A) for the first 18-month period of such project, award
planning grants described in paragraph (3); and
``(B) for the remaining 36-month period of such project,
provide to each State selected under paragraph (4) payments
in accordance with paragraph (5).
``(2) Purpose.--The purpose described in this paragraph is
for each State selected under paragraph (4) to increase the
treatment capacity of providers participating under the State
plan (or a waiver of such plan) to provide substance use
disorder treatment or recovery services under such plan (or
waiver) through the following activities:
``(A) For the purpose described in paragraph (3)(C)(i),
activities that support an ongoing assessment of the
behavioral health treatment needs of the State, taking into
account the matters described in subclauses (I) through (IV)
of such paragraph.
``(B) Activities that, taking into account the results of
the assessment described in subparagraph (A), support the
recruitment, training, and provision of technical assistance
for providers participating under the State plan (or a waiver
of such plan) that offer substance use disorder treatment or
recovery services.
``(C) Improved reimbursement for and expansion of, through
the provision of education, training, and technical
assistance, the number or treatment capacity of providers
participating under the State plan (or waiver) that--
``(i) are authorized to dispense drugs approved by the Food
and Drug Administration for individuals with a substance use
disorder who need
[[Page H5524]]
withdrawal management or maintenance treatment for such
disorder;
``(ii) have in effect a registration or waiver under
section 303(g) of the Controlled Substances Act for purposes
of dispensing narcotic drugs to individuals for maintenance
treatment or detoxification treatment and are in compliance
with any regulation promulgated by the Assistant Secretary
for Mental Health and Substance Use for purposes of carrying
out the requirements of such section 303(g); and
``(iii) are qualified under applicable State law to provide
substance use disorder treatment or recovery services.
``(D) Improved reimbursement for and expansion of, through
the provision of education, training, and technical
assistance, the number or treatment capacity of providers
participating under the State plan (or waiver) that have the
qualifications to address the treatment or recovery needs
of--
``(i) individuals enrolled under the State plan (or a
waiver of such plan) who have neonatal abstinence syndrome,
in accordance with guidelines issued by the American Academy
of Pediatrics and American College of Obstetricians and
Gynecologists relating to maternal care and infant care with
respect to neonatal abstinence syndrome;
``(ii) pregnant women, postpartum women, and infants,
particularly the concurrent treatment, as appropriate, and
comprehensive case management of pregnant women, postpartum
women and infants, enrolled under the State plan (or a waiver
of such plan);
``(iii) adolescents and young adults between the ages of 12
and 21 enrolled under the State plan (or a waiver of such
plan); or
``(iv) American Indian and Alaska Native individuals
enrolled under the State plan (or a waiver of such plan).
``(3) Planning grants.--
``(A) In general.--The Secretary shall, with respect to the
first 18-month period of the demonstration project conducted
under paragraph (1), award planning grants to at least 10
States selected in accordance with subparagraph (B) for
purposes of preparing an application described in paragraph
(4)(C) and carrying out the activities described in
subparagraph (C).
``(B) Selection.--In selecting States for purposes of this
paragraph, the Secretary shall--
``(i) select States that have a State plan (or waiver of
the State plan) approved under this title;
``(ii) select States in a manner that ensures geographic
diversity; and
``(iii) give preference to States with a prevalence of
substance use disorders (in particular opioid use disorders)
that is comparable to or higher than the national average
prevalence, as measured by aggregate per capita drug
overdoses, or any other measure that the Secretary deems
appropriate.
``(C) Activities described.--Activities described in this
subparagraph are, with respect to a State, each of the
following:
``(i) Activities that support the development of an initial
assessment of the behavioral health treatment needs of the
State to determine the extent to which providers are needed
(including the types of such providers and geographic area of
need) to improve the network of providers that treat
substance use disorders under the State plan (or waiver),
including the following:
``(I) An estimate of the number of individuals enrolled
under the State plan (or a waiver of such plan) who have a
substance use disorder.
``(II) Information on the capacity of providers to provide
substance use disorder treatment or recovery services to
individuals enrolled under the State plan (or waiver),
including information on providers who provide such services
and their participation under the State plan (or waiver).
``(III) Information on the gap in substance use disorder
treatment or recovery services under the State plan (or
waiver) based on the information described in subclauses (I)
and (II).
``(IV) Projections regarding the extent to which the State
participating under the demonstration project would increase
the number of providers offering substance use disorder
treatment or recovery services under the State plan (or
waiver) during the period of the demonstration project.
``(ii) Activities that, taking into account the results of
the assessment described in clause (i), support the
development of State infrastructure to, with respect to the
provision of substance use disorder treatment or recovery
services under the State plan (or a waiver of such plan),
recruit prospective providers and provide training and
technical assistance to such providers.
``(D) Funding.--For purposes of subparagraph (A), there is
appropriated, out of any funds in the Treasury not otherwise
appropriated, $50,000,000, to remain available until
expended.
``(4) Post-planning states.--
``(A) In general.--The Secretary shall, with respect to the
remaining 36-month period of the demonstration project
conducted under paragraph (1), select not more than 5 States
in accordance with subparagraph (B) for purposes of carrying
out the activities described in paragraph (2) and receiving
payments in accordance with paragraph (5).
``(B) Selection.--In selecting States for purposes of this
paragraph, the Secretary shall--
``(i) select States that received a planning grant under
paragraph (3);
``(ii) select States that submit to the Secretary an
application in accordance with the requirements in
subparagraph (C), taking into consideration the quality of
each such application;
``(iii) select States in a manner that ensures geographic
diversity; and
``(iv) give preference to States with a prevalence of
substance use disorders (in particular opioid use disorders)
that is comparable to or higher than the national average
prevalence, as measured by aggregate per capita drug
overdoses, or any other measure that the Secretary deems
appropriate.
``(C) Applications.--
``(i) In general.--A State seeking to be selected for
purposes of this paragraph shall submit to the Secretary, at
such time and in such form and manner as the Secretary
requires, an application that includes such information,
provisions, and assurances, as the Secretary may require, in
addition to the following:
``(I) A proposed process for carrying out the ongoing
assessment described in paragraph (2)(A), taking into account
the results of the initial assessment described in paragraph
(3)(C)(i).
``(II) A review of reimbursement methodologies and other
policies related to substance use disorder treatment or
recovery services under the State plan (or waiver) that may
create barriers to increasing the number of providers
delivering such services.
``(III) The development of a plan, taking into account
activities carried out under paragraph (3)(C)(ii), that will
result in long-term and sustainable provider networks under
the State plan (or waiver) that will offer a continuum of
care for substance use disorders. Such plan shall include the
following:
``(aa) Specific activities to increase the number of
providers (including providers that specialize in providing
substance use disorder treatment or recovery services,
hospitals, health care systems, Federally qualified health
centers, and, as applicable, certified community behavioral
health clinics) that offer substance use disorder treatment,
recovery, or support services, including short-term
detoxification services, outpatient substance use disorder
services, and evidence-based peer recovery services.
``(bb) Strategies that will incentivize providers described
in subparagraphs (C) and (D) of paragraph (2) to obtain the
necessary training, education, and support to deliver
substance use disorder treatment or recovery services in the
State.
``(cc) Milestones and timeliness for implementing
activities set forth in the plan.
``(dd) Specific measurable targets for increasing the
substance use disorder treatment and recovery provider
network under the State plan (or a waiver of such plan).
``(IV) A proposed process for reporting the information
required under paragraph (6)(A), including information to
assess the effectiveness of the efforts of the State to
expand the capacity of providers to deliver substance use
disorder treatment or recovery services during the period of
the demonstration project under this subsection.
``(V) The expected financial impact of the demonstration
project under this subsection on the State.
``(VI) A description of all funding sources available to
the State to provide substance use disorder treatment or
recovery services in the State.
``(VII) A preliminary plan for how the State will sustain
any increase in the capacity of providers to deliver
substance use disorder treatment or recovery services
resulting from the demonstration project under this
subsection after the termination of such demonstration
project.
``(VIII) A description of how the State will coordinate the
goals of the demonstration project with any waiver granted
(or submitted by the State and pending) pursuant to section
1115 for the delivery of substance use services under the
State plan, as applicable.
``(ii) Consultation.--In completing an application under
clause (i), a State shall consult with relevant stakeholders,
including Medicaid managed care plans, health care providers,
and Medicaid beneficiary advocates, and include in such
application a description of such consultation.
``(5) Payment.--
``(A) In general.--For each quarter occurring during the
period for which the demonstration project is conducted
(after the first 18 months of such period), the Secretary
shall pay under this subsection, subject to subparagraph (C),
to each State selected under paragraph (4) an amount equal to
80 percent of so much of the qualified sums expended during
such quarter.
``(B) Qualified sums defined.--For purposes of subparagraph
(A), the term `qualified sums' means, with respect to a State
and a quarter, the amount equal to the amount (if any) by
which the sums expended by the State during such quarter
attributable to substance use treatment or recovery services
furnished by providers participating under the State plan (or
a waiver of such plan) exceeds 1/4 of such sums expended by
the State during fiscal year 2018 attributable to substance
use treatment or recovery services.
``(C) Non-duplication of payment.--In the case that payment
is made under subparagraph (A) with respect to expenditures
for substance use treatment or recovery services furnished by
providers participating under the State plan (or a waiver of
such plan), payment may not also be made under subsection (a)
with respect to expenditures for the same services so
furnished.
``(6) Reports.--
``(A) State reports.--A State receiving payments under
paragraph (5) shall, for the period of the demonstration
project under this subsection, submit to the Secretary a
quarterly report, with respect to expenditures for substance
use treatment or recovery services for which payment is made
to the State under this subsection, on the following:
``(i) The specific activities with respect to which payment
under this subsection was provided.
``(ii) The number of providers that delivered substance use
disorder treatment or recovery services in the State under
the demonstration project compared to the estimated number of
providers that would have otherwise delivered such services
in the absence of such demonstration project.
``(iii) The number of individuals enrolled under the State
plan (or a waiver of such plan) who received substance use
disorder treatment
[[Page H5525]]
or recovery services under the demonstration project compared
to the estimated number of such individuals who would have
otherwise received such services in the absence of such
demonstration project.
``(iv) Other matters as determined by the Secretary.
``(B) CMS reports.--
``(i) Initial report.--Not later than October 1, 2020, the
Administrator of the Centers for Medicare & Medicaid Services
shall, in consultation with the Director of the Agency for
Healthcare Research and Quality and the Assistant Secretary
for Mental Health and Substance Use, submit to Congress an
initial report on--
``(I) the States awarded planning grants under paragraph
(3);
``(II) the criteria used in such selection; and
``(III) the activities carried out by such States under
such planning grants.
``(ii) Interim report.--Not later than October 1, 2022, the
Administrator of the Centers for Medicare & Medicaid Services
shall, in consultation with the Director of the Agency for
Healthcare Research and Quality and the Assistant Secretary
for Mental Health and Substance Use, submit to Congress an
interim report--
``(I) on activities carried out under the demonstration
project under this subsection;
``(II) on the extent to which States selected under
paragraph (4) have achieved the stated goals submitted in
their applications under subparagraph (C) of such paragraph;
``(III) with a description of the strengths and limitations
of such demonstration project; and
``(IV) with a plan for the sustainability of such project.
``(iii) Final report.--Not later than October 1, 2024, the
Administrator of the Centers for Medicare & Medicaid Services
shall, in consultation with the Director of the Agency for
Healthcare Research and Quality and the Assistant Secretary
for Mental Health and Substance Use, submit to Congress a
final report--
``(I) providing updates on the matters reported in the
interim report under clause (ii);
``(II) including a description of any changes made with
respect to the demonstration project under this subsection
after the submission of such interim report; and
``(III) evaluating such demonstration project.
``(C) AHRQ report.--Not later than three years after the
date of the enactment of this subsection, the Director of the
Agency for Healthcare Research and Quality, on consultation
with the Administrator of the Centers for Medicare & Medicaid
Services, shall submit to Congress a summary on the
experiences of States awarded planning grants under paragraph
(3) and States selected under paragraph (4).
``(7) Data sharing and best practices.--During the period
of the demonstration project under this subsection, the
Secretary shall, in collaboration with States selected under
paragraph (4), facilitate data sharing and the development of
best practices between such States and States that were not
so selected.
``(8) CMS funding.--There is appropriated, out of any funds
in the Treasury not otherwise appropriated, $5,000,000 to the
Centers for Medicare & Medicaid Services for purposes of
implementing this subsection. Such amount shall remain
available until expended.''.
SEC. 104. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.
(a) In General.--Title XIX of the Social Security Act is
amended by inserting after section 1927 (42 U.S.C. 1396r-8)
the following new section:
``SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK
BENEFICIARIES.
``(a) In General.--Beginning January 1, 2020, a State shall
operate a qualified drug management program under which a
State may enroll certain at-risk beneficiaries identified by
the State under the program.
``(b) Qualified Drug Management Program.--For purposes of
this section, the term `qualified drug management program'
means, with respect to a State, a program carried out by the
State (including through a contract with a pharmacy benefit
manager) that provides at least for the following:
``(1) Identification of at-risk individuals.--Under the
program, the State identifies, in accordance with subsection
(c), individuals enrolled under the State plan (or waiver of
the State plan) who are at-risk beneficiaries.
``(2) Elements of program.--
``(A) In general.--Under the program, the State, with
respect to each individual identified under paragraph (1) and
enrolled under the program under paragraph (5)--
``(i) subject to subparagraphs (B) and (C), selects at
least one, but not more than three, health care providers and
at least one, but not more than three, pharmacies for each
such individual for purposes of clause (ii), in accordance
with a selection process that takes into account reasonable
factors such as the individual's previous utilization of
items and services from health care providers and pharmacies,
geographic proximity of the individual to such health care
providers and pharmacies, access of the individual to health
care, reasonable travel time, information regarding housing
status, and any known preference of the individual for a
certain health care provider or pharmacy; and
``(ii) requires that any controlled substance furnished to
such individual during the period for which such individual
is enrolled under the program be prescribed by a health care
provider selected under clause (i) for such individual and
dispensed by a pharmacy selected under clause (i) for such
individual in order for such controlled substance to be
covered under the State plan (or waiver).
``(B) Beneficiary preference.--In the case of an individual
receiving a notice under paragraph (3)(A) of being identified
as potentially being an at-risk beneficiary described in such
paragraph, such individual may submit, during the 30-day
period following receipt of such notice, preferences for
which health care providers and pharmacies the individual
would prefer the State to select under subparagraph (A). The
State shall select or change the selection of health care
providers and pharmacies under subparagraph (A) for the
individuals based on such preferences, except that in the
case that State determines that such selection (or change of
selection) of a health care provider or pharmacy under
subparagraph (A) is contributing or would contribute to
prescription drug abuse or drug diversion by the individual,
the State may select or change the selection of health care
provider or pharmacy for the individual without regard to the
preferences of the individual described in this subparagraph.
If the State selects or changes the selection pursuant to the
preceding sentence without regard to the preferences of the
individual, the State shall provide the individual with at
least 30 days written notice of the selection or change of
selection and a rationale for the selection or change.
``(C) Treatment of pharmacy with multiple locations.--For
purposes of subparagraph (A)(i), in the case of a pharmacy
that has multiple locations that share real-time electronic
prescription data, all such locations of the pharmacy shall
collectively be treated as one pharmacy.
``(D) Treatment of existing ffs drug management programs.--
In the case of a patient review and restriction program (as
identified in the annual report submitted to the Secretary
under section 1927(g)(3)(D)) operated by a State pursuant to
section 1915(a)(2) before the date of the enactment of this
section, such program shall be treated as a qualified drug
management program.
``(E) Reasonable access.--The program shall ensure,
including through waiver of elements of the program
(including under subparagraph (A)(ii)), reasonable access to
health care (including access to health care providers and
pharmacies with respect to prescription drugs described in
subparagraph (A)) in the case of individuals with multiple
residences, in the case of natural disasters and similar
situations, and in the case of the provision of emergency
services (as defined for purposes of section 1860D-
4(c)(5)(D)(ii)(II)).
``(3) Notification to identified individuals.--Under the
program, the State provides each individual who is identified
under paragraph (1), prior to enrolling such individual under
the program, at least one notification of each of the
following:
``(A) Notice that the State has identified the individual
as potentially being an at-risk beneficiary for abuse or
misuse of a controlled substance.
``(B) The name, address, and contact information of each
health care provider and pharmacy that may be selected for
the individual under paragraph (2)(A).
``(C) Information describing all State and Federal public
health resources that are designed to address such abuse or
misuse to which the individual has access, including mental
health services, substance use disorder and recovery
services, and other counseling services.
``(D) Notice of, and information about, the right of the
individual to--
``(i) submit preferences of the individual for health care
providers and pharmacies to be selected under paragraph
(2)(A), including as described in paragraph (2)(B);
``(ii) appeal under paragraph (4)--
``(I) such identification described in subparagraph (A);
and
``(II) the selection of health care providers and
pharmacies under paragraph (2)(A).
``(E) An explanation of the meaning and consequences of the
identification of the individual as potentially being an at-
risk beneficiary for abuse or misuse of a controlled
substance, including an explanation of the program.
``(F) Information, including a contact list and clear
instructions, that explain how the individual can contact the
appropriate entities administering the program in order to
submit preferences described in paragraph (2)(B) and any
other communications relating to the program.
``(4) Appeals process.--Under the program, the State
provides for an appeals process under which, with respect to
an individual identified under paragraph (1)--
``(A) such individual may appeal--
``(i) such identification; and
``(ii) the selection of a health care provider or pharmacy
under paragraph (2)(A);
``(B) in the case of an appeal described in subparagraph
(A)(ii), the State shall accommodate the health care provider
or pharmacy preferred by the individual for selection for
purposes of paragraph (2)(A), unless the State determines
that a change to the selection of health care provider or
pharmacy under such paragraph is contributing or would
contribute to prescription drug abuse or drug diversion by
the individual;
``(C) such individual is provided a period of not less than
30 days following the date of receipt of the notice described
in paragraph (3) to submit such appeal; and
``(D) the State must make a determination with respect to
an appeal described in subparagraph (A), and notify the
individual of such determination, prior to enrollment of such
individual in the program.
``(5) Enrollment.--Under the program, the State initially
enrolls individuals who are identified under paragraph (1) in
the program for a 12-month period--
``(A) in the case of such an individual who does not submit
an appeal under paragraph (4) within the period applied by
the State pursuant to subparagraph (C) of such paragraph,
beginning on the day after the last day of such period; and
[[Page H5526]]
``(B) in the case of such an individual who does submit an
appeal under paragraph (4) within the period applied by the
State pursuant to subparagraph (C) of such paragraph but such
appeal is denied, beginning not later than 30 days after the
date of such denial.
``(6) Notification of health care providers and
pharmacies.--Under the program, the State provides to each
health care provider and pharmacy selected for an individual
under paragraph (2)--
``(A) notification that the individual is an at-risk
beneficiary enrolled under the program and that the provider
or pharmacy has been selected for the individual under
paragraph (2);
``(B) information on such program and the role of being so
selected; and
``(C) a process through which the provider or pharmacy can
submit a concern or complaint with respect to being so
selected.
``(7) Continuation of enrollment.--Under the program, the
State, with respect to an individual enrolled under the
program, provides for a process to--
``(A) not later than 30 days before the end of the 12-month
period for which the individual is so enrolled pursuant to
paragraph (5)--
``(i) assess, in accordance with publicly available
evidence-based guidelines, whether or not such individual
should continue to be enrolled under the program; and
``(ii) notify such individual of the results of the
assessment under clause (i);
``(B) continue, subject to subparagraph (C), enrollment of
such individual if such assessment recommends such
continuation; and
``(C) appeal the continuation of enrollment in accordance
with the appeals process described in paragraph (4).
``(c) At-Risk Beneficiary.--
``(1) Identification.--For purposes of this section, a
State shall identify an individual enrolled under the State
plan (or waiver of the State plan) as an at-risk beneficiary
if the individual is not an exempted individual described in
paragraph (2) and--
``(A) is identified as such an at-risk beneficiary through
the use of publicly available evidence-based guidelines that
indicate misuse or abuse of a controlled substance; or
``(B) the State received notification from a PDP sponsor or
Medicare Advantage organization that such individual was
identified as being an at-risk beneficiary for prescription
drug abuse for enrollment in a drug management program
established by the sponsor or organization pursuant to
section 1860D-4(c)(5) and such identification has not been
terminated under subparagraph (F) of such section.
``(2) Exempted individual described.--For purposes of
paragraph (1), an exempted individual described in this
paragraph is an individual who--
``(A) is receiving--
``(i) hospice or palliative care; or
``(ii) treatment for cancer;
``(B) is a resident of a long-term care facility, of a
facility described in section 1905(d), or of another facility
for which frequently abused drugs are dispensed for residents
through a contract with a single pharmacy; or
``(C) the State elects to treat as an exempted individual
for purposes of paragraph (1).
``(d) Application of Privacy Rules Clarification.--The
Secretary shall clarify privacy requirements, including
requirements under the regulations promulgated pursuant to
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note), related
to the sharing of data under subsection (b)(6) in the same
manner as the Secretary is required under subparagraph (J) of
section 1860D-4(c)(5) to clarify privacy requirements related
to the sharing of data described in such subparagraph.
``(e) Reports.--
``(1) Annual reports.--A State operating a qualified drug
management program shall include in the annual report
submitted to the Secretary under section 1927(g)(3)(D),
beginning with such reports submitted for 2021, the following
information:
``(A) The number of individuals enrolled under the State
plan (or waiver of the State plan) who are enrolled under the
program and the percentage of individuals enrolled under the
State plan (or waiver) who are enrolled under such program.
``(B) The number of prescriptions for controlled substances
that were dispensed per month during each such year per
individual enrolled under the program, including the daily
morphine milligram equivalents and the quantity prescribed
for each such prescription.
``(C) The number of pharmacies filling prescriptions for
controlled substances for individuals enrolled under such
program.
``(D) The number of health care providers writing
prescriptions for controlled substances (other than
prescriptions for a refill) for individuals enrolled under
such program.
``(E) Any other data that the Secretary may require.
``(F) Any report submitted by a managed care entity under
subsection (f)(1)(B) with respect to the year involved.
For each such report for a year after 2021, the information
described in this paragraph shall be provided in a manner
that compares such information with respect to the prior
calendar year to such information with respect to the second
prior calendar year.
``(2) MACPAC reports and review.--Not later than two years
after the date of the enactment of this section, the Medicaid
and CHIP Payment and Access Commission (in this section
referred to as `MACPAC'), in consultation with the National
Association of Medicaid Directors, pharmacy benefit managers,
managed care organizations, health care providers (including
pharmacists), beneficiary advocates, and other stakeholders,
shall publish a report that includes--
``(A) best practices for operating drug management
programs, based on a review of a representative sample of
States administering such a program;
``(B) a summary of the experience of the appeals process
under drug management programs operated by several States,
such as the frequency at which individuals appealed the
identification of being an at-risk individual, the frequency
at which individuals appealed the selection of a health care
provider or pharmacy under such a program, the timeframes for
such appeals, a summary of the reasons for such appeals, and
the design of such appeals processes;
``(C) a summary of trends and the effectiveness of
qualified drug management programs operated under this
section; and
``(D) recommendations to States on how improvements can be
made with respect to the operation of such programs.
In reporting on State practices, the MACPAC shall consider
how such programs have been implemented in rural areas, under
fee-for-service as well as managed care arrangements, and the
extent to which such programs have resulted in increased
efficiencies to such States or to the Federal Government
under this title.
``(3) Report on plan for coordinated care.--Not later than
January 1, 2021, each State operating a qualified drug
management program shall submit to the Administrator of the
Centers for Medicare & Medicaid Services a report on how such
State plans to provide coordinated care for individuals
enrolled under the State plan (or waiver of the State plan)
and--
``(A) who are enrolled under the program; or
``(B) who are enrolled with a managed care entity and
enrolled under such a qualified drug management program
operated by such entity.
``(f) Applicability to Managed Care Entities.--
``(1) In general.--With respect to any contract that a
State enters into on or after January 1, 2020, with a managed
care entity (as defined in section 1932(a)(1)(B)) pursuant to
section 1903(m), the State shall, as a condition of the
contract, require the managed care entity--
``(A) to operate a qualified drug management program (as
defined in subsection (b)) for at-risk beneficiaries who are
enrolled with such entity and identified by the managed care
entity by means of application of paragraph (2);
``(B) to submit to the State an annual report on the
matters described in subparagraphs (A) through (E) of
subsection (e)(1); and
``(C) to submit to the State a list (and as necessary
update such list) of individuals enrolled with such entity
under the qualified drug management program operated by such
entity under subparagraph (A) for purposes of allowing State
plans for which medical assistance is paid on a fee-for-
service basis to have access to such information.
``(2) Application.--For purposes of applying, with respect
to a managed care entity--
``(A) under paragraph (1)(A)--
``(i) the definition of the term `qualified drug management
program' under subsection (b), other than paragraph (2)(D) of
such subsection; and
``(ii) the provisions of paragraphs (1) and (2) of
subsection (c); and
``(B) under paragraph (1)(B), the report requirements
described in subparagraphs (A) through (E) of subsection
(e)(1);
each reference in such subsection (b) and paragraphs of
subsection (c) to `a State' or `the State' (other than to `a
State plan' or `the State plan') shall be deemed a reference
to the managed care entity, each reference under such
subsection, paragraphs, or subparagraphs to individuals
enrolled under the State plan (or waiver of the State plan)
shall be deemed a reference to individuals enrolled with such
entity, and each reference under such subsection, paragraphs,
or subparagraphs to individuals enrolled under the qualified
drug management program operated by the State shall be deemed
a reference to individuals enrolled under the qualified drug
management program operated by the managed care entity.
``(g) Controlled Substance Defined.--For purposes of this
section, the term `controlled substance' means a drug that is
included in schedule II, III, or IV of section 202(c) of the
Controlled Substances Act, or any combination thereof, as
specified by the State.''.
(b) Guidance on At-Risk Population Transitioning Between
Medicaid FFS and Managed Care.--Not later than October 1,
2019, the Secretary of Health and Human Services shall issue
guidance for State Medicaid programs, with respect to
individuals who are enrolled under a State plan (or waiver of
such plan) under title XIX of the Social Security Act and
under a drug management program, for purposes of providing
best practices--
(1) for transitioning, as applicable, such individuals from
fee-for-service Medicaid (and such a program operated by the
State) to receiving medical assistance under such title
through a managed care entity (as defined in section
1932(a)(1)(B) of the Social Security Act) with a contract
that with the State pursuant to section 1903(m) of such Act
(and such a program operated by such entity); and
(2) for transitioning, as applicable, such individuals from
receiving medical assistance under such title through a
managed care entity (as defined in section 1932(a)(1)(B) of
the Social Security Act) with a contract that with the State
pursuant to section 1903(m) of such Act (and such a program
operated by such entity) to fee-for-service Medicaid (and
such a program operated by the State).
(c) Guidance on At-Risk Population Transitioning to
Medicare.--
[[Page H5527]]
(1) In general.--Not later than January 1, 2020, the
Secretary of Health and Human Services, after consultation
with the Federal Coordinated Health Care Office established
under section 2602 of the Patient Protection and Affordable
Care Act (42 U.S.C. 1315b), shall issue guidance for State
Medicaid programs, with respect to transitioning individuals,
providing for--
(A) notification to be submitted by the State to the
Centers for Medicare & Medicaid Services and such individuals
of the status of such individuals as transitioning
individuals;
(B) notification to such individuals about enrollment under
a prescription drug plan under part D of such title or under
a MA-PD plan under part C of such title;
(C) best practices for transitioning such individuals to
such a plan; and
(D) best practices for coordination between the qualified
drug management program (as described in section 1927A(b) of
the Social Security Act, as added by subsection (a)) carried
out by the State and a drug management program carried out
under such a plan pursuant to section 1860D-4(c)(5) of the
Social Security Act (42 U.S.C. 1395w-10(c)(5)).
(2) Transitioning individuals.--For purposes of paragraph
(1), a transitioning individual is an individual who, with
respect to a month--
(A) is enrolled under the State plan (or waiver of the
State plan) and under the qualified drug management program
(as described in section 1927A(b) of the Social Security Act,
as added by subsection (a)) carried out by the State; and
(B) is expected to become eligible for the Medicare program
under title XVIII of such Act during the subsequent 12-month
period.
SEC. 105. MEDICAID DRUG REVIEW AND UTILIZATION.
(a) Medicaid Drug Utilization Review.--
(1) State plan requirement.--Section 1902(a) of the Social
Security Act (42 U.S.C. 1396a(a)), as amended by section 101,
is further amended--
(A) in paragraph (83), at the end, by striking ``and'';
(B) in paragraph (84), at the end, by striking the period
and inserting ``; and''; and
(C) by inserting after paragraph (84) the following new
paragraph:
``(85) provide that the State is in compliance with the
drug review and utilization requirements under subsection
(oo)(1).''.
(2) Drug review and utilization requirements.--Section 1902
of the Social Security Act (42 U.S.C. 1396a), as amended by
section 101, is further amended by adding at the end the
following new subsection:
``(oo) Drug Review and Utilization Requirements.--
``(1) In general.--For purposes of subsection (a)(85), the
drug review and utilization requirements under this
subsection are, subject to paragraph (3) and beginning
October 1, 2019, the following:
``(A) Claims review limitations.--
``(i) In general.--The State has in place--
``(I) safety edits (as specified by the State) for
subsequent fills for opioids and a claims review automated
process (as designed and implemented by the State) that
indicates when an individual enrolled under the State plan
(or under a waiver of the State plan) is prescribed a
subsequent fill of opioids in excess of any limitation that
may be identified by the State;
``(II) safety edits (as specified by the State) on the
maximum daily morphine equivalent that can be prescribed to
an individual enrolled under the State plan (or under a
waiver of the State plan) for treatment of chronic pain and a
claims review automated process (as designed and implemented
by the State) that indicates when an individual enrolled
under the plan (or waiver) is prescribed the morphine
equivalent for such treatment in excess of any limitation
that may be identified by the State; and
``(III) a claims review automated process (as designed and
implemented by the State) that monitors when an individual
enrolled under the State plan (or under a waiver of the State
plan) is concurrently prescribed opioids and--
``(aa) benzodiazepines; or
``(bb) antipsychotics.
``(ii) Managed care entities.--The State requires each
managed care entity (as defined in section 1932(a)(1)(B))
with respect to which the State has a contract under section
1903(m) or under section 1905(t)(3) to have in place, subject
to paragraph (3), with respect to individuals who are
eligible for medical assistance under the State plan (or
under a waiver of the State plan) and who are enrolled with
the entity, the limitations described in subclauses (I) and
(II) of clause (i) and a claims review automated process
described in subclause (III) of such clause.
``(iii) Rules of construction.--Nothing in this
subparagraph may be construed as prohibiting a State or
managed care entity from designing and implementing a claims
review automated process under this subparagraph that
provides for prospective or retrospective reviews of claims.
Nothing in this subparagraph shall be understood as
prohibiting the exercise of clinical judgment from a provider
enrolled as a participating provider in a State plan (or
waiver of the State plan) or contracting with a managed care
entity regarding the best items and services for an
individual enrolled under such State plan (or waiver).
=========================== NOTE ===========================
June 22, 2018, on page H5527, the following appeared: Nothing in
this subparagraph may be con garding the best items and services
for an individual enrolled under such State plan (or waiver).
The online version has been corrected to read: Nothing in this
subparagraph may be construed as prohibiting a State or managed
care entity from designing and implementing a claims review
automated process under this subparagraph that provides for
prospective or retrospective reviews of claims. Nothing in this
subparagraph shall be understood as prohibiting the exercise of
clinical judgment from a provider enrolled as a participating
provider in a State plan (or waiver of the State plan) or
contracting with a managed care entity regarding the best items
and services for an individual enrolled under such State plan (or
waiver).
========================= END NOTE =========================
``(B) Program to monitor antipsychotic medications by
children.--The State has in place a program (as designed and
implemented by the State) to monitor and manage the
appropriate use of antipsychotic medications by children
enrolled under the State plan (or under a waiver of the State
plan) and submits annually to the Secretary such information
as the Secretary may require on activities carried out under
such program for individuals not more than the age of 18
years generally and children in foster care specifically.
``(C) Fraud and abuse identification.--The State has in
place a process (as designed and implemented by the State)
that identifies potential fraud or abuse of controlled
substances by individuals enrolled under the State plan (or
under a waiver of the State plan), health care providers
prescribing drugs to individuals so enrolled, and pharmacies
dispensing drugs to individuals so enrolled.
``(D) Reports.--The State shall include in the annual
report submitted to the Secretary under section 1927(g)(3)(D)
information on the limitations, requirement, program, and
processes applied by the State under subparagraphs (A)
through (C) in accordance with such manner and time as
specified by the Secretary.
``(E) Clarification.--Nothing shall prevent a State from
satisfying the requirement--
``(i) described in subparagraph (A) by having safety edits
or a claims review automated process described in such
subparagraph that was in place before October 1, 2019;
``(ii) described in subparagraph (B) by having a program
described in such subparagraph that was in place before such
date; or
``(iii) described in subparagraph (C) by having a process
described in such subparagraph that was in place before such
date.
``(2) Annual report by secretary.--For each fiscal year
beginning with fiscal year 2020, the Secretary shall submit
to Congress a report on the most recent information submitted
by States under paragraph (1)(D).
``(3) Exceptions.--
``(A) Certain individuals exempted.--The drug review and
utilization requirements under this subsection shall not
apply with respect to an individual who--
``(i) is receiving--
``(I) hospice or palliative care; or
``(II) treatment for cancer;
``(ii) is a resident of a long-term care facility, of a
facility described in section 1905(d), or of another facility
for which frequently abused drugs are dispensed for residents
through a contract with a single pharmacy; or
``(iii) the State elects to treat as exempted from such
requirements.
``(B) Exception relating to ensuring access.--In order to
ensure reasonable access to health care, the Secretary shall
waive the drug review and utilization requirements under this
subsection, with respect to a State, in the case of natural
disasters and similar situations, and in the case of the
provision of emergency services (as defined for purposes of
section 1860D-4(c)(5)(D)(ii)(II)).''.
(3) Managed care entities.--Section 1932 of the Social
Security Act (42 U.S.C. 1396u-2) is amended by adding at the
end the following new subsection:
``(i) Drug Utilization Review Activities and
Requirements.--Beginning not later than October 1, 2019, each
contract under a State plan with a managed care entity (other
than a primary care case manager) under section 1903(m) shall
provide that the entity is in compliance with the applicable
provisions of section 438.3(s)(2) of title 42 of the Code of
Federal Regulations, section 483.3(s)(4)) of such title, and
section 483.3(s)(5) of such title, as such provisions were in
effect on March 31, 2018.''.
(b) Identifying and Addressing Inappropriate Prescribing
and Billing Practices Under Medicaid.--
(1) In general.--Section 1927(g) of the Social Security Act
(42 U.S.C. 1396r-8(g)) is amended--
(A) in paragraph (1)(A)--
(i) by striking ``of section 1903(i)(10)(B)'' and inserting
``of section 1902(a)(54)'';
(ii) by striking ``, by not later than January 1, 1993,'';
(iii) by inserting after ``gross overuse,'' the following:
``excessive utilization,''; and
(iv) by striking ``or inappropriate or medically
unnecessary care'' and inserting ``inappropriate or medically
unnecessary care, or prescribing or billing practices that
indicate abuse or excessive utilization''; and
(B) in paragraph (2)(B)--
(i) by inserting after ``gross overuse,'' the following:
``excessive utilization,''; and
(ii) by striking ``or inappropriate or medically
unnecessary care'' and inserting ``inappropriate or medically
unnecessary care, or prescribing or billing practices that
indicate abuse or excessive utilization''.
(2) Effective date.--The amendments made by paragraph (1)
shall take effect with respect to retrospective drug use
reviews conducted on or after October 1, 2020.
SEC. 106. GUIDANCE TO IMPROVE CARE FOR INFANTS WITH NEONATAL
ABSTINENCE SYNDROME AND THEIR MOTHERS; GAO
STUDY ON GAPS IN MEDICAID COVERAGE FOR PREGNANT
AND POSTPARTUM WOMEN WITH SUBSTANCE USE
DISORDER.
(a) Guidance.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall issue guidance to improve care for infants
with neonatal abstinence syndrome and their families. Such
guidance shall include--
(1) the types of services, including post-discharge
services and parenting supports, for families of babies with
neonatal abstinence syndrome that States may cover under the
Medicaid program under title XIX of the Social Security Act;
(2) best practices from States with respect to innovative
or evidenced-based payment models that focus on prevention,
screening, treatment, plans of safe care, and post-discharge
services for mothers and fathers with substance use disorders
and babies with neonatal abstinence syndrome that improve
care and clinical outcomes;
(3) recommendations for States on available financing
options under the Medicaid program under title XIX of such
Act and under the Children's Health Insurance Program under
title XXI of such Act for Children's Health Insurance Program
Health Services Initiative funds for parents with substance
use disorders, infants with neonatal abstinence syndrome, and
home visiting services; and
(4) guidance and technical assistance to State Medicaid
agencies regarding additional flexibilities and incentives
related to screening, prevention, and post-discharge
services, including parenting supports.
[[Page H5528]]
(b) GAO Study.--Not later than one year after the date of
the enactment of this Act, the Comptroller General of the
United States shall conduct a study, and submit to Congress a
report, addressing gaps in coverage for pregnant women with
substance use disorder under the Medicaid program under title
XIX of the Social Security Act, and gaps in coverage for
postpartum women with substance use disorder who had coverage
during their pregnancy under the Medicaid program under such
title.
SEC. 107. MEDICAID HEALTH HOMES FOR OPIOID-USE-DISORDER
MEDICAID ENROLLEES.
(a) Extension of Enhanced FMAP for Certain Health Homes for
Individuals With Substance Use Disorders.--Section 1945 of
the Social Security Act (42 U.S.C. 1396w-4) is amended--
(1) in subsection (c)--
(A) in paragraph (1), by inserting ``subject to paragraph
(4),'' after ``except that,''; and
(B) by adding at the end the following new paragraph:
``(4) Special rule relating to substance use disorder
health homes.--
``(A) In general.--In the case of a State with an SUD-
focused State plan amendment approved by the Secretary on or
after October 1, 2018, the Secretary may, at the request of
the State, extend the application of the Federal medical
assistance percentage described in paragraph (1) to payments
for the provision of health home services to SUD-eligible
individuals under such State plan amendment, in addition to
the first 8 fiscal year quarters the State plan amendment is
in effect, for the subsequent 2 fiscal year quarters that the
State plan amendment is in effect. Nothing in this section
shall be construed as prohibiting a State with a State plan
amendment that is approved under this section and that is not
an SUD-focused State plan amendment from additionally having
approved on or after such date an SUD-focused State plan
amendment under this section, including for purposes of
application of this paragraph.
``(B) Report requirements.--In the case of a State with an
SUD-focused State plan amendment for which the application of
the Federal medical assistance percentage has been extended
under subparagraph (A), such State shall, at the end of the
period of such State plan amendment, submit to the Secretary
a report on the following, with respect to SUD-eligible
individuals provided health home services under such State
plan amendment:
``(i) The quality of health care provided to such
individuals, with a focus on outcomes relevant to the
recovery of each such individual.
``(ii) The access of such individuals to health care.
``(iii) The total expenditures of such individuals for
health care.
For purposes of this subparagraph, the Secretary shall
specify all applicable measures for determining quality,
access, and expenditures.
``(C) Best practices.--Not later than October 1, 2020, the
Secretary shall make publicly available on the Internet
website of the Centers for Medicare & Medicaid Services best
practices for designing and implementing an SUD-focused State
plan amendment, based on the experiences of States that have
State plan amendments approved under this section that
include SUD-eligible individuals.
``(D) Definitions.--For purposes of this paragraph:
``(i) SUD-eligible individuals.--The term `SUD-eligible
individual' means, with respect to a State, an individual who
satisfies all of the following:
``(I) The individual is an eligible individual with chronic
conditions.
``(II) The individual is an individual with a substance use
disorder.
``(III) The individual has not previously received health
home services under any other State plan amendment approved
for the State under this section by the Secretary.
``(ii) SUD-focused state plan amendment.--The term `SUD-
focused State plan amendment' means a State plan amendment
under this section that is designed to provide health home
services primarily to SUD-eligible individuals.''.
(b) Requirement for State Medicaid Plans to Provide
Coverage for Medication-assisted Treatment.--
(1) Requirement for state medicaid plans to provide
coverage for medication-assisted treatment.--Section
1902(a)(10)(A) of the Social Security Act (42 U.S.C.
1396a(a)(10)(A)) is amended, in the matter preceding clause
(i), by striking ``and (28)'' and inserting ``(28), and
(29)''.
(2) Inclusion of medication-assisted treatment as medical
assistance.--Section 1905(a) of the Social Security Act (42
U.S.C. 1396d(a)) is amended--
(A) in paragraph (28), by striking ``and'' at the end;
(B) by redesignating paragraph (29) as paragraph (30); and
(C) by inserting after paragraph (28) the following new
paragraph:
``(29) subject to paragraph (2) of subsection (ee), for the
period beginning October 1, 2020, and ending September 30,
2025, medication-assisted treatment (as defined in paragraph
(1) of such subsection); and''.
(3) Medication-assisted treatment defined; waivers.--
Section 1905 of the Social Security Act (42 U.S.C. 1396d) is
amended by adding at the end the following new subsection:
``(ee) Medication-assisted Treatment.--
``(1) Definition.--For purposes of subsection (a)(29), the
term `medication-assisted treatment'--
``(A) means all drugs approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355),
including methadone, and all biological products licensed
under section 351 of the Public Health Service Act (42 U.S.C.
262) to treat opioid use disorders; and
``(B) includes, with respect to the provision of such drugs
and biological products, counseling services and behavioral
therapy.
``(2) Exception.--The provisions of paragraph (29) of
subsection (a) shall not apply with respect to a State for
the period specified in such paragraph, if before the
beginning of such period the State certifies to the
satisfaction of the Secretary that implementing such
provisions statewide for all individuals eligible to enroll
in the State plan (or waiver of the State plan) would not be
feasible by reason of a shortage of qualified providers of
medication-assisted treatment, or facilities providing such
treatment, that will contract with the State or a managed
care entity with which the State has a contract under section
1903(m) or under section 1905(t)(3).''.
(4) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall apply with respect
to medical assistance provided on or after October 1, 2020,
and before October 1, 2025.
(B) Exception for state legislation.--In the case of a
State plan under title XIX of the Social Security Act (42
U.S.C. 1396 et seq.) that the Secretary of Health and Human
Services determines requires State legislation in order for
the respective plan to meet any requirement imposed by the
amendments made by this subsection, the respective plan shall
not be regarded as failing to comply with the requirements of
such title solely on the basis of its failure to meet such an
additional requirement before the first day of the first
calendar quarter beginning after the close of the first
regular session of the State legislature that begins after
the date of the enactment of this Act. For purposes of the
previous sentence, in the case of a State that has a 2-year
legislative session, each year of the session shall be
considered to be a separate regular session of the State
legislature.
TITLE II--MEDICARE PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 201. AUTHORITY NOT TO APPLY CERTAIN MEDICARE TELEHEALTH
REQUIREMENTS IN THE CASE OF CERTAIN TREATMENT
OF A SUBSTANCE USE DISORDER OR CO-OCCURRING
MENTAL HEALTH DISORDER.
Section 1834(m) of the Social Security Act (42 U.S.C.
1395m(m)) is amended--
(1) in paragraph (2)(B)(i), by inserting ``and paragraph
(7)(E)'' after ``Subject to clause (ii)''; and
(2) by adding at the end the following new paragraphs:
``(7) Authority not to apply certain requirements in the
case of certain treatment of substance use disorder or co-
occurring mental health disorder.--
``(A) In general.--For purposes of payment under this
subsection, in the case of telehealth services described in
subparagraph (C) furnished on or after January 1, 2020, to an
eligible beneficiary (as defined in subparagraph (F)) for the
treatment of a substance use disorder or a mental health
disorder that is co-occurring with a substance use disorder,
the Secretary is authorized to, through rulemaking, not apply
any of the requirements described in subparagraph (B).
``(B) Requirements described.--For purposes of this
paragraph, the requirements described in this subparagraph
are any of the following:
``(i) Qualifications for an originating site under
paragraph (4)(C)(ii).
``(ii) Geographic limitations under paragraph (4)(C)(i).
``(C) Telehealth services described.--For purposes of this
paragraph, the telehealth services described in this
subparagraph are services that are both telehealth services
and identified by the Secretary, through rulemaking, as
services that are the most commonly furnished (as defined by
the Secretary) under this part to individuals diagnosed with
a substance use disorder or a mental health disorder that is
co-occurring with a substance use disorder.
``(D) Clarification.--Nothing in this paragraph shall be
construed as limiting or otherwise affecting the authority of
the Secretary to limit or eliminate the non-application
pursuant to this paragraph of any of the requirements under
subparagraph (B).
``(E) Treatment of originating site facility fee.--No
facility fee shall be paid under paragraph (2)(B) to an
originating site with respect to a telehealth service
described in subparagraph (B) for which payment is made under
this subsection by reason of the non-application of a
requirement described in subparagraph (B) pursuant to this
paragraph if payment for such service would not otherwise be
permitted under this subsection if such requirement were
applied.
``(F) Eligible beneficiary defined.--For purposes of this
paragraph, the term `eligible beneficiary' means an
individual who--
``(i) is entitled to, or enrolled for, benefits under part
A and enrolled for benefits under this part;
``(ii) has a diagnosis for a substance use disorder; and
``(iii) meets such other criteria as the Secretary
determines appropriate.
``(G) Report.--Not later than 5 years after the date of the
enactment of this paragraph, the Secretary shall submit to
Congress a report on the impact of any non-application under
this paragraph of any of the requirements described in
subparagraph (B) on
``(i) the utilization of health care services related to
substance use disorder, such as behavioral health services
and emergency department visits; and
``(ii) health outcomes related to substance use disorder,
such as substance use overdose deaths.
``(H) Funding.--For purposes of carrying out this
paragraph, in addition to funds otherwise
[[Page H5529]]
available, the Secretary shall provide for the transfer, from
the Federal Supplementary Medical Insurance Trust Fund under
section 1841, of $3,000,000 to the Centers for Medicare &
Medicaid Services Program Management Account to remain
available until expended.
``(8) Rule of construction.--Nothing in this subsection may
be construed as waiving requirements under this title to
comply with applicable State law, including State licensure
requirements.''.
SEC. 202. ENCOURAGING THE USE OF NON-OPIOID ANALGESICS FOR
THE MANAGEMENT OF POST-SURGICAL PAIN.
Section 1833(t)(6) of the Social Security Act (42 U.S.C.
1395l(t)(6)) is amended--
(1) in subparagraph (C)(i), by inserting ``or, in the case
of an eligible non-opioid analgesic (as defined in
subparagraph (J)), during a period of 5 years,'' after ``3
years,''; and
(2) by adding at the end the following new subparagraph:
``(J) Eligible non-opioid analgesic defined.--In this
paragraph, the term `eligible non-opioid analgesic' means a
drug or biological--
``(i) that is an analgesic that is not an opioid;
``(ii) that demonstrated substantial clinical improvement;
and
``(iii) for which payment--
``(I) as an outpatient hospital service under this part was
not being made as of the date of the enactment of this
subparagraph; or
``(II) was being made under this paragraph as of such
date.''.
SEC. 203. REQUIRING A REVIEW OF CURRENT OPIOID PRESCRIPTIONS
FOR CHRONIC PAIN AND SCREENING FOR OPIOID USE
DISORDER TO BE INCLUDED IN THE WELCOME TO
MEDICARE INITIAL PREVENTIVE PHYSICAL
EXAMINATION.
(a) In General.--Section 1861(ww) of the Social Security
Act (42 U.S.C. 1395x(ww)) is amended--
(1) in paragraph (1), by inserting ``and a review of
current opioid prescriptions and screening for opioid use
disorder (as defined in paragraph (4)),'' before ``but does
not include''; and
(2) by adding at the end the following new paragraph:
``(4)(A) For purposes of paragraph (1), the term `a review
of current opioid prescriptions and screening for opioid use
disorder' means, with respect to an individual--
``(i) a review by a physician or qualified non-physician
practitioner of all current prescriptions of the individual;
and
``(ii) in the case of an individual determined by the
review of a physician or qualified non-physician practitioner
under subparagraph (A) to have a current prescription for
opioids for chronic pain that has been prescribed for a
minimum period of time (as specified by the Secretary)--
``(I) a review by the physician or practitioner of the
potential risk factors to the individual for opioid use
disorder;
``(II) an evaluation by the physician or practitioner of
pain of the individual;
``(III) the provision of information regarding non-opioid
treatment options for the treatment and management of any
chronic pain of the individual; and
``(IV) if determined necessary by the physician or
practitioner based on the results of the review and
evaluation conducted as described in this paragraph, an
appropriate referral by the physician or practitioner for
additional treatment.
``(B) For purposes of this paragraph, the term `qualified
non-physician practitioner' means a physician assistant,
nurse practitioner, or certified clinical nurse
specialist.''.
(b) Effective Date.--The amendments made by subsection (a)
shall apply with respect to initial preventive physical
examinations furnished on or after January 1, 2020.
SEC. 204. MODIFICATION OF PAYMENT FOR CERTAIN OUTPATIENT
SURGICAL SERVICES.
(a) Freeze of Payment for Certain Services Furnished in
Ambulatory Surgical Centers.--Section 1833(i)(2) of the
Social Security Act (42 U.S.C. 1395l(i)(2)) is amended by
adding at the end the following new subparagraph:
``(F)(i) With respect to a targeted procedure (as defined
in clause (ii)) furnished during 2020 or a subsequent year
(before 2024) to an individual in an ambulatory surgical
center, the payment amount for such procedure that would
otherwise be determined under the revised payment system
under subparagraph (D), without application of this
subparagraph, shall be equal to the payment amount for such
procedure furnished in 2016.
``(ii) For purposes of clause (i), the term `targeted
procedure' means a procedure to which Healthcare Common
Procedure Coding System 62310 (or, for years beginning after
2016, 62321), 62311 (or, for years beginning after 2016,
62323), 62264, 64490, 64493, or G0260 (or any successor code)
applies.
``(iii) This subparagraph shall not be applied in a budget-
neutral manner.''.
(b) Data Collection.--
(1) In general.--The Comptroller General shall collect data
relating to the cost differential between targeted procedures
(as defined in section 1833(i)(2)(F)(ii) of the Social
Security Act, as added by subsection (a)) that are performed
in a hospital operating room and such procedures that are
performed in an office setting within a hospital in order to
determine whether such procedures are being properly coded
for claims, based on setting, for payment under section
1833(i)(2)(D) of the Social Security Act (42 U.S.C.
1395l(i)(2)(D)) and to determine if further changes are
needed in the classification system for covered outpatient
department services (as described in section 1833(t)(2)(A) of
the Social Security Act (42 U.S.C. 1395l(t)(2)(A)).
(2) Report.--Not later than 4 years after the date of the
enactment of this Act, the Comptroller General shall submit a
report to the Committee on Energy and Commerce and the
Committee on Ways and Means of the House of Representatives
and the Committee on Finance of the Senate containing--
(A) a determination of whether procedures described in
paragraph (1) are being properly coded for claims, based on
setting, for payment under section 1833(i)(2)(D) of the
Social Security Act (42 U.S.C. 1395l(i)(2)(D)); and
(B) recommendations on any changes the Comptroller General
determines are needed in the classification system for
covered outpatient department services (as described in
section 1833(t)(2)(A) of the Social Security Act (42 U.S.C.
1395l(t)(2)(A)).
(c) Study.--Not later than 3 years after the date of the
enactment of this Act, the Secretary of Health and Human
Services shall conduct a study and submit to Congress a
report on the extent to which procedures described in section
1833(i)(2)(F)(ii) of the Social Security Act, as added by
subsection (a), are effective at preventing the need for
opioids for individuals furnished such procedures.
SEC. 205. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED
PART D CONTROLLED SUBSTANCES.
(a) In General.--Section 1860D-4(e) of the Social Security
Act (42 U.S.C. 1395w-104(e)) is amended by adding at the end
the following:
``(7) Requirement of e-prescribing for controlled
substances.--
``(A) In general.--Subject to subparagraph (B), a
prescription for a covered part D drug under a prescription
drug plan (or under an MA-PD plan) for a schedule II, III,
IV, or V controlled substance shall be transmitted by a
health care practitioner electronically in accordance with an
electronic prescription drug program that meets the
requirements of paragraph (2).
``(B) Exception for certain circumstances.--The Secretary
shall, pursuant to rulemaking, specify circumstances with
respect to which the Secretary may waive the requirement
under subparagraph (A), with respect to a covered part D
drug, including in the case of--
``(i) a prescription issued when the practitioner and
dispenser are the same entity;
``(ii) a prescription issued that cannot be transmitted
electronically under the most recently implemented version of
the National Council for Prescription Drug Programs SCRIPT
Standard;
``(iii) a prescription issued by a practitioner who has
received a waiver or a renewal thereof for a specified period
determined by the Secretary, not to exceed one year, from the
requirement to use electronic prescribing, pursuant to a
process established by regulation by the Secretary, due to
demonstrated economic hardship, technological limitations
that are not reasonably within the control of the
practitioner, or other exceptional circumstance demonstrated
by the practitioner;
``(iv) a prescription issued by a practitioner under
circumstances in which, notwithstanding the practitioner's
ability to submit a prescription electronically as required
by this subsection, such practitioner reasonably determines
that it would be impractical for the individual involved to
obtain substances prescribed by electronic prescription in a
timely manner, and such delay would adversely impact the
individual's medical condition involved;
``(v) a prescription issued by a practitioner allowing for
the dispensing of a non-patient specific prescription
pursuant to a standing order, approved protocol for drug
therapy, collaborative drug management, or comprehensive
medication management, in response to a public health
emergency, or other circumstances where the practitioner may
issue a non-patient specific prescription;
``(vi) a prescription issued by a practitioner prescribing
a drug under a research protocol;
``(vii) a prescription issued by a practitioner for a drug
for which the Food and Drug Administration requires a
prescription to contain elements that are not able to be
included in electronic prescribing, such as a drug with risk
evaluation and mitigation strategies that include elements to
assure safe use; and
``(viii) a prescription issued by a practitioner for an
individual who--
``(I) receives hospice care under this title; or
``(II) is a resident of a skilled nursing facility (as
defined in section 1819(a)), or a medical institution or
nursing facility for which payment is made for an
institutionalized individual under section 1902(q)(1)(B), for
which frequently abused drugs are dispensed for residents
through a contract with a single pharmacy, as determined by
the Secretary in accordance with this paragraph.
``(C) Dispensing.--Nothing in this paragraph shall be
construed as requiring a sponsor of a prescription drug plan
under this part, MA organization offering an MA-PD plan under
part C, or a pharmacist to verify that a practitioner, with
respect to a prescription for a covered part D drug, has a
waiver (or is otherwise exempt) under subparagraph (B) from
the requirement under subparagraph (A). Nothing in this
paragraph shall be construed as affecting the ability of the
plan to cover or the pharmacists' ability to continue to
dispense covered part D drugs from otherwise valid written,
oral or fax prescriptions that are consistent with laws and
regulations. Nothing in this paragraph shall be construed as
affecting the ability of the beneficiary involved to
designate a particular pharmacy to dispense a prescribed drug
to the extent consistent with the requirements under
subsection (b)(1) and under this paragraph.
``(D) Enforcement.--The Secretary shall, pursuant to
rulemaking, have authority to enforce and specify appropriate
penalties for non-compliance with the requirement under
subparagraph (A).''.
[[Page H5530]]
(b) Effective Date.--The amendment made by subsection (a)
shall apply to coverage of drugs prescribed on or after
January 1, 2021.
SEC. 206. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS UNDER
MEDICARE TO ESTABLISH DRUG MANAGEMENT PROGRAMS
FOR AT-RISK BENEFICIARIES.
Section 1860D-4(c) of the Social Security Act (42 U.S.C.
1395w-104(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (E)
the following new subparagraph:
``(F) With respect to plan years beginning on or after
January 1, 2021, a drug management program for at-risk
beneficiaries described in paragraph (5).''; and
(2) in paragraph (5)(A), by inserting ``(and for plan years
beginning on or after January 1, 2021, a PDP sponsor shall)''
after ``A PDP sponsor may''.
SEC. 207. MEDICARE COVERAGE OF CERTAIN SERVICES FURNISHED BY
OPIOID TREATMENT PROGRAMS.
(a) Coverage.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (FF), by striking at the end ``and'';
(2) in subparagraph (GG), by inserting at the end ``;
and''; and
(3) by adding at the end the following new subparagraph:
``(HH) opioid use disorder treatment services (as defined
in subsection (jjj)).''.
(b) Opioid Use Disorder Treatment Services and Opioid
Treatment Program Defined.--Section 1861 of the Social
Security Act is amended by adding at the end the following
new subsection:
``(jjj) Opioid Use Disorder Treatment Services; Opioid
Treatment Program.--
``(1) Opioid use disorder treatment services.--The term
`opioid use disorder treatment services' means items and
services that are furnished by an opioid treatment program
for the treatment of opioid use disorder, including--
``(A) opioid agonist and antagonist treatment medications
(including oral, injected, or implanted versions) that are
approved by the Food and Drug Administration under section
505 of the Federal Food, Drug and Cosmetic Act for use in the
treatment of opioid use disorder;
``(B) dispensing and administration of such medications, if
applicable;
``(C) substance use counseling by a professional to the
extent authorized under State law to furnish such services;
``(D) individual and group therapy with a physician or
psychologist (or other mental health professional to the
extent authorized under State law);
``(E) toxicology testing, and
``(F) other items and services that the Secretary
determines are appropriate (but in no event to include meals
or transportation).
``(2) Opioid treatment program.--The term `opioid treatment
program' means an entity that is opioid treatment program (as
defined in section 8.2 of title 42 of the Code of Federal
Regulations, or any successor regulation) that--
``(A) is enrolled under section 1866(j);
``(B) has in effect a certification by the Substance Abuse
and Mental Health Services Administration for such a program;
``(C) is accredited by an accrediting body approved by the
Substance Abuse and Mental Health Services Administration;
and
``(D) meets such additional conditions as the Secretary may
find necessary to ensure--
``(i) the health and safety of individuals being furnished
services under such program; and
``(ii) the effective and efficient furnishing of such
services.''.
(c) Payment.--
(1) In general.--Section 1833(a)(1) of the Social Security
Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and (BB)'' and inserting ``(BB)''; and
(B) by inserting before the semicolon at the end the
following ``, and (CC) with respect to opioid use disorder
treatment services furnished during an episode of care, the
amount paid shall be equal to the amount payable under
section 1834(w) less any copayment required as specified by
the Secretary''.
(2) Payment determination.--Section 1834 of the Social
Security Act (42 U.S.C. 1395m) is amended by adding at the
end the following new subsection:
``(w) Opioid Use Disorder Treatment Services.--
``(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of section
1861(jjj)) an amount that is equal to 100 percent of a
bundled payment under this part for opioid use disorder
treatment services (as defined in paragraph (1) of such
section) that are furnished by such program to an individual
during an episode of care (as defined by the Secretary)
beginning on or after January 1, 2020. The Secretary shall
ensure, as determined appropriate by the Secretary, that no
duplicative payments are made under this part or part D for
items and services furnished by an opioid treatment program.
``(2) Considerations.--The Secretary may implement this
subsection through one or more bundles based on the type of
medication provided (such as buprenorphine, methadone,
naltrexone, or a new innovative drug), the frequency of
services, the scope of services furnished, characteristics of
the individuals furnished such services, or other factors as
the Secretary determine appropriate. In developing such
bundles, the Secretary may consider payment rates paid to
opioid treatment programs for comparable services under State
plans under title XIX or under the TRICARE program under
chapter 55 of title 10 of the United States Code.
``(3) Annual updates.--The Secretary shall provide an
update each year to the bundled payment amounts under this
subsection.''.
(d) Including Opioid Treatment Programs as Medicare
Providers.--Section 1866(e) of the Social Security Act (42
U.S.C. 1395cc(e)) is amended--
(1) in paragraph (1), by striking at the end ``and'';
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following new paragraph:
``(3) opioid treatment programs (as defined in paragraph
(2) of section 1861(jjj)), but only with respect to the
furnishing of opioid use disorder treatment services (as
defined in paragraph (1) of such section).''.
TITLE III--OTHER HEALTH PROVISIONS TO ADDRESS THE OPIOID CRISIS
SEC. 301. CLARIFYING FDA REGULATION OF NON-ADDICTIVE PAIN AND
ADDICTION THERAPIES.
(a) Public Meetings.--Not later than 1 year after the date
of enactment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall hold not less than one public meeting to address the
challenges and barriers of developing non-addictive medical
products intended to treat pain or addiction, which may
include--
(1) the application of novel clinical trial designs
(consistent with section 3021 of the 21st Century Cures Act
(Public Law 114-255)), use of real world evidence (consistent
with section 505F of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355g)), and use of patient experience data
(consistent with section 569C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-8c)) for the development of
non-addictive medical products intended to treat pain or
addiction; and
(2) the application of eligibility criteria under sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) for non-addictive medical products
intended to treat pain or addiction.
(b) Guidance.--Not later than one year after the public
meetings are conducted under subsection (a) the Secretary
shall issue one or more final guidance documents, or update
existing guidance documents, to help address challenges to
developing non-addictive medical products to treat pain or
addiction. Such guidance documents shall include information
regarding--
(1) how the Food and Drug Administration may apply sections
506 and 515B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e-3) to non-addictive medical products
intended to treat pain or addiction, including the
circumstances under which the Secretary--
(A) may apply the eligibility criteria under such sections
506 and 515B to non-opioid or non-addictive medical products
intended to treat pain or addiction;
(B) considers the risk of addiction of controlled
substances approved to treat pain when establishing unmet
medical need; and
(C) considers pain, pain control, or pain management in
assessing whether a disease or condition is a serious or
life-threatening disease or condition; and
(2) the methods by which sponsors may evaluate acute and
chronic pain, endpoints for non-addictive medical products
intended to treat pain, the manner in which endpoints and
evaluations of efficacy will be applied across and within
review divisions, taking into consideration the etiology of
the underlying disease, and the manner in which sponsors may
use surrogate endpoints, intermediate endpoints, and real
world evidence.
(c) Medical Product Defined.--In this section, the term
``medical product'' means a drug (as defined in section
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(g)(1))), biological product (as defined in section
351(i) of the Public Health Service Act (42 U.S.C. 262(i))),
or device (as defined in section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h))).
SEC. 302. SURVEILLANCE AND TESTING OF OPIOIDS TO PREVENT
FENTANYL DEATHS.
(a) Public Health Laboratories to Detect Fentanyl.--Part F
of title III of the Public Health Service Act (42 U.S.C. 262
et seq.) is amended--
(1) in the heading of part F, by striking ``and Clinical
Laboratories'' and inserting ``, Clinical Laboratories, and
Public Health Laboratories''; and
(2) by adding at the end the following new subpart:
``Subpart 4--Public Health Laboratories
``SEC. 355. PUBLIC HEALTH LABORATORIES TO DETECT FENTANYL.
``(a) In General.--The Secretary shall establish a program
to award grants to Federal, State, and local agencies to
support the establishment or operation of public health
laboratories to detect fentanyl, its analogues, and other
synthetic opioids, as described in subsection (b).
``(b) Standards.--The Secretary, in consultation with the
Director of the National Institute of Standards and
Technology, shall--
``(1) develop standards for safely and effectively handling
and testing fentanyl, its analogues, and other synthetic
opioids;
``(2) develop fentanyl and fentanyl analog reference
materials and quality control standards and protocols to
calibrate instrumentation for clinical diagnostics and
postmortem surveillance; and
``(3) include in the standards developed pursuant to
paragraph (1) procedures for encountering new and emerging
synthetic opioid formulations and reporting those findings to
other Federal, State, and local public health laboratories.
``(c) Laboratories.--The Secretary shall require grantees
under subsection (a) to--
``(1) follow the standards established under subsection (b)
and be capable of providing systematic and routine laboratory
testing of drugs
[[Page H5531]]
for the purposes of obtaining and disseminating public health
information to Federal, State, and local public health
officials, laboratories, and other entities the Secretary
deems appropriate;
``(2) work with law enforcement agencies and public health
authorities, as feasible, to develop real-time information on
the purity and movement of fentanyl, its analogues, and other
synthetic opioids;
``(3) assist State and local law enforcement agencies in
testing seized drugs when State and local forensic
laboratories request additional assistance;
``(4) provide early warning information and advice to
Federal, State, and local law enforcement agencies and public
health authorities regarding potential significant changes in
the supply of fentanyl, its analogues, and other synthetic
opioids;
``(5) provide biosurveillance for non-fatal exposures; and
``(6) provide diagnostic testing for non-fatal exposures of
emergency personnel.
``(d) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $15,000,000
for each of fiscal years 2019 through 2023.''.
(b) Enhanced Fentanyl Surveillance.--Title III of the
Public Health Service Act is amended by inserting after
section 317T of such Act (42 U.S.C. 247b-22) the following
new section:
``SEC. 317U. ENHANCED FENTANYL SURVEILLANCE.
``(a) In General.--The Director of the Centers for Disease
Control and Prevention shall enhance its drug surveillance
program by--
``(1) expanding its surveillance program to include all 50
States and the territories of the United States;
``(2) increasing and accelerating the collection of data on
fentanyl, its analogues, and other synthetic opioids and new
emerging drugs of abuse, including related overdose data from
medical examiners and drug treatment admissions; and
``(3) utilizing available and emerging information on
fentanyl, its analogues, and other synthetic opioids and new
emerging drugs of abuse, including information from--
``(A) the National Drug Early Warning System;
``(B) State and local public health authorities; and
``(C) Federal, State, and local public health laboratories.
``(b) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $10,000,000
for each of fiscal years 2019 through 2023.''.
(c) Pilot Program for Point-of-use Testing of Illicit Drugs
for Dangerous Contaminants.--Part P of title III of the
Public Health Service Act (42 U.S.C. 280g et seq.) is amended
by adding at the end the following new section:
``SEC. 399V-7. PILOT PROGRAM FOR POINT-OF-USE TESTING OF
ILLICIT DRUGS FOR DANGEROUS CONTAMINANTS.
``(a) In General.--The Secretary shall--
``(1) establish a pilot program through which 5 State or
local agencies conduct, in 5 States, point-of-use testing of
illicit drugs for dangerous contaminants;
``(2) establish metrics to evaluate the success of the
pilot program in reducing drug overdose rates; and
``(3) based on such metrics, conduct an annual evaluation
of the pilot program and submit an annual report to the
Congress containing the results of such evaluation.
``(b) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $5,000,000
for each of fiscal years 2019 through 2023.''.
SEC. 303. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT TO
MEDICATION-ASSISTED TREATMENT FOR OPIOID USE
DISORDERS.
(a) Conforming Applicable Number.--Subclause (II) of
section 303(g)(2)(B)(iii) of the Controlled Substances Act
(21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as follows:
``(II) The applicable number is--
``(aa) 100 if, not sooner than 1 year after the date on
which the practitioner submitted the initial notification,
the practitioner submits a second notification to the
Secretary of the need and intent of the practitioner to treat
up to 100 patients;
``(bb) 100 if the practitioner holds additional
credentialing, as defined in section 8.2 of title 42, Code of
Federal Regulations (or successor regulations); or
``(cc) 100 if the practitioner provides medication-assisted
treatment (MAT) using covered medications (as such terms are
defined in section 8.2 of title 42, Code of Federal
Regulations (or successor regulations)) in a qualified
practice setting (as described in section 8.615 of title 42,
Code of Federal Regulations (or successor regulations)).''.
(b) Eliminating Any Time Limitation for Nurse Practitioners
and Physician Assistants To Become Qualifying
Practitioners.--Clause (iii) of section 303(g)(2)(G) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)(G)) is
amended--
(1) in subclause (I), by striking ``or'' at the end; and
(2) by amending subclause (II) to read as follows:
``(II) a qualifying other practitioner, as defined in
clause (iv), who is a nurse practitioner or physician
assistant; or''.
(c) Imposing a Time Limitation for Clinical Nurse
Specialists, Certified Registered Nurse Anesthetists, and
Certified Nurse Midwifes To Become Qualifying
Practitioners.--Clause (iii) of section 303(g)(2)(G) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)(G)), as
amended by subsection (b), is further amended by adding at
the end the following:
``(III) for the period beginning on October 1, 2018, and
ending on October 1, 2023, a qualifying other practitioner,
as defined in clause (iv), who is a clinical nurse
specialist, certified registered nurse anesthetist, or
certified nurse midwife.''.
(d) Definition of Qualifying Other Practitioner.--Section
303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C.
823(g)(2)(G)(iv)) is amended by striking ``nurse practitioner
or physician assistant'' each place it appears and inserting
``nurse practitioner, clinical nurse specialist, certified
registered nurse anesthetist, certified nurse midwife, or
physician assistant''.
(e) Report by Secretary.--Not later than two years after
the date of the enactment of this Act, the Secretary of
Health and Human Services, in consultation with the Drug
Enforcement Administration, shall submit to Congress a report
that assesses the care provided by qualifying practitioners
(as defined in section 303(g)(2)(G)(iii) of the Controlled
Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are
treating, in the case of physicians, 100 or more patients,
and in the case of qualifying practitioners who are not
physicians, 30 or more patients. Such report shall include
recommendations on future applicable patient number levels
and limits. In preparing such report, the Secretary shall
study, with respect to opioid use disorder treatment--
(1) the average frequency with which qualifying
practitioners see their patients;
(2) the average frequency with which patients receive
counseling, including the rates by which such counseling is
provided by such a qualifying practitioner directly, or by
referral;
(3) the average frequency with which random toxicology
testing is administered;
(4) the average monthly patient caseload for each type of
qualifying practitioner;
(5) the treatment retention rates for patients;
(6) overdose and mortality rates; and
(7) any available information regarding the diversion of
drugs by patients receiving such treatment from such a
qualifying practitioner.
TITLE IV--OFFSETS
SEC. 401. PROMOTING VALUE IN MEDICAID MANAGED CARE.
Section 1903(m) of the Social Security Act (42 U.S.C.
1396b(m)) is amended by adding at the end the following new
paragraph:
``(7)(A) With respect to expenditures described in
subparagraph (B) that are incurred by a State for any fiscal
year after fiscal year 2020 (and before fiscal year 2025), in
determining the pro rata share to which the United States is
equitably entitled under subsection (d)(3), the Secretary
shall substitute the Federal medical assistance percentage
that applies for such fiscal year to the State under section
1905(b) (without regard to any adjustments to such percentage
applicable under such section or any other provision of law)
for the percentage that applies to such expenditures under
section 1905(y).
``(B) Expenditures described in this subparagraph, with
respect to a fiscal year to which subparagraph (A) applies,
are expenditures incurred by a State for payment for medical
assistance provided to individuals described in subclause
(VIII) of section 1902(a)(10)(A)(i) by a managed care entity,
or other specified entity (as defined in subparagraph
(D)(iii)), that are treated as remittances because the
State--
``(i) has satisfied the requirement of section 438.8 of
title 42, Code of Federal Regulations (or any successor
regulation), by electing--
``(I) in the case of a State described in subparagraph (C),
to apply a minimum medical loss ratio (as defined in
subparagraph (D)(ii)) that is equal to or greater than 85
percent; or
``(II) in the case of a State not described in subparagraph
(C), to apply a minimum medical loss ratio that is equal to
85 percent; and
``(ii) recovered all or a portion of the expenditures as a
result of the entity's failure to meet such ratio.
``(C) For purposes of subparagraph (B), a State described
in this subparagraph is a State that as of May 31, 2018,
applied a minimum medical loss ratio (as calculated under
subsection (d) of section 438.8 of title 42, Code of Federal
Regulations (as in effect on June 1, 2018)) for payment for
services provided by entities described in such subparagraph
under the State plan under this title (or a waiver of the
plan) that is equal to or greater than 85 percent.
``(D) For purposes of this paragraph:
``(i) The term `managed care entity' means a medicaid
managed care organization described in section
1932(a)(1)(B)(i).
``(ii) The term `minimum medical loss ratio' means, with
respect to a State, a minimum medical loss ratio (as
calculated under subsection (d) of section 438.8 of title 42,
Code of Federal Regulations (as in effect on June 1, 2018))
for payment for services provided by entities described in
subparagraph (B) under the State plan under this title (or a
waiver of the plan).
``(iii) The term `other specified entity' means--
``(I) a prepaid inpatient health plan, as defined in
section 438.2 of title 42, Code of Federal Regulations (or
any successor regulation); and
``(II) a prepaid ambulatory health plan, as defined in such
section (or any successor regulation).''.
SEC. 402. EXTENDING PERIOD OF APPLICATION OF MEDICARE
SECONDARY PAYER RULES FOR INDIVIDUALS WITH END
STAGE RENAL DISEASE.
Section 1862(b)(1)(C) of the Social Security Act (42 U.S.C.
1395y(b)(1)(C)) is amended--
(1) in the last sentence, by inserting ``and before January
1, 2020'' after ``date of enactment of the Balanced Budget
Act of 1997''; and
(2) by adding at the end the following new sentence:
``Effective for items and services furnished on or after
January 1, 2020 (with respect to periods beginning on or
after July 1, 2018), clauses (i) and (ii) shall be applied by
substituting `33-month' for `12-month' each place it
appears.''.
[[Page H5532]]
SEC. 403. REQUIRING REPORTING BY GROUP HEALTH PLANS OF
PRESCRIPTION DRUG COVERAGE INFORMATION FOR
PURPOSES OF IDENTIFYING PRIMARY PAYER
SITUATIONS UNDER THE MEDICARE PROGRAM.
Clause (i) of section 1862(b)(7)(A) of the Social Security
Act (42 U.S.C. 1395y(b)(7)(A)) is amended to read as follows:
``(i) secure from the plan sponsor and plan participants
such information as the Secretary shall specify for the
purpose of identifying situations where the group health plan
is or has been--
``(I) a primary plan to the program under this title; or
``(II) for calendar quarters beginning on or after January
1, 2020, a primary payer with respect to benefits relating to
prescription drug coverage under part D; and''.
TITLE V--OTHER MEDICAID PROVISIONS
Subtitle A--Mandatory Reporting With Respect to Adult Behavioral Health
Measures
SEC. 5001. MANDATORY REPORTING WITH RESPECT TO ADULT
BEHAVIORAL HEALTH MEASURES.
Section 1139B of the Social Security Act (42 U.S.C. 1320b-
9b) is amended--
(1) in subsection (b)--
(A) in paragraph (3)--
(i) by striking ``Not later than January 1, 2013'' and
inserting the following:
``(A) Voluntary reporting.--Not later than January 1,
2013''; and
(ii) by adding at the end the following:
``(B) Mandatory reporting with respect to behavioral health
measures.--Beginning with the State report required under
subsection (d)(1) for 2024, the Secretary shall require
States to use all behavioral health measures included in the
core set of adult health quality measures and any updates or
changes to such measures to report information, using the
standardized format for reporting information and procedures
developed under subparagraph (A), regarding the quality of
behavioral health care for Medicaid eligible adults.''; and
(B) in paragraph (5), by adding at the end the following
new subparagraph:
``(C) Behavioral health measures.--Beginning with respect
to State reports required under subsection (d)(1) for 2024,
the core set of adult health quality measures maintained
under this paragraph (and any updates or changes to such
measures) shall include behavioral health measures.''; and
(2) in subsection (d)(1)(A)--
(A) by striking ``the such plan'' and inserting ``such
plan''; and
(B) by striking ``subsection (a)(5)'' and inserting
``subsection (b)(5) and, beginning with the report for 2024,
all behavioral health measures included in the core set of
adult health quality measures maintained under such
subsection (b)(5) and any updates or changes to such measures
(as required under subsection (b)(3))''.
Subtitle B--Medicaid IMD Additional Info
SEC. 5011. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Institutes for
Mental Disease Are Decisive in Delivering Inpatient Treatment
for Individuals but Opportunities for Needed Access are
Limited without Information Needed about Facility Obligations
Act'' or the ``Medicaid IMD ADDITIONAL INFO Act''.
SEC. 5012. MACPAC EXPLORATORY STUDY AND REPORT ON
INSTITUTIONS FOR MENTAL DISEASES REQUIREMENTS
AND PRACTICES UNDER MEDICAID.
(a) In General.--Not later than January 1, 2020, the
Medicaid and CHIP Payment and Access Commission established
under section 1900 of the Social Security Act (42 U.S.C.
1396) shall conduct an exploratory study, using data from a
representative sample of States, and submit to Congress a
report on at least the following information, with respect to
services furnished to individuals enrolled under State plans
under the Medicaid program under title XIX of such Act (42
U.S.C. 1396 et seq.) (or waivers of such plans) who are
patients in institutions for mental diseases and for which
payment is made through fee-for-service or managed care
arrangements under such State plans (or waivers):
(1) A description of such institutions for mental diseases
in each such State, including at a minimum--
(A) the number of such institutions in the State;
(B) the facility type of such institutions in the State;
and
(C) any coverage limitations under each such State plan (or
waiver) on scope, duration, or frequency of such services.
(2) With respect to each such institution for mental
diseases in each such State, a description of--
(A) such services provided at such institution;
(B) the process, including any timeframe, used by such
institution to clinically assess and reassess such
individuals; and
(C) the discharge process used by such institution,
including any care continuum of relevant services or
facilities provided or used in such process.
(3) A description of--
(A) any Federal waiver that each such State has for such
institutions and the Federal statutory authority for such
waiver; and
(B) any other Medicaid funding sources used by each such
State for funding such institutions, such as supplemental
payments.
(4) A summary of State requirements (such as certification,
licensure, and accreditation) applied by each such State to
such institutions in order for such institutions to receive
payment under the State plan (or waiver) and how each such
State determines if such requirements have been met.
(5) A summary of State standards (such as quality
standards, clinical standards, and facility standards) that
such institutions must meet to receive payment under such
State plans (or waivers) and how each such State determines
if such standards have been met.
(6) Recommendations for actions by Congress and the Centers
for Medicare & Medicaid Services. such as how State Medicaid
programs may improve care and improve standards and including
a recommendation for how the Centers for Medicare & Medicaid
Services can improve data collection from such programs to
address any gaps in information.
(b) Stakeholder Input.--In carrying out subsection (a), the
Medicaid and CHIP Payment and Access Commission shall seek
input from State Medicaid directors and stakeholders,
including at a minimum the Substance Abuse and Mental Health
Services Administration, Centers for Medicare & Medicaid
Services, State Medicaid officials, State mental health
authorities, Medicaid beneficiary advocates, health care
providers, and Medicaid managed care organizations.
(c) Definitions.--In this section:
(1) Representative sample of states.--The term
``representative sample of States'' means a non-probability
sample in which at least two States are selected based on the
knowledge and professional judgment of the selector.
(2) State.--The term ``State'' means each of the 50 States,
the District of Columbia, and any commonwealth or territory
of the United States.
(3) Institution for mental diseases.--The term
``institution for mental diseases'' has the meaning given
such term in section 435.1009 of title 42, Code of Federal
Regulations, or any successor regulation.
Subtitle C--CHIP Mental Health Parity
SEC. 5021. SHORT TITLE.
This subtitle may be cited as the ``CHIP Mental Health
Parity Act''.
SEC. 5022. ENSURING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE
DISORDER SERVICES FOR CHILDREN AND PREGNANT
WOMEN UNDER THE CHILDREN'S HEALTH INSURANCE
PROGRAM.
(a) In General.--Section 2103(c)(1) of the Social Security
Act (42 U.S.C. 1397cc(c)(1)) is amended by adding at the end
the following new subparagraph:
``(E) Mental health and substance use disorder services (as
defined in paragraph (5)).''.
(b) Mental Health and Substance Use Disorder Services.--
(1) In general.--Section 2103(c) of the Social Security Act
(42 U.S.C. 1397cc(c)) is amended--
(A) by redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (6), (7), (8), and (9), respectively; and
(B) by inserting after paragraph (4) the following new
paragraph:
``(5) Mental health and substance use disorder services.--
Regardless of the type of coverage elected by a State under
subsection (a), child health assistance provided under such
coverage for targeted low-income children and, in the case
that the State elects to provide pregnancy-related assistance
under such coverage pursuant to section 2112, such pregnancy-
related assistance for targeted low-income women (as defined
in section 2112(d)) shall--
``(A) include coverage of mental health services (including
behavioral health treatment) necessary to prevent, diagnose,
and treat a broad range of mental health symptoms and
disorders, including substance use disorders; and
``(B) be delivered in a culturally and linguistically
appropriate manner.''.
(2) Conforming amendments.--
(A) Section 2103(a) of the Social Security Act (42 U.S.C.
1397cc(a)) is amended, in the matter before paragraph (1), by
striking ``paragraphs (5), (6), and (7)'' and inserting
``paragraphs (5), (6), (7), and (8)''.
(B) Section 2110(a) of the Social Security Act (42 U.S.C.
1397jj(a)) is amended--
(i) in paragraph (18), by striking ``substance abuse'' each
place it appears and inserting ``substance use''; and
(ii) in paragraph (19), by striking ``substance abuse'' and
inserting ``substance use''.
(C) Section 2110(b)(5)(A)(i) of the Social Security Act (42
U.S.C. 1397jj(b)(5)(A)(i)) is amended by striking
``subsection (c)(5)'' and inserting ``subsection (c)(6)''.
(c) Assuring Access to Care.--Section 2102(a)(7)(B) of the
Social Security Act (42 U.S.C. 1397bb(c)(2)) is amended by
striking ``section 2103(c)(5)'' and inserting ``paragraphs
(5) and (6) of section 2103(c)''.
(d) Mental Health Services Parity.--Subparagraph (A) of
paragraph (7) of section 2103(c) of the Social Security Act
(42 U.S.C. 1397cc(c)) (as redesignated by subsection (b)(1))
is amended to read as follows:
``(A) In general.--A State child health plan shall ensure
that the financial requirements and treatment limitations
applicable to mental health and substance use disorder
services (as described in paragraph (5)) provided under such
plan comply with the requirements of section 2726(a) of the
Public Health Service Act in the same manner as such
requirements or limitations apply to a group health plan
under such section.''.
(e) Effective Date.--
(1) In general.--Subject to paragraph (2), the amendments
made by this section shall take effect with respect to child
health assistance provided on or after the date that is one
year after the date of the enactment of this Act.
(2) Exception for state legislation.--In the case of a
State child health plan under title XXI of the Social
Security Act (or a waiver of such plan), which the Secretary
of Health and Human Services determines requires State
legislation in order for the respective plan (or waiver) to
meet any requirement imposed by the
[[Page H5533]]
amendments made by this section, the respective plan (or
waiver) shall not be regarded as failing to comply with the
requirements of such title solely on the basis of its failure
to meet such an additional requirement before the first day
of the first calendar quarter beginning after the close of
the first regular session of the State legislature that
begins after the date of enactment of this section. For
purposes of the previous sentence, in the case of a State
that has a 2-year legislative session, each year of the
session shall be considered to be a separate regular session
of the State legislature.
Subtitle D--Medicaid Reentry
SEC. 5031. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Reentry Act''.
SEC. 5032. PROMOTING STATE INNOVATIONS TO EASE TRANSITIONS
INTEGRATION TO THE COMMUNITY FOR CERTAIN
INDIVIDUALS.
(a) Stakeholder Group Development of Best Practices; State
Medicaid Program Innovation.--
(1) Stakeholder group best practices.--Not later than 6
months after the date of the enactment of this Act, the
Secretary of Health and Human Services shall convene a
stakeholder group of representatives of managed care
organizations, Medicaid beneficiaries, health care providers,
the National Association of Medicaid Directors, and other
relevant representatives from local, State, and Federal jail
and prison systems to develop best practices (and submit to
the Secretary and Congress a report on such best practices)
for States--
(A) to ease the health care-related transition of an
individual who is an inmate of a public institution from the
public institution to the community, including best practices
for ensuring continuity of health insurance coverage or
coverage under the State Medicaid plan under title XIX of the
Social Security Act, as applicable, and relevant social
services; and
(B) to carry out, with respect to such an individual, such
health care-related transition not later than 30 days after
such individual is released from the public institution.
(2) State medicaid program innovation.--The Secretary of
Health and Human Services shall work with States on
innovative strategies to help individuals who are inmates of
public institutions and otherwise eligible for medical
assistance under the Medicaid program under title XIX of the
Social Security Act transition, with respect to enrollment
for medical assistance under such program, seamlessly to the
community.
(b) Guidance on Innovative Service Delivery Systems
Demonstration Project Opportunities.--Not later than one year
after the date of the enactment of this Act, the Secretary of
Health and Human Services, through the Administrator of the
Centers for Medicare & Medicaid Services, shall issue a State
Medicaid Director letter, based on best practices developed
under subsection (a)(1), regarding opportunities to design
demonstration projects under section 1115 of the Social
Security Act (42 U.S.C. 1315) to improve care transitions for
certain individuals who are soon-to-be former inmates of a
public institution and who are otherwise eligible to receive
medical assistance under title XIX of such Act, including
systems for, with respect to a period (not to exceed 30 days)
immediately prior to the day on which such individuals are
expected to be released from such institution--
(1) providing assistance and education for enrollment under
a State plan under the Medicaid program under title XIX of
such Act for such individuals during such period; and
(2) providing health care services for such individuals
during such period.
(c) Rule of Construction.--Nothing under title XIX of the
Social Security Act or any other provision of law precludes a
State from reclassifying or suspending (rather than
terminating) eligibility of an individual for medical
assistance under title XIX of the Social Security Act while
such individual is an inmate of a public institution.
Subtitle E--Medicaid Partnership
SEC. 5041. SHORT TITLE.
This subtitle may be cited as the ``Medicaid Providers Are
Required To Note Experiences in Record Systems to Help In-
need Patients Act'' or the ``Medicaid PARTNERSHIP Act''.
SEC. 5042. MEDICAID PROVIDERS ARE REQUIRED TO NOTE
EXPERIENCES IN RECORD SYSTEMS TO HELP IN-NEED
PATIENTS.
(a) Requirements Under the Medicaid Program Relating to
Qualified Prescription Drug Monitoring Programs and
Prescribing Certain Controlled Substances.--Title XIX of the
Social Security Act (42 U.S.C. 1396 et seq.) is amended by
inserting after section 1943 the following new section:
``SEC. 1944. REQUIREMENTS RELATING TO QUALIFIED PRESCRIPTION
DRUG MONITORING PROGRAMS AND PRESCRIBING
CERTAIN CONTROLLED SUBSTANCES.
``(a) In General.--Beginning October 1, 2021, a State
shall, subject to subsection (d), require each covered
provider to check, in accordance with such timing, manner,
and form as specified by the State, the prescription drug
history of a covered individual being treated by the covered
provider through a qualified prescription drug monitoring
program described in subsection (b) before prescribing to
such individual a controlled substance.
``(b) Qualified Prescription Drug Monitoring Program
Described.--A qualified prescription drug monitoring program
described in this subsection is, with respect to a State, a
prescription drug monitoring program administered by the
State that, at a minimum, satisfies each of the following
criteria:
``(1) The program facilitates access by a covered provider
to, at a minimum, the following information with respect to a
covered individual, in as close to real-time as possible:
``(A) Information regarding the prescription drug history
of a covered individual with respect to controlled
substances.
``(B) The number and type of controlled substances
prescribed to and filled for the covered individual during at
least the most recent 12-month period.
``(C) The name, location, and contact information (or other
identifying number selected by the State, such as a national
provider identifier issued by the National Plan and Provider
Enumeration System of the Centers for Medicare & Medicaid
Services) of each covered provider who prescribed a
controlled substance to the covered individual during at
least the most recent 12-month period.
``(2) The program facilitates the integration of
information described in paragraph (1) into the workflow of a
covered provider, which may include the electronic system the
covered provider uses to prescribe controlled substances.
A qualified prescription drug monitoring program described in
this subsection, with respect to a State, may have in place,
in accordance with applicable State and Federal law, a data
sharing agreement with the State Medicaid program that allows
the medical director and pharmacy director of such program
(and any designee of such a director who reports directly to
such director) to access the information described in
paragraph (1) in an electronic format. The State Medicaid
program under this title may facilitate reasonable and
limited access, as determined by the State and ensuring
documented beneficiary protections regarding the use of such
data, to such qualified prescription drug monitoring program
for the medical director or pharmacy director of any managed
care entity (as defined under section 1932(a)(1)(B)) that has
a contract with the State under section 1903(m) or under
section 1905(t)(3), or the medical director or pharmacy
director of any entity has a contract to manage the
pharmaceutical benefit with respect to individuals enrolled
in the State plan (or waiver of the State plan). All
applicable State and Federal security and privacy laws shall
apply to the directors or designees of such directors of any
State Medicaid program or entity accessing a qualified
prescription drug monitoring program under this section.
``(c) Application of Privacy Rules Clarification.--The
Secretary shall clarify privacy requirements, including
requirements under the regulations promulgated pursuant to
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. 1320d-2 note), related
to the sharing of data under subsection (b) in the same
manner as the Secretary is required under subparagraph (J) of
section 1860D-4(c)(5) to clarify privacy requirements related
to the sharing of data described in such subparagraph.
``(d) Ensuring Access.--In order to ensure reasonable
access to health care, the Secretary shall waive the
application of the requirement under subsection (a), with
respect to a State, in the case of natural disasters and
similar situations, and in the case of the provision of
emergency services (as defined for purposes of section 1860D-
4(c)(5)(D)(ii)(II)).
``(e) Reports.--
``(1) State reports.--Each State shall include in the
annual report submitted to the Secretary under section
1927(g)(3)(D), beginning with such reports submitted for
2023, information including, at a minimum, the following
information for the most recent 12-month period:
``(A) The percentage of covered providers (as determined
pursuant to a process established by the State) who checked
the prescription drug history of a covered individual through
a qualified prescription drug monitoring program described in
subsection (b) before prescribing to such individual a
controlled substance.
``(B) Aggregate trends with respect to prescribing
controlled substances such as--
``(i) the quantity of daily morphine milligram equivalents
prescribed for controlled substances;
``(ii) the number and quantity of daily morphine milligram
equivalents prescribed for controlled substances per covered
individual; and
``(iii) the types of controlled substances prescribed,
including the dates of such prescriptions, the supplies
authorized (including the duration of such supplies), and the
period of validity of such prescriptions, in different
populations (such as individuals who are elderly, individuals
with disabilities, and individuals who are enrolled under
both this title and title XVIII).
``(C) Whether or not the State requires (and a detailed
explanation as to why the State does or does not require)
pharmacists to check the prescription drug history of a
covered individual through a qualified drug management
program before dispensing a controlled substance to such
individual.
``(2) Report by cms.--Not later than October 1, 2023, the
Administrator of the Centers for Medicare & Medicaid Services
shall publish on the publicly available website of the
Centers for Medicare & Medicaid Services a report including
the following information:
``(A) Guidance for States on how States can increase the
percentage of covered providers who use qualified
prescription drug monitoring programs described in subsection
(b).
``(B) Best practices for how States and covered providers
should use such qualified prescription drug monitoring
programs to reduce the occurrence of abuse of controlled
substances.
``(f) Increase to Federal Matching Rate for Certain
Expenditures Relating to Qualified Prescription Drug
Management Programs.--The Secretary shall increase the
Federal medical assistance percentage or Federal matching
rate that would otherwise apply
[[Page H5534]]
to a State under section 1903(a) for a calendar quarter
occurring during the period beginning October 1, 2018, and
ending September 30, 2021, for expenditures by the State for
activities under the State plan (or waiver of the State plan)
to implement a prescription drug management program that
satisfies the criteria described in paragraphs (1) and (2) of
subsection (b) if the State (in this subsection referred to
as the `administering State') has in place agreements with
all States that are contiguous to such administering State
that, when combined, enable covered providers in all such
contiguous States to access, through the prescription drug
management program, the information that is described in
subsection (b)(1) of covered individuals of such
administering State and that covered providers in such
administering State are able to access through such program.
In no case shall an increase under this subsection result in
a Federal medical assistance percentage or Federal matching
rate that exceeds 100 percent.
``(g) Rule of Construction.--Nothing in this section
prevents a State from requiring pharmacists to check the
prescription drug history of covered individuals through a
qualified drug management program before dispensing
controlled substances to such individuals.
``(h) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled
substance' means a drug that is included in schedule II of
section 202(c) of the Controlled Substances Act and, at the
option of the State involved, a drug included in schedule III
or IV of such section.
``(2) Covered individual.--The term `covered individual'
means, with respect to a State, an individual who is enrolled
in the State plan (or under a waiver of such plan). Such term
does not include an individual who--
``(A) is receiving--
``(i) hospice or palliative care; or
``(ii) treatment for cancer;
``(B) is a resident of a long-term care facility, of a
facility described in section 1905(d), or of another facility
for which frequently abused drugs are dispensed for residents
through a contract with a single pharmacy; or
``(C) the State elects to treat as exempted from such term.
``(3) Covered provider.--
``(A) In general.--The term `covered provider' means,
subject to subparagraph (B), with respect to a State, a
health care provider who is participating under the State
plan (or waiver of the State plan) and licensed, registered,
or otherwise permitted by the State to prescribe a controlled
substance (or the designee of such provider).
``(B) Exceptions.--
``(i) In general.--Beginning October 1, 2021, for purposes
of this section, such term does not include a health care
provider included in any type of health care provider
determined by the Secretary to be exempt from application of
this section under clause (ii).
``(ii) Exceptions process.--Not later than October 1, 2020,
the Secretary, after consultation with the National
Association of Medicaid Directors, national health care
provider associations, Medicaid beneficiary advocates, and
advocates for individuals with rare diseases, shall
determine, based on such consultations, the types of health
care providers (if any) that should be exempted from the
definition of the term `covered provider' for purposes of
this section.''.
(b) Guidance.--Not later than October 1, 2019, the
Administrator of the Centers for Medicare & Medicaid
Services, in consultation with the Director of the Centers
for Disease Control and Prevention, shall issue guidance on
best practices on the uses of prescription drug monitoring
programs required of prescribers and on protecting the
privacy of Medicaid beneficiary information maintained in and
accessed through prescription drug monitoring programs.
(c) Development of Model State Practices.--
(1) In general.--Not later than October 1, 2020, the
Secretary of Health and Human Services shall develop and
publish model practices to assist State Medicaid program
operations in identifying and implementing strategies to
utilize data sharing agreements described in the matter
following paragraph (2) of section 1944(b) of the Social
Security Act, as added by subsection (a), for the following
purposes:
(A) Monitoring and preventing fraud, waste, and abuse.
(B) Improving health care for individuals enrolled in a
State plan under title XIX of such Act (or waiver of such
plan) who--
(i) transition in and out of coverage under such title;
(ii) may have sources of health care coverage in addition
to coverage under such title; or
(iii) pay for prescription drugs with cash.
(C) Any other purposes specified by the Secretary.
(2) Elements of model practices.--The model practices
described in paragraph (1)--
(A) shall include strategies for assisting States in
allowing the medical director or pharmacy director (or
designees of such a director) of managed care organizations
or pharmaceutical benefit managers to access information with
respect to all covered individuals served by such managed
care organizations or pharmaceutical benefit managers to
access as a single data set, in an electronic format; and
(B) shall include any appropriate beneficiary protections
and privacy guidelines.
(3) Consultation.--In developing model practices under this
subsection, the Secretary shall consult with the National
Association of Medicaid Directors, managed care entities (as
defined in section 1932(a)(1)(B) of the Social Security Act)
with contracts with States pursuant to section 1903(m) of
such Act, pharmaceutical benefit managers, physicians and
other health care providers, beneficiary advocates, and
individuals with expertise in health care technology related
to prescription drug monitoring programs and electronic
health records.
(d) Report by Comptroller General.--Not later than October
1, 2020, the Comptroller General of the United States shall
issue a report examining the operation of prescription drug
monitoring programs administered by States, including data
security and access standards used by such programs.
TITLE VI--OTHER MEDICARE PROVISIONS
Subtitle A--Testing of Incentive Payments for Behavioral Health
Providers for Adoption and Use of Certified Electronic Health Record
Technology
SEC. 6001. TESTING OF INCENTIVE PAYMENTS FOR BEHAVIORAL
HEALTH PROVIDERS FOR ADOPTION AND USE OF
CERTIFIED ELECTRONIC HEALTH RECORD TECHNOLOGY.
Section 1115A(b)(2)(B) of the Social Security Act (42
U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the
following new clause:
``(xxv) Providing, for the adoption and use of certified
EHR technology (as defined in section 1848(o)(4)) to improve
the quality and coordination of care through the electronic
documentation and exchange of health information, incentive
payments to behavioral health providers (such as psychiatric
hospitals (as defined in section 1861(f)), community mental
health centers (as defined in section 1861(ff)(3)(B)),
hospitals that participate in a State plan under title XIX or
a waiver of such plan, treatment facilities that participate
in such a State plan or such a waiver, mental health or
substance use disorder providers that participate in such a
State plan or such a waiver, clinical psychologists (as
defined in section 1861(ii)), nurse practitioners (as defined
in section 1861(aa)(5)) with respect to the provision of
psychiatric services, and clinical social workers (as defined
in section 1861(hh)(1))).''.
Subtitle B--Abuse Deterrent Access
SEC. 6011. SHORT TITLE.
This subtitle may be cited at the ``Abuse Deterrent Access
Act of 2018''.
SEC. 6012. STUDY ON ABUSE-DETERRENT OPIOID FORMULATIONS
ACCESS BARRIERS UNDER MEDICARE.
(a) In General.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall conduct a study and submit to Congress a
report on the adequacy of access to abuse-deterrent opioid
formulations for individuals with chronic pain enrolled in an
MA-PD plan under part C of title XVIII of the Social Security
Act or a prescription drug plan under part D of such title of
such Act, taking into account any barriers preventing such
individuals from accessing such formulations under such MA-PD
or part D plans, such as cost-sharing tiers, fail-first
requirements, the price of such formulations, and prior
authorization requirements.
(b) Definition of Abuse-deterrent Opioid Formulation.--In
this section, the term ``abuse-deterrent opioid formulation''
means an opioid that is a prodrug or that has certain abuse-
deterrent properties, such as physical or chemical barriers,
agonist or antagonist combinations, aversion properties,
delivery system mechanisms, or other features designed to
prevent abuse of such opioid.
Subtitle C--Medicare Opioid Safety Education
SEC. 6021. SHORT TITLE.
This subtitle may be cited as the ``Medicare Opioid Safety
Education Act of 2018''.
SEC. 6022. PROVISION OF INFORMATION REGARDING OPIOID USE AND
PAIN MANAGEMENT AS PART OF MEDICARE & YOU
HANDBOOK.
(a) In General.--Section 1804 of the Social Security Act
(42 U.S.C. 1395b-2) is amended by adding at the end the
following new subsection:
``(d) The notice provided under subsection (a) shall
include--
``(1) educational resources, compiled by the Secretary,
regarding opioid use and pain management; and
``(2) a description of alternative, non-opioid pain
management treatments covered under this title.''.
(b) Effective Date.--The amendment made by subsection (a)
shall apply to notices distributed prior to each Medicare
open enrollment period beginning after January 1, 2019.
Subtitle D--Opioid Addiction Action Plan
SEC. 6031. SHORT TITLE.
This subtitle may be cited as the ``Opioid Addiction Action
Plan Act''.
SEC. 6032. ACTION PLAN ON RECOMMENDATIONS FOR CHANGES UNDER
MEDICARE AND MEDICAID TO PREVENT OPIOIDS
ADDICTIONS AND ENHANCE ACCESS TO MEDICATION-
ASSISTED TREATMENT.
(a) In General.--Not later than January 1, 2019, the
Secretary of Health and Human Services (in this section
referred to as the ``Secretary''), in collaboration with the
Pain Management Best Practices Inter-Agency Task Force
convened under section 101(b) of the Comprehensive Addiction
and Recovery Act of 2016 (Public Law 114-198), shall develop
an action plan that provides recommendations described in
subsection (b).
(b) Action Plan Components.--Recommendations described in
this subsection are, based on an examination by the Secretary
of potential obstacles to an effective response to the opioid
crisis, recommendations, as determined appropriate by the
Secretary, on the following:
(1) Recommendations on changes to the Medicare program
under title XVIII of the Social Security Act and the Medicaid
program under title XIX of such Act that would enhance
coverage and payment under such programs of all medication-
assisted treatment approved by the Food and Drug
Administration for the treatment of
[[Page H5535]]
opioid addiction and other therapies that manage chronic and
acute pain and treat and minimize risk of opioid addiction,
including recommendations on changes to the Medicare
prospective payment system for hospital inpatient department
services under section 1886(d) of such Act (42 U.S.C.
1395ww(d)) and the Medicare prospective payment system for
hospital outpatient department services under section 1833(t)
of such Act (42 U.S.C. 1395l(t)) that would allow for
separate payment for such therapies, if medically appropriate
and if necessary to encourage development and adoption of
such therapies.
(2) Recommendations for payment and service delivery models
to be tested by the Center for Medicare and Medicaid
Innovation and other federally authorized demonstration
projects, including value-based models, that may encourage
the use of appropriate medication-assisted treatment approved
by the Food and Drug Administration for the treatment of
opioid addiction and other therapies that manage chronic and
acute pain and treat and minimize risk of opioid addiction.
(3) Recommendations for data collection that could
facilitate research and policy making regarding prevention of
opioid addiction and coverage and payment under the Medicare
and Medicaid programs of appropriate opioid addiction
treatments.
(4) Recommendations for policies under the Medicare program
and under the Medicaid program that can expand access for
rural, or medically underserved communities to the full range
of medication-assisted treatment approved by the Food and
Drug Administration for the treatment of opioid addiction and
other therapies that manage chronic and acute pain and
treatment and minimize risk of opioid addiction.
(5) Recommendations on changes to the Medicare program and
the Medicaid program to address coverage or payment barriers
to patient access to medical devices that are non-opioid
based treatments approved by the Food and Drug Administration
for the management of acute pain and chronic pain, for
monitoring substance use withdrawal and preventing overdoses
of controlled substances, and for treating substance use
disorder.
(c) Stakeholder Meetings.--
(1) In general.--Beginning not later than 3 months after
the date of the enactment of this Act, the Secretary shall
convene a public stakeholder meeting to solicit public
comment on the components of the action plan recommendations
described in subsection (b).
(2) Participants.--Participants of meetings described in
paragraph (1) shall include representatives from the Food and
Drug Administration and National Institutes of Health,
biopharmaceutical industry members, medical researchers,
health care providers, the medical device industry, the
Medicare program, the Medicaid program, and patient
advocates.
(d) Request for Information.--Not later than 3 months after
the date of the enactment of this section, the Secretary
shall issue a request for information seeking public feedback
regarding ways in which the Centers for Medicare & Medicaid
Services can help address the opioid crisis through the
development of and application of the action plan.
(e) Report to Congress.--Not later than June 1, 2019, the
Secretary shall submit to Congress, and make public, a report
that includes--
(1) a summary of recommendations that have emerged under
the action plan;
(2) the Secretary's planned next steps with respect to the
action plan; and
(3) an evaluation of price trends for drugs used to reverse
opioid overdoses (such as naloxone), including
recommendations on ways to lower such prices for consumers.
(f) Definition of Medication-Assisted Treatment.--In this
section, the term ``medication-assisted treatment'' includes
opioid treatment programs, behavioral therapy, and
medications to treat substance abuse disorder.
Subtitle E--Advancing High Quality Treatment for Opioid Use Disorders
in Medicare
SEC. 6041. SHORT TITLE.
This subtitle may be cited as the ``Advancing High Quality
Treatment for Opioid Use Disorders in Medicare Act''.
SEC. 6042. OPIOID USE DISORDER TREATMENT DEMONSTRATION
PROGRAM.
Title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.) is amended by inserting after section 1866E (42 U.S.C.
1395cc-5) the following new section:
``SEC. 1866F. OPIOID USE DISORDER TREATMENT DEMONSTRATION
PROGRAM.
``(a) Implementation of 4-year Demonstration Program.--
``(1) In general.--Not later than January 1, 2021, the
Secretary shall implement a 4-year demonstration program
under this title (in this section referred to as the
`Program') to increase access of applicable beneficiaries to
opioid use disorder treatment services, improve physical and
mental health outcomes for such beneficiaries, and to the
extent possible, reduce expenditures under this title. Under
the Program, the Secretary shall make payments under
subsection (e) to participants (as defined in subsection
(c)(1)(A)) for furnishing opioid use disorder treatment
services delivered through opioid use disorder care teams, or
arranging for such services to be furnished, to applicable
beneficiaries participating in the Program.
``(2) Opioid use disorder treatment services.--For purposes
of this section, the term `opioid use disorder treatment
services'--
``(A) means, with respect to an applicable beneficiary,
services that are furnished for the treatment of opioid use
disorders and that utilize drugs approved under section 505
of the Federal Food, Drug, and Cosmetic Act for the treatment
of opioid use disorders in an outpatient setting; and
``(B) includes--
``(i) medication assisted treatment;
``(ii) treatment planning;
``(iii) psychiatric, psychological, or counseling services
(or any combination of such services), as appropriate;
``(iv) social support services, as appropriate; and
``(v) care management and care coordination services,
including coordination with other providers of services and
suppliers not on an opioid use disorder care team.
``(b) Program Design.--
``(1) In general.--The Secretary shall design the Program
in such a manner to allow for the evaluation of the extent to
which the Program accomplishes the following purposes:
``(A) Reduces hospitalizations and emergency department
visits.
``(B) Increases use of medication-assisted treatment for
opioid use disorders.
``(C) Improves health outcomes of individuals with opioid
use disorders, including by reducing the incidence of
infectious diseases (such as hepatitis C and HIV).
``(D) Does not increase the total spending on items and
services under this title.
``(E) Reduces deaths from opioid overdose.
``(F) Reduces the utilization of inpatient residential
treatment.
``(2) Consultation.--In designing the Program, including
the criteria under subsection (e)(2)(A), the Secretary shall,
not later than 3 months after the date of the enactment of
this section, consult with specialists in the field of
addiction, clinicians in the primary care community, and
beneficiary groups.
``(c) Participants; Opioid Use Disorder Care Teams.--
``(1) Participants.--
``(A) Definition.--In this section, the term `participant'
means an entity or individual--
``(i) that is otherwise enrolled under this title and that
is--
``(I) a physician (as defined in section 1861(r)(1));
``(II) a group practice comprised of at least one physician
described in subclause (I);
``(III) a hospital outpatient department;
``(IV) a federally qualified health center (as defined in
section 1861(aa)(4));
``(V) a rural health clinic (as defined in section
1861(aa)(2));
``(VI) a community mental health center (as defined in
section 1861(ff)(3)(B));
``(VII) a clinic certified as a certified community
behavioral health clinic pursuant to section 223 of the
Protecting Access to Medicare Act of 2014; or
``(VIII) any other individual or entity specified by the
Secretary;
``(ii) that applied for and was selected to participate in
the Program pursuant to an application and selection process
established by the Secretary; and
``(iii) that establishes an opioid use disorder care team
(as defined in paragraph (2)) through employing or
contracting with health care practitioners described in
paragraph (2)(A), and uses such team to furnish or arrange
for opioid use disorder treatment services in the outpatient
setting under the Program.
``(B) Preference.--In selecting participants for the
Program, the Secretary shall give preference to individuals
and entities that are located in areas with a prevalence of
opioid use disorders that is higher than the national average
prevalence.
``(2) Opioid use disorder care teams.--
``(A) In general.--For purposes of this section, the term
`opioid use disorder care team' means a team of health care
practitioners established by a participant described in
paragraph (1)(A) that--
``(i) shall include--
``(I) at least one physician (as defined in section
1861(r)(1)) furnishing primary care services or addiction
treatment services to an applicable beneficiary; and
``(II) at least one eligible practitioner (as defined in
paragraph (3)(A)), who may be a physician who meets the
criterion in subclause (I); and
``(ii) may include other practitioners licensed under State
law to furnish psychiatric, psychological, counseling, and
social services to applicable beneficiaries.
``(B) Requirements for receipt of payment under program.--
In order to receive payments under subsection (e), each
participant in the Program shall--
``(i) furnish opioid use disorder treatment services
through opioid use disorder care teams to applicable
beneficiaries who agree to receive the services;
``(ii) meet minimum criteria, as established by the
Secretary; and
``(iii) submit to the Secretary, in such form, manner, and
frequency as specified by the Secretary, with respect to each
applicable beneficiary for whom opioid use disorder treatment
services are furnished by the opioid use disorder care team,
data and such other information as the Secretary determines
appropriate to--
``(I) monitor and evaluate the Program;
``(II) determine if minimum criteria are met under clause
(ii); and
``(III) determine the incentive payment under subsection
(e).
``(3) Eligible practitioners; other provider-related
definitions and application provisions.--
``(A) Eligible practitioners.--For purposes of this
section, the term `eligible practitioner' means a physician
or other health care practitioner, such as a nurse
practitioner, that--
``(i) is enrolled under section 1866(j)(1);
``(ii) is authorized to prescribe or dispense narcotic
drugs to individuals for maintenance treatment or
detoxification treatment; and
``(iii) has in effect a waiver in accordance with section
303(g) of the Controlled Substances Act for such purpose and
is otherwise in compliance with regulations promulgated by
the Substance Abuse and Mental Health Services Administration
to carry out such section.
[[Page H5536]]
``(B) Addiction specialists.--For purposes of subsection
(e)(1)(B)(iv), the term `addiction specialist' means a
physician that possesses expert knowledge and skills in
addiction medicine, as evidenced by appropriate certification
from a specialty body, a certificate of advanced
qualification in addiction medicine, or completion of an
accredited residency or fellowship in addiction medicine or
addiction psychiatry, as determined by the Secretary.
``(d) Participation of Applicable Beneficiaries.--
``(1) Applicable beneficiary defined.--In this section, the
term `applicable beneficiary' means an individual who--
``(A) is entitled to, or enrolled for, benefits under part
A and enrolled for benefits under part B;
``(B) is not enrolled in a Medicare Advantage plan under
part C;
``(C) has a current diagnosis for an opioid use disorder;
and
``(D) meets such other criteria as the Secretary determines
appropriate.
Such term shall include an individual who is dually eligible
for benefits under this title and title XIX if such
individual satisfies the criteria described in subparagraphs
(A) through (D).
``(2) Voluntary beneficiary participation; limitation on
number of beneficiaries.--An applicable beneficiary may
participate in the Program on a voluntary basis and may
terminate participation in the Program at any time. Not more
than 20,000 applicable beneficiaries may participate in the
Program at any time.
``(3) Services.--In order to participate in the Program, an
applicable beneficiary shall agree to receive opioid use
disorder treatment services from a participant. Participation
under the Program shall not affect coverage of or payment for
any other item or service under this title for the applicable
beneficiary.
``(4) Beneficiary access to services.--Nothing in this
section shall be construed as encouraging providers to limit
applicable beneficiary access to services covered under this
title and applicable beneficiaries shall not be required to
relinquish access to any benefit under this title as a
condition of receiving services from a participant in the
Program.
``(e) Payments.--
``(1) Per applicable beneficiary per month care management
fee.--
``(A) In general.--The Secretary shall establish a schedule
of per applicable beneficiary per month care management fees.
Such a per applicable beneficiary per month care management
fee shall be paid to a participant in addition to any other
amount otherwise payable under this title to the health care
practitioners in the participant's opioid use disorder care
team or, if applicable, to the participant. A participant may
use such per applicable beneficiary per month care management
fee to deliver additional services to applicable
beneficiaries, including services not otherwise eligible for
payment under this title.
``(B) Payment amounts.--In carrying out subparagraph (A),
the Secretary shall--
``(i) consider payments otherwise payable under this title
for opioid use disorder treatment services and the needs of
applicable beneficiaries;
``(ii) pay a higher per applicable beneficiary per month
care management fee for an applicable beneficiary who
receives more intensive treatment services from a participant
and for whom those services are appropriate based on clinical
guidelines for opioid use disorder care;
``(iii) pay a higher per applicable beneficiary per month
care management fee for the month in which the applicable
beneficiary begins treatment with a participant than in
subsequent months, to reflect the greater time and costs
required for the planning and initiation of treatment, as
compared to maintenance of treatment;
``(iv) pay higher per applicable beneficiary per month care
management fees for participants that have established opioid
use disorder care teams that include an addiction specialist
(as defined in subsection (c)(3)(B)); and
``(v) take into account whether a participant's opioid use
disorder care team refers applicable beneficiaries to other
suppliers or providers for any opioid use disorder treatment
services.
``(C) No duplicate payment.--The Secretary shall make
payments under this paragraph to only one participant for
services furnished to an applicable beneficiary during a
calendar month.
``(2) Incentive payments.--
``(A) In general.--Under the Program, the Secretary shall
establish a performance-based incentive payment, which shall
be paid (using a methodology established and at a time
determined appropriate by the Secretary) to participants
based on the performance of participants with respect to
criteria, as determined appropriate by the Secretary, in
accordance with subparagraph (B).
``(B) Criteria.--
``(i) In general.--Criteria described in subparagraph (A)
may include consideration of the following:
``(I) Patient engagement and retention in treatment.
``(II) Evidence-based medication-assisted treatment.
``(III) Other criteria established by the Secretary.
``(ii) Required consultation and consideration.--In
determining criteria described in subparagraph (A), the
Secretary shall--
``(I) consult with stakeholders, including clinicians in
the primary care community and in the field of addiction
medicine; and
``(II) consider existing clinical guidelines for the
treatment of opioid use disorders.
``(C) No duplicate payment.--The Secretary shall ensure
that no duplicate payments under this paragraph are made with
respect to an applicable beneficiary.
``(f) Multipayer Strategy.--In carrying out the Program,
the Secretary shall encourage other payers to provide similar
payments and to use similar criteria as applied under the
Program under subsection (e)(2)(C). The Secretary may enter
into a memorandum of understanding with other payers to align
the methodology for payment provided by such a payer related
to opioid use disorder treatment services with such
methodology for payment under the Program.
``(g) Evaluation.--
``(1) In general.--The Secretary shall conduct an
intermediate and final evaluation of the program. Each such
evaluation shall determine the extent to which each of the
purposes described in subsection (b) have been accomplished
under the Program.
``(2) Reports.--The Secretary shall submit to the Secretary
and Congress--
``(A) a report with respect to the intermediate evaluation
under paragraph (1) not later than 3 years after the date of
the implementation of the Program; and
``(B) a report with respect to the final evaluation under
paragraph (1) not later than 6 years after such date.
``(h) Funding.--
``(1) Administrative funding.--For the purposes of
implementing, administering, and carrying out the Program
(other than for purposes described in paragraph (2)),
$5,000,000 shall be available from the Federal Supplementary
Medical Insurance Trust Fund under section 1841.
``(2) Care management fees and incentives.--For the
purposes of making payments under subsection (e), $10,000,000
shall be available from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 for each of fiscal
years 2021 through 2024.''.
``(3) Availability.--Amounts transferred under this
subsection for a fiscal year shall be available until
expended.
``(i) Waivers.--The Secretary may waive any provision of
this title as may be necessary to carry out the Program under
this section.''.
Subtitle F--Responsible Education Achieves Care and Healthy Outcomes
for Users' Treatment
SEC. 6051. SHORT TITLE.
This subtitle may be cited as the ``Responsible Education
Achieves Care and Healthy Outcomes for Users' Treatment Act
of 2018'' or the ``REACH OUT Act of 2018''.
SEC. 6052. GRANTS TO PROVIDE TECHNICAL ASSISTANCE TO OUTLIER
PRESCRIBERS OF OPIOIDS.
(a) Grants Authorized.--The Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall, through the Centers for Medicare & Medicaid Services,
award grants, contracts, or cooperative agreements to
eligible entities for the purposes described in subsection
(b).
(b) Use of Funds.--Grants, contracts, and cooperative
agreements awarded under subsection (a) shall be used to
support eligible entities through technical assistance--
(1) to educate and provide outreach to outlier prescribers
of opioids about best practices for prescribing opioids;
(2) to educate and provide outreach to outlier prescribers
of opioids about non-opioid pain management therapies; and
(3) to reduce the amount of opioid prescriptions prescribed
by outlier prescribers of opioids.
(c) Application.--Each eligible entity seeking to receive a
grant, contract, or cooperative agreement under subsection
(a) shall submit to the Secretary an application, at such
time, in such manner, and containing such information as the
Secretary may require.
(d) Geographic Distribution.--In awarding grants,
contracts, and cooperative agreements under this section, the
Secretary shall prioritize establishing technical assistance
resources in each State.
(e) Definitions.--In this section:
(1) Eligible entity.--The term ``eligible entity'' means--
(A) an organization--
(i) that has demonstrated experience providing technical
assistance to health care professionals on a State or
regional basis; and
(ii) that has at least--
(I) one individual who is a representative of consumers on
its governing body; and
(II) one individual who is a representative of health care
providers on its governing body; or
(B) an entity that is a quality improvement entity with a
contract under part B of title XI of the Social Security Act
(42 U.S.C. 1320c et seq.).
(2) Outlier prescriber of opioids.--The term ``outlier
prescriber of opioids'' means a prescriber, identified by the
Secretary of Health and Human Services (through use of
prescriber information provided by prescriber National
Provider Identifiers included pursuant to section 1860D-
4(c)(4)(A) of the Social Security Act (42 U.S.C. 1395w-
104(c)(4)(A)) on claims for covered part D drugs for part D
eligible individuals enrolled in prescription drug plans
under part D of title XVIII of such Act (42 U.S.C. 1395w-101
et seq.) and MA-PD plans under part C of such title (42
U.S.C. 1395w-21 et seq.)) as prescribing, as compared to
other prescribers in the specialty of the prescriber and
geographic area, amounts of opioids in excess of a threshold
(and other criteria) specified by the Secretary, after
consultation with stakeholders.
(3) Prescribers.--The term ``prescriber'' means any health
care professional, including a nurse practitioner or
physician assistant, who is licensed to prescribe opioids by
the State or territory in which such professional practices.
(f) Funding.--For purposes of implementing this section,
$75,000,000 shall be available from the Federal Supplementary
Medical Insurance Trust Fund under section 1841 of the Social
Security Act (42 U.S.C. 1395t), to remain available until
expended.
[[Page H5537]]
Subtitle G--Preventing Addiction for Susceptible Seniors
SEC. 6061. SHORT TITLE.
This subtitle may be cited as the ``Preventing Addiction
for Susceptible Seniors Act of 2018'' or the ``PASS Act of
2018''.
SEC. 6062. ELECTRONIC PRIOR AUTHORIZATION FOR COVERED PART D
DRUGS.
(a) Inclusion in Electronic Prescription Program.--Section
1860D-4(e)(2) of the Social Security Act (42 U.S.C. 1395w-
104(e)(2)) is amended by adding at the end the following new
subparagraph:
``(E) Electronic prior authorization.--
``(i) In general.--Not later than January 1, 2021, the
program shall provide for the secure electronic transmission
of--
``(I) a prior authorization request from the prescribing
health care professional for coverage of a covered part D
drug for a part D eligible individual enrolled in a part D
plan (as defined in section 1860D-23(a)(5)) to the PDP
sponsor or Medicare Advantage organization offering such
plan; and
``(II) a response, in accordance with this subparagraph,
from such PDP sponsor or Medicare Advantage organization,
respectively, to such professional.
``(ii) Electronic transmission.--
``(I) Exclusions.--For purposes of this subparagraph, a
facsimile, a proprietary payer portal that does not meet
standards specified by the Secretary, or an electronic form
shall not be treated as an electronic transmission described
in clause (i).
``(II) Standards.--In order to be treated, for purposes of
this subparagraph, as an electronic transmission described in
clause (i), such transmission shall comply with technical
standards adopted by the Secretary in consultation with the
National Council for Prescription Drug Programs, other
standard setting organizations determined appropriate by the
Secretary, and stakeholders including PDP sponsors, Medicare
Advantage organizations, health care professionals, and
health information technology software vendors.
``(III) Application.--Notwithstanding any other provision
of law, for purposes of this subparagraph, the Secretary may
require the use of such standards adopted under subclause
(II) in lieu of any other applicable standards for an
electronic transmission described in clause (i) for a covered
part D drug for a part D eligible individual.''.
(b) Sense of Congress Regarding Electronic Prior
Authorization.--It is the sense of the Congress that--
(1) there should be increased use of electronic prior
authorizations for coverage of covered part D drugs for part
D eligible individuals enrolled in prescription drug plans
under part D of title XVIII of the Social Security Act and
MA-PD plans under part C of such title to reduce access
delays by resolving coverage issues before prescriptions for
such drugs are transmitted; and
(2) greater priority should be placed on increasing the
adoption of use of such electronic prior authorizations among
prescribers of such drugs, pharmacies, PDP sponsors, and
Medicare Advantage organizations.
SEC. 6063. PROGRAM INTEGRITY TRANSPARENCY MEASURES UNDER
MEDICARE PARTS C AND D.
(a) In General.--Section 1859 of the Social Security Act
(42 U.S.C. 1395w-28) is amended by adding at the end the
following new subsection:
``(i) Program Integrity Transparency Measures.--
``(1) Program integrity portal.--
``(A) In general.--Not later than two years after the date
of the enactment of this subsection, the Secretary shall,
after consultation with stakeholders, establish a secure
Internet website portal (or other successor technology) that
would allow a secure path for communication between the
Secretary, MA plans under this part, prescription drug plans
under part D, and an eligible entity with a contract under
section 1893 (such as a Medicare drug integrity contractor or
an entity responsible for carrying out program integrity
activities under this part and part D) for the purpose of
enabling through such portal (or other successor
technology)--
``(i) the referral by such plans of substantiated fraud,
waste, and abuse for initiating or assisting investigations
conducted by the eligible entity; and
``(ii) data sharing among such MA plans, prescription drug
plans, and the Secretary.
``(B) Required uses of portal.--The Secretary shall
disseminate the following information to MA plans under this
part and prescription drug plans under part D through the
secure Internet website portal (or other successor
technology) established under subparagraph (A):
``(i) Providers of services and suppliers that have been
referred pursuant to subparagraph (A)(i) during the previous
12-month period.
``(ii) Providers of services and suppliers who are the
subject of an active exclusion under section 1128 or who are
subject to a suspension of payment under this title pursuant
to section 1862(o) or otherwise.
``(iii) Providers of services and suppliers who are the
subject of an active revocation of participation under this
title, including for not satisfying conditions of
participation.
``(iv) In the case of such a plan that makes a referral
under subparagraph (A)(i) through the portal (or other
successor technology) with respect to activities of
substantiated fraud, waste, or abuse of a provider of
services or supplier, if such provider or supplier has been
the subject of an administrative action under this title or
title XI with respect to similar activities, a notification
to such plan of such action so taken.
``(C) Rulemaking.--For purposes of this paragraph, the
Secretary shall, through rulemaking, specify what constitutes
substantiated fraud, waste, and abuse, using guidance such as
what is provided in the Medicare Program Integrity Manual
4.7.1. In carrying out this subsection, a fraud hotline tip
(as defined by the Secretary) without further evidence shall
not be treated as sufficient evidence for substantiated
fraud, waste, or abuse
``(D) HIPAA compliant information only.--For purposes of
this subsection, communications may only occur if the
communications are permitted under the Federal regulations
(concerning the privacy of individually identifiable health
information) promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996.
``(2) Quarterly reports.--Beginning two years after the
date of enactment of this subsection, the Secretary shall
make available to MA plans under this part and prescription
drug plans under part D in a timely manner (but no less
frequently than quarterly) and using information submitted to
an entity described in paragraph (1) through the portal (or
other successor technology) described in such paragraph or
pursuant to section 1893, information on fraud, waste, and
abuse schemes and trends in identifying suspicious activity.
Information included in each such report shall--
``(A) include administrative actions, pertinent information
related to opioid overprescribing, and other data determined
appropriate by the Secretary in consultation with
stakeholders; and
``(B) be anonymized information submitted by plans without
identifying the source of such information.
``(3) Clarification.--Nothing in this subsection shall be
construed as precluding or otherwise affecting referrals
described in subparagraph (A) that may otherwise be made to
law enforcement entities or to the Secretary.''.
(b) Contract Requirement to Communicate Plan Corrective
Actions Against Opioid Over-prescribers.--Section 1857(e) of
the Social Security Act (42 U.S.C. 1395w-27(e)) is amended by
adding at the end the following new paragraph:
``(5) Communicating plan corrective actions against opioids
over-prescribers.--
``(A) In general.--Beginning with plan years beginning on
or after January 1, 2021, a contract under this section with
an MA organization shall require the organization to submit
to the Secretary, through the process established under
subparagraph (B), information on the investigations and other
actions taken by such plans related to providers of services
who prescribe a high volume of opioids.
``(B) Process.--Not later than January 1, 2021, the
Secretary shall, in consultation with stakeholders, establish
a process under which MA plans and prescription drug plans
shall submit to the Secretary information described in
subparagraph (A).
``(C) Regulations.--For purposes of this paragraph,
including as applied under section 1860D-12(b)(3)(D), the
Secretary shall, pursuant to rulemaking--
``(i) specify a definition for the term `high volume of
opioids' and a method for determining if a provider of
services prescribes such a high volume; and
``(ii) establish the process described in subparagraph (B)
and the types of information that shall be submitted through
such process.''.
(c) Reference Under Part D to Program Integrity
Transparency Measures.--Section 1860D-4 of the Social
Security Act (42 U.S.C. 1395w-104) is amended by adding at
the end the following new subsection:
``(m) Program Integrity Transparency Measures.--For program
integrity transparency measures applied with respect to
prescription drug plan and MA plans, see section 1859(i).''.
SEC. 6064. EXPANDING ELIGIBILITY FOR MEDICATION THERAPY
MANAGEMENT PROGRAMS UNDER PART D.
Section 1860D-4(c)(2)(A)(ii) of the Social Security Act (42
U.S.C. 1395w-104(c)(2)(A)(ii)) is amended--
(1) by redesignating subclauses (I) through (III) as items
(aa) through (cc), respectively, and adjusting the margins
accordingly;
(2) by striking ``are part D eligible individuals who--''
and inserting ``are the following:
``(I) Part D eligible individuals who--''; and
(3) by adding at the end the following new subclause:
``(II) Beginning January 1, 2021, at-risk beneficiaries for
prescription drug abuse (as defined in paragraph (5)(C)).''.
SEC. 6065. MEDICARE NOTIFICATIONS TO OUTLIER PRESCRIBERS OF
OPIOIDS.
Section 1860D-4(c)(4) of the Social Security Act (42 U.S.C.
1395w-104(c)(4)) is amended by adding at the end the
following new subparagraph:
``(D) Outlier prescriber notification.--
``(i) Notification.--Beginning not later than two years
after the date of the enactment of this subparagraph, the
Secretary shall, in the case of a prescriber identified by
the Secretary under clause (ii) to be an outlier prescriber
of opioids, provide, subject to clause (iv), an annual
notification to such prescriber that such prescriber has been
so identified and that includes resources on proper
prescribing methods and other information specified in
accordance with clause (iii).
``(ii) Identification of outlier prescribers of opioids.--
``(I) In general.--The Secretary shall, subject to
subclause (III), using the valid prescriber National Provider
Identifiers included pursuant to subparagraph (A) on claims
for covered part D drugs for part D eligible individuals
enrolled in prescription drug plans under this part or MA-PD
plans under part C and based on the threshold established
under subclause (II), conduct an analysis to identify
prescribers that are outlier opioid prescribers for a period
specified by the Secretary.
[[Page H5538]]
``(II) Establishment of threshold.--For purposes of
subclause (I) and subject to subclause (III), the Secretary
shall, after consultation with stakeholders, establish a
threshold, based on prescriber specialty and geographic area,
for identifying whether a prescriber in a specialty and
geographic area is an outlier prescriber of opioids as
compared to other prescribers of opioids within such
specialty and area.
``(III) Exclusions.--The Secretary may exclude the
following individuals and prescribers from the analysis under
this clause:
``(aa) Individuals receiving hospice services.
``(bb) Individuals with a cancer diagnosis.
``(cc) Prescribers who are the subject of an investigation
by the Centers for Medicare & Medicaid Services or the Office
of Inspector General of the Department of Health and Human
Services.
``(iii) Contents of notification.--The Secretary shall,
based on input from stakeholders, specify the resources and
other information to be included in notifications provided
under clause (i).
``(iv) Modifications and expansions.--
``(I) Frequency.--Beginning 5 years after the date of the
enactment of this subparagraph, the Secretary may change the
frequency of the notifications described in clause (i) based
on stakeholder input.
``(II) Expansion to other prescriptions.--The Secretary may
expand notifications under this subparagraph to include
identifications and notifications with respect to concurrent
prescriptions of covered Part D drugs used in combination
with opioids that are considered to have adverse side effects
when so used in such combination, as determined by the
Secretary.
``(v) Opioids defined.--For purposes of this subparagraph,
the term `opioids' has such meaning as specified by the
Secretary through program instruction or otherwise.''.
SEC. 6066. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to
carry out the requirements of this subtitle and the
amendments made by this subtitle. Such requirements shall be
carried out using amounts otherwise authorized to be
appropriated.
Subtitle H--Expanding Oversight of Opioid Prescribing and Payment
SEC. 6071. SHORT TITLE.
This subtitle may be cited as the ``Expanding Oversight of
Opioid Prescribing and Payment Act of 2018''.
SEC. 6072. MEDICARE PAYMENT ADVISORY COMMISSION REPORT ON
OPIOID PAYMENT, ADVERSE INCENTIVES, AND DATA
UNDER THE MEDICARE PROGRAM.
Not later than March 15, 2019, the Medicare Payment
Advisory Commission shall submit to Congress a report on,
with respect to the Medicare program under title XVIII of the
Social Security Act, the following:
(1) A description of how the Medicare program pays for pain
management treatments (both opioid and non-opioid pain
management alternatives) in both inpatient and outpatient
hospital settings.
(2) The identification of incentives under the hospital
inpatient prospective payment system under section 1886 of
the Social Security Act (42 U.S.C. 1395ww) and incentives
under the hospital outpatient prospective payment system
under section 1833(t) of such Act (42 U.S.C. 1395l(t)) for
prescribing opioids and incentives under each such system for
prescribing non-opioid treatments, and recommendations as the
Commission deems appropriate for addressing any of such
incentives that are adverse incentives.
(3) A description of how opioid use is tracked and
monitored through Medicare claims data and other mechanisms
and the identification of any areas in which further data and
methods are needed for improving data and understanding of
opioid use.
SEC. 6073. NO ADDITIONAL FUNDS AUTHORIZED.
No additional funds are authorized to be appropriated to
carry out the requirements of this subtitle. Such
requirements shall be carried out using amounts otherwise
authorized to be appropriated.
Subtitle I--Dr. Todd Graham Pain Management, Treatment, and Recovery
SEC. 6081. SHORT TITLE.
This subtitle may be cited as the ``Dr. Todd Graham Pain
Management, Treatment, and Recovery Act of 2018''.
SEC. 6082. REVIEW AND ADJUSTMENT OF PAYMENTS UNDER THE
MEDICARE OUTPATIENT PROSPECTIVE PAYMENT SYSTEM
TO AVOID FINANCIAL INCENTIVES TO USE OPIOIDS
INSTEAD OF NON-OPIOID ALTERNATIVE TREATMENTS.
(a) Outpatient Prospective Payment System.--Section 1833(t)
of the Social Security Act (42 U.S.C. 1395l(t)) is amended by
adding at the end the following new paragraph:
``(22) Review and revisions of payments for non-opioid
alternative treatments.--
``(A) In general.--With respect to payments made under this
subsection for covered OPD services (or groups of services),
including covered OPD services assigned to a comprehensive
ambulatory payment classification, the Secretary--
``(i) shall, as soon as practicable, conduct a review (part
of which may include a request for information) of payments
for opioids and evidence-based non-opioid alternatives for
pain management (including drugs and devices, nerve blocks,
surgical injections, and neuromodulation) with a goal of
ensuring that there are not financial incentives to use
opioids instead of non-opioid alternatives;
``(ii) may, as the Secretary determines appropriate,
conduct subsequent reviews of such payments; and
``(iii) shall consider the extent to which revisions under
this subsection to such payments (such as the creation of
additional groups of covered OPD services to classify
separately those procedures that utilize opioids and non-
opioid alternatives for pain management) would reduce payment
incentives to use opioids instead of non-opioid alternatives
for pain management.
``(B) Priority.--In conducting the review under clause (i)
of subparagraph (A) and considering revisions under clause
(iii) of such subparagraph, the Secretary shall focus on
covered OPD services (or groups of services) assigned to a
comprehensive ambulatory payment classification, ambulatory
payment classifications that primarily include surgical
services, and other services determined by the Secretary
which generally involve treatment for pain management.
``(C) Revisions.--If the Secretary identifies revisions to
payments pursuant to subparagraph (A)(iii), the Secretary
shall, as determined appropriate, begin making such revisions
for services furnished on or after January 1, 2020. Revisions
under the previous sentence shall be treated as adjustments
for purposes of application of paragraph (9)(B).
``(D) Rules of construction.--Nothing in this paragraph
shall be construed to preclude the Secretary--
``(i) from conducting a demonstration before making the
revisions described in subparagraph (C); or
``(ii) prior to implementation of this paragraph, from
changing payments under this subsection for covered OPD
services (or groups of services) which include opioids or
non-opioid alternatives for pain management.''.
(b) Ambulatory Surgical Centers.--Section 1833(i) of the
Social Security Act (42 U.S.C. 1395l(i)) is amended by adding
at the end the following new paragraph:
``(8) The Secretary shall conduct a similar type of review
as required under paragraph (22) of section 1833(t)),
including the second sentence of subparagraph (C) of such
paragraph, to payment for services under this subsection, and
make such revisions under this paragraph, in an appropriate
manner (as determined by the Secretary).''.
SEC. 6083. EXPANDING ACCESS UNDER THE MEDICARE PROGRAM TO
ADDICTION TREATMENT IN FEDERALLY QUALIFIED
HEALTH CENTERS AND RURAL HEALTH CLINICS.
(a) Federally Qualified Health Centers.--Section 1834(o) of
the Social Security Act (42 U.S.C. 1395m(o)) is amended by
adding at the end the following new paragraph:
``(3) Additional payments for certain fqhcs with physicians
or other practitioners receiving data 2000 waivers.--
``(A) In general.--In the case of a Federally qualified
health center with respect to which, beginning on or after
January 1, 2019, Federally-qualified health center services
(as defined in section 1861(aa)(3)) are furnished for the
treatment of opioid use disorder by a physician or
practitioner who meets the requirements described in
subparagraph (C) the Secretary shall, subject to availability
of funds under subparagraph (D), make a payment (at such time
and in such manner as specified by the Secretary) to such
Federally qualified health center after receiving and
approving an application submitted by such Federally
qualified health center under subparagraph (B). Such a
payment shall be in an amount determined by the Secretary,
based on an estimate of the average costs of training for
purposes of receiving a waiver described in subparagraph
(C)(ii). Such a payment may be made only one time with
respect to each such physician or practitioner.
``(B) Application.--In order to receive a payment described
in subparagraph (A), a Federally-qualified health center
shall submit to the Secretary an application for such a
payment at such time, in such manner, and containing such
information as specified by the Secretary. A Federally-
qualified health center may apply for such a payment for each
physician or practitioner described in subparagraph (A)
furnishing services described in such subparagraph at such
center.
``(C) Requirements.--For purposes of subparagraph (A), the
requirements described in this subparagraph, with respect to
a physician or practitioner, are the following:
``(i) The physician or practitioner is employed by or
working under contract with a Federally qualified health
center described in subparagraph (A) that submits an
application under subparagraph (B).
``(ii) The physician or practitioner first receives a
waiver under section 303(g) of the Controlled Substances
Acton or after January 1, 2019.
``(D) Funding.--For purposes of making payments under this
paragraph, there are appropriated, out of amounts in the
Treasury not otherwise appropriated, $6,000,000, which shall
remain available until expended.''.
(b) Rural Health Clinic.--Section 1833 of the Social
Security Act (42 U.S.C. 1395l) is amended--
(1) by redesignating the subsection (z) relating to medical
review of spinal subluxation services as subsection (aa); and
(2) by adding at the end the following new subsection:
``(bb) Additional Payments for Certain Rural Health Clinics
With Physicians or Practitioners Receiving DATA 2000
Waivers.--
``(1) In general.--In the case of a rural health clinic
with respect to which, beginning on or after January 1, 2019,
rural health clinic services (as defined in section
1861(aa)(1)) are furnished for the treatment of opioid use
disorder by a physician or practitioner who meets the
requirements described in paragraph (3), the Secretary shall,
subject to availability of funds
[[Page H5539]]
under paragraph (4), make a payment (at such time and in such
manner as specified by the Secretary) to such rural health
clinic after receiving and approving an application described
in paragraph (2). Such payment shall be in an amount
determined by the Secretary, based on an estimate of the
average costs of training for purposes of receiving a waiver
described in paragraph (3)(B). Such payment may be made only
one time with respect to each such physician or practitioner.
``(2) Application.--In order to receive a payment described
in paragraph (1), a rural health clinic shall submit to the
Secretary an application for such a payment at such time, in
such manner, and containing such information as specified by
the Secretary. A rural health clinic may apply for such a
payment for each physician or practitioner described in
paragraph (1) furnishing services described in such paragraph
at such clinic.
``(3) Requirements.--For purposes of paragraph (1), the
requirements described in this paragraph, with respect to a
physician or practitioner, are the following:
``(A) The physician or practitioner is employed by or
working under contract with a rural health clinic described
in paragraph (1) that submits an application under paragraph
(2).
``(B) The physician or practitioner first receives a waiver
under section 303(g) of the Controlled Substances Acton or
after January 1, 2019.
``(4) Funding.--For purposes of making payments under this
subsection, there are appropriated, out of amounts in the
Treasury not otherwise appropriated, $2,000,000, which shall
remain available until expended.''.
SEC. 6084. STUDYING THE AVAILABILITY OF SUPPLEMENTAL BENEFITS
DESIGNED TO TREAT OR PREVENT SUBSTANCE USE
DISORDERS UNDER MEDICARE ADVANTAGE PLANS.
(a) In General.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall submit to Congress a report on the availability of
supplemental health care benefits (as described in section
1852(a)(3)(A) of the Social Security Act (42 U.S.C. 1395w-
22(a)(3)(A))) designed to treat or prevent substance use
disorders under Medicare Advantage plans offered under part C
of title XVIII of such Act. Such report shall include the
analysis described in subsection (c) and any differences in
the availability of such benefits under specialized MA plans
for special needs individuals (as defined in section
1859(b)(6) of such Act (42 U.S.C. 1395w-28(b)(6))) offered to
individuals entitled to medical assistance under title XIX of
such Act and other such Medicare Advantage plans.
(b) Consultation.--The Secretary shall develop the report
described in subsection (a) in consultation with relevant
stakeholders, including--
(1) individuals entitled to benefits under part A or
enrolled under part B of title XVIII of the Social Security
Act;
(2) entities who advocate on behalf of such individuals;
(3) Medicare Advantage organizations;
(4) pharmacy benefit managers; and
(5) providers of services and suppliers (as such terms are
defined in section 1861 of such Act (42 U.S.C. 1395x)).
(c) Contents.--The report described in subsection (a) shall
include an analysis on the following:
(1) The extent to which plans described in such subsection
offer supplemental health care benefits relating to coverage
of--
(A) medication-assisted treatments for opioid use,
substance use disorder counseling, peer recovery support
services, or other forms of substance use disorder treatments
(whether furnished in an inpatient or outpatient setting);
and
(B) non-opioid alternatives for the treatment of pain.
(2) Challenges associated with such plans offering
supplemental health care benefits relating to coverage of
items and services described in subparagraph (A) or (B) of
paragraph (1).
(3) The impact, if any, of increasing the applicable rebate
percentage determined under section 1854(b)(1)(C) of the
Social Security Act (42 U.S.C. 1395w-24(b)(1)(C)) for plans
offering such benefits relating to such coverage would have
on the availability of such benefits relating to such
coverage offered under Medicare Advantage plans.
(4) Potential ways to improve upon such coverage or to
incentivize such plans to offer additional supplemental
health care benefits relating to such coverage.
SEC. 6085. CLINICAL PSYCHOLOGIST SERVICES MODELS UNDER THE
CENTER FOR MEDICARE AND MEDICAID INNOVATION;
GAO STUDY AND REPORT.
(a) CMI Models.--Section 1115A(b)(2)(B) of the Social
Security Act (42 U.S.C. 1315a(b)(2)(B) is amended by adding
at the end the following new clauses:
``(xxv) Supporting ways to familiarize individuals with the
availability of coverage under part B of title XVIII for
qualified psychologist services (as defined in section
1861(ii)).
``(xxvi) Exploring ways to avoid unnecessary
hospitalizations or emergency department visits for mental
and behavioral health services (such as for treating
depression) through use of a 24-hour, 7-day a week help line
that may inform individuals about the availability of
treatment options, including the availability of qualified
psychologist services (as defined in section 1861(ii)).''.
(b) GAO Study and Report.--Not later than 18 months after
the date of the enactment of this Act, the Comptroller
General of the United States shall conduct a study, and
submit to Congress a report, on mental and behavioral health
services under the Medicare program under title XVIII of the
Social Security Act, including an examination of the
following:
(1) Information about services furnished by psychiatrists,
clinical psychologists, and other professionals.
(2) Information about ways that Medicare beneficiaries
familiarize themselves about the availability of Medicare
payment for qualified psychologist services (as defined in
section 1861(ii) of the Social Security Act (42 U.S.C.
1395x(ii)) and ways that the provision of such information
could be improved.
SEC. 6086. PAIN MANAGEMENT STUDY.
(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall conduct a study analyzing best practices as well as
payment and coverage for pain management services under title
XVIII of the Social Security Act and submit to the Committee
on Ways and Means and the Committee on Energy and Commerce of
the House of Representatives and the Committee on Finance of
the Senate a report containing options for revising payment
to providers and suppliers of services and coverage related
to the use of multi-disciplinary, evidence-based, non-opioid
treatments for acute and chronic pain management for
individuals entitled to benefits under part A or enrolled
under part B of title XVIII of the Social Security Act. The
Secretary shall make such report available on the public
website of the Centers for Medicare & Medicaid Services.
(b) Consultation.--In developing the report described in
subsection (a), the Secretary shall consult with--
(1) relevant agencies within the Department of Health and
Human Services;
(2) licensed and practicing osteopathic and allopathic
physicians, behavioral health practitioners, physician
assistants, nurse practitioners, dentists, pharmacists, and
other providers of health services;
(3) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(4) substance abuse and mental health professional
organizations;
(5) pain management professional organizations and advocacy
entities, including individuals who personally suffer chronic
pain;
(6) medical professional organizations and medical
specialty organizations;
(7) licensed health care providers who furnish alternative
pain management services;
(8) organizations with expertise in the development of
innovative medical technologies for pain management;
(9) beneficiary advocacy organizations; and
(10) other organizations with expertise in the assessment,
diagnosis, treatment, and management of pain, as determined
appropriate by the Secretary.
(c) Contents.--The report described in subsection (a) shall
include the following:
(1) An analysis of payment and coverage under title XVIII
of the Social Security Act with respect to the following:
(A) Evidence-based treatments and technologies for chronic
or acute pain, including such treatments that are covered,
not covered, or have limited coverage under such title.
(B) Evidence-based treatments and technologies that monitor
substance use withdrawal and prevent overdoses of opioids.
(C) Evidence-based treatments and technologies that treat
substance use disorders.
(D) Items and services furnished by practitioners through a
multi-disciplinary treatment model for pain management,
including the patient-centered medical home.
(E) Medical devices, non-opioid based drugs, and other
therapies (including interventional and integrative pain
therapies) approved or cleared by the Food and Drug
Administration for the treatment of pain.
(F) Items and services furnished to beneficiaries with
psychiatric disorders, substance use disorders, or who are at
risk of suicide, or have comorbidities and require
consultation or management of pain with one or more
specialists in pain management, mental health, or addiction
treatment.
(2) An evaluation of the following:
(A) Barriers inhibiting individuals entitled to benefits
under part A or enrolled under part B of such title from
accessing treatments and technologies described in
subparagraphs (A) through (F) of paragraph (1).
(B) Costs and benefits associated with potential expansion
of coverage under such title to include items and services
not covered under such title that may be used for the
treatment of pain, such as acupuncture, therapeutic massage,
and items and services furnished by integrated pain
management programs.
(C) Pain management guidance published by the Federal
Government that may be relevant to coverage determinations or
other coverage requirements under title XVIII of the Social
Security Act.
(3) An assessment of all guidance published by the
Department of Health and Human Services on or after January
1, 2016, relating to the prescribing of opioids. Such
assessment shall consider incorporating into such guidance
relevant elements of the ``Va/DoD Clinical Practice Guideline
for Opioid Therapy for Chronic Pain'' published in February
2017 by the Department of Veterans Affairs and Department of
Defense, including adoption of elements of the Department of
Defense and Department of Veterans Affairs pain rating scale.
(4) The options described in subsection (d).
(5) The impact analysis described in subsection (e).
(d) Options.--The options described in this subsection are,
with respect to individuals entitled to benefits under part A
or enrolled under part B of title XVIII of the Social
Security Act, legislative and administrative options for
accomplishing the following:
[[Page H5540]]
(1) Improving coverage of and payment for pain management
therapies without the use of opioids, including
interventional pain therapies, and options to augment opioid
therapy with other clinical and complementary, integrative
health services to minimize the risk of substance use
disorder, including in a hospital setting.
(2) Improving coverage of and payment for medical devices
and non-opioid based pharmacological and non-pharmacological
therapies approved or cleared by the Food and Drug
Administration for the treatment of pain as an alternative or
augment to opioid therapy.
(3) Improving and disseminating treatment strategies for
beneficiaries with psychiatric disorders, substance use
disorders, or who are at risk of suicide, and treatment
strategies to address health disparities related to opioid
use and opioid abuse treatment.
(4) Improving and disseminating treatment strategies for
beneficiaries with comorbidities who require a consultation
or comanagement of pain with one or more specialists in pain
management, mental health, or addiction treatment, including
in a hospital setting.
(5) Educating providers on risks of coadministration of
opioids and other drugs, particularly benzodiazepines.
(6) Ensuring appropriate case management for beneficiaries
who transition between inpatient and outpatient hospital
settings, or between opioid therapy to non-opioid therapy,
which may include the use of care transition plans.
(7) Expanding outreach activities designed to educate
providers of services and suppliers under the Medicare
program and individuals entitled to benefits under part A or
under part B of such title on alternative, non-opioid
therapies to manage and treat acute and chronic pain.
(8) Creating a beneficiary education tool on alternatives
to opioids for chronic pain management.
(e) Impact Analysis.--The impact analysis described in this
subsection consists of an analysis of any potential effects
implementing the options described in subsection (d) would
have--
(1) on expenditures under the Medicare program; and
(2) on preventing or reducing opioid addiction for
individuals receiving benefits under the Medicare program.
Subtitle J--Combating Opioid Abuse for Care in Hospitals
SEC. 6091. SHORT TITLE.
This subtitle may be cited as the ``Combating Opioid Abuse
for Care in Hospitals Act of 2018'' or the ``COACH Act of
2018''.
SEC. 6092. DEVELOPING GUIDANCE ON PAIN MANAGEMENT AND OPIOID
USE DISORDER PREVENTION FOR HOSPITALS RECEIVING
PAYMENT UNDER PART A OF THE MEDICARE PROGRAM.
(a) In General.--Not later than January 1, 2019, the
Secretary of Health and Human Services (in this section
referred to as the ``Secretary'') shall develop and publish
on the public website of the Centers for Medicare & Medicaid
Services guidance for hospitals receiving payment under part
A of title XVIII of the Social Security Act (42 U.S.C. 1395c
et seq.) on pain management strategies and opioid use
disorder prevention strategies with respect to individuals
entitled to benefits under such part.
(b) Consultation.--In developing the guidance described in
subsection (a), the Secretary shall consult with relevant
stakeholders, including--
(1) medical professional organizations;
(2) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(3) health care consumers or groups representing such
consumers; and
(4) other entities determined appropriate by the Secretary.
(c) Contents.--The guidance described in subsection (a)
shall include, with respect to hospitals and individuals
described in such subsection, the following:
(1) Best practices regarding evidence-based screening and
practitioner education initiatives relating to screening and
treatment protocols for opioid use disorder, including--
(A) methods to identify such individuals at-risk of opioid
use disorder, including risk stratification;
(B) ways to prevent, recognize, and treat opioid overdoses;
and
(C) resources available to such individuals, such as opioid
treatment programs, peer support groups, and other recovery
programs.
(2) Best practices for such hospitals to educate
practitioners furnishing items and services at such hospital
with respect to pain management and substance use disorders,
including education on--
(A) the adverse effects of prolonged opioid use;
(B) non-opioid, evidence-based, non-pharmacological pain
management treatments;
(C) monitoring programs for individuals who have been
prescribed opioids; and
(D) the prescribing of naloxone along with an initial
opioid prescription.
(3) Best practices for such hospitals to make such
individuals aware of the risks associated with opioid use
(which may include use of the notification template described
in paragraph (4)).
(4) A notification template developed by the Secretary, for
use as appropriate, for such individuals who are prescribed
an opioid that--
(A) explains the risks and side effects associated with
opioid use (including the risks of addiction and overdose)
and the importance of adhering to the prescribed treatment
regimen, avoiding medications that may have an adverse
interaction with such opioid, and storing such opioid safely
and securely;
(B) highlights multimodal and evidence-based non-opioid
alternatives for pain management;
(C) encourages such individuals to talk to their health
care providers about such alternatives;
(D) provides for a method (through signature or otherwise)
for such an individual, or person acting on such individual's
behalf, to acknowledge receipt of such notification template;
(E) is worded in an easily understandable manner and made
available in multiple languages determined appropriate by the
Secretary; and
(F) includes any other information determined appropriate
by the Secretary.
(5) Best practices for such hospital to track opioid
prescribing trends by practitioners furnishing items and
services at such hospital, including--
(A) ways for such hospital to establish target levels,
taking into account the specialties of such practitioners and
the geographic area in which such hospital is located, with
respect to opioids prescribed by such practitioners;
(B) guidance on checking the medical records of such
individuals against information included in prescription drug
monitoring programs;
(C) strategies to reduce long-term opioid prescriptions;
and
(D) methods to identify such practitioners who may be over-
prescribing opioids.
(6) Other information the Secretary determines appropriate,
including any such information from the Opioid Safety
Initiative established by the Department of Veterans Affairs
or the Opioid Overdose Prevention Toolkit published by the
Substance Abuse and Mental Health Services Administration.
SEC. 6093. REQUIRING THE REVIEW OF QUALITY MEASURES RELATING
TO OPIOIDS AND OPIOID USE DISORDER TREATMENTS
FURNISHED UNDER THE MEDICARE PROGRAM AND OTHER
FEDERAL HEALTH CARE PROGRAMS.
(a) In General.--Section 1890A of the Social Security Act
(42 U.S.C. 1395aaa-1) is amended by adding at the end the
following new subsection:
``(g) Technical Expert Panel Review of Opioid and Opioid
Use Disorder Quality Measures.--
``(1) In general.--Not later than 180 days after the date
of the enactment of this subsection, the Secretary shall
establish a technical expert panel for purposes of reviewing
quality measures relating to opioids and opioid use
disorders, including care, prevention, diagnosis, health
outcomes, and treatment furnished to individuals with opioid
use disorders. The Secretary may use the entity with a
contract under section 1890(a) and amend such contract as
necessary to provide for the establishment of such technical
expert panel.
``(2) Review and assessment.--Not later than 1 year after
the date the technical expert panel described in paragraph
(1) is established (and periodically thereafter as the
Secretary determines appropriate), the technical expert panel
shall--
``(A) review quality measures that relate to opioids and
opioid use disorders, including existing measures and those
under development;
``(B) identify gaps in areas of quality measurement that
relate to opioids and opioid use disorders, and identify
measure development priorities for such measure gaps; and
``(C) make recommendations to the Secretary on quality
measures with respect to opioids and opioid use disorders for
purposes of improving care, prevention, diagnosis, health
outcomes, and treatment, including recommendations for
revisions of such measures, need for development of new
measures, and recommendations for including such measures in
the Merit-Based Incentive Payment System under section
1848(q), the alternative payment models under section
1833(z)(3)(C), the shared savings program under section 1899,
the quality reporting requirements for inpatient hospitals
under section 1886(b)(3)(B)(viii), and the hospital value-
based purchasing program under section 1886(o).
``(3) Consideration of measures by secretary.--The
Secretary shall consider--
``(A) using opioid and opioid use disorder measures
(including measures used under the Merit-Based Incentive
Payment System under section 1848(q), measures recommended
under paragraph (2)(C), and other such measures identified by
the Secretary) in alternative payment models under section
1833(z)(3)(C) and in the shared savings program under section
1899; and
``(B) using opioid measures described in subparagraph (A),
as applicable, in the quality reporting requirements for
inpatient hospitals under section 1886(b)(3)(B)(viii),and in
the hospital value-based purchasing program under section
1886(o).
``(4) Prioritization of measure development.--The Secretary
shall prioritize for measure development the gaps in quality
measures identified under paragraph (2)(B).''.
(b) Expedited Endorsement Process for Opioid Measures.--
Section 1890(b)(2) of the Social Security Act (42 U.S.C.
1395aaa(b)(2)) is amended by adding at the end the following
new flush sentence:
``Such endorsement process shall, as determined practicable
by the entity, provide for an expedited process with respect
to the endorsement of such measures relating to opioids and
opioid use disorders.''.
SEC. 6094. TECHNICAL EXPERT PANEL ON REDUCING SURGICAL
SETTING OPIOID USE; DATA COLLECTION ON
PERIOPERATIVE OPIOID USE.
(a) Technical Expert Panel on Reducing Surgical Setting
Opioid Use.--
[[Page H5541]]
(1) In general.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall convene a technical expert panel, including
medical and surgical specialty societies and hospital
organizations, to provide recommendations on reducing opioid
use in the inpatient and outpatient surgical settings and on
best practices for pain management, including with respect to
the following:
(A) Approaches that limit patient exposure to opioids
during the perioperative period, including pre-surgical and
post-surgical injections, and that identify such patients at
risk of opioid use disorder pre-operation.
(B) Shared decision making with patients and families on
pain management, including recommendations for the
development of an evaluation and management code for purposes
of payment under the Medicare program under title XVIII of
the Social Security Act that would account for time spent on
shared decision making.
(C) Education on the safe use, storage, and disposal of
opioids.
(D) Prevention of opioid misuse and abuse after discharge.
(E) Development of a clinical algorithm to identify and
treat at-risk, opiate-tolerant patients and reduce reliance
on opioids for acute pain during the perioperative period.
(2) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall submit to Congress
and make public a report containing the recommendations
developed under paragraph (1) and an action plan for broader
implementation of pain management protocols that limit the
use of opioids in the perioperative setting and upon
discharge from such setting.
(b) Data Collection on Perioperative Opioid Use.--Not later
than 1 year after the date of the enactment of this Act, the
Secretary of Health and Human Services shall submit to
Congress a report that contains the following:
(1) The diagnosis-related group codes identified by the
Secretary as having the highest volume of surgeries.
(2) With respect to each of such diagnosis-related group
codes so identified, a determination by the Secretary of the
data that is both available and reported on opioid use
following such surgeries, such as with respect to--
(A) surgical volumes, practices, and opioid prescribing
patterns;
(B) opioid consumption, including--
(i) perioperative days of therapy;
(ii) average daily dose at the hospital, including dosage
greater than 90 milligram morphine equivalent;
(iii) post-discharge prescriptions and other combination
drugs that are used before intervention and after
intervention;
(iv) quantity and duration of opioid prescription at
discharge; and
(v) quantity consumed and number of refills;
(C) regional anesthesia and analgesia practices, including
pre-surgical and post-surgical injections;
(D) naloxone reversal;
(E) post-operative respiratory failure;
(F) information about storage and disposal; and
(G) such other information as the Secretary may specify.
(3) Recommendations for improving data collection on
perioperative opioid use, including an analysis to identify
and reduce barriers to collecting, reporting, and analyzing
the data described in paragraph (2), including barriers
related to technological availability.
SEC. 6095. REQUIRING THE POSTING AND PERIODIC UPDATE OF
OPIOID PRESCRIBING GUIDANCE FOR MEDICARE
BENEFICIARIES.
(a) In General.--Not later than 180 days after the date of
the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall post on the public website of the Centers for Medicare
& Medicaid Services all guidance published by the Department
of Health and Human Services on or after January 1, 2016,
relating to the prescribing of opioids and applicable to
opioid prescriptions for individuals entitled to benefits
under part A of title XVIII of the Social Security Act (42
U.S.C. 1395c et seq.) or enrolled under part B of such title
of such Act (42 U.S.C. 1395j et seq.).
(b) Update of Guidance.--
(1) Periodic update.--The Secretary shall, in consultation
with the entities specified in paragraph (2), periodically
(as determined appropriate by the Secretary) update guidance
described in subsection (a) and revise the posting of such
guidance on the website described in such subsection.
(2) Consultation.--The entities specified in this paragraph
are the following:
(A) Medical professional organizations.
(B) Providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x)).
(C) Health care consumers or groups representing such
consumers.
(D) Other entities determined appropriate by the Secretary.
Subtitle K--Stop Excessive Narcotics in Our Retirement Communities
Protection
SEC. 6101. SHORT TITLE.
This subtitle may be cited as the ``Stop Excessive
Narcotics in our Retirement Communities Protection Act of
2018'' or the ``SENIOR Communities Protection Act of 2018''.
SEC. 6102. SUSPENSION OF PAYMENTS BY MEDICARE PRESCRIPTION
DRUG PLANS AND MA-PD PLANS PENDING
INVESTIGATIONS OF CREDIBLE ALLEGATIONS OF FRAUD
BY PHARMACIES.
(a) In General.--Section 1860D-12(b) of the Social Security
Act (42 U.S.C. 1395w-112(b)) is amended by adding at the end
the following new paragraph:
``(7) Suspension of payments pending investigation of
credible allegations of fraud by pharmacies.--
``(A) In general.--The provisions of section 1862(o) shall
apply with respect to a PDP sponsor with a contract under
this part, a pharmacy, and payments to such pharmacy under
this part in the same manner as such provisions apply with
respect to the Secretary, a provider of services or supplier,
and payments to such provider of services or supplier under
this title.
``(B) Rule of construction.--Nothing in this paragraph
shall be construed as limiting the authority of a PDP sponsor
to conduct postpayment review.''.
(b) Application to MA-PD Plans.--Section 1857(f)(3) of the
Social Security Act (42 U.S.C. 1395w-27(f)(3)) is amended by
adding at the end the following new subparagraph:
``(D) Suspension of payments pending investigation of
credible allegations of fraud by pharmacies.--Section 1860D-
12(b)(7).''.
(c) Conforming Amendment.--Section 1862(o)(3) of the Social
Security Act (42 U.S.C. 1395y(o)(3)) is amended by inserting
``, section 1860D-12(b)(7) (including as applied pursuant to
section 1857(f)(3)(D)),'' after ``this subsection''.
(d) Clarification Relating to Credible Allegation of
Fraud.--Section 1862(o) of the Social Security Act (42 U.S.C.
1395y(o)) is amended by adding at the end the following new
paragraph:
``(4) Credible allegation of fraud.--In carrying out this
subsection, section 1860D-12(b)(7) (including as applied
pursuant to section 1857(f)(3)(D)), and section
1903(i)(2)(C), a fraud hotline tip (as defined by the
Secretary) without further evidence shall not be treated as
sufficient evidence for a credible allegation of fraud.''.
(e) Effective Date.--The amendments made by this section
shall apply with respect to plan years beginning on or after
January 1, 2020.
Subtitle L--Providing Reliable Options for Patients and Educational
Resources
SEC. 6111. SHORT TITLE.
This subtitle may be cited as the ``Providing Reliable
Options for Patients and Educational Resources Act of 2018''
or the ``PROPER Act of 2018''.
SEC. 6112. REQUIRING MEDICARE ADVANTAGE PLANS AND PART D
PRESCRIPTION DRUG PLANS TO INCLUDE INFORMATION
ON RISKS ASSOCIATED WITH OPIOIDS AND COVERAGE
OF NONPHARMACOLOGICAL THERAPIES AND NONOPIOID
MEDICATIONS OR DEVICES USED TO TREAT PAIN.
Section 1860D-4(a)(1) of the Social Security Act (42 U.S.C.
1395w-104(a)(1)) is amended--
(1) in subparagraph (A), by inserting ``, subject to
subparagraph (C),'' before ``including'';
(2) in subparagraph (B), by adding at the end the following
new clause:
``(vi) For plan year 2021 and each subsequent plan year,
subject to subparagraph (C), with respect to the treatment of
pain--
``(I) the risks associated with prolonged opioid use; and
``(II) coverage of nonpharmacological therapies, devices,
and nonopioid medications--
``(aa) in the case of an MA-PD plan under part C, under
such plan; and
``(bb) in the case of a prescription drug plan, under such
plan and under parts A and B.''; and
(3) by adding at the end the following new subparagraph:
``(C) Targeted provision of information.--A PDP sponsor of
a prescription drug plan may, in lieu of disclosing the
information described in subparagraph (B)(vi) to each
enrollee under the plan, disclose such information through
mail or electronic communications to a subset of enrollees
under the plan, such as enrollees who have been prescribed an
opioid in the previous two-year period.''.
SEC. 6113. REQUIRING MEDICARE ADVANTAGE PLANS AND
PRESCRIPTION DRUG PLANS TO PROVIDE INFORMATION
ON THE SAFE DISPOSAL OF PRESCRIPTION DRUGS.
(a) Medicare Advantage.--Section 1852 of the Social
Security Act (42 U.S.C. 1395w-22) is amended by adding at the
end the following new subsection:
``(n) Provision of Information Relating to the Safe
Disposal of Certain Prescription Drugs.--
``(1) In general.--In the case of an individual enrolled
under an MA or MA-PD plan who is furnished an in-home health
risk assessment on or after January 1, 2021, such plan shall
ensure that such assessment includes information on the safe
disposal of prescription drugs that are controlled substances
that meets the criteria established under paragraph (2). Such
information shall include information on drug takeback
programs that meet such requirements determined appropriate
by the Secretary and information on in-home disposal.
``(2) Criteria.--The Secretary shall, through rulemaking,
establish criteria the Secretary determines appropriate with
respect to information provided to an individual to ensure
that such information sufficiently educates such individual
on the safe disposal of prescription drugs that are
controlled substances.''.
(b) Prescription Drug Plans.--Section 1860D-4(c)(2)(B) of
the Social Security Act (42 U.S.C. 1395w-104(c)(2)(B)) is
amended--
(1) by striking ``may include elements that promote'';
(2) by redesignating clauses (i) through (iii) as
subclauses (I) through (III) and adjusting the margins
accordingly;
(3) by inserting before subclause (I), as so redesignated,
the following new clause:
``(i) may include elements that promote--'';
(4) in subclause (III), as so redesignated, by striking the
period at the end and inserting ``; and''; and
[[Page H5542]]
(5) by adding at the end the following new clause:
``(ii) with respect to plan years beginning on or after
January 1, 2021, shall provide for--
``(I) the provision of information to the enrollee on the
safe disposal of prescription drugs that are controlled
substances that meets the criteria established under section
1852(n)(2), including information on drug takeback programs
that meet such requirements determined appropriate by the
Secretary and information on in-home disposal; and
``(II) cost-effective means by which an enrollee may so
safely dispose of such drugs.''.
SEC. 6114. REVISING MEASURES USED UNDER THE HOSPITAL CONSUMER
ASSESSMENT OF HEALTHCARE PROVIDERS AND SYSTEMS
SURVEY RELATING TO PAIN MANAGEMENT.
(a) Restriction on the Use of Pain Questions in HCAHPS.--
Section 1886(b)(3)(B)(viii) of the Social Security Act (42
U.S.C. 1395ww(b)(3)(B)(viii)) is amended by adding at the end
the following new subclause:
``(XII)(aa) With respect to a Hospital Consumer Assessment
of Healthcare Providers and Systems survey (or a successor
survey) conducted on or after January 1, 2019, such survey
may not include questions about communication by hospital
staff with an individual about such individual's pain unless
such questions take into account, as applicable, whether an
individual experiencing pain was informed about risks
associated with the use of opioids and about non-opioid
alternatives for the treatment of pain.
``(bb) The Secretary shall not include on the Hospital
Compare Internet website any measures based on the questions
appearing on the Hospital Consumer Assessment of Healthcare
Providers and Systems survey in 2018 about communication by
hospital staff with an individual about such individual's
pain.''.
(b) Restriction on Use of 2018 Pain Questions in the
Hospital Value-based Purchasing Program.--Section
1886(o)(2)(B) of the Social Security Act (42 U.S.C.
1395ww(o)(2)(B)) is amended by adding at the end the
following new clause:
``(iii) HCAHPS pain questions.--The Secretary may not
include under subparagraph (A) a measure that is based on the
questions appearing on the Hospital Consumer Assessment of
Healthcare Providers and Systems survey in 2018 about
communication by hospital staff with an individual about the
individual's pain.''.
TITLE VII--OTHER HEALTH PROVISIONS
Subtitle A--Synthetic Drug Awareness
SEC. 7001. SHORT TITLE.
This subtitle may be cited as the ``Synthetic Drug
Awareness Act of 2018''.
SEC. 7002. REPORT ON EFFECTS ON PUBLIC HEALTH OF SYNTHETIC
DRUG USE.
(a) In General.--Not later than three years after the date
of the enactment of this Act, the Surgeon General of the
Public Health Service shall submit to Congress a report on
the health effects of new psychoactive substances (including
synthetic drugs) used since January 2010 by persons who are
at least 12 years of age but no more than 18 years of age.
(b) New Psychoactive Substance Defined.--For purposes of
subsection (a), the term ``new psychoactive substance'' means
a controlled substance analogue (as defined in section
102(32) of the Controlled Substances Act (21 U.S.C. 802(32)).
Subtitle B--Empowering Pharmacists in the Fight Against Opioid Abuse
SEC. 7011. SHORT TITLE.
This subtitle may be cited as the ``Empowering Pharmacists
in the Fight Against Opioid Abuse Act''.
SEC. 7012. PROGRAMS AND MATERIALS FOR TRAINING ON CERTAIN
CIRCUMSTANCES UNDER WHICH A PHARMACIST MAY
DECLINE TO FILL A PRESCRIPTION.
(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Administrator of the Drug
Enforcement Administration, the Commissioner of Food and
Drugs, the Director of the Centers for Disease Control and
Prevention, and the Assistant Secretary for Mental Health and
Substance Use, shall develop and disseminate programs and
materials for training pharmacists, health care providers,
and patients on--
(1) circumstances under which a pharmacist may, consistent
with section 201 of the Controlled Substances Act (21 U.S.C.
811) and regulations thereunder, including section 1306.04 of
title 21, Code of Federal Regulations, decline to fill a
prescription for a controlled substance because the
pharmacist suspects the prescription is fraudulent, forged,
or otherwise indicative of abuse or diversion; and
(2) any Federal requirements pertaining to declining to
fill a prescription under such circumstances.
(b) Materials Included.--In developing materials under
subsection (a), the Secretary of Health and Human Services
shall include information educating--
(1) pharmacists on how to decline to fill a prescription
and actions to take after declining to fill a prescription;
and
(2) other health care practitioners and the public on a
pharmacist's responsibility to decline to fill prescriptions
in certain circumstances.
(c) Stakeholder Input.--In developing the programs and
materials required under subsection (a), the Secretary of
Health and Human Services shall seek input from relevant
national, State, and local associations, boards of pharmacy,
medical societies, licensing boards, health care
practitioners, and patients.
Subtitle C--Indexing Narcotics, Fentanyl, and Opioids
SEC. 7021. SHORT TITLE.
This subtitle may be cited as the ``Indexing Narcotics,
Fentanyl, and Opioids Act of 2018'' or the ``INFO Act''.
SEC. 7022. ESTABLISHMENT OF SUBSTANCE USE DISORDER
INFORMATION DASHBOARD.
Title XVII of the Public Health Service Act (42 U.S.C. 300u
et seq.) is amended by adding at the end the following new
section:
``SEC. 1711. ESTABLISHMENT OF SUBSTANCE USE DISORDER
INFORMATION DASHBOARD.
``(a) In General.--Not later than six months after the date
of the enactment of this section, the Secretary of Health and
Human Services shall, in consultation with the Director of
National Drug Control Policy, establish and periodically
update a public information dashboard that--
``(1) coordinates information on programs within the
Department of Health and Human Services related to the
reduction of opioid abuse and other substance use disorders;
``(2) provides access to publicly available data from other
Federal agencies; State, local, and Tribal governments;
nonprofit organizations; law enforcement; medical experts;
public health educators; and research institutions regarding
prevention, treatment, recovery, and other services for
opioid use disorder and other substance use disorders;
``(3) provides comparable data on substance use disorder
prevention and treatment strategies in different regions and
population of the United States;
``(4) provides recommendations for health care providers on
alternatives to controlled substances for pain management,
including approaches studied by the National Institutes of
Health Pain Consortium and the National Center for
Complimentary and Integrative Health; and
``(5) provides guidelines and best practices for health
care providers regarding treatment of substance use
disorders.
``(b) Controlled Substance Defined.--In this section, the
term `controlled substance' has the meaning given that term
in section 102 of the Controlled Substances Act (21 U.S.C.
802).''.
SEC. 7023. INTERAGENCY SUBSTANCE USE DISORDER COORDINATING
COMMITTEE.
(a) Establishment.--Not later than three months after the
date of the enactment of this Act, the Secretary of Health
and Human Services (in this section referred to as the
``Secretary'') shall, in consultation with the Director of
National Drug Control Policy, establish a committee, to be
known as the Interagency Substance Use Disorder Coordinating
Committee (in this section referred to as the ``Committee''
), to coordinate all efforts within the Department of Health
and Human Services concerning substance use disorder.
(b) Membership.--
(1) Federal members.--The following individuals shall be
the Federal members of the Committee:
(A) The Secretary, who shall service as the Chair of the
Committee.
(B) The Attorney General of the United States.
(C) The Secretary of Labor.
(D) The Secretary of Housing and Urban Development.
(E) The Secretary of Education.
(F) The Secretary of Veterans Affairs.
(G) The Commissioner of Social Security.
(H) The Assistant Secretary for Mental Health and Substance
Use.
(I) The Director of the Centers for Disease Control and
Prevention.
(J) The Director of the National Institutes of Health and
the Directors of such national research institutes of the
National Institutes of Health as the Secretary determines
appropriate.
(K) The Administrator of the Centers for Medicare &
Medicaid Services.
(L) The Director of National Drug Control Policy.
(M) Representatives of other Federal agencies that serve
individuals with substance use disorder.
(2) Non-federal members.--The Committee shall include a
minimum of 17 non-Federal members appointed by the Secretary,
of which--
(A) at least two such members shall be an individual who
has received treatment for a diagnosis of an opioid use
disorder;
(B) at least two such members shall be an individual who
has received treatment for a diagnosis of a substance use
disorder other than an opioid use disorder;
(C) at least two such members shall be a State Alcohol and
Substance Abuse Director;
(D) at least two such members shall be a representative of
a leading research, advocacy, or service organization for
adults with substance use disorder;
(E) at least two such members shall--
(i) be a physician, licensed mental health professional,
advance practice registered nurse, or physician assistant;
and
(ii) have experience in treating individuals with opioid
use disorder or other substance use disorders;
(F) at least one such member shall be a substance use
disorder treatment professional who is employed with an
opioid treatment program;
(G) at least one such member shall be a substance use
disorder treatment professional who has research or clinical
experience in working with racial and ethnic minority
populations;
(H) at least one such member shall be a substance use
disorder treatment professional who has research or clinical
mental health experience in working with medically
underserved populations;
[[Page H5543]]
(I) at least one such member shall be a State-certified
substance use disorder peer support specialist;
(J) at least one such member shall be a drug court judge or
a judge with experience in adjudicating cases related to
substance use disorder;
(K) at least one such member shall be a law enforcement
officer or correctional officer with extensive experience in
interacting with adults with a substance use disorder; and
(L) at least one such member shall be an individual with
experience providing services for homeless individuals and
working with adults with a substance use disorder.
(c) Terms.--
(1) In general.--A member of the Committee appointed under
subsection (b)(2) shall be appointed for a term of three
years and may be reappointed for one or more three-year
terms.
(2) Vacancies.--A vacancy on the Committee shall be filled
in the same manner in which the original appointment was
made. Any individual appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of such
term and may serve after the expiration of such term until a
successor has been appointed.
(d) Meetings.--The Committee shall meet not fewer than two
times each year.
(e) Duties.--The Committee shall--
(1) monitor opioid use disorder and other substance use
disorder research, services, and support and prevention
activities across all relevant Federal agencies, including
coordination of Federal activities with respect to opioid use
disorder and other substance use disorders;
(2) identify and provide to the Secretary recommendations
for improving Federal grants and programs for the prevention
and treatment of, and recovery from, opioid use disorder and
other substance use disorders;
(3) review substance use disorder prevention and treatment
strategies in different regions and populations in the United
States and evaluate the extent to which Federal substance use
disorder prevention and treatment strategies are aligned with
State and local substance use disorder prevention and
treatment strategies;
(4) make recommendations to the Secretary regarding any
appropriate changes with respect to the activities and
strategies described in paragraphs (1) through (3);
(5) make recommendations to the Secretary regarding public
participation in decisions relating to opioid use disorder
and other substance use disorders and the process by which
public feedback can be better integrated into such decisions;
and
(6) make recommendations to ensure that opioid use disorder
and other substance use disorder research, services, and
support and prevention activities of the Department of Health
and Human Services and other Federal agencies are not
unnecessarily duplicative.
(f) Annual Report.--
(1) In general.--Not later than one year after the date of
the enactment of this Act, and annually thereafter for the
life of the Committee, the Committee shall publish on the
public information dashboard established under section
7022(a) a report summarizing the activities carried out by
the Committee pursuant to subsection (e), including any
findings resulting from such activities.
(2) Recommendation for committee extension.--After the
publication of the second report of the Committee under
paragraph (1), the Secretary shall submit to Congress a
recommendation on whether or not the operations of the
Committee should continue after the termination date
described in subsection (i).
(g) Working Groups.--The Committee may establish working
groups for purposes of carrying out the duties described in
subsection (e). Any such working group shall be composed of
members of the Committee (or the designees of such members)
and may hold such meetings as are necessary to enable the
working group to carry out the duties delegated to the
working group.
(h) Federal Advisory Committee Act.--The Federal Advisory
Committee Act (5 U.S.C. App.) shall apply to the Committee
only to the extent that the provisions of such Act do not
conflict with the requirements of this section.
(i) Sunset.--The Committee shall terminate on the date that
is six years after the date on which the Committee is
established under subsection (a).
Subtitle D--Ensuring Access to Quality Sober Living
SEC. 7031. SHORT TITLE.
This subtitle may be cited as the ``Ensuring Access to
Quality Sober Living Act of 2018''.
SEC. 7032. NATIONAL RECOVERY HOUSING BEST PRACTICES.
Part P of title III of the Public Health Service Act is
amended by adding at the end the following new section:
``SEC. 399V-7. NATIONAL RECOVERY HOUSING BEST PRACTICES.
``(a) Best Practices.--The Secretary of Health and Human
Services, in consultation with the Secretary for Housing and
Urban Development, patients with a history of opioid use
disorder, and other stakeholders, which may include State
accrediting entities and reputable providers, analysts, and
stakeholders of recovery housing services, such as the
National Alliance for Recovery Residences, shall identify or
facilitate the development of best practices, which may
include model laws for implementing suggested minimum
standards, for operating recovery housing.
``(b) Dissemination.--The Secretary shall disseminate the
best practices identified or developed under subsection (a)
to--
``(1) State agencies, which may include the provision of
technical assistance to State agencies seeking to adopt or
implement such best practices;
``(2) recovery housing entities; and
``(3) the public, as appropriate.
``(c) Definitions.--In this section:
``(1) The term `recovery housing' means a shared living
environment free from alcohol and illicit drug use and
centered on peer support and connection to services,
including medication-assisted treatment services, that
promote sustained recovery from substance use disorders.
``(2) The term `State' includes any of the several States,
the District of Columbia, each Indian tribe or tribal
organization (as those terms are defined in section 4 of the
Indian Self-Determination and Education Assistance Act), and
any territory or possession of the United States.
``(d) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $3,000,000
for the period of fiscal years 2019 through 2021.''.
Subtitle E--Advancing Cutting Edge Research
SEC. 7041. SHORT TITLE.
This subtitle may be cited as the ``Advancing Cutting Edge
Research Act'' or the ``ACE Research Act''.
SEC. 7042. UNIQUE RESEARCH INITIATIVES.
Section 402(n)(1) of the Public Health Service Act (42
U.S.C. 282(n)(1)) is amended--
(1) in subparagraph (A), by striking ``or'';
(2) in subparagraph (B), by striking the period and
inserting ``; or''; and
(3) by adding at the end the following:
``(C) high impact cutting-edge research that fosters
scientific creativity and increases fundamental biological
understanding leading to the prevention, diagnosis, or
treatment of diseases and disorders, or research urgently
required to respond to a public health threat.''.
Subtitle F--Jessie's Law
SEC. 7051. SHORT TITLE.
This subtitle may be cited as ``Jessie's Law''.
SEC. 7052. INCLUSION OF OPIOID ADDICTION HISTORY IN PATIENT
RECORDS.
(a) Best Practices.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services, in consultation with appropriate stakeholders,
including a patient with a history of opioid use disorder, an
expert in electronic health records, an expert in the
confidentiality of patient health information and records,
and a health care provider, shall identify or facilitate the
development of best practices regarding--
(A) the circumstances under which information that a
patient has provided to a health care provider regarding such
patient's history of opioid use disorder should, only at the
patient's request, be prominently displayed in the medical
records (including electronic health records) of such
patient;
(B) what constitutes the patient's request for the purpose
described in subparagraph (A); and
(C) the process and methods by which the information should
be so displayed.
(2) Dissemination.--The Secretary shall disseminate the
best practices developed under paragraph (1) to health care
providers and State agencies.
(b) Requirements.--In identifying or facilitating the
development of best practices under subsection (a), as
applicable, the Secretary, in consultation with appropriate
stakeholders, shall consider the following:
(1) The potential for addiction relapse or overdose,
including overdose death, when opioid medications are
prescribed to a patient recovering from opioid use disorder.
(2) The benefits of displaying information about a
patient's opioid use disorder history in a manner similar to
other potentially lethal medical concerns, including drug
allergies and contraindications.
(3) The importance of prominently displaying information
about a patient's opioid use disorder when a physician or
medical professional is prescribing medication, including
methods for avoiding alert fatigue in providers.
(4) The importance of a variety of appropriate medical
professionals, including physicians, nurses, and pharmacists,
to have access to information described in this section when
prescribing or dispensing opioid medication, consistent with
Federal and State laws and regulations.
(5) The importance of protecting patient privacy, including
the requirements related to consent for disclosure of
substance use disorder information under all applicable laws
and regulations.
(6) All applicable Federal and State laws and regulations.
SEC. 7053. COMMUNICATION WITH FAMILIES DURING EMERGENCIES.
(a) Promoting Awareness of Authorized Disclosures During
Emergencies.--The Secretary of Health and Human Services,
acting through the Administrator of the Centers for Medicare
& Medicaid Services and the Administrator of the Health
Resources and Services Administration, shall annually develop
and disseminate written materials (electronically or by other
means) to health care providers regarding permitted
disclosures under Federal health care privacy law during
emergencies, including overdoses, of certain health
information to families, caregivers, and health care
providers.
(b) Use of Material.--For the purposes of carrying out
subsection (a), the Secretary of Health and Human Services
may use material produced under section 11004 of the 21st
Century Cures Act (42 U.S.C. 1320d-2 note).
Subtitle G--Safe Disposal of Unused Medication
SEC. 7061. SHORT TITLE.
This subtitle may be cited as the ``Safe Disposal of Unused
Medication Act''.
SEC. 7062. DISPOSAL OF CONTROLLED SUBSTANCES OF A DECEASED
HOSPICE PATIENT BY EMPLOYEES OF A QUALIFIED
HOSPICE PROGRAM.
Subsection (g) of section 302 of the Controlled Substances
Act (21 U.S.C. 822) is amended by adding at the end the
following:
[[Page H5544]]
``(5)(A) In the case of a person receiving hospice care, an
employee of a qualified hospice program, acting within the
scope of employment, may handle, without being registered
under this section, any controlled substance that was
lawfully dispensed to the person receiving hospice care, for
the purpose of disposal of the controlled substance after the
death of such person, so long as such disposal occurs onsite
in accordance with all applicable Federal, State, Tribal, and
local law.
``(B) For the purposes of this paragraph:
``(i) The terms `hospice care' and `hospice program' have
the meanings given to those terms in section 1861(dd) of the
Social Security Act.
``(ii) The term `employee of a qualified hospice program'
means a physician, nurse, or other person who--
``(I) is employed by, or pursuant to arrangements made by,
a qualified hospice program;
``(II)(aa) is licensed to perform medical or nursing
services by the jurisdiction in which the person receiving
hospice care was located; and
``(bb) is acting within the scope of such employment in
accordance with applicable State law; and
``(III) has completed training through the qualified
hospice program regarding the disposal of controlled
substances in a secure and responsible manner so as to
discourage abuse, misuse, or diversion.
``(iii) The term `qualified hospice program' means a
hospice program that--
``(I) has written policies and procedures for assisting in
the disposal of the controlled substances of a person
receiving hospice care after the person's death;
``(II) at the time when the controlled substances are first
ordered--
``(aa) provides a copy of the written policies and
procedures to the patient or patient representative and
family;
``(bb) discusses the policies and procedures with the
patient or representative and the family in a language and
manner that they understand to ensure that these parties are
educated regarding the safe disposal of controlled
substances; and
``(cc) documents in the patient's clinical record that the
written policies and procedures were provided and discussed;
and
``(III) at the time following the disposal of the
controlled substances--
``(aa) documents in the patient's clinical record the type
of controlled substance, dosage, route of administration, and
quantity so disposed; and
``(bb) the time, date, and manner in which that disposal
occurred.''.
Subtitle H--Substance Use Disorder Workforce Loan Repayment
SEC. 7071. SHORT TITLE.
This subtitle may be cited as the ``Substance Use Disorder
Workforce Loan Repayment Act of 2018''.
SEC. 7072. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER
TREATMENT EMPLOYEES.
Title VII of the Public Health Service Act is amended--
(1) by redesignating part F as part G; and
(2) by inserting after part E (42 U.S.C. 294n et seq.) the
following:
``PART F--SUBSTANCE USE DISORDER TREATMENT EMPLOYEES
``SEC. 781. LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER
TREATMENT EMPLOYEES.
``(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, shall carry out a program under which--
``(1) the Secretary enters into agreements with individuals
to make payments in accordance with subsection (b) on the
principal of and interest on any eligible loan; and
``(2) the individuals each agree to complete a period of
service in a substance use disorder treatment job, as
described in subsection (d).
``(b) Payments.--For each year of obligated service by an
individual pursuant to an agreement under subsection (a), the
Secretary shall make a payment to such individual as follows:
``(1) Service in a shortage area.--The Secretary shall
pay--
``(A) for each year of obligated service by an individual
pursuant to an agreement under subsection (a), \1/6\ of the
principal of and interest on each eligible loan of the
individual which is outstanding on the date the individual
began service pursuant to the agreement; and
``(B) for completion of the sixth and final year of such
service, the remainder of such principal and interest.
``(2) Maximum amount.--The total amount of payments under
this section to any individual shall not exceed $250,000.
``(c) Eligible Loans.--The loans eligible for repayment
under this section are each of the following:
``(1) Any loan for education or training for a substance
use disorder treatment job.
``(2) Any loan under part E of title VIII (relating to
nursing student loans).
``(3) Any Federal Direct Stafford Loan, Federal Direct PLUS
Loan, or Federal Direct Unsubsidized Stafford Loan, or
Federal Direct Consolidation Loan (as such terms are used in
section 455 of the Higher Education Act of 1965).
``(4) Any Federal Perkins Loan under part E of title I of
the Higher Education Act of 1965.
``(5) Any other Federal loan as determined appropriate by
the Secretary.
``(d) Period of Service.--The period of service required by
an agreement under subsection (a) shall consist of up to 6
years of full-time employment, with no more than one year
passing between any two years of covered employment, in a
substance use disorder treatment job in the United States
in--
``(1) a Mental Health Professional Shortage Area, as
designated under section 332; or
``(2) a county (or a municipality, if not contained within
any county) where the mean drug overdose death rate per
100,000 people over the past 3 years for which official data
is available from the State, is higher than the most recent
available national average overdose death rate per 100,000
people, as reported by the Centers for Disease Control and
Prevention.
``(e) Ineligibility for Double Benefits.--No borrower may,
for the same service, receive a reduction of loan obligations
or a loan repayment under both--
``(1) this subsection; and
``(2) any Federally supported loan forgiveness program,
including under section 338B, 338I, or 846 of this Act, or
section 428J, 428 L, 455(m), or 460 of the Higher Education
Act of 1965.
``(f) Breach.--
``(1) Liquidated damages formula.--The Secretary may
establish a liquidated damages formula to be used in the
event of a breach of an agreement entered into under
subsection (a).
``(2) Limitation.--The failure by an individual to complete
the full period of service obligated pursuant to such an
agreement, taken alone, shall not constitute a breach of the
agreement, so long as the individual completed in good faith
the years of service for which payments were made to the
individual under this section.
``(g) Additional Criteria.--The Secretary--
``(1) may establish such criteria and rules to carry out
this section as the Secretary determines are needed and in
addition to the criteria and rules specified in this section;
and
``(2) shall give notice to the committees specified in
subsection (h) of any criteria and rules so established.
``(h) Report to Congress.--Not later than 5 years after the
date of enactment of the Substance Use Disorder Workforce
Loan Repayment Act of 2018, and every other year thereafter,
the Secretary shall prepare and submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report on--
``(1) the number and location of borrowers who have
qualified for loan repayments under this section; and
``(2) the impact of this section on the availability of
substance use disorder treatment employees nationally and in
shortage areas and counties described in subsection (d).
``(i) Definition.--In this section:
``(1) The term `municipality' means a city, town, or other
public body created by or pursuant to State law, or an Indian
Tribe.
``(2) The term `substance use disorder treatment job' means
a full-time job (including a fellowship)--
``(A) where the primary intent and function of the job is
the direct treatment or recovery support of patients with or
in recovery from a substance use disorder, such as a
physician, physician assistant, registered nurse, nurse
practitioner, advanced practice registered nurse, social
worker, recovery coach, mental health counselor, addictions
counselor, psychologist or other behavioral health
professional, or any other relevant professional as determine
by the Secretary; and
``(B) which is located at a substance use disorder
treatment program, private physician practice, hospital or
health system-affiliated inpatient treatment center or
outpatient clinic (including an academic medical center-
affiliated treatment program), correctional facility or
program, youth detention center or program, inpatient
psychiatric facility, crisis stabilization unit, community
health center, community mental health or other specialty
community behavioral health center, recovery center, school,
community-based organization, telehealth platform, migrant
health center, health program or facility operated by a tribe
or tribal organization, Federal medical facility, or any
other facility as determined appropriate for purposes of this
section by the Secretary.
``(j) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$25,000,000 for each of fiscal years 2019 through 2028.''.
Subtitle I--Preventing Overdoses While in Emergency Rooms
SEC. 7081. SHORT TITLE.
This subtitle may be cited as the ``Preventing Overdoses
While in Emergency Rooms Act of 2018''.
SEC. 7082. PROGRAM TO SUPPORT EMERGENCY ROOM DISCHARGE AND
CARE COORDINATION FOR DRUG OVERDOSE PATIENTS.
(a) In General.--The Secretary of Health and Human Services
shall establish a program (in this subtitle referred to as
the ``Program'') to develop protocols for discharging
patients who have presented with a drug overdose and enhance
the integration and coordination of care and treatment
options for individuals with substance use disorder after
discharge.
(b) Grant Establishment and Participation.--
(1) In general.--In carrying out the Program, the Secretary
shall award grants on a competitive basis to not more than 20
eligible entities described in paragraph (2).
(2) Eligibility.--
(A) In general.--To be eligible for a grant under this
subsection, an entity shall be--
(i) a health care site described in subparagraph (B); or
(ii) a health care site coordinator described in
subparagraph (C).
(B) Health care sites.--To be eligible for a grant under
this section, a health care site shall--
(i) submit an application to the Secretary at such time, in
such manner, and containing such information as specified by
the Secretary;
(ii) have an emergency department;
(iii)(I) have a licensed health care professional onsite
who has a waiver under section
[[Page H5545]]
303(g) of the Controlled Substances Act (21 U.S.C. 823(g)) to
dispense or prescribe covered drugs; or
(II) have a demonstrable plan to hire a sufficient number
of full-time licensed health care professionals who have
waivers described in subclause (I) to administer such
treatment onsite;
(iv) have in place an agreement with a sufficient number
and range of entities certified under applicable State and
Federal law, such as pursuant to registration or a waiver
under section 303(g) of the Controlled Substances Act (21
U.S.C. 823(g)) or certification as described in section 8.2
of title 42 of the Code of Federal Regulations, to provide
treatment for substance use disorder such that the entity or
the resulting network of entities with an agreement with the
hospital cumulatively are capable of providing all evidence-
based services for the treatment of substance use disorder,
as medically appropriate for the individual involved,
including--
(I) medication-assisted treatment;
(II) withdrawal and detoxification services that include
patient evaluation, stabilization, and readiness for and
entry into treatment; and
(III) counseling;
(v) deploy onsite peer recovery specialists to help connect
patients with treatment and recovery support services; and
(vi) include the provision of overdose reversal medication
in discharge protocols for opioid overdose patients.
(C) Health care site coordinators.--To be eligible for a
grant under this section, a health care site coordinator
shall--
(i) be an organization described in section 501(c)(3) of
the Internal Revenue Code of 1986 (and exempt from tax under
section 501(a) of such Code) or a State, local, or Tribal
government;
(ii) submit an application to the Secretary at such time,
in such manner, and containing such information as specified
by the Secretary; and
(iii) have an agreement with multiple eligible health care
sites described in subparagraph (B).
(3) Preference.--In awarding grants under this section, the
Secretary may give preference to eligible entities described
in paragraph (2) that meet either or both of the following
criteria:
(A) The eligible health care site is, or the eligible
health care site coordinator has an agreement described in
paragraph (2)(C)(iii) with a site that is, a critical access
hospital (as defined in section 1861(mm)(1) of the Social
Security Act (42 U.S.C. 1395x(mm)(1))), a low-volume hospital
(as defined in section 1886(d)(12)(C)(i) of such Act (42
U.S.C. 1395ww(d)(12)(C)(i))), or a sole community hospital
(as defined in section 1886(d)(5)(D)(iii) of such Act (42
U.S.C. 1395ww(d)(5)(D)(iii))).
(B) The eligible health care site or the eligible health
care site coordinator is located in a geographic area with a
drug overdose rate that is higher than the national rate, or
in a geographic area with a rate of emergency department
visits for overdoses that is higher than the national rate,
as determined by the Secretary based on the most recent data
from the Centers for Disease Control and Prevention.
(4) Medication-assisted treatment defined.--For purposes of
this section, the term ``medication-assisted treatment''
means the use of a drug approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a
biological product licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262), in combination with
behavioral health services, to provide an individualized
approach to the treatment of substance use disorders,
including opioid use disorders.
(c) Period of Grant.--A grant awarded to an eligible entity
under this section shall be for a period of at least 2 years.
(d) Grant Uses.--
(1) Required uses.--A grant awarded under this section to
an eligible entity shall be used for both of the following
purposes:
(A) To establish policies and procedures that address the
provision of overdose reversal medication, prescription and
dispensing of medication-assisted treatment to an emergency
department patient who has had a non-fatal overdose or who is
at risk of a drug overdose, and the subsequent referral to
evidence-based treatment upon discharge for patients who have
experienced a non-fatal drug overdose or who are at risk of a
drug overdose.
(B) To develop best practices for treating non-fatal drug
overdoses, including with respect to care coordination and
integrated care models for long term treatment and recovery
options for individuals who have experienced a non-fatal drug
overdose.
(2) Additional permissible uses.--A grant awarded under
this section to an eligible entity may be used for any of the
following purposes:
(A) To hire emergency department peer recovery specialists;
counselors; therapists; social workers; or other licensed
medical professionals specializing in the treatment of
substance use disorder.
(B) To establish integrated models of care for individuals
who have experienced a non-fatal drug overdose which may
include patient assessment, follow up, and transportation to
treatment facilities.
(C) To provide for options for increasing the availability
and access of medication-assisted treatment and other
evidence-based treatment for individuals with substance use
disorders.
(D) To offer consultation with and referral to other
supportive services that help in treatment and recovery.
(e) Reporting Requirements.--
(1) Reports by grantees.--Each eligible entity awarded a
grant under this section shall submit to the Secretary an
annual report for each year for which the entity has received
such grant that includes information on--
(A) the number of individuals treated at the site (or, in
the case of an eligible health care site coordinator, at
sites covered by the agreement referred to in subsection
(b)(2)(C)(iii)) for non-fatal overdoses in the emergency
department;
(B) the number of individuals administered each medication-
assisted treatment at such site or sites in the emergency
department;
(C) the number of individuals referred by such site or
sites to other treatment facilities after a non-fatal
overdose, the types of such other facilities, and the number
of such individuals admitted to such other facilities
pursuant to such referrals;
(D) the frequency and number of patient readmissions for
non-fatal overdoses and substance use disorder;
(E) for what the grant funding was used; and
(F) the effectiveness of, and any other relevant additional
data regarding, having an onsite health care professional to
administer and begin medication-assisted treatment for
substance use disorders.
(2) Report by secretary.--Not less than one year after the
conclusion of the Program, the Secretary shall submit to
Congress a report that includes--
(A) findings of the Program;
(B) overall patient outcomes under the Program, such as
with respect to hospital readmission;
(C) what percentage of patients treated by a site funded
through a grant under this section were readmitted to a
hospital for non-fatal or fatal overdose;
(D) an evaluation determining the effectiveness of having a
practitioner onsite to administer and begin medication-
assisted treatment for substance use disorder; and
(E) a compilation of voluntary guidelines and best
practices from the reports submitted under paragraph (1).
(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this subtitle $50,000,000 for
the period of fiscal years 2019 through 2023.
Subtitle J--Alternatives to Opioids in the Emergency Department
SEC. 7091. SHORT TITLE.
This subtitle may be cited as the ``Alternatives to Opioids
in the Emergency Department Act'' or the ``ALTO Act''.
SEC. 7092. EMERGENCY DEPARTMENT ALTERNATIVES TO OPIOIDS
DEMONSTRATION PROGRAM.
(a) Demonstration Program Grants.--The Secretary of Health
and Human Services (in this section referred to as the
``Secretary'') shall carry out a demonstration program under
which the Secretary shall award grants to hospitals and
emergency departments, including freestanding emergency
departments, to develop, implement, enhance, or study
alternative pain management protocols and treatments that
limit the use and prescription of opioids in emergency
departments.
(b) Eligibility.--To be eligible to receive a grant under
subsection (a), a hospital or emergency department shall
submit an application to the Secretary at such time, in such
manner, and containing such information as the Secretary may
require.
(c) Geographic Diversity.--In awarding grants under this
section, the Secretary shall seek to ensure geographical
diversity among grant recipients.
(d) Use of Funds.--Grants under subsection (a) shall be
used to--
(1) target common painful conditions, such as renal colic,
sciatica, headaches, musculoskeletal pain, and extremity
fractures;
(2) train providers and other hospital personnel on
protocols and the use of treatments that limit the use and
prescription of opioids in the emergency department; and
(3) provide alternatives to opioids to patients with
painful conditions, not including patients who present with
pain related to cancer, end-of-life symptom palliation, or
complex multisystem trauma.
(e) Consultation.--The Secretary shall implement a process
for recipients of grants under subsection (a) to consult (in
a manner that allows for sharing of evidence-based best
practices) with each other and with persons having robust
knowledge, including emergency departments and physicians
that have successfully deployed alternative pain management
protocols, such as non-drug approaches studied through the
National Center for Complimentary and Integrative Health
including acupuncture that limit the use of opioids. The
Secretary shall offer to each recipient of a grant under
subsection (a) technical support as necessary.
(f) Report to the Secretary.--Each recipient of a grant
under this section shall submit to the Secretary (during the
period of such grant) annual reports on the progress of the
program funded through the grant. These reports shall
include, in accordance with State and Federal statutes and
regulations regarding disclosure of patient information--
(1) a description of and specific information about the
alternative pain management protocols employed;
(2) data on the alternative pain management protocols and
treatments employed, including--
(A) during a baseline period before the program began, as
defined by the Secretary;
(B) at various stages of the program, as determined by the
Secretary; and
(C) the conditions for which the alternative pain
management protocols and treatments were employed;
(3) the success of each specific alternative pain
management protocol;
(4) data on the opioid prescriptions written, including--
(A) during a baseline period before the program began, as
defined by the Secretary;
(B) at various stages of the program, as determined by the
Secretary; and
(C) the conditions for which the opioids were prescribed;
[[Page H5546]]
(5) the demographic characteristics of patients who were
treated with an alternative pain management protocol,
including age, sex, race, ethnicity, and insurance status and
type;
(6) data on patients who were eventually prescribed opioids
after alternative pain management protocols and treatments
were employed; and
(7) any other information the Secretary deems necessary.
(g) Report to Congress.--Not later than one year after
completion of the demonstration program under this section,
the Secretary shall submit a report to the Congress on the
results of the demonstration program and include in the
report--
(1) the number of applications received and the number
funded;
(2) a summary of the reports described in subsection (f),
including standardized data; and
(3) recommendations for broader implementation of pain
management protocols that limit the use and prescription of
opioids in emergency departments or other areas of the health
care delivery system.
(h) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $10,000,000
for each of fiscal years 2019 through 2021.
Subtitle K--Stop Counterfeit Drugs by Regulating and Enhancing
Enforcement Now
SEC. 7101. SHORT TITLE.
This subtitle may be cited as the ``Stop Counterfeit Drugs
by Regulating and Enhancing Enforcement Now Act'' or the
``SCREEN Act''.
SEC. 7102. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS
OFFERED FOR IMPORTATION.
(a) Increasing the Maximum Dollar Amount of Drugs Subject
to Destruction.--The sixth sentence in section 801(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is
amended by striking ``except that the Secretary'' and all
that follows through the two periods at the end and inserting
``except that the Secretary of Health and Human Services may
destroy, without the opportunity for export, any drug refused
admission under this section, if such drug is declared to be
valued at an amount that is $2,500 or less (or such higher
amount as the Secretary of the Treasury may set by regulation
pursuant to section 498(a)(1) of the Tariff Act of 1930 or
such higher amount as the Commissioner of Food and Drugs may
set based on a finding by the Commissioner that the higher
amount is in the interest of public health), or if such drug
is entering the United States by mail, and was not brought
into compliance as described under subsection (b).''.
(b) Destruction of Articles of Concern.--The sixth sentence
of section 801(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381(a)), as amended by subsection (a), is further
amended by inserting before the period at the end the
following: ``; and the Secretary of Health and Human Services
may destroy, without the opportunity for export, any article
refused admission under clause (6) of the third sentence of
this subsection''.
(c) Technical Amendments.--The seventh, eighth, and ninth
sentences of section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) are amended--
(1) by striking ``a drug'' each place it appears and
inserting ``an article''; and
(2) by striking ``the drug'' each place it appears and
inserting ``the article''.
(d) Rule of Construction.--The last sentence in section
801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(a)) is amended to read as follows: ``Clauses (2), (5),
and (6) of the third sentence of this subsection shall not be
construed to prohibit the admission of narcotic or
nonnarcotic drugs or other substances, the importation of
which is permitted under the Controlled Substances Import and
Export Act.''.
SEC. 7103. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF
ADULTERATED OR MISBRANDED DRUG PRODUCTS.
(a) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
``(eee) The failure to comply with any order issued under
section 569D.''.
(b) Notification, Nondistribution, and Recall of
Adulterated or Misbranded Drugs.--Subchapter E of chapter V
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb
et seq.) is amended by adding at the end the following:
``SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF
ADULTERATED OR MISBRANDED DRUGS.
``(a) Order To Cease Distribution and Recall.--
``(1) In general.--Upon a determination that the use or
consumption of, or exposure to, a drug may present an
imminent or substantial hazard to the public health, the
Secretary shall issue an order requiring any person who
distributes the drug to immediately cease distribution of the
drug.
``(2) Hearing.--An order under paragraph (1) shall provide
the person subject to the order with an opportunity for an
informal hearing, to be held not later than 10 days after the
date of issuance of the order, on--
``(A) the actions required by the order; and
``(B) whether the order should be amended to require a
recall of the drug.
``(3) Inadequate grounds.--If, after providing an
opportunity for a hearing under paragraph (2), the Secretary
determines that inadequate grounds exist to support the
actions required by the order, the Secretary shall vacate the
order.
``(4) Amendment to order to require recall.--If, after
providing an opportunity for an informal hearing under
paragraph (2), the Secretary determines that the order should
be amended to include a recall of the drug with respect to
which the order was issued, the Secretary shall--
``(A) amend the order to require a recall; and
``(B) after consultation with the drug sponsor, specify a
timetable in which the recall will occur.
``(5) Notice to persons affected.--An order under this
subsection shall require any person who distributes the drug
to provide for notice, including to individuals as
appropriate, to persons who may be affected by the order to
cease distribution of or recall the drug, as applicable.
``(6) Action following order.--Any person who is subject to
an order under paragraph (1) or (4) shall immediately cease
distribution of or recall, as applicable, the drug and
provide notification as required by such order.
``(b) Notice to Consumers and Health Officials.--The
Secretary shall, as the Secretary determines to be necessary,
provide notice of a recall order under this section to--
``(1) consumers to whom the drug was, or may have been,
distributed; and
``(2) appropriate State and local health officials.
``(c) Order To Recall.--
``(1) Contents.--An order to recall a drug under subsection
(a) shall--
``(A) require periodic reports to the Secretary describing
the progress of the recall; and
``(B) provide for notice, including to individuals as
appropriate, to persons who may be affected by the recall.
``(2) Assistance allowed.--In providing for notice under
paragraph (1)(B), the Secretary may allow for the assistance
of health professionals, State or local officials, or other
individuals designated by the Secretary.
``(3) Nondelegation.--An order under this section shall be
ordered by the Secretary or an official designated by the
Secretary. An official may not be so designated under this
section unless the official is the Director of the Center for
Drug Evaluation and Research, is an official senior to such
Director, or is so designated by such Director.
``(d) Savings Clause.--Nothing contained in this section
shall be construed as limiting--
``(1) the authority of the Secretary to issue an order to
cease distribution of, or to recall, an drug under any other
provision of this Act or the Public Health Service Act; or
``(2) the ability of the Secretary to request any person to
perform a voluntary activity related to any drug subject to
this Act or the Public Health Service Act.''.
(c) Drugs Subject to Refusal.--The third sentence of
subsection (a) of section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by inserting ``or (5)
in the case of a drug, such drug is subject to an order under
section 568 to cease distribution of or recall the drug,''
before ``then such article shall be refused admission''.
(d) Application.--Sections 301(eee) and 569D of the Federal
Food, Drug, and Cosmetic Act, as added by subsections (a) and
(b), shall apply with respect to a drug as of such date, not
later than 1 year after the date of the enactment of this
Act, as the Secretary of Health and Human Services shall
specify.
SEC. 7104. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADULTERATED
OR MISBRANDED DRUGS.
Section 801 of the Federal Food, Drug, and Cosmetic Act is
amended by adding at the end the following:
``(t) Single Source Pattern of Shipments of Adulterated or
Misbranded Drugs.--If the Secretary identifies a pattern of
adulterated or misbranded drugs being offered for import from
the same manufacturer, distributor, or importer, the
Secretary may by order choose to treat all drugs being
offered for import from such manufacturer, distributor, or
importer as adulterated or misbranded unless otherwise
demonstrated.''.
SEC. 7105. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE
OPIOID AND SUBSTANCE USE EPIDEMIC.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following:
``SEC. 1015. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE
OPIOID AND SUBSTANCE USE EPIDEMIC.
``(a) In General.--The Commissioner of Food and Drugs shall
use any funds appropriated pursuant to the authorization of
appropriations under subsection (c) to carry out the programs
and activities described in subsection (d) to strengthen and
facilitate the Food and Drug Administration's efforts to
address the opioid and substance use epidemic. Such funds
shall be in addition to any funds which are otherwise
available to carry out such programs and activities.
``(b) FDA Opioid and Substance Use Epidemic Response
Fund.--
``(1) Establishment of fund.--There is established in the
Treasury a fund, to be known as the FDA Opioid and Substance
Use Epidemic Response Fund (referred to in this subsection as
the `Fund'), for purposes of funding the programs and
activities described in subsection (d).
``(2) Transfer.--For the period of fiscal years 2019
through 2023, $110,000,000 shall be transferred to the Fund
from the general fund of the Treasury.
``(3) Amounts deposited.--Any amounts transferred under
paragraph (2) shall remain unavailable in the Fund until such
amounts are appropriated pursuant to subsection (c).
``(c) Appropriations.--
``(1) Authorization of appropriations.--For the period of
fiscal years 2019 through 2023, there is authorized to be
appropriated from the Fund to the Food and Drug
Administration, for the purpose of carrying out the programs
and activities described in subsection (d), an amount
[[Page H5547]]
not to exceed the total amount transferred to the Fund under
subsection (b)(2). Notwithstanding subsection (g), such funds
shall remain available until expended.
``(2) Offsetting future appropriations.--For any of fiscal
years 2019 through 2023, for any discretionary appropriation
out of the Fund to the Food and Drug Administration pursuant
to the authorization of appropriations under paragraph (1)
for the purpose of carrying out the programs and activities
described in subsection (d), the total amount of such
appropriations for the applicable fiscal year (not to exceed
the total amount remaining in the Fund) shall be subtracted
from the estimate of discretionary budget authority and the
resulting outlays for any estimate under the Congressional
Budget and Impoundment Control Act of 1974 or the Balanced
Budget and Emergency Deficit Control Act of 1985, and the
amount transferred to the Fund shall be reduced by the same
amount.
``(d) Food and Drug Administration.--The entirety of the
funds made available pursuant to subsection (c)(1) shall be
for the Commissioner of Food and Drugs, pursuant to
applicable authorities in the Public Health Service Act (42
U.S.C. 201 et seq.) or this Act and other applicable Federal
law, to support widespread innovation in non-opioid and non-
addictive medical products for pain treatment, access to
opioid addiction treatments, appropriate use of approved
opioids, and efforts to reduce illicit importation of
opioids. Such support may include the following programs and
activities:
``(1) Obligating contract funds beginning in fiscal year
2019 for an educational campaign that will--
``(A) educate patients and their families to differentiate
opioid medications;
``(B) raise awareness about preferred storage and disposal
methods; and
``(C) inform patients, families, and communities about
medication-assisted treatment options.
``(2) Building the Food and Drug Administration's presence
in international mail facilities, including through--
``(A) improvements in equipment and information technology
enhancements to identify unapproved, counterfeit, or other
unlawful pharmaceuticals for destruction;
``(B) increased and improved surveillance;
``(C) renovations at international mail facility locations;
and
``(D) the purchase of laboratory equipment.
``(3) Enhancing the identification and targeting of
entities offering products and products being offered by such
entities for import into the United States through review and
analysis of Internet websites, import data, and other sources
of intelligence for purposes of making the best use of the
Food and Drug Administration's inspection and analytical
resources.
``(4) Increasing the number of staff of the Food and Drug
Administration to increase the number of packages being
examined, ensuring the safety of the staff undertaking such
examinations, and ensuring that packages identified as
illegal, counterfeit, misbranded, or adulterated are removed
from commerce through available authorities, including
administrative destruction.
``(5) Enhancing the Food and Drug Administration's criminal
investigations resources (including full-time equivalent
employees and equipment), imports surveillance, and
international work.
``(6) Obtaining for the Food and Drug Administration
equipment and full-time equivalent employees needed to
efficiently screen and analyze products offered for import,
including by building data libraries of new substances and
analogues to facilitate identification and evaluation of
pharmaceutical-based agents and by purchasing screening
technologies for use at international mail facilities.
``(7) Operating the Food and Drug Administration's forensic
laboratory facility to ensure adequate laboratory space and
functionality for additional work and full-time equivalent
employees.
``(e) Accountability and Oversight.--
``(1) Work plan.--
``(A) In general.--Not later than 180 days after the date
of enactment of this Act, the Commissioner of Food and Drugs
shall submit to the Committee on Health, Education, Labor and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, a work plan
including the proposed allocation of funds appropriated
pursuant to the authorization of appropriations under
subsection (c) for each of fiscal years 2019 through 2023 and
the contents described in subparagraph (B).
``(B) Contents.--The work plan submitted under subparagraph
(A) shall include--
``(i) the amount of money to be obligated or expended out
of the Fund in each fiscal year for each program and activity
described in subsection (d); and
``(ii) a description and justification of each such program
and activity.
``(2) Reports.--
``(A) Annual reports.--Not later than October 1 of each of
fiscal years 2020 through 2024, the Secretary of Health and
Human Services shall submit to the Committee on Health,
Education, Labor and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a
report that includes--
``(i) the amount of money obligated or expended out of the
Fund in the prior fiscal year for each program and activity
described in subsection (d);
``(ii) a description of all programs and activities using
funds provided pursuant to the authorization of
appropriations under subsection (c); and
``(iii) how the programs and activities are advancing
public health.
``(B) Additional reports.--At the request of the Committee
on Health, Education, Labor and Pensions of the Senate or the
Committee on Energy and Commerce of the House of
Representatives, the Commissioner shall provide an update in
the form of testimony and any additional reports to the
respective congressional committee regarding the allocation
of funding under this section or the description of the
programs and activities undertaken with such funding.
``(f) Limitations.--Notwithstanding any transfer authority
authorized by this section or any appropriations Act, any
funds made available pursuant to the authorization of
appropriations under subsection (c) may not be used for any
purpose other than the programs and activities described in
subsection (d) to strengthen and facilitate the Food and Drug
Administration's efforts to address the opioid and substance
use epidemic.
``(g) Sunset.--This section shall expire on September 30,
2022, except that--
``(1) this subsection does not apply to reporting under
subsection (e)(2); and
``(2) this section shall remain in effect until such time,
and to such extent, as may be necessary for the funds
transferred by subsection (b)(2) to be fully expended.''.
SEC. 7106. CONSIDERATION OF POTENTIAL FOR MISUSE AND ABUSE
REQUIRED FOR DRUG APPROVAL.
(a) In General.--Section 505(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(d)) is amended--
(1) in the first sentence--
(A) by striking ``or (7)'' and inserting ``(7)''; and
(B) by inserting ``or (8) if the drug is or contains a
controlled substance for which a listing in any schedule is
in effect under the Controlled Substances Act or that is
permanently scheduled pursuant to section 201 of such Act, on
the basis of information submitted to him as part of the
application, or upon the basis of any other information
before him with respect to such drug, the drug is unsafe for
use due to the risks of abuse or misuse or there is
insufficient information to show that the drug is safe for
use considering such risks;'' before ``he shall issue an
order refusing to approve the application''; and
(2) in the second sentence, by striking ``(6)'' and
inserting ``(8)''.
(b) Withdrawal Authority.--Section 505(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended in
the first sentence--
(1) by striking ``or (5)'' and inserting ``(5)''; and
(2) by inserting the following: ``; or (6) that, in the
case of a drug that is or contains a controlled substance for
which a listing in any schedule is in effect under the
Controlled Substances Act or that is permanently scheduled
pursuant to section 201 of such Act, on the basis of new
information before him with respect to such drug, evaluated
together with the information available to him when the
application was approved, that the drug is unsafe for use due
to the risks of abuse or misuse'' after ``of a material
fact''.
(c) Rule of Construction.--Nothing in the amendments made
by this section shall be construed to limit or narrow, in any
manner, the meaning or application of the provisions of
paragraphs (1), (2), (3), (4), (5), and (7) of section 505(d)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(d)) or paragraphs (1) and (2) of section 505(e) of such
Act (21 U.S.C. 355(e)).
Subtitle L--Treatment, Education, and Community Help to Combat
Addiction
SEC. 7111. SHORT TITLE.
This subtitle may be cited as the ``Treatment, Education,
and Community Help to Combat Addiction Act of 2018'' or the
``TEACH to Combat Addiction Act of 2018''.
SEC. 7112. ESTABLISHMENT OF REGIONAL CENTERS OF EXCELLENCE IN
SUBSTANCE USE DISORDER EDUCATION.
Part D of title V of the Public Health Service Act is
amended by inserting after section 549 (42 U.S.C. 290ee-4)
the following new section:
``SEC. 550. REGIONAL CENTERS OF EXCELLENCE IN SUBSTANCE USE
DISORDER EDUCATION.
``(a) In General.--The Secretary, in consultation with such
other agencies as are appropriate, shall, subject to the
availability of appropriations, establish a solicitation
process and award cooperative agreements to eligible entities
for the designation of such entities as Regional Centers of
Excellence in Substance Use Disorder Education and support of
such regional centers of excellence to enhance and improve
how health professionals are educated in substance use
disorder prevention, treatment, and recovery through
development, evaluation, and distribution of evidence-based
curricula for health profession schools. An eligible entity
designated by the Secretary as a Regional Center of
Excellence in Substance Use Disorder Education shall carry
out the activities described in subsection (b).
``(b) Selection of Centers of Excellence.--
``(1) Eligible entities.--To be eligible to receive a
cooperative agreement under subsection (a), an entity shall--
``(A) be an entity specified by the Secretary that offers
education to students in various health professions, which
may include--
``(i) a health system;
``(ii) a teaching hospital;
``(iii) a medical school;
``(iv) a certified behavioral health clinic; or
``(v) any other health profession school, school of public
health, or Cooperative Extension Program at institutions of
higher education engaged in an aspect of the prevention,
treatment, or recovery of substance use disorders;
``(B) be accredited by the appropriate educational
accreditation body;
[[Page H5548]]
``(C) demonstrate an existing strategy, and have in place a
plan for continuing such strategy, or a proposed strategy to
implement a curriculum based on best practices for substance
use disorder prevention, treatment, and recovery;
``(D) demonstrate community engagement and participation
through community partners, including other health profession
schools, mental health counselors, social workers, peer
recovery specialists, substance use treatment programs,
community health centers, physicians' offices, certified
behavioral health clinics, law enforcement, and the business
community; and
``(E) provide to the Secretary such information, at such
time, and in such manner, as the Secretary may require.
``(2) Diversity.--In awarding cooperative agreements under
subsection (a), the Secretary shall take into account
regional differences among eligible entities and shall make
an effort to ensure geographic diversity.
``(c) Dissemination of Information.--
``(1) Public posting.--The Secretary shall make information
provided to the Secretary under subsection (b)(1)(E)
publically available on the Internet website of the
Department of Health and Human Services.
``(2) Evaluation.--The Secretary shall evaluate each
project carried out by a Regional Center of Excellence in
Substance Use Disorder Education under this section and shall
disseminate the findings with respect to each such evaluation
to appropriate public and private entities.
``(d) Funding.--There is authorized to be appropriated to
carry out this section, $4,000,000 for each of fiscal years
2019 through 2023.''.
Subtitle M--Guidance From National Mental Health and Substance Use
Policy Laboratory
SEC. 7121. GUIDANCE FROM NATIONAL MENTAL HEALTH AND SUBSTANCE
USE POLICY LABORATORY.
Section 501A(b) of the Public Health Service Act (42 U.S.C.
290aa-0(b)) is amended--
(1) in paragraph (5), by striking ``and'' at the end;
(2) in paragraph (6), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(7) issue and periodically update guidance for entities
applying for grants from the Substance Abuse and Mental
Health Services Administration in order to--
``(A) encourage the funding of evidence-based practices;
``(B) encourage the replication of promising or effective
practices; and
``(C) inform applicants on how to best articulate the
rationale for the funding of a program or activity.''.
Subtitle N--Comprehensive Opioid Recovery Centers
SEC. 7131. SHORT TITLE.
This subtitle may be cited as the ``Comprehensive Opioid
Recovery Centers Act of 2018''.
SEC. 7132. COMPREHENSIVE OPIOID RECOVERY CENTERS.
(a) In General.--Part D of title V of the Public Health
Service Act is amended by adding at the end the following new
section:
``SEC. 550. COMPREHENSIVE OPIOID RECOVERY CENTERS.
``(a) In General.--The Secretary shall award grants on a
competitive basis to eligible entities to establish or
operate a comprehensive opioid recovery center (referred to
in this section as a `Center').
``(b) Grant Period.--
``(1) In general.--A grant awarded under subsection (a)
shall be for a period not less than three years and not more
than five years.
``(2) Renewal.--A grant awarded under subsection (a) may be
renewed, on a competitive basis, for additional periods of
time, as determined by the Secretary. In determining whether
to renew a grant under this paragraph, the Secretary shall
consider the data submitted under subsection (h).
``(c) Minimum Number of Centers.--The Secretary shall
allocate the amounts made available under subsection (i) in
such amounts that not fewer than 10 Centers will be
established across the United States.
``(d) Application.--In order to be eligible for a grant
under subsection (a), an entity shall submit an application
to the Secretary at such time and in such manner as the
Secretary may require. Such application shall include--
``(1) evidence that such entity carries out, or is capable
of coordinating with other entities to carry out, the
activities described in subsection (g); and
``(2) such other information as the Secretary may require.
``(e) Priority.--In awarding grants under subsection (a),
the Secretary shall give priority to eligible entities
located in a State or Indian country (as defined in section
1151 of title 18, United States Code)--
``(1) with a high per capita drug overdose mortality rate,
as determined by the Director of the Centers for Disease
Control and Prevention; or
``(2) based on any other criteria or need, as determined by
the Secretary.
``(f) Use of Grant Funds.--An eligible entity awarded a
grant under subsection (a) shall use the grant funds to
establish or operate a Center to carry out the activities
described in subsection (g).
``(g) Center Activities and Services.--Each Center shall,
at a minimum, carry out the activities described in this
subsection. In the case of a Center that determines that a
service described in paragraph (2) cannot reasonably be
carried out by the Center, such Center shall contract with
such other entities as may be necessary to ensure that
patients have access to the full range of services described
in such paragraph.
``(1) Community outreach.--Each Center shall carry out the
following outreach activities:
``(A) Train and supervise outreach staff to work with
schools, workplaces, faith-based organizations, State and
local health departments, law enforcement, and first
responders to ensure that such institutions are aware of the
services of the Center.
``(B) Disseminate and make available online evidence-based
resources that educate professionals and the public on opioid
use disorder and other substance use disorders.
``(2) Treatment and recovery services.--Each Center shall
provide the following treatment and recovery services:
``(A) Ensure that intake evaluations meet the clinical
needs of patients.
``(B) Periodically conduct patient assessments to ensure
continued and meaningful recovery, as defined by the
Assistant Secretary for Mental Health and Substance Use.
``(C) Provide the full continuum of treatment services,
including--
``(i) all drugs approved under section 505 of the Federal
Food, Drug, and Cosmetic Act and all biological products
licensed under section 351 of this Act, including methadone,
to treat substance use disorders, including opioid use
disorder and alcohol use disorder;
``(ii) withdrawal management, which shall include medically
supervised detoxification that includes patient evaluation,
stabilization, and readiness for and entry into treatment;
``(iii) counseling and case management, including
counseling and recovery services for any possible co-
occurring mental illness;
``(iv) residential rehabilitation;
``(v) recovery housing;
``(vi) community-based and peer recovery support services;
``(vii) job training and placement assistance to support
reintegration into the workforce; and
``(viii) other best practices, as determined by the
Secretary.
``(D) Administer an onsite pharmacy and provide toxicology
services.
``(E) Establish and operate a secure and confidential
electronic health information system.
``(F) Offer family support services such as child care,
family counseling, and parenting interventions to help
stabilize families impacted by substance use disorder.
``(h) Data Reporting and Program Oversight.--With respect
to a grant awarded under subsection (a) to an eligible entity
for a Center, not later than 90 days after the end of the
first year of the grant period, and annually thereafter for
the duration of the grant period (including the duration of
any renewal period for such grant), the entity shall submit
data, as appropriate, to the Secretary regarding--
``(1) the programs and activities funded by the grant;
``(2) health outcomes of individuals with a substance use
disorder who received services from the Center;
``(3) the effectiveness of interventions designed, tested,
and evaluated by the Center; and
``(4) any other information that the Secretary may require
for the purpose of--
``(A) evaluating the effectiveness of the Center; and
``(B) ensuring that the Center is complying with all the
requirements of the grant, including providing the full
continuum of services described in subsection (g)(2)(C) and
providing drugs and devices for overdose reversal under such
subsection.
``(i) Authorization of Appropriations.--There is authorized
to be appropriated $10,000,000 for each of fiscal years 2019
through 2023 for purposes of carrying out this section.''.
(b) Reports to Congress.--
(1) Preliminary report.--Not later than three years after
the date of the enactment of this Act, the Secretary of
Health and Human Services shall submit to Congress a
preliminary report that analyzes data submitted under section
550(h) of the Public Health Service Act, as added by
subsection (a).
(2) Final report.--Not later than one year after submitting
the preliminary report required under paragraph (1), the
Secretary of Health and Human Services shall submit to
Congress a final report that includes--
(A) an evaluation of the effectiveness of comprehensive
opioid recovery centers established or operated pursuant to
section 550 of the Public Health Service Act, as added by
subsection (a);
(B) recommendations on whether the grant program
established under such section 550 should be reauthorized and
expanded; and
(C) standards and best practices for the treatment of
substance use disorders, as identified through such grant
program.
Subtitle O--Poison Center Network Enhancement
SEC. 7141. SHORT TITLE.
This subtitle may be cited as the ``Poison Center Network
Enhancement Act of 2018''.
SEC. 7142. REAUTHORIZATION OF POISON CONTROL CENTERS NATIONAL
TOLL-FREE NUMBER.
Section 1271 of the Public Health Service Act (42 U.S.C.
300d-71) is amended to read as follows:
``SEC. 1271. ESTABLISHMENT AND MAINTENANCE OF THE NATIONAL
TOLL-FREE NUMBER AND ENHANCED COMMUNICATIONS
CAPABILITIES.
``(a) In General.--The Secretary shall provide coordination
and assistance to poison control centers for--
``(1) the development, establishment, implementation, and
maintenance of a nationwide toll-free phone number; and
``(2) the enhancement of communications capabilities, which
may include text capabilities.
``(b) Consultation.--The Secretary may consult with
nationally recognized professional organizations in the field
of poison control to determine the best and most effective
means of
[[Page H5549]]
achieving the goals described in paragraphs (1) and (2) of
subsection (a).
``(c) Rule of Construction.--In assisting with public
health emergencies, responses, or preparedness, nothing in
this section shall be construed to restrict the work of
poison control centers or the use of their resources by the
Secretary or other governmental agencies.
``(d) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $700,000 for
each of fiscal years 2019 through 2023.''.
SEC. 7143. REAUTHORIZATION OF NATIONWIDE PUBLIC AWARENESS
CAMPAIGN TO PROMOTE POISON CONTROL CENTER
UTILIZATION.
Section 1272 of the Public Health Service Act (42 U.S.C.
300d-72) is amended to read as follows:
``SEC. 1272. NATIONWIDE PUBLIC AWARENESS CAMPAIGN TO PROMOTE
POISON CONTROL CENTER UTILIZATION AND THEIR
PUBLIC HEALTH EMERGENCY RESPONSE CAPABILITIES.
``(a) In General.--The Secretary shall--
``(1) carry out, and expand upon, a national public
awareness campaign to educate the public and health care
providers about--
``(A) poisoning, toxic exposure, and drug misuse
prevention; and
``(B) the availability of poison control center resources
in local communities; and
``(2) as part of such campaign, highlight the nationwide
toll-free number and enhanced communications capabilities
supported under section 1271.
``(b) Consultation.--In carrying out and expanding upon the
national campaign under subsection (a), the Secretary may
consult with nationally recognized professional organizations
in the field of poison control response for the purpose of
determining the best and most effective methods for achieving
public awareness.
``(c) Contract With Entity.--The Secretary may carry out
subsection (a) by entering into contracts with one or more
public or private entities, including nationally recognized
professional organizations in the field of poison control and
national media firms, for the development and implementation
of the awareness campaign under subsection (a), which may
include--
``(1) the development and distribution of poisoning and
toxic exposure prevention, poison control center, and public
health emergency awareness and response materials;
``(2) television, radio, internet, and newspaper public
service announcements; and
``(3) other means and activities to provide for public and
professional awareness and education.
``(d) Evaluation.--The Secretary shall--
``(1) establish baseline measures and benchmarks to
quantitatively evaluate the impact of the nationwide public
awareness campaign carried out under this section; and
``(2) on a biennial basis, prepare and submit to the
appropriate committees of Congress an evaluation of the
nationwide public awareness campaign.
``(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $800,000 for
each of fiscal years 2019 through 2023.''.
SEC. 7144. REAUTHORIZATION OF THE POISON CONTROL CENTER GRANT
PROGRAM.
Section 1273 of the Public Health Service Act (42 U.S.C.
300d-73) is amended to read as follows:
``SEC. 1273. MAINTENANCE OF THE POISON CONTROL CENTER GRANT
PROGRAM.
``(a) Authorization of Program.--The Secretary shall award
grants to poison control centers accredited under subsection
(c) (or granted a waiver under subsection (d)) and nationally
recognized professional organizations in the field of poison
control for the purposes of--
``(1) preventing, and providing treatment recommendations
for, poisonings and toxic exposures including opioid and drug
misuse;
``(2) assisting with public health emergencies, responses,
and preparedness; and
``(3) complying with the operational requirements needed to
sustain the accreditation of the center under subsection (c).
``(b) Additional Uses of Funds.--In addition to the
purposes described in subsection (a), a poison center or
professional organization awarded a grant under such
subsection may also use amounts received under such grant--
``(1) to research, establish, implement, and evaluate best
practices in the United States for poisoning prevention,
poison control center outreach, opioid and drug misuse
information and response, and public health emergency,
response, and preparedness programs;
``(2) to research, develop, implement, revise, and
communicate standard patient management guidelines for
commonly encountered toxic exposures;
``(3) to improve national toxic exposure and opioid misuse
surveillance by enhancing cooperative activities between
poison control centers in the United States and the Centers
for Disease Control and Prevention and other governmental
agencies;
``(4) to research, improve, and enhance the communications
and response capability and capacity of the Nation's network
of poison control centers to facilitate increased access to
the centers through the integration and modernization of the
current poison control centers communications and data
system, including enhancing the network's telephony,
internet, data, and social networking technologies;
``(5) to develop, support, and enhance technology and
capabilities of nationally recognized professional
organizations in the field of poison control to collect
national poisoning, toxic occurrence, and related public
health data;
``(6) to develop initiatives to foster the enhanced public
health utilization of national poison data collected by such
organizations;
``(7) to support and expand the toxicologic expertise
within poison control centers; and
``(8) to improve the capacity of poison control centers to
answer high volumes of contacts and internet communications,
and to sustain and enhance the poison control center's
network capability to respond during times of national crisis
or other public health emergencies.
``(c) Accreditation.--Except as provided in subsection (d),
the Secretary may award a grant to a poison control center
under subsection (a) only if--
``(1) the center has been accredited by a nationally
recognized professional organization in the field of poison
control, and the Secretary has approved the organization as
having in effect standards for accreditation that reasonably
provide for the protection of the public health with respect
to poisoning; or
``(2) the center has been accredited by a State government,
and the Secretary has approved the State government as having
in effect standards for accreditation that reasonably provide
for the protection of the public health with respect to
poisoning.
``(d) Waiver of Accreditation Requirements.--
``(1) In general.--The Secretary may grant a waiver of the
accreditation requirements of subsection (c) with respect to
a nonaccredited poison control center that applies for a
grant under this section if such center can reasonably
demonstrate that the center will obtain such an accreditation
within a reasonable period of time as determined appropriate
by the Secretary.
``(2) Renewal.--The Secretary may renew a waiver under
paragraph (1).
``(3) Limitation.--The Secretary may not, after the date of
enactment of the Poison Control Network Enhancement Act of
2018, grant to a poison control center waivers or renewals
that total more than 5 years.
``(e) Supplement Not Supplant.--Amounts made available to a
poison control center under this section shall be used to
supplement and not supplant other Federal, State, or local
funds provided for such center.
``(f) Maintenance of Effort.--A poison control center, in
utilizing the proceeds of a grant under this section, shall
maintain the annual recurring expenditures of the center for
its activities at a level that is not less than 80 percent of
the average level of such recurring expenditures maintained
by the center for the preceding 3 fiscal years for which a
grant is received.
``(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $28,600,000 for
each of fiscal years 2019 through 2023. The Secretary may
utilize an amount not to exceed 6 percent of the amount
appropriated pursuant to the preceding sentence for each
fiscal year for coordination, dissemination, technical
assistance, program evaluation, data activities, and other
program administration functions, which are determined by the
Secretary to be appropriate for carrying out the program
under this section.''.
Subtitle P--Eliminating Opioid Related Infectious Diseases
SEC. 7151. SHORT TITLE.
This subtitle may be cited as the ``Eliminating Opioid
Related Infectious Diseases Act of 2018''.
SEC. 7152. REAUTHORIZATION AND EXPANSION OF PROGRAM OF
SURVEILLANCE AND EDUCATION REGARDING INFECTIONS
ASSOCIATED WITH ILLICIT DRUG USE AND OTHER RISK
FACTORS.
Section 317N of the Public Health Service Act (42 U.S.C.
247b-15) is amended to read as follows:
``SEC. 317N. SURVEILLANCE AND EDUCATION REGARDING INFECTIONS
ASSOCIATED WITH ILLICIT DRUG USE AND OTHER RISK
FACTORS.
``(a) In General.--The Secretary may (directly and through
grants to public and nonprofit private entities) provide for
programs for the following:
``(1) To cooperate with the States and Indian tribes in
implementing or maintaining a surveillance system to
determine the incidence of infections commonly associated
with illicit drug use, including infections commonly
associated with injection drug use such as viral hepatitis,
human immunodeficiency virus, and infective endocarditis, and
to assist the States in determining the prevalence of such
infections, which may include the reporting of cases of such
infections.
``(2) To identify, counsel, and offer testing to
individuals who are at risk of infections as a result of
injection drug use, receiving blood transfusions prior to
July 1992, or other risk factors.
``(3) To provide appropriate referrals for counseling,
testing, and medical treatment of individuals identified
under paragraph (2) and to ensure, to the extent practicable,
the provision of appropriate follow-up services.
``(4) To develop and disseminate public information and
education programs for the detection and control of
infections described in paragraph (1), with priority given to
high-risk populations as determined by the Secretary.
``(5) To improve the education, training, and skills of
health professionals in the detection and control of
infections and the coordination of treatment of addiction and
infectious diseases described in paragraph (1), with priority
given to substance use disorder treatment providers,
pediatricians and other primary care providers, obstetrician-
gynecologists, infectious diseases clinicians, and HIV
clinicians.
``(b) Laboratory Procedures.--The Secretary may (directly
or through grants to public and nonprofit private entities)
carry out programs to provide for improvements in the quality
of clinical-laboratory procedures regarding infections
described in subsection (a)(1).
``(c) Definitions.--In this section:
``(1) The term `Indian tribe' has the meaning given that
term in section 4 of the Indian Self-Determination and
Education Assistance Act.
[[Page H5550]]
``(2) The term `injection drug use' means--
``(A) intravenous administration of a substance in schedule
I under section 202 of the Controlled Substances Act;
``(B) intravenous administration of a substance in schedule
II, III, IV, or V under section 202 of the Controlled
Substances Act that has not been approved for intravenous use
under--
``(i) section 505 of the Federal Food, Drug and Cosmetic
Act; or
``(ii) section 351 of the Public Health Service Act; or
``(C) intravenous administration of a substance in schedule
II, III, IV, or V under section 202 of the Controlled
Substances Act that has not been prescribed to the person
using the substance.
``(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $40,000,000 for each of the fiscal years 2019
through 2023.''.
Subtitle Q--Better Pain Management Through Better Data
SEC. 7161. SHORT TITLE.
This subtitle may be cited as the ``Better Pain Management
Through Better Data Act of 2018''.
SEC. 7162. GUIDANCE ADDRESSING ALTERNATIVE APPROACHES TO DATA
COLLECTION AND LABELING CLAIMS FOR OPIOID
SPARING.
(a) In General.--For purposes of assisting sponsors in
collecting and incorporating opioid-sparing data in product
labeling, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
conduct a public meeting and update or issue one or more
guidances in accordance with subsection (b).
(b) Guidance.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall update or issue one or more guidances addressing--
(A) alternative methods for data collection on opioid
sparing;
(B) alternative methods for inclusion of such data in
product labeling; and
(C) investigations other than clinical trials, including
partially controlled studies and objective trials without
matched controls such as historically controlled analyses,
open-label studies, and meta-analyses, on opioid sparing for
inclusion in product labeling.
(2) Contents.--The guidances under paragraph (1) shall
address--
(A) innovative clinical trial designs for ethically and
efficiently collecting data on opioid sparing for inclusion
in product labeling;
(B) primary and secondary endpoints for the reduction of
opioid use while maintaining adequate pain control;
(C) use of real world evidence, including patient
registries, and patient reported outcomes to support
inclusion of opioid-sparing data in product labeling; and
(D) how sponsors may obtain feedback from the Secretary
relating to such issues prior to--
(i) commencement of such data collection; or
(ii) the submission of resulting data to the Secretary.
(3) Public meeting.--Prior to updating or issuing the
guidances required by paragraph (1), the Secretary shall
consult with stakeholders, including representatives of
regulated industry, academia, patients, and provider
organizations, through a public meeting to be held not later
than 12 months after the date of enactment of this Act.
(4) Timing.--The Secretary shall--
(A) not later than 12 months after the date of the public
meeting required by paragraph (3), update or issue the one or
more draft guidances required by paragraph (1); and
(B) not later than 12 months after the date on which the
public comment period for such draft guidances closes,
finalize such guidances.
(c) Definition.--In this section:
(1) The terms ``opioid sparing'' and ``opioid-sparing''
refer to the use of drugs or devices (as defined in section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321)) that reduce pain while enabling the reduction,
replacement, or avoidance of oral opioids.
(2) The term ``Secretary'' means the Secretary of Health
and Human Services.
Subtitle R--Special Registration for Telemedicine Clarification
SEC. 7171. SHORT TITLE.
This subtitle may be cited as the ``Special Registration
for Telemedicine Clarification Act of 2018''.
SEC. 7172. DEADLINE FOR INTERIM FINAL REGULATIONS FOR A
SPECIAL REGISTRATION TO ENGAGE IN THE PRACTICE
OF TELEMEDICINE.
Section 311(h)(2) of the Controlled Substances Act (21
U.S.C. 831(h)(2)) is amended by striking ``The Attorney
General shall, with the concurrence of the Secretary,
promulgate regulations'' and inserting ``Not later than 1
year after the date of enactment of the Special Registration
for Telemedicine Clarification Act of 2018, the Attorney
General shall, with the concurrence of the Secretary,
promulgate interim final regulations''.
Subtitle S--Peer Support Communities of Recovery
SEC. 7181. SHORT TITLE.
This subtitle may be cited as the ``Peer Support
Communities of Recovery Act''.
SEC. 7182. BUILDING COMMUNITIES OF RECOVERY.
Section 547 of the Public Health Service Act (42 U.S.C.
290ee-2) is amended--
(1) in subsection (a)--
(A) in the heading, by striking ``Definition'' and
inserting ``Definitions'';
(B) in the matter preceding paragraph (1), by striking ``In
this section, the term `recovery community organization'
means an independent nonprofit organization that--'' and
inserting ``In this section:'';
(C) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively, and moving such
subparagraphs (as so redesignated) 2 ems to the right;
(D) by inserting before subparagraph (A) (as so
redesignated) the following:
``(1) Recovery community organization.--The term `recovery
community organization' means an independent nonprofit
organization that--''; and
(E) by adding at the end the following:
``(2) Eligible entity.--The term `eligible entity' means--
``(A) a national nonprofit entity focused on substance use
disorder with a network of local affiliates and partners that
are geographically and organizationally diverse; or
``(B) a nonprofit organization--
``(i) focused on substance use disorder;
``(ii) established by individuals in personal or family
recovery; and
``(iii) serving prevention, treatment, recovery, payor,
faith-based, and criminal justice stakeholders in the
implementation of local addiction and recovery
initiatives.'';
(2) in subsection (b)--
(A) by striking ``The Secretary shall award grants to
recovery community organizations'' and inserting ``The
Secretary--
``(1) shall award grants to recovery community
organizations'';
(B) by striking ``services.'' and inserting ``services and
allow such organizations to use such grant funds to carry out
the activities described in subparagraphs (A) through (C) of
subsection (c)(2); and''; and
(C) by adding at the end the following:
``(2) may award grants to eligible entities for purposes of
establishing regional technical assistance centers, in
accordance with subsection (c)(2)(D).'';
(3) by striking subsection (c);
(4) by redesignating subsections (d) and (e) as subsections
(c) and (d), respectively;
(5) in subsection (c) (as so redesignated)--
(A) in paragraph (1), by striking ``shall be used'' and
inserting ``to a recovery community organization shall be
used'';
(B) in paragraph (2)--
(i) in subparagraph (A), in the matter preceding clause
(i), by inserting before ``build'' the following: ``in the
case of a grant awarded to a recovery community
organization,'';
(ii) in subparagraph (B)--
(I) by inserting before ``reduce'' the following: ``in the
case of a grant awarded to a recovery community
organization,''; and
(II) by striking ``and'' at the end;
(iii) in subparagraph (C)--
(I) by inserting before ``conduct'' the following: ``in the
case of a grant awarded to a recovery community
organization,''; and
(II) by striking the period at the end and inserting ``;
and''; and
(iv) by adding at the end the following:
``(D) in the case of a grant awarded to an eligible entity,
provide for the establishment of regional technical
assistance centers to provide regional technical assistance
for the following:
``(i) Implementation of regionally driven, peer-delivered
addiction recovery support services before, during, after, or
in conjunction with addiction treatment.
``(ii) Establishment of recovery community organizations.
``(iii) Establishment of recovery community centers.''; and
(6) in subsection (d) (as so redesignated), by inserting
before the period the following: ``, and $15,000,000 for each
of fiscal years 2019 through 2023''.
Subtitle T--Stop Illicit Drug Importation
SEC. 7191. SHORT TITLE.
This short title may be cited as the ``Stop Illicit Drug
Importation Act of 2018''.
SEC. 7192. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS
OFFERED FOR IMPORTATION.
(a) Articles Treated as Drugs for Purposes of
Importation.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end
the following:
``(t) Articles Treated as Drugs for Purposes of This
Section.--
``(1) Labeled articles.--An article shall not be treated as
a drug pursuant to this subsection if--
``(A) an electronic import entry for such article is
submitted using an authorized electronic data interchange
system; and
``(B) such article is designated in such system as a drug,
device, dietary supplement, or other product that is
regulated under this Act.
``(2) Articles covered.--Subject to paragraph (1), for
purposes of this section, an article described in this
paragraph may be treated by the Secretary as a drug if it--
``(A) is or contains an ingredient that is an active
ingredient that is contained within--
``(i) a drug that has been approved under section 505 of
this Act; or
``(ii) a biological product that has been approved under
section 351 of the Public Health Service Act;
``(B) is or contains an ingredient that is an active
ingredient in a drug or biological product if--
``(i) an investigational use exemption has been authorized
for such drug or biological product under section 505(i) of
this Act or section 351(a) of the Public Health Service Act;
``(ii) substantial clinical investigation has been
instituted for such drug or biological product; and
``(iii) the existence of such clinical investigation has
been made public; or
``(C) is or contains a substance that has a chemical
structure that is substantially similar
[[Page H5551]]
to the chemical structure of an active ingredient in a drug
or biological product described in subparagraph (A) or (B).
``(3) Effect.--Except to the extent that an article may be
treated as a drug pursuant to paragraph (2), this subsection
shall not be construed as bearing on or being relevant to the
question of whether any article is a drug as defined in
section 201(g).''.
(b) Articles of Concern.--
(1) Delivery by treasury to hhs.--The first sentence of
section 801(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381(a)) is amended by striking ``and cosmetics''
and inserting ``cosmetics, and potential articles of concern
(as defined in subsection (u))''.
(2) Refused admission.--The third sentence of section
801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(a)) is amended by striking ``then such article shall be
refused admission'' and inserting ``or (5) such article is an
article of concern (as defined in subsection (u)), or (6)
such article is a drug that is being imported or offered for
import in violation of section 301(cc), then such article
shall be refused admission''.
(3) Definition of article of concern.--Section 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as
amended, is further amended by adding at the end the
following:
``(u) Article of Concern Defined.--For purposes of
subsection (a), the term `article of concern' means an
article that is or contains a drug or other substance--
``(1) for which, during the 24-month period prior to the
article being imported or offered for import, the Secretary
of Health and Human Services--
``(A) has requested that, based on a determination that the
drug or other substance appears to meet the requirements for
temporary or permanent scheduling pursuant to section 201 of
the Controlled Substances Act, the Attorney General initiate
the process to control the drug or other substance in
accordance with such Act; or
``(B) has, following the publication by the Attorney
General of a notice in the Federal Register of the intention
to issue an order temporarily scheduling such drug or
substance in schedule I of section 202 of the Controlled
Substances Act pursuant to section 201(h) of such Act, made a
determination that such article presents an imminent hazard
to public safety; and
``(2) with respect to which the Attorney General has not--
``(A) scheduled the drug or other substance under such Act;
or
``(B) notified the Secretary of Health and Human Services
that the Attorney General has made a determination not to
schedule the drug or other substance under such Act.''.
SEC. 7193. SEIZURE.
Section 304(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 334(b)) is amended by striking the first sentence
and inserting the following: ``The article, equipment, or
other thing proceeded against shall be liable to seizure by
process pursuant to the libel, and the procedure in cases
under this section shall conform, as nearly as may be, to the
procedure in admiralty rather than the procedure used for
civil asset forfeiture proceedings set forth in section 983
of title 18, United States Code. On demand of either party
any issue of fact joined in any such a case brought under
this section shall be tried by jury. A seizure brought under
this section is not governed by Rule G of the Supplemental
Rules of Admiralty or Maritime Claims and Asset Forfeiture
Actions. Exigent circumstances shall be deemed to exist for
all seizures brought under this section, and in such cases,
the summons and arrest warrant shall be issued by the clerk
of the court without court review.''.
SEC. 7194. DEBARRING VIOLATIVE INDIVIDUALS OR COMPANIES.
(a) Prohibited Act.--Section 301(cc) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended--
(1) by inserting after ``an article of food'' the
following: ``or a drug''; and
(2) by inserting after ``a person debarred'' the following:
``from such activity''.
(b) Debarment.--Section 306(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(b)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by striking
``paragraph (2)'' and inserting ``paragraph (2) or (3)'';
(B) in subparagraph (B), by striking ``or'' at the end;
(C) in subparagraph (C), by striking the period at the end
and inserting ``, or''; and
(D) by adding at the end the following:
``(D) a person from importing or offering to import into
the United States--
``(i) a controlled substance as defined in section 102(6)
of the Controlled Substances Act; or
``(ii) any drug, if such drug is declared to be valued at
an amount that is $2,500 or less (or such higher amount as
the Secretary of the Treasury may set by regulation pursuant
to section 498(a)(1) of the Tariff Act of 1930), or if such
drug is entering the United States by mail.''; and
(2) in paragraph (3)--
(A) in the paragraph heading after ``food'' by inserting
``or drug'';
(B) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively, and moving the indentation of
each such clause 2 ems to the right;
(C) after making the amendments required by subparagraph
(B), by striking ``A person is subject'' and inserting the
following:
``(A) Food.--A person is subject''; and
(D) by adding at the end the following:
``(B) Importation of drugs.--A person is subject to
debarment under paragraph (1)(D) if--
``(i) the person has been convicted of a felony for conduct
relating to the importation into the United States of any
drug or controlled substance (as defined in section 102 of
the Controlled Substances Act); or
``(ii) the person has engaged in a pattern of importing or
offering for import articles of drug that are--
``(I)(aa) adulterated, misbranded, or in violation of
section 505; and
``(bb) present a threat of serious adverse health
consequences or death to humans or animals; or
``(II) controlled substances whose importation is
prohibited pursuant to section 401(m) of the Tariff Act of
1930.
``(C) Definition.--For purposes of subparagraph (B), the
term `pattern of importing or offering for import articles of
drug' means importing or offering for import articles of drug
described in subclause (I) or (II) of subparagraph (B)(ii) in
an amount, frequency, or dosage that is inconsistent with
personal or household use by the importer.''.
Subtitle U--Creating Opportunities That Necessitate New and Enhanced
Connections That Improve Opioid Navigation Strategies
SEC. 7201. SHORT TITLE.
This subtitle may be cited as the ``Creating Opportunities
that Necessitate New and Enhanced Connections That Improve
Opioid Navigation Strategies Act of 2018'' or the
``CONNECTIONS Act''.
SEC. 7202. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
Part P of title III of the Public Health Service Act (42
U.S.C. 280g et seq.) is amended by adding at the end the
following new section:
``SEC. 399V-7. PREVENTING OVERDOSES OF CONTROLLED SUBSTANCES.
``(a) Evidence-Based Prevention Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out any evidence-
based prevention activity described in paragraph (2);
``(B) provide training and technical assistance to States,
localities, and Indian tribes for purposes of carrying out
any such activity; and
``(C) award grants to States, localities, and Indian tribes
for purposes of carrying out any such activity.
``(2) Evidence-based prevention activities.--An evidence-
based prevention activity described in this paragraph is any
of the following activities:
``(A) With respect to a State, improving the efficiency and
use of the State prescription drug monitoring program by--
``(i) encouraging all authorized users (as specified by the
State) to register with and use the program and making the
program easier to use;
``(ii) enabling such users to access any updates to
information collected by the program in as close to real-time
as possible;
``(iii) providing for a mechanism for the program to
automatically flag any potential misuse or abuse of
controlled substances and any detection of inappropriate
prescribing practices relating to such substances;
``(iv) enhancing interoperability between the program and
any electronic health records system, including by
integrating the use of electronic health records into the
program for purposes of improving clinical decisionmaking;
``(v) continually updating program capabilities to respond
to technological innovation for purposes of appropriately
addressing a controlled substance overdose epidemic as such
epidemic may occur and evolve;
``(vi) facilitating data sharing between the program and
the prescription drug monitoring programs of neighboring
States; and
``(vii) meeting the purpose of the program established
under section 399O, as described in section 399O(a).
``(B) Achieving community or health system interventions
through activities such as--
``(i) establishing or improving controlled substances
prescribing interventions for insurers and health systems;
``(ii) enhancing the use of evidence-based controlled
substances prescribing guidelines across sectors and health
care settings; and
``(iii) implementing strategies to align the prescription
of controlled substances with the guidelines described in
clause (ii).
``(C) Evaluating interventions to better understand what
works to prevent overdoses, including those involving
prescription and illicit controlled substances.
``(D) Implementing projects to advance an innovative
prevention approach with respect to new and emerging public
health crises and opportunities to address such crises, such
as enhancing public education and awareness on the risks
associated with opioids.
``(b) Enhanced Surveillance of Controlled Substance
Overdose Grants.--
``(1) In general.--The Director of the Centers for Disease
Control and Prevention may--
``(A) to the extent practicable, carry out any controlled
substance overdose surveillance activity described in
paragraph (2);
``(B) provide training and technical assistance to States
for purposes of carrying out any such activity;
``(C) award grants to States for purposes of carrying out
any such activity; and
``(D) coordinate with the Assistant Secretary for Mental
Health and Substance Use to collect data pursuant to section
505(d)(1)(A) (relating to the number of individuals admitted
to the emergency rooms of hospitals as a result of the abuse
of alcohol or other drugs).
``(2) Controlled substance overdose surveillance
activities.--A controlled substance overdose surveillance
activity described in this paragraph is any of the following
activities:
``(A) Enhancing the timeliness of reporting data to the
public, including data on fatal and nonfatal overdoses of
controlled substances.
``(B) Enhancing comprehensiveness of data on controlled
substances overdoses by collecting information on such
overdoses from appropriate
[[Page H5552]]
sources such as toxicology reports, autopsy reports, death
scene investigations, and other risk factors.
``(C) Using data to help identify risk factors associated
with controlled substances overdoses.
``(D) With respect to a State, supporting entities involved
in providing information to inform efforts within the State,
such as by coroners and medical examiners, to improve
accurate testing and reporting of causes and contributing
factors to controlled substances overdoses.
``(E) Working to enable information sharing regarding
controlled substances overdoses among data sources.
``(c) Definitions.--In this section:
``(1) Controlled substance.--The term `controlled
substance' has the meaning given that term in section 102 of
the Controlled Substances Act.
``(2) Indian tribe.--The term `Indian tribe' has the
meaning given that term in section 4 of the Indian Self-
Determination and Education Assistance Act.
``(d) Authorization of Appropriations.--For purposes of
carrying out this section and section 399O, there is
authorized to be appropriated $486,000,000 for each of fiscal
years 2019 through 2023.''.
SEC. 7203. PRESCRIPTION DRUG MONITORING PROGRAM.
Section 399O of the Public Health Service Act (42 U.S.C.
280g-3) is amended to read as follows:
``SEC. 399O. PRESCRIPTION DRUG MONITORING PROGRAM.
``(a) Program.--
``(1) In general.--Each fiscal year, the Secretary, in
consultation with the Director of National Drug Control
Policy, acting through the Director of the Centers for
Disease Control and Prevention, the Assistant Secretary for
Mental Health and Substance Use, and the National Coordinator
for Health Information Technology, shall support States for
the purpose of improving the efficiency and use of PDMPs,
including--
``(A) establishment and implementation of a PDMP;
``(B) maintenance of a PDMP;
``(C) improvements to a PDMP by--
``(i) enhancing functional components to work toward--
``(I) universal use of PDMPs among providers and their
delegates, to the extent that State laws allow, within a
State;
``(II) more timely inclusion of data within a PDMP;
``(III) active management of the PDMP, in part by sending
proactive or unsolicited reports to providers to inform
prescribing; and
``(IV) ensuring the highest level of ease in use and access
of PDMPs by providers and their delegates, to the extent that
State laws allow;
``(ii) improving the intrastate interoperability of PDMPs
by--
``(I) making PDMPs more actionable by integrating PDMPs
within electronic health records and health information
technology infrastructure; and
``(II) linking PDMP data to other data systems within the
State, including--
``(aa) the data of pharmacy benefit managers, medical
examiners and coroners, and the State's Medicaid program;
``(bb) worker's compensation data; and
``(cc) prescribing data of providers of the Department of
Veterans Affairs and the Indian Health Service within the
State;
``(iii) improving the interstate interoperability of PDMPs
through--
``(I) sharing of dispensing data in near-real time across
State lines; and
``(II) integration of automated queries for multistate PDMP
data and analytics into clinical workflow to improve the use
of such data and analytics by practitioners and dispensers;
or
``(iv) improving the ability to include treatment
availability resources and referral capabilities within the
PDMP.
``(2) State legislation.--As a condition on the receipt of
support under this section, the Secretary shall require a
State to demonstrate that the State has enacted legislation
or regulations--
``(A) to provide for the implementation of the PDMP; and
``(B) to permit the imposition of appropriate penalties for
the unauthorized use and disclosure of information maintained
by the PDMP.
``(b) PDMP Strategies.--The Secretary shall encourage a
State, in establishing, improving, or maintaining a PDMP, to
implement strategies that improve--
``(1) the reporting of dispensing in the State of a
controlled substance to an ultimate user so the reporting
occurs not later than 24 hours after the dispensing event;
``(2) the consultation of the PDMP by each prescribing
practitioner, or their designee, in the State before
initiating treatment with a controlled substance, or any
substance as required by the State to be reported to the
PDMP, and over the course of ongoing treatment for each
prescribing event;
``(3) the consultation of the PDMP before dispensing a
controlled substance, or any substance as required by the
State to be reported to the PDMP;
``(4) the proactive notification to a practitioner when
patterns indicative of controlled substance misuse by a
patient, including opioid misuse, are detected;
``(5) the availability of data in the PDMP to other States,
as allowable under State law; and
``(6) the availability of nonidentifiable information to
the Centers for Disease Control and Prevention for
surveillance, epidemiology, statistical research, or
educational purposes.
``(c) Drug Misuse and Abuse.--In consultation with
practitioners, dispensers, and other relevant and interested
stakeholders, a State receiving support under this section--
``(1) shall establish a program to notify practitioners and
dispensers of information that will help to identify and
prevent the unlawful diversion or misuse of controlled
substances; and
``(2) may, to the extent permitted under State law, notify
the appropriate authorities responsible for carrying out drug
diversion investigations if the State determines that
information in the PDMP maintained by the State indicates an
unlawful diversion or abuse of a controlled substance.
``(d) Evaluation and Reporting.--As a condition on receipt
of support under this section, the State shall report on
interoperability with PDMPs of other States and Federal
agencies, where appropriate, intrastate interoperability with
health information technology systems such as electronic
health records, health information exchanges, and e-
prescribing, where appropriate, and whether or not the State
provides automatic, up-to-date, or daily information about a
patient when a practitioner (or the designee of a
practitioner, where permitted) requests information about
such patient.
``(e) Evaluation and Reporting.--A State receiving support
under this section shall provide the Secretary with aggregate
nonidentifiable information, as permitted by State law, to
enable the Secretary--
``(1) to evaluate the success of the State's program in
achieving the purpose described in subsection (a); or
``(2) to prepare and submit to the Congress the report
required by subsection (i)(2).
``(f) Education and Access to the Monitoring System.--A
State receiving support under this section shall take steps
to--
``(1) facilitate prescribers and dispensers, and their
delegates, as permitted by State law, to use the PDMP, to the
extent practicable; and
``(2) educate prescribers and dispensers, and their
delegates on the benefits of the use of PDMPs.
``(g) Electronic Format.--The Secretary may issue
guidelines specifying a uniform electronic format for the
reporting, sharing, and disclosure of information pursuant to
PDMPs.
``(h) Rules of Construction.--
``(1) Functions otherwise authorized by law.--Nothing in
this section shall be construed to restrict the ability of
any authority, including any local, State, or Federal law
enforcement, narcotics control, licensure, disciplinary, or
program authority, to perform functions otherwise authorized
by law.
``(2) Additional privacy protections.--Nothing in this
section shall be construed as preempting any State from
imposing any additional privacy protections.
``(3) Federal privacy requirements.--Nothing in this
section shall be construed to supersede any Federal privacy
or confidentiality requirement, including the regulations
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law 104-
191; 110 Stat. 2033) and section 543 of this Act.
``(4) No federal private cause of action.--Nothing in this
section shall be construed to create a Federal private cause
of action.
``(i) Progress Report.--Not later than 3 years after the
date of enactment of the CONNECTIONS Act, the Secretary
shall--
``(1) complete a study that--
``(A) determines the progress of States in establishing and
implementing PDMPs consistent with this section;
``(B) provides an analysis of the extent to which the
operation of PDMPs has--
``(i) reduced inappropriate use, abuse, diversion of, and
overdose with, controlled substances;
``(ii) established or strengthened initiatives to ensure
linkages to substance use disorder treatment services; or
``(iii) affected patient access to appropriate care in
States operating PDMPs;
``(C) determine the progress of States in achieving
interstate interoperability and intrastate interoperability
of PDMPs, including an assessment of technical, legal, and
financial barriers to such progress and recommendations for
addressing these barriers;
``(D) determines the progress of States in implementing
near real-time electronic PDMPs;
``(E) provides an analysis of the privacy protections in
place for the information reported to the PDMP in each State
receiving support under this section and any recommendations
of the Secretary for additional Federal or State requirements
for protection of this information;
``(F) determines the progress of States in implementing
technological alternatives to centralized data storage, such
as peer-to-peer file sharing or data pointer systems, in
PDMPs and the potential for such alternatives to enhance the
privacy and security of individually identifiable data; and
``(G) evaluates the penalties that States have enacted for
the unauthorized use and disclosure of information maintained
in PDMPs, and the criteria used by the Secretary to determine
whether such penalties qualify as appropriate for purposes of
subsection (a)(2); and
``(2) submit a report to the Congress on the results of the
study.
``(j) Advisory Council.--
``(1) Establishment.--A State may establish an advisory
council to assist in the establishment, improvement, or
maintenance of a PDMP consistent with this section.
``(2) Limitation.--A State may not use Federal funds for
the operations of an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP.
``(3) Sense of congress.--It is the sense of the Congress
that, in establishing an advisory council to assist in the
establishment, improvement, or maintenance of a PDMP, a State
should consult with appropriate professional boards and other
interested parties.
``(k) Definitions.--For purposes of this section:
[[Page H5553]]
``(1) The term `controlled substance' means a controlled
substance (as defined in section 102 of the Controlled
Substances Act) in schedule II, III, or IV of section 202 of
such Act.
``(2) The term `dispense' means to deliver a controlled
substance to an ultimate user by, or pursuant to the lawful
order of, a practitioner, irrespective of whether the
dispenser uses the internet or other means to effect such
delivery.
``(3) The term `dispenser' means a physician, pharmacist,
or other person that dispenses a controlled substance to an
ultimate user.
``(4) The term `interstate interoperability' with respect
to a PDMP means the ability of the PDMP to electronically
share reported information with another State if the
information concerns either the dispensing of a controlled
substance to an ultimate user who resides in such other
State, or the dispensing of a controlled substance prescribed
by a practitioner whose principal place of business is
located in such other State.
``(5) The term `intrastate interoperability' with respect
to a PDMP means the integration of PDMP data within
electronic health records and health information technology
infrastructure or linking of a PDMP to other data systems
within the State, including the State's Medicaid program,
workers' compensation programs, and medical examiners or
coroners.
``(6) The term `nonidentifiable information' means
information that does not identify a practitioner, dispenser,
or an ultimate user and with respect to which there is no
reasonable basis to believe that the information can be used
to identify a practitioner, dispenser, or an ultimate user.
``(7) The term `PDMP' means a prescription drug monitoring
program that is State-controlled.
``(8) The term `practitioner' means a physician, dentist,
veterinarian, scientific investigator, pharmacy, hospital, or
other person licensed, registered, or otherwise permitted, by
the United States or the jurisdiction in which the individual
practices or does research, to distribute, dispense, conduct
research with respect to, administer, or use in teaching or
chemical analysis, a controlled substance in the course of
professional practice or research.
``(9) The term `State' means each of the 50 States, the
District of Columbia, and any commonwealth or territory of
the United States.
``(10) The term `ultimate user' means a person who has
obtained from a dispenser, and who possesses, a controlled
substance for the person's own use, for the use of a member
of the person's household, or for the use of an animal owned
by the person or by a member of the person's household.
``(11) The term `clinical workflow' means the integration
of automated queries for prescription drug monitoring
programs data and analytics into health information
technologies such as electronic health record systems, health
information exchanges, and/or pharmacy dispensing software
systems, thus streamlining provider access through automated
queries.''.
Subtitle V--Securing Opioids and Unused Narcotics With Deliberate
Disposal and Packaging
SEC. 7211. SHORT TITLE.
This subtitle may be cited as the ``Securing Opioids and
Unused Narcotics with Deliberate Disposal and Packaging Act
of 2018'' or the ``SOUND Disposal and Packaging Act''.
SEC. 7212. IMPROVED TECHNOLOGIES, CONTROLS, OR MEASURES WITH
RESPECT TO THE PACKAGING OR DISPOSAL OF CERTAIN
DRUGS.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act is amended by inserting after section 505-1 (21
U.S.C. 355-1) the following new section:
``SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL
FEATURES.
``(a) Orders.--
``(1) In general.--The Secretary may issue an order
requiring the holder of a covered application to implement or
modify one or more technologies, controls, or measures with
respect to the packaging or disposal of one or more drugs
identified in the covered application, if the Secretary
determines such technologies, controls, or measures to be
appropriate to help mitigate the risk of abuse or misuse of
such drug or drugs, which may include by reducing the
availability of unused drugs.
``(2) Prior consultation.--The Secretary may not issue an
order under paragraph (1) unless the Secretary has consulted
with relevant stakeholders, through a public meeting,
workshop, or otherwise, about matters that are relevant to
the subject of the order.
``(3) Assuring access and minimizing burden.--Technologies,
controls, or measures required under paragraph (1) shall--
``(A) be commensurate with the specific risk of abuse or
misuse of the drug listed in the covered application;
``(B) considering such risk, not be unduly burdensome on
patient access to the drug, considering in particular any
available evidence regarding the expected or demonstrated
public health impact of such technologies, controls, or
measures; and
``(C) reduce the risk of abuse or misuse of such drug.
``(4) Order contents.--An order issued under paragraph (1)
may--
``(A) provide for a range of options for implementing or
modifying the technologies, controls, or measures required to
be implemented by such order; and
``(B) incorporate by reference standards regarding
packaging or disposal set forth in an official compendium,
established by a nationally or internationally recognized
standard development organization, or described on the public
website of the Food and Drug Administration, so long as the
order includes the rationale for incorporation of such
standard.
``(5) Orders applicable to drug class.--When a concern
about the risk of abuse or misuse of a drug relates to a
pharmacological class, the Secretary may, after consultation
with relevant stakeholders, issue an order under paragraph
(1) which applies to the pharmacological class.
``(b) Compliance.--The holder of a covered application
shall--
``(1) submit a supplement containing proposed changes to
the covered application to comply with an order issued under
subsection (a) not later than--
``(A) 180 calendar days after the date on which the order
is issued; or
``(B)(i) such longer time period as specified by the
Secretary in such order; or
``(ii) if a request for an alternative date is submitted by
the holder of such application not later than 60 calendar
days after the date on which such order is issued--
``(I) such requested alternative date if agreed to by the
Secretary; or
``(II) another date as specified by the Secretary; and
``(2) implement the changes approved pursuant to such
supplement not later than the later of--
``(A) 90 calendar days after the date on which the
supplement is approved; or
``(B) the end of such longer period as is--
``(i) determined to be appropriate by the Secretary; or
``(ii) approved by the Secretary pursuant to a request by
the holder of the covered application that explains why such
longer period is needed, including to satisfy any other
applicable Federal statutory or regulatory requirements.
``(c) Alternative Measures.--The holder of the covered
application may propose, and the Secretary shall approve,
technologies, controls, or measures regarding packaging,
storage, or disposal other than those specified in the
applicable order issued under subsection (a), if such
technologies, controls, or measures are supported by data and
information demonstrating that such alternative technologies,
controls, or measures can be expected to mitigate the risk of
abuse or misuse of the drug or drugs involved, including by
reducing the availability of unused drugs, to at least the
same extent as the technologies, controls, or measures
specified in such order.
``(d) Dispute Resolution.--If a dispute arises in
connection with a supplement submitted under subsection (b),
the holder of the covered application may appeal a
determination made with respect to such supplement using
applicable dispute resolution procedures specified by the
Secretary in regulations or guidance.
``(e) Definitions.--In this section--
``(1) the term `covered application' means an application
submitted under subsection (b) or (j) of section 505 for
approval under such section or an application submitted under
section 351 of Public Health Service Act for approval under
such section, with respect to a drug that is or contains an
opioid for which a listing in schedule II or III (on a
temporary or permanent basis) is in effect under section 202
of the Controlled Substances Act; and
``(2) the term `relevant stakeholders' may include
scientific experts within the drug manufacturing industry;
brand and generic drug manufacturers; standard development
organizations; wholesalers and distributors; payers; health
care providers; pharmacists; pharmacies; manufacturers;
poison centers; and representatives of the National Institute
on Drug Abuse, the National Institutes of Health, the Centers
for Disease Control and Prevention, the Centers for Medicare
& Medicaid Services, the Drug Enforcement Agency, the
Consumer Product Safety Commission, individuals who
specialize in treating addiction, and patient and caregiver
groups.''.
(b) Prohibited Acts.--Section 501 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351) is amended by
inserting after paragraph (j) the following:
``(k) If it is a drug approved under a covered application
(as defined in section 505-2(e)), the holder of which does
not meet the requirements of paragraphs (1) and (2) of
subsection (b) of such section.''.
(c) Required Content of an Abbreviated New Drug
Application.--Section 505(j)(2)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is amended--
(1) in clause (vii)(IV), by striking ``and'' at the end;
(2) in clause (viii), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(ix) if the drug is or contains an opioid for which a
listing in schedule II or III (on a temporary or permanent
basis) is in effect under section 202 of the Controlled
Substances Act, information to show that the applicant has
proposed technologies, controls, or measures related to the
packaging or disposal of the drug that provide protections
comparable to those provided by the technologies, controls,
or measures required for the applicable listed drug under
section 505-2, if applicable.''.
(d) Grounds for Refusing To Approve an Abbreviated New Drug
Application.--Section 505(j)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)(4)), is amended--
(1) in subparagraph (J), by striking ``or'' at the end;
(2) in subparagraph (K), by striking the period at the end
and inserting ``; or''; and
(3) by adding at the end the following:
``(L) if the drug is a drug described in paragraph
(2)(A)(ix) and the applicant has not proposed technologies,
controls, or measures related to the packaging or disposal of
such drug that the Secretary determines provide protections
comparable to those provided by the technologies, controls,
or measures required for the applicable listed drug under
section 505-2.''.
[[Page H5554]]
(e) Rules of Construction.--
(1) Any labeling describing technologies, controls, or
measures related to packaging or disposal intended to
mitigate the risk of abuse or misuse of a drug product that
is subject to an abbreviated new drug application, including
labeling describing differences from the reference listed
drug resulting from the application of section 505-2 of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(a), shall not be construed--
(A) as changes to labeling not permissible under clause (v)
of section 505(j)(2)(A) of such Act (21 U.S.C. 355(j)(2)(A)),
or a change in the conditions of use prescribed, recommended,
or suggested in the labeling proposed for the new drug under
clause (i) of such section; or
(B) to preclude approval of an abbreviated new drug
application under subparagraph (B) or (G) of section
505(j)(4) of such Act (21 U.S.C. 355(j)(4)).
(2) For a covered application that is an application
submitted under subsection (j) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355), subsection
(j)(2)(A) of such section 505 shall not be construed to limit
the type of data or information the Secretary of Health and
Human Services may request or consider in connection with
making any determination under section 505-2.
(f) GAO Report.--Not later than 12 months after the date of
enactment of this Act, the Comptroller General of the United
States shall prepare and submit to the Congress a report
containing--
(1) a description of available evidence, if any, on the
effectiveness of site-of-use, in-home controlled substance
disposal products and packaging technologies;
(2) identification of ways in which such disposal products
intended for use by patients, consumers, and other end users
that are not registrants under the Controlled Substances Act,
are made available to the public and barriers to the use of
such disposal products;
(3) identification of ways in which packaging technologies
are made available to the public and barriers to the use of
such technologies;
(4) a description of Federal oversight, if any, of site-of-
use, in-home controlled substance disposal products,
including--
(A) identification of the Federal agencies that oversee
such products;
(B) identification of the methods of disposal of controlled
substances recommended by these agencies for site-of-use, in-
home disposal; and
(C) a description of the effectiveness of such
recommendations at preventing the diversion of legally
prescribed controlled substances;
(5) a description of Federal oversight, if any, of
controlled substance packaging technologies, including--
(A) identification of the Federal agencies that oversee
such technologies;
(B) identification of the technologies recommended by these
agencies, including unit dose packaging, packaging that
provides a set duration, or other packaging systems that may
mitigate abuse or misuse; and
(C) a description of the effectiveness of such
recommendations at preventing the diversion of legally
prescribed controlled substances; and
(6) recommendations on--
(A) whether site-of-use, in-home controlled substance
disposal products and packaging technologies require Federal
oversight and, if so, which agencies should be responsible
for such oversight and, as applicable, approval of such
products or technologies; and
(B) the potential role of the Federal Government in
evaluating such products to ensure product efficacy.
Subtitle W--Postapproval Study Requirements
SEC. 7221. POSTAPPROVAL STUDY REQUIREMENTS.
(a) Purposes of Study.--Section 505(o)(3)(B) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(B)) is
amended by adding at the end the following:
``(iv) To assess a potential reduction in effectiveness of
the drug for the conditions of use prescribed, recommended,
or suggested in the labeling thereof if--
``(I) the drug involved--
``(aa) is or contains a substance for which a listing in
any schedule is in effect (on a temporary or permanent basis)
under section 201 of the Controlled Substances Act; or
``(bb) is a drug that has not been approved under this
section or licensed under section 351 of the Public Health
Service Act, for which an application for such approval or
licensure is pending or anticipated, and for which the
Secretary provides notice to the sponsor that the Secretary
intends to issue a scientific and medical evaluation and
recommend controls under the Controlled Substances Act; and
``(II) the potential reduction in effectiveness could
result in the benefits of the drug no longer outweighing the
risks.''.
(b) Establishment of Requirement.--Section 505(o)(3)(C) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(o)(3)(C)) is amended by striking ``such requirement'' and
all that follows through ``safety information.'' and
inserting the following: ``such requirement--
``(i) in the case of a purpose described in clause (i),
(ii), or (iii) of subparagraph (B), only if the Secretary
becomes aware of new safety information; and
``(ii) in the case of a purpose described in clause (iv) of
such subparagraph, if the Secretary determines that new
effectiveness information exists.''.
(c) Applicability.--Section 505(o)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) is amended by
adding at the end the following new subparagraph:
``(G) Applicability.--The conduct of a study or clinical
trial required pursuant to this paragraph for the purpose
specified in subparagraph (B)(iv) shall not be considered a
new clinical investigation for the purpose of a period of
exclusivity under clause (iii) or (iv) of subsection
(c)(3)(E) or clause (iii) or (iv) of subsection (j)(5)(F).''.
(d) New Effectiveness Information Defined.--Section
505(o)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(o)(2)) is amended by adding at the end the
following new subparagraph:
``(D) New effectiveness information.--The term `new
effectiveness information', with respect to a drug that is or
contains a controlled substance for which a listing in any
schedule is in effect (on a temporary or permanent basis)
under section 201 of the Controlled Substances Act, means new
information about the effectiveness of the drug, including a
new analysis of existing information, derived from--
``(i) a clinical trial; an adverse event report; a
postapproval study or clinical trial (including a study or
clinical trial under paragraph (3));
``(ii) peer-reviewed biomedical literature;
``(iii) data derived from the postmarket risk
identification and analysis system under subsection (k); or
``(iv) other scientific data determined to be appropriate
by the Secretary.''.
(e) Conforming Amendments With Respect to Labeling
Changes.--Section 505(o)(4) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(o)(4)) is amended--
(1) in subparagraph (A)--
(A) in the heading, by inserting ``or new effectiveness''
after ``safety'';
(B) by striking ``safety information'' and inserting ``new
safety information or new effectiveness information such'';
and
(C) by striking ``believes should be'' and inserting
``believes changes should be made to'';
(2) in subparagraph (B)(i)--
(A) by striking ``new safety information'' and by inserting
``new safety information or new effectiveness information'';
and
(B) by inserting ``indications,'' after ``boxed
warnings,'';
(3) in subparagraph (C), by inserting ``or new
effectiveness information'' after ``safety information''; and
(4) in subparagraph (E), by inserting ``or new
effectiveness information'' after ``safety information''.
(f) Rule of Construction.--Nothing in the amendments made
by this section shall be construed to alter, in any manner,
the meaning or application of the provisions of paragraph (3)
of section 505(o) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(o)) with respect to the authority of the
Secretary of Health and Human Services to require a
postapproval study or clinical trial for a purpose specified
in clauses (i) through (iii) of subparagraph (B) of such
paragraph (3) or paragraph (4) of such section 505(o) with
respect to the Secretary's authority to require safety
labeling changes.
TITLE VIII--MISCELLANEOUS
Subtitle A--Synthetics Trafficking and Overdose Prevention
SEC. 8001. SHORT TITLE; TABLE OF CONTENTS.
This subtitle may be cited as the ``Synthetics Trafficking
and Overdose Prevention Act of 2018'' or ``STOP Act of
2018''.
SEC. 8002. CUSTOMS FEES.
(a) In General.--Section 13031(b)(9) of the Consolidated
Omnibus Budget Reconciliation Act of 1985 (19 U.S.C.
58c(b)(9)) is amended by adding at the end the following:
``(D)(i) With respect to the processing of items that are
sent to the United States through the international postal
network by `Inbound Express Mail service' or `Inbound EMS'
(as that service is described in the mail classification
schedule referred to in section 3631 of title 39, United
States Code), the following payments are required:
``(I) $1 per Inbound EMS item.
``(II) If an Inbound EMS item is formally entered, the fee
provided for under subsection (a)(9), if applicable.
``(ii) Notwithstanding section 451 of the Tariff Act of
1930 (19 U.S.C. 1451), the payments required by clause (i),
as allocated pursuant to clause (iii)(I), shall be the only
payments required for reimbursement of U.S. Customs and
Border Protection for customs services provided in connection
with the processing of an Inbound EMS item.
``(iii)(I) The payments required by clause (i)(I) shall be
allocated as follows:
``(aa) 50 percent of the amount of the payments shall be
paid on a quarterly basis by the United States Postal Service
to the Commissioner of U.S. Customs and Border Protection in
accordance with regulations prescribed by the Secretary of
the Treasury to reimburse U.S. Customs and Border Protection
for customs services provided in connection with the
processing of Inbound EMS items.
``(bb) 50 percent of the amount of the payments shall be
retained by the Postal Service to reimburse the Postal
Service for services provided in connection with the customs
processing of Inbound EMS items.
``(II) Payments received by U.S. Customs and Border
Protection under subclause (I)(aa) shall, in accordance with
section 524 of the Tariff Act of 1930 (19 U.S.C. 1524), be
deposited in the Customs User Fee Account and used to
directly reimburse each appropriation for the amount paid out
of that appropriation for the costs incurred in providing
services to international mail facilities. Amounts deposited
in accordance with the preceding sentence shall be available
until expended for the provision of such services.
``(III) Payments retained by the Postal Service under
subclause (I)(bb) shall be used to directly reimburse the
Postal Service for the costs incurred in providing services
in connection with the customs processing of Inbound EMS
items.
``(iv) Beginning in fiscal year 2021, the Secretary, in
consultation with the Postmaster General, may adjust, not
more frequently than once
[[Page H5555]]
each fiscal year, the amount described in clause (i)(I) to an
amount commensurate with the costs of services provided in
connection with the customs processing of Inbound EMS items,
consistent with the obligations of the United States under
international agreements.''.
(b) Conforming Amendments.--Section 13031(a) of the
Consolidated Omnibus Budget Reconciliation Act of 1985 (19
U.S.C. 58c(a)) is amended--
(1) in paragraph (6), by inserting ``(other than an item
subject to a fee under subsection (b)(9)(D))'' after
``customs officer''; and
(2) in paragraph (10)--
(A) in subparagraph (C), in the matter preceding clause
(i), by inserting ``(other than Inbound EMS items described
in subsection (b)(9)(D))'' after ``release''; and
(B) in the flush at the end, by inserting ``or of Inbound
EMS items described in subsection (b)(9)(D),'' after
``(C),''.
(c) Effective Date.--The amendments made by this section
shall take effect on January 1, 2020.
SEC. 8003. MANDATORY ADVANCE ELECTRONIC INFORMATION FOR
POSTAL SHIPMENTS.
(a) Mandatory Advance Electronic Information.--
(1) In general.--Section 343(a)(3)(K) of the Trade Act of
2002 (Public Law 107-210; 19 U.S.C. 2071 note) is amended to
read as follows:
``(K)(i) The Secretary shall prescribe regulations
requiring the United States Postal Service to transmit the
information described in paragraphs (1) and (2) to the
Commissioner of U.S. Customs and Border Protection for
international mail shipments by the Postal Service (including
shipments to the Postal Service from foreign postal operators
that are transported by private carrier) consistent with the
requirements of this subparagraph.
``(ii) In prescribing regulations under clause (i), the
Secretary shall impose requirements for the transmission to
the Commissioner of information described in paragraphs (1)
and (2) for mail shipments described in clause (i) that are
comparable to the requirements for the transmission of such
information imposed on similar non-mail shipments of cargo,
taking into account the parameters set forth in subparagraphs
(A) through (J).
``(iii) The regulations prescribed under clause (i) shall
require the transmission of the information described in
paragraphs (1) and (2) with respect to a shipment as soon as
practicable in relation to the transportation of the
shipment, consistent with subparagraph (H).
``(iv) Regulations prescribed under clause (i) shall allow
for the requirements for the transmission to the Commissioner
of information described in paragraphs (1) and (2) for mail
shipments described in clause (i) to be implemented in
phases, as appropriate, by--
``(I) setting incremental targets for increasing the
percentage of such shipments for which information is
required to be transmitted to the Commissioner; and
``(II) taking into consideration--
``(aa) the risk posed by such shipments;
``(bb) the volume of mail shipped to the United States by
or through a particular country; and
``(cc) the capacities of foreign postal operators to
provide that information to the Postal Service.
``(v)(I) Notwithstanding clause (iv), the Postal Service
shall, not later than December 31, 2018, arrange for the
transmission to the Commissioner of the information described
in paragraphs (1) and (2) for not less than 70 percent of the
aggregate number of mail shipments, including 100 percent of
mail shipments from the People's Republic of China, described
in clause (i).
``(II) If the requirements of subclause (I) are not met,
the Comptroller General of the United States shall submit to
the appropriate congressional committees, not later than June
30, 2019, a report--
``(aa) assessing the reasons for the failure to meet those
requirements; and
``(bb) identifying recommendations to improve the
collection by the Postal Service of the information described
in paragraphs (1) and (2).
``(vi)(I) Notwithstanding clause (iv), the Postal Service
shall, not later than December 31, 2020, arrange for the
transmission to the Commissioner of the information described
in paragraphs (1) and (2) for 100 percent of the aggregate
number of mail shipments described in clause (i).
``(II) The Commissioner, in consultation with the
Postmaster General, may determine to exclude a country from
the requirement described in subclause (I) to transmit
information for mail shipments described in clause (i) from
the country if the Commissioner determines that the country--
``(aa) does not have the capacity to collect and transmit
such information;
``(bb) represents a low risk for mail shipments that
violate relevant United States laws and regulations; and
``(cc) accounts for low volumes of mail shipments that can
be effectively screened for compliance with relevant United
States laws and regulations through an alternate means.
``(III) The Commissioner shall, at a minimum on an annual
basis, re-evaluate any determination made under subclause
(II) to exclude a country from the requirement described in
subclause (I). If, at any time, the Commissioner determines
that a country no longer meets the requirements under
subclause (II), the Commissioner may not further exclude the
country from the requirement described in subclause (I).
``(IV) The Commissioner shall, on an annual basis, submit
to the appropriate congressional committees--
``(aa) a list of countries with respect to which the
Commissioner has made a determination under subclause (II) to
exclude the countries from the requirement described in
subclause (I); and
``(bb) information used to support such determination with
respect to such countries.
``(vii)(I) The Postmaster General shall, in consultation
with the Commissioner, refuse any shipments received after
December 31, 2020, for which the information described in
paragraphs (1) and (2) is not transmitted as required under
this subparagraph, except as provided in subclause (II).
``(II) If remedial action is warranted in lieu of refusal
of shipments pursuant to subclause (I), the Postmaster
General and the Commissioner shall take remedial action with
respect to the shipments, including destruction, seizure,
controlled delivery or other law enforcement initiatives, or
correction of the failure to provide the information
described in paragraphs (1) and (2) with respect to the
shipments.
``(viii) Nothing in this subparagraph shall be construed to
limit the authority of the Secretary to obtain information
relating to international mail shipments from private
carriers or other appropriate parties.
``(ix) In this subparagraph, the term `appropriate
congressional committees' means--
``(I) the Committee on Finance and the Committee on
Homeland Security and Governmental Affairs of the Senate; and
``(II) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on
Homeland Security of the House of Representatives.''.
(2) Joint strategic plan on mandatory advance
information.--Not later than 60 days after the date of the
enactment of this Act, the Secretary of Homeland Security and
the Postmaster General shall develop and submit to the
appropriate congressional committees a joint strategic plan
detailing specific performance measures for achieving--
(A) the transmission of information as required by section
343(a)(3)(K) of the Trade Act of 2002, as amended by
paragraph (1); and
(B) the presentation by the Postal Service to U.S. Customs
and Border Protection of all mail targeted by U.S. Customs
and Border Protection for inspection.
(b) Capacity Building.--
(1) In general.--Section 343(a) of the Trade Act of 2002
(Public Law 107-210; 19 U.S.C. 2071 note) is amended by
adding at the end the following:
``(5) Capacity building.--
``(A) In general.--The Secretary, with the concurrence of
the Secretary of State, and in coordination with the
Postmaster General and the heads of other Federal agencies,
as appropriate, may provide technical assistance, equipment,
technology, and training to enhance the capacity of foreign
postal operators--
``(i) to gather and provide the information required by
paragraph (3)(K); and
``(ii) to otherwise gather and provide postal shipment
information related to--
``(I) terrorism;
``(II) items the importation or introduction of which into
the United States is prohibited or restricted, including
controlled substances; and
``(III) such other concerns as the Secretary determines
appropriate.
``(B) Provision of equipment and technology.--With respect
to the provision of equipment and technology under
subparagraph (A), the Secretary may lease, loan, provide, or
otherwise assist in the deployment of such equipment and
technology under such terms and conditions as the Secretary
may prescribe, including nonreimbursable loans or the
transfer of ownership of equipment and technology.''.
(2) Joint strategic plan on capacity building.--Not later
than one year after the date of the enactment of this Act,
the Secretary of Homeland Security and the Postmaster General
shall, in consultation with the Secretary of State, jointly
develop and submit to the appropriate congressional
committees a joint strategic plan--
(A) detailing the extent to which U.S. Customs and Border
Protection and the United States Postal Service are engaged
in capacity building efforts under section 343(a)(5) of the
Trade Act of 2002, as added by paragraph (1);
(B) describing plans for future capacity building efforts;
and
(C) assessing how capacity building has increased the
ability of U.S. Customs and Border Protection and the Postal
Service to advance the goals of this subtitle and the
amendments made by this subtitle.
(c) Report and Consultations by Secretary of Homeland
Security and Postmaster General.--
(1) Report.--Not later than 180 days after the date of the
enactment of this Act, and annually thereafter until 3 years
after the Postmaster General has met the requirement under
clause (vi) of subparagraph (K) of section 343(a)(3) of the
Trade Act of 2002, as amended by subsection (a)(1), the
Secretary of Homeland Security and the Postmaster General
shall, in consultation with the Secretary of State, jointly
submit to the appropriate congressional committees a report
on compliance with that subparagraph that includes the
following:
(A) An assessment of the status of the regulations required
to be promulgated under that subparagraph.
(B) An update regarding new and existing agreements reached
with foreign postal operators for the transmission of the
information required by that subparagraph.
(C) A summary of deliberations between the United States
Postal Service and foreign postal operators with respect to
issues relating to the transmission of that information.
(D) A summary of the progress made in achieving the
transmission of that information for the percentage of
shipments required by that subparagraph.
[[Page H5556]]
(E) An assessment of the quality of that information being
received by foreign postal operators, as determined by the
Secretary of Homeland Security, and actions taken to improve
the quality of that information.
(F) A summary of policies established by the Universal
Postal Union that may affect the ability of the Postmaster
General to obtain the transmission of that information.
(G) A summary of the use of technology to detect illicit
synthetic opioids and other illegal substances in
international mail parcels and planned acquisitions and
advancements in such technology.
(H) Such other information as the Secretary of Homeland
Security and the Postmaster General consider appropriate with
respect to obtaining the transmission of information required
by that subparagraph.
(2) Consultations.--Not later than 180 days after the date
of the enactment of this Act, and every 180 days thereafter
until the Postmaster General has met the requirement under
clause (vi) of section 343(a)(3)(K) of the Trade Act of 2002,
as amended by subsection (a)(1), to arrange for the
transmission of information with respect to 100 percent of
the aggregate number of mail shipments described in clause
(i) of that section, the Secretary of Homeland Security and
the Postmaster General shall provide briefings to the
appropriate congressional committees on the progress made in
achieving the transmission of that information for that
percentage of shipments.
(d) Government Accountability Office Report.--Not later
than June 30, 2019, the Comptroller General of the United
States shall submit to the appropriate congressional
committees a report--
(1) assessing the progress of the United States Postal
Service in achieving the transmission of the information
required by subparagraph (K) of section 343(a)(3) of the
Trade Act of 2002, as amended by subsection (a)(1), for the
percentage of shipments required by that subparagraph;
(2) assessing the quality of the information received from
foreign postal operators for targeting purposes;
(3) assessing the specific percentage of targeted mail
presented by the Postal Service to U.S. Customs and Border
Protection for inspection;
(4) describing the costs of collecting the information
required by such subparagraph (K) from foreign postal
operators and the costs of implementing the use of that
information;
(5) assessing the benefits of receiving that information
with respect to international mail shipments;
(6) assessing the feasibility of assessing a customs fee
under section 13031(b)(9) of the Consolidated Omnibus Budget
Reconciliation Act of 1985, as amended by section 8002, on
international mail shipments other than Inbound Express Mail
service in a manner consistent with the obligations of the
United States under international agreements; and
(7) identifying recommendations, including recommendations
for legislation, to improve the compliance of the Postal
Service with such subparagraph (K), including an assessment
of whether the detection of illicit synthetic opioids in the
international mail would be improved by--
(A) requiring the Postal Service to serve as the consignee
for international mail shipments containing goods; or
(B) designating a customs broker to act as an importer of
record for international mail shipments containing goods.
(e) Technical Correction.--Section 343 of the Trade Act of
2002 (Public Law 107-210; 19 U.S.C. 2071 note) is amended in
the section heading by striking ``advanced'' and inserting
``advance''.
(f) Appropriate Congressional Committees Defined.--In this
section, the term ``appropriate congressional committees''
means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on
Homeland Security of the House of Representatives.
SEC. 8004. INTERNATIONAL POSTAL AGREEMENTS.
(a) Existing Agreements.--
(1) In general.--In the event that any provision of this
subtitle, or any amendment made by this Act, is determined to
be in violation of obligations of the United States under any
postal treaty, convention, or other international agreement
related to international postal services, or any amendment to
such an agreement, the Secretary of State should negotiate to
amend the relevant provisions of the agreement so that the
United States is no longer in violation of the agreement.
(2) Rule of construction.--Nothing in this subsection shall
be construed to permit delay in the implementation of this
subtitle or any amendment made by this subtitle.
(b) Future Agreements.--
(1) Consultations.--Before entering into, on or after the
date of the enactment of this Act, any postal treaty,
convention, or other international agreement related to
international postal services, or any amendment to such an
agreement, that is related to the ability of the United
States to secure the provision of advance electronic
information by foreign postal operators, the Secretary of
State should consult with the appropriate congressional
committees (as defined in section 8003(f)).
(2) Expedited negotiation of new agreement.--To the extent
that any new postal treaty, convention, or other
international agreement related to international postal
services would improve the ability of the United States to
secure the provision of advance electronic information by
foreign postal operators as required by regulations
prescribed under section 343(a)(3)(K) of the Trade Act of
2002, as amended by section 8003(a)(1), the Secretary of
State should expeditiously conclude such an agreement.
SEC. 8005. COST RECOUPMENT.
(a) In General.--The United States Postal Service shall, to
the extent practicable and otherwise recoverable by law,
ensure that all costs associated with complying with this
subtitle and amendments made by this subtitle are charged
directly to foreign shippers or foreign postal operators.
(b) Costs Not Considered Revenue.--The recovery of costs
under subsection (a) shall not be deemed revenue for purposes
of subchapter I and II of chapter 36 of title 39, United
States Code, or regulations prescribed under that chapter.
SEC. 8006. DEVELOPMENT OF TECHNOLOGY TO DETECT ILLICIT
NARCOTICS.
(a) In General.--The Postmaster General and the
Commissioner of U.S. Customs and Border Protection, in
coordination with the heads of other agencies as appropriate,
shall collaborate to identify and develop technology for the
detection of illicit fentanyl, other synthetic opioids, and
other narcotics and psychoactive substances entering the
United States by mail.
(b) Outreach to Private Sector.--The Postmaster General and
the Commissioner shall conduct outreach to private sector
entities to gather information regarding the current state of
technology to identify areas for innovation relating to the
detection of illicit fentanyl, other synthetic opioids, and
other narcotics and psychoactive substances entering the
United States.
SEC. 8007. CIVIL PENALTIES FOR POSTAL SHIPMENTS.
Section 436 of the Tariff Act of 1930 (19 U.S.C. 1436) is
amended by adding at the end the following new subsection:
``(e) Civil Penalties for Postal Shipments.--
``(1) Civil penalty.--A civil penalty shall be imposed
against the United States Postal Service if the Postal
Service accepts a shipment in violation of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002.
``(2) Modification of civil penalty.--
``(A) In general.--U.S. Customs and Border Protection shall
reduce or dismiss a civil penalty imposed pursuant to
paragraph (1) if U.S. Customs and Border Protection
determines that the United States Postal Service--
``(i) has a low error rate in compliance with section
343(a)(3)(K) of the Trade Act of 2002;
``(ii) is cooperating with U.S. Customs and Border
Protection with respect to the violation of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002; or
``(iii) has taken remedial action to prevent future
violations of section 343(a)(3)(K)(vii)(I) of the Trade Act
of 2002.
``(B) Written notification.--U.S. Customs and Border
Protection shall issue a written notification to the Postal
Service with respect to each exercise of the authority of
subparagraph (A) to reduce or dismiss a civil penalty imposed
pursuant to paragraph (1).
``(3) Ongoing lack of compliance.--If U.S. Customs and
Border Protection determines that the United States Postal
Service--
``(A) has repeatedly committed violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002,
``(B) has failed to cooperate with U.S. Customs and Border
Protection with respect to violations of section
343(a)(3)(K)(vii)(I) of the Trade Act of 2002, and
``(C) has an increasing error rate in compliance with
section 343(a)(3)(K) of the Trade Act of 2002,
civil penalties may be imposed against the United States
Postal Service until corrective action, satisfactory to U.S.
Customs and Border Protection, is taken.''.
SEC. 8008. REPORT ON VIOLATIONS OF ARRIVAL, REPORTING, ENTRY,
AND CLEARANCE REQUIREMENTS AND FALSITY OR LACK
OF MANIFEST.
(a) In General.--The Commissioner of U.S. Customs and
Border Protection shall submit to the appropriate
congressional committees an annual report that contains the
information described in subsection (b) with respect to each
violation of section 436 of the Tariff Act of 1930 (19 U.S.C.
1436), as amended by section 8007, and section 584 of such
Act (19 U.S.C. 1584) that occurred during the previous year.
(b) Information Described.--The information described in
this subsection is the following:
(1) The name and address of the violator.
(2) The specific violation that was committed.
(3) The location or port of entry through which the items
were transported.
(4) An inventory of the items seized, including a
description of the items and the quantity seized.
(5) The location from which the items originated.
(6) The entity responsible for the apprehension or seizure,
organized by location or port of entry.
(7) The amount of penalties assessed by U.S. Customs and
Border Protection, organized by name of the violator and
location or port of entry.
(8) The amount of penalties that U.S. Customs and Border
Protection could have levied, organized by name of the
violator and location or port of entry.
(9) The rationale for negotiating lower penalties,
organized by name of the violator and location or port of
entry.
(c) Appropriate Congressional Committees Defined.--In this
section, the term ``appropriate congressional committees''
means--
(1) the Committee on Finance and the Committee on Homeland
Security and Governmental Affairs of the Senate; and
[[Page H5557]]
(2) the Committee on Ways and Means, the Committee on
Oversight and Government Reform, and the Committee on
Homeland Security of the House of Representatives.
SEC. 8009. EFFECTIVE DATE; REGULATIONS.
(a) Effective Date.--This subtitle and the amendments made
by this subtitle (other than the amendments made by section
8002) shall take effect on the date of the enactment of this
Act.
(b) Regulations.--Not later than one year after the date of
the enactment of this Act, such regulations as are necessary
to carry out this subtitle and the amendments made by this
subtitle shall be prescribed.
Subtitle B--Recognizing Early Childhood Trauma Related to Substance
Abuse
SEC. 8011. SHORT TITLE.
This subtitle may be cited as the ``Recognizing Early
Childhood Trauma Related to Substance Abuse Act of 2018''.
SEC. 8012. RECOGNIZING EARLY CHILDHOOD TRAUMA RELATED TO
SUBSTANCE ABUSE.
(a) Dissemination of Information.--The Secretary of Health
and Human Services shall disseminate information, resources,
and, if requested, technical assistance to early childhood
care and education providers and professionals working with
young children on--
(1) ways to properly recognize children who may be impacted
by trauma related to substance abuse by a family member or
other adult; and
(2) how to respond appropriately in order to provide for
the safety and well-being of young children and their
families.
(b) Goals.--The information, resources, and technical
assistance provided under subsection (a) shall--
(1) educate early childhood care and education providers
and professionals working with young children on
understanding and identifying the early signs and risk
factors of children who might be impacted by trauma due to
exposure to substance abuse;
(2) suggest age-appropriate communication tools,
procedures, and practices for trauma-informed care, including
ways to prevent or mitigate the effects of trauma;
(3) provide options for responding to children impacted by
trauma due to exposure to substance abuse that consider the
needs of the child and family, including recommending
resources and referrals for evidence-based services to
support such family; and
(4) promote whole-family and multi-generational approaches
to prevent separation and support re-unification of families
whenever possible and in the best interest of the child.
(c) Rule of Construction.--Such information, resources, and
if applicable, technical assistance, shall not be construed
to amend the requirements under--
(1) the Child Care and Development Block Grant Act of 1990
(42 U.S.C. 9858 et seq.);
(2) the Head Start Act (42 U.S.C. 9831 et seq.); or
(3) the Individuals with Disabilities Education Act (20
U.S.C. 1400 et seq.).
Subtitle C--Assisting States' Implementation of Plans of Safe Care
SEC. 8021. SHORT TITLE.
This subtitle may be cited as the ``Assisting States'
Implementation of Plans of Safe Care Act''.
SEC. 8022. ASSISTING STATES WITH IMPLEMENTATION OF PLANS OF
SAFE CARE.
(a) In General.--The Secretary of Health and Human Services
shall provide written guidance and, if appropriate, technical
assistance to support States in complying with, and
implementing, subsections (b)(2)(B)(iii) and (d)(18) of
section 106 of the Child Abuse Prevention and Treatment Act
(42 U.S.C. 5106a) in order to promote better protections for
young children and family-centered responses.
(b) Requirements.--The guidance and technical assistance
shall--
(1) enhance States' understanding of requirements and
flexibilities under the law, including clarifying key terms;
(2) address State-identified challenges with developing,
implementing, and monitoring plans of safe care;
(3) disseminate best practices related to developing and
implementing plans of safe care, including differential
response, collaboration and coordination, and identification
and delivery of services, while recognizing needs of
different populations and varying community approaches across
States;
(4) support collaboration between health care providers,
social service agencies, public health agencies, and the
child welfare system, to promote a family-centered treatment
approach;
(5) prevent separation and support reunification of
families if in the best interests of the child;
(6) recommend treatment approaches for serving infants,
pregnant women, and postpartum women whose infants may be
affected by substance use that are designed to keep infants
with their mothers and families whenever appropriate,
including recommendations to encourage pregnant women to
receive health and other support services during pregnancy;
(7) support State efforts to develop technology systems to
manage and monitor implementation of plans of safe care; and
(8) help States improve the long-term safety and well-being
of young children and their families.
(c) Construction.--The guidance and technical assistance
shall not be construed to amend the requirements of the Child
Abuse Prevention and Treatment Act (42 U.S.C. 5101 et seq.).
(d) Definition.--For purposes of this section, the term
``State'' has the meaning given such term in section 3 of the
Child Abuse Prevention and Treatment Act (42 U.S.C. 5101
note).
Subtitle D--Improving the Federal Response to Families Impacted by
Substance Use Disorder
SEC. 8031. SHORT TITLE.
This subtitle may be cited as the ``Improving the Federal
Response to Families Impacted by Substance Use Disorder
Act''.
SEC. 8032. INTERAGENCY TASK FORCE TO IMPROVE THE FEDERAL
RESPONSE TO FAMILIES IMPACTED BY SUBSTANCE USE
DISORDERS.
(a) Establishment.--There is established a task force, to
be known as the ``Interagency Task Force to Improve the
Federal Response to Families Impacted by Substance Use
Disorders'' (in this section referred to as ``Task Force'').
(b) Responsibilities.--The Task Force--
(1) shall identify, evaluate, and recommend ways in which
Federal agencies can better coordinate responses to substance
use disorders and the opioid crisis; and
(2) shall carry out the additional duties described in
subsection (d).
(c) Membership.--
(1) Number and appointment.--The Task Force shall be
composed of 12 Federal officials having responsibility for,
or administering programs related to, the duties of the Task
Force. The Secretary of Health and Human Services, the
Secretary of Education, the Secretary of Agriculture, and the
Secretary of Labor shall each appoint two members to the Task
Force from among the Federal officials employed by the
Department of which they are the head. Additional Federal
agency officials appointed by the Secretary of Health and
Human Services shall fill the remaining positions of the Task
Force.
(2) Chairperson.--The Secretary of Health and Human
Services shall designate a Federal official employed by the
Department of Health and Human Services to serve as the
chairperson of the Task Force.
(3) Deadline for appointment.--Each member shall be
appointed to the Task Force not later than 60 days after the
date of the enactment of this Act.
(4) Additional agency input.--The Task Force may seek input
from other Federal agencies and offices with experience,
expertise, or information relevant in responding to the
opioid crisis.
(5) Vacancies.--A vacancy in the Task Force shall be filled
in the manner in which the original appointment was made.
(6) Prohibition of compensation.--Members of the Task Force
may not receive pay, allowances, or benefits by reason of
their service on the Task Force.
(d) Duties.--The Task Force shall carry out the following
duties:
(1) Solicit input from stakeholders, including frontline
service providers, medical professionals, educators, mental
health professionals, researchers, experts in infant, child,
and youth trauma, child welfare professionals, and the
public, in order to inform the activities of the Task Force.
(2) Develop a strategy on how the Task Force and
participating Federal agencies will collaborate, prioritize,
and implement a coordinated Federal approach with regard to
responding to substance use disorders, including opioid
misuse, that shall include--
(A) identifying options for the coordination of existing
grants that support infants, children, and youth, and their
families as appropriate, who have experienced, or are at risk
of experiencing, exposure to substance abuse disorders,
including opioid misuse; and
(B) other ways to improve coordination, planning, and
communication within and across Federal agencies, offices,
and programs, to better serve children and families impacted
by substance use disorders, including opioid misuse.
(3) Based off the strategy developed under paragraph (2),
evaluate and recommend opportunities for local- and State-
level partnerships, professional development, or best
practices that--
(A) are designed to quickly identify and refer children and
families, as appropriate, who have experienced or are at risk
of experiencing exposure to substance abuse;
(B) utilize and develop partnerships with early childhood
education programs, local social services organizations, and
health care services aimed at preventing or mitigating the
effects of exposure to substance use disorders, including
opioid misuse;
(C) offer community-based prevention activities, including
educating families and children on the effects of exposure to
substance use disorders, including opioid misuse, and how to
build resilience and coping skills to mitigate those effects;
(D) in accordance with Federal privacy protections, utilize
non-personally identifiable data from screenings, referrals,
or the provision of services and supports to evaluate and
improve processes addressing exposure to substance use
disorders, including opioid misuse; and
(E) are designed to prevent separation and support
reunification of families if in the best interest of the
child.
(4) In fulfilling the requirements of paragraphs (2) and
(3), consider evidence-based, evidence-informed, and
promising best practices related to identifying, referring,
and supporting children and families at risk of experiencing
exposure to substance abuse or experiencing substance use
disorder, including opioid misuse, including--
(A) prevention strategies for those at risk of experiencing
or being exposed to substance abuse, including misuse of
opioids;
(B) whole-family and multi-generational approaches;
(C) community-based initiatives;
(D) referral to, and implementation of, trauma-informed
practices and supports; and
(E) multi-generational practices that assist parents,
foster parents, and kinship and other caregivers
(e) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App. 2) shall not apply to the Task Force.
[[Page H5558]]
(f) Action Plan; Reports.--The Task Force--
(1) shall prepare a detailed action plan to be implemented
by participating Federal agencies to create a collaborative,
coordinated response to the opioid crisis, which shall
include--
(A) relevant information identified and collected under
subsection (d);
(B) a proposed timeline for implementing recommendations
and efforts identified under subsection (d); and
(C) a description of how other Federal agencies and offices
with experience, expertise, or information relevant in
responding to the opioid crisis that have provided input
under subsection (c)(4) will be participating in the
coordinated approach;
(2) shall submit to the Congress a report describing the
action plan prepared under paragraph (1), including, where
applicable, identification of any recommendations included in
such plan that require additional legislative authority to
implement; and
(3) shall submit a report to the Governors describing the
opportunities for local- and State-level partnerships,
professional development, or best practices recommended under
subsection (d)(3).
(g) Dissemination.--
(1) In general.--The action plan and reports required under
subsection (f) shall be--
(A) disseminated widely, including among the participating
Federal agencies and the Governors; and
(B) be made publicly available online in an accessible
format.
(2) Deadline.--The action plan and reports required under
subsection (f) may be released on separate dates but shall be
released not later than 9 months after the date of the
enactment of this Act.
(h) Termination.--The Task Force shall terminate 30 days
after the dissemination of the action plan and reports under
subsection (g).
(i) Funding.--The administrative expenses of the Task Force
shall be paid out of existing Department of Health and Human
Services funds or appropriations.
(j) Definitions.--For purposes of this section:
(1) The term ``Governor'' means the chief executive officer
of a State.
(2) The term ``participating Federal agencies'' means all
the Executive agencies (as defined in section 105 of title 5,
United States Code) whose officials have been appointed to
the Task Force.
(3) The term ``State'' means each of the several States,
the District of Columbia, the Commonwealth of Puerto Rico,
the Virgin Islands, Guam, American Samoa, and the
Commonwealth of the Northern Mariana Islands.
Subtitle E--Establishment of an Advisory Committee on Opioids and the
Workplace
SEC. 8041. ESTABLISHMENT OF AN ADVISORY COMMITTEE ON OPIOIDS
AND THE WORKPLACE.
(a) Establishment.--Not later than 90 days after enactment
of this Act, the Secretary of Labor shall establish an
Advisory Committee on Opioids and the Workplace (referred to
in this subtitle as the ``Advisory Committee'') to advise the
Secretary on actions the Department of Labor can take to
provide informational resources and best practices on how to
appropriately address the impact of opioid abuse on the
workplace and support workers abusing opioids.
(b) Membership.--
(1) Composition.--The Secretary of Labor shall appoint as
members of the Advisory Committee 19 individuals with
expertise in employment, workplace health programs, human
resources, substance use disorder, and other relevant fields.
The Advisory Committee shall be composed as follows:
(A) 4 of the members shall be individuals representative of
employers or other organizations representing employers.
(B) 4 of the members shall be individuals representative of
workers or other organizations representing workers, of which
at least 2 must be representatives designated by labor
organizations.
(C) 3 of the members shall be individuals representative of
health benefit plans, employee assistance plan providers,
workers' compensation program administrators, and workplace
safety and health professionals.
(D) 8 of the members shall be individuals representative of
substance abuse treatment and recovery experts, including
medical doctors, licensed addiction therapists, and
scientific and academic researchers, of which 1 individual
may be a representative of a local or State government agency
that oversees or coordinates programs that address substance
use disorder.
(2) Chair.--From the members appointed under paragraph (1),
the Secretary of Labor shall appoint a chairperson.
(3) Terms.--Each member of the Advisory Committee shall
serve for a term of three years. A member appointed to fill a
vacancy shall be appointed only for the remainder of such
term.
(4) Quorum.--A majority of members of the Advisory
Committee shall constitute a quorum and action shall be taken
only by a majority vote of the members.
(5) Voting.--The Advisory Committee shall establish voting
procedures.
(6) No compensation.--Members of the Advisory Committee
shall serve without compensation.
(7) Disclosure.--Every member of the Advisory Committee
must disclose the entity, if applicable, that he or she is
representing.
(c) Duties.--
(1) Advisement.--
(A) In general.--The Advisory Committee established under
subsection (a) shall advise the Secretary of Labor on actions
the Department of Labor can take to provide informational
resources and best practices on how to appropriately address
the impact of opioid abuse on the workplace and support
workers abusing opioids.
(B) Considerations.--In providing such advice, the Advisory
Committee shall take into account--
(i) evidence-based and other employer substance abuse
policies and best practices regarding opioid use or abuse,
including benefits provided by employee assistance programs
or other employer-provided benefits, programs, or resources;
(ii) the effect of opioid use or abuse on the safety of the
workplace as well as policies and procedures addressing
workplace safety and health;
(iii) the impact of opioid abuse on productivity and
absenteeism, and assessments of model human resources
policies that support workers abusing opioids, such as
policies that facilitate seeking and receiving treatment and
returning to work;
(iv) the extent to which alternative pain management
treatments other than opioids are or should be covered by
employer-sponsored health plans;
(v) the legal requirements protecting employee privacy and
health information in the workplace, as well as the legal
requirements related to nondiscrimination;
(vi) potential interactions of opioid abuse with other
substance use disorders;
(vii) any additional benefits or resources available to an
employee abusing opioids that promote retaining employment or
reentering the workforce;
(viii) evidence-based initiatives that engage employers,
employees, and community leaders to promote early
identification of opioid abuse, intervention, treatment, and
recovery;
(ix) workplace policies regarding opioid abuse that reduce
stigmatization among fellow employees and management; and
(x) the legal requirements of the Mental Health Parity and
Addiction Equity Act and other laws related to health
coverage of substance abuse and mental health services and
medications.
(2) Report.--Prior to its termination as provided in
subsection (j), the Advisory Committee shall issue a report
to the Secretary of Labor and to the Committee on Education
and the Workforce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate, detailing successful programs and policies involving
workplace resources and benefits, including recommendations
or examples of best practices for how employers can support
and respond to employees impacted by opioid abuse.
(d) Meetings.--The Advisory Committee shall meet at least
twice a year at the call of the chairperson.
(e) Staff Support.--The Secretary of Labor shall make
available staff necessary for the Advisory Committee to carry
out its responsibilities.
(f) Federal Advisory Committee Act.--The Federal Advisory
Committee Act shall apply to the Advisory Committee
established under this subtitle.
(g) No Appropriated Funds.--No additional funds are
authorized to be appropriated to carry out this subtitle.
Expenses of the Advisory Committee shall be paid with funds
otherwise appropriated to Departmental Management within the
Department of Labor.
(h) Ex Officio.--Three nonvoting representatives from
agencies within the Department of Health and Human Services
whose responsibilities include opioid prescribing guidelines,
workplace safety, and monitoring of substance abuse and
prevention programs shall be appointed by the Secretary of
Labor and designated as ex officio members.
(i) Agenda.--The Secretary of Labor or a representative of
the Secretary shall consult with the Chair in establishing
the agenda for Committee meetings.
(j) Termination.--The Advisory Committee established under
this subtitle shall terminate three years after the date of
enactment of this Act.
Subtitle F--Veterans Treatment Court Improvement
SEC. 8051. SHORT TITLE.
This subtitle may be cited as the ``Veterans Treatment
Court Improvement Act of 2018''.
SEC. 8052. HIRING BY DEPARTMENT OF VETERANS AFFAIRS OF
ADDITIONAL VETERANS JUSTICE OUTREACH
SPECIALISTS.
(a) Hiring of Additional Veterans Justice Outreach
Specialists.--
(1) In general.--Not later than one year after the date of
the enactment of this Act, the Secretary of Veterans Affairs
shall hire not fewer than 50 Veterans Justice Outreach
Specialists and place each such Veterans Justice Outreach
Specialist at an eligible Department of Veterans Affairs
medical center in accordance with this section.
(2) Requirements.--The Secretary shall ensure that each
Veterans Justice Outreach Specialist employed under paragraph
(1)--
(A) serves, either exclusively or in addition to other
duties, as part of a justice team in a veterans treatment
court or other veteran-focused court; and
(B) otherwise meets Department hiring guidelines for
Veterans Justice Outreach Specialists.
(b) Eligible Department of Veterans Affairs Medical
Centers.--For purposes of this section, an eligible
Department of Veterans Affairs medical center is any
Department of Veterans Affairs medical center that--
(1) complies with all Department guidelines and regulations
for placement of a Veterans Justice Outreach Specialist;
(2) works within a local criminal justice system with
justice-involved veterans;
(3) maintains an affiliation with one or more veterans
treatment courts or other veteran-focused courts; and
[[Page H5559]]
(4) either--
(A) routinely provides Veterans Justice Outreach
Specialists to serve as part of a justice team in a veterans
treatment court or other veteran-focused court; or
(B) establishes a plan that is approved by the Secretary to
provide Veterans Justice Outreach Specialists employed under
subsection (a)(1) to serve as part of a justice team in a
veterans treatment court or other veteran-focused court.
(c) Placement Priority.--The Secretary shall prioritize the
placement of Veterans Justice Outreach Specialists employed
under subsection (a)(1) at eligible Department of Veterans
Affairs medical centers that have or intend to establish an
affiliation, for the purpose of carrying out the Veterans
Justice Outreach Program, with a veterans treatment court, or
other veteran-focused court, that--
(1) was established on or after the date of the enactment
of this Act; or
(2)(A) was established before the date of the enactment of
this Act; and
(B) is not fully staffed with Veterans Justice Outreach
Specialists.
(d) Reports.--
(1) Report by secretary of veterans affairs.--
(A) In general.--Not later than one year after the date of
the enactment of this Act, the Secretary of Veterans Affairs
shall submit to Congress a report on the implementation of
this section and its effect on the Veterans Justice Outreach
Program.
(B) Contents.--The report submitted under paragraph (1)
shall include the following:
(i) The status of the efforts of the Secretary to hire
Veterans Justice Outreach Specialists pursuant to subsection
(a)(1), including the total number of Veterans Justice
Outreach Specialists hired by the Secretary pursuant to such
subsection and the number that the Secretary expects to hire
pursuant to such subsection.
(ii) The total number of Veterans Justice Outreach
Specialists assigned to each Department of Veterans Affairs
medical center that participates in the Veterans Justice
Outreach Program, including the number of Veterans Justice
Outreach Specialists hired under subsection (a)(1)
disaggregated by Department of Veterans Affairs medical
center.
(iii) The total number of eligible Department of Veterans
Affairs medical centers that sought placement of a Veterans
Justice Outreach Specialist under subsection (a)(1), how many
Veterans Justice Outreach Specialists each such center
sought, and how many of such medical centers received no
placement of a Veterans Justice Outreach Specialist under
subsection (a)(1).
(iv) For each eligible Department of Veterans Affairs
medical center--
(I) the number of justice-involved veterans who were served
or are expected to be served by a Veterans Justice Outreach
Specialist hired under subsection (a)(1); and
(II) the number of justice-involved veterans who do not
have access to a Veterans Justice Outreach Specialist.
(2) Report by comptroller general of the united states.--
(A) In general.--Not later than three years after the date
of the enactment of this Act, the Comptroller General of the
United States shall submit to Congress a report on the
implementation of this section and the effectiveness of the
Veterans Justice Outreach Program.
(B) Contents.--The report required by subparagraph (A)
shall include the following:
(i) An assessment of whether the Secretary has fulfilled
the Secretary's obligations under this section.
(ii) The number of veterans who are served by Veterans
Justice Outreach Specialists hired under subsection (a)(1),
disaggregated by demographics (including discharge status).
(iii) An identification of any subgroups of veterans who
underutilize services provided under laws administered by the
Secretary, including an assessment of whether these veterans
have access to Veterans Justice Outreach Specialists under
the Veterans Justice Outreach Program.
(iv) Such recommendations as the Comptroller General may
have for the Secretary to improve the effectiveness of the
Veterans Justice Outreach Program.
(e) Definitions.--In this section:
(1) Justice team.--The term ``justice team'' means the
group of individuals, which may include a judge, court
coordinator, prosecutor, public defender, treatment provider,
probation or other law enforcement officer, program mentor,
and Veterans Justice Outreach Specialist, who assist justice-
involved veterans in a veterans treatment court or other
veteran-focused court.
(2) Justice-involved veteran.--The term ``justice-involved
veteran'' means a veteran with active, ongoing, or recent
contact with some component of a local criminal justice
system.
(3) Local criminal justice system.--The term ``local
criminal justice system'' means law enforcement, jails,
prisons, and Federal, State, and local courts.
(4) Veterans justice outreach program.--The term ``Veterans
Justice Outreach Program'' means the program through which
the Department of Veterans Affairs identifies justice-
involved veterans and provides such veterans with access to
Department services.
(5) Veterans justice outreach specialist.--The term
``Veterans Justice Outreach Specialist'' means an employee of
the Department of Veterans Affairs who serves as a liaison
between the Department and the local criminal justice system
on behalf of a justice-involved veteran.
(6) Veterans treatment court.--The term ``veterans
treatment court'' means a State or local court that is
participating in the veterans treatment court program (as
defined in section 2991(i)(1) of the Omnibus Crime Control
and Safe Streets Act of 1968 (42 U.S.C. 3797aa(i)(1))).
Subtitle G--Peer Support Counseling Program for Women Veterans
SEC. 8061. PEER SUPPORT COUNSELING PROGRAM FOR WOMEN
VETERANS.
(a) In General.--Section 1720F(j) of title 38, United
States Code, is amended by adding at the end the following
new paragraph:
``(4)(A) As part of the counseling program under this
subsection, the Secretary shall emphasize appointing peer
support counselors for women veterans. To the degree
practicable, the Secretary shall seek to recruit women peer
support counselors with expertise in--
``(i) female gender-specific issues and services;
``(ii) the provision of information about services and
benefits provided under laws administered by the Secretary;
or
``(iii) employment mentoring.
``(B) To the degree practicable, the Secretary shall
emphasize facilitating peer support counseling for women
veterans who are eligible for counseling and services under
section 1720D of this title, have post-traumatic stress
disorder or suffer from another mental health condition, are
homeless or at risk of becoming homeless, or are otherwise at
increased risk of suicide, as determined by the Secretary.
``(C) The Secretary shall conduct outreach to inform women
veterans about the program and the assistance available under
this paragraph.
``(D) In carrying out this paragraph, the Secretary shall
coordinate with such community organizations, State and local
governments, institutions of higher education, chambers of
commerce, local business organizations, organizations that
provide legal assistance, and other organizations as the
Secretary considers appropriate.
``(E) In carrying out this paragraph, the Secretary shall
provide adequate training for peer support counselors,
including training carried out under the national program of
training required by section 304(c) of the Caregivers and
Veterans Omnibus Health Services Act of 2010 (38 U.S.C. 1712A
note).''.
(b) Funding.--The Secretary of Veterans Affairs shall carry
out paragraph (4) of section 1720F(j) of title 38, United
States Code, as added by subsection (a), using funds
otherwise made available to the Secretary. No additional
funds are authorized to be appropriated by reason of such
paragraph.
(c) Report to Congress.--Not later than two years after the
date of the enactment of this Act, the Secretary of Veterans
Affairs shall submit to the Committees on Veterans' Affairs
of the Senate and House of Representatives a report on the
peer support counseling program under section 1720F(j) of
title 38, United States Code, as amended by this section.
Such report shall include--
(1) the number of peer support counselors in the program;
(2) an assessment of the effectiveness of the program; and
(3) a description of the oversight of the program.
Subtitle H--Treating Barriers to Prosperity
SEC. 8071. SHORT TITLE.
This subtitle may be cited as the ``Treating Barriers to
Prosperity Act of 2018''.
SEC. 8072. DRUG ABUSE MITIGATION INITIATIVE.
(a) In General.--Chapter 145 of title 40, United States
Code, is amended by inserting after section 14509 the
following:
``Sec. 14510. Drug abuse mitigation initiative
``(a) In General.--The Appalachian Regional Commission may
provide technical assistance to, make grants to, enter into
contracts with, or otherwise provide amounts to individuals
or entities in the Appalachian region for projects and
activities to address drug abuse, including opioid abuse, in
the region, including projects and activities--
``(1) to facilitate the sharing of best practices among
States, counties, and other experts in the region with
respect to reducing such abuse;
``(2) to initiate or expand programs designed to eliminate
or reduce the harm to the workforce and economic growth of
the region that results from such abuse;
``(3) to attract and retain relevant health care services,
businesses, and workers; and
``(4) to develop relevant infrastructure, including
broadband infrastructure that supports the use of
telemedicine.
``(b) Limitation on Available Amounts.--Of the cost of any
activity eligible for a grant under this section--
``(1) not more than 50 percent may be provided from amounts
appropriated to carry out this section; and
``(2) notwithstanding paragraph (1)--
``(A) in the case of a project to be carried out in a
county for which a distressed county designation is in effect
under section 14526, not more than 80 percent may be provided
from amounts appropriated to carry out this section; and
``(B) in the case of a project to be carried out in a
county for which an at-risk designation is in effect under
section 14526, not more than 70 percent may be provided from
amounts appropriated to carry out this section.
``(c) Sources of Assistance.--Subject to subsection (b), a
grant provided under this section may be provided from
amounts made available to carry out this section in
combination with amounts made available--
``(1) under any other Federal program (subject to the
availability of subsequent appropriations); or
``(2) from any other source.
``(d) Federal Share.--Notwithstanding any provision of law
limiting the Federal share under any other Federal program,
amounts made available to carry out this section may be used
to increase that Federal share, as the Appalachian Regional
Commission determines to be appropriate.''.
[[Page H5560]]
(b) Clerical Amendment.--The analysis for chapter 145 of
title 40, United States Code, is amended by inserting after
the item relating to section 14509 the following:
``14510. Drug abuse mitigation initiative.''.
Subtitle I--Supporting Grandparents Raising Grandchildren
SEC. 8081. SHORT TITLE.
This subtitle may be cited as the ``Supporting Grandparents
Raising Grandchildren Act''.
SEC. 8082. FINDINGS.
Congress finds the following:
(1) More than 2,500,000 grandparents in the United States
are the primary caretaker of their grandchildren, and experts
report that such numbers are increasing as the opioid
epidemic expands.
(2) Between 2009 and 2016, the incidence of parental
alcohol or other drug use as a contributing factor for
children's out-of-home placement rose from 25.4 to 37.4
percent.
(3) When children cannot remain safely with their parents,
placement with relatives is preferred over placement in
foster care with nonrelatives because placement with
relatives provides stability for children and helps them
maintain family connections.
(4) The number of foster children placed with a grandparent
or other relative increased from 24 percent in 2006 to 32
percent in 2016, according to data from the Department of
Health and Human Services.
(5) Grandparents' lives are enhanced by caring for their
grandchildren; the overwhelming majority of grandparents
report experiencing significant benefits in serving as their
grandchildren's primary caregivers.
(6) Providing full-time care to their grandchildren may
decrease grandparents' ability to address their own physical
and mental health needs and personal well-being.
(7) Grandparents would benefit from better coordination and
dissemination of information and resources available to
support them in their caregiving responsibilities.
SEC. 8083. ADVISORY COUNCIL TO SUPPORT GRANDPARENTS RAISING
GRANDCHILDREN.
(a) Establishment.--There is established an Advisory
Council to Support Grandparents Raising Grandchildren.
(b) Membership.--
(1) In general.--The Advisory Council shall be composed of
the following members, or their designee:
(A) The Secretary of Health and Human Services.
(B) The Secretary of Education.
(C) The Administrator of the Administration for Community
Living.
(D) The Director of the Centers for Disease Control and
Prevention.
(E) The Assistant Secretary for Mental Health and Substance
Use.
(F) The Assistant Secretary for the Administration for
Children and Families.
(G) A grandparent raising a grandchild.
(H) An older relative caregiver of children.
(I) As appropriate, the head of other Federal departments,
or agencies, identified by the Secretary of Health and Human
Services as having responsibilities, or administering
programs, relating to current issues affecting grandparents
or other older relatives raising children.
(2) Lead agency.--The Department of Health and Human
Services shall be the lead agency for the Advisory Council.
(c) Duties.--
(1) In general.--
(A) Information.--The Advisory Council shall identify,
promote, coordinate, and disseminate to the public
information, resources, and the best practices available to
help grandparents and other older relatives--
(i) meet the health, educational, nutritional, and other
needs of the children in their care; and
(ii) maintain their own physical and mental health and
emotional well-being.
(B) Opioids.--In carrying out the duties described in
subparagraph (A), the Advisory Council shall consider the
needs of those affected by the opioid crisis.
(C) Native americans.--In carrying out the duties described
in subparagraph (A), the Advisory Council shall consider the
needs of members of Native American tribes.
(2) Report.--
(A) In general.--Not later than 180 days after the date of
enactment of this Act, the Advisory Council shall submit a
report to--
(i) the appropriate committees;
(ii) the State agencies that are responsible for carrying
out family caregiver programs; and
(iii) the public online in an accessible format.
(B) Report format.--The report shall include--
(i) best practices, resources, and other useful information
for grandparents and other older relatives raising children
identified under paragraph (1)(A) including, if applicable,
any information related to the needs of children who have
been impacted by the opioid epidemic;
(ii) an identification of any gaps in items under clause
(i); and
(iii) where applicable, identification of any additional
Federal legislative authority necessary to implement the
activities described in clause (i) and (ii).
(3) Follow-up report.--Not later than 2 years after the
date on which the report required under paragraph (2)(A) is
submitted, the Advisory Council shall submit a follow-up
report that includes the information identified in paragraph
(2)(B) to--
(A) the appropriate committees;
(B) the State agencies that are responsible for carrying
out family caregiver programs; and
(C) the public online in an accessible format.
(4) Public input.--
(A) In general.--The Advisory Council shall establish a
process for public input to inform the development of, and
provide updates to, the best practices, resources, and other
information described in paragraph (1) that shall include--
(i) outreach to States, local entities, and organizations
that provide information to, or support for, grandparents or
other older relatives raising children; and
(ii) outreach to grandparents and other older relatives
with experience raising children.
(B) Nature of outreach.--Such outreach shall ask
individuals to provide input on--
(i) information, resources, and best practices available,
including identification of any gaps and unmet needs; and
(ii) recommendations that would help grandparents and other
older relatives better meet the health, educational,
nutritional, and other needs of the children in their care,
as well as maintain their own physical and mental health and
emotional well-being.
(d) FACA.--The Advisory Council shall be exempt from the
requirements of the Federal Advisory Committee Act (5 U.S.C.
App.).
(e) Funding.--No additional funds are authorized to be
appropriated to carry out this subtitle.
(f) Sunset.--The Advisory Council shall terminate on the
date that is 3 years after the date of enactment of this Act.
SEC. 8084. DEFINITIONS.
In this subtitle:
(1) Advisory council.--In this subtitle, the term
``Advisory Council'' means the Advisory Council to Support
Grandparents Raising Grandchildren that is established under
section 8083.
(2) Appropriate committees.--In this subtitle, the term
``appropriate committees'' means the following:
(A) The Special Committee on Aging of the Senate.
(B) The Committee on Health, Education, Labor, and Pensions
of the Senate.
(C) The Committee on Education and the Workforce of the
House of Representatives.
(D) The Committee on Energy and Commerce of the House of
Representatives.
Subtitle J--Reauthorizing and Extending Grants for Recovery From Opioid
Use Programs
SEC. 8091. SHORT TITLE.
This subtitle may be cited as the ``Reauthorizing and
Extending Grants for Recovery from Opioid Use Programs Act of
2018'' or the ``REGROUP Act of 2018''.
SEC. 8092. REAUTHORIZATION OF THE COMPREHENSIVE OPIOID ABUSE
GRANT PROGRAM.
Section 1001(a)(27) of the Omnibus Crime Control and Safe
Streets Act of 1968 (34 U.S.C. 10261(a)(27)) is amended by
striking ``through 2021'' and inserting ``and 2018, and
$330,000,000 for each of fiscal years 2019 through 2023''.
The Acting CHAIR. No further amendment to the bill, as amended, shall
be in order except those printed in part B of House Report 115-766.
Each such further amendment may be offered only in the order printed in
the report, by a Member designated in the report, shall be considered
as read, shall be debatable for the time specified in the report
equally divided and controlled by the proponent and an opponent, shall
not be subject to amendment, and shall not be subject to a demand for
division of the question.
Amendment No. 1 Offered by Mr. Walden
The Acting CHAIR. It is now in order to consider amendment No. 1
printed in part B of House Report 115-766.
Mr. WALDEN. Mr. Chairman, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 65, line 18, insert ``(as described in paragraph
(4)(F))'' after ``telehealth services''.
Page 68, line 21, insert ``, as determined by the
Secretary'' after ``clinical improvement''.
Page 70, line 24, strike ``certified''.
Page 70, after line 25, insert the following:
(b) Clarification.--Nothing in the amendments made by
subsection (a) shall be construed to prohibit separate
payment for structured assessment and intervention services
for substance abuse furnished to an individual on the same
day as an initial preventive physical examination.
Page 71, line 1, redesignate the subsection (b) as a
subsection (c).
Page 71, strike line 21 and all that follows through page
72, line 2, and insert the following:
``(ii) For purposes of clause (i), the term `targeted
procedure' means a procedure to which Healthcare Common
Procedure Coding System code 62310 (or, for years beginning
after 2016, 62321), 62311 (or, for years beginning after
2016, 62323), 62264, 64490, 64493, or G0260, or any successor
code, apply.''.
Page 95, line 1, strike ``100 or more'' and insert ``more
than 100''.
Page 95, line 2, strike ``30 or more'' and insert ``more
than 30''.
Page 95, line 13, insert ``the frequency of toxicology
testing, including'' before ``the average''.
page 96, line 10, strike ``2025'' and insert ``2024''.
page 97, strike line 7, and insert ``that is at least 85
percent but not greater than the minimum medical loss ratio
(as so defined)
[[Page H5561]]
that such State applied as of May 31, 2018; or''.
The Acting CHAIR. Pursuant to House Resolution 949, the gentleman
from Oregon (Mr. Walden) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentleman from Oregon.
Mr. WALDEN. Mr. Chairman, I appreciate all the work that has been
done on this bill up to this point, the great bipartisan work, the
biggest effort, I think, Congress has ever undertaken to address this
terrible, terrible addiction problem of opioids and everything related
to it.
This amendment before us is a bipartisan manager's amendment. It is
filed by chairmen and ranking members of the Committees on Energy and
Commerce and Ways and Means. This amendment makes simple technical
corrections and conforming changes to the underlying H.R. 6 bill that
the leaders of our two committees introduced last week.
As has been noted, the policies in H.R. 6 were moved through regular
order in our two committees. I appreciate the bipartisan cooperation
and teamwork of my colleagues and our terrific staffs who have joined
me in introducing H.R. 6.
Mr. Chair, I encourage support of the amendment, and I urge adoption
of the amendment.
Mr. Chairman, I yield back the balance of my time.
The Acting CHAIR. The question is on the amendment offered by the
gentleman from Oregon (Mr. Walden).
The amendment was agreed to.
The Acting CHAIR. The Committee will rise informally.
The SPEAKER pro tempore (Mr. Marshall) assumed the chair.
____________________