[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.

                          ____________________