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21–277—PDF 2016

S. HRG. 114–339 

EXAMINING HEROIN AND OPIATE ABUSE IN 

SOUTHWESTERN PENNSYLVANIA 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH CARE 

OF THE

COMMITTEE ON FINANCE 

UNITED STATES SENATE 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

(PITTSBURGH, PA) 

OCTOBER 15, 2015 

( 

Printed for the use of the Committee on Finance 

COMMITTEE ON FINANCE 

ORRIN G. HATCH, Utah, Chairman 

CHUCK GRASSLEY, Iowa 

MIKE CRAPO, Idaho 

PAT ROBERTS, Kansas 

MICHAEL B. ENZI, Wyoming 

JOHN CORNYN, Texas 

JOHN THUNE, South Dakota 

RICHARD BURR, North Carolina 

JOHNNY ISAKSON, Georgia 

ROB PORTMAN, Ohio 

PATRICK J. TOOMEY, Pennsylvania 

DANIEL COATS, Indiana 

DEAN HELLER, Nevada 

TIM SCOTT, South Carolina 

RON WYDEN, Oregon 

CHARLES E. SCHUMER, New York 

DEBBIE STABENOW, Michigan 

MARIA CANTWELL, Washington 

BILL NELSON, Florida 

ROBERT MENENDEZ, New Jersey 

THOMAS R. CARPER, Delaware 

BENJAMIN L. CARDIN, Maryland 

SHERROD BROWN, Ohio 

MICHAEL F. BENNET, Colorado 

ROBERT P. CASEY, Jr., Pennsylvania 

MARK R. WARNER, Virginia 

CHRIS CAMPBELL, Staff Director 

JOSHUA SHEINKMAN, Democratic Staff Director 

SUBCOMMITTEE ON HEALTH CARE

PATRICK J. TOOMEY, Pennsylvania, Chairman 

CHUCK GRASSLEY, Iowa 

PAT ROBERTS, Kansas 

MICHAEL B. ENZI, Wyoming 

RICHARD BURR, North Carolina 

DANIEL COATS, Indiana 

DEAN HELLER, Nevada 

TIM SCOTT, South Carolina 

DEBBIE STABENOW, Michigan 

MARIA CANTWELL, Washington 

ROBERT MENENDEZ, New Jersey 

BENJAMIN L. CARDIN, Maryland 

SHERROD BROWN, Ohio 

MARK R. WARNER, Virginia 

(II) 

(III) 

C O N T E N T S 

OPENING STATEMENTS 

Page 

Toomey, Hon. Patrick J., a U.S. Senator from Pennsylvania, chairman, 

Subcommittee on Health Care, Committee on Finance .................................... 2 

Casey, Hon. Robert P., Jr., a U.S. Senator from Pennsylvania ........................... 4 

MODERATOR 

Farah, Tony, M.D., chief medical officer, Allegheny Health Network, Pittsburgh, PA .............................................................................................................. 1 

WITNESSES 

Ling, Shari M., M.D., Deputy Chief Medical Officer, Centers for Medicare 

and Medicaid Services, Department of Health and Human Services, Baltimore, MD .............................................................................................................. 6 

Capretto, Neil A., D.O., F.A.S.A.M., medical director, Gateway Rehab, Aliquippa, PA ............................................................................................................ 13 

Vittone, Eugene A., II, District Attorney, Washington County, PA .................... 15 

Kabazie, A. Jack, M.D., system director, Division of Pain Medicine, Allegheny 

Health Network, Pittsburgh, PA ........................................................................ 17 

Potts, Ashley, team leader, Crisis Stabilization and Diversion Unit, Southwestern Pennsylvania Human Services, Inc., Charleroi, PA ........................... 19 

ALPHABETICAL LISTING AND APPENDIX MATERIAL 

Capretto, Neil A., D.O., F.A.S.A.M.: 

Testimony .......................................................................................................... 13 

Prepared statement .......................................................................................... 35 

Casey, Hon. Robert P., Jr.: 

Opening statement ........................................................................................... 4 

Kabazie, A. Jack, M.D.: 

Testimony .......................................................................................................... 17 

Prepared statement .......................................................................................... 39 

Ling, Shari M., M.D.: 

Testimony .......................................................................................................... 6 

Prepared statement .......................................................................................... 41 

Potts, Ashley: 

Testimony .......................................................................................................... 19 

Prepared statement .......................................................................................... 45 

Toomey, Hon. Patrick J.: 

Opening statement ........................................................................................... 2 

Prepared statement .......................................................................................... 47 

Vittone, Eugene A., II: 

Testimony .......................................................................................................... 15 

Prepared statement .......................................................................................... 48 

COMMUNICATIONS

American Association for the Treatment of Opioid Dependence (AATOD) ........ 53 

American Psychiatric Association et al. ................................................................. 55 

Beacon Health Options ............................................................................................ 58 

Clark, Allan W., M.D. .............................................................................................. 61 

Conemaugh Memorial Medical Center .................................................................. 69 

Gateway Health Plan .............................................................................................. 70 

Page

IV 

Geary, Karen, RPh, MHA ....................................................................................... 73 

Hospital and Healthsystem Association of Pennsylvania (HAP) ......................... 75 

Kmiec, Julie, D.O. .................................................................................................... 76 

National Association of Chain Drug Stores (NACDS) .......................................... 79 

Partsch, Deborah ..................................................................................................... 84 

Pennsylvania Medical Society ................................................................................. 85 

Pew Charitable Trusts ............................................................................................ 86 

Pfizer ......................................................................................................................... 88 

Pinnacle Treatment Centers ................................................................................... 90 

Pittsburgh Tribune-Review ...................................................................................... 93 

Positive Recovery Solutions (PRS) ......................................................................... 94 

Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center and Addiction Medicine Services ..................................................... 96 

Wong, Kevin M., M.D., CMD, FAAFP ................................................................... 97 

(1) 

EXAMINING HEROIN AND OPIATE ABUSE IN 

SOUTHWESTERN PENNSYLVANIA 

THURSDAY, OCTOBER 15, 2015 

U.S. SENATE, SUBCOMMITTEE ON HEALTH CARE, COMMITTEE ON FINANCE, Pittsburgh, PA. 

The hearing was convened, pursuant to notice, at 2:13 p.m., in 

the McGovern Auditorium, Allegheny General Hospital, 320 East 

North Avenue, Pittsburgh, PA, Hon. Patrick J. Toomey (chairman 

of the subcommittee) presiding. 

Also present: Senator Casey. 

Dr. FARAH. Good afternoon. On behalf of Allegheny Health Network, I would like to welcome Senator Toomey, who sits on the 

Senate Finance Subcommittee on Health Care, and Senator Casey, 

who sits on the Senate Health, Education, Labor, and Pensions 

Committee. And a special welcome to our friends from CMS—Dr. 

Ling, thank you—Gateway Rehab, and Washington County, who 

have agreed to testify today. Nobody understands the complexity 

and severity of this issue more than our medical professionals and 

our law enforcement community. Thank you, Senator Toomey and 

Senator Casey, for your leadership on this issue. 

Senator Toomey and others have introduced the Stopping Medication Abuse and Protecting Seniors Act. This is the act which is 

meant to prevent inappropriate access to opioids for Medicare patients, and the law would identify medical beneficiaries with a history of drug abuse and lock them into one prescriber and one pharmacy to reduce physician and pharmacy shopping. 

Just a few days ago, Senator Casey visited an addiction treatment center in Norristown, PA. Senator Casey supports the Treatment and Recovery Investment Act, which would increase funding 

for prevention and treatment programs, including recovery programs for teenagers and pregnant women. 

Both of these laws could help ease the drug abuse problem, and 

both our Senators understand the gravity of the opioid epidemic. 

The epidemic is growing in Appalachia, in Pennsylvania, and our 

own region. Pennsylvania now has the seventh-highest drug overdose death rate in the United States, West Virginia nearby has the 

highest overdose death rate, and Ohio has the eighth-highest rate. 

In our own State, we have more than 2,400 overdose deaths per 

year, and most of them are related to prescription painkillers. We 

now lose more people in Pennsylvania to overdose deaths than to 

car accidents. 

2 

This is a battle on multiple fronts. Painkiller abuse is linked to 

heroin abuse. A 2014 study found that 80 percent of the people who 

now use heroin were addicted to opioid painkillers first. The Attorney General’s office says that Pennsylvania has about 40,000 heroin users, and that number is growing every year. 

It is growing nationally too. Laws to restrict prescription shopping and to prevent painkiller abuse can work, but then some of 

those people who can no longer find painkillers are switching to 

heroin. You stop one, and the other then doubles. 

We are trying to do our part here at Allegheny Health Network, 

and what we are doing is training our emergency room physicians, 

nurses, social workers, and dentists to spot the early signs of abuse 

and to know more about pain medications. And more than a year 

ago, we became one of the first health networks in the State to 

help equip law enforcement with Narcan, the generic then being 

naloxone. This is a life-saving heroin overdose drug. We have already seen the benefits of that. 

Obviously these are serious problems that require serious leadership and a thoughtful response, not just from the medical and law 

enforcement communities, but from policymakers as well, which is 

why we are here today. I would like to thank Senator Toomey for 

convening this hearing and also thank Senator Casey for attending. 

And we thank you both for allowing Allegheny General Hospital 

and the Allegheny Health Network to be your host today. 

OPENING STATEMENT OF HON. PATRICK J. TOOMEY, A U.S. 

SENATOR FROM PENNSYLVANIA, CHAIRMAN, SUBCOMMITTEE ON HEALTH CARE, COMMITTEE ON FINANCE 

Senator TOOMEY. Thank you very much, Dr. Farah. I appreciate 

that. I appreciate you joining us today. I want to also thank John 

Paul and the Allegheny Health Network for making this terrific facility available to us. I also want to thank my fellow Finance Committee member, Senator Casey, for joining me today. I know that 

he and I both care very, very deeply about this very, very pressing 

problem that is occurring all across the Commonwealth and, in 

fact, across our country. 

The fact is, as Dr. Farah mentioned, more Pennsylvanians will 

die this year from overdoses and misuse just of heroin and prescription painkillers than from influenza or homicide. And unlike 

past drug epidemics that tended to skew towards younger populations and were concentrated in specific locales, today heroin and 

prescription drug overdoses are spread across all races, regions, demographics, and ages. 

As the Senate Finance Subcommittee on Health Care will hear 

today from our witnesses, sadly southwestern Pennsylvania has 

been hit particularly hard by this epidemic. It seems to me that 

stopping this epidemic and healing our communities will require at 

least a three-pronged approach, and I am trying to pursue that as 

chairman of the Senate Finance Subcommittee on Health Care. 

One element of this approach is to stop the illegal diversion of prescription painkillers, a second is reducing the overuse of opioids for 

treating long-term pain, and a third is to help those battling with 

addiction to receive the appropriate treatment. 

3 

Our witnesses today will discuss these issues and other issues 

that they will bring up, and I want to really thank all of our witnesses for taking the time to be with us today and for sharing their 

expertise and helping to shed light so that we can hopefully develop policies that will be helpful for our communities. 

Our first panel will consist of Dr. Shari Ling. Dr. Ling is the 

Deputy Chief Medical Officer from the Centers for Medicare and 

Medicaid Services at the United States Department of Health and 

Human Services. After Dr. Ling testifies, Senator Casey and I will 

ask her some questions, and then we will proceed to a second 

panel. 

And the second panel will consist of Dr. Neil Capretto—Dr. 

Capretto is the medical director of the Gateway Rehabilitation Center; Mr. Gene Vittone, who is the district attorney for Washington 

County; Dr. Jack Kabazie, who is the system director for the Division of Pain Medicine here at the Allegheny Health Network; and 

Ms. Ashley Potts, who is the team leader in the Crisis Stabilization 

and Diversion Unit for Southwestern Pennsylvania Human Services. I also want to point out that joining us this afternoon is U.S. 

Attorney David Hickton, who has provided outstanding leadership 

in this and many other areas. So, David, thank you for joining us. 

I would like, just for a moment though, to consider how we arrived at this point. It seems to me the seeds of this crisis may well 

have been planted 2 decades ago with the advent of readily available painkillers like hydrocodone and oxycodone. And while these 

drugs no doubt produce immediate pain relief, they are easily 

abused. They are highly addictive, and they can be frequently diverted. The data that I have seen suggests that something on the 

order of 80 percent of heroin users previously abused prescription 

opioids. 

And despite the crackdown on many of the so-called ‘‘pill mills’’ 

where unethical physicians intentionally prescribe very large 

amounts of powerful opioids in exchange for cash, the problem of 

diversion and over-prescribing still does exist. In fact, the nonpartisan Government Accountability Office has found that there 

are more than 170,000 Medicare enrollees who are actively engaged 

in doctor shopping—shopping for physicians who will unknowingly 

write redundant opioid prescriptions. 

Now, when insurance plans, including Medicaid, spot this kind 

of fraud, the insurer will then limit or, as we say, lock in the individual to a single doctor or pharmacy in order to stop the pill diversion and help control access to the addictive medication. But unfortunately, Medicare does not have that tool, and that is why I have 

introduced bipartisan legislation, the Stopping Medication Abuse 

and Protecting Seniors Act. This legislation, which Senator Casey 

has co-sponsored—which I appreciate—will not only help individuals battling addiction to get treatment, but it will also save taxpayers something on the order of $79 million by stopping the illegal 

diversion of pain pills. 

I think Medicare and other insurers also need to work with physicians to stop the medically unnecessary use of opioids to treat 

pain. This year about 260 million painkiller prescriptions will be 

filled—260 million. That is enough for every adult American to 

have their own bottle of pills, and, while opioids can certainly help 

4 

control intense pain immediately after surgery or a visit to the dentist or a traumatic event, the medical community has become concerned that long-term opioid use becomes less effective over time 

and is associated with higher rates of substance abuse, emergency 

room visits, accidental overdoses, and falls, especially in senior citizens. 

Now, fortunately medical specialty societies have begun developing new guidelines that reduce both the dosage and the length 

of time that prescription opioids can be safely taken. For instance, 

the American Academy of Neurology now says that the risk of 

opioid abuse outweighs any benefits for treating headaches, lower 

back pain, and fibromyalgia. And when opioids are used in combination with other narcotics like Valium or Xanax, that combination can be deadly. 

To help providers know the panoply of medications a patient is 

taking, I think there needs to be broader usage of robust prescription drug monitoring programs. Making them interoperable across 

State lines is particularly important for people who live near State 

lines. And it will help physicians as well as law enforcement to spot 

diversion and abuse, and that is why I have introduced with our 

colleague, the Democratic Senator from New Hampshire, Jeanne 

Shaheen, the reauthorization of the National All Schedules Prescription Electronic Reporting Act. NASPER is a Federal grant program that provides grants to States to develop interoperable prescription drug monitoring programs. 

Finally, I think we need to explore ways to improve access to and 

the quality of care for people who are suffering from addiction. 

While addiction to an opioid, or alcohol for that matter, often has 

been viewed as a moral failing, in many ways it is a chronic disease like diabetes or heart disease. And while the medical profession continues to debate the optimal treatment approaches, I think 

everyone agrees that opioid addiction can be treated with professional help. So Congress and my subcommittee are closely examining a number of legislative ideas in this area. 

Ending the epidemic of heroin addiction will require changes in 

the practice of medicine, government regulations, and societal 

views. There are steps we can and should take today that end diversion, reduce non-medical use of opioids, and approach this addiction like a treatable disease. So I want to thank everyone who 

is here today. This turnout, I think, shows the extent to which this 

tragedy affects so many people across southwestern Pennsylvania. 

I appreciate the passion with which you approach this issue to find 

solutions. By working together at the Federal, State, and local levels, with health care, law enforcement, and others coming together, 

I am confident that we can defeat this scourge. 

[The prepared statement of Senator Toomey appears in the appendix.] 

Senator TOOMEY. I would now like to recognize Senator Casey for 

his opening remarks. 

OPENING STATEMENT OF HON. ROBERT P. CASEY, JR., 

A U.S. SENATOR FROM PENNSYLVANIA 

Senator CASEY. Senator Toomey, thank you very much, and I am 

honored to be here, and I am grateful that Senator Toomey called 

5 

this hearing. We are both members of the Finance Committee, but 

I am not a member of his subcommittee, so I am here by special 

permission or designation. So I am grateful to have that opportunity because, as he said, this is a problem and a challenge for 

our country that knows no geographic or political boundaries. This 

affects all of us, all of our communities, in one way or the other. 

We are so grateful that Allegheny General Hospital has us here, 

and we are grateful for our witnesses, and we will be getting to our 

witnesses shortly. I will try to be as brief as I can. I want to thank 

David Hickton for being here, someone who has been in the trenches on this at the Federal level—and every level of government has 

to work on this problem. 

We are here today because of a problem our country confronts, 

which might be described as the dark night of addiction and death 

that comes from the problems people have ultimately with painkillers, opioids, and often, unfortunately, the related abuse of heroin. And that dark night, I think, requires some light, and one of 

the reasons we gather and have a hearing like this is to hear from 

experts to consider different perspectives on how to confront this, 

and hope that together we can bring some of that light. 

The numbers and the data points are almost endless. There are 

so many ways you could describe the problem. One has already 

been mentioned, the idea that in Pennsylvania today we can report 

sadly that the number of people who will die from overdose is higher than the number of people who would die from auto accidents. 

It is hard to comprehend that that is true, but that is what we are 

told. 

Another way to look at it is, over 5 years, 3,000 people in this 

State have died either by way of opioid problems or heroin. If you 

look at it over a longer period of time, over 20 years, there has 

been a 470-percent increase in overdose deaths. Twenty years, 

Pennsylvania, 470-percent increase. The Coroners Association— 

maybe the most graphic number of all—tells us that just between 

2009 and 2014, about 5 years, the number of overdose deaths went 

from 47—47—to 800. So no matter what number you use—we 

could go on and on with the numbers, and I will not—there is almost no way to adequately describe the horror that this has 

brought to our communities and to our families. 

So what do we do about it? Well, if you are a legislator—and 

Senator Toomey outlined that we have a number of legislative proposals. The bill that he worked on and has sponsored with Senator 

Brown is one of those. I will just highlight very quickly a few others. Senate bill 1410 would increase the block grant funding, the 

so-called Substance Abuse Prevention and Treatment Block Grant. 

That particular block grant helps our States with planning, with 

implementing and evaluating efforts to prevent and treat substance 

abuse, and is funded now at about $1.45 million. I believe, and others believe, that number should go up. 

Secondly, a piece of legislation that I have worked on deals with 

a segment of this problem as it relates to newborns. Senator 

McConnell, the majority leader, and I have a bill, Senate bill 799. 

The neonatal abstinence syndrome problem is the focus of this bill. 

That occurs when infants are born addicted to opioids, and what 

we would do with our bill is very simple. We direct the Department 

6 

of Health and Human Services to develop a strategy to fill in the 

gaps, whether they are research gaps or program gaps, and also at 

the same time require that HHS develop recommendations for preventing and treating this condition, so-called neonatal abstinence 

syndrome, among other things we can do. 

Finally, as Senator Toomey mentioned, there have been legislative efforts. I do not think we are there in terms of progress yet 

when it comes to establishing requirements for DEA-registered prescribers and that interoperability that Senator Toomey mentioned. 

That is also part of the problem. Sometimes the first line of defense 

is a pharmacist, among the most trusted people in a community, 

and they can help us enormously in terms of pointing out problems. 

I have been to a couple of places in this State over the last couple 

of months where we are seeing the manifestation of what a lot of 

advocates and a lot of experts in this room would tell us over and 

over again: good treatment works, but it has to be good treatment, 

and it has to be sustained, and we have to make sure we have the 

resources to sustain it. 

So we are grateful that, on a day like today when we will focus 

on much of the horror, on much of the tragedy, much of that darkness, that so many people in this room, by way of your work, by 

way of your presence here, or by way of your testimony, starting 

with Dr. Ling, can bring some light to that darkness. And I want 

to thank Senator Toomey for gathering us today. 

Senator TOOMEY. Thank you, Senator Casey. We will now hear 

from our first witness. Dr. Shari Ling is currently the Deputy Chief 

Medical Officer serving in the Center for Clinical Standards and 

Quality at the Centers for Medicare and Medicaid Services. Dr. 

Ling is a geriatrician and rheumatologist who received her medical 

training at Georgetown University School of Medicine, Georgetown 

University Medical Center, and Johns Hopkins University. She 

also is a researcher and staff clinician at the National Institutes of 

Health’s National Institute on Aging, studying human aging and 

age-associated chronic diseases with attention to musculoskeletal 

conditions and mobility function. 

Dr. Ling, thank you very much for joining us. Please present us 

a summary of your testimony. 

STATEMENT OF SHARI M. LING, M.D., DEPUTY CHIEF MEDICAL 

OFFICER, CENTERS FOR MEDICARE AND MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES, 

BALTIMORE, MD 

Dr. LING. Good afternoon, and, Chairman Toomey, Senator 

Casey, please accept my sincere thanks for the invitation to discuss 

the Centers for Medicare and Medicaid Services’ work to ensure 

that all Medicare and Medicaid beneficiaries are receiving the 

medications that they need while also reducing and preventing prescription drug abuse. 

As you have heard already, opioid addiction is taking a real toll 

on communities, families, and individuals, both here in Pennsylvania and across our Nation. And as a practicing rheumatologist 

and geriatrician, I understand the challenges of effectively managing frail, older adult patients with debilitating chronic pain. It 

begins with identifying the underlying source or cause of painful 

7 

symptoms, particularly in older adult patients where it can be challenging to decide which condition is the problem. 

It then proceeds with understanding all of the medical, psychological, social, and other issues that must be addressed in every patient’s plan of care. Intervention that addresses the underlying 

cause will improve symptoms; that is, it will alleviate pain if addressed effectively. However, when pain persists despite conservative management attempts and threatens the quality of life and 

function, chronic pain management should include non-pharmacologic as well as medicinal agents, but each time with clear and precise treatment goals. There will be patients for whom opioid medications are necessary, but oftentimes other pain management strategies can be as effective and more appropriate. 

Combating non-medical prescription opioid use, overuse, dependence, and overdose is a priority for the Department of Health and 

Human Services, Secretary Burwell, and the administration at 

large. As part of that commitment, the Secretary has launched an 

evidence-based opioid initiative that focuses on three targeted 

areas: that is, informing opioid prescribing practices, increasing the 

use of naloxone as a second point, and the third being expanding 

the use of medication-assisted treatment to treat the opioid use disorder itself. 

As part of our role in these efforts across HHS, CMS has released guidance to help States implement comprehensive evidencebased service delivery approaches to Substance Use Disorder treatment. Overall, CMS recognizes our responsibility to protect the 

health of Medicare and Medicaid beneficiaries here in Pennsylvania and across the Nation by putting appropriate safeguards into 

place that prevent non-medical use and abuse of opioids, while ensuring that beneficiaries access the needed medications that are 

appropriate for them. 

Since its inception, the Medicare Part D prescription drug benefit 

program has made medications more available and more affordable 

for Medicare beneficiaries, leading to improvements in access to 

prescription drugs, better health outcomes in general, and greater 

beneficiary satisfaction with their Medicare coverage. But despite 

these successes, Medicare Part D is not immune from the nationwide epidemic of opioid abuse. The structure of the program, in 

which Part D plan sponsors do not have access to Part D prescriber 

and pharmacy data beyond the transactions that they manage for 

their own enrollees, makes it more difficult to identify prescribers 

or pharmacies that are outliers in their prescribing or dispensing 

patterns relative to the entire Part D program. 

CMS has taken several steps to protect beneficiaries from the 

harm and damaging effects associated with non-medical prescription drug use, and to prevent and detect fraud related to prescription drugs. To prevent overutilization of opioid medications through 

strengthening CMS’s monitoring of Part D plan sponsors, CMS has 

implemented the Medicare Part D Overutilization Monitoring System, or abbreviated as OMS. OMS requires Part D sponsors to implement effective safeguards to deter overutilization while maintaining a commitment to provide coverage for appropriate drug 

therapies that meet safety and efficacy standards. Through this 

system, CMS provides quarterly reports to sponsors’ drug plans on 

8 

beneficiaries with potential opioid overutilization, and sponsors are 

expected to utilize various drug utilization monitoring tools if necessary to prevent overutilization. 

We believe this Part D overutilization policy has played a key 

role in reducing opioid utilization in the program. That is, from 

2011 through 2014, the number of potential overutilizers decreased 

by approximately 26 percent, or said another way, 7,500 beneficiaries over that 3-year period of time did not become overutilizers. So there was a significant reduction, but as we have heard 

from the numbers shared today, we have a long way to go. 

CMS has also used and has available new tools to take action 

against problematic prescribers. CMS issued a regulation that both 

requires prescribers of Part D drugs to enroll in Medicare, and establishes a new revocation authority for abusive prescribing patterns. CMS is actively working to enroll over 400,000 prescribers 

in Part D by January of 2016. Requiring prescribers to enroll in 

Medicare will help CMS make sure that Part D drugs are prescribed by qualified individuals and will prevent prescriptions from 

excluded or already revoked prescribers from being filled. 

Additionally, CMS has established its authority to remove prescribers from Medicare when they demonstrate irresponsible prescribing patterns, have their DEA certificate of regulation suspended or revoked, or if any State has suspended or revoked the 

physician’s or eligible professional’s ability to prescribe. These new 

revocation authorities provide CMS with the ability to remove 

problematic prescribers from the Medicare program and prevent 

them from treating people with Medicare. 

In addition to these initiatives, the President’s budget includes 

several proposals that would provide CMS with additional tools to 

prevent inappropriate use of opioids. One proposal to prevent prescription drug abuse in Medicare Part D would give CMS the authority to establish a program, commonly referred to as ‘‘lock-in,’’ 

that would require high-risk beneficiaries to only utilize certain 

prescribers and/or pharmacies to obtain controlled substance prescriptions similar to the requirement in many States in Medicaid 

programs. 

So in conclusion, CMS is dedicated to providing the best possible 

care to beneficiaries while also ensuring taxpayer dollars are spent 

on medically appropriate care. CMS has broadened its focus from 

ensuring beneficiaries have access to prescribed drugs to ensuring 

that Part D sponsors implement effective safeguards and provide 

coverage for drug therapies that meet the standards for safety and 

efficacy. 

Although there is still a great deal of work that needs to be done, 

CMS is confident that our initiatives will help to reduce the rate 

of opioid addiction and overdoses in the Medicare population. 

Thank you. 

[The prepared statement of Dr. Ling appears in the appendix.] 

Senator TOOMEY. Thank you very much, Dr. Ling. I am going to 

begin the questions, and I will try to keep to the 5-minute guidelines that we have established. Then I will yield the mic to Senator 

Casey. 

I just want to confirm, though, and I think you stated it clearly, 

that it is both your view and the position of CMS that the lock-in 

9 

approach to a single provider and a single pharmacy for high-risk 

beneficiaries and beneficiaries who are abusing prescription opioids 

would likely reduce the diversion of pain pills. And so, you and 

CMS are supportive of that approach for Medicare, correct? 

Dr. LING. So, if I may expand on it just a bit—— 

Senator TOOMEY. Sure. 

Dr. LING. CMS is supportive of the principle of lock-in because 

what it does achieve is, it provides some guarantee of continuity of 

a source of that prescribing, and it is one measure that can complement the tools that are already in place. And we believe that 

that would result in better outcomes in general. 

Senator TOOMEY. Okay, great. Thank you. Doctor, now you are 

a geriatrician. Maybe you could share with us just briefly some 

comments on vulnerabilities that might be greater among the older 

population, senior citizens, specifically with risk to either accidental misuse or other adverse effects from the use of opioids. 

Could you share with us your thoughts on that? 

Dr. LING. Certainly, I would be delighted to. The older adult population not only has a higher prevalence of chronic conditions, including those chronic conditions that can cause painful symptoms— 

many of which can be managed without the use of opioid medications—but likely secondary problems. 

We actually know from the Medicare data that among people, as 

an example, who have arthritis, which is a common reason that one 

would seek treatment from painful symptoms, the majority of those 

people also have competing other medical conditions, some of which 

may be related to the painful symptoms that they have; that is, 

they may have difficulty sleeping or sleep disturbance. They actually also may have kidney impairment, so their kidneys may not 

be functioning quite correctly. 

And so, you can see how not only they may be at risk of a temptation to overuse prescription medications that could be potentially 

harmful, but taken together with the management of other competing conditions that may be associated, such as a sleep disorder, 

they may also be at increased risk of adverse events occurring. And 

those adverse events could include unintentional overdose from 

opioid medication. It could, as you alluded to earlier, Senator, increase the risk of falls, of confusion—and the cycle continues. 

Senator TOOMEY. Thank you. I want to ask a question about the 

Overutilization Monitoring System, which sounds like it might indeed be helpful in spotting excessively high consumption of opioids. 

My understanding is that CMS tells plan sponsors when they identify a patient, a beneficiary, exceeding the equivalent of 90 milligrams of morphine per day. But I have seen some data suggesting 

that even at levels lower than that, maybe as low as 50 milligrams, 

there could be a significant risk of overdose, deaths, emergency 

room visits, accidental falls, and other unintended bad outcomes. 

So my question is, is CMS able to track the outcomes for individuals who receive opioids at that lower threshold, and is it your 

view that we have to consider the consequences that are occurring 

at those lower thresholds, or do you think 90 milligrams is all we 

need to know? 

Dr. LING. I will answer it in a couple of ways. Thank you for your 

question, first of all, because it actually gives me an opportunity 

10 

to talk about some of the balance in the system. We still want to 

maintain access for people who have painful symptoms, so it becomes an issue of threshold and what threshold to set in a monitoring program. 

Indeed it is true that CMS provides plans with prescription drug 

event data. Some of the data can include dosing. Obviously, we 

have dosing as part of the data and a great deal of other data, but 

we provide that data on a quarterly basis. And then the plans are 

expected to review those data and to look at those data and to try 

to understand and work with prescribers as well as pharmacies 

looking for those overutilizers and, if necessary, put in place some 

case management efforts to try to curb that prescribing pattern. 

Mind you, it is very safety-focused, so reaching a safety threshold, that is where we started. It is also a preventive action, so it 

is expected that the plans would put in place strategies to monitor 

and prevent future events from occurring. But it is a starting place, 

and the data do exist that would permit us to look further than 

what is currently utilized as a threshold. 

Having said that, we believe that it is an effective method of 

monitoring, and in support of the Secretary’s initiative in delivery 

system reform whereby information is used—that is, the Part D 

data being available to plans—it is an important step to achieving 

the reductions that we are hoping to achieve. 

Senator TOOMEY. Okay. Thank you very much. Senator Casey? 

Senator CASEY. Thanks very much, Doctor. Thanks for your testimony. 

I want to ask you a question that relates to the position CMS is 

in as a payer, the Federal Government entity that oversees and has 

to operate both Medicare and Medicaid in addition to other programs, and this connection, which I think you began to focus on in 

your written testimony as well as the summary you provided. At 

the bottom on page 1 of your testimony, you said, ‘‘The monetary 

costs and associated collateral impact to society due to Substance 

Use Disorder,’’ so-called SUD, ‘‘including opioid use disorder, are 

high.’’ You go on to say, ‘‘In 2009, health insurance payers spent 

$24 billion treating Substance Use Disorder, of which Medicaid accounted for 21 percent. The Medicare program itself through Medicare Part D spent $2.7 billion on opioids in 2011.’’ 

What I am getting at is the connection between the two where 

you literally have a connection between two activities that relate 

to the Federal Government. What can you tell us, if anything, 

about whether or not CMS can use its leverage as a payer and encourage prescribers to scrutinize their activities or prescriptions 

more generally? 

Dr. LING. Let me answer this in a couple of ways, and please let 

me know if I do not address your question fully. 

Senator CASEY. Sure. 

Dr. LING. So, as a payer, as you know, we are amidst delivery 

system reform, and part of that effort is to pay for high-value 

health care. That means quality health care or cost relative to 

quality. It is also a reform that requires that we practice differently, so how we actually deliver that care is more and more coordinated, it is better coordinated to be able to deliver the high 

value of care. 

11 

Now quality, as a focus, is an important factor because misuse 

of opioids, overuse of opioids, death from opioid use, are some of 

many undesirable events that we would think of as low-value 

health care. So, I think there is incredible opportunity to think 

about this problem in the context of delivery system reform and 

how we can go about placing the pieces that are necessary to improve the outcomes for medical care. Now, having said that, I do 

want to mention though, since you mentioned Medicare and also 

Medicaid, they are two distinct programs and authorities, but common to both is the need to improve how we deliver care. 

I did want to mention that, within the Medicaid space, we have 

provided letters of guidance to State Medicaid Directors on the construct and the composition of comprehensive care services that are 

needed to address addiction and abuse. And there are also additional proposals in the President’s 2016 budget that go further to 

expect or require States—many States monitor their prescription 

drug use patterns already, but it actually proposes to require 

States to do that, but also to use those data to adjust their planning and their strategies to meet the needs of the population. 

Now, they can choose to focus on prescription drugs or opioids, 

they can choose something else, but the opportunity exists. And I 

will conclude by also saying that there are two new programs—that 

is, the section 1115 waiver through the 1115 waiver authority, as 

well as a Medicaid innovation accelerator program—that will support new care and payment models for States in this space with addiction and opioid overuse as a focal point. So there are new demonstration authorities that can support us in figuring out how we 

provide better care and deliver that care that meets the needs of 

the population and contributes a solution to this problem. 

Senator CASEY. And I appreciate what you are trying to get to 

in that answer, but I just hope you use that leverage as a payer. 

And I know that is a startling number, Medicare through Part D 

spending $2.7 billion on opioids in 1 year, but that is a lot of leverage. 

My last question—I know I am probably over my time. I will just 

be really brief. Naloxone is a remarkable advancement. Here you 

can literally, at the scene of an overdose, be able to reverse that 

horrific consequence. It is a lifesaver. It is a wonderful innovation. 

The problem we are having is—one problem among several, I 

guess, is kind of a patchwork where some States are using it, some 

communities are using it, others not as much. 

There are no Federal standards. I am not sure there need to be. 

But what can you tell us about what HHS, CMS, can do to advance 

the use of naloxone, or what they are doing currently? 

Dr. LING. Yes. So, as you know, increasing the availability and 

access to naloxone is the second prong in the Secretary’s proposal 

to address this problem, the first being, of course, providing the 

education and information to providers so that they are aware of 

their prescribing practices and how to improve on them. 

If I can go into a little detail, naloxone is available, and it is covered in specific instances. So, as part of the Part B service or benefit, it is coverable if it is incident to a physician’s care services 

under Part B of Medicare. Now, that is important because physician services are also what are needed for comprehensive addiction 

12 

management, so it is not just a prescription, but it is actually much 

more than that. 

So the medication is available. There are other medications that 

are also available through Part D, pretty much medications such 

as methadone for pain. And buprenorphine and naloxone for any 

medically accepted indication are also available through Part D. So 

those are available. 

Senator CASEY. I hope we can work on that so we make it more 

readily available. Thank you. 

Dr. LING. Yes. 

Senator TOOMEY. I have just one quick follow-up for a second 

round, Dr. Ling, if I could, and that is, it is my understanding that 

there is a widespread view in the medical community that opioids 

may not be a suitable treatment for long-term chronic pain management, episodes lasting 60 and 90 days and longer. And in light 

of that, my understanding is that in Massachusetts, Massachusetts 

Blue Cross and Blue Shield has adopted a policy of requiring prior 

authorization for any prescription that exceeds 30 days for opioids. 

And I am just wondering whether you think that is an approach 

that has some merit or not. My understanding is it has reduced the 

frequency of these longer-term prescriptions. What are your 

thoughts on that, Dr. Ling? 

Dr. LING. So my thoughts are, there are many approaches that 

need to be taken. It is also a proposal to require additional clinical 

information on prescriptions so that there is a means of identifying 

and knowing about off-label uses beyond what would be medically 

indicated perhaps. Prior authorization is one such mechanism. 

I will also remind you that, as part of the Overutilization Monitoring System, the authority that we have is to encourage certain 

desirable plan behaviors. And so, plans have the ability in their 

toolbox to implement formulary edits, such as a maximum number 

that can be dispensed at a given time, and other safety edits. Those 

can all be put in place and should be used by plans when appropriate. 

So there are many different mechanisms that can achieve the 

same outcome, but really the outcome that we want and that we 

remain focused on is, how do we actually improve the outcomes, reduce these events of harm, improve safety, and still make available 

the treatment and services that the populations need to improve 

their own health? 

Senator TOOMEY. Senator Casey, anything else? 

Senator CASEY. No. Thank you very much. 

Dr. LING. Thank you. 

Senator TOOMEY. All right. Dr. Ling, thank you very much. 

Our second panel can now take their seats. Let me start with the 

introductions of the people on our second panel here, and then I 

will recognize them individually to give their testimony. 

First, Dr. Neil Capretto is the medical director of Gateway Rehabilitation Center in Beaver County. He is certified by the American 

Board of Psychiatry and Neurology with qualifications in addiction 

psychiatry, and is a medical review officer and fellow of the American Society of Addiction Medicine. He is frequently consulted in 

both local and national press on addiction and treatment, and has 

13 

served on the U.S. Attorney’s Working Group on Drug Overdose 

and Addiction. 

Mr. Gene Vittone is the District Attorney for Washington County. Prior to being elected, Mr. Vittone served as prosecutor for more 

than a decade and supervised the Elder Abuse Prosecution Unit. 

He has prosecuted numerous crimes, including violent felonies, sex 

crimes, child abuse, drug trafficking, and financial crimes. He is active in his local community as a volunteer firefighter and EMT. 

Dr. Jack Kabazie is the system director, Division of Pain Medicine, for the Allegheny Health Network. Overseeing the operations 

of all Allegheny Health Network pain physicians, Dr. Kabazie is 

often called on to provide expert commentary in the media on addiction and opioid abuse. He is a member of the American Society 

of Addiction Medicine and received his medical doctorate from the 

Medical College of Pennsylvania. Dr. Kabazie also served in the 

military for the U.S. Special Forces as a Green Beret from 1972 to 

1975. 

And finally, Ms. Ashley Potts is a team leader for the Crisis Stabilization and Diversion Unit of Southwestern Pennsylvania 

Human Services in Washington County. Ashley started using OxyContin when she was 13 years old, then became addicted to heroin 

by 17. She was lucky to finally get help and has been clean since 

September 11, 2006. She is a graduate of California University of 

Pennsylvania, is currently pursuing a masters degree, and had previously worked at the Washington, PA Drug and Alcohol Commission in Prevention Services. 

Dr. Capretto, you may begin with your testimony. 

STATEMENT OF NEIL A. CAPRETTO, D.O., F.A.S.A.M., MEDICAL 

DIRECTOR, GATEWAY REHAB, ALIQUIPPA, PA 

Dr. CAPRETTO. Thank you. Thank you very much, Senators 

Toomey and Casey, for inviting me here to speak with you today 

about the opioid epidemic in southwestern Pennsylvania. 

I have now been at Gateway full-time practicing addiction medicine for 26 years. And during that time, I have been directly involved in treating well over 15,000 individuals in our community 

struggling with prescription, opioid, and heroin addiction. I have 

really personally witnessed the evolution of this epidemic on a dayby-day basis starting in the mid- to late-90s, and it has devastated 

the lives of thousands of individuals and families in our community. 

The sad news is, as of today, there are more people in our region 

addicted to prescription opioids and heroin than at any time in our 

lives. And most signs indicate that if this problem is not addressed 

adequately, it is likely to continue to grow. It has also led to record 

numbers of overdose deaths. 

When I finished my residency at St. Francis in Pittsburgh in 

1985, there were 22 drug overdose deaths in Allegheny County, 

and there was outrage about that, and it was considered an inappropriate, tragic loss of life that must be corrected. But as this new 

opioid epidemic started coming in in the 90s, in 1998 Allegheny 

County reached over 100 with 104. We thought, would we ever see 

that again? Well, it stayed over 100. In 2002, it went over 200. It 

14 

has been over 200 a year every year since then. Last year we set 

a record with 307, going from 22 to 307. 

The other news is, surrounding counties are now actually seeing 

higher rates based on their populations. You know, the Centers for 

Disease Control last year described this as the worst drug overdose 

epidemic in U.S. history. Well, how did we get there? I talk about 

the perfect storm, and I often give lectures for many hours, but you 

have summarized it. 

In a nutshell, it has been this dramatic rise of prescription medicine starting in the 1990s. We absolutely have to treat pain, but 

how to do that properly is open for debate. There was heavy marketing by pharmaceutical companies. There was a dramatic rise in 

prescriptions of opioids. Western Pennsylvania was hit particularly 

hard because of our demographics. There was over a 500-percent 

increase in oxycodone. 

Thousands of people in our area became addicted. It spilled onto 

the streets, and at the same time this was occurring, the new heroin was coming in. Old heroin from Asia was about 10-percent 

pure. New heroin coming from Colombia and Mexico was well over 

50-percent pure. You could now snort that, avoid using a needle. 

And by the thousands, people who got addicted to prescription 

opioids who could no longer afford them switched over to heroin, 

and it spread through every community. It is everywhere, in every 

town, rural and suburban. You cannot get away from it at this 

point. In the last probably 5 to 10 years, the last several thousand 

new heroin users I have talked to in our area, probably easily 90 

to 95 percent of them all started with prescription medicines. 

So what should we do about it? I mean, obviously we have to 

focus on safe and proper use of opioid pain medications. Dr. Ling 

gave some suggestions. I mean, we definitely have to educate our 

medical community, and we are starting to do that. I mean, there 

are efforts going on. The medical community is making progress. 

The Pennsylvania Medical Society has some good guidelines. But, 

goodness, we have a long, long way to go. I mean, these prescription drugs in our community did not come from Afghanistan or Colombia. They came from our medical system, and we have to come 

out of denial that that is the reality. 

We need things like Prescription Drug Monitoring Programs. The 

good news is, our legislature in Pennsylvania passed one last fall. 

The bad news is, it is not funded yet. We are desperately waiting 

for that to become available. Such programs work, and as you said, 

Senator Toomey, we really need this to be regional and national to 

make it very effective. 

The Stop Medication Abuse and Protecting Seniors Act to me is 

a very good thing. You identify people who are already drug 

diverters and drug seekers, and you direct them to particularly a 

healthcare professional, to one pharmacy. And what you end up 

doing is, you are going to provide medical care to that person. You 

are going to protect them from devolving into their addiction. You 

are going to reduce drug diversion on the street. You are going to 

protect the community, and you are going to save money. That 

seems like a pretty common-sense no-brainer to me, you know. 

And obviously we have to provide treatment. As we restrict prescription medicines, we have to be careful about people converting 

15 

over to heroin, which is happening. We have to make sure that it 

is adequate, available, and of enough duration of time. The National Institute of Drug Abuse suggests a minimum of 90 days of 

treatment for people with addition. That is the minimum. Few people really get that over time. We also have to have adequate availability of naloxone to save lives. That is evolving, and I want to see 

that continue to expand. 

And finally, when we look at all these numbers and data of thousands of thousands, it is important that we just not get numb to 

those numbers. And it is important that we never, ever forget that 

behind every number is a real life, a real family struggling, like 16- 

year-old Billy, whom I met back in 2001. Great kid. Great sense 

of humor. Good student. I had a son about the same age. He had 

an infectious laugh. He won an award for drafting and talked about 

his dreams to be an architect one day. 

Like many kids, he was at a party and somebody offered him this 

new drug called OxyContin. He liked it, quickly became addicted 

to it, escalated his use, could not afford it, switched over to heroin 

use, and Billy died of a heroin overdose 2 days before his 17th 

birthday. And I talked to his mother on what would have been his 

birthday, and I will never forget her words. She said, ‘‘Today I just 

bought the last birthday present I will ever buy for my son, and 

it was a casket.’’ Those words continue to haunt me. 

But since Billy died in 2001, there have been nearly 5,000 other 

people in western Pennsylvania who have died from this condition. 

It is really a major epidemic, and I thank you, Senators, for addressing it and for inviting me today to speak on the issue. Thank 

you. 

[The prepared statement of Dr. Capretto appears in the appendix.] 

Senator TOOMEY. Thank you, Dr. Capretto. I appreciate that. 

Mr. Vittone? 

STATEMENT OF EUGENE A. VITTONE II, DISTRICT ATTORNEY, 

WASHINGTON COUNTY, PA 

Mr. VITTONE. Thank you, Senator. Good afternoon. Thank you, 

Senator Toomey and Senator Casey, for the honor and opportunity 

to provide testimony to this committee. I met Senator Toomey last 

year when he convened a working panel in Washington County, 

and I appreciate your efforts to fight the increasing problem with 

addiction in our country. 

I would also like to thank our local United States Attorney, 

David Hickton, for his leadership and help on this immense national problem of opioid abuse. Mr. Hickton is a champion and a 

great partner for law enforcement as we fight this epidemic. 

It is no secret that our Nation is in the midst of an epidemic of 

drug-related deaths caused by prescription drug abuse. This is a 

public health and a public safety crisis. Nationally, tens of thousands have died due to overdoses caused by opioid drugs. We in 

Washington County are not immune. Since 2011, we have had 

more than 230 Washington County residents lose their lives due to 

accidental poisoning caused by opioid drugs. In August of this year, 

we had a string of overdoses caused by fentanyl-laced heroin, which 

16 

claimed several lives and placed Washington County in the national news. 

This epidemic, however, goes beyond the overdoses. It significantly impacts the area where I work, which is the criminal justice 

system. I reviewed our criminal case filings for 2014 and found 

that at least 30 percent of our criminal cases were directly linked 

to opioid abuse coming from both pills and heroin. This is roughly 

equivalent to the exact number that we are running into with alcohol. Based upon my 17 years of working in the Washington County 

District Attorney’s Office, I can assure you this is a new phenomenon. Not too long ago, it was rare to see a heroin case in our 

court. Now it is rare not to have a case involving heroin or prescription medication. 

Our coroner in Washington County, Tim Worco, does a very good 

job of documenting the deaths, and his data reveals that this is not 

just a problem for young people. This data reads that 41 percent 

of our deaths since 2011 were people over the age of 40, and 46 

percent were a combination of two or more drugs, and 57 percent 

were from prescription medications. 

Now, the connection between opioid medication abuse and heroin 

is well established. As local law enforcement officials, we have had 

to respond to this, and we have developed an evolving plan to deal 

with it. We conduct local drug educational seminars at local schools 

to warn children of the dangers of the abuse of pharmaceuticals. 

We have drop boxes in our police stations for unwanted medications. We have embedded a Federal prosecutor in my office to aggressively go after the dealers who are distributing these drugs, 

and we have heightened and promoted, in connection with our local 

SCA, treatment for nonviolent criminal offenders. 

What we are trying to do is work on both the supply side and 

demand side of the problem. While I am proud of what we have 

done thus far, I feel that these measures will not be sufficient alone 

to eliminate the problem. Dr. Capretto talked about the Prescription Medication Monitoring Program. I second what he said. We 

did get that established last October. However, the funding did not 

come through. I have learned from our State representative, Brandon Neuman, that some funding has come through from the Federal side, but we really do need to get that program in place. And, 

Senator Toomey, your bill on NASPER is certainly going to be helpful in helping us with interstate medication diversion. 

Now, Washington County geographically is close to Maryland, 

Ohio, and West Virginia. Due to our location, we are an easy drive 

for those looking to acquire medications, either using forged prescriptions or through doctor shopping. An example of this is, in 

2013, we arrested 12 individuals who were operating as far to the 

east as Chambersburg and as far north as Warren County. 

What is interesting is that they were not going into other States 

to get the medications. They were staying in Pennsylvania because 

they could get the diversion. They obtained Opana, OxyContin, and 

other opioids from various pharmacies. They would not have been 

able to do this had there been a lock-in provision with our health 

insurance plans. We have also seen Suboxone starting to be diverted. We have had increased criminal activity near Suboxone 

17 

clinics, and we have made arrests of people selling Suboxone on the 

street. 

In 2012, the United States Attorney’s Office arrested Dr. Oliver 

Herndon, who was dispensing powerful oxycodone and oxymorphone in the area. He was one of the largest suppliers of diverted 

medications on the eastern seaboard. His parking lot frequently 

had cars from out of State in his lot. During one visit by an undercover officer, he actually told the undercover officer that you need 

to get these prescriptions filled as far away from here as you can 

because the pharmacies were on to him. He was also medical director for a hospice organization and two nursing homes. He was successfully prosecuted in Federal court for Drug Act violations. 

So as I said, over 50 percent of the people who die from accidental overdoses are over the age of 40. These facts emphasize the 

need for the legislation Senator Toomey is requesting on a lock-in 

for medication, and I would like to second that also. 

In closing, I am thankful for the opportunity to address the committee today. In the 4 years I have been District Attorney, I have 

had to learn a great deal about this, both on the medical end and 

on the law enforcement end. We need to help at all levels of government to make this happen. I am just one District Attorney in 

one county in Pennsylvania, but there are many more facing the 

same crisis, and we would like to continue to serve, and do our job, 

and do the best we can to fight this epidemic. 

Thank you. 

[The prepared statement of Mr. Vittone appears in the appendix.] 

Senator TOOMEY. Thank you very much, Mr. Vittone. 

Dr. Kabazie? 

STATEMENT OF A. JACK KABAZIE, M.D., SYSTEM DIRECTOR, 

DIVISION OF PAIN MEDICINE, ALLEGHENY HEALTH NETWORK, PITTSBURGH, PA 

Dr. KABAZIE. Senator Toomey, Senator Casey, thank you for 

shining a spotlight on this devastating epidemic that we have in 

our region and across the country. 

In the 1980s and 1990s, multiple factors contributed to a change 

in opioid prescribing for chronic non-malignant pain. Based on 

scant and faulty medical data, the risk of addiction was touted as 

rare, end organ toxicity non-existent, and incidence of tolerance extremely low. Armed with this information, physicians became less 

reluctant to prescribe opioids. Patient advocacy groups demanded 

better treatment for chronic pain, and pharmaceutical companies 

began reformulating opioids into extended-release preparations. 

This brought about a dramatic increase in analgesic prescribing for 

chronic non-malignant pain that coincided with the rise in opioidrelated morbidity and mortality. 

Currently, we in this Nation consume more opioids than the rest 

of the world combined. Primary care physicians and internal medicine physicians prescribe the majority of opioid preparations in this 

country, but most were not trained in addiction or pain management. While most doctors prescribe opioids with good intent, once 

they move down that path, it is an extremely difficult path to reverse. This can lead to disgruntled patients. It can lead to frustrated physicians. In addition, physicians who have compensation 

18 

or employment tied to patient satisfaction scores may feel pressure, 

if you will, to prescribe opioids in response to patient pain complaints. 

Nationally, there are major disparities in prescribing opioids for 

chronic pain. In some regions, including southwestern Pennsylvania, this has resulted in ‘‘pill mills’’ for profit. There are also physicians who tacitly prescribe opioids to continue patients on a long 

path of procedures that financially benefit the physician with little 

long-term benefit to the patient. In some circles, these are known 

as ‘‘pills for pokes’’ practices. This is a very small—very, very 

small—but difficult practice pattern to detect without close oversight. 

While much attention has been focused on opioid abuse, addiction, and mortality, there is also the issue of unintentional overdose from misuse and subsequent adverse events. This is an issue 

especially in the elderly population, who are at extreme risk for 

falls and fractures, cognitive impairment, and unintentional overdosing. Many of these seniors forget that they took one dose, and 

they take another dose, and this places them in significant danger. 

These adverse events result in increased emergency room visits, 

hospital admissions, and length of stay, adding strain to the 

healthcare costs in the United States. 

To curb the prescription opioid epidemic, State medical boards 

have published guidelines on the use of opioids to treat chronic, 

non-malignant pain. However, studies show that many providers 

do not follow these guidelines even with high-risk patients. Prescription drug monitoring programs are useful. However, they are 

significantly underutilized when they are not mandatory. 

To further address inappropriate opioid prescribing, Physicians 

for Responsible Opioid Prescribing, or PROP for short, has petitioned for a mandatory limit on the amount and duration of opioids 

that can be prescribed to a patient with chronic non-malignant 

pain. This has resulted in condemnation from patient advocacy 

groups who fear absolute rules will leave many chronic pain patients without help. 

We cannot address the opioid epidemic by painting this with a 

broad brush of absolutes, mandating dosing and time limits. There 

is, in fact, a small subset of patients who will require large doses 

of opioids for extended periods of time, and with monitoring they 

do very well. They should not be denied this therapeutic option. 

However, this should be a treatment of last resort. When all other 

attempts to control their pain have failed, they can be, in fact, candidates—if they have a well-defined pain generator—for opioids on 

an ongoing basis. However, most patients with chronic pain can be 

treated with satisfactory results using a multidisciplinary approach 

without the use of long-term opioid therapy. 

We need more than published guidelines that are either ignored 

or underutilized. It has already been shown that if there are guidelines, they do not necessarily have to be followed. One group of 

physicians that I asked about the published guidelines stated to 

me, ‘‘They are only guidelines.’’ 

The Risk Evaluation and Mitigation Strategy, or REMS for short, 

is a voluntary program using extended-release and long-acting 

opioids. Rather than a voluntary program, why not develop a manVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 R:\DOCS\21277.000 TIMD
19 

datory REMS coupled with obtaining a DEA number to prescribe 

opioids for chronic pain for longer than 3 months? This might be 

one strategy. You should also include short-acting opioids, as they 

are widely associated with abuse. Pill mill laws should be enacted 

in every single State in this Nation and adhered to, and offenders 

should be prosecuted. 

A prescription monitoring program, easily accessible and userfriendly, should be mandatory across the Nation, but it should be 

mandatory every time a prescription is written and every time a 

prescription is filled in a pharmacy. Referral to a multidisciplinary 

pain program should be made in a timely fashion for evaluation 

and treatment, and, to curtail this prescription opioid epidemic, all 

stakeholders need to come together to solve this problem. 

Senators, thank you very much. 

[The prepared statement of Dr. Kabazie appears in the appendix.] 

Senator TOOMEY. Thank you, Dr. Kabazie. 

Ms. Potts? 

STATEMENT OF ASHLEY POTTS, TEAM LEADER, CRISIS STABILIZATION AND DIVERSION UNIT, SOUTHWESTERN PENNSYLVANIA HUMAN SERVICES, INC., CHARLEROI, PA 

Ms. POTTS. Yes. First, I want to thank Senator Toomey and Senator Casey for giving me the opportunity to testify before you 

today. It is an honor to be able to be here before you. 

My name is Ashley Potts, and I currently work for Southwestern 

Pennsylvania Human Services. I am the team leader for the Crisis 

Diversion Unit. Before working there, I worked for 3 years at the 

Washington County Drug and Alcohol Commission on their Drug 

Court program. However, it is important to understand that 9 

years ago, I found myself homeless, facing a State prison sentence, 

and addicted to heroin. 

A few things about my story that I think are prevalent to understand are the impact of stigma, the importance of treatment, and 

that recovery is possible. I took my first drink of alcohol when I 

was 9 years old. My mother has addiction issues, so culturally I did 

not really understand the fact that it was wrong and it was not 

something that I should be doing. As Senator Toomey said, I took 

my first OxyContin when I was 13 years old, and despite the fact 

that it physically made me ill, I had fallen in love with that feeling. 

I started having behavioral issues in school, I started acting out, 

and my addiction just continued to progress. 

It is also important to understand that I always said, ‘‘I am 

never going to be a heroin addict.’’ That was something that I was 

never going to do. But just because these prescription pain pills are 

approved by the FDA, that does not make them safe. 

I kept having behavioral issues. When I was 15, I was expelled 

from school. I started using crack cocaine at the age of 16, and I 

started running away. I ran away multiple times. I got arrested 

several times. And when I was 17 years old, again, despite the fact 

that I said I was never going to be a heroin addict, I found myself 

an IV drug user. 

When I was 18, it was the first time I decided that I was going 

to try to stop using drugs, and I remember I had not talked to my 

20 

father for quite some period of time because I was a runaway. And 

I called him, and I begged him. I said, ‘‘Dad, if you do not come 

get me, I am going to kill myself.’’ I was only 18. He came, he got 

me, I moved back into his house, and I went through the physical 

withdrawals of heroin. And despite the fact that with every agonizing breath I said, ‘‘I am never going to use again,’’ I still did not 

go to treatment. I still did not have any supports. I still did not 

participate in a 12-step fellowship. 

After moving in with my father, I found out that I was 4 months 

pregnant. I was able to remain abstinent for the remainder of my 

pregnancy. I gave birth to a child on May 20, 2005. Her name is 

Riley. Shortly after having Riley, I thought that I could just drink 

alcohol. Me thinking I could just drink alcohol led me to just snorting bags of heroin, which ultimately led to me being in the same 

position that I was when I started: back to being an IV drug user. 

I moved out of my father’s home. I moved into a house, and my 

addiction just continued to escalate. My father had knocked on the 

door one day, and he begged me to give him temporary custody of 

my daughter and for me to go to rehab, which I did. I spent 20- 

some days in rehab, and despite the fact that my family had 

begged them to keep me, I refused a halfway house, and I returned 

home to my father’s house. 

I got out of rehab on May 13th, and Riley would have been one 

on May 20th. And despite the fact that I was determined to be the 

best mom that I could be, on May 17th I was using, and I missed 

her first birthday. I was kicked out of my father’s home, told if I 

ever stepped foot on his property again that I would be arrested. 

I was homeless. I was living in my car. I lost the ability to function 

as a normal human being. I did not shower. I did not brush my 

teeth. I was living on the street. 

I moved back in with my mother for a period of time, after which 

ultimately I was walked out of her home in handcuffs. I wrote 

fraudulent checks. I robbed an innocent person’s house. I did things 

that I said that I would never do because I was a slave to a needle. 

And again, I always said that this was something I was never 

going to do, and I woke up one day and realized that that is exactly 

what I had become. 

I was 20 years old, and I remember I never thought that I would 

live to see my 21st birthday. The time came down where I decided 

that my daughter deserved another chance, and I was either going 

to get clean and really try this thing, or I was going to commit suicide. So I decided to go to treatment, and this time I did long-term 

treatment. And I truly believe in long-term treatment wholeheartedly. 

I spent 216 days in treatment. I did 7 days of detox, 29 days in 

inpatient, and then 6 months in a halfway house. When they offered me a halfway house this time, I jumped on the opportunity. 

While I was in the halfway house, I was testing at a 6th grade education level. I turned myself in because I had multiple warrants 

out for my arrest, and I just continued to do what they do. For the 

first time in my life, I was willing to try something different because I did not want to live that way anymore, because I knew if 

I went back out there, I would become another statistic of what we 

are talking about today. 

21 

In April of 2007, as I was supposed to go to State prison, my life 

truly changed forever, when the judge granted me 216 days time 

served and immediate parole. But something also happened on that 

day. I became a convicted felon. I have two felony convictions on 

my record, and this is where stigma really comes into play. 

So at 13, when I took my first OxyContin, I did not understand 

the gravity of how being a convicted felon would impact the rest 

of my life, because I did not even think I would live to see the rest 

of my life. So it is important to understand that recovery is possible, because 9 years ago I was homeless. I was on my way to 

State prison. Today I am on a management team with Southwestern Pennsylvania Human Services. We are an organization 

that provides treatment to individuals all the way from adolescence, all the way up to the Area Agency on Aging, and everybody 

in between. 

I am in graduate school. I went from testing at a 6th-grade level 

to being in graduate school. I went through some of the programs 

in the halfway house; I now sit on the board of directors. 

You know, my felonies have affected my life in many ways. I 

have been kicked out of college and laughed at by landlords when 

applying for housing. I have been hired and fired in the same day, 

and it has impacted every decision that I have ever made with my 

life. But it is important to understand that, despite the fact that 

society tried to bring me down, I never gave up, you know. I just 

continued to do everything that I could to stand up for a purpose 

and let everybody know that recovery is possible. 

And despite all this stuff I have on my record, today I am relatively successful, and today I do everything that I can in order to 

try to give back and let everybody know that recovery is possible 

and that treatment works. Thank you. [Applause.] 

[The prepared statement of Ms. Potts appears in the appendix.] 

Senator TOOMEY. Ms. Potts, thank you so much for having the 

courage to share your testimony with us, and for being the inspiration that you are to so many people, and for your leadership. We 

are very, very grateful. 

I will begin the questions now of our second panel witnesses. 

Thank you all for your testimony. I would like to start with Dr. 

Capretto. You have been in the trenches of fighting addiction for 

a long time. 

Dr. CAPRETTO. Yes. 

Senator TOOMEY. Could you just briefly summarize for us the demographic changes you have seen from the time you first got into 

addiction medicine to what you are contending with today? 

Dr. CAPRETTO. In terms of opioid addiction, when I started at 

Gateway full time in 1989, we averaged four people in detox. Three 

were alcohol and one was maybe opioid. And usually almost all 

those came from the city, usually the inner city, the poor, impoverished areas. As this has spread, right now we have 28 detox beds. 

We still have three alcohol, and the rest are opioids with usually 

a dozen people waiting to come in every day. 

The demographics—it is everyone. It is every community, and it 

is actually mainly disproportionately Caucasians, middle and upper 

middle class right now, in terms of the pills and the heroin. And 

it is all age groups. We certainly see the young age group, but I 

22 

am starting to see newer people over 40, over 50, even over 60 

using heroin for the first time, and usually because they got on 

pain medicine and were given a lot. 

The community is different. You know, 20 years ago, if you got 

on these medicines, you took them for a few days; your doctor gave 

you a limited supply. Now you are likely to get a larger supply, but 

then your neighbors or co-workers are going to say, what did you 

get, we will give you some money for that, you know, stay on it, 

that is some good stuff. So the culture—it is definitely everybody 

and all age groups. In fact, one of the leading groups of overdose 

deaths is the over-50 group right now. 

Senator TOOMEY. Thank you. My understanding is, the FDA recently approved an indication for the use of OxyContin to treat severe pain in patients age 11 to 16 who may suffer from cancer or 

other very serious and painful conditions. What are your thoughts 

on the suitability of providing a drug like that to people of that 

age? 

Dr. CAPRETTO. Well, for the poor kids who have cancer and are 

terminal, which is a small number, we absolutely have to help 

them. Okay. My concern is that the headlines are, OxyContin for 

kids, so if it is safe for kids, then people think well, it is approved, 

it is safe, so kids are more likely to take it. Adults are more likely 

to take it because it is safe for kids, though it is intended to be for 

pain specialists giving it to terminal kids. 

My concern will be—what we saw with regular OxyContin is— 

maybe it is going to be given for kids with a sprained ankle from 

soccer or an infected tooth. And again, we have seen this with 

adults. So I do have concerns about that. We certainly need to educate the medical profession and the public about this. 

Senator TOOMEY. Yes, that seems very, very important. Thank 

you. Mr. Vittone, you talked about, and we have heard a lot about, 

pill mills that have been closed down and where bad physicians 

have been successfully prosecuted. 

Mr. VITTONE. Yes, sir. 

Senator TOOMEY. Is it your view, though, that prescription painkiller diversion is still a serious problem despite this? 

Mr. VITTONE. Very much so. As I indicated, just from Coroner 

Worco’s data, 57 percent of the deaths we have had have been due 

to prescription drugs. So we are still seeing the diversion. I checked 

with the head of my drug task force the other day to see what the 

effect is, and he confirmed for me that diversion is still a big problem in Washington County. 

Senator TOOMEY. Yes, hence the need for the legislation that 

might—— 

Mr. VITTONE. Exactly. 

Senator TOOMEY [continuing]. Help to impede this. Thank you 

very much. Dr. Kabazie, in your testimony you mentioned something that you called ‘‘pills for pokes.’’ Could you explain exactly 

what that is, and why is it worrisome? 

Dr. KABAZIE. It is an underground term that patients use as they 

discuss with each other diversion and abuse in obtaining pills. 

What it refers to—and again, it is a very small problem in regards 

to the numbers of physicians who do this, but it is still a real probVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 R:\DOCS\21277.000 TIMD
23 

lem. Physicians may, in fact, see an opportunity to do a procedure 

on a patient in exchange for giving the patient opioids. 

In other words, the patient will come into the office and have a 

complaint of low back pain, and the physician may say, well, I 

think we need to do a procedure that may help you with your low 

back pain. I am not sure it will, but it might. And in turn the patient says, yes, but I was thinking more along the lines of some 

pain pills. Could you give me some pain pills? 

And the doctor will think about that for a second and say, sure, 

I will give you some pain pills, but I still think I need to do that 

procedure. And if I give you the pain pills, we should do this procedure, and then it seems to roll on and on and on. 

And I have seen this at least in the southwestern Pennsylvania 

area, and in some cases in other States, and what this rolls into 

is an ongoing cycle of bringing the patient back, doing a procedure 

that may give the patient some temporary relief, if that, followed 

by another procedure in exchange for medications that continue to 

escalate in quantity and dose. 

Now, it is a very hard thing to track because most of the physicians—and again, the small amount of physicians—who do this, 

they document as best they can to cover their tracks in that regard. 

Senator TOOMEY. And you pointed out, I am sure correctly, that 

this is a tiny percentage of physicians who are doing this. What is 

their motivation? 

Dr. KABAZIE. It is purely—well, the motivation is this. With physicians, it is the state of affairs. Physicians get paid to do procedures. That is what we get paid to do at present. We get paid to 

do procedures. We typically do not get paid as much money if we 

sit and talk to a patient or handle routine problems. So doing a 

procedure in exchange for medications generates money for the 

physician. 

Senator TOOMEY. Yet another reason why it would be good to get 

away from the fee-for-service payment model that we generally 

have, but that is another topic. [Laughter.] 

Ms. Potts, I wonder if you could—and I am going over slightly, 

Bob. Thank you. Do you have some advice for people who might be 

currently struggling with addiction and looking for a way out? 

Ms. POTTS. Absolutely. My advice would be that there is help, 

that even if people say that you are not worth it or you are not 

going to make it, I am living proof of that, because I was told I was 

never going to make it. But long-term treatment does work, individualized treatment works, and we need to just wrap them around 

with supports and let them know there are peer-to-peer supports. 

We have been there before. We can jump in there and help pull you 

out of that hole. 

Senator TOOMEY. Thank you very much. Senator Casey? 

Senator CASEY. Thanks very much. Ms. Potts, I will start with 

you and pick up where Senator Toomey left off. You said in your 

testimony—you said 216 days of treatment? 

Ms. POTTS. Yes. 

Senator CASEY. Tell us about it, because we often will say good 

treatment works, but you have to sustain it. We all say that, but 

I am not sure those of us who are not professionals or have experience with it fully understand what we are saying or the meaning 

24 

of it. And I guess I would ask you to look at the treatment question 

in two ways, and I am assuming in my question that both were essential for you, both duration and quality. 

But tell me if you can, and I know this is difficult because cases 

vary. But you were in a severe circumstance, as difficult as it gets, 

I guess, based upon your testimony. Walk us through those 216 

days. What was it about the quality or the nature of the treatment 

that was effective in your case other than the necessary duration 

of it? 

Ms. POTTS. Okay. Other than the length of being there—— 

Senator CASEY. Right. 

Ms. POTTS [continuing]. I think it is important to understand 

that when I first walked in the doors, I had nothing but the clothes 

that I had on, just dirty clothes. I was not living as a normal person would. I had no idea how to write a job resume. I had no idea 

how to interact with people in the community. I had no idea how 

to speak to people. In my case, I was literally that stereotypical 

street junkie, so that was the level that I was at. 

So the importance of that is, when I went to my first court hearing, I had on a hoodie and ripped-up jeans and all that, and by the 

time I went to sentencing court, I was dressed like a professional, 

and I had letters that I had been volunteering, and that I had a 

job, and that I was employable. So I went from not understanding 

the importance of having a job or being employed to being able to 

have that. 

You know, statistics say the longer that we are in treatment, the 

better success that we have, so it takes time for our brains to start 

going back to normal. And Dr. Capretto could probably speak more 

on the brain and the brain functioning on drugs. It takes at least 

90 days just for that normal chemistry to come back in the brain. 

And I just think that the longer—you know, you learn life skills. 

You learn all of these things that in my case I missed growing up 

along the way. 

Senator CASEY. What would you recommend in terms of the 

structures we have in place now for the kind of quality treatment 

that you are talking about? I hope that your case was not unique 

in the sense that you had the benefit of programs that others often 

do not. 

Ms. POTTS. No, there are plenty of me’s out there. 

Senator CASEY. In other words, if you were designing the ideal 

treatment course, what would be the elements of it? 

Ms. POTTS. The ideal treatment course to me would be opioids 

detox, long-term treatment, halfway house, partial hospitalization, 

intensive inpatient treatment, and then outpatient, and you are in 

that continuum for up to 2 years. I did outpatient after I was in 

the halfway house, so I stayed connected to those services. I stayed 

in therapy, and I stayed doing the things that were suggested to 

me because I was not going to fix 20 years of trauma in 6 months, 

if that makes sense. 

Senator CASEY. Yes, that is very helpful. [Applause.] 

It is important for us to hear the nature of it, but also the duration of it, and we have to figure out ways to support that. Dr. 

Capretto, in your testimony in the recommendations, you quoted a 

study—this is on page 4 of your testimony, and I am quoting from 

25 

the summary of the study and your testimony. You say, ‘‘Physicians who check the PDMP,’’ the management program for prescriptions, ‘‘change their original decisions about the prescribed 

medication more than 40 percent of the time.’’ Tell us about that. 

Dr. CAPRETTO. Right. There was a study of physicians who use 

it, and Dr. Kabazie said it is important that they use it. It found 

that they actually changed their original decision about 41 percent 

of the time. About 70 percent was to prescribe less because they 

found out information, but about 30 percent of it was to prescribe 

more because somebody that they were worried about, they saw 

that they were not involved with diversion, so they could build 

trust with the legitimate patient. And we need to do this. 

I have a colleague in another State who has a big pain practice, 

and he was only using it for the patients who really looked suspicious, and somebody challenged him to do everybody in his practice. And he said if he were to pick the least likely five in his practice—and the number-one least likely guy, he was a CPA, banker, 

always came in with a suit, never missed an appointment in a 

year. He checked the database, and that person was going to five 

different physicians for opioids. So you cannot judge a book by its 

cover. So it is a useful tool, and it gives us information. It is one 

piece of the whole puzzle, as many of these pieces are. 

Senator CASEY. Just one question for the panel. I know we may 

go to a second round, which is helpful, I think. But just one question about this, the price dynamic of this. I heard testimony recently just in the last 2 weeks from someone who had been addicted and had a real problem for years. He was saying that the 

price of heroin—— 

Two things on heroin. Number one, the strength of it, the—what 

is a better word? 

Dr. CAPRETTO. The potency. 

Dr. VITTONE. The potency. 

Senator CASEY. Potency. ‘‘Potency’’ is a better word. The potency 

of it is much greater. 

Dr. CAPRETTO. Absolutely. 

Senator CASEY. And the price, according to this individual—and 

now he was talking about the market that he was living in then— 

but the price is literally the same price as the early 1970s, at least 

according to his testimony. Even if he is off by a little bit—— 

Dr. CAPRETTO. It is actually less than that. 

Senator CASEY. Yes. And so, that is the heroin problem. So how 

do you deal with that price dynamic where, if you are aggressive 

on opioids and the price goes up, they will turn to heroin and start 

there as opposed to starting with opioids? And I know it is both a 

medical and a healthcare issue, but also a long-term issue. 

Dr. CAPRETTO. Well, two ways. Number one, you want to limit 

or minimize new people getting addicted to opioids with all the 

things we have talked about it, but, number two, you want to have 

adequate treatment safety nets. You want to have adequate 

naloxone to keep people from dying. You want to have adequate access and availability of treatment. They say with this disease, only 

around 10 percent of people who have the problem ever get any 

type of legitimate treatment for it. 

26 

So we need to reach out to them because, if we do not, it costs 

us. Even if you do not care about these people, and look at the wonderful turnaround with Ashley, it is a good investment in reducing 

crime, improving jobs, taxes, everything. It is a good human investment, and signs indicate that the purity is going to continue as cartels are getting more aggressive, and the price may come down. So 

we absolutely have to hit this head-on. 

Mr. VITTONE. Senator, if I can follow up on that, we have always 

had heroin in Washington County, though not to the extent we 

have it now. So the difference has been the prescription pills that 

came out in the 1990s that really added fuel to that fire. So it is 

cross-cultural, and now it is all over the area because of that. So 

I do not know that you are going to ever eliminate completely that 

heroin baseline, but it certainly was not at this level. Do you agree, 

Doctor? 

Dr. CAPRETTO. Oh, absolutely, nowhere near it. 

Mr. VITTONE. You know, this is several years ago, so—— 

Senator CASEY. Thank you. 

Senator TOOMEY. Dr. Capretto, so we have discussed how, I 

think you indicated, a vast majority of heroin addicts actually were 

initially addicted to prescription opioids. 

Dr. CAPRETTO. Yes. 

Senator TOOMEY. Could you share with us a little bit, how does 

that initial addiction occur? Is it people who had surgery and then 

get hooked on the medicine that was prescribed post-surgery? Is it 

kids that raid the medicine cabinet? Is it both? Is it others? How 

does it happen? 

Dr. CAPRETTO. It is all of the above. You know, back in the 1990s 

when this was being marketed, they were trying to tell doctors this 

will never occur if you give it to your pain patients, less than 1 percent. We now know that is not true. 

I would say of the people whom I see, probably about 30 percent 

of them, it started with going to a physician who kept them on it 

too long, and it evolved into an addiction. Another group gets it recreationally. It is diverted. And then there is the in-between. They 

might have had a pain problem, and I hear this, and they were on 

it for a while. They kind of liked it, and they got away from it, but 

now they go to their local bar or sporting event, and there are people using it. These are very much part of our culture and available, 

so they get back on it. But it all comes back to their original 

source, which is our medical community. 

Senator TOOMEY. Yes. Dr. Kabazie, this might be difficult to generalize, but I am wondering if you can give us any sense of how 

long a period of time it is safe for most people to be consuming a 

prescription opioid. Is it possible to generalize? Is there a point beyond which the risk of addiction becomes much greater than a 

shorter duration, or is it too specific to the individual? 

Dr. KABAZIE. It is. It is very specific to the individual. We know 

addiction is a biopsychosocial disease, and Dr. Capretto knows this 

quite well. If you are genetically predisposed to addiction, to a substance, and you are never exposed to that substance, you have absolutely zero chance of becoming addicted to it. But if you are genetically predisposed and you are exposed to even a small amount, 

then you are off to the races. 

27 

So keeping in mind that this is a disease, there is a bio, a psycho, 

and a social component. And so, it is people, places, and things. It 

would be too generalized to say that there is a discrete time period 

at which the incidence or risk of addiction goes up. We just cannot 

say that. We do know that we continue to monitor for that. We also 

know that the higher the dose, the more likely addiction will occur. 

People who have an addiction issue many times, and I am sure 

Dr. Capretto has seen this, do not take the medication, the opioid, 

the heroin, to get high anymore. They are so far along that they 

are taking it just to function. On the street it is called ‘‘dope sick.’’ 

They are deathly afraid of getting dope sick, and they will do anything they possibly can to keep from getting dope sick. 

Without their medication, without their prescription drugs, without their heroin, they will get violently ill. They cannot function. 

Once they get it, they can function as normal human beings, and 

you would never know that they have a problem because they need 

that just to function. It is a scary proposition to anyone who has 

an addiction issue. 

Alcoholics can be the same way. You can have a functioning alcoholic and never know it. As long as they are drinking, they are 

completely straight and they are functioning, and without, they do 

not do a very good job. 

We know that the longer you are on an opioid, the more likely 

you are to become tolerant. You are certainly going to be dependent, and then the long-term effect can be endocrine dysfunction. We 

certainly know that now. We probably knew it back in the 80s and 

90s, and we just sort of ignored it. And we know that opioids over 

time can actually cause pain, and that is called opioid-induced 

hyperalgesia, which causes a significant problem if a patient goes 

to surgery and the pain is extremely difficult to control because 

they are on high-dose opioids. 

We have a patient who is on an opioid—and I think my orthopedic colleagues have seen this. If they are on opioids and going in, 

for instance, for a joint replacement, it could be extremely difficult 

to control their pain and get them through the rehab that they 

need. So our job is to try to get them off the opioids if we can so 

that they do not suffer in that regard. 

Senator TOOMEY. Thank you very much, Doctor. My last question 

is for Ms. Potts. Dr. Kabazie described this addiction as a biopsychosocial issue or problem. Could you give us a sense—I think 

we intuitively understand that there is a chemical problem here. 

There is a biological problem that has to be solved. But what about 

the social problems? What about the behavioral issues? How important are they for someone recovering from an addiction like this? 

Ms. POTTS. Absolutely. He mentioned people, places, and things, 

and individually, for me, I had to make a geographical change. I 

live 75 miles now from where I used to live because I know that 

going back to the same people, to the same problems, to the same 

situations, and not knowing anything different, I would ultimately 

end up with the same issues. So for me, I had to move away and 

start a whole new life. 

Senator TOOMEY. Thank you very much. My understanding is, 

that is a really important part of the curing process. Senator 

Casey, did you have any other questions? 

28 

Senator CASEY. I did, but just maybe I will do it by way of a 

lightening round because I took more than my time last time. 

Maybe starting with Dr. Capretto and going down the panel, if you 

had to, in a little more than a sound bite, kind of itemize steps you 

hope we would take on a whole range of issues, whether it is 

healthcare legislation, or legislation in Washington, local law enforcement, more resources, more treatment options, what would be 

your top three? 

Dr. CAPRETTO. We need to really make sure there are adequate 

treatment options that are available to people in a timely fashion 

and in a long enough period of time that is overseen by people who 

really understand how to treat addiction, not just manage funds. 

And we also need greater emphasis on education of our medical 

community, starting in medical school residencies, to treat this. 

This condition is so prevalent, yet the medical community gets 

minimal, and sometimes very little to no, education on this issue. 

And we have to worry about our kids. 

I mean, one of the things I did not mention with OxyContin is 

the developing brain. We know that the younger kids start using 

it—I mean, nobody questions the logic of a pregnant female abstaining from use of alcohol or drugs because of the developing 

brain. At birth, is the brain done developing? Absolutely not. It 

continues to develop until the mid-20s. The earlier you expose that 

brain to drugs of abuse, whether it be opioids, alcohol, marijuana, 

the greater likelihood addiction will develop, and it will derail their 

life in so many ways. So, a comprehensive approach. 

Senator CASEY. Thanks. 

Mr. VITTONE. A prescription medication database is a huge asset. 

We need to know who is getting what. Also, law enforcement needs 

access to that, where prescribing patterns become criminal. The 

second thing I would advocate, as Dr. Capretto indicated, is education for the medical professionals, law enforcement, and the community as to the dangers. 

And lastly, treatment. In speaking with Secretary Gary Tennis 

of the Pennsylvania Department of Drug and Alcohol Programs— 

I have asked him, ‘‘Why are people dying in Washington County?’’ 

He said it is because they are being under-treated. They are not 

getting enough treatment. They need to get, as Ashley said, that 

full panoply of treatment, and that needs to be available. Thank 

you. 

Senator CASEY. Thank you. Doctor? 

Dr. KABAZIE. I will leave the treatment and the law enforcement 

to my two colleagues to the left here. I think we need mandatory, 

mandatory, mandatory prescription monitoring. We need to monitor the drugs in the United States, and it has to be mandatory. 

In other words, we need a Prescription Drug Monitoring Program 

that is nationwide, or at least one in which the States will exchange information. And that needs to be mandatory, so we need 

physicians to use it every time they write a prescription, and we 

need pharmacists to use it every time they fill a prescription. 

We already know that voluntary guidelines do not work. They do 

not work. We have plenty of guidelines out there that nobody follows, so we need to make those things mandatory. I know I will 

get pushback from some of the people in the medical community, 

29 

but without making these mandatory, they will not work. We need 

to have a mandatory REMS project, a Risk, Evaluation, and Mitigation Strategy, that is mandatory for physicians to take if they 

want to prescibe opioids across the class, not only for extendedrelease medications, but for short-acting medications. I think those 

two things will go a long way to cutting down at least on the prescription drug problems that we have right now and the epidemic 

that we have right now with physicians writing inappropriate prescriptions. 

Senator CASEY. And, Ms. Potts, I know—now that we know 

something about you, we are calling you ‘‘Ashley.’’ Is that all right? 

Ms. POTTS. Absolutely. Absolutely. [Laughter.] 

I agree with what everybody said. You know, I think that we 

should not put a limit on treatment. If we take, for example, two 

20-year-olds both addicted to heroin, one has been using 3 months, 

one has been using since the age of 10, one is going to need a little 

bit longer treatment than the other one. So I think it is important 

to have an individualized treatment approach with a comprehensive support team—and what everybody else said, of course. 

Senator CASEY. Thank you very much. 

Senator TOOMEY. Thank you. At this time, I would like to ask 

our panelists to stay here if they would, and I would like to use 

this opportunity to give the audience a chance to ask questions or 

make some comments. They can direct it at any of our witnesses, 

or myself, or Senator Casey as they see fit, but we only have a few 

minutes. 

I want to ask anybody who would like to ask a question or make 

a comment to approach the mics on either side of the room. Please 

state your name and any affiliation that you have that would be 

relevant, and then please try to ask your question as succinctly as 

you can so that we can get to multiple questions. And we will start 

with the gentleman on the left. 

Dr. WONG. Hi. My name is Kevin Wong. I have been a family 

physician in Westmoreland County for over 33 years, and I appreciate the Senators’ efforts to help as well as our panelists’. 

We have heard over the years how people like Dr. Kabazie help 

family physicians try to prescribe appropriately. We do need the 

PDMPs in this State. As you know, that is locked up, and that is 

why the Federal Government needs to get after every State that 

does not have one. And it needs to be interoperable immediately, 

because otherwise, as you just said, we are a terrible State. We 

have West Virginia next to us, and Ohio is just as bad, and drug 

abusers can all go back and forth over the waters as they see fit. 

The PDMPs also need the pharmacists, who are our line of defense when somebody is prescribing, to not have fear of a HIPAA 

violation, to call a physician and say, you just prescribed somebody 

a prescription and another physician had just prescribed recently. 

The pharmacists are very afraid or do not want to get involved. 

As Dr. Kabazie said, the pills for pokes are something we see as 

family physicians. I have had many patients go to some of these 

places, be there a year, 15 months, finally get kicked out for breaking the pain contract. They come back to me with two to three 

times the amount of pain meds we sent them to the clinic with in 

the first place. We need legitimate pain clinics that are treating 

30 

people. As we said, we need to think and not poke. Thank you very 

much. 

Senator TOOMEY. Thank you very much. Unless there is a response to that—— 

Dr. CAPRETTO. We agree. 

Senator TOOMEY. I think that was more a recommendation, 

which I think the panel is probably sympathetic to. The gentleman 

on the right. 

Dr. FULLER. Hi. I am Dr. Mark Fuller. I am the CEO of Value 

Behavioral Health. We are a Medicaid managed care program. We 

help administer the Pennsylvania Health Choices Program in western Pennsylvania. So the first thing I want to say is, thank you to 

both Senators for your advocacy, for dragging this problem out in 

the light of day where we can have this kind of discussion. 

The second thing I want to say is, as a payer, we are fully committed to doing whatever we need to do to crush this epidemic. We 

are all in, so anything we can do, we are there for. Thank you. 

Senator TOOMEY. Thank you. 

Senator CASEY. Thank you. 

Senator TOOMEY. Yes, ma’am? 

Ms. BESICK. My name is Pat Besick. I am the manager of the Behavioral Health Unit at Saint Clair Hospital. And I really appreciate everyone’s expertise today, but there was something that nobody really talked about, which is really a barrier. Drug treatment 

is voluntary unless you are in drug court. So we get families involuntarily committing people to our psych unit just to get them in 

treatment, thinking they are going to take care of their drug problem. And once we have done the evaluation and have them a few 

days, maybe the doctor started an antidepressant for the 

depression/anxiety, which, of course, you would have when you are 

abusing drugs or alcohol. We get to a point where, if a patient does 

not want to go for treatment, it stops there. 

So it is voluntary. You can have all the treatment centers, but 

how do you get to the next level where people will go into treatment? At some point, Ms. Potts, you had the insight to put things 

together, but it took a while to say, ‘‘My life is not going too well, 

I need to change something.’’ 

But this is a huge barrier with most people. They will not take 

that step, and families can be upset. Smart families will say, ‘‘Well, 

you cannot come back home,’’ and they kind of force the issue, but 

that is pretty much what we have to do with people to get them 

into treatment. So what are we doing to address the issue of people 

who just will not go into treatment? 

Senator TOOMEY. Anybody? 

Dr. CAPRETTO. That is clearly an obstacle. You cannot, in mental 

health, commit somebody to addiction treatment. There can be leverage in the legal system. Drug court is a wonderful thing. Families can put pressure, and sometimes families themselves, I recommend they reach out to a therapist, maybe an interventionalist, 

to try to help raise the bar. 

Those who are working with them in hospital, I encourage you 

to get trained in motivational interviewing to kind of help move 

them along. I would welcome any leverage or help from legislature 

in getting people in. But it is an obstacle, absolutely. 

31 

Ms. POTTS. I also think it is important to understand that addiction is a family disease, so families are struggling along with that 

individual. And just because they are showing up again, and again, 

and again, at least they are showing up, and at least we still have 

the opportunity to try to save that person’s life. 

Senator TOOMEY. Mr. Vittone, did you have something you wanted to add? 

Mr. VITTONE. Yes. The drug courts do work. We have had one 

since 2005 in Washington County. You use the leverage of the 

criminal justice system to get these people to reform, but it is a 

very intense process. It is very time-consuming. It is well worth it, 

and we have been able to get people to reform and get into recovery, so it does work. 

Senator TOOMEY. Great points. Thank you. The gentleman on the 

right. 

Dr. PIERCE. Thank you. It has been a very informative day, and 

I would like to thank the Senator for all your efforts as far as helping with this problem. I would like to thank the expert panel witnesses for your testimony. I learned a lot personally. My name is 

Dr. Pierce. I am the regional medical director in Pennsylvania overseeing four methadone clinics. I also do buprenorphine therapy in 

my office. This is a passion and a calling for me. 

I would just like to say, without taking up too much time, one 

of the things that I noticed—and I do the initial evaluation of a lot 

of patients, in fact, most of the patients at the methadone clinics. 

And a lot of times what you see is that really people are predisposed to getting this disease process. It is a chronic relapsing 

disease of the brain. And really there is not much we can do to stop 

them from getting this disease once they become exposed to the 

drug itself. 

I mean, when you look at people who have—when they are 

younger, we call them adverse childhood events, which means traumatic events that children are exposed to during the developmental 

years: the physical abuse, the sexual abuse, the verbal abuse, parents that divorce, and abandonment issues. These are one part of 

the environmental insults that contribute to a person getting or 

being predisposed to this disease. 

Also, you have the adolescent exposure to substances of abuse, 

but then you look at tobacco, and alcohol, and marijuana, which 

will probably be legalized in this State, and those three major substances in themselves, when used during the adolescent years, actually contribute to predisposing a person to entering this process. 

Now, you add to that the undiagnosed and untreated mental health 

disorders, which can be as little as social anxiety or mild depression—it does not have to be a full-blown bipolar disorder. 

But these are the three conditions that predispose people to getting this disease process, so by the time they take the opioid pill, 

they are set up to get it. And it really does not matter if you give 

them 30 milligrams, 60, or 100, they are probably going to get the 

disease process. So I think what we have to really focus on is the 

treatment component of it. 

And what I am seeing now is that we have the buprenorphine, 

different companies are making it now. But the problem is that 

when you get this disease process, about one out of 10 can go to 

32 

detox, can go to rehab, and be successful. But there are another 90 

out of 100 people who, no matter how long you keep them in rehab, 

they are not going to be able to stop the cycle of this disease. 

Part of this disease process is that the part of the brain responsible for controlling behavior is now compromised. It is not functioning. So therefore, the simple act of choosing to do something or 

not to do it has been taken away. It is robbed from the patient. 

Their brain has essentially been hijacked. So what we have to do 

is have a medication that can help them to be in the state of mind 

where they can actually now get the therapy that they need. 

And these different medications—one of them is methadone, 

which is used very successfully. Another one is the buprenorphine. 

And basically what these medications are is, they are relapse prevention medication. It stops the patient from relapsing so they can 

get the therapy that they need in order to make the cognitive and 

behavioral changes that will allow them to be successful as far as 

getting off the medication once and for all. 

So my point is that we have this limit on physicians as far as, 

they can only treat 100 buprenorphine patients at one time, and 

that is limiting our ability to help patients who have this disease 

process. Granted, only 20 percent of the people who have this disease process are actually in medical treatment, but if you do not 

have the physicians available outside of a methadone clinic—not 

everyone wants to go to a methadone clinic. Not everybody needs 

to go to a methadone clinic. 

We have to have individualized treatment for these different patients. I mean, not everybody needs to go to detox and rehab. That 

is like taking every depressed patient and telling them you are 

going to put them into a confined setting and give them a rehab 

and not give them any medication. It just does not work. 

So I think we need to eliminate that limit of 100 patients and 

allow some physicians, maybe the ones who are board certified in 

addiction medicine, to be able to increase the number of people 

they could treat. I think that would go a long way to helping this 

situation. 

Senator TOOMEY. Well, thank you very much for that thought. 

Senator Casey, you had a comment? 

Senator CASEY. I know we have to move on, but there is a new 

bill that speaks to this, Doctor. I hope you can take a look at it, 

Senate bill 1455, which would lift that cap. But 1455 is the bill. 

Dr. PIERCE. Thank you. 

Senator TOOMEY. Could I ask the panelists, does everyone on the 

panel agree that that cap should be lifted? 

Dr. CAPRETTO. I agree, but you have to be careful about how you 

do it. I would recommend a first step, making it for addiction specialists, those who could provide kind of wraparound services and 

not just open it up to everybody. We certainly do not want to create 

pill mills in that direction. 

Dr. PIERCE. I agree, and certainly only those board certified by 

the American Board of Addiction Medicine. That would be the criterion to do that. 

Senator TOOMEY. Dr. Kabazie, did you want to respond? 

Dr. KABAZIE. Well, I think we need to be very, very careful. I 

think everyone who prescribes Suboxone has seen Suboxone preVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00036 Fmt 6633 Sfmt 6633 R:\DOCS\21277.000 TIMD
33 

scribers who are not doing it appropriately. And, if we open up that 

cap, that will open up the floodgates. And again, I am going to harp 

on physician reimbursement here. It is very easy to see a Suboxone 

patient in very quick fashion, sign your name to that prescription, 

and send them out the door. And just as I have seen very, very bad 

pain physicians, I have seen very, very bad Suboxone providers. 

And that Suboxone either ends up on the street or in the hands of 

someone who should not have it. And we need to look at that very, 

very carefully. 

You know, I may speak out of turn here, but I do not understand 

an obstetrician, an OBGYN, prescribing more than a hundred 

Suboxone prescriptions or patients, a pediatrician, orthopedic surgeon, prescribing Suboxone to more than a hundred patients or 

even a hundred patients, simply because they sat through a course 

for 8 hours. That is a problem. 

So in the right hands, it would be an appropriate thing to do, but 

only in the right hands, and I think we need to look at that more 

closely. 

Senator TOOMEY. Thank you very much. We only have time for 

two more questions, so I want to let the gentleman who has been 

waiting patiently over here and then the lady at the other mic ask 

their questions. And then I am going to see if Dr. Farah wants to 

wrap things up here. 

Mr. BACHARACH. I will be relatively short. My name is Paul 

Bacharach. I am the CEO at Gateway Rehab. I work with Dr. 

Capretto every day. In western Pennsylvania, we have an elderly 

population, and one of the impediments to—and this may be more 

directed to Dr. Ling. One of the impediments to treatment is the 

fact that Medicare does not cover non-hospital residential treatment for addiction, so there are very limited resources when it 

comes to hospitals providing short-term rehab and detox. We are 

unable to provide services to Medicare patients because it is not 

currently a covered service—that is the short-term detox, and 28- 

day. 

So I think one of the things that needs to be looked at to provide 

access to that elderly population that obviously is vulnerable also 

is to at least open up coverage for that group. 

Senator TOOMEY. Great. Thank you very much. The lady on the 

right. 

Ms. BELL. Hi. Thank you. My name is Alice Bell, and I am the 

overdose prevention project coordinator for Prevention Point Pittsburgh, which provides harm reduction-based services in southwestern Pennsylvania. A large part of my job is making sure that 

naloxone is available to people who might be at risk of an overdose 

or who might witness an overdose. And I appreciate Senator 

Casey’s support of those efforts and his comments regarding that. 

The one thing that I feel is missing in the conversation today is 

the dramatic increase that we have seen in heroin use. And I 

would agree that doing a better job of more careful opioid prescribing is part of that, that if we do not have young people starting to get involved with prescription opioid misuse and abuse, then 

we are going to see less heroin use. 

I do have a real fear that at this point we are seeing such a high 

level of heroin use that we are going to have young people starting 

34 

on heroin because they have friends who are already doing heroin, 

and that we have to look at that as a problem in its own right. And 

a big issue that we are seeing is a dramatic increase in injectionrelated blood-borne diseases, like hepatitis-C and HIV. 

And so I feel like, to address that problem, we really need to look 

at the need for access to sterile injection equipment for people who 

are already injecting. That is a small piece of the large problem 

that is being discussed here, but it is an important piece. When we 

look at lives and we look at costs as well, the cost to treat hepatitis-C, to treat HIV, that could easily be prevented if people have 

greater access to sterile injection equipment. Thank you. 

Senator TOOMEY. Does anybody want to react to that? 

Dr. CAPRETTO. I totally agree, and I also share Alice’s concern 

that now that there is so much heroin out there, even though historically it has been prescription medicines leading to heroin, as it 

is out there and available, that is definitely something that we may 

see that may also harm reductions. 

I really want to personally thank—Alice has done more to champion the cause of overdose prevention and harm reduction in our 

area than anybody, so thank you very much, Alice. [Applause.] 

Senator TOOMEY. And on that note, I want to thank everybody 

who came out today, and thank the audience members who made 

comments or asked questions. I thought that was a very thoughtful 

contribution to this process. I really want to thank the witnesses 

for all of your time, including Dr. Ling, and your very helpful testimony. [Applause.] 

And, Dr. Farah, as our host this afternoon, do you want to wrap 

things up? 

Dr. FARAH. Sure. Senator Toomey, thank you very much for 

chairing this session. I think everyone in this audience would more 

than agree that this has been invaluable, not only in accomplishing 

the goals that you have set out to achieve, but also to educate us. 

I think a big part of what we heard today, from the panelists especially, is the educational piece that we can all use whether we are 

medical professionals or not. 

I also want to thank Senator Casey. Thank you for participating 

here at Allegheny General Hospital. All the panelists, Dr. Ling, 

U.S. Attorney David Hickton, thank you for attending this. 

I think we would all agree that this has been a remarkable show 

of bipartisan leadership here in western Pennsylvania on an issue 

that is impacting not only friends and families, but our patients as 

well. And on behalf of Allegheny Health Network, I would like to 

thank both of the Senators. We are very proud to have you represent us here in Pennsylvania and the United States. Thanks 

again. [Applause.] 

Senator TOOMEY. Thank you very much, Dr. Farah. The hearing 

is adjourned. 

[Whereupon, at 4:10 p.m., the hearing was concluded.] 

(35) 

A P P E N D I X 

ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD

PREPARED STATEMENT OF NEIL A. CAPRETTO, D.O., F.A.S.A.M., 

MEDICAL DIRECTOR, GATEWAY REHAB

INTRODUCTION

Mr. Chairman and members of the committee, thank you very much for inviting 

me to speak with you today about the epidemic of opioid abuse in southwestern 

Pennsylvania, which has devastated the lives of thousands of individuals and families, and has led to record numbers of overdose deaths in our region. 

I am an addiction psychiatrist and the medical director at Gateway Rehab, which 

is our region’s largest nonprofit addiction treatment provider. Our mission is to help 

all affected by addictive diseases to become healthy in body, mind and spirit. With 

20 locations throughout western Pennsylvania and eastern Ohio, Gateway Rehab 

treats more than 1,500 patients daily. 

I have worked full time at Gateway since 1989 but started in the field of addiction 

in 1981 at St. Francis Hospital in Pittsburgh. I am board certified in general psychiatry, addiction psychiatry, and addiction medicine, and I am a fellow of the American Society of Addiction Medicine. 

I served as a co-chair of the Western Pennsylvania U.S. Attorney’s Working Group 

on Drug Overdose and Addiction, and currently serve on the board of directors of 

the Pennsylvania Society of Addiction Medicine, the Allegheny County Overdose 

Prevention Coalition, and the Beaver County Prescription Drug Abuse Coalition. I 

also consult with many professional and grassroots groups focused on addressing the 

addiction problem in our community. 

During my career at Gateway Rehab, I have directly been involved in treating 

more than 15,000 individuals in our region with prescription opioid and heroin addiction. I have personally witnessed, on a day-by-day basis, the evolution of our current opioid epidemic, which began in the late 1990s. The sad reality is that, today 

there are more people in our community with addiction from opioid pain pills and 

heroin than at any other time in our history and, if this problem is not addressed 

adequately, it will continue to worsen. 

OUR REGION’S OPIOID EPIDEMIC

When I finished my residency in psychiatry in 1985, there were 22 accidental 

drug overdose deaths in Allegheny County, which, at that time, appropriately was 

viewed as an unacceptable tragic loss of lives that must be corrected. 

With a rising opioid problem beginning in the late 1990s, Allegheny County saw 

triple-digit overdose deaths for the first time in 1998 with 104. This number remained over 100 for the next 3 years and then reached more than 200 in 2002, remaining such every year since. However, in 2014, Allegheny County set a new 

record with 307 accidental drug overdose deaths (OverdoseFreePA 2015). 

Moreover, based on population, most surrounding counties are now seeing higher 

overdose death rates than Allegheny County. Drug overdose deaths are now the 

leading cause of accidental death in our region, far exceeding traffic fatalities. 

36 

CAUSES

Several factors have contributed to our current opioid epidemic; however, by far, 

the primary factor in our region leading new individuals into opioid addiction is prescription opioid pain pills. 

In the mid to late 1990s, the medical profession came under increasing criticism 

for not adequately treating pain, and there was a greater national emphasis to treat 

non-cancer pain with opioids. However, much of this emphasis was coming from 

pharmaceutical companies who sold opioid pain medications. Also, many physicians 

declared that abuse and addiction of opioid medications was essentially a non-issue 

(Van Zee 2009). Then, in 2000, the Joint Commission declared pain as ‘‘The Fifth 

Vital Sign.’’ These circumstances resulted in a very quick and dramatic rise in the 

medical community prescribing opioids for pain. 

From 1999 to 2011, consumption of hydrocodone more than doubled and consumption of oxycodone increased by nearly 500 percent (Jones 2013). Unfortunately, during that same time, we saw the rate nationally of unintentional death from prescription opioids nearly quadruple (Chen, Hedegaard, Warner 2014), and the Centers for 

Disease Control and Prevention in 2014 described this as the ‘‘worse drug overdose 

epidemic in U.S. history’’ (Paulozzi 2010). 

Historically, most drug trends would start in other parts of our country and then 

reach southwestern Pennsylvania several years later. However, with the prescription opioid abuse problem, southwestern Pennsylvania was one of the first and 

hardest hit areas of our country. This was largely due to the demographics of our 

region, which included an older population and a large blue collar, working population that both have higher rates of medical problems resulting in pain. This led 

to heavy marketing of physicians in our area by pharmaceuticals to prescribe more 

opioids. 

In March of 1999, I saw my first patient come to Gateway with OxyContin addiction. By July 2000, I had seen more than 300. By the end of 2005, I had seen more 

than 2,000 people in our region with OxyContin addiction. OxyContin significantly 

accelerated and expanded the opioid addiction problem in our regional at a level 

never seen before. 

By the end of 2001, we were seeing large numbers of people, of all ages and from 

all social economic levels, coming into treatment with opioid addiction from virtually 

every community in our region. As many of these people continued to use more 

opioid pain pills, over time they developed tolerance, which resulted in them needing larger daily amounts to keep from going into opioid withdrawal and getting sick. 

The average person we were seeing was using more than 150 mg of Oxycodone per 

day, and some more than double that amount. 

The price of Oxycodone on the street at that time was approximately 70 cents to 

a dollar per milligram. It was costing most people hundreds of dollars a day to support their opioid pill addiction. We then started to see a growing number of people 

who could no longer afford their opioid pills switch to a ‘‘new’’ heroin that would 

give them a similar and often stronger effect than opioid pills for about a quarter 

of the daily cost. This trend continues today and has created thousands of new people in our region addicted to heroin. 

Of the several thousand heroin users that I have interviewed since 2000, well over 

90 percent have told me they started with opioid pain pills. This is the primary reason why, 20 years ago in 1995, heroin use was essentially unheard of in the vast 

majority of communities in our region, especially the suburbs and the rural communities. Now, today, fueled by opioid pill addiction, heroin addiction has spread like 

an infectious disease into every community in our region. 

We first started seeing this ‘‘new’’ heroin in the mid-1990s. Most heroin in our 

region prior to that point, I am told, averaged about 10 percent purity. That was 

still strong enough to cause severe addiction and death from an overdose, but the 

only way to get an appreciable effect from 10 percent heroin was to inject it intravenously. However, fears over contracting HIV in the late 1980s led to an increased 

reluctance by many to use a drug intravenously. In the mid-late 1990s, we starting 

seeing people come into treatment reporting they were using this ‘‘new’’ type of heroin, which would give a very strong effect by simply snorting intranasally. 

This ‘‘new’’ heroin was much stronger, usually greater than 40 percent purity, and 

often, in our area, reached levels of 70–90 percent purity. Besides just giving a 

much more powerful opioid effect, this stronger heroin allowed people to get an appreciable effect from snorting intranasally, without injecting intravenously. HowVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00040 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
37 

ever, almost all new heroin users that I have seen in the past 20 years that started 

out by snorting heroin, well over 80 percent switched over to intravenous use within 

6–12 months because, as they developed tolerance to heroin, they learned that using 

heroin intravenously gives a quicker and stronger effect. As large numbers of individuals addicted to heroin switched from snorting it to injecting it, several thousand 

new people in our community developed Hepatitis C. 

Two other destructive trends we are seeing, which have magnified the opioid problem in our region, include adding fentanyl to heroin and opioid enhancement with 

sedatives. 

Although heroin is very potent and results in high rates of addiction, and it alone 

is very capable of causing an overdose death, in what is believed to be an effort to 

create greater demand for their product, some drug traffickers are adding fentanyl 

to heroin. Fentanyl is about 70–100 times stronger than morphine per milligram 

and is much stronger than heroin alone. Due to its high opioid potency, fentanyllaced heroin generally leads to a greater street demand and, unfortunately, spikes 

in overdose deaths because it is more lethal. I have talked to people who were using 

more than 20 bags of heroin per day who went unconscious with the needle still 

in their arm after only using one or two bags of fentanyl-laced heroin. We have seen 

several spikes in overdose deaths in our community in the last several years due 

to fentanyl-laced heroin. 

Another growing trend, which I believe is largely unrecognized and/or neglected 

by much of the medical community, is the growing number of people with opioid addiction to pain pills or heroin who also take large amounts of sedatives to boost the 

effects of their opioids. The majority of these sedatives are benzodiazepines, drugs 

such as Xanax, Ativan and Klonopin. Adding these sedatives to opioids will definitely boost the effect, but it also increases the danger of an overdose death. 

A significant proportion of overdose deaths we are now seeing in our area are 

showing a combination of opioids and sedatives. Over the past 2 years, approximately 50 percent of the individuals coming to Gateway to seek treatment for abusing opioids also are addicted to sedatives and, if not detoxed properly, sedative withdrawal can result in seizures and possible death. 

Some have referred to our current opioid epidemic crisis as a ‘‘perfect storm’’ that 

resulted from the dramatic rise in opioid pain pills at the same time the ‘‘new’’ and 

stronger heroin was introduced. These factors, along with the enhancing effects of 

fentanyl and sedatives, have continued to fuel this storm of opioid addiction in our 

community to now the highest level ever seen. 

RECOMMENDATIONS

Unfortunately, there is not one easy, clear solution to this problem. It is clear that 

properly addressing this problem will require a large, multidimensional collaborative effort from many parts of our community. The Western Pennsylvania U.S. Attorney’s Working Group on Drug Overdose and Addiction, under U.S. Attorney 

David Hickton, which I co-chaired along with Dr. Michael Flaherty, released a comprehensive 51-page report in September 2014, which discussed this issue in detail 

and offered many recommendations (U.S. Attorney’s Working Group on Drug Overdose and Addiction 2014). 

One other obvious and important area of focus is the proper and safe use of opioid 

pain pills. There is consensus within the medical community that it is important 

to treat pain properly, and that no individual with legitimate pain should be neglected. The challenge, though, is to treat pain adequately while minimizing the potential for addiction, not only in the patient but also in the community. This will 

require several measures, including better education of the medical community and 

the public, along with better management and monitoring of opioid pain medications. This would include not only an assessable State prescription drug-monitoring 

program (PDMP) for health professionals, which we hope to soon have in Pennsylvania, but, also, a national monitoring program for all scheduled prescriptions to 

minimize interstate drug diversion, which is a significant problem in our tri-state 

region. 

Use of PDMPs by a health professional is an integral part of practicing responsible medicine. A responsible physician would not order antihypertensive medication 

for a patient without first checking their blood pressure or order insulin without 

first checking blood glucose. Therefore, in light of our current opioid epidemic, a responsible physician should not order powerful opioids without first checking a prescription database. 

38 

One study (Baehren 2010) showed that physicians who check a PDMP changed 

their original decision about the prescribed medication more than 40 percent of the 

time. The majority of these changes were to prescribe less medications, but in some 

cases more because it helped build trust with legitimate patients. Another study 

(Feldman, Williams, Coates 2012) found that use of a PDMP increased physician 

confidence that the medications they prescribed were medically warranted. 

In light of the significant problem we have with prescription medicine abuse in 

our community, I believe the actions called for in Stopping Medication Abuse and 

Protecting Seniors Act [S. 1913] or lock-in bill are very much needed. The patient 

would continue to have adequate access to necessary medical care and medications 

in a manner that would likely improve the quality of their medical treatment, and 

reduce the likelihood of them progressing into addiction. It would also help to protect the public safety by minimizing the possibility of drug diversion in the community. In addition, it would likely result in saving taxpayer dollars. 

For those individuals currently struggling with addiction, it is very important to 

offer them evidenced-based, comprehensive treatment of adequate intensity, and for 

a significant period. For those seeking help, comprehensive treatment should be 

readily available and not difficult to access. This would include reducing or removing the barriers that restrict Medicare patients from non-hospital, addiction treatment programs, which would not only improve their access to treatment but would 

also save taxpayer dollars 

It also will be very important to increase professional and public overdose prevention training, and increase the availability and use of naloxone to help decrease the 

tragic number of overdose deaths. 

I believe that over time such efforts can not only improve our ability to better 

treat patients with legitimate pain but, also, help reduce the problem with opioid 

addiction in our community. 

Thank you, again, for your time and for inviting me to discuss this important 

topic. 

REFERENCES

Baehren, D. et al. A statewide prescription monitoring program affects emergency 

department prescribing behaviors. Annals of Emergency Medicine, 2010 Jul; 56(1): 

19–23. Available at http://www.ncbi.nlm.nih.giv/pubmed/20045578. 

Centers for Disease Control and Prevention. National Vital Statistics System, 

1999–2008; Automation of Reports and Consolidated Orders System (ARCOS) of the 

Drug Enforcement Administration (DEA), 1999–2010; Treatment Episode Data Set, 

1999–2009 Centers for Disease Control and Prevention. Rates of prescription painkiller sales, deaths and substance abuse treatment admissions (1999–2010). Available at: http://www.cdc.gov/vitalsigns/painkilleroverdoses/infographic.html. 

Chen L.H., Hedegaard H., Warner M. 2014. Drug-Poisoning Deaths Involving 

Opioid Analgesics: United States, 1999–2011. NCHS Data Brief No. 166. Hyattsville, MD: Natl. Cent. Health Stat. 

Feldman, L., Williams, K.S., Coates, J. Influencing controlled substance prescribing: attending and resident physician use of a state prescription monitoring 

program. Pain Medicine, 2012, 13: 908–914. Available at: http:// 

www.ncbi.nlm.nih.gov/pubmed/22681237. 

Jones C.M. 2013. Trends in the distribution of selected opioids by State, U.S., 

1999–2011. Presented at Natl. Meet. Safe States Alliance, June 6, Baltimore, MD. 

OverdoseFreePA. Available at: http://www.overdosefreepa.pitt.edu/overdosedata/. 

Paulozzi L.J. 2010. The epidemiology of drug overdoses in the United States. Presented at Promis. Leg. Responses to the Epidemic of Prescr. Drug Overdoses in the 

U.S., Maimonides Med. Cent. Dep. Psychiatry, Dec. 2, Grand Rounds, Brooklyn. 

U.S. Attorney’s Working Group on Drug Overdose and Addiction: Prevention, 

Intervention, Treatment and Recovery. Final Report. Sept. 2014. Available at: 

http://www.justice.gov/sites/default/files/usao-wdpa/legacy/2014/09/29/US%20 

Attorney%27s%20Working%20Group%20on%20Addiction%20Final%20Report.pdf. 

Van Zee A. The promotion and marketing of oxycontin: commercial triumph, public health tragedy. Am J Public Health. 2009 Feb;99(2):221–7. doi: 10.2105/ 

AJPH.2007.131714. Epub 2008 Sep 17. Available at: 

39 

http://www.ncbi.nlm.nih.gov/pubmed/18799767. 

PREPARED STATEMENT OF A. JACK KABAZIE, M.D., SYSTEM DIRECTOR, DIVISION OF

PAIN MEDICINE, ALLEGHENY HEALTH NETWORK, AND PROGRAM DIRECTOR, PAIN

MEDICINE FELLOWSHIP

INTRODUCTION

Mr. Chairman and committee members, thank you for the invitation and opportunity to address you on this important issue that has contributed to the staggering 

increase in abuse, diversion, addiction and overdose deaths in our region and the 

country. 

I am the Medical Director for the Allegheny Health Network Division of Pain 

Medicine, board certified in anesthesiology and pain medicine by the American 

Board of Anesthesiology and American Board of Medical Specialties. My responsibilities include oversite of both employed and independent pain medicine physicians 

in the Allegheny Health Network, developing policy and procedures and direct patient care. During my career I have been invited to lecture on pain medicine at national, regional and local meetings. 

In addition to my role as medical director, I am also the Program Director for the 

Multidisciplinary Pain Medicine Fellowship, Allegheny General Hospital/Western 

Pennsylvania Hospital Medical Education Consortium. The fellowship involves multiple medical disciplines, including psychiatry, neurology, physical medicine and rehabilitation and anesthesiology. Since starting the fellowship in 2000, I have trained 

51 fellows and countless residents. 

My medical career began at the Western Pennsylvania Hospital. After completing 

my fellowship, I started a pain medicine program to serve patients in the community, and assist my medical colleagues with their chronic pain patients. Around that 

time Purdue launched Oxycontin and a small but nationally influential group of 

physicians in positions of prominence were extolling the virtues and safety of opioids 

for chronic nonmalignant pain. Since that time I have observed a dramatic increase 

in opioid prescribing in southwestern Pennsylvania by physicians, many of which 

were ill equipped and under trained to deal appropriately with chronic pain patients. 

THE PRESCRIPTION OPIOID EPIDEMIC

One of the major contributors to the current opioid epidemic in the United States 

is the over prescribing of opioids for chronic pain. As a Nation, we consume approximately 99 percent of the hydrocodone, 80 percent of the oxycodone and 58 percent 

of the methadone produced in the world (Institute of Addiction Medicine). This has 

contributed to a dramatic increase in opioid abuse, addiction and deaths due to overdose. In addition to the tragic personal toll, the direct and indirect economic cost 

associated with opioids places a significant burden on health care dollars (Birnbaum 

HG). 

MULTIPLE DRIVERS OF THE EPIDEMIC

In the 1980s and 1990s, multiple factors contributed to a change in opioid prescribing for chronic nonmalignant pain. Based on scant and faulty medical data, the 

risk of addiction was touted as rare, end organ toxicity nonexistent and the incidence of tolerance low (Portenoy RK). Armed with this information, physicians became less reluctant to prescribe opioids, patient advocacy groups demanded better 

treatment for chronic pain, and pharmaceutical companies began reformulating 

opioids into extended release preparations (1996 Purdue launches Oxycontin). This 

brought about in a dramatic increase in analgesic prescribing for chronic nonmalignant pain that coincided with the rise in opioid related morbidity and mortality 

(Braden JB). Little has been done to effectively address and curtail the over prescribing of opioids. 

Primary care physicians and internal medicine physicians prescribe the majority 

of opioid medications in the United States, and most were not trained in addiction 

or pain management (Volkow ND). While most doctors prescribe opioids with good 

intent and to treat their patients’ pain with compassion, once that treatment path 

is started, it is often times very difficult to reverse. This can lead to disgruntled patients and frustrated physicians. Physicians who have compensation or employment 

40 

tied to patient satisfaction scores may feel pressure to prescribe opioids in response 

to patient pain complaints. 

Nationally, there are major disparities in prescribing opioids for chronic pain 

(Paulozzi LJ). In some regions, including southwestern Pennsylvania, this has resulted in ‘‘pill mills’’ for profit. They prey on those with the disease of addiction out 

of greed. This has been addressed by legislation and law enforcement. Ten States 

have enacted a pill mill law as of May 2013. There are also physicians who tacitly 

prescribe opioids to continue patients on a long path of procedures that financially 

benefit the physician with little long term benefit to the patient, in some circles 

known as ‘‘pills for pokes.’’ This is a very small but difficult practice pattern to detect without close oversite. 

While much attention has been focused on opioid abuse, addiction, and mortality, 

there is also the issue of unintentional opioid misuse and subsequent adverse 

events. This is an issue especially in the elderly population who are at increased 

risk of falls and fractures (Miller M), cognitive impairment and unintentional overdosing. These adverse events result in increased emergency room visits, hospital admissions and length of stay adding strain to the health care costs in the United 

States (Birnbaum HG). 

To curb the prescription opioid epidemic, State medical boards and physician 

groups have developed and published guidelines on the use of opioids to treat chronic nonmalignant pain (Hughes MA). The Center for Disease Control and Prevention 

is currently drafting guidelines as well. Where treatment strategies do exist to aid 

providers, studies show that some providers do not follow them, even for high risk 

patients (Gupta A). When queried about inappropriate opioid prescribing in light of 

published guidelines, one group of physicians responded, ‘‘they are only guidelines.’’ 

While opioid prescribing has slowed, it still remains at problematic levels. The CDC 

found that in 2012, United States physicians wrote 82.5 prescriptions for opioids for 

every 100 people. 

A promising tool to combat prescription drug abuse are State Prescription Drug 

Monitoring Programs (PDMPs). As of July 2013 there are 47 States with operational 

PDMPs, however they are significantly underutilized when not mandatory. To further address inappropriate opioid prescribing, Physicians for Responsible Opioid 

Prescribing (PROP) has petitioned for a mandatory limit on the amount and duration of opioids that can be prescribed to a patient with chronic nonmalignant pain. 

This has resulted in condemnation from patient advocacy groups, fearing absolute 

rules will leave many chronic pain patients without help. 

RECOMMENDATIONS FOR CONSIDERATION

We cannot address the opioid epidemic by painting with a broad brush of absolutes, mandating dosing and time limits. There is a small subset of patients who 

will require large doses of opioids for extended periods of time and do well (Kalso 

E). They should not be denied this therapeutic option. However, this should be a 

treatment of last resort, when all other attempts to control chronic pain have failed. 

Most patients with chronic pain can be treated with satisfactory results using a 

multidisciplinary approach without the use of long term opioid therapy (Flor H). 

To engage physicians in this endeavor we will require more than published guidelines that are either ignored or underutilized. Many physicians have opted out of 

the Risk Evaluation and Mitigation Strategy (REMS) for extended release and long 

acting (ER/LA) opioids as it is voluntary. Mandatory REMS coupled with obtaining 

a DEA number to prescribe opioids for chronic pain of longer than 3 months might 

be one strategy. This should include short-acting opioids as well as they are widely 

associated with abuse (MMWR). The REMS would require physicians to discuss 

with and educate the patient about potential risks, possible benefits, outline goals, 

and develop an exit strategy. This would not interfere with a physicians’ ability to 

treat acute pain with opioids for a short period of time when appropriate. 

Enacting pill mill laws in all States may be a promising modality to help curb 

abuse, diversion and overdose. 

There needs to be in place in every State, and on the Federal level, a prescription 

drug monitoring program, easily accessible and user friendly that is available to 

physicians and pharmacies. The use of this program should be mandatory before 

prescribing or dispensing controlled substances. 

41 

1 National Center for Health Statistics/Centers for Disease Control and Prevention, National 

Vital Statistics Report, Final death data for each calendar year (October 2014). 2 Centers for Disease Control and Prevention. Drug Overdose in the United States: Fact Sheet, 

Home and Recreational Safety, accessed on October 28, 2013 from http://www.cdc.gov/ 

drugoverdose/index.html. 3Suzuki, Shinobu. Potentially Inappropriate Opioid Use in Medicare Part D. MEDPAC. October 9, 2014, http://www.medpac.gov/documents/october-2014-meeting-presentation-potentiallyinappropriate-opioid-use-in-medicare-part-d-.pdf?sfvrsn=0. 

Referrals to multidisciplinary pain programs should be made in a timely fashion 

for patients on opioids for chronic pain for evaluation, treatment recommendations 

and if necessary, reasonable medication management and monitoring. 

To curtail the prescription opioid epidemic, all stakeholders need to come together 

and act quickly to address this national health crisis. 

Thank you for your invitation and the opportunity to discuss this important issue. 

REFERENCES

(1) Institute of Addiction Medicine. February 22, 2013. 2p2. 

(2) Physicians for Responsible Opioid Prescribing. www.responsibleopioidprescribing.org. 

(3) Flor H et al. Pain. Vol 49, Issue 2, may 1992, pg. 221–230. 

(4) Bureau of Justice Assistance, Office of Justice Programs. U.S. D.O.J. 

(5) Birnbaum HG et al. Pain Med 2011;12(4):657–667. 

(6) Paulozzi LJ et el. Morb Mortal Wkly Rep 2014; 63(26). 

(7) Miller m et al. J Am Geriatr Soc. 2011;59(3):430–438. 

(8) Hughes MA et al. J Mange Care Med. 2011;14(3):52–58. 

(9) Kalso E et al. Pain Vol 112, Issue 3 Dec 2004, pp 372–380. 

(10) Volkow ND et al. JAMA. 2011;305(13):1346–1347. 

(11) Braden JB et al. J. Pain. 2008;9(11):1026–1035. 

(12) Portenoy RK, Foley KM. Pain. 1986 May;25(2):171–86 

(13) Prescription Drug Monitoring Programs: an Assessment of the Evidence for 

Best Practices. Sep 20, 2012. 

(14) Gupta A et al. Pain Physician. 2011;14:383–389. 

(15) MMWR Morb Mortal Wkly Rep. 2010;59(23):705–709. 

PREPARED STATEMENT OF SHARI M. LING, M.D., DEPUTY CHIEF MEDICAL OFFICER, CENTERS FOR MEDICARE AND MEDICAID SERVICES, DEPARTMENT OF HEALTH AND

HUAMN SERVICES

Chairman Toomey and members of the subcommittee, thank you for inviting me 

to discuss the Centers for Medicare and Medicaid Services’ (CMS) work to ensure 

that all Medicare and Medicaid beneficiaries are receiving the medicines they need 

while also reducing and preventing non-medical prescription drug use. 

Opioid addiction is taking a real toll on communities, families and individuals 

both here in Pennsylvania and across the Nation. Deaths from drug overdose have 

risen steadily over the past two decades and have become the leading cause of injury death in the United States. Prescription drugs, especially opioid analgesics— 

a class of prescription drugs such as hydrocodone, oxycodone, and morphine used 

to treat both acute and chronic pain—have increasingly been implicated in drug 

overdose deaths over the last decade. From 1999 to 2013, the rate for drug poisoning 

deaths involving opioid analgesics nearly quadrupled. Deaths related to heroin also 

have increased sharply since 2010, with a 39-percent increase between 2012 and 

2013.1 It is estimated that 12 percent of all Medicaid beneficiaries ages 18–64 and 

15 percent of uninsured individuals who could be eligible for Medicaid coverage have 

a Substance Use Disorder. Given these alarming trends, it is time for a smart and 

sustainable response to prevent non-medical prescription opioid use and overdose 

and to treat people with opioid use disorder. The monetary costs and associated collateral impact to society due to Substance Use Disorder (SUD), including opioid use 

disorder, are high. In 2009, health insurance payers spent $24 billion for treating 

SUDs, of which Medicaid accounted for 21 percent of spending.2 The Medicare program, through Part D, spent $2.7 billion on opioids overall in 2011, of which $1.9 

billion (69 percent) was accounted for by opioid users with spending in the top 5 

percent.3

Combating non-medical prescription opioid use, dependence, and overdose is a priority for Department of Health and Human Services (HHS) Secretary Burwell and 

42 

4State Medicaid Director Letter, ‘‘New Service Delivery Opportunities for Individuals with a 

Substance Use Disorder,’’ 

http://www.medicaid.gov/federal-policy-guidance/downloads/SMD15003.pdf. 

5 In 2013, more than one million distinct health care providers collectively prescribed $103 billion in prescription drugs under the Part D program. In all, Part D spent $3.9 billion on prescription opioids in 2013, https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/ 

2015-Fact-sheets-items/2015-04-30.html. 

the administration at large. As part of that commitment, the Secretary launched an 

evidence-based opioid initiative that focuses on three targeted areas: informing 

opioid prescribing practices, increasing the use of naloxone (a drug that reverses the 

deadly respiratory effects of opioid drug overdose), and expanding the use of medication-assisted treatment to treat opioid use disorder. As part of our role in these efforts across HHS, CMS released guidance 4 to help States implement comprehensive, 

evidence-based service delivery approaches to Substance Use Disorder treatment. 

CMS is establishing a new Medicaid demonstration opportunity for States seeking 

to undertake significant improvements in the delivery of care to individuals with 

Substance Use Disorder. 

Moving forward, CMS has a responsibility to protect the health of Medicare and 

Medicaid beneficiaries, here in Pennsylvania and across the Nation, by putting appropriate safeguards in place to help prevent non-medical use and abuse of opioids, 

while ensuring that beneficiaries can access needed medications and appropriate 

treatments for SUD. 

PREVENTING OVERPRESCRIBING AND ABUSE OF OPIOIDS IN MEDICARE PART D

Since its inception in 2006, the Medicare Part D prescription drug benefit program has made medicines more available and affordable for Medicare beneficiaries, 

leading to improvements in access to prescription drugs, better health outcomes, 

and more beneficiary satisfaction with their Medicare coverage.5

Despite these successes, Part D is not immune from the nationwide epidemic of 

opioid abuse. Based on input from the Department of Health and Human Services’ 

Office of the Inspector General (HHS OIG), the Government Accountability Office 

(GAO), and stakeholders, over the past several years, CMS has broadened from the 

initial focus of strengthening beneficiary access to prescribed drugs to also address 

prescription drug abuse and fraud. CMS is aware of potential fraud at the prescriber and pharmacy levels through ‘‘pill mill’’ schemes. This is a term used by 

local and State investigators to describe a physician, clinic, or pharmacy that is prescribing or dispensing opioids for non-medical and inappropriate purposes. The 

structure of the program, in which Part D plan sponsors do not have access to Part 

D prescriber and pharmacy data beyond the transactions they manage for their own 

enrollees, makes it more difficult to identify prescribers or pharmacies that are 

outliers in their prescribing or dispensing patterns relative to the entire Part D program. We believe that broader reforms that result in better-coordinated care will 

help address several issues with the complex health care delivery system, including 

non-medical use of prescription drugs. CMS has, however, taken several steps to 

protect beneficiaries from the harm and damaging effects associated with non-medical prescription drug use and to prevent and detect fraud related to prescription 

drugs. 

Initiatives to Strengthen Medicare Part D and Reduce Opioid Overutilization 

A centerpiece of our strategy to reduce the inappropriate use of opioid analgesics 

in Part D is the adoption of a policy and guidance by which CMS encourages case 

management of Part D enrollees who have potential opioid overutilization that may 

present a serious threat to patient safety. To strengthen CMS’s monitoring of Part 

D plan sponsors and to prevent overutilization of these medications, the Medicare 

Part D Overutilization Monitoring System (OMS) was implemented in 2013. The 

OMS requires Part D sponsors to implement effective safeguards to deter overutilization while maintaining a commitment to provide coverage for appropriate drug 

therapies that meet safety and efficacy standards. Through this system, CMS provides quarterly reports to sponsors on beneficiaries with potential opioid overutilization identified through analyses of Prescription Drug Event (PDE) data and through 

beneficiaries referred by the CMS Center for Program Integrity (CPI). Sponsors are 

expected to utilize various drug utilization monitoring (DUM) tools, including: 

formulary-level controls at point of sale (such as safety edits and quantity limits); 

a review of previous claim and clinical activity to identify at-risk beneficiaries, case 

management outreach to beneficiaries’ prescribers and pharmacies, and beneficiarylevel point of sale claim edits, if necessary to prevent continued overutilization of 

43 

6OMS defines overutilization as the use of opioids with cumulative daily morphine equivalent 

dose (MED) exceeding 120mg for at least 90 consecutive days with more than three prescribers 

and more than three pharmacies contributing to their opioid claims. 7There were 29,404 potential opioid overutilizers, (or 0.29 percent of all Part D opioid users) 

in 2011 and there were 21,838 potential opioid overutilizers, (0.18 percent of all Part D opioid 

users) in 2014. 8Fiscal Year 2016 Budget in Brief, http://www.hhs.gov/budget/fy2016-hhs-budget-in-brief/ 

hhs-fy2016budget-in-brief-overview.html. 

opioids. Lastly, sponsors that have concluded such point of sale edits are appropriate are expected to share information with a new sponsor when the beneficiary 

moves to another plan in accordance with applicable law. To support additional 

monitoring by the new sponsor, the CMS Medicare Advantage and Prescription 

Drug System (MARx) notifies a sponsor when a beneficiary targeted for an opioid 

point of sale edit changes plans. 

We believe this Part D overutilization policy has played a key role in reducing 

opioid overutilization in the program. From 2011 through 2014, the number of potential opioid overutilizers, based on the CMS definition in the OMS,6 decreased by 

approximately 26 percent, or 7,500 beneficiaries.7

CMS has new tools to take action against problematic prescribers. CMS issued a 

Final Rule on May 23, 2014, that both requires prescribers of Part D drugs to enroll 

in Medicare or have a valid opt-out affidavit on file and establishes a new revocation 

authority for abusive prescribing patterns. CMS is actively working to enroll over 

400,000 prescribers of Part D drugs by January 2016, and will enforce the requirement that plans deny Part D claims that are written by prescribers who do not meet 

the necessary requirements by June 2016. These prescribers will be subject to the 

same risk-based screening requirements that have already contributed to the removal of nearly 575,000 provider and supplier enrollments from the Medicare program since the enactment of the Affordable Care Act. Requiring prescribers to enroll 

in Medicare will help CMS make sure that Part D drugs are prescribed by qualified 

individuals, and will prevent prescriptions from excluded or already revoked prescribers from being filled. Currently CMS is monitoring Part D claims data to identify provider types with a disproportionate number of unenrolled prescribers, such 

as dentists, and focusing our outreach strategy to target them. As we approach the 

implementation date, CMS and Part D sponsors will begin to target individual high 

volume prescribers that remain unenrolled. Upon enforcement of the enrollment requirement, CMS will require Part D plans to use point of sale edits to stop filling 

and paying for prescriptions from unenrolled prescribers after the affected beneficiaries have received a 3 month provisional supply and written notice from their 

plans. 

Additionally, CMS has established its authority to remove physicians or eligible 

professionals from Medicare when they demonstrate abusive prescribing patterns. A 

revocation for abusive prescribing would be based on criteria that demonstrates a 

pattern of improper prescribing and would address situations where the prescribing 

was not in compliance with Medicare requirements or where there were patient 

safety issues involved. CMS may also revoke a prescriber’s Medicare enrollment if 

his or her Drug Enforcement Administration (DEA) Certificate of Registration is 

suspended or revoked, or the applicable licensing or administrative body for any 

State in which a physician or eligible professional practices has suspended or revoked the physician or eligible professional’s ability to prescribe drugs. These new 

revocation authorities provide CMS with the ability to remove problematic prescribers from the Medicare program and prevent them from treating people with 

Medicare. 

Proposals to Further Fight Opioid Overutilization in Medicare Part D 

In addition to these initiatives, the FY 2016 President’s Budget 8 includes several 

proposals that would provide CMS with additional tools to prevent inappropriate 

use of opioids. One proposal to prevent prescription drug abuse in Medicare Part 

D would give the Secretary of Health and Human Services (HHS) the authority to 

establish a program that would require high-risk Medicare beneficiaries to only utilize certain prescribers and/or pharmacies to obtain controlled substance prescriptions, similar to requirements in many State Medicaid programs. The Medicare program would be required to ensure that beneficiaries retain reasonable access to 

services of adequate quality. Currently, CMS requires Part D sponsors to conduct 

drug utilization reviews, which assess the prescriptions filled by a particular enrollee. These efforts can identify overutilization that results from inappropriate or 

even illegal activity by an enrollee, prescriber, or pharmacy. However, CMS’s statuVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00047 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
44 

tory authority to take preventive measures in response to this information is limited. 

In addition to CMS’s existing authority, the FY 2016 President’s Budget also proposes to provide the Secretary with new authorities to: (1) suspend coverage and 

payment for drugs prescribed by providers who have been engaged in misprescribing 

or overprescribing drugs with abuse potential; (2) suspend coverage and payment for 

Part D drugs when those prescriptions present an imminent risk to patients; and 

(3) require additional information on certain Part D prescriptions, such as diagnosis 

and incident codes, as a condition of coverage. While Part D sponsors have the authority to deny coverage for a prescription drug on the basis of lack of medical necessity, there are currently no objective criteria to inform the medical necessity determination, such as maximum daily dosages, for some controlled substances, especially opioids. Therefore, the only basis for establishing medical necessity in these 

cases is prescriber attestation. If the integrity of the prescriber is compromised, the 

finding of medical necessity is compromised as well. If the Secretary had clear authority to intervene in these patterns suggestive of abusive prescribing or harmful 

medical care, the incidence of coverage and payment of such questionable prescribing could be reduced in Medicare. 

Data Analysis Conducted by the Medicare Drug Integrity Contractor (MEDIC) 

CMS also contracts with the National Benefit Integrity (NBI) MEDIC, which is 

charged with identifying and investigating potential fraud and abuse, and developing cases for referral to law enforcement agencies. In September 2013, CMS directed the MEDIC to increase its focus on proactive data analysis in Part D, including producing, at a minimum, quarterly reports to plan sponsors on specific data 

projects, such as high risk pharmacies assessments. 

These assessments contain a list of pharmacies identified by CMS as high risk 

and provide plan sponsors with information to initiate new investigations, conduct 

audits, and ultimately terminate pharmacies from their network. For example, one 

Part D plan sponsor terminated 51 pharmacies from its network as a result of the 

March 2015 Pharmacy Risk Assessment. Another Part D plan sponsor opened investigations on 16 pharmacies as a result of the September 2014 Pharmacy Risk Assessment. The NBI MEDIC also conducts data analysis and other work to support 

ongoing law enforcement activities. Examples of the assistance that the NBI MEDIC 

provides includes: data, data analysis, impact calculations, clinical review of claims 

and medical records, and prescription drug invoice reconciliation reviews. 

Data to Identify Outlier Prescribers 

CMS used prescription drug event (PDE) data to identify 1,525 prescribers as 

outliers of Schedule II controlled substances in the 95th percentile for the number 

of prescriptions and the number of 30-day equivalent prescriptions. Using this information, CMS developed reports that clearly identified the differences in prescribing 

patterns for the identified outliers. Similar to CMS’s comparative billing report initiatives, the goal is to: (1) proactively educate providers about aberrant prescribing 

practices; (2) act as a deterrent by making providers aware of the Government’s 

monitoring of their prescribing practices; and (3) reduce inappropriate prescribing. 

CMS then sent these reports to half of the providers, alerting them about their status as outliers. CMS also shared the list of outlier prescribers with Part D plan 

sponsors in an effort to augment their current utilization management program. We 

are further developing this and other approaches, using a similar analysis related 

to prescribing of atypical antipsychotics. 

CONCLUSION

CMS is dedicated to providing the best possible care to beneficiaries while also 

ensuring taxpayer dollars are spent on medically appropriate care. CMS has broadened its focus from ensuring beneficiaries have access to prescribed drugs to ensuring that Part D sponsors and State Medicaid programs implement effective safeguards and provide coverage for drug therapies that meet standards for safety and 

efficacy. Although there is still work that needs to be done, CMS is confident that 

our initiatives will help to reduce the rate of opioid addiction and overdoses in both 

Medicare and Medicaid. 

45 

PREPARED STATEMENT OF ASHLEY POTTS, TEAM LEADER, CRISIS STABILIZATION AND

DIVERSION UNIT, SOUTHWESTERN PENNSYLVANIA HUMAN SERVICES, INC. 

My name is Ashley Potts and I currently work for Southwestern Pennsylvania 

Human Services (SPHS) as a Team Leader for the Crisis Diversion Unit. I am currently pursuing my Master’s Degree in Social Work, I have a Bachelor’s Degree of 

Arts, and an Associate’s Degree in Science. Before accepting my position at SPHS, 

I worked for the Washington Drug and Alcohol Commission (WDAC) as a case manager for Washington County’s Restrictive Treatment Program, Drug Court, for 3 

years. However, 9 years ago my life was completely different. At 20 years old I 

found myself homeless, addicted to heroin, and suicidal. I was facing a State prison 

sentence and no one in my family wanted to be around me. Telling you about my 

history will help you understand the importance of treatment, the impact of stigma, 

the need to have awareness on preventing addiction, and recovery is possible. 

I took my first drink of alcohol when I was 9 years old. My mother suffers from 

addiction issues of her own, so culturally I did not process that it was wrong. When 

I was 12 years old, I started smoking marijuana and drinking on a more regular 

basis. At 13, I was given my first Oxycontin. This is where my love for prescription 

pain pills started. I started having behavioral issues in school, getting suspended 

on a regular basis, receiving multiple fines, and eventually, I was expelled from high 

school in the ninth grade. This is the first time I thought that maybe I should stop 

using drugs. I quit abusing cocaine and prescription pain pills; however, I still did 

not seek treatment or therapy for the issue. I was able to remain abstinent from 

these substances for the remainder of my ninth grade year. 

At the beginning of my sophomore year of high school, I was allowed to return 

to my old school. Things were going well in the beginning, but eventually I fell back 

into old habits. This is the year I began using crack. My life started to spiral out 

of control and I began running away from home. I was apprehended by the police 

several times, yet I still continued to run away. Eventually, I assumed they were 

no longer looking for me. I quit going to school and just continued to use drugs. 

Someone once told me, ‘‘Ashley if you play with fire long enough, eventually you will 

get burned.’’ I did not understand what that meant at that moment but later it all 

made sense. My entire life I was determined never to be a heroin addict, I hated 

heroin addicts, I was better than them. The price of prescription pills were very expensive. The price for Oxycontin on the street was $1.00 a milligram; an 80 milligram pill was $80.00. I could not financially support this habit despite a life of 

crime, and eventually I gave into heroin; it was only $10.00 a bag. I was 17 years 

old. 

After breaking into my father’s home and stealing some of his belongings, I was 

sentenced to juvenile probation for 6 months. During this time I was ordered to an 

outpatient program and my probation officer would come to school to visit me. I had 

moved in with my mother. I was able to graduate from high school despite my drug 

abuse and lack of attendance. The summer after high school graduation, I was 18 

years old, and I had not spoken to my father in quite some time. I called him repeatedly and told him if he did not pick me up that I was going to kill myself. 

My father came to pick me up. I returned to his house and went through the 

physical withdrawals of heroin. With every agonizing breath I said to myself, ‘‘I am 

never going to use again.’’ At this time, I still had not received any inpatient treatment; therefore, none of my behaviors were changing. After a short time of living 

there, I found out that I was pregnant and I was able to remain abstinent the duration of my pregnancy. Once I had my daughter Riley, everything changed. I was determined to be the best mom I could be; everything was going to be great. 

A few weeks after I had my daughter, I thought I could just drink alcohol. This 

lead to just snorting bags of heroin, which ultimately led to me having a needle in 

my arm again. Things were worse this time, worse than ever before. I took my 

daughter and left my father’s house. A few weeks later, there was a knock at the 

door where I was staying with my daughter, it was my father. He begged me to let 

him have temporary custody of Riley and for me to go to rehab. I agreed. This was 

the first time I was going to go to an inpatient rehabilitation facility. I remember 

the car ride there, laying in the back seat, too sick to even sit up, the agonizing 

pain was back and with every breath I said, ‘‘I am never going to use again.’’ The 

rehabilitation stay was short, only 24 days, even though my family begged them to 

keep me. I refused a halfway house and returned home; it was May 13th. Riley had 

her first birthday party on May 20th, but on May 17th I was using, nowhere to be 

found. All the dreams I had of being the best mother I could be were shattered and 

46 

enslaved to a needle. My father informed me to never step foot on his property again 

or I would be arrested. 

I was living in my car. I started selling all the things I had that were worth any 

amount of money: clothes, cell phone, and eventually my car. I had nowhere to stay. 

I moved in back in with my mother. I began writing fraudulent checks to support 

my drug habit. I stole my mother’s checkbook and wrote fraudulent checks in her 

name. I broke into an innocent person’s home and stole their belongings. I had become the exact thing I hated most in this world. I felt like a zombie, a hollow corpse. 

My mother had me walked out of her home in handcuffs. Everyone was done with 

me. I had several warrants out for my arrest and no desire to live anymore. In my 

head, there were only two options: go to treatment and stop using or kill myself. 

I decided to try treatment one more time. Again, going through the physical withdrawals and with every agonizing breath saying, ‘‘I am never going to use again.’’ 

I spent 7 long days in a detoxification unit and then 29 days in an inpatient rehabilitation program. The time came again where they offered me a halfway house, 

this time I said yes. This time I was homeless and had no place to return to. I 

transitioned to a halfway house in Washington, Pennsylvania; it was October 16, 

2006. Making the decision to go to a halfway house was the best decision I had ever 

made. I spent 216 days in treatment; those were the best days of my life because 

those 216 days saved my life. 

When I arrived at the halfway house, the first thing I did was turn myself into 

all the municipalities that were searching for me. They told me to stay where I was, 

and the court process would be started. I listened. For the first time in my life, I 

listened. While I was there, I was encouraged to participate in the Intensive Vocational Rehabilitation Program (IVRP), a program to assist with job development. I 

took an I.Q. test and scored at a sixth grade level; I was 20 years old. Several 

months went by and it was time for me to go to my sentencing court hearing. I had 

7 months clean at the time and was prepared to face my consequences and go to 

jail that day. However, when I stood in front of the judge, he granted me 216 days 

time served and immediate parole. I finally felt like I had a second chance at life 

and was ready to take full advantage of it. Something happened this day, though; 

I became a convicted felon. 

I returned to Washington and continued with my recovery process. I had decided 

I wanted to go to college. Due to my low education scores, I first attended Careerlink to take some refresher courses. I enrolled at Community College of Allegheny 

County (CCAC), I still had to take prerequisite courses; however, I was just so excited to be in college. It was surreal, the girl everyone said couldn’t make it, the 

girl that was told she was not college material. I was in college. I transferred to 

a technical school as I wanted to pursue a career in the medical field. I attended 

6 hour classes, 4 days a week. It became time to participate in an internship; however nowhere in Ohio, Pennsylvania, or West Virginia would accept me due to my 

criminal record. I was forced to quit the program. 

This was my first true encounter with stigma. The decisions that I had made during my active addiction would haunt me for the rest of my life. It was a hard internal battle to continue to pursue a college education. I took a year off from school, 

but then I decided to go back. I returned to CCAC to finish my associate’s degree 

and then I decided to go further. I enrolled at California University to obtain a 

bachelor’s degree. I was sure to select a program that did not require an internship, 

so I would not have to face that stigma again. I was able to move forward with my 

career and obtain a job at the Washington Drug and Alcohol Commission. An employee there had vouched for my character due to my record. This had happened 

several times while employed there. To be able to work with the Restrictive Treatment Program and complete assessments at the jail, the executive director had to 

speak with people individually and let them know that I was not the person that 

I had appeared to be on a piece of paper. 

While assessing individuals for the Restrictive Treatment Program applications 

for Medicare/Medicaid would be completed. Most of these individuals were eligible 

to receive Medicaid to assist with treatment for their addictions. It is important to 

have policies in place to continue to assist these individuals to gain access to the 

treatment that they need. It is also important to have policies in place that monitor 

the distribution prescription pain pills. Speaking from personal experience having 

easy access to prescription pain pills can have a devastating impact on one’s life. 

During my 3 years of employment with WDAC, I had the opportunity to learn 

about the individuals on the Restrictive Treatment Program and what had led them 

47 

to the criminal justice system. In some cases their stories began by receiving a 

‘‘harmless’’ prescription from their doctor for pain. These scenarios could include a 

sports injury or even child birth, either way they had the same outcome, drug court. 

Despite the fact that prescription painkillers are approved by the Food and Drug 

Administration, it is important to understand that does not make them safe. While 

working for WDAC, I also learned that medically assisted treatments such as 

Suboxone were being identified by individuals as a drug of choice rather that a 

treatment method. The Restrictive Treatment Program had individuals who were 

utilizing Vivitrol as a medical assisted treatment and they were diligently working 

to create more specialty tracks to include other medical assisted treatments and address the various issues attached to them. 

During my recovery process, I have had several encounters with stigma. My felony convictions have affected every decision I have made from employment, to housing, to schooling. I have not been hired for several positions due to my criminal 

record: laughed at by landlords when seeking rental properties; and forced out of 

school. No matter how hard society tried to bring me down, I was determined not 

to let it. I have spent several years rehabilitating my life and I never gave up on 

my dreams. I went from testing at a sixth grade education level to being enrolled 

in graduate school maintaining a 3.8 GPA. I went from being a client in the IVRP 

to sitting on their Board of Directors. I went from volunteering at the Washington 

Drug and Alcohol Commission to being an employee. Recently I was promoted within SPHS to be a team leader for their crisis diversion unit and join their management team. I have filed for a Governor’s Pardon for my felony convictions and have 

devoted my life to helping others. I am proof that treatment works, I am proof of 

being a good person with much to offer beyond my history of addiction, and finally, 

I am proof that recovery does happen. 

PREPARED STATEMENT OF HON. PATRICK J. TOOMEY, 

A U.S. SENATOR FROM PENNSYLVANIA

Thank you to John Paul and Allegheny Health Network for hosting this field 

hearing, and thank you for my fellow Finance Committee member, Senator Casey, 

for being here, too. He and I care deeply about how an epidemic of prescription 

opioid and heroin abuse is affecting Pennsylvania’s families. 

More Pennsylvanians will die this year from overdoses and misuse of heroin and 

prescription painkillers than from influenza or homicide. And unlike past drug 

epidemics that skewed younger and were felt in specific locales, today, heroin and 

painkiller abuse are spread across all age, demographic groups, and regions. 

As the Senate Finance Subcommittee on Health Care will hear today from our 

witnesses, sadly, southwestern Pennsylvania has been hit severely hard by this epidemic. 

Stopping this epidemic and healing our communities will require a three-prong 

approach that I am pursuing as chairman of the Senate Finance Subcommittee on 

Health Care: 

1. Stopping the illegal diversion of prescription painkillers; 

2. Reducing the overuse of opioids for treating long-term pain; and 

3. Helping those battling addiction receive appropriate treatment. 

Our witnesses will discuss those issues. Joining us are: Dr. Shari Ling, Deputy 

Chief Medical Officer, Centers for Medicare and Medicaid Services at the United 

States Department of Health and Human Services; Dr. Neil A. Capretto, Medical 

Director, Gateway Rehabilitation Center; Mr. Gene Vittone, District Attorney for 

Washington County; Dr. Jack Kabazie, System Director, Division of Pain Medicine, 

Allegheny Health Network; and Ms. Ashley Potts, Team Leader, Crisis Stabilization 

and Diversion Unit, Southwestern Pennsylvania Human Services. 

First, let’s consider how we arrived at this point. The seeds of this crisis were 

planted 2 decades ago with the advent of readily available painkillers like hydrocodone and oxycodone. While these drugs can help produce immediate pain relief, 

they are also easily abused, highly addictive, and commonly diverted. 

Nearly 80 percent of heroin users previously abused prescription opioids. 

Despite the crackdown on many so-called ‘‘pill mills’’ where unethical physicians 

prescribed large amounts of powerful opioids in exchange for cash, the problems of 

diversion and overprescribing still exist. 

48 

In fact, the nonpartisan Government Accountability Office has found there are 

more than 170,000 Medicare enrollees who are actively engaged in ‘‘doctor shopping’’ 

for physicians who will unknowingly write redundant opioid prescriptions. 

When other insurance plans, including Medicaid, spot this kind of fraud, the insurer limits or ‘‘locks’’ the individual to a single doctor or pharmacy to stop pill diversion and help control access to the addictive medication. 

Unfortunately, Medicare doesn’t have this tool. That’s why I’ve authored the bipartisan Stopping Medication Abuse and Protecting Seniors Act. My legislation, 

which Senator Casey has cosponsored, will not only help individuals battling addiction get treatment, it will also save taxpayers $79 million by stopping the illegal 

diversion of pain pills. 

Medicare and other insurers must also work with physicians to stop the medically 

unnecessary use of opioids to treat pain. This year, about 260 million painkiller prescriptions will be filled, enough for every American adult to have their own bottle 

of pills. While opioids can help control intense pain immediately after a surgery or 

a visit to the dentist, long-term opioid use becomes less effective in most patient 

populations, and is associated with higher rates of substance abuse, emergency room 

visits, accidental overdoses, and falls, especially in senior citizens. 

Medical specialty societies have begun developing new guidelines that reduce both 

the dosage and the length of time prescription opioids can safely be taken. For instance, the American Academy of Neurology now says that the risks of opioid use 

outweighed any benefits for treating headaches, lower back pain, and fibromyalgia. 

And, when opioids are used in combination with other narcotics like Valium or 

Xanax, the combination is deadly. To help providers know the panoply of medications a patient is taking, there must be broader usage of robust prescription drug 

monitoring programs. Making them interoperable across State lines will also help 

physicians, as well as law enforcement, to spot diversion and abuse. 

Finally, we must also explore ways to improve access to, and the quality of care. 

While addiction to an opioid or alcohol is often viewed as a moral failing, in many 

ways it is a chronic disease like diabetes and heart disease. The medical profession 

continues to debate the optimal approach, but everyone agrees that opioid addiction 

can be treated with professional help. Congress and my subcommittee are closely 

examining a number of legislative proposals in this area. 

Ending the epidemic of heroin addiction will require changes in the practice of 

medicine, government regulation, and societal views. There are steps we can and 

should take today that end diversion, reduce non-medical use of opioids, and approach addiction like a treatable disease. 

I thank all of you for being here today. It shows there is a commitment and desire 

in southwestern Pennsylvania to end this epidemic. By working together at the Federal, State and local level, I am confident that opioid abuse is an enemy we can defeat. 

PREPARED STATEMENT OF EUGENE A. VITTONE II, M.B.A., M.H.A, J.D., 

DISTRICT ATTORNEY, WASHINGTON COUNTY, PA 

INTRODUCTION

Good afternoon. I would like to thank the chairman, Senator Pat Toomey, for the 

honor and opportunity to provide testimony to the committee. I first met the Senator last year when he convened a working panel in Washington County to address 

the increasing problem of addiction in our country. He is truly a champion in this 

area, and I thank him for his recognition and dedication to resolving this deadly 

national problem. 

I would be remiss if I did not also thank our local United States Attorney, David 

Hickton, for his leadership and assistance on the problem of opiate abuse. Mr. 

Hickton is also a champion and a great partner for law enforcement, who are on 

the front lines fighting the epidemic of opiate drug abuse. 

It is no secret that our Nation is in the midst of an epidemic of drug-related 

deaths caused by prescription drug abuse. This is both a public health and a public 

safety crisis. Many thousands have died due to overdoses caused by opiate drugs 

and heroin. Washington County is not immune from this peril. Since 2011, more 

than 230 Washington County residents have lost their lives due to accidental poiVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00052 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
49 

soning caused by opiate drugs. In August of this year, we had a spate of drug 

overdoses caused by fentanyl-laced heroin which claimed several lives and placed 

Washington County in the national news. This epidemic however goes beyond the 

overdose deaths caused by opiate abuse. The epidemic also significantly impacts the 

area where I work, which is the criminal justice system. 

I recently conducted a statistical review of the criminal case filings for 2014 and 

discovered that at least 75 percent of the filed cases had a connection to drugs and 

alcohol. Thirty percent of our cases were directly linked to opiate abuse, both pills 

and heroin. This is roughly equivalent to the number of cases that we have arising 

from alcohol, including driving under the influence. From my 17 years working in 

the Washington County District Attorneys Office, I can assure you that this is a 

new event. Not too long ago, it was rare to see a heroin case in court—now it is 

rare not to have a case involving heroin or someone in opiate addiction. 

Our coroner, Tim Warco, has been very good about documenting the toll arising 

from this epidemic. A review of his data about the deaths over the past 5 years indicates that this is a problem not just for young people but for all age ranges. Fortyone percent of our deaths were people over the age of 40. Forty-six percent were 

from a combination of two or more drugs and, why we are here today, 57 percent 

were from prescription medications. 

The connection between opioid medication abuse and heroin is well established. 

As local law enforcement professionals, we have had to become educated in many 

different areas of the law—which were not known to us—in order to fight the abuse 

of these medications. We have responded in Washington County with numerous 

drug educational summits at local schools to warn children of the dangers of abuse 

of pharmaceuticals. We have drop boxes for unwanted medications in our police stations, we have embedded a Federal prosecutor in our office to aggressively go after 

drug dealers, and we have heightened and promoted treatment for non-violent 

criminal offenders. These measures are designed to work on both the supply side 

and demand side of the epidemic. While I am proud of what we have done thus far, 

I fear that these measures will not be sufficient alone to eliminate the problems of 

rampant opiate addiction. 

Last fall, the Pennsylvania General Assembly enacted legislation providing for an 

improved Prescription Drug Monitoring Program (PDMP). This legislation was sorely needed as our old system was inadequate to inform health care providers of who 

was receiving what opiod medications. Since that legislation was passed, the PDMP 

has not come into being largely due to the fact that no money was set aside for its 

development. State Representative Brandon Neuman has indicated to me that some 

Federal funding has become available to initiate the work of development of the 

PDMP. S.B. 480, which reauthorizes the National All Schedules Prescription Electronic Reporting Reauthorization Act would help Pennsylvania’s PDMP. This would 

also provide for improved communication with neighboring States to prevent prescription medication diversion. It is imperative that this be done as soon as possible 

as Pennsylvania has become a source location for those coming from other States 

looking to acquire opioid medications through diversion. 

Washington County sits in the southwestern corner of Pennsylvania and is close 

to Maryland, Ohio, and abuts West Virginia along its western edge. Due to our geographical location we are an easy drive for those looking to acquire medications, 

whether they are looking to use forged prescriptions or prescriptions acquired 

through doctor shopping. In 2012, my office in combination with other law enforcement agencies arrested 12 individuals who were acquiring pills in 7 different Pennsylvania Counties. They were traveling as far north as the New York State line and 

to the east as far as Chambersburg. That scheme wasn’t too sophisticated—they 

would simply go to different physicians—claim pain and obtain prescriptions which 

they would then alter. They were also manufacturing prescriptions utilizing a scanner and computer. They operated for at least a year and acquired tens of thousands 

of pills of Opana, OxyContin and other medications before they were arrested. There 

is no doubt that they would had been detected sooner had a PDMP been in place. 

They also would not have been able to utilize third-party insurance to pay for the 

medications if a ‘‘lock’’ had been in place to prevent them from doctor shopping. 

There is also an emerging trend we are seeing in the diversion of Suboxone which 

is a drug utilized in medication-assisted treatment of people with opiate addiction. 

Traditionally, methadone was utilized to wean people off of heroin. Suboxone is also 

an opiate but is prescribed to people in an attempt to lessen the effects of withdrawal and help them in recovery. I have heard reports of increased criminal activVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00053 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
50 

ity near Suboxone clinics, and recently we have made arrests of individuals selling 

Suboxone on the street. 

In 2012, a physician, Oliver Herndon, was arrested and charged with dispensing 

powerful opiate drugs, oxycodone and oxymorphone. According to DEA Agents who 

investigated, Dr. Herndon was one of the largest suppliers of diverted Opana in the 

eastern United States. His parking lot had cars from many different States and individuals came from out of State to get prescriptions filled. Many pharmacies independently refused to fill the large prescriptions that were written. During one visit 

by an undercover agent, when asked where his prescription could be filled, he was 

told by Herndon the further away that he could get the prescription filled the easier 

it would be. Investigators learned that many of the pills were being sold on the 

street and were surprised to learn that once Herndon was arrested the price of 

Opana doubled on the street. Herndon provided a letter to his patients denying that 

he was under DEA investigation and indicating that he was the medical director 

for a hospice organization and two nursing homes. Herndon was successfully prosecuted in Federal Court for the Drug Act violations and also for insurance fraud 

from the hundreds of thousands of dollars that were fraudulently submitted as 

claims. 

I indicated earlier that over 50 percent of the people who die from overdoses are 

over the age of 40. I just spoke about a doctor who was supplying pills to people 

of all ages and was also medical director for two nursing homes and a hospice organization. These facts emphasize the need for a lock provision in health insurance 

policies, particularly Medicare, which require a patient with a drug abuse medical 

history to ‘‘lock in’’ with a particular physician and pharmacy. This would help 

eliminate diversion of medications, and the prescribing patterns may be clearly evaluated. This would reduce Medicare fraud attributable to the filing of false claims 

and diversion of medications. This lock-in provision is the centerpiece of S.B. 1913 

entitled the Stopping Medication Abuse and Protecting Seniors Act sponsored by 

Chairman Toomey. 

In closing, I am thankful for the opportunity to address the committee today and 

talk about this important challenge which is facing Washington County and our Nation. In the 4 years during which I have been learning about the epidemic and attempting to develop the means to fight this problem, I have learned many things. 

Much of what we have learned has been put into practice as an ever-evolving plan 

of action. I have had to accept that as a law enforcement professional, I cannot 

make this problem go away by myself. I cannot stop the accidental overdose deaths 

and devastation caused by the addiction sweeping our Nation. I need the help of 

all levels of government in combating this problem. I pray for consistency in the various regulatory agencies involved with the regulation of these powerful medications, 

and I look for a faster response to problems once they are identified. I am just one 

district attorney in a county in Pennsylvania, but there are many more like me facing the same crisis, and we need the ability to do our jobs and maintain the criminal justice system in the wake of the increased demands created by the opiate epidemic. Those of us in law enforcement, who are on the front lines of the opiate epidemic, will continue to enforce the law and do our best to protect the public we 

serve. 

Thank you. 

STATISTICAL REVIEW OF CRIMINAL CASE FILINGS IN WASHINGTON COUNTY

Study Design—A statistical sample representing a 95 percent confidence interval 

was taken from the 3,377 criminal cases filed in Washington County in 2014. The 

goal was to determine within a measure of certainty the number of cases driven by 

drugs and the specific drugs which drove the criminal case. The sample size was 

345 cases. 345 numbers were drawn randomly from an Internet randomization service and criminal complaints and affidavits of probable cause for each of the specific 

cases corresponding to the randomly generated numbers were reviewed. Note was 

made of the charges filed, the police department and any mention of a drug in the 

original criminal complaint. These results were tallied and are given below. 

Limitations—In many cases, a specific drug may not be named in the criminal 

complaint as the use of a drug may not be relevant to the crime charged. For example, in a possession case the type of drug would be relevant; in a theft case, the 

fact that the offender had a drug problem would not be an element of the crime 

charged. This limitation on the study design would mean that the results demonstrated are more likely than not higher than indicated below. 

51 

Results—A tabulation of a statistically valid sample of criminal case filings for 

Washington County in 2014 yielded the following results: 

Offenders use of a drug— 74.78 percent of the cases (258/345) 

Type of drug 

Prescription medication— 7.25 percent of the cases (25/345) 

Heroin 22.61 percent of the cases (78/345) 

Cocaine 2.9 percent of the cases (10/345) 

Alcohol 32.17 percent of the cases (111/345) 

Cannabis 9.86 percent of the cases (34/345) 

Discussion: The results demonstrate that alcohol is still the most commonly 

abused drug resulting in criminal charges. DUIs and alcohol based crimes account 

for almost a third of the criminal cases filed in Washington County. Heroin is the 

second most commonly implicated drug in criminal cases. Use of an illicit drug other 

than alcohol resulted in 42.6 percent of the criminal cases filed in Washington 

County. The correlation between offender drug use and criminal activity has been 

well documented and the data produced in this statistical review of the filings in 

Washington County serves to support this correlation. 

Other results: 

Felony charge filed 25.79 percent (89/345) 

Misdemeanors 74.21 percent (256/345) 

Domestic violence crime 5.5 percent (19/345) 

Child Abuse 3.18 percent (11/345) 

ACCIDENTAL OVERDOSE DEATHS IN WASHINGTON COUNTY 

2011–2015 

Year 2011 2012 2013 2014 2015 Total 

Total deaths 46 40 58 36 50 230 

Combined drugs 29 22 12 19 25 107 46.52% 

Prescription meds 33 22 26 27 23 131 56.96% 

Number of drugs found on toxocology 

1 17 22 46 17 19 121 53.07% 

2 14 7 6 9 18 54 23.68% 

3 15 7 0 5 6 33 14.47% 

4 0 4 6 4 1 15 6.58% 

5 or more 0 0 0 1 0 1 0.44% 

Gender 

Male 30 23 36 23 35 147 65.04% 

Female 16 13 22 13 15 79 34.96% 

Age 

<19 14 2 1 2 1 20 9.09% 

<29 0 3 25 5 10 43 19.55% 

<39 10 12 10 12 15 59 26.82% 

<49 13 13 16 6 10 58 26.36% 

<59 7 5 5 8 8 33 15.00% 

>60 2 1 1 3 0 7 3.18% 

Source: 

Washington County Coroners Office 

Timothy Warco, Coroner 

http://www.co.washington.pa.us/index.aspx?NID=386. 

(53) 

COMMUNICATIONS

AMERICAN ASSOCIATION FOR THE TREATMENT OF

OPIOID DEPENDENCE (AATOD) 

225 Varick Street, 4th Floor, New York, NY 10014 • Phone: (212) 566–5555 • Fax: (212) 366–4647 

E-mail: info@aatod.org. • www.aatod.org 

Recommendations on Increasing Access to Effective Treatment for Opioid 

Addiction from the American Association for the Treatment of Opioid 

Dependence (AATOD) 

My name is Mark Parrino, and I am writing on behalf of the American Association 

for the Treatment of Opioid Dependence (AATOD), which represents 1,000 Opioid 

Treatment Programs throughout the United States, treating 340,000 patients on 

any given day. These are the treatment programs that treat opioid addiction under 

certification through the Substance Abuse and Mental Health Services Administration. All of these programs must comply with SAMHSA’s operating requirements, 

which were promulgated during 2001. All of the Opioid Treatment Programs (OTPs) 

must also comply with the Drug Enforcement Administration’s security requirements. Finally, all of the OTPs are regulated by the State Opioid Treatment Authorities, which have different and at times more stringent, standards of regulation. 

The Senate Finance Subcommittee on Health Care and its members understand 

that our country is experiencing a public health crisis of untreated opioid addiction. 

It is useful to reference a recent article on this topic, which was published in the 

New England Journal of Medicine on January 15, 2015, ‘‘Trends in Opioid Analgesic 

Use and Mortality in the United States.’’ Dr. Richard Dart is the lead author in this 

article, which made the following point: ‘‘Whatever the measure, the past few decades have been characterized by increasing use and diversion of prescription drugs, 

including opioid medications, in the United States. An estimated 25 million people 

initiated non-medical use of pain relievers between 2002 and 2011.’’ 

As the subcommittee knows, there have been a number of national reports from the 

Substance Abuse and Mental Health Services Administration (SAMHSA) and the 

Centers for Disease Control and Prevention (CDC), documenting the increase in the 

use of prescription opioids. SAMHSA has also documented the fact that 80% of new 

heroin addicted individuals report using prescription opioids as a gateway drug. 

Need for Public Education 

One of AATOD’s primary recommendations, which has been made to the representatives at the Department of Health and Human Services and other federal agencies 

which have jurisdiction in this area, is the need to provide a meaningful and clear 

public education campaign for Americans, underscoring the dangers of opioid abuse 

and addiction. There has been a loss of intergenerational knowledge given the fact 

that people do not understand how they can get into trouble when abusing prescription opioids. Additionally, Americans need to understand that heroin use is not a 

safe alternative when they do not have access to prescription opioids. We recommend that the Department of Health and Human Services (HHS), in conjunction 

with its agencies, work with the White House Office of National Drug Control Policy 

in developing these clear messages to the American public. This would need to be 

a sustained campaign, since it took years for the American people to get to the current place of prescription and heroin abuse. 

AATOD supports a number of the elements in Congressman Bucshon’s legislation, 

especially in providing guidance to medial practitioners who work under the aegis 

of the Drug Abuse Treatment Act of 2000. Such practices need to provide greater 

education to their patients about the available medications to treat their illness. 

54 

Recommended Policy Initiatives 

At the present time, 49 states have either enacted or implemented statewide Prescription Drug Monitoring Programs (PDMPs). These programs need to be utilized 

by physicians in general practice in addition to dentists and substance abuse treatment providers. It is understood that not all of these PDMPs are easy to use and 

should also be utilized by other clinical/administrative support personnel in a medical practitioner’s office. Ultimately, medical practitioners must utilize these databases as a method of treating their patients with a greater margin of safety. Increasing such utilization of PDMPs will help in better treating individuals who are 

abusing opioids. However, it is part of a solution, not the only solution. 

The Use of Medications to Treat Chronic Opioid Addiction 

There are three federally approved medications to treat chronic opioid addiction in 

the United States: methadone, buprenorphine, and Vivitrol/Naltrexone. It is recommended that all three medications be used in conjunction with other clinical support services, including counseling. Methadone is primarily offered through OTPs, 

while buprenorphine is primarily offered through DATA 2000 practices. Injectable 

Naltrexone products may be used in any medical setting including OBOTs and 

OTPs. 

The National Institutes on Drug Abuse (NIDA) has funded numerous studies in support of the use of these medications in treating chronic opioid addiction. There are 

guidelines for the use of such medications through the Treatment Improvement Protocol series, published by SAMHSA, in addition to recently released guidelines for 

the use of medications in treating opioid addiction through the American Society of 

Addiction Medicine. Physicians need to be trained in how such medications are used 

and when opioid addicted people would benefit from each of the three medications, 

as stated above. 

Opioid Overdose Prevention Toolkits 

AATOD agrees with the recommendations of ONDCP and HHS in increasing the 

utilization of opioid overdose prevention tool kits. We have already seen the benefits 

of widespread availability through emergency responders and police forces in different cities of the United States. The key recommendation is to ensure that individuals who receive such overdose prevention tool kits get access to emergency room 

care once they have been revived. The Vermont Hub and Spoke model provides even 

more support in how such treatment is coordinated once the individual is saved, 

brought to an emergency room, and then referred to treatment through the available resources. 

Recommendations to Increase Access to Medication Assisted Treatment for 

Opioid Addiction 

Congress passed the Drug Abuse Treatment Act of 2000 and subsequently amended 

it so that physicians who are DATA 2000 waived could treat up to 100 patients per 

practice. It is understood that a few congressional offices and HHS are considering 

how to increase access to such care under the aegis of DATA 2000. For the record, 

our Association has opposed the elimination of this patient limit as proposed by the 

TREAT Act. 

• Before federal agencies and congressional offices proceed with recommendations 

to increase access to such treatment options, there needs to be a better understanding of what treatment is offered through DATA 2000 practices at the present 

time. 

• If there is going to be any consideration in adjusting this patient number, there 

should be clear conditions placed on practices that wish to treat a greater number 

of patients. Illustratively, physicians should be offering counseling services and 

conducting toxicology profiles on patients to better guide success in treatment. 

• Such practitioners also need to be accessing PDMP databases before and during 

the patient’s care. 

• The practitioner needs to assess the patient for their clinical needs, which may 

include counseling and other ancillary support services to treat co-morbidities 

such as infectious diseases (Hepatitis C) or psychiatric co-morbidity (depression, 

anxiety). 

• Patient outcomes need to be followed as a method of better understanding the 

success of such treatment interventions. In this case, physicians need to be able 

to provide information about the length of time a patient remains in treatment 

and relapse rates. 

55 

Increasing Access to the Use of Medications in Opioid Treatment Programs 

At the present time, SAMHSA has certified approximately 1,300 OTPs, which operate in 49 states. Approximately 350,000 patients are treated through theseOTPs at 

any given point in time. AATOD has identified the lack of Medicaid reimbursement 

for OTP services as a major impediment in l7 states in this country. AATOD has 

also learned that utilization of such services increases by a factor of 25 percent 

when Medicaid reimbursement is available. Accordingly, AATOD is working with a 

number of policy partners to address this impediment. 

If the experience of OTPs provides any guidance to Congress and this Subcommittee 

in its deliberations, the following illustration provides an important reference. OTPs 

expanded quickly in the late 1960s without any operating requirements. Congress 

passed legislation that created a regulatory oversight structure for these OTPs in 

1972. The House Select Committee on Narcotics Abuse and Control directed the 

United States General Accounting Office to develop a report on Methadone Maintenance Treatment. This report was published in March 1990: ‘‘Methadone Maintenance—Some Treatment Programs Are Not Effective; Greater Federal Oversight 

Needed.’’ SAMHSA published its first Treatment Improvement Protocol in 1993 

‘‘State Methadone Treatment Guidelines’’ as a method of responding to the recommendations of the GAO report. The FDA asked the Institute of Medicine to 

evaluate the federal regulation of methadone treatment. The IOM released its findings in 1995, laying the foundation for the FDA to end its oversight of the OTPs 

and transition the oversight to SAMHSA. This was finalized in 2001. SAMHSA also 

published more detailed guidelines for OTPs in 2007 and these were revised during 

March 2015. The point in siting these references is to advise Congress that it took 

these interventions to improve the quality and practices of OTPs. 

Conclusion 

In summary, AATOD is pleased to work with members of Congress on the best 

methods of increasing access to treatment for opioid addiction and in educating 

America about the dangers of opioid abuse. This will take a sustained and coordinated effort so that federal policy and legislation need to be based on evidence and 

what is known to be effective. We have learned a great deal over the past 50 years 

of the most effective methods of treating opioid addiction. It is clear that our nation 

got into this problem in major part as a result of the improper and unsupervised 

prescribing of opioids for pain management. The way out is not to provide a different medication without appropriate supervision and the provision of essential 

services, which must be used in support of opioid addicted individuals. This explains 

our opposition to the element of the TREAT Act which completely eliminates the 

existing 100 patient restriction. Additionally, we are asking Congress to expand access to OTPs through Medicaid and Medicare to remove the existing impediments 

as stated above. We look forward to working with the House and other members 

of the legislature as these issues move forward. 

AMERICAN PSYCHIATRIC ASSOCIATION

AMERICAN ACADEMY OF ADDICTION PSYCHIATRY

AMERICAN OSTEOPATHIC ACADEMY OF ADDICTION MEDICINE

The Honorable Sylvia M. Burwell 

Secretary 

U.S. Department of Health and Human Services 

200 Independence Avenue, S.W. 

Washington, DC 20201 

Dear Secretary Burwell, 

We are writing on behalf of three of the foremost nationally recognized addiction 

medical specialty associations, representing more than 60,000 physicians, to express 

our concerns regarding proposals to raise the patient limits currently reflected by 

the Drug Addiction Treatment Act of 2000 (DATA 2000). Because our organizations 

are entrusted by the law to train prescribers and health professionals on the front 

lines of treating this public health crisis, we are in eager to work with the Department of Health and Human Services in order to develop recommendations. 

As you are well aware, addiction to prescription drugs and heroin is a public health 

crisis. Yet, as the number of people addicted to these opioids increases, there continues to be a shortage of physicians who are appropriately trained to treat them. 

56 

The shortage severely complicates and impairs our ability to effectively address the 

epidemic, particularly in many rural and underserved areas of the nation. 

We sincerely value and appreciate your interest in addressing this growing and complex problem. While we are aware of proposals to raise patient limits, the potentially adverse consequences of increased patient limits are of significant concern, including: 

• proliferation of ‘‘pill mills’’ and the erosion of evidence-based treatment; 

• inadequate safety monitoring to protect against diversion; and 

• underutilization of evidence-based mental health and substance abuse counseling services. 

As organizations authorized to train physicians to treat opioid use disorders, we 

strongly believe that all aspects of the problem and possible solutions should be 

fully evaluated and considered before moving forward with any proposed policy 

changes. 

We believe that: 

• There is a need to address this public health matter as a priority. 

• The real complexities of addressing this issue go beyond increasing the patient 

limit. 

• Simply increasing the per-prescriber patient limit is problematic even for addiction specialists; handling 100 buprenorphine-maintained patients in a clinically 

adequate manner is challenging. There must be frank discussions of multidisciplinary and other models that might better address the issue without adding 

undue risk for patients, or increasing regulatory scrutiny for all providers, 

which is against the spirit of DATA 2000. 

• The right balance between patient volume and clinical responsiveness must be 

determined. 

Our members are among the leading clinical experts in the treatment of opioid use 

disorders and are uniquely positioned to address these issues. We are currently formulating more specific recommendations and welcome an opportunity to work with 

you on how to effectively confront this public health crisis. 

Sincerely, 

Saul Levin, MD, MPH 

CEO and Medical Director 

American Psychiatric Association 

Laurence M. Westreich, MD 

President 

American Academy of Addiction Psychiatry 

Margaret Kotz, DO 

President 

American Osteopathic Academy of Addiction Medicine 

Cc: Pamela Hyde, J.D., Administrator, SAMHSA 

Elinore McCance-Katz, M.D., Ph.D., Chief Medical Officer, SAMHSA 

H. Westley Clark, M.D., J.D., M.P.H., Director, Center for Substance Abuse 

Treatment 

Michael Botticelli, Acting Director, ONDCP 

Recommendations of the 

American Psychiatric Association, 

American Academy of Addiction Psychiatry, and the 

American Osteopathic Academy of Addiction Medicine on 

Revisions to the Drug Addiction Treatment Act of 2000 

1. Replace practice limits of 30/100 patients with a 3 tiered system: 

• Tier 1: Small Primary Care or Psychiatry practices: physicians can follow up to 30 patients at one time, as with the present system. There will 

be NO DEA INSPECTIONS unless DEA or single state agency review of state 

PDMP data suggests the 30 patient limit has been exceeded (or other violations 

of standard clinical practice regulations have occurred). 

Comment: DEA inspections are frequently mentioned as a reason for physicians not prescribing. This change should expand the number of small preVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00060 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
57 

scribers. Data groups and SAMHSA should notify all individuals who have 

taken waiver training of this new option and widely publicize the change. 

• Tier 2: 

Æ OPTION ONE—SOLO PRACTICE MODEL (this practice can occur in 

a group setting, or multiple physicians can practice within the same 

system) Æ After 1 year of practice, physicians can apply to go up from the 30 

patient limit to 150 patients. Æ Prescribers in this group would be required to: 

1. take 3 hours of approved addiction related CME annually, 

2. certify that they follow a nationally recognized set of standard evidencebased guidelines for the treatment of patients with substance use disorders, and 

3. would be subject to occasional DEA inspections as in the current system. 

Comment: This tier is comparable to the current system. The increase to 150 

patients would immediately address identified need for additional services but 

not increase the numbers in individual practices to a range that is incompatible with good clinical practice. 

Æ OPTION TWO—MULTIDISCIPLINARY PRACTICE Æ After 1 year of practice, a physician can apply to go from the 30 patient limit to a range of up to 340 patients with the addition of up 

to three physician extenders to the practice (Physician Assistant, 

Nurse Practitioner). The physician would be capped at 100 patients, each 

physician extender would be capped at 80 patients, with the total practice 

capped at 180 to 340 patients depending on the number of physician extenders in the group. This group of practitioners would be required to: 

1. take 3 hours of approved addiction related CME/CEU annually, 

2. certify that they follow a nationally recognized set of standard evidencebased guidelines for the treatment of patients with substance use disorders, and 

3. be subject to occasional DEA inspections as in the current system. 

Physicians in this type of practice would be required to be certified in Addiction Psychiatry by the ABPN or in Addiction Medicine by ABAM or ASAM, or 

have subspecialty board certification in addiction medicine from the American 

Osteopathic Association (AOA), unless SAMHSA grants an exemption for nonspecialists practicing in high-need rural areas. 

Comment: In this type of multidisciplinary practice the physician would be 

required to supervise the physician extenders. To allow for the time for required supervision, should the physician be capped at 80 patients? 

This would drop the total maximum number for the practice to 320. 

• Tier 3: Practices that are over 340 patients would require separate registration as a specialized Opioid Treatment Program, and would be 

monitored accordingly with varying staffing requirements related to the 

number of patients being treated, much more specific regulation of practice, and 

would be subject to periodic reviews by DEA and CARF or The Joint Commission. Physicians working in such a setting would be required to be certified in 

Addiction Psychiatry by the ABPN or in Addiction Medicine by ABAM or ASAM 

or have subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA). SAMHSA/CSAT should call a meeting of 

the DATA groups, the DEA, CARF, The Joint Commission to work out the details of regulations for this class of OTP. Practices of this type could be staffed 

by one or more physicians and a mix of RNs, MSWs, PhDs, Pharmacists and 

drug counselors comparable to the staffing in a methadone maintenance program, or they could follow the staffing guidelines described for Tier 2/Option 

Two above. 

Comment: While this model is inconsistent with the intent of DATA 2000, 

it recognizes the need for expanded services and protects the integrity of the 

DATA 2000 system, which is much better suited for providing services that 

are integrated into standard mental health and primary care settings under 

the ACA. 

2. Permit buprenorphine prescribing by Physician Assistants and Nurse 

Practitioners in those states or jurisdictions where such practice is permitted. 

Prescribers will be required to take a standard 8 hour face-to-face waiver course, 

58 

practice under the supervision of a physician certified in Addiction Psychiatry by 

the American Board of Psychiatry and Neurology (ABPN) or Addiction Medicine 

by the American Board of Addiction Medicine (ABAM) or the American Society 

of Addiction Medicine (ASAM) or have subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA), (unless exempted by SAMHSA for non-specialists working in high-need, rural areas), and take 

3 hours of approved addiction related CME/CEU annually. See Tier 2/Option Two 

above. 

3. Explore options under telemedicine that would permit delivery of 

buprenorphine services in rural or underserved areas. Those telemedicine 

programs treating more than 340 patients will be held to Tier 3 standards. 

4. Additional Federal funds are needed for buprenorphine training for 

physicians and physician extenders, and for ongoing CME programs to 

enhance the clinical skills of treatment providers. Additionally, set-aside 

funding is recommended for residency training programs to provide 

training in Medication Assisted Treatment and would also provide physician training in MAT through funding additional ABPN-approved addiction psychiatry fellowships, as well as general practice addiction 

medicine fellowships. 

5. Funds are also needed to cover the costs for an expanded treatment system for uninsured individuals with opioid use disorders, as well as those 

covered under Medicaid programs. 

6. This program should be enacted for a trial period and re-evaluated in 

three years to determine if it is successful in expanding treatment capacity and whether increasing the number of patients treated by each 

waivered physicians has a negative impact on the quality of treatment, 

or a negative impact on public health associated with increased diversion of buprenorphine or other unanticipated negative consequences. 

BEACON HEALTH OPTIONS

Senate Finance Health Care Subcommittee 

Investigation into opiate abuse epidemic 

Field Hearing 

Thursday, October 15, 2015 

Allegheny General Hospital—Magovern Auditorium 

320 E North Avenue, Pittsburgh, PA 15212 

Testimony of Steve Bentsen, MD, MBA, DFAPA, Regional Chief Medical Officer, 

Board Certified in Addiction Medicine, Beacon Health Options. 

Senator Toomey and members of the Subcommittee, my name is Steve Bentsen, 

MD, DFAPA, and I serve as Beacon Health Options’ Regional Chief Medical Officer 

and I am certified by the American Board of Psychiatry and Neurology in Addiction 

Psychiatry. Thank you for the opportunity to testify before the Subcommittee today 

to discuss actions we are taking to address the opioid crisis. 

About Beacon Health Options (Beacon). 

Beacon is the largest mental health specialty company in America. We operate in 

13 counties in western Pennsylvania as Value Behavioral Health of Pennsylvania 

in the HealthChoices managed Medicaid program. Overall the company serves 47 

million people across all 50 states and the United Kingdom, including more than 

13 million Medicaid and other publicly funded members across 26 states and the 

District of Columbia through direct-to-state contracts and 50 health plan partnerships. 

Substance abuse is a chronic illness and should be treated through a 

chronic care model. 

Beacon proposed in a recent White Paper that a chronic disease model of care is 

required to treat opioid addiction. This framework has been applied to other chronic 

conditions, such as diabetes and cancer. The White Paper is available online at 

59 

http://beaconlens.com/wp-content/uploads/2015/07/Confronting-the-Crisis-ofOpioid-Addiction.pdf. The six tenets set forth in the paper are as follows: 

1. Increase community resources and policies: To really have impact, providers 

need to create partnerships with local groups including state agencies, 

courts, schools etc. to link resources and promote better health. 

2. Increase collaboration between payers and providers: The relationship between purchasers and providers must prioritize chronic care over episodic 

care through alternative payment methods. 

3. Improve access to resources for self-management: Promote verbal and written 

explanation of treatment options, alternatives, risks and benefits of all 

evidence-based treatments including Medication-Assisted Therapies (MAT) 

4. Improve design of delivery system: Build a continuum of care based on the 

chronic care model; including ASAM’s 10 levels of care and pain management 

services. 

5. Increase decision support: Apply evidence-based clinical practice guidelines to 

MAT, including real time support for prescriber such as the MCPAP model 

for adults with substance use disorders. 

6. Implement clinical information systems: Improve care coordination through 

EHRs. Create registries of MAT recipients and prescribers. 

These tenets are summarized in chart below: 

Accepting opioid addiction as a chronic illness provides an evidence-based framework for a chronic care model that includes changes at all levels—clinical, social, 

legislative etc. We strongly support the increased use of evidence based practices in 

the treatment of substance abuse, such as cognitive-behavioral therapy, medication 

assisted therapy and contingency management interventions. Additional steps need 

to be taken to recruit, train and retain a strong workforce of treatment professionals 

to provide needed therapies for substance abuse treatment. At Beacon, we are working with various stakeholders to turn chaos into order in an organized, step-by-step 

fashion. 

Scope of the substance use disorder problem in Pennsylvania. 

We are in the midst of a national ‘‘Substance Abuse’’ crisis. The United States averages 110 overdose deaths from legal and illegal drugs every day. The heroin death 

toll has quadrupled in the decade that ended in 2013, according to the Centers for 

Disease Control and Prevention. By all accounts, it has only grown worse since. In 

Washington County, Pennsylvania there have been more than 50 fatal overdoses 

this year with a number occurring in a single 24 hour period, according to local 

news accounts. Unfortunately there are similar stories in other counties in Pennsylvania as well as nearby states. 


101515.001
60 

Opioids, both in prescription drug form as well as illicit sources such as heroin, are 

taking an enormous toll on all of our communities. A recent report published by the 

Trust for America’s Health and the Robert Wood Johnson Foundation showed that 

Pennsylvania is near the top in the nation for drug overdose deaths. In fact, death 

from drug overdoses now exceeds death from car accidents in Pennsylvania (and 35 

other states). No socio-demographic group is being spared. We see reports of young, 

middle-aged and older people dying of these drugs. The demand for substance abuse 

services in the communities we serve has sky-rocketed. And unfortunately, many of 

the people who need treatment are still not seeking it due to a lack of information 

about treatment or the negative stigma that is still attached to drug abuse and addiction. We are working closely with local counties, providers, oversight groups, 

state officials, law enforcement, education and consumer advocates to help confront 

this crisis. We believe that a concerted and cooperative effort is one of our strongest 

weapons. 

One example of a successful initiative we undertook involved helping people stay in 

treatment once they were admitted. We have seen a number of people leaving rehabilitation programs without the ongoing transitional services or resources in place 

to sustain recovery or leaving before program completion due to lack of engagement. 

This can lead to early relapse and readmission or death. Through a cooperative effort with counties, oversight bodies and providers, an innovative series of initiatives 

were implemented including: the use of motivational interviewing, focusing more on 

individuals early in treatment when the against medical advice (AMA) rate is high, 

improving weekend programming, better matching with therapists, better use of 

peers, family members, and other social supports to name just a few. Our work 

showed improvements in treatment retention with significant decreases in individuals leaving against medical advice including: a 39% decrease in premature discharges from short term residential treatment, a 46.5% decrease on long term residential treatment and a 50% decrease in premature discharges among individuals 

in short term dual diagnosis residential treatment programs. This demonstrates 

that we can make a difference when we focus on specific areas in need of improvement and when we work cooperatively. We have also provided substance abuse 

trainings to emergency departments and mental health units. In addition, we have 

recently completed a best practice guidelines for Suboxone prescribers. 

Recommendations for federal action. 

Increasing access to treatment—including MAT services. 

There are currently three FDA-approved medications for the treatment of opioid dependence and relapse prevention. Scientific research has shown that these medications are an effective component of treatment, decrease the risk of future overdose 

and should be made available to all patients as part of a comprehensive treatment 

plan that includes counseling and behavioral interventions. In addition we support 

availability of rescue naloxone. Congress has already taken some steps to increase 

the use of MAT, appropriating $12 million in the FY 2015 budget for states to expand access to opioid treatment services where MAT is an allowable use. SAMHSA 

has already released a Request for Application for this grant, and states have applied. The Administration has proposed doubling this funding to $25 million in FY 

2016. I encourage Congress to consider appropriating this additional funding given 

the serious challenges that states face in responding to this epidemic. 

Better Physician training, member awareness, and increased efforts that promote alternative pain strategies to opioid prescription for pain management. 

We need to focus on function (rather than pills), cognitive and behavioral approaches, and non-opioid medications and devices. Physicians receive little to no 

training about substance use disorders during medical school. As a result, it is reasonable to believe that this lack of understanding has likely contributed to the significant increases we’ve seen in prescriptions for opioid pain relievers during the 

last decade despite their significant risks. We need to include primary care physicians in the screening of individuals and educate them on recognizing the signs of 

addiction. Members should also be messaged regarding the appropriate non-opiate 

treatments available for acute pain. Providers who say no to opiate medications 

should not risk negative patient satisfaction ratings. Beacon proposes that addiction 

be deemed a primary care specialty. In addition, there needs to be better training 

in the areas of diagnosis, treatment and referral of individuals with opioid dependence. Moreover, Beacon recommends that changes be made to the 42 CFR Part 2 

confidentiality regulation to allow sharing of addiction-related information about patients for the purposes of care management and coordination. 

61 

Linkage to treatment. 

In many cases identification of substance use does not result in treatment engagement. Use and provision of rescue naltrexone is an opportunity for engagement but 

rarely occurs. Frequently health care providers are unsure how to refer a member 

for substance use treatment when overuse is identified. In addition, as mentioned 

above, a significant number of patients who complete detoxification services do not 

engage in recommended treatment post discharge. We have found in pilot programs 

provision of case management and/or community peer supports significantly increases engagement and retention in treatment with resulting decrease in hospital 

readmissions. Due to fragmentation in the current substance use treatment system, 

Beacon recommends use of case management and peer support services for treatment engagement. Case management services can also enable care linkages for medical and psychiatric co-morbidities which are common in members with substance 

use conditions. 

Innovating in reimbursement models that focus on quality, rather than quantity, of 

service. 

Relative to the treatment of hypertension or diabetes, there is a significant disparity 

in the provision of best practice care for those receiving substance use services. Reimbursement models can improve this disparity. The specifications for provider performance would target outcomes, member engagement and movement along the continuum to less restrictive, intensive, community-based services, and ultimately, 

maintenance treatment. An ‘‘episode bundle’’ would pay a provider a flat set amount 

for a continuum—for example, detox, rehabilitation step-down and two months of 

outpatient treatment, followed by a year of follow-up care. Over that continuum, the 

provider would be held to quality outcomes, such as detox readmission, therapy completion and self-reports by members. Beacon would like to see the use of more flexible payment strategies used to support better treatment and outcomes. 

Conclusion 

We commend Senator Toomey for identifying the opioid issue as a top priority and 

appreciate Congress’ commitment to holding this hearing to continue this important 

dialogue. Our current health care system needs to recognize the chronic disease of 

opioid addiction and combat the opioid crisis with solutions like those set forth 

above. Support by all stakeholders is required to confront and address this crisis. 

Thank you. 

LETTER SUBMITTED FOR THE RECORD BY

ALLAN W. CLARK, M.D. 

October 7, 2015 

The Honorable Pat Toomey 

Chairman, Senate Committee on Finance 

Subcommittee on Health Care 

248 Russell Senate Office Building 

Washington, DC 20510 

The Honorable Debbie Stabenow 

Ranking Member, Senate Committee on Finance 

Subcommittee on Health Care 

731 Hart Senate Office Building 

Washington, DC 20510 

Dear Chairman Toomey and Ranking Member Stabenow, 

I submit this statement for the record on behalf of the patients and families in 

southwestern Pennsylvania, northern West Virginia, and eastern Ohio. I have been 

providing psychiatric care to adults, children and their families in this small part 

of our country for 30 years. As a result of the current epidemic in opiate drug misuse and overdose deaths, I have focused my medical practice to treatment of Opiate 

Use Disorders and the other mental health problems frequently associated with substance use disorders for the last 8 years. 

Through the determined work of our patients, dedicated physicians, and legislators 

in the House and Senate, these patients are recovering the quality of life lost. It 

reminds me that Americans have always overcome national crises through their 

selflessness and unity of purpose. 

62 

The passage of the DATA 2000 Act delivered an effective, evidenced-based and accessible treatment (buprenorphine products) for Opiate Use Disorders to the medical 

office. The position paper I submit to the Subcommittee describes a model of care 

for these patients informed by current research, practical experience in service delivery and patient response to interventions. I suggest that this model which minimizes the problems that have arisen with the use of buprenorphine in the medical 

office while keeping those interventions which have shown great promise. It is my 

intent, through submission of this paper, to do my part as a citizen and expert in 

the treatment of addiction, in providing the Senate Subcommittee on Health Care 

with testimony which may assist members in the important decisions which lie 

ahead in the area of the treatment of Opiate Use Disorders and resolution of the 

current opiate misuse crisis. 

In the spirit of disclosure, I attest that I receive no money from any company, agency or insurance group which may or may not benefit from the model of treatment 

for Opiate Use Disorder described. As an Air Force veteran, I believe service to 

country is its own reward. 

Respectfully submitted, 

Allan W. Clark, M.D. 

Quality and Outcomes Management in the Treatment of Opiate Use 

Disorder with Buprenorphine Products 

Allan William Clark, M.D. 

ABSTRACT 

In the U.S. we face yet another public health crisis. Although smoking and obesity 

related deaths far surpass all other causes of death in this country, death rate due 

to prescription opiates increased 3-fold from 2001 to 2013, and heroin overdoses increased 5-fold during the same time period. 

At the same time, recent legislative actions (Affordable Care Act 2010, Mental 

Health Parity and Addiction Act of 2008) are reshaping they way in which mental 

health care and addiction treatment are delivered in the U.S. 

The Mental Health Parity and Addiction Act of 2008 ‘‘requires group health plans 

and health insurance issuers to ensure that financial requirements (such as co-pays, 

deductibles) and treatment limitations (such as visit limits) applicable to mental 

health or substance use disorder (MH/SUD) benefits are no more restrictive than 

the predominant requirements or limitations applied to substantially all medical/ 

surgical benefits. MHPAEA supplements prior provisions under the Mental Health 

Parity Act of 1996 (MHPA), which required parity with respect to aggregate lifetime 

and annual dollar limits for mental health benefits.’’ 

The Affordable Care Act 2010 (ACA) empowered the Department of Health and 

Human Services (HHS), under Congress oversight, to develop a National Quality 

Strategy (NQS) to better meet the promise of providing all Americans with access 

to health care that is safe, effective, and affordable. 

The author will review current efforts and strategies developed thus far by 

SAMSHA as part of a NQS as they may apply to the use of buprenorphine products 

in treatment of Opiate Use Disorder. Specifically, the author suggests a quality 

management strategy that links providers with these national strategies. 

INTRODUCTION 

Opiate Use Disorder is defined in the DSM–V as ‘‘a maladaptive pattern of substance use leading to clinically significant impairment or distress’’ as manifested by 

2 or more symptoms from a list of 11 core symptoms. Buprenorphine and 

buprenorphine/naloxone for the treatment of DSM–V Opiate Use Disorder in the 

outpatient medical office has been controversial. Despite promising data regarding 

efficacy and safety, concerns about misuse, diversion, and quality of care persist. 

Clinics that specialize in the care of patients with Opiate Use Disorder are viewed 

with suspicion (New York Times 2013). Insurance companies, private and public, 

concerned over the cost of treatment, restrict dose or duration of the buprenorphine 

treatment in an effort to control costs and increase profit. Pharmacists feel new 

pressures to verify prescriptions in the wake of legal consequences faced by 

Wallgreens and other pharmacies sanctioned for their role in the development of 

Florida ‘‘pill mills’’ (Wall Street Journal, April 2012). Physicians and hospitals are 

reluctant to use buprenorphine in the outpatient setting due to the requirement for 

63 

1See reference number 1. 

DEA inspections without ‘‘probable cause.’’ The DATA 2000 amendment requires 

physicians to comply with random inspections by agents of the DEA to verify compliance with the law. Normally, law enforcement would not be allowed to inspect 

a physician’s practices unless they were able to obtain a warrant by a judge. 

Quality of service management and outcome assessments could provide the relevant 

clinical information needed to address the current dilemmas. In fact, the development of quality delivery measures and strategies for outcomes research form the 

foundation of the current U.S. healthcare reform. In 2010, the Patient Protection 

and Affordable Care Act (PPACA—or ACA) charged the U.S. Department of Health 

and Human Services (HHS) with developing a National Quality Strategy (NQS) to 

better meet the promise of providing all Americans with access to health care that 

is safe, effective, and affordable. The Secretary of HHS reported to Congress in 

March 2011 on a National Strategy for Quality Improvement in Health Care. Over 

the last 2 years, the Substance Abuse and Mental Health Services Administration 

(SAMHSA), using the National Strategy for Quality Improvement (NQS) as a model, 

has developed the National Behavioral Health Quality Framework (NBHQF). The 

NBHQF has been noted in the NQS Report to Congress as an important effort in 

development of credible research on the critical concern over availability and safety 

of current treatments for mental health and substance use disorder. 

In this draft, SAMSHA, ‘‘recognized that relatively few acceptable outcome measures exist that are endorsed through NQF or other relevant national entities for 

mental health disorders.’’ The current leadership in behavioral health care quality 

encourages a collaborative relationship between all stakeholders in the development 

of new measures as evidence accrues. They add, ‘‘over time, it is expected that a 

rich catalog of behavioral health outcome, process, and structural measures will be 

endorsed and/or accepted as achieving the appropriate level of evidence by the field 

and payers.’’ 

By contributing to development of new quality measures in our treatment of patients with Opiate Use Disorder, we add much needed clinical expertise to the critical process of ‘‘achieving the appropriate level of evidence’’ acceptable to all stakeholders. 

REVIEW 

Medication-Assisted Treatment of Opiate Use Disorder with buprenorphine is an 

emerging treatment born out of the DATA 2000 Act allowing buprenorphine and 

buprenorphine/nalaxone combination use in outpatient medical practice. Led by an 

unusual public/private partnership between SAMSHA and Reckitt Benckiser (drug 

manufacturer), this project’s aim was to improve accessibility and decrease stigma 

for patients seeking treatment of Opiate Use Disorder. Twenty-four randomized controlled trials (RCTs) comparing buprenorphine to methadone in the maintenance 

treatment of opioid dependence with a total number of 4,497 participants were included in a 2008 Cochrane systematic review and meta-analysis. The main outcome 

measures were treatment retention and suppression of illicit opioid use. Results indicate buprenorphine is more effective than placebo and as effective as methadone 

with both drugs being more effective at higher doses. As part of a comprehensive 

treatment program, MAT (medication-assisted treatment) has been shown to: 1

• Improve survival. • Increase retention in treatment. • Decrease illicit opiate use. • Decrease hepatitis and HIV seroconversion. • Decrease criminal activities. • Increase employment. • Improve birth outcomes with perinatal addicts. 

An analysis of French overdose deaths between 1995 and 1998 found an average annual death rate of 0.47% for patients taking methadone, compared with 0.05% for 

buprenorphine. In the United States, the danger of overdose was addressed by the 

addition of nalaxone to the formulation. When injected, buprenorphine/naloxone 

may cause an initial dysphoria due to brief opiate receptor blockade. Buprenorphine/ 

naloxone combination was the preferred formulation to avoid problems with intravenous use and death found in Europe. 

Physicians who use these medications in the office for opiate dependence must follow specific protocols in the course of treatment. For example, the DATA 2000 Act 

acknowledges the importance of psychosocial interventions in the treatment of adVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00067 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
64 

diction. DATA 2000 states, ‘‘the physicians must attest that they have the capacity 

to refer addiction treatment patients for appropriate counseling and other nonpharmacologic therapies.’’ The ‘‘assisting’’ treatments typically include substance 

abuse counseling, group therapy, 12 Step self-help groups, and other social supports. 

The guidelines for the use of buprenorphine for Opiate Use Disorder published by 

the World Health Organization states, ‘‘psychosocial interventions can add to the effectiveness of treatment.’’ Further, they recommend that psychosocial services 

should be made available to all patients, although patients who decline these services should not be denied access to medication. 

The NBHQF framework has identified six NQS health priorities or goals (evidencebased practice, person-centered care, coordinated care, reduction of adverse events, 

and cost reductions) that will be tracked via a set of core behavioral health quality 

measures. SAMSHA specifically intends that this document be a ‘‘guiding document’’ 

for the delivery of behavioral healthcare. SAMHSA has been working with the HHS 

Assistant Secretary for Policy and Evaluation, CMS (Center for Medicare and Medicaid Services) and NQF to develop measure concepts and to vet and validate measures or instruments for measure development. 

The NQF (National Quality Forum) is a non-profit, non-partisan public service organization. NQF reviews, endorses and recommends use of standardized healthcare 

performance measures. Performance measures, also called quality measures, are essential tools used to evaluate how well healthcare services are being delivered. NQF 

endorsed measures that ‘‘are often invisible at the clinical bedside but quietly influenced the care delivered to millions of patients everyday.’’ The participation by 

groups such as the NQF, representing a wide range of stakeholders, insures outcome measures can fulfill the stated expectation of this collaborative group to ‘‘seek 

meaningful, real life outcomes for people who are striving to attain and sustain recovery; build resilience, and work, learn, and participate fully in their communities.’’ 

At this early phase of behavioral health quality measurement development, it is understood that the available measures are insufficient to provide meaningful information in all behavioral health care settings. 

Most of the currently approved NBHQF quality measures are ‘‘process measures.’’ 

‘‘Processes’’ are specific patient interventions performed by health care professionals 

that result in an particular outcome. Process measures are frequently used in performance measurement. Process measures are generally much easier to construct, 

require less data collection and analysis to produce, and are easier for both clinicians and non-clinicians to understand. Many performance measurement systems, 

such as the Health Plan Employer Data Information Set (HEDIS), are primarily 

measures of process of care. Process improvement, when linked to processes proven 

by randomized clinical trials to improve outcomes, is an important part of continuous quality improvement (CQI). Implementation of CQI programs based on process 

improvement can reduce variation and enhance patient care. 

Practice guidelines for the treatment of illness were developed for this purpose. 

Many practice guidelines (Federation of State Medical Boards, American Psychiatric 

Association, American Society of Addiction Medicine) use a grading system to link 

the strength of the empirical data to the specific guideline. Recommendations to initiate and monitor a process (intervention) are made based upon the strength and 

quality of the research linking the intervention to desired outcome. 

In these systems, an ‘‘I’’ (Roman numeral I) or ‘‘A’’ is given to those guidelines, or 

process measures, that are recommended ‘‘with substantial confidence’’ to produce 

desirable outcome based upon large randomized clinical trials. For example, one of 

the NBHQF process measures looks at the percentage of patients diagnosed with 

a new episode of major depression, treated with an antidepressant medication, and 

who remained on an antidepressant medication treatment for 6 months. Several 

large random clinical trials support this strongly indicates quality outcome defined 

as reduction of depressive symptoms. 

A ‘‘II’’ (Roman numeral II) or ‘‘B’’ rating is given to guidelines, or process measures, 

that have support from observational studies or small randomized clinical trials. An 

example of this type of guideline is the Management of Substance Use Disorder published in 2009 by the VA/DoD. They recommend that identifying and addressing 

other biopsychosocial problems may be more effective than increasing the intensity 

of addiction focused treatments when a patient has a lapse or minor ‘‘slip.’’ 

Finally, a ‘‘III’’ rating denotes those guidelines or process measures that are developed from expert opinion but which have little scientific evidence to support the 

process indicators (e.g., the Agency for Healthcare Policy and Research’s low back 

65 

pain guidelines, most of which is supported by expert opinion). Essentially, practice 

guidelines such as those described above and the NBCQF constitute a outcome management strategy. 

In his classic article, Ellwood coined the term outcomes management as ‘‘a technology of patient experience designed to help patients, payers, and providers make 

rational medical care-related choices based on better insight into the effect of these 

choices on the patient’s life.’’ Further, he states that this technology ‘‘consists of a 

common patient-understood language of health outcomes; a national data base containing information and analysis on clinical, financial, and health outcomes that estimates as best we can the relation between medical interventions and health outcomes, as well as the relation between health outcomes and money; and an opportunity for each decision-maker to have access to the analyses that are relevant to 

the choices they must make.’’ 

Further guidelines have been published by SAMSHA to aid in the development of 

relevant measures. To the extent possible, measures included in the NBHQF will: 

1. Be endorsed by NQF or other relevant national quality entity where possible; 

2. Be relevant to NQS and NBHQF priorities; 

3. Address ‘‘high-impact’’ health conditions; 

4. Promote alignment with program attributes and across programs, including 

health and social programs, and across HHS; 

5. Reflect a mix of measurement types: outcome, process, cost/appropriateness, and 

structure; 

6. Apply across patient-centered episodes of care; and 

7. Account for population disparities. 

With the above background, we now may begin to consider useful measures for the 

outpatient medical office using buprenorphine products for the treatment of Opiate 

Use Disorder. I will organize this discussion around the five health care priorities 

designated by the U.S. Department of Health and Human Services. 

The first priority is to ensure healthcare interventions are effective. The goal specifically aims to ‘‘promote the most effective prevention, treatment, and recovery practices for behavioral health disorders.’’ SAMSHA places a heavy emphasis on the inclusion of interventions shown to be effective in large randomized clinical trials. 

Measures within this group focus on processes or clinical interventions strongly 

linked to substantial empirical evidence for quality outcome. An example of outcomes management in action is the currently approved COMS process measure involving treatment of major depression. There is substantial clinical evidence that 

proper use of an antidepressant results in a desirable outcome for patients suffering 

from major depression. In all practice guidelines, this recommendation is categorized as I or A. As such, given the high prevalence and impact of major depression, this was chosen and approved as a process measure. In this case, the NBHQF 

targets percentage of patients diagnosed with major depression who receive 

antidepressant treatment. 

Several different accrediting bodies have developed practice guidelines for use of 

buprenorphine in the office using the above described grading system. These guidelines organize current empirical evidence demonstrating reduction of opioid use, reduction of opioid-related health and social problems, and better engagement and retention in treatment with the use of buprenorphine. As with the use of antidepressants for Major Depressive episodes, a patient who presents with depression 

may choose cognitive behavioral therapy or other treatments which have been 

shown empirically to reduce depressive symptoms instead of an antidepressant. 

Other patients may chose to take an antidepressant and engage in one of theses 

other psychosocial treatments. The point is not that every patient suffering from 

Opiate Use Disorder take buprenorphine, but that they are given a choice of interventions based upon empirical evidence. The ability to provide buprenorphine treatment to any patient for which it is indicated is a measure of quality care. 

A second ‘‘high impact’’ and well researched process is the identification and treatment of co-morbid psychiatric diagnosis in persons suffering from Opiate Use Disorder. Coexisting psychiatric disorders are present in 20% to 60% of the persons entering addiction treatment, especially older individuals, those living in urban areas, 

patients who are incarcerated, or patients of a lower socioeconomic status. Presence 

of major depression is linked to poor outcome in patients suffering from Opiate Use 

66 

2See reference number 2. 

Disorder, as well as many other indicators of health (heart disease, stroke).2 Regularly monitoring of depressive and anxiety disorders in patients with Opiate Use 

Disorder allows the providers to identify and address these potential obstacles to 

satisfying recovery. Unless comorbidity is taken into consideration, measures of the 

outcome of treatment for opiate addiction will fail to tease apart the possibility of 

better outcomes of patients with no comorbidity, thereby compromising a fair test 

of treatment effects. The identification, monitoring, referral and/or treatment of comorbid conditions signals quality of care in the treatment of Opiate Use Disorder 

for the above reasons as delineated in the practice guidelines. 

As we have discussed, the NQF has challenges providers to develop outcome measures which ‘‘seek meaningful, real life outcomes for people who are striving to attain 

and sustain recovery; build resilience, and work, learn, and participate fully in their 

communities.’’ Several promising surveys to measure this concept are being developed by the WHO (World Health Organization). The WHO Quality of Life instruments define health as ‘‘a state of complete physical, mental, and social well-being, 

not merely the absence of disease.’’ WHO, with the aid of 15 collaborating centers 

around the world, has developed 2 interments for measuring quality of life (the 

WHOQOL–100 and the WHOQOL–BREF), that can be used in a variety of cultural 

settings while allowing the results from different populations and countries to be 

compared. Both instruments show good discriminant validity, content validity, and 

test-retest reliability. The routine use of the QOLBREF in the treatment of Opiate 

Use Disorder and comorbid conditions provides crucial data with which to ensure 

that the interventions which the patients chooses are effective. 

In summary, under the priority of effective care, we attach measures to processes 

which have substantial clinical evidence supporting our outcome goals. 

• Percent of patients diagnosed with Opiate Use Disorder offered buprenorphine as part of their overall treatment. 

• Percentage of patients presenting for Opiate Use Disorder who receive a comprehensive psychiatric evaluation to identify comorbid diagnosis. 

• Monthly assessment using PHQ–9 and GAD–7 to monitor for these syndromes as treatment progresses. 

• Monthly urine drug analysis. 

• QOL BREF every 6 months. 

The second healthcare goal identified is person-centered care. Morris Chavez, M.D. 

in the 1950s at the Massachusetts General Hospital Alcoholism Clinic was able to 

dramatically improve engagement and retention in treatment of alcoholics presenting to the MGH emergency room using novel interventions considered patientcentered. He concluded that these patients achieved better outcome when they received ‘‘caring and organized’’ treatment. The concept of person-centered care has 

gained considerable momentum in current healthcare reform. This has become a key 

determinate of quality care. Large randomized clinical trials have shown that engagement and retention are crucial to the recovery process from mental illness and 

substance use disorders. 

SAMSHA’s Working Definition of Recovery from Mental Disorders and Substance 

Use Disorders revised in 2011 describes 10 Guiding Principles of Recovery. These 

person-centered concepts were vetted by SAMSHA with consumers, persons in recovery, family members, advocates, policy-makers, administrators, providers and 

others. In this manner, concept validity was established for this dimension of quality care. The Patient Assessment of Care for Chronic Conditions published by Group 

Health (PAIAC) measures patient engagement in care. It is a self-administered assessment asking questions about were they given a written list of things they could 

do to improve their health, were they encouraged to go to a group to help them cope 

better with a their chronic condition, and asked how the chronic condition effects 

their life. It consists of 20 questions answered on a Likert scale. Higher scores signify better engagement. The problem with this measure is that it is designed to be 

scored by an independent agency for reasons of confidentiality and candor. As an 

alternative one could gather this extremely useful data while preserving confidentiality. This would allow for outside agency review in an HIPAA compliant manner 

when requested. 

67 

3See reference number 3. 

4See reference number 4. 

The inclusion of a competent family/social network assessment at onset of treatment 

is recommended in the NBHQF draft. Again, this is an evidenced based process indicator strongly linked to better outcome in several large randomized trials and has 

been included as a recommendation in two practice parameters addressing buprenorphine use for Opiate Use Disorder.3 The stronger the link between family/social 

network assessment and targeted intervention aimed to strengthen resiliency and 

mitigate vulnerabilities the better the outcome. Thereby, presence of this assessment in the EHR signals a quality process linked to quality outcome. 

Recommended measures targeting the evidence base currently available would include: 

• PAIAC every 6 months. 

• Presence of competent family/social network assessment at onset of treatment 

in the EHR. 

The third priority is ‘‘to encourage effective coordination within behavioral health 

care, and between behavioral health care and community-based primary care providers, and other health care, recovery, and social support services.’’ 

One process in the treatment of those with Opiate Use Disorder that we may chose 

to monitor relates powerfully to this aspect of care is ensuring that those suffering 

from addiction is ensuring that care is coordinated with other mental healthcare 

providers. With high percentages of co-occurring psychiatric disorders, these patients often seek and are engaged in mental health treatment which may include 

prescription of potentially abusable medications. For example, patients may fear 

telling the physician prescribing buprenorphine of their alprazolam prescription because they think the doctor will take it away abruptly. At times of crisis, patients 

may see their PCP for ‘‘emergency’’ medication contraindicated in the treatment of 

the Opiate Use Disorder. For these reason, the following process measures appear 

to have the most support. 

• Percent of patients who have had co-treating physicians notified of their ongoing treatment for Opiate Use Disorder. 

The fourth priority is to ‘‘assist communities to utilize best practices to enable 

healthy living.’’ One of the NBHQF measures involves the presence of an assessment of tobacco use and, if indicated, a tobacco cessation intervention. These measures are included to promote preventive care across the broad spectrum of health 

care services. Body mass index at onset of treatment and at regular intervals has 

also been included in the NBHQF under this goal for similar reasons. Obesity is the 

major preventable cause of illness in the U.S.4 Regular monitoring of weight in behavioral health care is quite common given the propensity of many psychiatric medications to cause weight gain. Patients seeking treatment for Opiate Use Disorder 

with buprenorphine often come with a long list of psychiatric medication, and have 

trouble maintaining a healthy weight. One could debate the wisdom of initiating 

treatment for Tobacco Use Disorder, Obesity, and Opiate Use Disorder at the same 

time. However, assessment and monitoring of these high impact problems allows for 

the discussion to be postponed until the patient may be better equipped or motivated to address these health concerns. The recommended measures under this priority would be: 

• Presence of screening or intervention/treatment for tobacco use in EHR. 

• Body Mass Index on intake and every 6 months. 

The fifth priority is safety. The goal aims to ‘‘make behavioral healthcare safer by 

reducing harm caused in the delivery of care.’’ NBHQF measures include presence 

of suicide risk assessments, patients discharged on multiple psychiatric medications, 

and percentage of patients engaged in behavioral health treatment hospitalized for 

overdose. 

Diversion and misuse of buprenorphine is a major safety concern in the treatment 

of Opiate Use Disorder to individuals and the community. Some patients attempt 

to use buprenorphine intravenously. This practice may lead to the addition of intravenous benzodiazepines, overdose and death. Another danger of buprenorphine 

treatment is diversion. Patients who falsely present for treatment of Opiate Use 

Disorder with the intention of selling this medicine for profit and fund further illicit 

drug use. One could make an argument for inclusion of pill counts into the treatVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00071 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
68 

5See reference number 5. 

ment process. Pill counts can aid in determining compliance with medications in the 

absence of reliable blood levels. Pill counts are a reasonable method to detect diversion of medication prescribed to a patient. This allows for investigating suspicions 

in higher risk patients and routine monitoring of the patient population as well. Pill 

counts can go along way to reassure partners in the treatment of our patients that 

diversion is being effectively addressed. Pill counts done at the pharmacy dispensing 

the prescription for buprenorphine is particularly helpful in reassuring pharmacists 

the provider is responsible addressing diversion. 

Should all patients enrolled in a clinic be given regular random pill counts? Until 

further information is available perhaps we may track the percentage of patients 

in the practice receiving pill counts in a month. Standardizing pill count practices 

and procedures would give the practitioner and other stakeholders critical data in 

the quest for safely delivered care. For example, a written office protocol where in 

clinic staff members ask the patient to go to their pharmacy for the count within 

a short period of time (1 hour). We take into consideration factors like the patient 

needing to go after work, distance to pharmacy and other related obstacles. We have 

found it essential to verify claims that a patient must wait until after work to comply with the pill counts. We have found instances where the patient was not at work 

as they said. This process, in conjunction with patient cross referencing to State 

Prescription Monitoring Programs, provides a formidable defense against diversion. 

In the absence of vetted and validated measures, the following is recommended: 

• Percentage of active patients pill counted per month. 

• Use of State Prescription Monitoring programs. 

Although listed as the last criterion, the importance of affordability is critical. The 

NBHQF goals’ stated purpose is to ‘‘foster affordable high-quality behavioral healthcare for individuals, families, employers, and governments by developing and advancing new and recovery-oriented delivery.’’ Methadone treatment studies since 

2006 have shown cost-effectiveness when compared with other treatments, and cost 

effectiveness for HIV prevention. Buprenorphine has been studied much less, but 

available studies are very encouraging as this medication appears to be cost-effective as well.5 With the development and wide spread use of outcome measures 

which better capture the quality of life outcomes achieved via different interventions, cost/benefit data will become increasingly relevant. Until that time, aggregated data regarding the cost per patient per month or year maybe the most useful 

and easily provided data that can be shared with all stakeholders. 

CONCLUSIONS 

Wisely chosen quality measures as part of an outcome management strategy can 

guide us through the treacherous waters of health care reform. SAMSHA and other 

thought leaders have developed the NBHQF as a way to coordinate efforts nationally in this arena. This framework allows for the development of a common language or method to report data satisfying to all stakeholders. The current efforts 

in behavioral health care reform are designed to be a cooperative process. We have 

a choice between focusing on the current controversies in the use of buprenorphine 

in the medical office, and perhaps abandon efforts to increase access and availability 

of this promising approach, or we may use the legitimate questions posed by stakeholders as a stimulus to find workable solutions. In either case, we must recognize 

that we have an critical role in healthcare reform. Joining the current efforts appears to be the way forward in the second decade of use of buprenorphine in the 

outpatient medical office. 

REFERENCES 

1. National Center for Health Statistics 2013. 

2. United States Department of Labor. 

3. Availability Without Accessibility? State Medicaid and Authorization Requirements for Opioid Dependence Medications. The Avisa Group, June 2013. 

4. Buprenorphine maintenance versus placebo or methadone maintenance for opioid 

dependence. 

Mattick RP1, Kimber J, Breen C, Davoli M. 

5. Department of Health and Human Services, Substance Abuse and Mental Health 

Services Administration, Center for Substance Abuse Treatment, Division of Pharmacologic Therapies. (n.d.). Pharmacotherapy for Substance Use Disorders. 

69 

6. Am. J. Addict. 2004;13 Suppl 1:S17–28. French field experience with buprenorphine. Auriacombe M, Fatse ́as M, Dubernet J, Dauloue`de JP, Tignol J. 

7. Paul M. Ellwood (June 9, 1988). ‘‘Outcomes Management.’’ New England Journal 

of Medicine 318 (23): 1549–1556. 

8. Effect of buprenorphine dose on treatment outcome. 

Fareed A, Vayalapalli S, Casarella J, Drexler K. 

9. Robins et al., 1991; Kessler et al., 1994; Room, 1998; Sacks and Ries, 2005. 

10. Kessler et al., 1994; Dausey and Desai, 2003. 

11. Practice Guidelines for the Treatment of Patients With Substance Use Disorders 

Second Edition, 2010, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction 2010. 

12. Average annual number of deaths 2000–2004. Source: CDC SAMMEC, MMWR 

2008;57(45):1226–1228. 

CONEMAUGH MEMORIAL MEDICAL CENTER

1086 Franklin Street 

Johnstown, PA 15905–4398 

814–534–9000 

www.conemaugh.org 

Tuesday, October 13, 2015 

Senator Pat Toomey 

C/O Katelyn King Lamm 

Regional Manager for Southwest Pennsylvania 

Landmarks Building 

100 W. Station Square Drive, Suite 225 

Pittsburgh, PA 15219 

Dear Senator Toomey: 

Thank you for hosting the Senate finance Subcommittee on Health Care Field Hearing in Pittsburgh. I would like to take this opportunity to address the opiate addiction epidemic in western Pennsylvania and specifically the Greater Johnstown region. 

I am a family physician and serve as Chair of the Department of Family Medicine 

and direct the Conemaugh Memorial Medical Center Family Medicine Residency. 

Within our office, we provide a Ryan White funded HIV clinic and a suboxone program. 

Each day I see our patients suffering from the ravages of opiate abuse. As I rounded 

today, a patient wanted to make sure she could be discharged tomorrow to attend 

the funeral of a friend’s son who just died of an overdose. This is becoming evermore-common. Within our practice we are frequently admitting patients with infected injection sites. One patient had her finger amputated as the infection traveled 

to her bone. 

In our Level 3 NICU, generally 60% or more of the babies are being treated for 

methadone or heroin withdrawal. These children are so jittery. Parenting a newborn 

is always a challenge; I cannot imagine how these parents struggling with their own 

addiction now try to parent these extremely fussy newborns. From a health care utilization perspective, the cost of treating these babies is enormous. 

As physicians are trying to limit prescription drug access we are seeing patients 

turn to cheaper heroin. It is not uncommon that users of heroin share needles or 

engage in unprotected sex. These practices may result in transmission of HIV or 

hepatitis C. Such practices could result in an epidemic in our region similar to the 

ongoing situation in Austin, Indiana where a drug fueled outbreak has led to 153 

confirmed HIV cases. As you are likely aware, the Centers for Disease Control and 

Prevention recently issued a health advisory alerting states, health departments, 

and doctors nationwide to be on the lookout for clusters of HIV and hepatitis C 

among intravenous drug users and take steps to prevent them. Our region has little 

access to hepatitis C treatment. We are seeing many young people who are infected 

and likely spreading the infection to their peers. We are also seeing Hepatitis C in 

our pregnant mothers. 

70 

We need help to combat this problem. Our drug treatment facilities are overburdened. Even law enforcement struggles to keep up. Needle exchanges are not legal 

in our state. 

I thank you for the opportunity to share my experiences and concerns. 

Sincerely, 

Jeanne Spencer, MD, FAAFP, AAHIVS 

Chair of Family Medicine 

Program Director, Family Medicine Residency Program 

Johnstown, PA 15905 

GATEWAY HEALTH PLAN

CINDY PIGG, BS PHARMACY, VICE PRESIDENT

Four Gateway Center 

444 Liberty Street, Suite 2100 

Pittsburgh, PA 15222 

cpigg@gatewayhealthplan.com 

TESTIMONY 

Before The 

UNITED STATES SENATE 

COMMITTEE ON FINANCE 

SUBCOMMITTEE ON HEALTH CARE 

FIELD HEARING 

On 

OPIATE ABUSE IN SOUTHWESTERN PENNSYLVANIA 

On 

OCTOBER 15, 2015 

Mr. Chairman and committee members, I would like to thank you for the opportunity to speak with you about opioid addiction. My name is Cindy Pigg. I am a 

Pharmacist and Vice President of Pharmacy at Gateway Health Plan and serve on 

the Board of the Academy of Managed Care Pharmacy. Headquartered in Pittsburgh, PA. Gateway Health is a Managed Care Organization that has served the 

Commonwealth’s Medicaid and Medicare Advantage population for over 20 years. 

Our mission embraces quality, innovation, and financial soundness. We are the second largest participating plan in the statewide Medicaid HealthChoices Program delivering quality care to more than 300,000 PA Medicaid beneficiaries in 40 counties. 

Gateway Health’s SM robust provider network encompasses more than 9,000 physicians and 100 hospitals. We also serve over 50,000 Pennsylvanians in 32 counties 

who are qualified for Medicare Advantage Special Needs Plans (SNPs). These individuals are those who are either dually eligible for Medicare and Medicaid or have 

chronic conditions such as diabetes, cardiovascular disorders or chronic heart failure. Many have physical disabilities as well as behavioral health issues. 

AMCP is a national professional association of 7,000 pharmacists and other health 

care practitioners who serve society by the application of sound medication management principles and strategies to assist patients in achieving positive therapeutic 

outcomes. In Pennsylvania alone, we have over 480 active members. AMCP’s members develop and provide a diversified range of clinical, educational and business 

management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. 

Studies and reports document the opioid abuse problem in Pennsylvania and 

nationwide 

According to the Centers for Disease Control and Prevention (CDC), deaths associated with prescription medications have increased more than 300 percent since 

1998, while prescribing rates for these drugs quadrupled between 1999 and 2010. 

Deaths connected to prescription drug misuse now exceed those from heroin and coVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00074 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
71 

1 CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999– 

2008. MMWR 2011; 60: 1–6. 2http://www.pamedsoc.org/opioids. 

3Pennsylvania Medical Society, August 11, 2015: http://bit.ly/1PguMyI. Accessed October 6, 

2015. 4 Centers for Disease Control and Prevention. Prescription painkiller overdoses in the U.S. November 2011. Available at: http://www.cdc.gov/vitalsigns/painkilleroverdoses/. Accessed on 

August 25, 2015. 5Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and comorbidities associated 

with opioid abuse in managed care and Medicaid beneficiaries in the United States: a comparison of two recently published studies. J Pain Palliat Care Pharmacother. 32010;24(3):251–58. 6 Hansen RN, Oster G, Edelsberg J, Woody GE, Sullivan SD. Economic costs of nonmedical 

use of prescription opioids. Clin J Pain. 2011;27(3):194–202. 7 Announcement of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Centers for Medicare and 

Medicaid Services, April 2, 2012. Available at 

http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=15078. Accessed September 4, 2015. 8Peirce GL, Smith MJ, Abate MA, Halverson J (2012). Doctor and Pharmacy Shopping for 

Controlled Substances. Medical Care 50:7. http://bit.ly/1i3C8Zm. Accessed September 11, 2015. 

caine combined.1 The Pennsylvania Medical Society reports that more Pennsylvanians die from drug overdoses than from any other type of injury, including car accidents.2 In 2014, that’s 2,400 deaths attributed to drug overdoses, or 7 people a day 

in Pennsylvania.3 Moreover, the economic costs of prescription drug abuse are substantial. The nonmedical use of controlled substances amounts to $73 billion annually in unnecessary costs, including lost productivity, increased costs to the criminal 

justice system, and health care expenditures.4, 5, 6

Rates of prescription drug abuse related to emergency department visits and treatment admissions have reached epidemic levels in the United States. All too often, 

many of us know someone who is battling drug addiction. There is a definite need 

for action on many fronts to address this growing concern. Patients, providers, patient family members, health plans, community based organizations, employers, and 

government must all work together to formulate and implement solutions. 

S. 1913—a solution that addresses a program where abuse has been documented 

One area where change can be affected is in the Medicare Part D program. That 

Program does not currently permit the use of a drug management program (DMP) 

by prescription drug plans (PDPs) and Medicare Advantage prescription drug plans 

(MA–PD) to limit patients with a history of abuse, misuse or diversion to a single 

prescriber and/or pharmacy. 

In terms of the impact to beneficiaries, a 2012 CMS study found that less than 1% 

of beneficiaries would be directed into a DMP. The study further found that only 

0.7% of Medicare Part D beneficiaries received opioids from at least 4 prescribers 

and 4 or more pharmacies, signaling a high-risk patient.7 (Those beneficiaries in 

hospice or those with a diagnosis of cancer were excluded from the study.) In essence, DMP programs help to mitigate the issues associated with doctor or pharmacy shopping and may reduce the number of inappropriate controlled substance 

prescriptions.8 The limited number of beneficiaries that may be included in the 

DMP is encouraging because it is an indicator that the majority of beneficiaries in 

the Program will not have any change in their prescriber or pharmacy. On the other 

hand, that small group of beneficiaries that are at-risk, will have an opportunity to 

receive better coordination of care by the prescriber, pharmacy and PDP working 

together through the DMP. 

Senator Toomey’s bill S. 1913, Stopping Medication Abuse and Protecting Seniors 

Act of 2015, would allow PDPs and MA–PDs to proactively identify individuals at 

risk for controlled substance abuse, misuse or improper utilization. The Secretary 

of Health and Human Services (HHS) would determine the criteria for the ‘‘at risk’’ 

designation. The plans would work with a beneficiary’s prescriber and give the beneficiary notice that they had been identified as a potential participant for enrollment 

in a drug management program (DMP). The beneficiary has appeal rights and can 

submit their preference of a specific prescriber and pharmacy. The use of DMPs may 

improve continuity of care among at-risk plan beneficiaries, while ensuring beneficiaries with legitimate medical needs have continued access to effective pain control. Furthermore, at risk beneficiaries are still able to receive non-controlled prescriptions at other pharmacies and from other prescribers. Another advantage of a 

DMP is that it works as prospective identification program allowing the plan to act 

in real time; as opposed to a retrospective program which combs through past data 

to find anomalies. 

72 

9 Roberts AW, Cockrell Skinner A. Assessing the Present State and Potential of Medicaid Controlled Substance Lock-in Programs. J Manag Care Pharm. 2014;20(5):439–46. 10 CDC; National Center for Injury Prevention and Control. Beneficiary review and restriction 

programs. Lessons learned from state Medicaid programs (2012), 

http://www.cdc.gov/homeandrecreationalsafety/pdf/PDO_beneficiary_review_meeting-a.pdf. 

Accessed on August 25, 2015. 11 North Carolina Department of Health and Human Services. 2.3 million pills off the streets, $5.2 million saved by narcotics lock-in. May 14, 2012. 12SoonerCare Pharmacy Lock-in Program Promotes Appropriate Use of Medications. September 9, 2009 [press release], http://okhca.org/about.aspx?id=10973. Accessed on August 25, 

2015. 13 Centers for Disease Control and Prevention; National Center for Injury Prevention and Control. Patient review and restriction programs. Lessons learned from state Medicaid programs 

(2012), http://1.usa.gov/1UJuEag. Accessed on August 25, 2015. 

Prospective Drug Management Programs (DMPs) are more beneficial to the patient 

In 2013, CMS launched a federal initiative called Medicare Part D’s Overutilization 

Monitoring System (OMS) to partner with PDPs and MA–PDs to identify Medicare 

beneficiaries who may be misusing or abusing controlled substances. OMS uses a 

retrospective approach, whereby a contractor is utilized to identify beneficiaries who 

receive certain quantities of controlled substance prescriptions on a monthly basis. 

Reports are then provided to Part D plans on a quarterly basis. While OMS has 

been successful in reducing inappropriate controlled substance utilization, plans 

must rely on reports from the contractor to identify beneficiaries and then assign 

case managers to work with the beneficiary. 

The DMPs we are talking about today, such as the one defined in Senate bill 1913, 

is a prospective program and allows Part D plans to directly identify beneficiaries, 

provide notice to enroll and select a prescriber and pharmacy, and then take additional actions necessary to reduce the risk of inappropriate controlled substance utilization. This type of program is proactive and highly desirable. In addition, the 

plans must provide the beneficiary with information on other organizations that can 

provide them with contact information regarding drug management programs. The 

prospective approach allows the identification of at-risk beneficiaries earlier and 

PDP and MA–PD’s can offer them assistance sooner. 

DMPs have been successfully utilized by state Medicaid programs. On the state 

level, 46 state Medicaid programs have successfully implemented DMPs with positive results.9 An evaluation of state Medicaid DMPs, performed by a CDC expert 

panel, concluded that these programs have the potential to reduce opioid usage to 

safer levels and thus save lives and lower health care costs.10

A few examples from other states: 

• In 2012, the State of North Carolina, announced $5.2 million in savings from 

their state Medicaid DMP program.11

• In 2009, the Oklahoma Medicaid department found that its lock-in program reduced doctor shopping, utilization rates of controlled substances, and emergency 

room visits with a savings of $600 per person in costs.12

• Florida reported 1,315 individuals had been placed into their Medicaid PRR between October 2002 and March 2005. During this time period, cumulative savings for medical and pharmaceutical expenses topped $12.5 million.13

Prescription Drug Monitoring Programs 

Another area that we believe would assist PDPs and MA–PDs to help an at-risk 

beneficiary is to allow pharmacists in those plans access to information in the Prescription Drug Monitoring Program (PDMP). In order for a DMP to be successful, 

AMCP recommends real-time data sharing of information compiled in PDMPs with 

prescribers, pharmacies, managed care organizations, and pharmacy benefit management companies (PBMs). In Pennsylvania, where access was recently amended, 

data in PDMPs is generally available to prescribers, pharmacists and other health 

care providers, and law enforcement personnel, but not PDPs, and MA–PDs and 

PBMs. Congress could help to encourage PMP data sharing by passing legislation 

to require states to adopt this practice and increase funding of existing PDMP programs. 

Many inappropriate controlled substance prescriptions are purchased through cashbased transactions and not adjudicated to a private insurance plans, Medicare Part 

D, or Medicaid.4 This means that PDPs, MA–PDs or PBMs may be unaware of certain controlled substance prescriptions for some individuals and thus do not have 

all the information necessary to establish a basis for inappropriate utilization or 

73 

abuse. Allowing access by PDPs, MA–PDs and PBMs could help to reduce inappropriate utilization or abuse by implementing systems to flag inappropriate utilization 

and provide other interventions to ensure appropriateness of the prescription prior 

to dispensing. 

Managed care pharmacists are well-positioned to help reduce prescription opioid 

abuse, misuse, and diversion in two distinct ways. First, we have been managing 

programs on the commercial side and in state Medicaid programs. Through specific 

modeling tools unique to the industry, we have been able to identify beneficiaries 

at-risk for abuse, misuse or diversion and offer them the help they need. Secondly, 

through these same tools, the long-term results of having fewer at-risk beneficiaries 

involved in the misuse, abuse, or diversion of controlled substances will ultimately 

result in reduced costs to the overall health care system. 

On behalf of Gateway Health Plan and AMCP, we strongly support S. 1913 and 

your tireless efforts to address this important societal problem. In our opinion, S. 

1913 strikes the appropriate balance by preserving the beneficiaries’ rights to be notified, submit their preferences for prescriber and pharmacy and exercise appeal 

rights. On the other hand, the PDPs and MA–PDs will have the authority to identify at-risk beneficiaries in a prospective manner and help them obtain the necessary treatment sooner and improve their ability to address their addictions. Earlier this year, legislative language contained in another bill creating a drug management program in Medicare Part D for at-risk beneficiaries received a score from the 

Congressional Budget Office as saving $115 million over 9 years. Prescribers and 

pharmacies will also be aware of the at-risk beneficiaries’ need for assistance. This 

concludes my testimony. Thank you again for inviting me to speak here today. 

Please feel free to contact me, or my colleagues at AMCP as a resource in tackling 

this very important issue. We will continue to work with you to enact this legislation. 

KAREN GEARY, RPH, MHA 

99 Sever Lane 

West Newton, PA 

Gearykd1@aol.com 

TESTIMONY 

Submitted for the record of the 

UNITED STATES SENATE FINANCE 

HEALTH CARE SUBCOMMITTEE 

FIELD HEARING 

On 

OPIATE ABUSE IN SOUTHWESTERN PENNSYLVANIA 

On 

OCTOBER 15, 2015 

Mr. Chairman and committee members, I would like to thank you for the opportunity to submit comments for the record of the field hearing on opioid abuse. My 

name is Karen Geary. I am a Pharmacist, a life-long resident of western Pennsylvania and a member of Academy of Managed Care Pharmacy. 

AMCP is a national professional association of 7,000 pharmacists and other health 

care practitioners who serve society by the application of sound medication management principles and strategies to assist patients in achieving positive therapeutic 

outcomes. In Pennsylvania alone, we have over 480 active members. AMCP’s members develop and provide a diversified range of clinical, educational and business 

management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. 

Opioid abuse is a problem in Pennsylvania and nationwide and needs to be addressed 

According to the Centers for Disease Control and Prevention (CDC), deaths associated with prescription medications have increased more than 300 percent since 

1998, while prescribing rates for these drugs quadrupled between 1999 and 2010. 

Deaths connected to prescription drug misuse now exceed those from heroin and coVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00077 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
74 

1 CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999– 

2008. MMWR 2011; 60: 1–6. 2http://www.pamedsoc.org/opioids. 

3Pennsylvania Medical Society, August 11, 2015: http://bit.ly/1PguMyI. Accessed October 6, 

2015. 4 Centers for Disease Control and Prevention. Prescription painkiller overdoses in the U.S. November 2011. Available at: http://www.cdc.gov/vitalsigns/painkilleroverdoses/. Accessed on 

August 25, 2015. 5Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and comorbidities associated 

with opioid abuse in managed care and Medicaid beneficiaries in the United States: a comparison of two recently published studies. J Pain Palliat Care Pharmacother. 32010;24(3):251–58. 6 Hansen RN, Oster G, Edelsberg J, Woody GE, Sullivan SD. Economic costs of nonmedical 

use of prescription opioids. Clin J Pain. 2011;27(3):194–202. 7Peirce GL, Smith MJ, Abate MA, Halverson J (2012) Doctor and Pharmacy Shopping for 

Controlled Substances. Medical Care 50:7. http://bit.ly/1i3C8Zm Accessed September 11, 2015 8 Announcement of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Centers for Medicare and 

Medicaid Services, April 2, 2012. Available at 

http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=15078. Accessed September 4, 2015. 

caine combined.1 The Pennsylvania Medical Society reports that more Pennsylvanians die from drug overdoses than from any other type of injury, including car accidents.2 In 2014, that’s 2,400 deaths attributed to drug overdoses, or 7 people a day 

in Pennsylvania.3

Rates of prescription drug abuse related to emergency department visits and treatment admissions have reached epidemic levels in the United States. All too often, 

many of us know someone who is battling drug addiction. Moreover, the economic 

costs of prescription drug abuse are substantial. The nonmedical use of controlled 

substances amounts to $73 billionannually in unnecessary costs, including lost productivity, increased costs to the criminal justice system, and health care expenditures.4, 5, 6

There is a definite need for action on many fronts to address this growing concern. 

Patients, providers, patient family members, health plans, community based organizations, employers, and government must all work together to formulate and implement solutions. One area where change can be affected is in the Medicare Part D 

program. That Program does not currently limit patients with a history of abuse, 

misuse or diversion to a single prescriber and/or pharmacy. The use of a drug management program (DMP) by prescription drug plans (PDPs) and Medicare Advantage prescription drug plans (MA–PD) is a managed care pharmacy solution to control access to addictive medicines. 

Senator Toomey’s bill S. 1913, Stopping Medication Abuse and Protecting Seniors 

Act of 2015, would allow PDPs and MA–PDs to proactively identify individuals at 

risk for controlled substance abuse, misuse or improper utilization. The Secretary 

of Health and Human Services (HHS) would determine the criteria for the ‘‘at risk’’ 

designation. The plans would work with a beneficiary’s prescriber and give the beneficiary notice that they had been identified as a potential participant for enrollment 

in a drug management program (DMP). 

The beneficiary has appeal rights and can submit their preference of a specific prescriber and pharmacy. The use of DMPs may improve continuity of care among atrisk plan beneficiaries, while ensuring beneficiaries with legitimate medical needs 

have continued access to effective pain control. At risk beneficiaries are still able 

to receive non-controlled prescriptions at other pharmacies and from other prescribers. In essence, DMP programs help to mitigate the issues associated with doctor or pharmacy shopping and may reduce the number of inappropriate controlled 

substance prescriptions.7

In terms of the impact to beneficiaries, a 2012 CMS study found that less than 1% 

of beneficiaries would be directed into a DMP. The study further found that only 

0.7% of Medicare Part D beneficiaries received opioids from at least 4 prescribers 

and 4 or more pharmacies, signaling a high-risk patient.8 (Those beneficiaries in 

hospice or those with a diagnosis of cancer were excluded from the study.) 

The limited number of beneficiaries that may be included in the DMP is encouraging because it is an indicator that the majority of beneficiaries in the Program 

will not have any change in their prescriber or pharmacy as a result of S. 1913. 

On the other hand, that small group of beneficiaries that are at-risk, will have an 

opportunity to receive better coordination of care by the prescriber, pharmacy and 

PDP working together through the DMP. 

75 

Managed care pharmacists are prepared to work with at-risk Medicare beneficiaries 

Managed care pharmacists are well-positioned to help reduce prescription opioid 

abuse, misuse, and diversion in two distinct ways. First, we experience with DMPs 

on the commercial side and in state Medicaid programs. Through specific modeling 

tools unique to the industry, we have been able to identify beneficiaries at-risk for 

abuse, misuse or diversion and offer them the help they need. Secondly, through 

these same tools, the long-term results of having fewer at-risk beneficiaries involved 

in the misuse, abuse, or diversion of controlled substances will ultimately result in 

reduced costs to the overall health care system. 

On behalf of myself and AMCP, we strongly support S. 1913 and your tireless efforts to authorize a program that will address this important societal problem. In 

our opinion, S. 1913 preserves the beneficiaries’ rights to be notified, to submit preferences for prescriber and pharmacy and to exercise appeal rights. However, the 

PDPs and MA–PDs will be able to identify at-risk beneficiaries sooner and help 

them obtain the necessary treatment and improve their ability to address their addictions. Prescribers and pharmacies will also be aware of the at-risk beneficiaries’ 

need for assistance. 

I unfortunately will be out of town during the October 15th field hearing but this 

is an important issue to me and I wanted to provide input for the record. Thank 

you the opportunity to be included. Please feel free to contact me, or my colleagues 

at AMCP as a resource in tackling this very important issue. We will continue to 

work with you to enact this legislation. 

THE HOSPITAL AND HEALTHSYSTEM ASSOCIATION

OF PENNSYLVANIA (HAP) 

4750 Lindle Road 

P.O. Box 8600 

Harrisburg, PA 17105–8600 

717–564–9200 Phone 

717–561–5334 Fax 

https://www.haponline.org/ 

Testimony of Michael J. Consuelos, M.D. 

Senior Vice President for Clinical Integration 

The Hospital and Healthsystem Association of Pennsylvania (HAP) 

The U.S. Senate Committee on Finance 

Subcommittee on Health Care 

‘‘Examining Heroin and Opiate Abuse 

in Southwestern Pennsylvania’’ 

October 15, 2015 

Chairman Toomey, Ranking Member Stabenow, and members of the Subcommittee, 

my name is Michael J. Consuelos, M.D., and I am the senior vice president for clinical integration for The Hospital and Healthsystem Association of Pennsylvania 

(HAP). HAP represents and advocates for the nearly 240 acute and specialty care 

hospitals and health systems across state. We appreciate the opportunity to describe 

how HAP and Pennsylvania hospitals are working to reduce opioid addiction and 

opioid related deaths. 

Opioid abuse is a terrible problem in Pennsylvania, and only coordinated efforts 

across sectors of public and private stakeholders can increase the chance of stemming what has become a public health epidemic. In 2014, in the State of Pennsylvania, approximately 2,500 people died from drug overdoses, more than double the 

1,200 people who died from motor vehicle accidents. 

HAP has joined the Pennsylvania Medical Society (PAMED), the Pennsylvania Department of Health (DOH), the Pennsylvania Department of Drug and Alcohol Programs (DDAP), and other stakeholders on the Safe and Effective Prescribing Practices and Pain Management Task Force. This taskforce has prepared three guidelines for providers who regularly prescribe opiate pain medications. These include 

prescribing guidelines for: 

76 

• emergency departments; 

• dental practices; and 

• the treatment of chronic non-cancer pain. 

We are now working on guidelines for geriatric patients and obstetrical patients. 

The taskforce is also collaborating on providing professional continuing education 

programs for physicians, nurses, and pharmacists. This important education supports the written prescribing guidelines and promulgates the use of naloxone under 

Pennsylvania Act 139. Act 139 provides liability protections for first responders administering life-saving opioid reversal medication. 

Individual hospitals are assessing the impact of opioid dependency and related 

deaths in the communities they serve. Many are identifying opioid abuse as a major 

community health issue as they develop their most recent Community Health Needs 

Assessments. Emergency departments are seeing a growing number of opioid 

overdoses and working closely with local emergency medical services personnel and 

police on the proper use of naloxone by first responders. 

Lastly, the HAP Behavioral Health Taskforce is evaluating Pennsylvania’s existing 

laws, policies, and regulations addressing the treatment of drug abuse. Hospitals 

primarily rely on DDAP and country treatment and prevention programs. Better 

alignment between medical and behavioral health regulations can provide better 

transitions to, and adherence with, treatment services. 

This activity is just a start and requires sustained support and additional resources 

to truly make an impact on this public health problem. HAP supports the following: 

• Implementation of Pennsylvania’s Achieving Better Care by Monitoring All Prescriptions (ABC–MAP) Prescription Drug Monitoring Program (POMP) to improve safe prescribing practices and identification of drug-seeking patients so 

they can receive the proper treatment. 

• Federal legislation, such as S. 480, the National All-Schedules Prescription 

Electronic Reporting (NASPER) Reauthorization Act of 2015, introduced by Senators Shaheen (D–NH) and Toomey (R–PA), could support Pennsylvania in implementing ABC–MAP. Importantly, NASPER goes beyond providing grant support to states to establish prescription drug monitoring programs, but also ensures interoperability between state monitoring programs and within health information technology systems. 

• Increasing the use of naloxone and supporting the development and distribution 

of the life-saving drug, to help reduce the number of deaths associated with prescription opioid and heroin overdose. S. 707, the Opioid Overdose Reduction Act, 

would expand important liability protections for the emergency administration 

of an opioid overdose drug. 

• Expanding the use of Medication-Assisted Treatment (MAT), a comprehensive 

way to address the needs of individuals, which combines the use of medication 

with counseling and behavioral therapies to treat substance use disorders. 

• Proliferating drug take-back programs, which provide safe and efficient means 

to destroy prescribed pain medications, thereby removing them from the streets. 

• Assessment and evaluation of prenatal opioid abuse and neonatal abstinence 

syndrome, as outlined in S. 799, the Protecting Our Infants Act, introduced by 

Senators McConnell (R–KY) and Casey (D–PA), will initiate positive steps to decrease the number of infants suffering from opioid dependency. 

In conclusion, HAP and Pennsylvania hospitals are working diligently with other 

stakeholders to address the epidemic of opioid abuse and overdose deaths. This good 

work requires continued support and collaboration to fully make an impact on the 

future health and wellbeing of Pennsylvanians. 

LETTER SUBMITTED FOR THE RECORD BY JULIE KMIEC, D.O. 

125 Avenue F 

Pittsburgh, PA 15221 

412–992–8529 

kmiecja@msn.com 

Senator Pat Toomey 

100 W. Station Square Dr. 

77 

Suite 225 

Pittsburgh, PA 15219 

October 14, 2015 

Dear Senator Toomey, 

I am an addiction psychiatrist and treat patients primarily who are addicted to 

opioids. Today’s opioid epidemic stems back to the mid 1990s. In 1995, Purdue 

Pharma released OxyContin, which is an extended release oxycodone tablet, which 

was initially billed by the pharmaceutical company to have low abuse potential. 

Around the same time, there was a focus developing on assessing and treating pain. 

A joint consensus statement from two pain societies published in 1996 stated that 

development of addiction is low when opioids are used for pain and withholding 

opioids based on concerns about respiratory depression is unwarranted. Judicious 

use of opioid pain medications was encouraged to alleviate suffering. As you are 

aware, prescribing of opioid pain medications increased. From 1991 to 2013, the 

number of opioids prescribed in the United States went from 76 million to 207 million per IMS Health, Vector One prescription records.i In that same period of time, 

deaths from prescription opioids tripled.ii

Today, it is estimated 1.9 million Americans abuse or are addicted to pill opioids.iii

In Allegheny County, the SAMHSA National Survey on Drug Use and Health found 

that the prevalence of pill opioid use from 2010–2012 was 4.05%.iv About 75% of 

those using opioid pills will go on to use heroin due to cost.v My patients tell me 

that they buy pills for $1 per milligram, whereas heroin costs $10 per stamp bag. 

Patients usually start out using heroin intranasally, then as their tolerance grows, 

they need to use more and more to get the same effect, so they switch to injecting 

it in order to use less and get a greater effect. However, with time, they become 

tolerant to the effects of the injected heroin as well, and again start using more and 

more. Currently, there are 517,000 Americans addicted to heroin.iii Each day, 46 

Americans die from prescription opioid overdoses vi and 22 die from heroin 

overdoses.vii In 2014, there were 299 overdose deaths in Allegheny County alone.viii

I see patients in all phases of their addiction, actively using, in detoxification, and 

in recovery. Sadly, I have treated several patients who have overdosed on opioids 

and died. About 50% of my patients have survived or witnessed an accidental overdose at some time in their lives. 

To address the opioid epidemic, addiction physicians have recognized to effectively 

treat this opioid and overdose epidemic, we need to take a multifaceted approach. 

We need to: 

1. Emphasize prevention. Encourage patients to discard of all unused medications, 

especially narcotic medications, by returning them to participating take-back 

pharmacies, police departments, or utilizing drug take-back days so unused drugs 

are not used by unintended recipients. 

2. Educate medical students, residents, and physicians about addiction and proper 

opioid prescribing. An organization, Physicians for Responsible Opioid Prescribing (www.supportprop.org) provides continuing medical education on responsible opioid prescribing. In addition to physicians, dentists, advance practice 

nurses, and physician’s assistants also need basic and continuing education on 

proper opioid prescribing. All healthcare professionals need more training in recognizing signs and symptoms of addictive disorders and effectively working with 

patients with addictive disorders. I am a member of The Coalition on Physician 

Education in Substance Use Disorders (COPE) and we are working on encouraging the integration of increased education on addiction into allopathic and osteopathic medical school curricula. 

3. Use prescription drug monitoring databases to ensure we have as much data 

available to us as possible to make sound clinical decisions. Of note, Pennsylvania’s prescription drug monitoring database which was signed into law on October 27, 2014, and anticipated to take effect June 30, 2015, is still not available 

due to budget constraints. Hence, physicians in Pennsylvania still do not have 

this resource available to possibly inform prescribing. 

4. Use FDA-approved medications to treat opioid use disorder, including methadone, buprenorphine, and naltrexone. These medications are effective in reducing 

opioid use, preventing relapse, reducing transmission of HIV and hepatitis C 

from injection drug use, and reducing emergency room visits and hospitalizations.ix These medications, however, are underutilized currently. 

5. Provide overdose prevention training and co-prescribe naloxone when prescribing 

opioids in case of accidental overdose. 

78 

Opioid use disorder, also known as opioid addiction, is a chronic, relapsing, lifethreatening, but treatable disease of the brain. Addiction is not a choice or lack of 

willpower. It is not a time-limited illness. Yet, the patients I see each day are given 

these messages by their friends, family, the media, healthcare workers, and insurance providers. 

Patients with addictive disorders face barriers when trying to seek medications for 

treatment of opioid use disorder, including wait-lists to get into methadone maintenance programs and buprenorphine clinics, difficulty finding physicians who accept 

Medicaid who will prescribe stabilizing medications,x difficulty getting into rehabilitation programs, rigorous prior-authorization requirements xi which set up barriers 

to patients being able to afford medications. 

Eleven states have implemented lifetime limits for how long their Medicaid programs will pay for buprenorphine,xii 14 states have implemented buprenorphine 

dose limits,xiii and one state (i.e., Maine) has implemented a 2-year lifetime limit 

for Medicaid payment for methadone. These limits have restricted patients’ access 

to treatment and put them at risk for relapse and overdose, and there is no evidence 

behind these practices.xiv

Fortunately, Pennsylvania has not instituted a lifetime limit for buprenorphine 

treatment but Pennsylvania Medicaid does have a dose limit of 16 mg daily. Patients on buprenorphine treatment need their treating physician to submit prior authorizations documenting participation in psychosocial therapy, urine drug testing, 

relapse status, every 6 months. Some managed care companies require patients who 

want to use extended release naltrexone for treatment to use the immediate release 

naltrexone first, as part of a step therapy requirement. The patient is required to 

‘‘fail’’ this treatment in order to be approved for the more expensive treatment. This 

puts the patient at risk for relapse and overdose. In fact, I had one patient for whom 

the insurance company refused to authorize the extended release naltrexone and required him to take the naltrexone tablets first. The patient took the tablets for a 

short time and relapsed on heroin and then overdosed. Fortunately he survived the 

overdose, underwent detoxification again, and then started the extended release 

naltrexone and began a long period of recovery. 

Despite The Mental Health Parity and Addiction Equity Act of 2008, there are still 

private insurers in the southwest Pennsylvania region that do not pay for outpatient 

detoxification. These patients who have this insurance company who come to the 

program have to pay out-of-pocket or try to find an inpatient detoxification facility. 

In Pennsylvania, patients with opioid use disorders have to complete several hurdles 

in order to get lifesaving medications authorized by their insurance companies as 

described above. These same patients could get prescriptions for most immediate release (e.g., oxycodone) and several extended release opioids (e.g., oxymorphone ER, 

Fentanyl patch), without any step therapy requirements, prior authorizations, and/ 

or requirements for additional treatment such as physical therapy. 

In closing, patients with addiction need to be treated as all other patients with 

chronic diseases. A patient with high blood pressure is not expected to stop blood 

pressure medications once his/her blood pressure is stabilized or to maintain the 

gains made by medication through lifestyle changes (e.g., diet and exercise) if these 

haven’t been successful treatments previously. Likewise, limits on medications to 

treat opioid and other addictions should not be time limited. Once patients stabilize 

on methadone or buprenorphine, they should not be expected to stop the medications and maintain their recovery with therapy alone. Patients with opioid addiction 

should not need to ‘‘fail’’ a treatment before their insurance will pay for a more expensive medication, especially since ‘‘failure’’ could be a matter of life and death. 

I am hopeful that you will find my comments helpful in understanding the opioid 

epidemic and barriers those with the disease of opioid addiction are facing in Allegheny County, Pennsylvania, and also in the greater United States. 

Respectfully submitted, 

Julie Kmiec, D.O. 

Addiction Psychiatrist 

______________________________ 

i IMS Health, Vector One: National, Years 1991–1996, Data Extracted 201. IMS Health, National Prescription Audit, Years 1997–2013, Data Extracted 2014. iiMack, K.A. Drug-induced deaths—United States, 1999–2010. MMWR Surveill Summ. 2013 

Nov 22;62 Suppl 3:161–3. CDC. 

79 

iii In 2013, the National Survey on Drug Use and Health (NSDUH) estimated that 1.9 million 

Americans live with opioid pain reliever addiction and 517,000 are addicted to heroin. http:// 

www.samhsa.gov/data/sites/default/files/NSDUH-SR200-RecoveryMonth-2014/NSDUHSR200-RecoveryMonth-2014.htm. ivhttp://www.samhsa.gov/data/sites/default/files/substate2k12-StateTabs/NSDUHsubstate 

StateTabsPA2012.htm. v Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The changing face of heroin use in the United 

States: a retrospective analysis of the past 50 years. JAMAPsychiatry. 2014 Jul 1;71(7):821–6. 

doi: 10.1001/jamapsychiatry.2014.366. PubMed PMID: 24871348. vi According to the Centers for Disease Control and Prevention (CDC), 46 Americans die every 

day from opioid prescription drug overdoses: that translates to almost 2 deaths an hour and 

17,000 annually. CDC Vital Signs, July 2014 (http://www.cdc.gov/vitalsigns/opioid-prescribing/). vii According to the Centers for Disease Control and Prevention (CDC). more than 8,000 Americans die annually from heroin overdoses. http://www.cdc.gov/nchs/data/databriefs/db190.htm. viiihttp://www.achd.net/pr/pubs/2015release/052115_nalaxone.html. ixhttp://www.asam.org/docs/default-source/2015-conference-epk/asam-impact_cce-4-02- 

14.pdf?sfvrsn=4#search=‘‘proven clinical and cost effectiveness opioid use’’. x A shortage of Medicaid-eligible physicians or organizational providers who prescribe addiction medications has developed—one state has only one Medicaid-eligible methadone clinic. This 

can be especially harmful when low-income opioid addiction patients are unable to find/access 

Medicaid-eligible providers in their area, according to The Avisa Group (Availability without accessibility? State Medicaid coverage and authorization requirements for opioid dependence medications; Rinaldo, S. and Rinaldo, D. 2013). xi Rigorous prior-authorization requirements for continued use of medications, sometimes within as little as 6 months. Prior authorization requirements can also change substantially over 

time, without notice, and severely restrict or deny access to medication, according to research 

conducted by The Avisa Group (Availability without accessibility? State Medicaid coverage and 

authorization requirements for opioid dependence medications; Rinaldo. S. and Rinaldo, D., 

2013). xii Eleven states impose preset ‘‘lifetime’’ medication limits on buprenorphine, according to The 

Avisa Group (Availability without accessibility? State Medicaid coverage and authorization requirements for opioid dependence medications; Rinaldo, S. and Rinaldo, D. 2013). xiiihttp://www.asam.org/docs/default-source/2015-conference-epk/asam-impact_barriers4-02- 

14.pdf?sfvrsn=4#search=‘‘medications for the treatment of opioid use disord’’. xivStabilizing medications for patients living with chronic opioid addiction disease are uniquely controlled, with insurance limitations not supported by medical knowledge, according to 

Treatment Research Institute findings (FDA approved medications for the treatment of opiate 

dependence: Literature reviews on effectiveness and cost effectiveness; Chalk, M. et al., 2013). 

NATIONAL ASSOCIATION OF CHAIN DRUG STORES (NACDS) 

1776 Wilson Blvd, Suite 200 

Arlington, VA 22209 

703–549–3001 

www.nacds.org 

Statement 

Of 

The National Association of Chain Drug Stores 

For 

United States Senate 

Committee on Finance 

Subcommittee on Health Care 

Field Hearing on: 

‘‘Opiate Abuse in Southwestern Pennsylvania’’ 

October 15, 2015 

The National Association of Chain Drug Stores (NACDS) thanks Chairman Toomey, 

Ranking Member Stabenow, and members of the Senate Finance Subcommittee on 

Health Care for the opportunity to submit a statement for the hearing on Opiate 

Abuse in southwestern Pennsylvania. NACDS and the chain pharmacy industry are 

committed to partnering with federal and state agencies, law enforcement personnel, policymakers and others to work on viable strategies to prevent prescription 

drug diversion and abuse. Our members are engaged daily in activities aimed at 

80 

preventing drug diversion and abuse. Since our members operate pharmacies in almost every community in the U.S., we support policies and initiatives to combat the 

prescription drug abuse problem in southwestern Pennsylvania and nationwide. We 

believe that holistic approaches must be implemented at the federal level. 

NACDS represents traditional drug stores and supermarkets and mass merchants 

with pharmacies. Chains operate more than 40,000 pharmacies, and NACDS’s 115 

chain member companies include regional chains, with a minimum of four stores, 

and national companies. Chains employ more than 3.2 million individuals, including 

179,000 pharmacists. They fill over 2.9 billion prescriptions yearly, and help patients use medicines correctly and safely, while offering innovative services that improve patient health and healthcare affordability. NACDS members also include 

more than 850 supplier partners and nearly 60 international members representing 

22 countries. For more information, visit www.nacds.org. 

Background 

First enacted in 1970, the federal Controlled Substances Act (CSA) regulates the 

manufacture, importation, possession, use, and distribution of prescription drugs 

that have a potential for diversion and abuse and are collectively known as ‘‘controlled substances.’’ The CSA creates a closed system of distribution for controlled 

substances; the Drug Enforcement Administration (DEA) often refers to this as 

‘‘cradle-to-grave’’ control over controlled substances. DEA has implemented a very 

tight and comprehensive regulatory regime pursuant to the CSA. States have followed this lead and have implemented similar, sometimes duplicative regimes. This 

matrix of regulation has created a multi-layered system of checks and balances to 

protect Americans from the dangers of prescription drug abuse. Pharmacists and 

other pharmacy personnel are all trained to understand and comply with this complex regulatory matrix. 

Chain Pharmacy Initiatives 

To comply with DEA’s ‘‘cradle to grave’’ regulatory regime, chain pharmacies have 

created a variety of loss prevention and internal security systems that are in place 

from member prescription drug distribution centers right down to the point of dispensing to the patient. Our members undertake initiatives to ensure that prescription drugs are accounted for throughout every step along the way. Some of those 

initiatives could include conducting background checks before hiring personnel who 

have access to prescription drugs, training employees on controlled substance laws 

and regulations within 30 days of hire, maintaining electronic inventories of controlled substances and conducting random audits. Our members work closely with 

law enforcement to see that perpetrators of crimes relating to controlled substances 

are brought to justice. 

Specifically at the pharmacy level, examples of NACDS-member initiatives include 

training pharmacy personnel on how to handle suspect prescription drug orders, and 

exception reporting, in which exceptionally large or unusual orders of controlled substances will trigger an internal investigation. Chain pharmacies also may maintain 

perpetual inventories of controlled substances that are randomly audited by internal 

security personnel. Pursuant to DEA and state regulations, pharmacy and chain distribution centers are required to be highly secured with physical barriers and utilize 

heavy duty safes, secure cages, and complex alarm systems. Some pharmacy chains 

also utilize cameras and closed-circuit television surveillance to ensure compliance 

with policies and procedures. Some pharmacies require employees to read and sign 

‘‘codes of conduct,’’ which commits them to compliance and some will conduct drug 

testing, including random, for cause, and pre-employment testing. 

Chain pharmacies are committed to ensuring that prescription drugs remain under 

tight control for the purposes of providing care to their patients, and are not diverted for nefarious purposes. Our members’ efforts are evidence of this commitment. 

Legislative Initiatives 

NACDS shares the goals of policymakers to curb the incidence of fraud and abuse 

and appreciates the work that has been done over the last year, such as with the 

21st Century Cures Initiative. NACDS believes that any potential programs aimed 

at ‘‘locking-in’’ a beneficiary to a certain pharmacy or pharmacies—such as the one 

included in the 21st Century Cures Initiative or in S. 1913, the Stopping Medication 

Abuse and Protecting Seniors Act of 2015—must ensure that legitimate beneficiary 

access to needed medications is not impeded. Policies to reduce overutilization must 

maintain access to prescription medications by the beneficiaries who need them 

most. 

81 

1 In order for a prescription for a controlled substance to be valid, federal law (21 CFR 

§ 1306.04(a)) requires that the prescription be issued for a legitimate medical purpose by a prescriber acting in the usual course of his or her practice. The rule places a corresponding responsibility upon the dispensing pharmacist to establish the validity of the prescription by ensuring the prescription is written for a legitimate medical purpose. 2 21 CFR 1306.04(a). 

3 East Main Street Pharmacy, 75 FR 66149, 66163 (Oct. 27, 2010). 

While the use of a single pharmacy could decrease incidents of fraud, waste and 

abuse as well as provide the potential for better care coordination, a lock-in provision may actually be a barrier to care as supply chain issues exist around these 

medications which are beyond the pharmacy’s control. Also, patients often legitimately see multiple doctors representing different specialties in different locations. 

In addition, there are instances due to location and/or services offered (e.g., com- pounded or specialty drugs) that a single pharmacy may not meet all the needs of 

a specific patient. 

In order to protect legitimate patient access while combatting prescription drug 

abuse and diversion, mechanisms must be included in any legislation that would 

allow a pharmacy, in consultation with the prescriber, to fill legitimate prescriptions 

without needlessly delaying treatment for beneficiaries. This includes ensuring that 

back-up systems are in place which would allow a beneficiary to obtain needed 

medication in the event their ‘‘locked-in’’ pharmacy is unable to supply the medication. Without this, the potential for harm from unnecessary delay in obtaining medication is possible. 

Additionally, NACDS believes a beneficiary should be able to select a pharmacy location, or number of locations that are under common ownership and that electronically share a real time, online database. The ability to share real-time data will ensure that beneficiaries are only obtaining the necessary prescriptions while protecting beneficiary access and health. 

The Role of DEA 

According to DEA regulations, the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility also rests with the pharmacist who fills the prescription. 

An order purporting to be a prescription that is not issued in the usual course of 

professional treatment is not a prescription within the meaning and intent of section 

309 of the CSA (21 U.S.C. 829), and any person knowingly filling such a purported 

prescription, as well as the person issuing it, is subject to the penalties provided 

for violations of the CSA. 

Community pharmacists are front-line healthcare providers and are one of the most 

accessible members of a healthcare team. As such, the CSA requires pharmacists 

to take on diverse and sometimes conflicting roles. On the one hand, pharmacists 

have a strong ethical duty to serve the medical needs of their patients in providing 

neighborhood care. On the other hand, community pharmacists are also required to 

be evaluators of the legitimate medical use of controlled substances.1 As briefly 

mentioned above, the CSA requires that a pharmacist, prior to dispensing any controlled substance, make the following determinations-whether the prescription complies with all legal and regulatory requirements, and whether the prescription has 

been issued for a ‘‘legitimate medical purpose’’ ‘‘by a prescriber acting in the usual 

course of his or her practice.’’ 2 The former obligation is called ‘‘corresponding responsibility,’’ and if the two elements are not met, the prescription is not valid. DEA 

interprets a pharmacist’s corresponding responsibility ‘‘as prohibiting a pharmacist 

from filling a prescription for a controlled substance when he either ‘knows or has 

reason to know that the prescription was not written for a legitimate medical purpose.’ ’’ 3

Pharmacies fully understand that controlled substances are subject to abuse by a 

minority of individuals who improperly obtain controlled substance prescriptions 

from physicians and other prescribers. Pharmacies strive to treat medical conditions 

and ease patients’ pain while simultaneously guarding against the abuse of controlled substances. The key is to guard against abuse while still achieving our primary goal of assisting patients who need pharmacy services. 

The Role of FDA 

In 2007, Congress passed the Food and Drug Administration Amendments Act of 

2007 (FDAAA), which provided FDA the authority to impose risk management plans 

on prescription drugs; this program is known as Risk Evaluation and Mitigation 

82 

4 ‘‘Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved;’’ Government Accountability Office; February 2015; pp. 43–51. 5 Ibid. 

6 Ibid., at 46. 

7 Ibid., at 29. 

8 Ibid., at 47. 

9 Ibid. 

10 Ibid. 

Strategies (REMS). A REMS will be imposed if FDA finds that a REMS is necessary 

to ensure that the benefits of a drug product outweigh the risks of the drug product. 

Among the numerous REMS that FDA has implemented is a REMS for extended 

release and long-acting opioid products (‘‘ER/LA opioid drugs’’). These are pain relieving medications that have an elevated potential for abuse. The central component of this ‘‘Opioid REMS’’ is an education program for prescribers (e.g., physicians, 

nurse practitioners, physician assistants) so that ER/LA opioid drugs can be prescribed and used safely. NACDS agrees that prescribers should be properly educated 

about the risks and benefits of prescription drugs, including those that have elevated abuse potential like ER/LA opioid drugs. It is critical that all prescribers understand the nature of addiction and abuse before issuing prescriptions for these 

medications. NACDS supports FDA’s Opioid REMS. 

In 2011, FDA announced a REMS for another class of drugs with elevated abuse 

potential: transmucosal immediate-release fentanyl (TIRF) products. NACDS and 

other industry stakeholders worked closely with FDA to design and implement this 

REMS. We are appreciative of this collaborative effort spearheaded by FDA, and believe such a collaborative effort should serve as a model for similar programs to address prescription drug abuse. 

The GAO Report 

Numerous groups and state and federal entities are working to reduce the problem 

of prescription diversion and abuse. Unfortunately, in their efforts to combat prescription drug abuse, federal agencies have not been effectively coordinating their 

efforts to assure access to prescription controlled substances for patients who legitimately need these medications. In GAO’s recent report that examines shortages of 

prescription drugs that contain controlled substances, GAO found that DEA and 

FDA have not established a sufficiently collaborative relationship to ensure an adequate supply of controlled substance medications.4 GAO found that the barriers to 

coordination prevent DEA and FDA from preventing or alleviating shortages.5 Although critical to their efforts, a memorandum of understanding (MOU) between the 

two agencies has not been updated in 40 years.6

Specific to DEA, GAO found that: 

• DEA does not meet its requirements due to lack of internal controls for data reliability, performance measures, and performance monitoring; 7

• Insufficient internal DEA controls lead to errors in its data system; 8

• DEA has not met required time frames for more than a decade; 9 and 

• DEA is not prepared to respond to future prescription drug shortages.10

Considering the patient harm that occurs due to prescription drug shortages, the 

concerns identified by GAO about lack of federal agency coordination, and serious 

DEA deficiencies, we believe that Congress should act. Federal agencies must come 

together behind a comprehensive approach and pursue drug abuse prevention policies that are strategically designed to target enforcement efforts while still maintaining access to prescription controlled substances for patients who legitimately 

need these medications. 

Since NACDS and our members are focusing our energies on real, workable solutions that will address the problem of prescription drug abuse while also ensuring 

that legitimate patients are able to receive their prescription pain medications, we 

support the ‘‘Ensuring Patient Access and Effective Drug Enforcement Act of 2015,’’ 

which has been introduced in the Senate as S. 483, sponsored by Sen. Orrin Hatch 

(R–UT) and Sen. Sheldon Whitehouse (D–RI). This legislation would promote cooperation among key government agencies, such as DEA and FDA, to jointly identify obstacles to legitimate patient access to controlled substances, issues with diversion of controlled substances, and how collaboration between law enforcement agencies and healthcare stakeholders can benefit patients and prevent diversion and 

abuse of controlled substances. 

83 

S. 483 also facilitates open dialogue on issues related to prescription drug diversion 

and abuse by directing key federal agencies to consult with patient groups; pharmacies; drug manufacturers; common or contract carriers and warehousemen; hospitals, physicians, and other healthcare providers; state attorneys general; federal, 

state, local, and tribal law enforcement agencies; health insurance providers and entities that provide pharmacy benefit management services on behalf of a health insurance provider; and wholesale drug distributors. 

We believe that bringing together stakeholders to address the problems associated 

with prescription drug abuse in this manner would provide better solutions than 

have been developed to date. Improved collaboration and coordination among federal 

agencies and other stakeholders would benefit all, including the patient, whose legitimate access to medication must be preserved in order for any potential solution 

to be successful. 

Additional DEA Recommendations 

Although the GAO report focuses on the quota process for prescription drugs, we 

have a number of additional concerns about DEA processes and functions that 

should be brought to light. DEA’s enforcement activities include conducting inspections of the entities that are subject to its regulatory oversight. Although such enforcement activities are essential to its mission, DEA has been criticized for an alleged lack of transparency in its inspection and other enforcement actions, and even 

inconsistency among the actions of its numerous field offices. Such opaqueness and 

inconsistency impose challenges on the compliance efforts of DEA registrants. 

To help address the problems of DEA opaqueness and inconsistency, we support efforts to promote accountability and transparency with respect to DEA’s inspection 

and enforcement programs. The following recommendations, drawn from FDA transparency and oversight and enforcement initiatives, could serve as a model for DEA: 

1. Development of a Comprehensive DEA Investigation Program, Corresponding Inspector Manual and Compliance Policy Guides: Specifically, DEA would set forth 

guidance for its oversight of regulated facilities inspections that provide clear and 

firm direction. 

2. Accountability and Consistency Among Field Offices: DEA would ensure the uniformity and effectiveness of its inspection program and oversight over field offices. DEA would provide public training for inspectors and develop an audit 

process to ensure that inspections are carried out consistently across field offices. 

3. Transparency and Communication—DEA Inspection Observations: DEA would 

provide substantive and timely feedback to inspected regulated facilities regarding agency observations and facility compliance. Specifically, DEA would provide 

regulated facilities with substantive written feedback upon completion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the CSA and implementing regulations. Without receiving such information, it is difficult for regulated facilities to implement 

requisite facility and process improvements and take corrective actions where 

necessary. 

4. Public Disclosure—Oversight of Inspections: An important mechanism of accountability is public disclosure of information. Disclosure of final inspection reports 

of regulated facilities would provide the public with a rationale for DEA enforcement actions and the industry with transparency into agency decision-making, 

allowing them to make more informed actions to enhance facility compliance. 

5. Ombudsman Office: An ombudsman office would address complaints and assist 

in resolving disputes between companies and DEA regarding interactions with 

the agency on inspections and compliance issues. 

We believe these recommendations would greatly increase predictability and transparency in DEA regulation. The adoption of such recommendations would greatly 

enhance the compliance efforts of DEA registrants, thus leading to more effective 

DEA regulation and oversight. Enhanced compliance efforts by DEA registrants and 

more effective DEA regulation and oversight would have highly beneficial impacts 

on efforts to combat prescription drug diversion and abuse. 

Conclusion 

NACDS thanks the Subcommittee for consideration of our comments. We look forward to working with policymakers and stakeholders on these important issues. 

84 

iSOURCE: ‘‘Substances Act.’’ Revised 2010. 

http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf. Accessed 

June 28th, 2013. 

STATEMENT SUBMITTED FOR THE RECORD BY DEBORAH PARTSCH

Written testimony relative to Senate bill 1913: Stopping Medication Abuse 

and Protecting Seniors Act of 2015 to prevent inappropriate access to 

opioids and improve patient care for at-risk beneficiaries. 

Mr. Chairman and committee members, my name is Deborah Partsch, and I am a 

Pharmacist who has lived and practiced professionally in western Pennsylvania for 

over 16 years. I respectfully submit a written testimony as an individual and as a 

member of the Academy of Managed Care Pharmacy. I think it is also important 

to note that I am an employee of Highmark Inc. a Pittsburgh-based Blue Cross and 

Blue Shield-affiliated health insurance company. I have held various positions within Highmark which has afforded me the opportunity to develop expertise on insurance-related aspects of pharmacy and health care policy. Briefly: 

• Substance abuse has been a problem in this country for decades, and has expanded from illegal to legal substances (prescription medications). I support bill 

S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, which 

would allow prescription drug plans and Medicare Advantage prescription drug 

plans to proactively and prospectively identify individuals at risk for controlled 

substance abuse, misuse or improper utilization. Many prescription drug plans 

covering non-Medicare eligible individuals utilize a Designated Pharmacy Program. The program’s intent is to deter drug-seeking members from doctor shopping, which is the practice of seeking the same type of prescriptions from multiple physicians. Additionally, the Controlled Substance Act provides the pharmacist an affirmative obligation to only fill prescriptions that are ‘‘issued in the 

usual course of professional treatment,’’ i and prescriptions that do not meet this 

requirement are considered improper. 

• Relative to concerns you may hear of limiting access to a designated pharmacy, 

I would highlight the pivotal model to reform the health care industry is the 

creation of Patient Center Medical Home programs and Accountable Care Organizations. Stimulated by Health Care Reform, these centralized health care 

partnerships seek to better manage an individual’s care in a streamlined manner. For the intent of the bill to be successful, I recommend real-time data sharing of information compiled in Prescription Drug Management Programs with 

key stakeholders including prescribers, pharmacies, managed care organizations, and pharmacy benefit management companies (PBMs). 

• Lastly, patients, providers, patient family members, health plans, community 

based organizations, employers, pharmaceutical companies and government 

must all work together to formulate and implement solutions. As an employee 

of Highmark, I wanted to share with you one initiative that Highmark has 

taken to address the issue of opioid abuse. As a health insurer with over 5 million members, the issue of opioid abuse is certainly of importance to Highmark. 

Earlier this year, Highmark, through its Foundation, provided a grant of 

$50,000 to support a state initiative that provides grants to first responders to 

purchase naloxone, a drug that reverses heroin and opioid overdoses. These 

grants enable first responders to administer the drug to individuals experiencing an overdose. According to the Pennsylvania Department of Drug and Alcohol Prevention Programs, results to date have been positive—289 drug 

overdoses have been reversed statewide since the implementation of this initiative. I am proud of my employer and other health insurers for supporting initiatives such as this one and I would like to encourage the drug industry to be 

a part of the solution by ensuring that the price of treatments like Naloxone 

remain reasonable. 

Thank you again for accepting my written testimony. Please feel free to contact me 

at 412–544–2489 or deborah.partsch@highmark.com, or my colleagues at AMCP as 

a resource in tackling this very important issue. We will continue to work with you 

to enact this legislation. 

AMCP is a national professional association of 7,000 pharmacists and other health 

care practitioners who serve society by the application of sound medication management principles and strategies to assist patients in achieving positive therapeutic 

outcomes. In Pennsylvania alone, we have over 480 active members. AMCP’s members develop and provide a diversified range of clinical, educational and business 

85 

management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. 

THE PENNSYLVANIA MEDICAL SOCIETY

Written Testimony 

By Karen Rizzo, MD, FACS 

October 16, 2015 

Stopping Medication Abuse and Protecting Seniors Act 

The Pennsylvania Medical Society thanks you for the opportunity to present this 

written testimony regarding the Stopping Medication Abuse and Protecting Seniors 

Act. 

Our nation is unquestionably facing an opioid abuse crisis. According to a report by 

the Centers for Disease Control (CDC), there were 16,007 opioid overdose deaths in 

the U.S. in 2012, the most recent year for which statistics were available. Pennsylvania’s death rate exceeds the national average, and in 2011 we ranked 21st per 

capita among the states in opioid prescriptions written. Nationally and in Pennsylvania overdose deaths now exceed motor vehicle deaths. Magnifying the situation, 

prescription opioids can become gateway drugs to heroin. Indeed, up to 80 percent 

of heroin addicts started on opioids. 

While there is a clear need to act aggressively in response to this epidemic, we must 

also act prudently, because prescription opioid medications are an essential tool for 

physicians who treat their patients who are living with chronic pain. 

Reducing opioid abuse requires a comprehensive effort, and the Pennsylvania Medical Society has initiated a multi-pronged approach to the problem: 

• Our ‘‘Pills for Ills, not Thrills’’ campaign provides physicians with a wide range 

of information and resources they can use in their practices; 

• We secured a grant to host a six-credit Risk Evaluation and Mitigation Strategies Continuing Medical Education (CME) program on extended release and 

long acting opioids; 

• We actively promote Pennsylvania’s medication drop box program. Several tons 

of medications have been turned in since the program was initiated less than 

2 years ago; 

• We were early advocates for the recently enacted statewide controlled substance 

database legislation, where prescribers will be able to look to identify patients 

who might be scammers or have an abuse problem; 

• We were strong supporters of Senate bill 1164, now Act 198 of 2014, which provides Good Samaritan protection to those who aid persons who experience a 

drug overdose, and expands the prescribing of life-saving naloxone to first responders as well as friends and family members of persons at risk of experiencing an overdose. 

• Additionally, we initiated a process to create opioid prescribing guidelines, giving prescribers clear, concise guidance as to best practices when utilizing these 

pain medications. We merged our effort with that of the Commonwealth’s own 

task force, and the chronic, non-cancer pain prescribing guidelines that resulted 

from that collaboration have been viewed more than 10,000 times on PAMED’s 

website. 

• Finally, we actively participated in the Joint State Government Commission’s 

examination of the state’s drug laws and regulations, which produced recommendations for further actions. 

Of course, much remains to be done. We are currently coordinating an effort by key 

provider organizations, including the PA Department of Health and the PA Department of Drug and Alcohol Programs, to develop four new continuing education programs focusing on the opioid prescribing guidelines, the new naloxone/Good Samaritan law, the forthcoming ABC–MAP controlled substances database, and ‘‘warm 

86 

hand-offs,’’ to better direct overdose survivors and abusers to appropriate treatment 

programs. 

While we continue our efforts to combat opioid abuse, we also wish to offer a word 

of caution. Overzealousness in the campaign to eliminate opioid abuse can also lead 

to negative consequences. According to published reports, new laws aimed at eliminating Florida’s pill mills have left many legitimate chronic pain sufferers scrambling to find pharmacies that have controlled substances, like Oxycodone, and are 

willing to dispense them. 

Additionally, well-meaning legislation which would require physicians and patients 

to follow a rigid, one-size-fits-all protocol, may be detrimental to patient care by impeding the individualized treatment that is the hallmark of the physician-patient relationship. In that regard, we are concerned that the one prescriber/one pharmacy 

provisions of the Stopping Medication Abuse and Protecting Seniors Act would create a bureaucratic impediment to that needed clinical flexibility. 

There is no question that limiting the number of prescribers and pharmacies from 

which a patient obtains scheduled drugs is a key element of the campaign to eliminate prescription opioid abuse, and we commend Senator Toomey and his cosponsors for identifying that need. However, we believe this objective can be accomplished without placing additional governmental restrictions on prescribers, patients, and pharmacies. 

Pennsylvania’s new ABC–MAP controlled substance database will allow prescribers 

and pharmacies to quickly identify patients who have an abuse problem or are trying to scam the system. One of the system’s primary purposes is to flag patients 

who are obtaining scheduled drugs from multiple prescribers and multiple pharmacies. 

Additionally, the legislation authorizes the ABC–MAP board to aid prescribers in 

identifying those individuals and direct them to treatment programs. Further, the 

state attorney general’s office will have unrestricted access to Schedule II prescribing and dispensing data, and can access Schedule III–V data with a court 

order. 

It should also be noted that Pennsylvania’s new opioid prescribing guidelines for 

chronic, non-cancer pain recommend the use of patient agreements, which typically 

include restrictions on multiple prescribers and pharmacies, as well as compliance 

checks involving urine and saliva screening and pill counts. 

We believe these new tools will have a major impact on the opioid abuse crisis without reducing practitioners’ clinical treatment options or limiting patient access. 

Again, we wish to thank you for your leadership on this important public health 

issue, and for offering us the opportunity to comment on the Stopping Medication 

Abuse and Protecting Seniors Act. 

The Pennsylvania Medical Society is committed to continuing its campaign to eliminate opioid abuse. We look forward to working with the Congress, Governor Wolf, 

the General Assembly, and other stakeholders in that ongoing endeavor. 

THE PEW CHARITABLE TRUSTS

Testimony for the 

Senate Committee on Finance, Subcommittee on Health Care 

United States Senate 

Field Hearing on Opiate Abuse 

October 15, 2015 

Cynthia Reilly, Director, Prescription Drug Abuse Project 

Chairman Toomey, Ranking Member Stabenow, and members of the Senate Committee on Finance, Subcommittee on Health Care, I am submitting testimony on behalf of The Pew Charitable Trusts. Pew is an independent nonpartisan research and 

policy organization dedicated to serving the public. Pew’s prescription drug abuse 

project works to develop and support policies that will help reduce the inappropriate 

87 

i Roberts AW and Skinner AC. Assessing the present state and potential of Medicaid controlled substance lock-in programs. J Manag Care Pharm. 2014;20(5):439–46c. ii Centers for Disease Control and Prevention; National Center for Injury Prevention and Control (2012). Patient review and restriction programs. Lessons learned from state Medicaid programs. Available at http://www.cdc.gov/homeandrecreationalsafety/pdf/PDO_patient_review_ 

meeting-a.pdf. iii Medicare Payment Advisory Commission (2015). Medicare and the Health Care Delivery 

System, Report to the Congress. Chapter 5. Available at http://www.medpac.gov/documents/ 

reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf?sfvrsn 

=0. iv Centers for Medicare and Medicaid Services (2013). Supplemental guidance related to improving drug utilization controls. Correspondence from Cynthia G. Tudor, director, Medicare 

Drug Benefit and C and D Data Group dated Sept. 6, 2012. Available at http://www.cms.gov/ 

Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/HPMSSuppleme 

ntalGuidanceRelated-toImprovingDURcontrols.pdf. 

use of prescription drugs while ensuring that patients with legitimate medical needs 

have access to effective pain management. Pew encourages Congress to pursue policy solutions to address the nation’s prescription drug abuse epidemic. The Stopping 

Medication Abuse and Protecting Seniors Act of 2015 is one such proposal that has 

been introduced in by Senators Toomey (R–PA), Brown (D–OH), Portman (R–OH), 

Kaine (D–VA), and Casey (D–PA). Pew supports this bill, which authorizes the use 

of drug management programs in Medicare. 

Our testimony makes two key points: 

• The use of opioids for non-cancer pain among Medicare beneficiaries is common, 

with some patients obtaining these prescription from multiple prescribers and 

pharmacies—a factor that places these individuals at increased risk for overdose and other adverse events, and 

• Medicare beneficiaries would benefit from drug management programs that 

allow plan sponsors to prevent inappropriate access to controlled substances 

that are susceptible to abuse and better coordinate patient care. 

The drug management programs described in the legislation, which are also known 

as patient review and restriction programs (PRRs), can play an important role in 

preventing prescription drug abuse by assigning patients who are at risk for drug 

abuse to pre-designated pharmacies and prescribers to obtain these drugs. Through 

this mechanism, PRRs allow plan sponsors and providers to improve care coordination and prevent inappropriate access to medications that are susceptible to abuse. 

The effectiveness of PRRs has led to their adoption in the public and private sector, 

with major insurers operating these programs in their Medicaid managed care and 

employer-based plans. In addition, 46 state Medicaid programs currently operate 

PRRs.i An evaluation of state Medicaid PRR programs performed by a Centers for 

Disease Control and Prevention expert panel concluded that these programs have 

the potential to reduce opioid usage to safer levels and thus save lives and lower 

health care costs.ii

The need for these programs in Medicare is highlighted by the growing concern 

about potential overuse of opioids among these beneficiaries. Analyses conducted by 

the Medicare Payment Advisory Commission (MedPAC), the Centers for Medicare 

and Medicaid Services (CMS) and the Government Accountability Office (GAO) have 

sought to quantify the extent of opioid overuse in this population. A MedPAC analysis of 2012 prescription drug event data found that 10.7 million (87 percent) of the 

roughly 12 million Medicare Part D beneficiaries who were prescribed prescription 

opioids received these therapies for conditions not associated with cancer treatment 

or hospice care. Among beneficiaries with the highest expenditures for opioids used 

for these indications, 32 percent obtained these prescriptions from four or more prescribers and 32 percent used three or more pharmacies. MedPAC also found that 

these beneficiaries accounted for 68 percent of the program’s total gross spending 

on opioids for non-cancer, non-hospice-related care. On average, these patients filled 

23 opioid prescriptions at a cost of $3,500 per beneficiary.iii

Evaluations by CMS and GAO found similar trends in the use of opioids for noncancer, non-hospice-related care and instances in which multiple prescribers and 

pharmacies were used to obtain these therapies, respectively.iv Further, the CMS 

analysis identified approximately 225,000 beneficiaries who received potentially unVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00091 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
88 

vGovernment Accountability Office (GAO) (2011). Medicare Part D: Instances of questionable 

access to prescription drugs, Report to Congressional Requesters. Available at http:// 

www.gao.gov/assets/590/585424.pdf. 

safe opioid dosing, which was defined as doses that exceeded 120 mg daily morphine 

equivalent dose for 90 or more consecutive days.v

The Stopping Medication Abuse and Protecting Seniors Act of 2015, which would 

authorize the use of PRRs in Medicare, would help reduce prescription drug abuse 

in this population. In addition, the legislation has strong beneficiary protections to 

ensure that patients with legitimate medical needs have access to effective pain 

management. Beneficiaries have the right to appeal their identification as at-risk 

and subsequent enrollment in a PRR. Patient input on the selection of prescribers 

and pharmacies will also ensure reasonable access, including consideration of geographic location, cost-sharing, travel time, and multiple residencies. Furthermore, 

patients receiving hospice care, those residing in long-term care facilities, and other 

beneficiaries the Secretary elects to treat as exempt would be excluded from enrollment in a PRR. This mechanism can be used to avoid enrollment of patients with 

medical diagnoses that require high doses or combinations of controlled substances 

to manage their pain. 

There is substantial support to advance this policy as an effective tool to decrease 

opioid abuse. The policy has been proposed in the FY 2016 Budget request for the 

Department of Health and Human Services. A proposal similar to the Senate bill 

is part of the 21st Century Cures Act, which passed the House of Representatives 

with broad bipartisan support on July 10, 2015. 

We urge the Senate to help address the nation’s prescription drug abuse epidemic 

by passing legislation that would authorize the use of PRRs in Medicare. We look 

forward to working with Congress to refine the Stopping Medication Abuse and Protecting Seniors Act of 2015 and other legislative proposals that would expand use 

of the PRRs to ensure that these programs work as intended to prevent prescription 

drug abuse in Medicare. 

PFIZER

Testimony of Mr. Ken W. Cole 

Senior Vice President, U.S. Government Relations, Pfizer Inc. 

Before the Senate Finance Subcommittee on Health 

Hearing on Opiate Abuse 

October 15, 2015 

Mr. Chairman and members of the subcommittee, 

Thank you for the opportunity to submit testimony for the Senate Committee on Finance Subcommittee on Health Care Field Hearing, ‘‘Examining Heroin and Opiate 

Abuse in Southwestern Pennsylvania.’’ We are including Pfizer’s comments, dated 

January 9, 2015, submitted to the FDA addressing the agency’s ‘‘Development and 

Regulation of Abuse-Deterrent Formulations of Opioid Medications; Public Meeting 

[FDA–2014–N–1359]’’ for your reference. Further, we appreciate your commitment 

and attention to the prescription drug epidemic and welcome your request for policy 

proposals for Congress to consider for addressing this crisis. 

Pfizer is a global leader in healthcare, helping change lives for the better by providing access to safe, effective, and affordable medicines and related healthcare 

services. Pfizer is one of the world’s largest research-based biopharmaceutical companies. As part of our mission, we believe we can best ensure that people everywhere have access to innovative medicines and quality healthcare by working in 

partnership with all stakeholders, including patients, healthcare providers, managed care organizations, governments, and non-governmental organizations. 

As you know, abuse of prescription opioids continues to take a devastating toll on 

individuals, families and communities across the nation. According to the Centers 

for Disease Control and Prevention (CDC), every day in the United States, 44 people 

die as a result of prescription opioid overdose. Deaths from overdose of prescription 

opioid painkillers have tripled since 2001, killing more than 16,000 in the United 

States in 2013. The rising prevalence of chronic pain and the increasing use and 

89 

1 NIH Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic 

Pain, September 29–30, 2014, Draft Statement. 2http://www.fingertipformulary.com//. Accessed October 2014. 3http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf. 

abuse of opioid analgesics have created an epidemic of distress, disability, and danger to a large percentage of Americans. 

As you examine potential policy proposals to address the prescription drug crisis, 

we respectfully request that the subcommittee consider the role that abusedeterrent opioids (ADOs) can play in reducing opioids misuse and abuse. Pfizer is 

well aware of the urgent need for new, powerful analgesics that are safer than 

opioids, and we are working to develop them. However, until powerful yet safer alternatives to opioids become available, and possibly even after they become available, opioid analgesics are likely to remain an indispensable component of pain therapy. Pfizer shares the vision of the future articulated by the Food and Drug Administration (FDA) in which most or all opioid analgesics are available to pain patients 

who need them in formulations that are less susceptible to abuse than the majority 

of currently available opioids. While no ADO to date can entirely eliminate the risk 

of abuse, ADOs are an important part of a comprehensive strategy to reduce prescription opioid-related abuse, misuse and overdose. 

We are concerned however, that current policies restricting access to these new 

technologies as they become available could stifle innovation, limit patient access, 

and only perpetuate the prescription drug abuse crisis. Existing payment structures 

help illustrate system-wide barriers at both the formulary and provider level to the 

adoption of new pain therapies and treatment modalities and, more importantly, to 

the appropriate management of patients with pain. For example, non-opioid analgesics are uniformly recommended as first-line treatments by chronic pain and opioid 

use guidelines; however, patient access to the branded non-opioid analgesics is often 

restricted by prior authorization/step-edits and/or higher patient co-pays/coinsurance.1 In contrast, patient access to currently available, largely generic, and 

largely non-abuse-deterrent opioid analgesics is unrestricted as they are placed on 

preferred formulary tiers with lower patient out-of-pocket expenses.2 These policies, 

which disadvantage appropriate first-line therapies—either non-opioid alternatives 

or ADOs—and provide preferential access to the currently available non-ADOs, contribute to opioid overprescribing, and are likely to delay, if not prevent, the adoption 

of ADOs. 

To help ensure patient access for Medicare beneficiaries, Pfizer recommends that 

the Centers for Medicare and Medicaid Services (CMS) propose a requirement that 

ADOs be placed in each drug class where ADOs exist. Per the Medicare Prescription 

Drug Benefit Manual, CMS requires that formularies contain at least two drugs for 

each category/class, but ‘‘may require more than 2 drugs for particular categories 

or classes if additional drugs present unique and important therapeutic advantages 

in terms of safety and efficacy, and their absence from the sponsor’s formulary 

would substantially discourage enrollment by beneficiaries with certain disease 

states.’’ 

In addition to proposals to address prescription opioid abuse and misuse through 

CMS, we would also urge you to consider ways in which policies and programs at 

other federal agencies could be strengthened. In particular, you may wish to consider how the Food and Drug Administration’s regulatory authorities can be utilized 

to encourage health care providers to consider prescribing ADOs, as appropriate, before prescribing opioids without abuse-deterrent properties, and to not approve new 

opioids that lack meaningful abuse-deterrent properties, except under limited circumstances. 

We have recently seen strides made in the development of ADOs. Since 2010, four 

such products have been approved by FDA. And in April of this year, FDA issued 

final guidance establishing a pathway for the development of ADOs, clarifying the 

types of data required for abuse-deterrent labeling.3 In Pfizer’s view, the labeling 

of these opioid products should support and guide appropriate opioid prescribing. 

We appreciate FDA’s actions in 2013 mandating new labeling for extended-release/ 

long-acting (ER/LA) opioids. The changes clarified that these products should only 

be used for pain severe enough to require daily, around-the-clock, long-term opioid 

treatment for patients for whom other, lower-risk pain medications are inadequate. 

These critical labeling changes were an important first step to help ensure that proVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00093 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
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viders are fully aware of the risks posed by these products and, ultimately, they will 

help save lives. 

Yet currently, the labels of extended release opioids fail to provide guidance to physicians that opioids without abuse-deterrent properties should only be prescribed 

when an abuse-deterrent version is not available, or when an ADO is not appropriate for the patient. Similar to the new safety labeling mandated in 2013, such 

labeling could have a significant, positive impact on provider knowledge of ADO options and could help ensure that payors, including CMS, are providing access to 

ADOs. 

Additionally, Pfizer recommends that FDA not approve opioids or opioid formulations lacking meaningful abuse-deterrent properties unless the new medicine fulfills 

an unmet need or provides a unique therapeutic benefit. In fact, FDA should encourage and support, through the development of guidance documents, a transition 

of all opioid medications, both immediate release and extended release, toward 

abuse deterrence (since both IR and ER opioids formulations can be abused)—similar processes, guidances, and expectations to those currently in place for extended 

release opioids should be followed for IR opioids, when and where there is evidence 

that developing such technologies is feasible. 

Pfizer also recommends that FDA implement prominent labeling to distinguish between abuse-deterrent and non-abuse deterrent products, in order to inform patients, providers, and federal and private payers, and to encourage innovation. 

Please see the attached for Pfizer’s full comments to the docket for FDA’s October, 

2014, public workshop entitled, ‘‘Development and Regulation of Abuse-Deterrent 

Opioid Medications.’’ 

Finally, we would respectfully request that you consider ways to ensure a coordinated policy response to the role of ADOs in helping to address the prescription 

drug abuse epidemic across federal agencies, including CMS, CDC, the National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration. Pfizer would also welcome appropriate recognition and reference updates incorporating the important concepts outlined in the FDA final guidance on 

the evaluation and labeling of ADOs in policy guidance and educational documents 

addressing opioids. For example, CMS should acknowledge FDA’s final guidance establishing labeling standards for ADOs and levels of abuse deterrence in its 2017 

call letter and discuss the potential role of ADOs in reducing the growing problem 

associated with opioid misuse. Similarly, the NIH’s National Pain Strategy, the National Drug Control Strategy, and the Department of Health and Human Services 

recent initiative on opioid abuse should recognize the importance of ADOs as an 

emerging treatment option for clinicians and should integrate the concepts in FDA’s 

recent guidance into relevant clinical, policy and research objectives. 

Mr. Chairman, thank you again for the opportunity to submit testimony and for 

your efforts to address this critical public health threat. We look forward to working 

with you to turn the tide of this epidemic. 

PINNACLE TREATMENT CENTERS

U.S. Senate 

Committee on Finance 

Subcommittee on Health Care 

Field Hearing on Opiate Abuse in Southwestern Pennsylvania 

Allegheny General Hospital—Magovern Auditorium 

October 15, 2015 

Statement for the Record 

October 14, 2015 

The Honorable Pat Toomey 

Chairman 

U.S. Senate 

Committee on Finance 

Subcommittee on Health Care 

248 Russell Senate Office Building 

91 

1 ‘‘Confronting an Epidemic: The Case for Eliminating Barriers to Medication-Assisted Treatment of Heroin and Opioid Addiction,’’ Legal Action Center, March 2015. 

Washington, DC 20510 

The Honorable Debbie Stabenow 

Ranking Member 

U.S. Senate 

Committee on Finance 

Subcommittee on Health Care 

731 Hart Senate Office Building 

Washington, DC 20510 

Dear Chairman Toomey and Ranking Member Stabenow, 

I appreciate the opportunity to submit a statement for the record to this important 

hearing. 

I am Joe Pritchard, CEO of Pinnacle Treatment Centers. Pinnacle currently operates 29 treatment centers in Pennsylvania, Kentucky, Michigan, New Jersey, and 

Virginia. On behalf of the Opioid Treatment Program (OTP) Consortium, of which 

Pinnacle is a member, I would like to thank you for holding this important hearing 

today. The OTP Consortium is a group of over 300 opioid treatment centers located 

in 39 states. 

As you and your colleagues seek to address our nation’s growing opioid abuse epidemic, I want to express our strong opposition to S. 1455, The Recovery Enhancement for Addiction Treatment (TREAT) Act. 

OTP clinics provide comprehensive treatment to patients suffering from prescription 

opioid and heroin addiction via Medication-Assisted Treatment (MAT). MAT emphasizes patient-focused care in an individualized and integrated approach that includes counseling, behavioral therapies, drug testing, and the use of medication. 

OTP clinics are highly regulated by the states and federal government and have 

very low drug diversion rates. The National Institutes of Health (NIH) finds that 

our treatment protocols—which involve providing medications including methadone, 

buprenorphine and vivitrol, medical services, and psychosocial services including 

counseling for all patients—have ‘‘the highest probability of being the most effective 

of all treatments for opioid addiction.’’ 1

The TREAT Act seeks to remove the limit on the number of opioid addicted patients 

that a Drug Addiction Treatment Act (DATA) 2000-waivered physician can treat. 

Under current law, DATA 2000 physicians can treat 30 patients in the first year 

and apply for a waiver after the first year to treat up to 100 patients. These caps 

were put in place in exchange for the lax regulations governing the DATA 2000 program. In order to receive a DATA 2000 waiver, physicians only need to take an 8- 

hour online course, which focuses primarily on the medication (buprenorphine) that 

they would be allowed to prescribe to patients. DATA 2000 patients are not required 

to provide MAT. They are not required to provide counseling or behavioral therapy 

(or to refer it out), they are not required to administer random testing to determine 

illicit drug use or guide clinical decision making, they are not required to reference 

Prescription Drug Monitoring Program databases, and, as a result, most do not. Instead, DATA 2000 patients often receive a 30-day supply of buprenorphine and are 

told to return in another month or more for a refill. Prescribing more medication 

is not the answer and it certainly is not MAT. In our opinion, DATA 2000 practices 

that begin to exceed 100 patients become unregulated addiction treatment services, 

opening the door for poor practices to set back the gains achieved by highly regulated MAT services. 

Medications like methadone and buprenorphine help to stabilize the patient—that’s 

when the real work begins. These medications allow the patient to receive the treatment and services needed to address the underlying issues that led to their addiction in the first place. These patients need counseling and their providers need to 

be conducting random drug testing to help inform clinical decisions. Providers 

should be required to consult PDMP databases to prevent diversion. Seeing patients 

once per month and simply filling out a prescription once every 30–90 days will not 

address the opioid epidemic. That is why additional requirements should be placed 

on DATA 2000 physicians who want to treat more than 100 patients for opioid addiction. 

The OTP Consortium strongly recommends expanding access to treatment as a key 

component of addressing the opioid epidemic. However, there is no evidence to sugVerDate Mar 15 2010 20:20 Aug 23, 2016 Jkt 000000 PO 00000 Frm 00095 Fmt 6601 Sfmt 6621 R:\DOCS\21277.000 TIMD
92 

2 Jones, Campopiano, Baldwin, and McCance-Katz, ‘‘National and State Treatment Need and 

Capacity for Opioid Agonist Medication-Assisted Treatment,’’ American Journal of Public 

Health, June 2015, page e3. 3 Miller, T. and Hendrie, D. Substance Abuse Prevention Dollars and Cents: A Cost-Benefit 

Analysis. DHHS Pub. No. (SMA) 07–4298. Rockville, MD: Center for Substance Abuse Prevention, SAMHSA, 2008. 4 Jone et al., page 6. 

5 Ibid. 6 AK, AL, AZ, CA, CT, DE, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NH, NM, NV, NY, 

OH, OR, PA, UT, VA, VT, WA, and WI. 

gest that existing DATA 2000 physicians have reached their patient capacity. According to a June 2015 HHS study, through 2012, just 27.5% of DATA 2000 physicians had a waiver to prescribe to as many as 100 patients.2 If just one-quarter of 

DATA 2000 physicians have applied for and received a waiver to go beyond the initial 30-patient limit, it’s unlikely that lifting the cap will have an impact on access. 

Those who want to go above 100 are essentially drug treatment centers rather than 

a general medical practice and should be regulated as such to ensure their patients 

suffering from opioid addiction are receiving the evidence-based care they need. 

Worse yet, without regulation, these practices run the risk of becoming ‘‘pill mills.’’ 

Additionally, before considering whether to increase the DATA 2000 patient cap, 

Congress and HHS should seek information about the type of care being provided 

and patient outcomes in DATA 2000 practices. Specifically, Congress and HHS 

should measure: 

• The number of patients in treatment within each DATA 2000 practice relative 

to its cap; • Patient level outcomes and practice performance measures; • The percentage of practices offering counseling on-site; • The percentage of physicians referring patients for counseling and other services; and • The percentage of practices offering toxicology testing to guide therapeutic dosing and decision making and to avoid the widespread diversion of this drug in 

the general community. 

If the cap on DATA 2000 facilities were to be lifted, Congress and HHS should adopt 

patient safeguards and reforms that have proven to work in the OTP setting. Specifically, DATA 2000 practices should: 

• Conduct a minimum amount of counseling per patient, per month; • Employ prescription drug diversion control strategies; • Perform drug testing to make sure patients are taking their prescribed medications, are not using illicit drugs, and to guide treatment decisions (e.g., increase 

or decrease intensity); • Use Prescription Drug Monitoring Programs to ensure patients are not getting 

opiates elsewhere; and • Provide each patient with a comprehensive ASAM Patient Placement Assessment. 

These reforms would ensure that raising the cap does not result in significant unintended consequences like greater diversion, drug use, crime, and higher health care 

spending. Such reforms should be adopted through an open process that engages 

stakeholders before increasing the patient cap. 

At a minimum, these important patient protections should be added to the TREAT 

Act and apply to any waivered physician seeking to treat more than 100 patients. 

We strongly recommend that Congress and HHS expand and increase the availability of treatment to overcome the opiate epidemic via OTPs as OTPs are required 

to adopt and implement evidence-based MAT. In fact, one study found that those 

who receive MAT are 75% less likely to have an addiction-related death than those 

who do not receive MAT.3 A recent HHS report stated that increasing the number 

of OTPs would ‘‘help address treatment gaps’’ and that ‘‘OTPs are important . . . 

because they offer onsite medical care for those receiving methodone.’’ 4 The same 

report found that 82% of OTPs nationally operated at 80% capacity in 2012.5 Increasing OTP availability would truly increase access. Specifically, Congress should: 

• Expand Medicaid coverage of prescription drugs to treat opioid addiction. (Currently, just 28 states cover all three 6); • Allow Medicare to pay for methadone to treat opioid addiction; and • Enforce parity by requiring private insurance to provide methadone as a treatment option. 

93 

If Congress or HHS chooses to examine lifting the DATA 2000 patient cap, it should 

first reform DATA 2000 practices for the first time in 15 years to ensure that these 

physicians who seek a larger addiction practice are, at a minimum, providing counseling, employing anti-diversion programs, and conducting random drug testing. 

Thank you for your attention to this important matter. Again, the OTP Consortium 

and its 300+ treatment centers strongly opposes S. 1455 and instead strongly supports expanding access to treatment that has proven to be the most effective for decades—MAT. The Consortium looks forward to working with you to combat this 

crushing disease. 

Sincerely, 

Joe Pritchard 

CEO 

Pinnacle Treatment Centers 

Pittsburgh Tribune-Review 

OCTOBER 15, 2015 

Senate Health Care Subcommittee Explores Ways of Stopping Addiction 

(By Ben Schmitt) 

At 13, Ashley Potts popped her first OxyContin pill and immediately fell in love. 

Her life spiraled out of control as she became addicted, stole money, got arrested 

several times, got expelled from high school and graduated to crack cocaine. 

Although she made a pact with herself never to inject heroin, she was shooting up 

by 17. Heroin was much cheaper: $10 a bag instead of $80 for a street prescription 

pill. Potts found it much easier to obtain. 

‘‘I felt like a zombie, a hollow corpse,’’ she said. ‘‘In my head, there were only two 

options: Go to treatment and stop using or kill myself.’’ 

Potts, 29, of Washington told her story to a crowd of more than 300 people who 

packed Allegheny General Hospital’s Magovern Auditorium on Thursday for a Senate health care subcommittee field hearing on the national and regional heroin and 

opioid addiction crisis. U.S. Senator Pat Toomey, a Republican from Lehigh Valley, 

convened the hearing along with Senator Bob Casey, a Democrat from Scranton. 

She described herself as a full-on street junkie, who had cleaned up and relapsed 

several times by 2006 with a young daughter and not much hope. She contemplated 

suicide often but decided to try one more stint in detoxification and long-term treatment. 

Potts eventually got clean and went to college. She works as a team leader for the 

crisis diversion unit of Southwestern Pennsylvania Human Services. When she finished her story, the crowd heartily applauded. 

Still, Toomey, Casey and a panel of experts pointed out that while Potts’ tale inspires, there are many people of all ages, races and demographics losing their battles with heroin and painkillers such as OxyContin, Vicodin and Percocet at startling rates. 

Pennsylvanians are more likely to die from an opiate overdose than an auto accident, according to a report from the Trust for America’s Health and the Robert 

Wood Johnson Foundation. A contributing factor is the over-prescribing of addictive 

painkillers to seniors and others. The Government Accountability Office estimates 

170,000 Medicare beneficiaries nationwide may be battling addiction to pain medication, Toomey said. 

‘‘Ending the epidemic of heroin addiction will require changes in the practice of 

medicine, government regulation and societal views,’’ he said. 

As chairman of the Senate Committee on Finance Subcommittee on Health Care, 

Toomey described possible solutions as threefold: halting illegal diversion of prescription painkillers, reducing overuse of opioids for treating long-term pain and 

helping addicts receive proper treatment. He introduced bipartisan legislation to 

prevent inappropriate access to opioids and improve patient care for at-risk seniors. 

One of the panelists, Neil Capretto, medical director of Gateway Rehabilitation Center, testified that OxyContin, the brand name for oxycodone, is a morphine-like drug 

94 

that accelerated the opioid addiction problem in the region ‘‘at a level never seen 

before.’’ 

‘‘Of the several thousand heroin users that I have interviewed since 2000, well over 

90 percent told me they started with opioid pain pills,’’ he said. 

Dr. Jack Kabazie, system director of Allegheny Health Network’s Division of Pain 

Medicine, said Americans consume more opiate painkillers than the rest of the 

world combined. 

‘‘While most doctors prescribe opioids with good intents, once they move down that 

path, it is an extremely difficult path to reverse,’’ he said. ‘‘In addition, physicians 

who have compensation or employment tied to patient satisfaction scores may feel 

pressure to prescribe opioids in response to patient pain complaints.’’ 

As the hearing was underway, Drug Enforcement Administration officials told the 

Tribune-Review they plan to hire drug diversion investigators for their Pittsburgh 

office. The investigators plan to focus on rogue pharmacies and doctors who write 

prescriptions for narcotic painkillers without cause, said Special Agent in Charge 

Gary Tuttle, who in July was promoted to head the agency’s Philadelphia Field Division, which covers Pennsylvania and Delaware. 

The beginning of a statewide prescription-drug database will help DEA agents keep 

tabs on the distribution of prescription painkillers from doctors and pharmacies, 

Tuttle said. 

The DEA plans to combat the heroin and opiate drug problem through education, 

outreach and treatment, Tuttle said. 

‘‘I’m not saying we have a silver bullet,’’ he said. ‘‘But we have to move people away 

from use, from that disease.’’ 

Potts, the recovering heroin addict, said the large turnout at the hearing moved her 

but highlighted the devastation caused by opiate abuse. 

‘‘We’re not just statistics—we’re real live people,’’ she said. ‘‘The problem is astronomical. Every day I wake up grateful to be alive.’’ 

Dr. Tony Farah, chief medical officer for AHN, concurred. 

‘‘I think everyone saw today the passion and the interest in the audience not only 

from the medical professionals but from the lay audiences as well,’’ he said. ‘‘This 

really underscores the incredible need for people not only to be educated on this 

problem but also to understand the role that each of them can play in addressing 

this major issue.’’ 

Ben Schmitt is a staff writer for Trib Total Media. He can be reached at 412–320– 

7991 or bschmitt@tribweb.com. Staff writer Jason Cato contributed to this report. 

POSITIVE RECOVERY SOLUTIONS (PRS) 

730 Brookline Blvd 

Pittsburgh, PA 15226 

Office (412) 207–8874 

Fax (412) 892–9404 

October 7, 2015 

The Honorable Pat Toomey 

Chairman 

U.S. Senate 

Committee on Finance 

Subcommittee on Health Care 

248 Russell Senate Office Building 

Washington, DC 20510 

The Honorable Debbie Stabenow 

Ranking Member 

U.S. Senate 

Committee on Finance 

Subcommittee on Health Care 

731 Hart Senate Office Building 

Washington, DC 20510 

Dear Chairman Toomey and Ranking Member Stabenow, 

95 

Good afternoon. I would like to thank you for giving me the opportunity to speak 

to you on behalf of Positive Recovery Solutions (PRS). My name is Amanda Cope. 

I am a registered nurse and have developed my career to specialize in addiction 

medicine. I celebrated 9 years sober on May 6th. Addiction medicine has been a passion for me since starting my own journey on the road to recovery. I am so grateful 

to be a part of this process to reach those in need of help. I have always strived 

to be an example of sobriety to each of our patients at PRS. 

PRS is a private physician group dedicated to helping those with alcohol and opiate 

dependence. We have two physical locations, one in Pittsburgh, PA and one in 

Washington, PA. We started out as a suboxone clinic dedicated to helping those suffering from opiate addiction. Through our expansion over the past 20 months we 

have incorporated Vivitrol to help battle the horrific epidemic of heroin overdose 

that is taking place in Pennsylvania. We are on the front lines of this battle and 

work diligently to reach as many underserved populations as possible. Through our 

suboxone treatment we set into place practices and policies that reduce the rate of 

diversion and misuse of the medication. Patients are required to have weekly office 

appointments where they are urine drug screened at each appointment and given 

a 7 day prescription. The patient will be seen weekly for a minimum of 12 weeks 

until they have reached 12 consecutive clean urine drug screens. Patients are required to provided monthly verification from their behavioral entities that they are 

compliant with their drug and alcohol counseling sessions. We stand firmly on the 

belief that medication alone is not the answer. We also are an insurance based clinic. We do not charge patients cash for their office visits. We have a maxium dose 

of 16 mg per day of suboxone. After a patient has reached 12 consecutive clean urine 

drug screens they may then graduate to a biweekly program at the physicians discretion. Month long prescriptions are not given at PRS. Patients are not discharged 

for positive urine drug screens. PRS makes every possible attempt to get the patient 

the appropriate level of care. If a patient has 3 positive UDS they will be recommended to receive drug and alcohol counseling at a higher level. We will elevate 

a patients level of care all the way back into inpatient rehabilitation in an effort 

not to discharge. We employ every means possible to keep a patient active in treatment and on the road to recovery. 

Approximately 1 year ago I had a meeting with a Vivitrol representative named Joanne Kommer. Joanne explained the Vivitrol medication to me and its valuable use 

in the fight against opiate dependence. PRS immediately incorporated Vivitrol treatment into our practice. We were very excited in the complete abstinence model that 

it supported. The success stories from people that were already on Vivitrol was a 

cause of great excitement for us. We added PRS onto the provider locater website 

for Vivitrol and that is where the idea for a mobile Vivitrol unit formed. Through 

our addition to the provider locater site one thing became rapidly clear to us. Patients were traveling from very far distances in order to be followed on the medication. Sometimes as far as 4 hours away. We quickly realized that providers were 

either unable or unwilling to provide follow-up care for these patients. A lot of patients were induced in an inpatient setting then could not follow up with their 

monthly injections due to lack of providers or the providers that would do the 

follow-up care would charge a large cash amount to receive their injection. We immediately started researching our idea of a mobile unit. PRS had meetings with 

local SCA in surrounding counties to establish that they did in fact have a need in 

their community. Specifically Kami Anderson of Indiana, Armstrong, and Clarion 

and Judy Rosser of Blair county. These ladies were pivotal in the formation of our 

pilot program. As mentioned earlier, PRS believes firmly that patients need the 

whole picture of recovery, not just medication. It is with that philosophy that we 

have created relationships with local behavioral health entities in order to give the 

patient the best chance of recovery. Gateway rehab, Cove forge, Pyramid, The Open 

Door, Arc Manor, Blairdap are just a few of the entities that we work with to provide the patient the appropriate level of care. Our program is designed that when 

a patient is referred to our services they must consent to allow open lines of communication between PRS and the behavioral health entity. PRS is strictly the medical 

aspect of treatment. We do not provide drug and alcohol counseling. With that in 

mind, that is why our program is so enticing to programs that have no ability to 

provide medication assisted therapy. We work together to complete the picture of 

a successful road to recovery. 

Our mobile unit launched the first week of July 2015 and has been a success from 

day one. Our mobile unit functions in the exact fashion as our brick and mortar locations. The unit is equipped with a private waiting area, a restroom for urine specimen collection, a private assessment room, and a private injection room. We have 

96 

contracted with Blair, Indiana, Clarion, and Armstong counties to be able to provide 

services to unfunded patients. Once a patient has flipped to Medicaid coverage we 

then bill the appropriate insurance. Of the 67 counties in Pennsylvania, 37 of those 

have expressed interest in having our services made available to them. More will 

be revealed when the budget is passed. PRS had the capability and intention to provide services to the entire state of Pennsylvania. We have applied to programs such 

as ‘‘Pay for success’’ and up to this point have been privately funded for the purchase of the mobile unit. We look forward to expand and service as much as the 

patient population as possible. 

Current challenges to our program include the Prior authorization process. We have 

attended meetings in Harrisburg with Secretary Tennis and Secretary Dallas who 

are working with us to make this mobile unit a success. Currently we are trying 

to have an agreement similar to the one with the Department of Corrections where 

we can get a verbal authorization and bypass the faxing of documents which then 

leads to a wait from anywhere between 24 hours to 3 weeks. Our desire to get these 

patients safe as soon as possible relies on the ability to be able to administer the 

medication as soon as the treatment team deems it to be medically appropriate. Our 

unit is currently available to each county on a biweekly schedule. The first appointment will include their ‘‘New patient assessment’’ where we do a complete drug history, past medical history, medication check, UDS, confirmation of drug and alcohol 

counseling and other pertinent information is obtained. PRS would like the ability 

to give the injection at the first assessment when medically appropriate. We continue to work on a daily basis to find new ways to help stop the devastating effects 

of overdoses in our communities. We appreciate immensely your interest in learning 

about our innovative program. Together we can help stop this horrific epidemic and 

assist in bringing back together families, loved ones and communities. I thank you 

for your time today. God Bless. 

Amanda Cope, RN 

Positive Recovery Solutions 

WESTERN PSYCHIATRIC INSTITUTE AND CLINIC OF THE

UNIVERSITY OF PITTSBURGH MEDICAL CENTER

ADDICTION MEDICINE SERVICES

Oxford Building, Suite 900 

3501 Forbes Avenue 

Pittsburgh, PA 15213 T 412–246–5910 

F 412–246–5858 

October 12, 2015 

U.S. Senator Pat Toomey 

248 Russell Senate Office Building 

Washington, DC 20510 

Dear Senator Toomey: 

We appreciate your legislative efforts to address the problem of prescription opioid 

addiction, which is a significant issue in western Pennsylvania as well as other 

areas of the U.S. We are writing to share our ideas as we both have worked in the 

field of addiction treatment and research for several decades and have seen firsthand the havoc that opioid addiction creates for affected individuals, families, and 

society. Here are some of our thoughts about this problem and potential solutions 

from the perspectives of education and treatment. 

The U.S. Attorney in Pittsburgh published a final report and recommendations on 

prevention, intervention, treatment, and recovery related to drug overdose and addiction (September 29, 2014). Dr. Douaihy served on the committee that generated 

this report. 

Key elements of this report that we believe are relevant to what you wish to accomplish with your legislation include: 

1. Education, prevention and family intervention: 

a. Develop a public awareness and education plan to reduce overdose deaths. 

b. Coordinate websites containing information on overdose prevention and links 

to recovery-based resources. 

c. Assure access to and promote a regional hotline dedicated to OD prevention. 

97 

d. Promote physician education and intervention programs. 

e. Educate buprenorphine providers on the best practice guidelines (Community 

Care Behavioral Organization in PA published excellent guidelines on ‘‘best 

practices’’ for treatment of opioid addiction). 

2. Treatment: 

a. Promote efforts to increase the availability of naloxone in the community as 

a safe antidote to opioid overdose. 

b. Support Good Samaritan Laws and Prescription Drug Monitoring Programs. 

c. Support measures to increase capacity for treatment of addiction. 

d. Implement screening and referral interventions for early identification of 

drug problems (e.g., in medical settings). 

Treatment needs to be long-term since opioid addiction is a chronic condition. Presently, many treatment resources focus on the acute phase of illness (detoxification, 

rehabilitation, intensive outpatient) and not on long-term or ‘‘continuation’’ treatment. 

Recovery from addiction must be emphasized as this is the best antidote for relapse. 

Engagement in community mutual support programs helps many sustain long-term 

recovery. Treatment can help prepare an individual for recovery, but is not a replacement for it. 

Family involvement in treatment and recovery needs to be emphasized. Many treatment programs DO NOT include families or offer services to them. There is a significant research and clinical literature documenting the adverse impact of opioid 

addiction on family units and individual members, including children. Addiction 

contributes to higher rates of family break-up, abuse and neglect, dependence on 

welfare, and involvement in criminal justice and other social services. Addiction creates a huge emotional and financial burden for families who spend an incredible 

amount of time, energy and money on their addicted loved one. Children of opioid 

addicted parents are at higher risk for psychiatric and substance use disorders, behavior problems, and academic problems. 

Addressing addiction requires considering multiple perspectives. We wish you well 

in your attempts to help addicted individuals, families and communities. 

Sincerely, 

Dennis C. Daley, Ph.D. Antoine Douaihy, M.D. 

Professor of Psychiatry and Social Work Professor of Psychiatry 

Director, Regional Research and Medical Director 

Training Center of Clinical Trials Addiction Medicine Services 

Network of the National Institute 

on Drug Abuse 

LETTER SUBMITTED BY KEVIN M. WONG, M.D., CMD, FAAFP 

October 14, 2015 

The Honorable Pat Toomey 

Chairman 

U.S. Senate 

Committee on Finance 

Subcommittee on Health Care 

248 Russell Senate Office Building 

Washington, DC 20510 

The Honorable Debbie Stabenow 

Ranking Member 

U.S. Senate 

Committee on Finance 

Subcommittee on Health Care 

731 Hart Senate Office Building 

Washington, DC 20510 

Dear Chairman Toomey and Ranking Member Stabenow, 

S. 1913—Stopping Medication Abuse and Protecting Seniors Act of 2015 is 

a laudable effort to help reduce the narcotic abuse. As a practicing family physician 

98 

for over 33 years, I have always tried to treat patients to the best of my ability following the adage, ‘‘First do no harm.’’ Even with clinical indications for appropriate 

use of long term narcotics and prescribing, an experienced clinician will eventually 

be ‘‘beaten’’ by a patient seeking narcotics for inappropriate reasons. If we don’t prescribe to some of these patients because they don’t fit the typical pattern, we will 

inadequately treat someone who has a true medical need. 

A few years ago, I had an 80 year old frail female patient with documented severe 

arthritis who had been on a stable regimen of long acting narcotics for her chronic 

pain. I never suspected that she might be diverting her medications and was greatly 

surprised to receive a call from the pharmacist saying, ‘‘we have a problem!’’ When 

we filled Mrs. T’s prescription today, she stood at our counter, made us count out 

the tablets, stating she had been shorted last month. After she was satisfied the 

count was correct, the bottle was placed in a bag and she left. As soon she walked 

out to the parking lot, we saw her on our security camera hand the same bag to 

a man, who handed her cash, which she held up in the sunlight to count each bill 

(she had poor eye sight). The pharmacist said they wouldn’t report her if she didn’t 

show up there again! When I called her family to tell them I would not be prescribing her narcotics anymore, they were livid, claiming I was abandoning her. 

After I explained she would not be withdrawing from narcotics, since she handed 

over her entire amount, they calmed down. After that, she transferred to another 

physician and I eventually found out she continued to get narcotics, until I happened to see that physician and he mentioned her name, saying she came to see 

him as I had been too busy. After I told him the story, he stopped writing the prescription and she moved onto another doctor. 

This bill would eliminate this specific scenario. However there are many more reasons it needs to pass. Even with the current guidelines proposed by organizations 

to help physicians (American Academy of Family Physicians, American Academy of 

Pain Medicine, AMA, CDC) without support from the federal and state agencies, the 

problem of narcotic abuse will continue to grow as witnessed by the current trends. 

State-based Prescription Drug Monitoring Programs (PDMPs) have been successful 

in aiding physicians decrease narcotic diversion, however the programs are NOT 

fully functional in all states (currently 49 states, District of Columbia, and Guam). 

Even in states where PDMPs have been created, they are NOT all helpful to physicians—Pennsylvania is a perfect example. The registry is currently accessible only 

to law enforcement. Many states have been happy with the PDMPs, but the next 

step requires federal help—link all the state PDMPs to prevent migration from state 

to neighboring states that either don’t have a physician accessible database or don’t 

share data. 

Other significant improvements for PDMPs: 

(1) Require the data be reported by the pharmacist, live to ensure the patient 

didn’t get a narcotic recently from another physician and report it to BOTH 

physicians, if a concern is discovered, BEFORE filling the prescription. 

(2) Require photo IDs for anyone prescribed and picking up a narcotic prescription. 

Physicians who are trying to do the best for their patients need as much support 

as possible. Family doctors find it very hard to follow these appropriate guidelines 

when they are constantly held to a different standard of care compared to pain clinics who will prescribe narcotics and tranquilizers concurrently, even though there 

is strong evidence against concurrent use of this combination of medications which 

can lead to fatalities. 

The good news is that there is some preliminary evidence that an insurer in western 

Pennsylvania trying to aid physicians care for their Medicare patients has found 

that only 0.13% (∼200/150,000) for the first 2 Quarters of this year hit the high dose 

narcotic threshold. It is hoped with further measures as outlined previously to minimize inappropriate use and diversion, this number can continue to drop. 

Thank you for your efforts to protect our vulnerable patients and help doctors care 

for them appropriately. 

Kevin M. Wong, M.D., CMD, FAAFP 

Past President, Pennsylvania Academy of Family Physicians 

99 

Resources: 

http://www.aafp.org/news/health-of-the-public/20150408hhsopioids.html 

http://www.aafp.org/news/health-of-the-public/20150408hhsopioids.html 

http://www.ama-assn.org/ama/pub/advocacy/topics/preventing-opioid-abuse/ 

opioid-abuse-task-force.page 

http://www.pdmpassist.org/content/prescription-drug-monitoring-frequently-askedquestions-faq 

http://www.aafp.org/news/health-of-the-public/20150729opioidtaskforce.html 

http://www.cdc.gov/drugoverdose/prescribing/guideline.html 

http://www.aafp.org/news/health-of-the-public/20150128nihopioidstudy.html 

Æ