[Senate Hearing 115-782]
[From the U.S. Government Publishing Office]
S. Hrg. 115-782
THE OPIOID CRISIS:
THE ROLE OF TECHNOLOGY
AND DATA IN PREVENTING
AND TREATING ADDICTION
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING THE OPIOID CRISIS, FOCUSING ON THE ROLE OF TECHNOLOGY AND
DATA IN PREVENTING AND TREATING ADDICTION
__________
FEBRUARY 27, 2018
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky MICHAEL F. BENNET, Colorado
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
TODD YOUNG, Indiana ELIZABETH WARREN, Massachusetts
ORRIN G. HATCH, Utah TIM KAINE, Virginia
PAT ROBERTS, Kansas MAGGIE HASSAN, New Hampshire
LISA MURKOWSKI, Alaska TINA SMITH, Minnesota
TIM SCOTT, South Carolina DOUG JONES, Alabama
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Democratic Staff Director
John Righter, Democratic Deputy Staff Director
C O N T E N T S
----------
STATEMENTS
TUESDAY, FEBRUARY 27, 2018
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State
of Washington, Opening statement............................... 3
Witnesses
Mahon, Snezana, Pharm.D., Vice President, Clinical Product
Development, Express Scripts, St. Louis, MO.................... 5
Prepared statement........................................... 7
Summary statement............................................ 11
Green, Sherry L., J.D., Chief Executive Officer, Sherry L. Green
& Associations, LLC, Co-founder, National Alliance for Model
State Drug Laws, Sante Fe, NM.................................. 12
Prepared statement........................................... 13
Summary statement............................................ 14
Clark, H. Westley, M.D., J.D., M.P.H., Dean's Executive
Professor, Public Health Program, Santa Clara University, Santa
Clara, CA...................................................... 15
Prepared statement........................................... 17
Summary statement............................................ 23
Shah, Sanket J., Clinical Assistant Professor, Health
Informatics, University of Illinois at Chicago, Hinsdale, IL... 24
Prepared statement........................................... 26
Summary statement............................................ 27
THE OPIOID CRISIS:
THE ROLE OF TECHNOLOGY
AND DATA IN PREVENTING
AND TREATING ADDICTION
----------
Tuesday, February 27, 2018
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:07 a.m. in
room SD-430, Dirksen Senate Office Building, Hon. Lamar
Alexander, presiding.
Present: Senators Alexander [presiding], Isakson, Cassidy,
Young, Roberts, Murray, Casey, Bennet, Murphy, Warren, Hassan,
Kaine, and Smith.
OPENING STATEMENT OF SENATOR ALEXANDER
The Chairman. Good morning. The Senate Committee on Health,
Education, Labor, and Pensions will please come to order.
This is the fifth in a series of hearings this Congress has
had on the opioid crisis to date.
Today, we are looking at the role data and technology can
play in combating the opioid crisis. The Committee plans to
hold a mark-up on legislation to address opioids as soon as the
end of March.
We are getting a number of good ideas from all directions.
We had a meeting yesterday with Governors, and more than 30
Senators attended to hear their thoughts. We will have a
hearing with Governors in another week or 10 days to formally
receive many of their thoughts.
Like many doctors, Johns Hopkins surgeon, Martin Makary,
was taught to prescribe opioids for patients during medical
school and, quote, ``Gave out opioids like candy. My colleagues
and I were unaware that about 1 in 16 patients became chronic
users.''
After seeing his own father recover from gallbladder
surgery with a single Ibuprofen tablet, Dr. Makary realized the
extent to which the medical community had been over prescribing
opioid painkillers.
Data and technology can help identify these intentional or
unintentional actions so that behaviors can be improved.
For example, Dr. Makary said, quote, ``My colleagues at
Johns Hopkins and I have used data to identify the average
number of opioids a doctor prescribes after a routine C-
section. The range of doctors' prescribing patterns is
stunning. Some doctors average 3 to 10 opioid tablets after a
C-section, while other doctors still average 30 or 60.''
As we have examined this crisis over the last 5 months, we
have learned that strong local communities are key to finding
solutions, and Washington's role is usually to support those
efforts and create an environment for success.
When we look at what the Federal Government can do, sharing
more data and utilizing new technologies may be the most
helpful thing we can do. Data can paint a more complete picture
of the opioid crisis, for example, revealing which communities
are seeing a spike in prescriptions such as a West Virginia
town of 3,191 people that saw 20.8 million painkillers shipped
to its two pharmacies for over a decade.
Helping doctors avoid prescribing opioids to someone
recovering from addiction; we have suggested that in Jessie's
Law, which the Senate passed last year. We can make it easier
for doctors to be alerted to a patient's opioid abuse history,
and recording the last time someone who overdosed had filled a
prescription by checking health records and the prescription
drug monitoring system.
Tennessee has found that less than 50 percent of people who
died from an overdose in 2017 had filled a prescription in the
prior 60 days, suggesting that more people dying from an
overdose are buying heroin or fentanyl illegally.
Quality data gives everyone the ability to make informed
decisions about how best to address the opioid crisis.
For state and local governments, it means having
Prescription Drug Monitoring Programs, or PDMP's, that are easy
to use. PDMP's are data bases that nearly every state uses to
track controlled substance prescriptions so state officials can
see what is happening at the community level, and doctors and
pharmacists can check a patient's history with controlled
substances before writing or filling a prescription.
For Tennessee, this has proved to be an invaluable tool.
Between 2015 and 2017, the number of prescriptions written for
opioids has decreased by 14 percent. The Tennessee Department
of Health attributes these decreases to doctors and pharmacists
using a PDMP more. However, in our state of 6.6 million people,
there were still 7.6 million opioid prescriptions written in
2016.
For individual doctors, nurses, and patients, data can mean
helping prevent more people from sliding down the slope of
addiction.
As we consider new legislation, I want to hear specific
suggestions about how the Federal Government can help states
and local communities take full advantage of the amazing
potential that technology has to offer in solving the opioid
crisis.
Then there are prescription drug monitoring programs.
Questions we have about those include the Federal Government
preventing states from using the PDMP's in ways they think
would best help their communities, as well as other questions.
E-prescribing, while we do not want to mandate burdensome
rules for doctors to follow, how can we encourage doctors to
prescribe medications, especially controlled substances,
electronically wherever possible?
Then, predicting problems and avoiding them. In the private
sector, healthcare companies like clearinghouses, hospitals,
and insurance companies have a lot of data, and these
businesses use that data to their advantage to make
improvements in their businesses.
I would like to hear about how the Federal Government can
start using all the data it collects to identify and prevent
over prescribing before it leads to addiction and overdoes.
Finally, privacy. New technology and more data can be
useful tools, but we have to consider everyone's privacy and
there is a lot at stake.
Addiction can impact every aspect of a person's life from
their ability to find a job, and housing, and keeping custody
of their child. So we need to ensure that whatever action we
take, privacy is protected.
Senator Murray.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman.
Last week, I was home in Washington State, and I heard
firsthand from families and communities who are facing this
epidemic. I heard from a young man who ended up in foster care
because his parents struggled with drug use and mental health
issues.
I heard from a mother who felt helpless as her son
experienced addiction. He sought help. He struggled with
relapse and tragically died of an opioid overdose.
I heard from another young parent whose children were taken
away because she was unable to overcome her addiction.
I heard from an elementary school principal, whose students
should be learning to read and write, should be running around
full of energy and excitement, but are, instead, struggling to
focus at school because of the trauma of their parents'
addiction at home.
On a previous trip to a hospital in Longview, Washington, I
heard how half--half--of the babies there were born to mothers
addicted to opioids.
Just as I have been listening to voices back in Washington
State, this Committee has been listening here in Washington, DC
and learning more about what our communities need to fight this
national epidemic.
I am very grateful to all of our witnesses today for adding
your voices to this discussion.
Technology and data offer important opportunities to
address the opioid crisis, to prevent addition, and avoid the
tragedy so many families are facing.
While we can see the promise of this approach through
efforts, such as Prescription Drug Monitoring Programs, which
almost every state has established, there is a lot more we can
do.
These electronic data bases, which keep track of
prescriptions for controlled substances, can be a great
resource to fight opioid misuse. However, Big Data, by itself,
does not guarantee a big impact. We need to use that data
creatively, protecting the privacy of patients while finding
innovative ways to protect their safety and health. Some states
are pioneering ways to make that happen.
For example, some states require doctors to check the data
base so they are aware of a patient's existing prescriptions
before they write new ones. States that require this saw a drop
in opioid prescriptions, drug-related hospitalizations, and
overdose deaths.
Others have built-in systems that alert doctors of alarming
patterns or signs that a patient may be at-risk of drug misuse.
Others have made PDMP's easier to access and use by integrating
them with Electronic Health Records.
Still, while many states are looking at new ways to put
their data to good use, there is also important data that many
still cannot use, like the data collected by their neighboring
states. Too many of the PDMP systems are not sufficiently
interoperable, and that means they are not sharing data and
working effectively with each other.
As a result, the prescription a patient receives in one
state may not show up in the system of another state. Two
doctors in different states may not see they are writing
prescriptions for the same patient. They may not have the data
to see a pattern of substance misuse or to prevent one from
developing.
We need more states to move toward an interoperable PDMP
system so that we can put the pieces together and give doctors
a full picture of a patient's prescription history.
It is not just states that have to understand the role that
technology and data can play in addressing this epidemic.
Pharmacies, prescribers, patients, all stakeholders have to
take a look at how advances can help prevent and address opioid
misuse, whether through more responsible prescribing based on
risk factors, safe disposal of controlled substances, or safety
checks by pharmacists when they dispense.
We must also be mindful of the importance of patient
privacy; data has to be easy to use, but hard to misuse. People
dealing with addiction already face stigma and may fear
speaking out or seeking help. We have to ensure that our data
practices and protocols do not create new risks or fears that a
patient's most private battles might be made public against
their wishes.
Striking that balance is not an easy task, but it is an
important one. We have made great progress so far in striking
difficult balances in responding to this crisis with bipartisan
solutions.
I am hopeful that through conversations like the one we are
having today, we can continue that bipartisan progress as we
look at how technology can empower partners fighting this
crisis at every level, from Federal, state, and local
governments, to healthcare providers, to educators, to public
safety officials, and to families like the ones I meet in
Washington State.
I look forward to hearing from all of our witnesses today,
and learning more from your expertise and experience.
Mr. Chairman, I very much look forward to our continued
work together, and with many Senators to find and move forward
key legislative solutions to the challenges we face fighting
this crisis.
The Chairman. Thank you, Senator Murray.
Thanks for your cooperation, and that of your healthcare
staff and others, for working on the bipartisan legislation we
hope to mark-up soon.
I am pleased to welcome our four witnesses. I thank each of
you for being here.
The first witness we will hear from is Snezana Mahon. Ms.
Mahon serves as the Vice President of Clinical Product
Development at Express Scripts.
In this role, she oversees the company's clinical
initiatives and utilization management programs that aim to
make the use of prescription medicine safer, more affordable,
and more accessible for both patients and payers.
Prior to this role, she served as the Senior Director of
Medicare Strategy at Express Scripts, providing guidance to
Medicare Advantage and Part D plans.
Next, is Ms. Sherry Green. She has 24 years of experience
in developing opioid and other drug abuse-related policies. She
draws on this expertise to consult state legislators and
healthcare professionals on strategies to prevent opioid abuse.
She is the co-founder of the National Alliance for Model
State Drug Laws where she served as the Chief Executive Officer
for 20 years.
Next, is Dr. Westley Clark. He serves as the Dean's
Executive Professor of Public Health at Santa Clara University
in California.
Previously, Dr. Clark served as Director of the Center for
Substance Abuse Treatment at the Substance Abuse and Mental
Health Services Administration, which we call SAMHSA. He led
the agency's effort to provide individuals with addictive
disorders effective and accessible treatments.
He has also been Chief of the Associated Substance Abuse
programs at the U.S. Department of Veterans Affairs Medical
Center in San Francisco and Associate Clinical Professional in
the Department of Psychiatry at the University of California at
San Francisco.
Last, we will hear from Mr. Sanket Shah. Mr. Shah is a
Clinical Assistant Professor of Health Informatics in the
Department of Biomedical and Health Information Sciences at the
University of Illinois at Chicago.
Mr. Shah has developed course curricula focused on
healthcare business intelligence, healthcare data, knowledge
management, and consumer informatics. He is also Director at
Blue Health Intelligence, an independent licensee of the Blue
Cross Blue Shield Association and home to one of the Nation's
largest commercial healthcare data bases of medical and
pharmacy claims.
Welcome, again, to our witnesses.
Ms. Mahon, we will hear from you to begin.
STATEMENT OF SNEZANA MAHON, PHARM.D., VICE PRESIDENT, CLINICAL
PRODUCT DEVELOPMENT, EXPRESS SCRIPTS, ST. LOUIS, MISSOURI
Dr. Mahon. Good morning, Chairman Alexander, Ranking Member
Murray, and Members of the Committee.
I am Snezana Mahon. I am the Vice President of Clinical
Product Development at Express Scripts.
It is an honor to come before the Committee today to
discuss the solutions that can address the opioid epidemic that
is not only devastating our healthcare system, but also
splintering American families. I applaud the Committee's
attention to this crisis.
I am a registered pharmacist and received my Doctorate of
Pharmacy from the St. Louis College of Pharmacy. Before joining
Express Scripts, I practiced in the retail pharmacy setting for
7 years. Now, I lead a clinical product organization that is
responsible for focusing on systematic programs and changes
that can address this crisis on a broader scale.
Express Scripts is the Nation's largest standalone Pharmacy
Benefit Manager. We manage the pharmacy benefit for more than
80 million Americans. I want to leave the Committee today three
figures and three ideas. I will tackle the figures first.
Sixty percent; that is the amount our program has reduced
the average day supply of first-time opioid users.
Eighty-seven percent of new prescriptions initially written
for a long-acting opioid were subsequently filled for a short-
acting opioid.
Ninety-six percent of initially written prescriptions for a
longer day supply were rewritten and filled for a 7-day supply.
How did we achieve these results?
First, pharmacies and pharmacists are frequently not aware
of other medications patients may be taking. At the pharmacy
counter, we leveraged several utilization management
strategies.
We have instituted a 7-day limit for first-time opioid
users. We also implemented morphine equivalent dose
interventions on new and current users in line with the CDC
guidelines, as well as we preferred a short-acting opioid
before a long-acting one.
Second, our program also engages patients by educating them
about the risks before it occurs, and sending them educational
letters in their home after their first fill.
If the patient continues to refill their prescription, we
have a specialized pharmacist reach out to the patient and talk
to them about the risks of overuse and abuse, and we also give
them instructions on proper safe disposal.
We directly provide patients with a drug deactivation
disposal bag that enables them to safely dispose of their
unused medications.
Third, for prescribers, we focused on making information
more readily available to them. Similar to pharmacies, the
average prescriber is not always aware of prescriptions their
patients are taking from other prescribers.
We alert the provider via the Electronic Health Record, or
fax, or letter on the potential of misuse and abuse, as well as
the member's morphine equivalent dose, so the prescriber has a
more complete picture of the patient's entire history.
So far, our data suggests that the program is working.
However, we continue to develop new strategies and implement
new best practices. As a result of our program, we are now
launching additional point of sale interventions regarding
fentanyl.
We also are recommending the addition of Naloxone for
patients via Electronic Health Record, as well as a fax or a
letter to the provider for certain individuals. And finally, we
are educating providers on their prescribing pattern by
comparing them to their peers, as well as communicating with
them to encourage more conservative opioid prescribing.
These private sector efforts could be accelerated by
policies that support safe opioid utilization. The first is
electronic prescribing. Currently, increasing numbers of states
now require its use for these medications.
Encouraging e-prescribing controlled substances would
restrict pharmacy shopping, enable better prescription
tracking, as well as reducing fraud, waste, and abuse.
Express Scripts supports H.R. 3528, the Every Prescription
Conveyed Securely Act, which would move Medicare to a system of
e-prescribing for opioids.
We also support requiring a 7-day fill for initial opioid
prescriptions with exceptions for hospice, cancer, and
palliative care.
The S. 892 Opioid Addiction Prevention Act introduced by
Senators Gillibrand and McCain would be a positive step forward
in preventing addiction before it begins.
The final policy recommendation is one we would continue to
recommend the Committee avoid is mandating coverage of so-
called abuse deterrent opioids.
Manufacturers have been developing and selling these novel
approaches with a goal of making their products less
susceptible to abuse. Unfortunately, abuse deterrent is not the
same as abuse proof.
Mandating the coverage of abuse deterrent opioids is a
flawed approach and the FDA acknowledges that these products
are not abuse proof. We do not want prescribers or patients to
believe that these products are less addictive and cause over-
utilization patterns to continue.
Again, thank you for the incredible opportunity to present
Express Scripts' data-driven solutions today as we continue to
lead the industry in developing strategies to prevent
addiction.
[The prepared of Dr. Mahon follows:]
prepared statement of snezana mahon
Good morning Chairman Alexander, Ranking Member Murray, and Members
of the Committee. My name is Snezana Mahon and I am the Vice President
of Clinical Product Development for Express Scripts. It is an honor to
come before the Committee today to discuss solutions that can address
an epidemic that is not only devastating our health care system but
also splintering American families: opioid addiction. I applaud the
Committee's attention to this crisis, having already held two hearings
this year following two other hearings last fall, and I am honored that
you asked me before the Committee today to share what Express Scripts
is doing to address opioid addiction--namely, developing and offering
new tools aimed at preventing addiction from starting even before a
patient picks up their first opioid prescription at the pharmacy
counter.
About Express Scripts
Headquartered in St. Louis, Express Scripts is the Nation's largest
stand-alone pharmacy benefit manager (PBM). We manage the pharmacy
benefits for more than 80 million Americans, including those in health
plans, union-sponsored plans, state employee health plans, and public
purchasers, including TRICARE, Medicare Part D, and Medicaid. Our
services include providing network-pharmacy claims processing, home
delivery pharmacy care, specialty pharmacy care, benefit-design
consultation, drug utilization review, formulary management, and
medical and drug data analysis services.
Because Express Scripts interacts with patients, pharmacies,
prescribers, and payers, our company is uniquely situated to collect
data when patients receive and fill a prescription for an opioid under
their pharmacy benefit. We can leverage that data across the care
continuum in order to design interventions aimed at preventing opioid
addiction from beginning in the first place. With 2 million Americans
addicted to prescription narcotics, and more than 1,000 people treated
daily in emergency departments for misusing prescription opioids, this
is a $53 billion public health crisis.
Our Advanced Opioid Management Program
To test out how we could help minimize early opioid exposure and
prevent progression to overuse and abuse, we started with a pilot in
2016. In a study of just more than 100,000 Express Scripts members new
to opioid therapy, we observed a 38 percent reduction in
hospitalizations and 40 percent reduction in emergency room (ER) visits
in the intervention group versus control group during 6 months of
follow-up. Half of the members received an educational letter from the
Express Scripts Neuroscience Therapeutic Resource Center (TRC) and half
no intervention at all. A subset of those receiving the TRC educational
letter who had high-risk patterns of opioid use also received a
counseling call from a Neuroscience TRC specialized pharmacist. Among
this subset, we observed a 19 percent decrease in the days' supply of
opioid dispensing during 6 months of follow-up. Most importantly,
patients got the medicine they needed while we helped prevent
unnecessary refills that could put patients at risk of harm.
With such success, we expanded the program as an offering to our
clients more broadly. This past September, Express Scripts launched our
comprehensive Advanced Opioid Management (AOM) solution focused on
opioid abuse education and prevention. This product was developed by
leveraging our substantial healthcare data analytics capabilities and
works across the full prescription drug continuum: from providing new
tools for physicians at the point of care, patient education and
outreach--including safe disposal of unused opioids--to safety checks
for dispensing pharmacies.
More specifically:
Engaging Prescribers----
A prescription from a physician or other prescriber remains the
only lawful means for a patient to receive an opioid from a pharmacy.
These clinicians are not always aware of prescriptions from other
prescribers that their patients are taking. Nor are they necessarily
aware of CDC recommendations to start short acting opioid therapy
before advancing to longer acting forms.
The AOM solution delivers automated messages at the
provider point of care via Electronic Health Record (EHR) on potential
misuse and abuse, along with morphine equivalent dose (MED)
communications to ensure prescribers have a more complete picture of
their patient's history;
Enhanced Prior Authorization is applied to long-acting
opioid prescriptions for patients without such drugs existing in their
claim history to help encourage use of such a medication only where
clinically appropriate; and
When data suggests potential ``doctor shopping'' behavior,
limiting patients to a single provider for obtaining these medications.
Patient Education and Outreach----
Using our data analytics capabilities as a PBM, we have found that
one of the keys to address prescription drug abuse is patient outreach
and education, and believe this approach could be applied across both
the public and private payer-based healthcare insurance marketplace.
The AOM solution engages patients by communication, specifically:
Proactive Member Education: An important step in
preventing opioid overuse is educating members about such risks before
they occur. Through our AOM solution, ESI provides proactive education
to members new to opioid therapy through an educational letter;
Proactive Member Education through Specialized Pharmacist
Outreach: If the member continues opioid therapy, specific utilization
trends will trigger an Express Scripts specialized pharmacist from our
Neuroscience Therapeutic Resource Center (TRC) to contact that member
and provide a live clinical consultation educating the member on
potential risks, and instructions on safe use--including proper storage
and disposal of unused pills; and
Providing Drug Disposal Bags: The AOM solution also
directly provides patients with drug deactivation disposal bags that
chemically neutralize opioids that enables them to safely dispose
unused medications and thereby prevent future opioid diversion or
misuse.
Engaging Pharmacies----
Similar to prescribers, pharmacies and pharmacists are frequently
not aware of other medications a patient is taking. AOM endeavors to
close these gaps in care by aggregating a patient's entire opioid
utilization profile and limit initial opioid prescriptions.
The AOM solution involves an intervention at the pharmacy
point of sale (POS) for members accumulating greater than 200mg
Morphine Equivalent Dose (MED)--a widely accepted clinical threshold at
which greater quantities of Morphine Milligram Equivalents (MME) may be
considered dangerous and potentially an indicator for misuse/abuse.
Pharmacists are alerted at doses of 90 mg MME. A prior authorization is
required for members accumulating quantities of opioid medication
exceeding 200mg MME per day;
Concurrent drug utilization review programs are run to
help pharmacists identify the most pertinent clinical patient safety
and utilization concerns; and
First-time users prescribed short-acting opioids are
restricted under the solution to an initial 7-day supply.
Most importantly, we know the AOM solution works, based on data
collected from both our initial pilot test on 100,000 members conducted
in 2016, and the first 2 months of full operation for 4.6 million
patients currently benefiting from this program. Key results include:
Since becoming fully operational for nearly five million
patients beginning on September 1, 2017 we have seen:
59.5 percent reduction in the average days' supply per
claim for first time opioid users
95.9 percent of the prescriptions that were reprocessed
because of our utilization management edits were filled for a 7-days'
supply or less;
Only 4.1 percent of opioid prescriptions providing more
than a 7-day supply were approved for patients after a prior
authorization (PA) requirement was triggered; and
87 percent of new opioid prescriptions initially written
for a long-acting opioid were subsequently filled with a short-acting
opioid first due to implementation of the new enhanced prior
authorization program.
Continuing to Develop and Implement Best Practices
In less than 6 months, our program has grown to nearly 7 million
Americans enrolled. As a data driven firm, we're constantly evaluating
marketplace behavior and trends and recommending changes to our program
as a result. We recently announced some changes to our opioid program:
New point-of-sale alerts: Fentanyl is being targeted
specifically, as it is an incredibly potent drug, and fentanyl-related
deaths are on the rise. New requirements are being added to the
coverage approval criteria to tighten the criteria for fentanyl
products.
Additionally, a new drug quantity management (DQM) program
for fentanyl patches has been created for a complete and comprehensive
DQM solution for opioids.
New physician care alert: We're recommending the addition
of naloxone for potentially high-risk members who are receiving a large
number of opioid prescriptions where treatment does not appear to be
coordinated.
Physician education/peer comparison: Prescriber
educational messaging that leverages behavioral science and social
norming based on area of practice and peer comparison to encourage more
conservative opioid prescription.
Policies Lawmakers Should Consider
Given the success of our program, Express Scripts also advocates
for meaningful policy change that we think could expand on the some of
the lessons we've learned. Acknowledging that some of the following
policy options extend beyond the scope of this Committee's
jurisdiction, should the Senate take up another legislative package on
opioid abuse, I wanted to highlight them today given this Committee's
comprehensive look at the problem.
Electronic Prescribing----
Electronic prescribing (or ``e-prescribing'') has been shown to
dramatically reduce medication errors and fraud; yet, until 2010 the
Drug Enforcement Agency (DEA) barred its use for ordering controlled
substances. Currently, increasing numbers of states now require its use
for these medications. Mandating e-prescribing controlled substances
would restrict pharmacy shopping, enable better prescription tracking,
and reduce fraud and waste as well. ESI supports H.R. 3528, the Every
Prescription Conveyed Securely (EPCS) Act, as it would move Medicare to
a system of mandatory e-prescribing for opioids as this would go a long
way toward saving lives and stopping addiction by eliminating the
possibility of fraudulent paper claims. Express Scripts urges the
Senate to examine policies that increase the use of electronic
prescribing for controlled substances, whether it is through the
Medicare program, the DEA, or through the commercial insurance market
through policies in this Committee's jurisdiction.
Mandating 7-Day Fill Limit on Initial Opioid Prescriptions----
Another effective tool for reducing opioid abuse in the program
would involve implementing a 7-day supply limit for first fills of
short acting opioids, with exceptions allowed for hospice and
palliative care patients. S. 892, the Opioid Addiction Prevention Act,
introduced by Senators Gillibrand and McCain, would also be a positive
step forward to preventing addiction before it begins. Though this
legislation falls outside of the HELP Committee's jurisdiction, the
bill would benefit commercially insured patients across the country.
Currently, there is a patchwork of state laws around the country on
fill limits. To illustrate this, below is a table that shows how these
laws currently vary depending on geography:
Table 1: Opioid Related Quantity Limit Laws
------------------------------------------------------------------------
State Qty 1st Fill Qty Qty for Minors
------------------------------------------------------------------------
Alaska ---- 7 days 7 days
------------------------------------------------------------------------
Arizona ---- 5 days ----
------------------------------------------------------------------------
Connecticut ---- 7 days 7 days
------------------------------------------------------------------------
Delaware 31 days 7 days 7 days
------------------------------------------------------------------------
Hawaii 30 days ---- ----
------------------------------------------------------------------------
Illinois 30 days ---- ----
------------------------------------------------------------------------
Louisiana ---- 7 days 7 days
------------------------------------------------------------------------
Maine 7 acute, 30 ---- ----
chronic
------------------------------------------------------------------------
Massachusetts 30 days 7 days ----
------------------------------------------------------------------------
New Hampshire 34 days ---- ----
------------------------------------------------------------------------
New Jersey 30 days 5 days ----
------------------------------------------------------------------------
New York 30 days 7 days ----
------------------------------------------------------------------------
Ohio 90 days 14 days ----
------------------------------------------------------------------------
Pennsylvania ---- ---- 7 days
------------------------------------------------------------------------
Rhode Island 30 days 20 doses & 30 MME/ ----
day
------------------------------------------------------------------------
South Carolina 30 days ---- ----
------------------------------------------------------------------------
Tennessee 30 days ---- ----
------------------------------------------------------------------------
Utah 30 days 7 days ----
------------------------------------------------------------------------
Vermont ---- 7 days & 50 MME/ 3 days & 24 MME/
day day
------------------------------------------------------------------------
Virginia 7 acute, 14 ---- ----
surgical
------------------------------------------------------------------------
West Virginia 30 days ---- ----
------------------------------------------------------------------------
Resisting the False Appeal of Incentivizing Use of Abuse Deterrent
Opioid Formulations----
Opioid manufacturers have been developing and selling novel (and
expensive) approaches with a stated goal of making their products less
susceptible to abuse, which typically means the product is engineered
in some way to make it more difficult (but not impossible) to crush it
up and make it injectable. Unfortunately--as tacitly admitted by use of
the term ``abuse deterrent'' vs. ``abuse proof''--these efforts are
consistently defeated and, in any event, remain equally susceptible to
misuse as any other oral medication. Nevertheless, over the last 2
years approximately 50 pieces of legislation requiring coverage of
Abuse-Deterrent Formulations (ADF) of opioid products have been
introduced in more than 30 different states. While the goal of these
bills--to reduce opioid abuse--is laudable, mandating coverage of ADF
opioids fails to take into account several substantial flaws with this
approach, namely:
The FDA fully acknowledges that these products are not
abuse proof;
Concerns expressed by clinical experts that ADF opioids
will mislead prescribers and patients into thinking the products are
less addictive, and thus overprescribing patterns will continue or,
potentially, increase; and
While ADF opioids make tampering more difficult, these
products are considerably more expensive than non-ADF opioids, thereby
shrinking available coverage dollars for other drugs offered by a
health plan payer.
Instead of mandating first-line coverage for ADF opioids, we
reiterate that the best approach to reducing opioid misuse is through
comprehensive, well-coordinated efforts among providers, public and
private healthcare payers, and law enforcement that emphasizes patient
education on drug safety--including counseling and addiction treatment.
Again, thank you for the incredible opportunity to present Express
Scripts' data-driven solutions as we continue to lead our industry in
developing strategies to prevent addiction. I am happy to answer any
questions you may have, and offer to continue to be a resource to this
Committee as you consider further legislation to address this epidemic
and save lives.
______
[summary statement of snezana mahon]
Express Scripts has developed a novel and comprehensive opioid
management program for plan sponsors of prescription drug benefits. The
program touches the entire patient care continuum and has promising
early outcomes.
Express Scripts Advanced Opioid Management Program
The AOM solution delivers automated messages at the
prescriber point of care via Electronic Health Record (EHR) on
potential misuse and abuse, along with morphine equivalent dose
(MED) communications to ensure prescribers have a complete
picture of their patient's history.
If the patient continues opioid therapy, specific
utilization trends will trigger an Express Scripts specialized
pharmacist from our Neuroscience Therapeutic Resource Center
(TRC) to contact that member and provide a live clinical
consultation educating the member on potential risks, and
instructions on safe use--including proper storage and disposal
of unused pills.
Intervening at the pharmacy point of sale (POS) for
members accumulating greater than 200mg Morphine Equivalent
Dose (MED).
Outcomes Data
59.5 percent reduction in the average days' supply
per claim for first time opioid users.
95.9 percent of the prescriptions that were
reprocessed because of our utilization management edits were
filled for a 7-days' supply or less.
Only 4.1 percent of opioid prescriptions providing
more than a 7-day supply were approved for patients after a
prior authorization (PA) requirement was triggered.
87 percent of new opioid prescriptions initially
written for a long-acting opioid were subsequently filled with
a short-acting opioid first due to implementation of the new
enhanced prior authorization program.
Policies Lawmakers Should Consider
Electronic Prescribing--Mandating e-prescribing
controlled substances would restrict pharmacy shopping, enable
better prescription tracking, and reduce fraud and waste as
well.
7-Day Fill Limit on Initial Opioid Prescriptions--S.
892, the Opioid Addiction Prevention Act, introduced by
Senators Gillibrand and McCain, would also be a positive step
forward to preventing addiction before it begins.
Resisting the False Appeal of Incentivizing Use of
Abuse Deterrent Opioid Formulations--We remain concerned that
ADF opioids will mislead prescribers and patients into thinking
the products are less addictive, and thus overprescribing
patterns will continue or, potentially, increase.
______
The Chairman. Thank you, Dr. Mahon.
Ms. Green, welcome.
STATEMENT OF SHERRY L. GREEN, J.D., CHIEF EXECUTIVE OFFICER,
SHERRY L. GREEN AND ASSOCIATES; CO-FOUNDER, NATIONAL ALLIANCE
FOR MODEL STATE DRUG LAWS, SANTA FE, NEW MEXICO
Ms. Green. Thank you, Chairman Alexander, Ranking Member
Murray, and Members of the Committee.
Thank you for this opportunity to make recommendations
about the proper role of policy and technology in data
projects. I am going to recommend three quality control
principles that should be involved in all data and technology
projects.
The first is that the best practices for healthcare that we
want the technology projects to actually achieve need to remain
very clear and very consistent. When those standards appear to
be uncertain or sometimes in conflict, the result is that the
technology projects lose their focus. And what we see is that
the measures of success for some vendors simply becomes staying
ahead of their competitors.
This is less about what technology can do and more about
what technology should do to achieve the best practices that we
believe are necessary to help address the opioid epidemic.
Second, the legislative and policy changes that we actually
need to be in place to optimize technology projects need to
keep pace with the adoption of those technology projects.
When those legislative changes, as often happens, lag
behind they actually hinder, not support, the technological
enhancements. And that causes the enhancements to be completely
unable to fully operationalize the best practices we want them
to achieve.
The third principle is that the federally funded projects
from now on should actually breakdown data silos, not
incentivize the creation of new silos. We need to continue to
heed the lessons that we learned from the Federal efforts to
computerize medical records.
While we obviously gained many benefits from that effort,
we also now understand that the significant Federal funding
that was put out there actually incentivized data vendors to
make data sharing difficult and more costly. So much so, the
Congress had to step back in and actually prohibit information
blocking.
We should proactively avoid this kind of situation again
with any new funding for data projects by proactively including
in technology grants and contracts those safeguards that will
actually facilitate data sharing, as well as prevent the
exclusionary data access that sometimes happens when people are
simply trying to increase their market dominance.
I want to thank you again for this opportunity to make
these recommendations, and at the end of the panel, I am happy
to answer any questions you might have.
[The prepared statement of Ms. Green follows:]
prepared statement of sherry l. green
Chairman Alexander, Ranking Member Murray, and Members of the
Committee, I thank you for this opportunity to share recommendations
regarding the proper role of policy in data and technology projects
intended to help address the opioid crisis. My recommendations
represent quality control principles necessary to ensure that the
activities of such projects remain aligned with the goals of
congressional opioid abuse prevention strategies, including the
Protecting Our Infants Act, the Comprehensive Addiction and Recovery
Act, and the 21st Century Cures Act. Based on 24 years of drafting and
helping implement drug and alcohol policies, including those for opioid
abuse, I respectfully offer the following points of consideration.
Health care standards of quality and best practices which
technology and data projects are to facilitate must remain clear and
consistent. Technology and data solutions can significantly advance
improved responses by health care professionals and public health
officials to the opioid epidemic. The unrelenting misuse, abuse,
addiction to and diversion of opioids and other potentially addictive
substances place new demands on prescribers and dispensers. Training
and beliefs of years past must be set aside. Professionals and
officials must learn and use new approaches to manage pain,
particularly chronic noncancer pain, and treat drug and alcohol
addiction. More than ever before treatment decisions for each patient
must represent a careful weighing of multiple factors to balance
appropriate patient care with prevention of misuse, abuse, addiction to
and diversion of medication. This transition in practice must be
expeditious rather than gradual. Technology and data solutions can
effect a more timely transition through (1) efficient delivery of new
education and training, and (2) improved coordination and analysis of
data relied upon for clinical treatment and public health decisions.
As the search for tools to address the opioid epidemic ramps up, so
too do the competing claims that various technology and data solutions
can do more, and do more faster. But the true value of a solution can
only be realized in its use to achieve or improve upon new standards
and best practices for clinical care and public health. Where the
standards are uncertain or seemingly in conflict, the focus for a
technology and data vendor can become doing more, and doing more faster
than its competitors.
The use of technology and data solutions to enhance prescription
drug monitoring programs (PDMPs) is informative. Over the past 18
months, numerous well-intended technology and data vendors promoted
their solutions to PDMP Administrators (Administrators). The vendors
described in detail how their solutions can improve the Administrators'
ability to ``catch'' doctor shoppers and detect fraud. Detecting and
preventing fraud is certainly one of the goals of PDMPs. However,
states are transforming their programs into better health care
information delivery tools. The vendors were silent regarding how their
solutions can help accomplish PDMPs' health care goals. Policymakers,
professionals, and officials must articulate consistently and
repeatedly the standards which technology and data solutions are to
facilitate.
Only by doing so will technology and data solutions remain
effective as means to a new health care and public health practice and
approach to addressing the opioid epidemic.
Legislative and regulatory changes necessary to optimize technology
and data solutions must keep pace with the adoption of the solutions.
Processes for refining and updating technology and data often proceed
at a faster pace than amendments to statutes or even regulations.
Technology and data solutions do not operate in a vacuum; they must
comply with applicable policies that govern access, use, and disclosure
of various types of data. When those policies fail to support the
standards of quality and best practices for use of data that
implementation of a solution is designed to achieve, the solution is
unable to fully operationalize the standards and best practices.
A primary objective of Federal and state PDMP enhancement
initiatives is integrating PDMP data into health and pharmacy
information technology (IT). Millions of public dollars are being spent
on integration technology. This integration removes barriers to easy
access of PDMP data and allows health care professionals to efficiently
rely upon the data to inform patient care decisions. Access, use, and
disclosure rules for PDMP data may differ from those for medication
history traditionally maintained by health and pharmacy IT. The
variances may be in one or more of the following categories: (1)
authorized users of data, (2) methods of accessing data, (3) allowable
purposes for accessing data, (4) storage and retention of data, (5)
presentation of data to authorized users, (6) disclosure and use of
data in health and pharmacy IT, and (7) tracking of requests for data.
Failure to reconcile these governance rules prior to PDMP data
integration can impede effective use of PDMP data in the clinical
workflow. Simultaneously, health and pharmacy IT systems are at greater
risk of violating idiosyncratic PDMP data usage provisions.
Policymakers and regulators must proactively modify laws and rules to
timely support rather than hinder technology and data enhancements
needed to improve prescribing and dispensing of potentially abused
substances.
New or expanded technology and data solutions to address the opioid
epidemic must strive to break down data silos, not incentivize the
creation of new silos. Prior Federal efforts strove to encourage an
interconnected web of health care providers and consolidation of
patient information. Significant Federal dollars intended to bring
about the web and consolidation inadvertently incentivized the practice
of data siloing. Health IT vendors were reluctant to share information
for fear of losing customers to their competitors. Based on this fear,
the vendors made the existence of data sharing costly and inconvenient.
Congress responded by prohibiting and penalizing information blocking.
The National Academy of Sciences (NAS) reviewed electronic systems
developed from initiatives to computerize medical records (EMRs). NAS
found that EMRs ``offer potential improvements to health care
delivery'' through collection of and quicker access to key patient
data. \1\ Clinical notes, urine drug tests results, and signed opioid
treatment agreements may now be included in EMRs.
---------------------------------------------------------------------------
\1\ National Academy of Sciences, Pain Management and the Opioid
Epidemic: Balancing Societal and Individual Benefits and Risks of
Prescription Opioid Use, p.306 (2017).
---------------------------------------------------------------------------
However, EMRs still have data gaps. Often missing is information
important to understanding a patient's comprehensive, and sometimes
complex, relationships with potentially addictive substances. These
gaps contribute to ongoing pressure for health care professionals and
officials to use PDMPs, tools originally designed to assist
investigations of violations of controlled substances laws. The data in
PDMPs already exist throughout health care systems, but the data are
maintained in piecemeal fashion. A PDMP has value for health care
professionals because it provides in a single location a more complete
picture of a patient's prescription history than can often be found in
any other single source. The consolidation of patient data has yet to
be fully realized in the health care sector. As a result, state and
Federal agencies are spending millions of public dollars to transform
PDMPs into optimal health care information delivery tools.
Policymakers must heed the lessons learned from the EMR development
process. Federally funded technology and data projects to address the
opioid epidemic must incorporate requirements to effect proper data
sharing and prevent exclusionary data access primarily used to gain a
competitive advantage and increase market dominance. Examples of such
requirements can be found in the Prescription Drug Monitoring Act of
2017 as introduced, S. 778 (Act). Funding a single hub for sharing PDMP
data, the Act retains states' ownership rights to determine disclosure
parameters, and ensures cost efficient data access for patient care and
public health surveillance activities.
With the urgent need to save lives and stop other devastating
consequences of opioid abuse, hundreds of millions of taxpayer dollars
are and will be expended to expeditiously respond to the need. As
technology and data projects race forward to make quick progress, the
projects risk losing focus unless proper guidance is in place. I urge
Committee Members to take a lead in adopting appropriate quality
control measures and safeguards to ensure that the projects remain
aligned with congressional goals for effectively tackling opioid abuse.
______
[Summary Statement of Sherry L. Green]
Chairman Alexander, Ranking Member Murray, and Members of the
Committee, I thank you for this opportunity to share recommendations
regarding the proper role of policy in data and technology projects
intended to help address the opioid crisis. My recommendations
represent quality control principles necessary to ensure that such
projects remain aligned with the goals of congressional opioid abuse
prevention strategies, including the Protecting Our Infants Act, the
Comprehensive Addiction and Recovery Act, and the 21st Century Cures
Act.
Health care standards of quality and best practices which
technology and data projects are to facilitate must remain clear and
consistent. As the search for tools to address the opioid epidemic
ramps up, so too do the competing claims of various technology and data
vendors. Where the standards are uncertain or seemingly in conflict,
the focus for a technology and data vendor can become doing more, and
doing more faster than its competitors. Only by consistently repeating
the standards which technology and data solutions are to facilitate
will the solutions remain an effective means to a new health care
practice and approach to addressing the opioid epidemic.
Legislative and regulatory changes necessary to optimize technology
and data solutions must keep pace with the adoption of the solutions.
Technology and data solutions do not operate in a vacuum; they must
comply with access, use, and disclosure policies for various types of
data. When those policies fail to support the standards of quality and
best practices for use of data that implementation of a solution is
designed to achieve, the solution is unable to fully operationalize the
standards and best practices. Policymakers and regulators must
proactively modify laws and rules to timely support rather than hinder
technology and data enhancements needed to improve patient care and
public health.
New or expanded technology and data solutions to address the opioid
epidemic must strive to break down data silos, not incentivize the
creation of new silos. Policymakers must heed the lessons learned from
Federal efforts to computerize medical records. Federal funds for the
initiative inadvertently incentivized health IT vendors to create data
silos and Congress had to prohibit information blocking. Consolidation
of patient data still has yet to be fully realized in the health care
sector. As a result, health care professionals are required or
encouraged to use PDMPs, tools originally designed to assist law
enforcement. A PDMP has value because it provides in a single location
a more complete prescription history for a patient than exists in other
single sources. Federally funded technology and data projects must
include requirements to effect data sharing and prevent exclusionary
data access used to increase market dominance.
I urge Committee Members to take a lead in adopting appropriate
quality control measures and safeguards to ensure that technology and
data projects remain aligned with congressional goals for effectively
tackling opioid abuse.
______
The Chairman. Thank you, Ms. Green.
Dr. Clark, welcome.
STATEMENT OF H. WESTLEY CLARK, M.D., J.D., M.P.H., DEAN'S
EXECUTIVE PROFESSOR, PUBLIC HEALTH PROGRAM, SANTA CLARA
UNIVERSITY, SANTA CLARA, CALIFORNIA
Dr. Clark. Thank you, Mr. Chairman, and Ranking Member,
Senator Murray, other Members of the HELP Committee.
Thank you for inviting me to participate in this important
discussion about the opioid crisis. I have submitted my full
testimony for the record and will not attempt to repeat it
here.
It is clear that the roles of technology and data are
important in preventing and treating addiction. However, those
roles need to be approached with care and sensitivity. Data can
be abused; technology can be misused.
Under the guise of addressing the opioid crisis, there is
an assault against individuals who present for substance use
disorder treatment. There are those who would strip away the
privacy protections offered by 42 U.S. Code Sec. 290dd-2 and 42
CFR Part 2. In so doing, they would be decreasing the demand
for substance use disorder treatment and increasing the demand
for illegal substances.
While the theme of this hearing involves opioids, Federal
substance use disorder confidentiality regulations cover a
broad range of psychoactive substances including alcohol,
marijuana, cocaine, methamphetamine, and others. Although 2.1
million people meet criteria for opioid use disorders, 18
million people meet criteria for disorders of other substances
of abuse.
The core principles underlying the existing substance use
disorder confidentiality provisions include providing patients
the opportunity to be informed about who is requesting their
substance use records and the opportunity to consent to whom
their information should be disclosed.
While the technology exists to allow patients a role in
determining what can happen to their substance use disorder
treatment records, in terms of to whom that information is
disseminated, the Electronic Health Record industry and the
integrated service provider community have shown little
interest in exploiting that technology. Instead, they argue,
somewhat disingenuously, that asking for patient consent to
disclose sensitive information is too burdensome, too
cumbersome, and unnecessary. They say, ``All you need is
HIPAA.''
The Federal Substance Use Confidentiality regulations were
promulgated because it was recognized that harm could occur to
those who present for treatment, as treatment records could be
misused, either willfully or negligently.
Keep in mind that 42 CFR Part 2 has been changed twice in
the past year, but that is not enough for those who would
ignore the potential loss of employment, loss of child custody,
discrimination, and stigma often associated with substance use.
Comparing the phenomena associated with substance use with
such conditions as hypertension, diabetes, asthma, or HIV is
disingenuous from a confidentiality point of view as those
conditions are not illegal under the law, and are protected by
the Americans with Disabilities Act, while active substance use
is not protected by the ADA.
Trust is the cornerstone of effective behavioral health
treatment particularly for the treatment of those substances
for which no medication is available. Unconsented disclosure of
sensitive information derived from the therapy records of those
in substance use disorder treatment may actually precipitate
relapse and overdoses given the violation of trust associated
with the unconsented release of information. Without trust, the
data from patients will be fraught with omissions, evasions, or
deception. Data analytics will become an illusion.
It is well known that behavioral health treatment records
need to contain descriptive narratives about a patient's life
experiences including information about trauma, marital
problems, violence, incarceration, sexual encounters, as well
as substance issues.
While HIPAA allows for separate psychotherapy notes,
currently used EHR's actually discourage those separate notes.
How is a substance use treatment provider going to explain to a
patient inquiring about the confidentiality of their treatment
records that HIPAA allows for providing such descriptive
information when that information includes information going to
non-healthcare providers, cost management, customer service,
and business planning among other things?
The HITECH Act failed mental health and substance use
disorder treatment providers by providing almost no incentives
to them while promoting technology to primary care providers
and hospitals.
To compensate for that failure, advocates for eviscerating
or abandoning 42 U.S. Code Sec. 290dd-2 or 42 CFR Part 2
proposed to abandon the very people we are trying to encourage
into treatment. Please, do not allow this to happen.
Incidentally, HIPAA contains a self-pay out of pocket
provision that allows those with the financial means to
withhold sensitive information from their health plans. The 42
CRF Part 2, on the other hand, does not discriminate based on
economic status, thus permitting respect for the agency and
autonomy of the rich and poor alike.
Existing data segmentation strategies, such as consent to
share, would actually facilitate patient consent under the 42
CFR Part 2, an information exclusion under HIPAA. However,
there is little interest in this technology among those who
should be interested.
[The prepared statement of Dr. Clark follows:]
prepared statement of h. westley clark
My name is Dr. H. Westley Clark. I am a psychiatrist and addiction
medicine specialist. I retired from Federal service after proving
clinical care to our Nation's veterans for 14 years and after directing
the Center for Substance Abuse Treatment in the Substance Abuse and
Mental Health Services Administration for 16 years.
I am currently teaching undergraduates about substances of misuse
to undergraduates at Santa Clara University, recognizing that the young
men and women of this Nation are both at risk for substance misuse and
have the potential to changing the cultural dynamic which puts their
age cohort at greatest risk for misuse and overdose.
I am here to advocate for maintaining the integrity of 42 USC 290-
dd and to keeping those Federal regulations that protect individuals
with substance use disorders who would be discouraged from seeking
substance use disorder treatment, because they would be subject to
discrimination and legal consequences in the event that their
information is improperly used or disclosed.
As you well know, we are in the midst of the worse opioid epidemic
that this Nation has ever seen. And, at the same time, less than 10
percent of people who need treatment seek treatment. Instead of
recognizing that we need to reassure those in need of treatment that
they can trust the weakening 42 USC 290-dd and 42 CFR Part 2.
It is argued that the opioid epidemic justifies modifying 42 CFR
Part 2 to address the opioid overdose deaths and the misuse of opioids.
While the issue of opioid misuse is of major importance, we should keep
in mind that 42 CFR Part 2 does not just apply to opioids.
Data from the National Survey on Drug Use and Health reveals that
65 million Americans 12 and Older admit to binge drinking in the past
month. Of these, 16 million admit to being heavy drinkers. We should
also be aware that 24 million people admit to being past month users of
marijuana. \1\
---------------------------------------------------------------------------
\1\ Source: SAMHSA, Center for Behavioral Health Statistics and
Quality. National Survey on Drug Use and Health, 2016.
---------------------------------------------------------------------------
These numbers alone suggest the magnitude of the issues we are
confronting today, as they exceed the 3.4 million people who admit to
past month use of pain relievers and the 475,000 who admit to past
month users of heroin.
The critical question today is how do we get the 28.6 million
Americans who are current illegal drug users and the 65 million people
who are binge drinkers to discuss their substance use with the medical
community? Sally Satel, psychiatrist, author and commentator asked:
``[W]hat should we do about the opioid crisis? First, we must
be realistic about who is getting in trouble with opioid pain
medications. Contrary to popular belief, it is rarely the
people for whom they are prescribed. Most lives do not come
undone, let alone end in overdose, after analgesia for a broken
leg or a trip to the dentist. There is a subset of patients who
are vulnerable to abusing their medication--those with
substance use histories or with mental health problems.
Ideally, they should inform physicians of their history, and,
in turn, their doctors should elicit such information from
them.'' \2\
---------------------------------------------------------------------------
\2\ Satel, Sally, ``The Myth of the Roots of the Opioid Crisis'',
Politico Magazine, February 21, 2018, https://www.politico.com/
magazine/story/2018/02/21/the-myth-of-the-roots-of-the-opioid-crisis-
217034, accessed 02/24/2018.
Although the use of alcohol is legal for those over the age of 21,
the medical community should also communicate with their patients about
alcohol use. However, as for all psychoactive substances,
communications between clinician and patient require trust. Trust is
not possible if the function of disclosure is the release of sensitive
information into a virtual data storm sewer.
It is often argued that substance use should be treated like HIV,
the flu, diabetes or hypertension and therefore should be treated like
those conditions. Those who make this argument blind themselves to the
reality that many substances of misuse are illegal, and that disclosure
of such information can give rise to harm to the individual affected.
The harms to which a person who admits to substance use may suffer
includes the loss of employment, the loss of housing, the loss of child
custody, the loss of benefits, stigma and discrimination, the loss of
privacy and the loss of autonomy. \3\ Medical records can also be used
to incriminate a person and subject that person arrest, prosecution,
and incarceration.
---------------------------------------------------------------------------
\3\ Lopez, Karla and Reid, Deborah, ``Discrimination Against
Patients with Substance Use Disorder Remains Prevalent and Harmful: The
Case for 42 CFR Part 2, ``Health Affairs Blog, April 13, 2017, DOI:
10.1377/hblog20170413.059618, accessed 02/25/2018.
---------------------------------------------------------------------------
It is irresponsible to ignore the real harms to which a person with
a history of substance use could be subject. It is also irresponsible
to ignore the implication that modern electronic health information has
for privacy and confidentiality. It is sometimes said that computers
have eidetic memories--they don't forget. Thus, people in recovery from
alcohol and drug use who have long since stopped using are still at
risk for discrimination and stigma.
The case is often made that the health care delivery systems need
to know about the substance use history of a patient. You don't hear
why providers can't simply ask patients themselves about their
substance use histories. You hear that it is too confusing for
clinicians to know about 42 CFR Part 2 and to apply the rules. Yet,
these same clinicians and health care systems spend quite a bit of time
learning about and executing reimbursement rules, licensing rules,
administrative rules, quality standard rules, and all the other rules
that are necessary to get paid for the services delivered to the very
people whose agency and dignity are now deemed too inconvenient to
respect.
No, I rarely hear or read about concern about the harm to the
patient. Instead, I hear concern for the convenience of the delivery
system, a concern that creates an adversarial relationship between
patient and practitioner rather than respect for and trust from the
patient. What appears to underlie the argument for administrative
efficiency and systems needs is distrust of the patient, if not
contempt for the patient.
Now is the time to welcome people with substance use disorders into
the health care delivery system, not with the demand that such
individuals concede their agency, dignity and privacy to the
administrative convenience of the health care delivery system, but with
the old adage of ``First, do no harm.''
Distrust and Contempt for people with substance use disorders has
led to distortions and misinterpretation of 42 CFR Part 2. Emergency
room clinicians argue that a patient with an opioid use disorder comes
into the ED following an overdose and is unresponsive, 42 CFR part 2
keeps them from getting lifesaving information. Not true, 42 CFR Part 2
allows those emergency room clinicians to access Part 2 protected
information kept either by a health information exchange or a substance
use disorder treatment program in order to treat the patient in the
emergency status.
Internists may argue that it is critical not to prescribe an opioid
to an opioid dependent patient who is on methadone. However, they don't
establish that asking the patient about their methadone treatment is
ineffective. Furthermore, they don't establish that checking the PDMP
is ineffective. If the PDMP is ineffective, they don't argue for
improving PDMPs by making them real time and regional.
Family members, concerned about the welfare of their opioid
dependent adult relative, are not precluded from getting information
when an unconscious adult is brought into the ER following an opioid
overdose. Emergency room clinicians under this situation are not
prohibited from sharing information with those concerned family
members.
It is argued that 42 CFR Part 2 perpetuates the stigma of
addiction. This disingenuous argument ignores the laws, regulations,
policies and social view about addiction and substance use disorders.
It is not illegal to be depressed. It is not illegal to have diabetes.
It is not illegal to have a broken leg. It is illegal to use heroin.
People with untreated or active diabetes are protected by the Americans
with Disabilities Act. People with untreated or active substance use
are not. There are no signs posted at the employment office of
employers declaring that the workplace is a hypertension free workplace
and that all new applicants will have their blood pressure checked;
there are no signs saying that anyone with evidence of hypertension
shall be denied employment.
The Department of Health and Human Services has already moved to
accommodate the modernization of 42 CFR Part 2 through two rounds of
rulemaking, including a 2017 Final Rule and a 2018 Final Rule. However,
the EHR community and a number of health systems remain restless,
impatient and intolerant of those with substance use disorders,
suggesting that information sharing is more important than the people
about whom that information is shared. Thus, the regulatory efforts to
allow patient to provide a general disclosure for substance use
disorder information, to offer some flexibility in transmitting
substance use data electronically, and to clarify the circumstances in
which providers can disclose patient information to contractors and
subcontractors for payment and healthcare operations is not enough. The
critics of 42 CFR seek to expose those with substance use disorders who
seek treatment, making the exercise of treatment a dangerous
proposition.
Patient Attitudes Toward Treatment
We spend millions of dollars collecting information about the
substance use patterns of people in the US. Perhaps we should be
concerned about the reality that 89 percent of people, who meet
criteria for needing substance use disorder treatment, did not receive
such treatment. \4\
---------------------------------------------------------------------------
\4\ Source: SAMHSA, Center for Behavioral Health Statistics and
Quality, National Survey on Drug Use and Health, 2015 and 2016.
---------------------------------------------------------------------------
Of the 28.6 million people who misused illicit drugs and the 65
million people who were binge drinkers in the past month, only 3.8
million people received treatment in the past year. Of course, mere use
does not equate with dependence or needing treatment. However, NSDUH
data indicate that over 20 million people 12 or older met criteria for
a substance use disorder in the past year in 2016, with 2.1 million
meeting criteria for an opioid use disorder.
What is equally interesting is that of the people who met criteria
for needing treatment and did not receive treatment, 95.5 percent
perceived no need for treatment. In short, 18.7 million people needed
but did not receive treatment; of these, 17.9 million perceived no need
for treatment.
Now comes the critics of 42 CFR Part 2, under the flag of bringing
integrated treatment to those in need, claiming that it is 42 CFR Part
2 that operates as a barrier to effective and efficient treatment of
opioid use disorders, claiming that there is no need for special
concerns about substance use disorders, today, never mentioning how
they will explain to those actually seeking treatment and those in need
of treatment the ramifications of attenuating 42 CFR Part 2.
Changing 42 CFR Part 2 and the Response of Substance Users
It is important to recognize that 42 CFR Part 2 does not apply to
most clinicians or most clinical settings. In fact, 42 CFR Part 2 only
applies to programs that hold themselves out ``as providing, and
provides, alcohol or drug abuse diagnosis treatment, referral for
treatment or prevention.'' Of course, 42 CFR Part 2 governs substance
use disorder patient records for those patients who receive, diagnosis,
referral or treatment from (a) an identified unit of a general medical
facility that holds itself out as providing, and provides alcohol or
drug use disorder diagnosis, treatment or referral for treatment or (b)
medical personnel or other staff in the general medical care facility
whose primary function is to provide those services.
It is the patient records of a substance use disorder program
(which includes the substance use patient records clinicians who hold
themselves out as treating people with substance use disorders in even
in non-specialty settings), that are controlled by 42 CFR Part 2. This
creates a responsibility for the substance use disorder program to
explain to the patient the meaning of confidentiality as it applies to
information disclosed to the treatment program.
For the millions of people whose substance use does not meet
criteria for protection under 42 CFR Part 2, HIPAA controls. HIPAA
regulations allow for unconsented disclosure of patient information
for, among other things, healthcare operations.
Healthcare operations include:
Underwriting, enrollment, premium rating, and other
activities related to the creation, renewal, or replacement of
a contract of health insurance or health benefits, and ceding,
securing, or placing a contract for reinsurance of risk
relating to claims for health care (including stop-loss
insurance and excess of loss insurance)
Reviewing the competence or qualifications of health
care professionals, evaluating practitioner and provider
performance, health plan performance, conducting training
programs in which students, trainees, or practitioners in areas
of health care learn under supervision to practice or improve
their skills as health care providers, training of non-health
care professionals, accreditation, certification, licensing, or
credentialing activities;
Business planning and development, such as conducting
cost-management and planning-related analyses related to
managing and operating the entity, including formulary
development and administration, development or improvement of
methods of payment or coverage policies
Business management and general administrative
activities of the entity, including, but not limited to:
(i) Management activities relating to implementation of and
compliance with the requirements of this subchapter;
(ii) Customer service, including the provision of data analyses
for policy holders, plan sponsors, or other customers, provided
that protected health information is not disclosed to such
policy holder, plan sponsor, or customer.
(iii) Resolution of internal grievances;
(iv) The sale, transfer, merger, or consolidation of all or
part of the covered entity with another covered entity, or an
entity that following such activity will become a covered
entity and due diligence related to such activity; and
(v) Consistent with the applicable requirements of Sec.
164.514, creating de-identified health information or a limited
data set, and fundraising for the benefit of the covered
entity.
Do non-42 CFR Part 2 covered providers explain the width and depth
of the health care operations provision under HIPAA? Would patients
exempted from 42 CFR Part 2 protections feel that disclosing histories
of substance use is wise under HIPAA, even if experimental or rare use
of psychoactive substances is involved? Much of the literature favoring
weakening 42 CFR Part 2 or aligning it much more substantively does not
discuss this perspective.
Moving from HIPAA into those programs whose records are controlled
by 42 CFR Part 2, it is clear that those with moderate to severe
substance use disorders requiring treatment already do not believe that
treatment is warranted. How are we going to encourage them to
participate in treatment when we propose to broadcast their personal
information through network of uncertainty entities with uncertain
purpose?
Unfortunately, there are more serious consequences to voiding the
patient's right to consent to the disclosure of sensitive information.
The unconsented disclosure of sensitive information resulting in harm
to the patient could easily give rise to suicide, relapse to substance
use or overdose; these are tragic events that we should be avoiding
rather than pretending that the agency and dignity of the patient has
no value and can be compromised for the convenience of EHR vendors,
data miners and health care operations. Furthermore, we should
recognize that many in substance use disorder treatment are at risk for
depression, anxiety and other psychiatric disorders, any of which would
be made worse by a breach of trust by substance use disorder treatment
programs and the health care delivery system.
Blaming the Vulnerable
The Health Information Technology for Economic and Clinical Health
Act (HITECH Act) was enacted under Title XIII of the American Recovery
and Reinvestment Act of 2009. \5\ It provided billions of dollars of
incentives to an array of primary care hospitals and to physicians to
adopt electronic health records and to promote the exchange of health
information. However, that same act essentially ignored the behavioral
health community; as a result, there were no incentives available for
substance use disorder treatment programs to adopt electronic health
records. In addition, there were no incentives to the electronic health
record industry to develop software and protocols specific to the
behavioral health community and the sensitive information generated by
behavioral health providers, information of little use to most primary
care providers.
---------------------------------------------------------------------------
\5\ The American Recovery and Reinvestment Act of 2009, (Public
Law 111-5).
---------------------------------------------------------------------------
At the time of the unfolding of the HITECH Act, I was the Health
Information Technology Strategic Initiative Lead for SAMHSA. My team
and I met with a number of software vendors in an effort to address the
unique needs of the behavioral health community and to compensate for
the omission of behavioral health from the promulgated incentives
provided to general medicine. We met with little success.
However, in order to compensate for excluding behavior health from
the incentives, standards, and designs for the evolving EHR systems,
information exchanges, and the growing recognition that comprehensive
health care required addressing behavioral health, efforts were mounted
to promote the fiction that behavioral health patient information
contained nothing unique and distinct from the general health care
environment.
The notion that all health care information is equivalent runs
counter to the historical status recognized in the psychotherapist-
patient privilege which was justified on the grounds that some personal
health information was more sensitive than others. Discussions of
mental health, substance use, and sexual health are inhibited unless
the patient has certain reassurances that highly sensitive personal
health information would remain between themselves and their health
care providers. Indeed, ``the prevailing legal default and ethical norm
in Western nations both strongly favor the preservation of patient
confidence in the absence of compelling grounds to act otherwise.''
1A\6\
---------------------------------------------------------------------------
\6\ Shenoy, A and Appel, JM, ``Safeguarding Confidentiality in
Electronic Health Record'', Cambridge Quarterly of Healthcare Ethics
(2017), 26, 337-341.
---------------------------------------------------------------------------
As Shenoy and Appel point out, the behavioral health record ``often
combines data related to the patient's present symptoms, with a
descriptive narrative of the patient's life experience, including
sensitive details of psychological trauma, domestic violence,
incarceration, sexual encounters, and substance abuse. Much of this
information is of great value to a therapist, but not always of
clinical use to many other medical providers. The stigma attached to
mental healthcare among some individuals and in certain cultural
communities even leads some patients to avoid using their insurance for
psychiatric care in order to protect their privacy.'' \7\
---------------------------------------------------------------------------
\7\ Ibid.
---------------------------------------------------------------------------
At SAMHSA, we recognized the continued sensitivity of behavioral
health information, especially for substance use in particular. As a
result, we developed an open source codebase through a contract that
would provide an inexpensive software application for the behavioral
health community. \8\ Unfortunately, due to complaints of unfair
competition we discontinued our efforts.
---------------------------------------------------------------------------
\8\ http://www.feisystems.com/what-we-do/learn-about-wits/why-
choose-wits-2/.
---------------------------------------------------------------------------
The HITECH Act with its focus on meaningful use and information
exchange did not change the unique character of behavioral health
information. As a result, we developed Consent2Share, an open-source
data segmentation platform that could be incorporated into existing
electronic health records to allow patients to be able to consent to
the disclosure of highly sensitive patient information. \9\
---------------------------------------------------------------------------
\9\ Department of Health and Human Services: 42 CFR Part 2:
Confidentiality of substance use disorder patient records; proposed
rule. Federal Register 81: 6988-7024, 2016.
---------------------------------------------------------------------------
Consent2Share was developed evolved within the Data Segmentation
for Privacy (DS4P) initiative within ONC's Standards and
Interoperability (S&I) Framework to improve the interoperability of the
plethora of EHRs containing sensitive information that must be
protected. The DS4P initiative met its two goals, which were to:
Demonstrate how standards can be used to support current privacy
policies, including 42 CFR Part 2, for sharing sensitive health
information across organizational boundaries; and develop standards
that will enable sensitive electronic health information to flow more
freely to authorized users while improving the ability of health IT
systems to implement current privacy protection requirements for
certain Types of health care data, such as substance use disorder
patient records.
Unfortunately, the EHR vendor community felt no need to support
data segmentation, dismissing the importance of privacy and
confidentiality to patients. Furthermore, health information exchanges
chose to ignore the importance of privacy and confidentiality to the
patients by choosing not to embrace the utility of data segmentation
and patient choice. Naturally, without data segmentation and consent
management capacities, substance abuse treatment programs operating
under 42 CFR Part 2 requirements have diminished capacities to share
information with integrated treatment models that ignore patient
choice.
In short, SAMHSA was able to demonstrate that patient choice could
be respected without compromising the agility and flexibility of
required for integrated information exchange. However, for matters of
mere convenience and low market demand, most EHR vendors and health
information exchanges chose to support the less expensive and ethically
problematic position of eviscerating 42 CFR Part 2.
Economic Disparities, HIPAA, and Confidentiality
What is remarkable about the industry and provider objections to
having patients weigh in on whether their private medical information
should be disclosed is the loophole in HIPAA that allows rich people or
middle people to have the right to restrict certain disclosures of
protected health information to a health plan where the individual pays
out of pocket in full for the health care or service received. \10\
Health care providers, under HIPAA, are required to include such a
statement in the notice of privacy practices provided to the patient.
Thus, if a patient is rich and can pay for their own treatment in full,
including substance use disorder treatment or if they are middle class
and can mortgage their home to pay for their treatment in full, they
can avoid disclosing the fact that they are in substance use disorder
treatment to their health plan. What is amazing is that providers who
are committed to doing no harm are willing to sacrifice poor whites,
poor blacks, poor Hispanics, poor Native Americans, poor Alaskan
Natives, poor Hawaiians, and poor Asians in the service of a fiction of
needing highly sensitive personal information without a patient's
consent when they could most likely receive that information simply by
asking the patient. In situations where a patient refuses consent to
disclose sensitive information to entities outside of the treatment
situation, that should be the patient's prerogative.
---------------------------------------------------------------------------
\10\ Department of Health and Human Services; 45 CFR Parts 160 and
164: Modifications to the HIPAA Privacy, Security, Enforcement, and
Breach Notification Rules Under the Health Information Technology for
Economic and Clinical Health Act and the Genetic Information
Nondiscrimination Act; Other Modifications to the HIPAA Rules. Federal
Register 78 (17: 5566-5702)
---------------------------------------------------------------------------
Given the well documented harm that can happen to a person who is
an admitted substance user, it should not be EHR vendors or health
systems that should decide what sensitive information should be
disclosed outside of a substance use treatment process. Financial
ability should not be the deciding factor on whether a person retains a
modicum of control over their personal information.
Increased Liability for Substance Use Disorder Treatment Programs
Substance Use Disorder treatment programs have a duty to inform
patients about the limits of confidentiality. Given the spectrum of
entities under the rubric of healthcare operations, it would be
difficult for a substance use disorder treatment program to accomplish
this with any degree of effectiveness; this would expose the covered
program to liability.
Given that the potential harms from inappropriate disclosure of
sensitive information garnered during substance use disorder treatment
is real, the disclosure of that information may give rise to legal
claims including lawsuits for some form of negligence. Unfortunately,
since substance abuse treatment programs will be the entities releasing
information under the proposed modified 42 CFR Part 2, undoubtedly they
will bear the brunt of the legal burden. Increased liability insurance,
legal costs, and impaired reputations will ensue. After all, once
sensitive information is released into the entity that releases that
information has no control over its distribution. The question would
become should substance abuse treatment program that released the
information have known that it contained information that could be used
to the detriment of their current or past patient.
Substance use disorder treatment programs caught up in lawsuits may
have to withdraw from the treatment marketplace. Treatment programs
that close under the weight of malpractice claims will only diminish
the number of available treatment slots. The cost of care will also
increase as treatment programs have to compensate for the increased
administrative costs of doing business.
Conclusion
We cannot adequately address the current opioid epidemic if we
remove the protections that 42 CFR part 2 and its authorizing
legislation, 42 USC Sec. 290dd-2, offers. We cannot treat those
experiencing substance use disorders with contempt by weakening the
protections that they currently have. We cannot treat those who
experience substance use disorders as a means to an end, attempting to
compensate for the lack of public investment in electronic health
records for the behavioral health treatment communities following the
HITECH Act's focus on primary care.
Efforts to balance the health information technology requirements
of integrated systems while preserving a patient experiencing a
substance use disorder's right to consent to the disclosure of their
substance use treatment history and sensitive matters subsumed under
that history have been thwarted by the EHR industry and by health
information exchanges. The claim that it would cost too much is
overshadowed by the existence of open source strategies that could
accomplish the necessary consent management strategies and by the
inherent right of a person to determine what happens to sensitive
information.
In truth, 42 CFR Part 2 has been changed in 2017 and 2018. Now is
the time to leave it alone, to let the health care delivery system gain
a modicum of expertise to those changes, and to allow the information
technology industry an opportunity to further pursue technological
accommodations to existing information systems to permit patient
consent to sensitive information.
______
[Summary Statement of H. Westley Clark]
1. 42 USC 290-dd, the authorizing legislation for substance use
disorder (SUD) treatment should remain as is.
2. Because two changes to 42 CFR Part 2, the implementing
regulations of 42 USC 290-dd, have already occurred, once in 2017 and
once in 2018, no further changes should be executed at this time.
3. The promulgated changes to 42 CFR Part 2 promoted a closer
alignment with HIPAA.
4. The public policy purpose of 42 USC 290-dd and 42 CFR Part 2 is
to encourage people in need of SUD disorder treatment to enter such
treatment, fostering (a) an increased demand for SUD treatment and (b)
a decrease demand for illegal substances. Although new technologies
have arisen, including electronic health records (EHRs), and new
service models have evolved, the original purpose of 42 USC 290-dd and
42 CFR Part 2 has not changed. Additional efforts to align 42 CFR Part
2 with HIPAA may eviscerate the purpose of 42 CFR Part 2 and also
impose burdens on those who are in Recovery from SUDs.
5. Epidemiological data demonstrate that most people in need of SUD
treatment do not receive it and do not perceive a need for such
treatment. Violating their confidentiality will not encourage a demand
for treatment for those with active SUDs.
6. While the opioid epidemic is a major public health concern, 42
USC 290-dd and 42 CFR Part 2 also encourage those with other SUDs to
enter treatment; this includes individuals with alcohol dependence and
dependence on substances subject to the Controlled Substances Act such
as, marijuana, cocaine, methamphetamine and other psychoactive
substances.
7. The core principles underlying the existing substance use
disorder confidentiality provisions are providing patients the
opportunity to be informed about whom is requesting their substance use
records and the opportunity consent to whom their information should be
disclosed.
8. Despite new EHRs and integrated service models, the information
disclosed by patients in substance use disorder treatment is uniquely
sensitive, often involving illegal acts, psychological trauma, domestic
violence, and potentially compromising activities the disclosure of
which can result in substantial harm to patients.
9. Comparing the phenomena associated with substance use with such
conditions as hypertension, diabetes, asthma, or HIV is disingenuous as
those conditions are not illegal under the law and are protected by the
Americans with Disability Act, while active substance use is.
10. Trust is the corner stone of effective SUD treatment,
particularly for the treatment of those substances for which no
medication is available. Unconsented disclosure of sensitive
information derived from the records of those in substance use disorder
treatments may precipitate relapse and overdoses, given the violation
of trust associated with the unconsented release of such information.
11. Acquiring patient consent to disclose sensitive information
preserves trust and permits a balancing of policy interests associated
with facilitating integrated care.
12. The technology exists, although resisted by EHR vendors and
some health care systems, to facilitate patient consent to the
disclosure of sensitive information. The lack of interest in this
technology may be a product of the lack of incentives within the HITECH
Act for behavioral health treatment providers; patients interested in
SUD treatment should not be punished by this policy omission.
13. Further weakening of 42 USC 290-dd and 42 CFR Part 2 will
increase the administrative costs of substance use disorder treatment
programs due to liability issues associated with inappropriate
disclosures.
14. HIPAA contains a self-pay, out-of-pocket provision, that allows
those with the means to withhold sensitive information from their
health plans. 42 CFR Part 2, on the other hand, does not discriminate
based on economic status, thus permitting respect for the agency and
autonomy of the rich and the poor alike.
______
The Chairman. Thank you, Dr. Clark.
Mr. Shah, welcome.
STATEMENT OF SANKET J. SHAH, CLINICAL ASSISTANT PROFESSOR,
HEALTH INFORMATICS, UNIVERSITY OF ILLINOIS AT CHICAGO,
HINSDALE, ILLINOIS
Mr. Shah. Good morning, Chairman Alexander, Ranking Member
Murray, and Members of the HELP Committee.
My name is Sanket Shah and today, I am going to provide you
my view on how technology, specifically analytics, can help
curb the overuse, misuse, and abuse of opioids.
Healthcare data and analytics can play a key role in
helping to combat this national crisis. Descriptive,
diagnostic, predictive, and prescriptive analytics make it
possible to identify individuals who are at-risk of becoming
opioid dependent. Armed with this information and the right
technologies, healthcare providers and communities can make
better informed decisions and understand the risk of possible
dependency.
The first area we all should start with is descriptive
analytics. Descriptive analytics identify what is happening and
where.
According to a 2017 study published by the Blue Cross Blue
Shield Association, opioid use disorder diagnoses increased 493
percent from 2010 through 2016. The same study identified that
women aged 45 and older have higher rates of opioid use
disorder than males, while males under the age of 45 have
higher rates of opioid use disorder than females. We also know
that females fill more opioid prescriptions across all age
groups than males.
Once we understand what is happening, our focus must shift
to why it is happening. This is where diagnostic analytics come
into play.
For instance, we know potential determinants for opioid
dependency include gender, age, whether the patient sought
treatment for an acute injury or a chronic condition, and the
size and dosage of the prescription.
We also know that many patients engage in doctor and
pharmacy shopping practices to obtain harmful, large quantities
of opioids from various sources.
According to a report published by the Inspector General of
the United States Department of Health and Human Services, one
such egregious case in Illinois revealed a Medicare enrollee
received 73 prescriptions for opioid drugs from 11 prescribers
and filled them at 20 different pharmacies.
When you couple these factors with the lack of effective
risk assessment and decision support tools available to
providers, we miss the early warning signs for potential opioid
dependency.
Here we are. We already know the what and the why. The role
of technology and analytics can help prevent addiction. Here is
where we must focus on predictive analytics. Predictive
analytics enables us to leverage data to anticipate what is to
come.
For example, according to a study published in the
``British Medical Journal,'' the duration of opioid treatment
is a far more potent predictor of abuse and overdose than just
dosage alone. In fact, each additional week of opioid use
increased the risk of dependence, abuse, or overdose by nearly
20 percent. Each additional refill boosted the risk by 44
percent with the first refill doubling that risk.
To truly have predictive analytics, we need more data
sources. Currently, we find ourselves in data silos across the
public and private healthcare sectors.
My recommendation is to open the lines of communication and
pathways to share data for a holistic view to help combat this
epidemic.
The Federal Government has the means and infrastructure to
create an integrated data environment which we can source from
at the local and state levels. Having access to such a vast
data repository would enable us to create robust predictive
analytics that leverage multiple sources, including social
determinants of health, medical, and family history, and also
true episodes of care.
A secure and encrypted data repository would empower our
healthcare informaticists to administer and deploy innovative
technologies to enhance our predictive capabilities. We can
collaborate on advanced machine learning algorithms for deeper
pattern analyses from both the provider and patient fronts.
The insights gained could be tremendous. We all can
potentially benefit from these new technologies by knowing
which patients might respond better to non-pharmacologic,
multimodal therapies, or targeted care management programs.
To accomplish this, we simply need access to more substance
abuse data. I ask you all to consider and support the
Prescription Drug Monitoring Act of 2017 which requires any
state that receives Federal grant funding to establish a
Prescription Drug Monitoring Program to share their data with
other states.
In addition, I also ask you to consider supporting the
Protecting Jessica Grubb's Legacy Act, which calls for
modernizing Part 2, and allows for closer alignment with HIPAA
regulations, and sharing of substance abuse disorder records
for true, accurate diagnoses and effective treatment.
Our predictive analytics have identified at-risk
individuals for developing an addiction. We can use
prescriptive analytics to offer up actionable insights.
Providers and health plans can predict what may happen and make
the necessary changes to true, proper treatment plans.
Armed with actionable insights, new treatment models and
alerts can be developed to deemphasize opioid medication use
for at-risk individuals. This includes the right decision
support tools at the point of care.
Ultimately, technology alone will not help curb this
epidemic. We must also use the information and insights we have
gained to educate our providers, patients, and communities
about proper adherence and potential risks of opioid use.
America's prescription opioid epidemic continues to be a
public health crisis. However, using descriptive, diagnostic,
predictive, and prescriptive analytics, may provide an
opportunity to identify at-risk individuals and change the
course to help address this epidemic.
We have the data. I ask your help to share that data.
Thank you.
[The prepared statement of Mr. Shah follows:]
prepared statement of sanket j. shah
Good morning Chairman Alexander, Ranking Member Murray, and Members
of the HELP Committee. My name is Sanket Shah and today I am going to
provide you my view on how the role of technology, and more
specifically, analytics may help curb the overuse, misuse, and abuse of
opioids. Healthcare data and analytics can play a key role in helping
to combat this national crisis. Descriptive, diagnostic, predictive,
and prescriptive analytics make it possible to identify individuals who
are at risk of becoming opioid dependent. Armed with this information
and the right technologies, healthcare providers and communities can be
better informed about the risk of possible dependency.
The first area we all should start with is descriptive analytics.
Descriptive analytics identify what's happening and where. According to
a 2017 study published by the Blue Cross Blue Shield Association,
opioid use disorder diagnoses increased 493 percent from 2010 through
2016. The same study also has identified that women aged 45 and older
have higher rates of opioid use disorder than males, while males under
the age of 45 have higher rates of opioid use disorder than females. We
also know females fill more opioid prescriptions than males across all
age groups. \1\
---------------------------------------------------------------------------
\1\ ``America's Opioid Epidemic.'' Blue Cross Blue Shield
Association (BCBSA), 29 June 2017, www.bcbs.com/the-health-of-america/
reports/americas-opioid-epidemic-and-its-effect-on-the-nations-
commercially insured.
---------------------------------------------------------------------------
Once we understand what is happening, our focus must shift to why
it's happening. This is where diagnostic analytics come into play. For
instance, we know potential determinants for opioid dependency include
gender, age, whether the patient sought treatment for an acute injury
or a chronic condition, and the size of the dosage and duration of the
prescription. \2\ We also know that many patients engage in doctor and
pharmacy shopping practices to obtain harmful quantities of opioids
from various sources. According to a report published by the Inspector
General of the United States Department of Health and Human Services,
one such egregious case in Illinois revealed a Medicare enrollee
received 73 prescriptions for opioid drugs from 11 prescribers and
filled them at 20 different pharmacies. \3\ When you couple these
factors with the lack of effective risk assessment and decision support
tools available to providers, we miss the early warning signs for
potential dependency.
---------------------------------------------------------------------------
\2\ America's Opioid Epidemic. BCBSA.
\3\ ``Opioids in Medicare Part D: Concerns about Extreme Use and
Questionable Prescribing.'' HHS OIG Data Brief, July 2017, oig.hhs.gov/
oei/reports/oei-02-17-00250.pdf.
---------------------------------------------------------------------------
Here we are, we already know the what and the why. The role of
technology and analytics can help prevent addiction. Here is where we
must focus on predictive analytics. Predictive analytics enables us to
leverage data to anticipate what is to come. For example, according to
a study published in the British Medical Journal, the duration of
opioid treatment is a far more potent predictor of abuse and overdose
than just dosage. In fact, each additional week of opioid use increased
the risk of dependence, abuse, or overdose by nearly 20 percent. Each
additional refill boosted the risk by 44 percent with the first refill
more than doubling the risk. \4\
---------------------------------------------------------------------------
\4\ Brat, Gabriel A, et al. ``Postsurgical Prescriptions for
Opioid Naive Patients and Association with Overdose and Misuse:
Retrospective Cohort Study.'' Bmj, Dec. 2017, doi:10.1136/bmj.j5790.
---------------------------------------------------------------------------
To truly have accurate predictive analytics we need more data
sources. Currently, we find ourselves in data silos across the public
and private healthcare sectors. My recommendation is to open the lines
of communication and pathways to share data for a ``holistic view'' to
help combat this epidemic. The Federal Government has the means and
infrastructure to create an integrated data environment which we can
source from at local and state levels. Having access to such a vast
data repository will enable the creation of robust predictive analytics
that leverages multiple variables such as social determinants of
health, family and medical history, and access to complete episodes of
care. A secure and encrypted data repository would empower our
healthcare informaticists to administer and deploy innovative
technologies to enhance our predictive capabilities. We can collaborate
on advanced machine learning algorithms for deeper pattern analyses
from both the provider and patient fronts. The insights gained could be
tremendous. We all can potentially benefit by knowing which patients
might respond better to non-pharmacologic, multi-modal therapies, or
targeted care management programs.
To accomplish this, we simply need access to more substance abuse
data. I ask you all to consider and support the Prescription Drug
Monitoring Act of 2017 (S. 778) which requires any state that receives
Federal grant funding to establish a prescription drug monitoring
program to share their data with other states. In addition, this act
also contains components to help fund a data sharing hub which I spoke
of earlier. I also ask you all to consider supporting the Protecting
Jessica Grubb's Legacy Act (S. 1850) which calls for modernizing Part 2
to align with HIPAA regulations and will grant appropriate sharing of
substance use disorder records to ensure persons with opioid use
disorder and other substance use disorders receive accurate diagnoses
and effective treatment.
Once predictive analytics have identified at-risk individuals for
developing an addiction, we can use prescriptive analytics to offer up
actionable insights. Providers and health plans can predict what may
happen and make the necessary changes to treatment plans. Armed with
actionable insights, new treatment models and alerts can be developed
to de-emphasize opioid medication use for at-risk individuals. This
includes the right decision support tools for our providers at the
point of care.
Ultimately, technology alone will not be able to curb this
epidemic. We must also use the information and insights we have gained
to continue to educate our providers, patients, and communities on the
proper adherence and potential risks of opioid use. America's
prescription opioid epidemic continues to be a public health crisis.
Using descriptive, diagnostic, predictive, and prescriptive analytics,
we have an opportunity to identify at-risk individuals and change the
course to help address the epidemic.
We have the data. We need your help to share it.
List of recommendations to consider:
Pass S. 778--Prescription Drug Monitoring Act of 2017
Pass S. 1850--Protecting Jessica Grubb's Legacy Act
Create and enable authorized access to an integrated,
secure data repository for opioid prescriptions, treatments,
overdoses, and individuals at risk
______
[Summary Statement of Sanket J. Shah]
Using healthcare data and analytics can play a key role in helping
to combat this national crisis. Descriptive, diagnostic, predictive,
and prescriptive analytics make it possible to identify individuals who
are at risk of becoming opioid dependent. Armed with this information
and the right technologies, healthcare providers and communities can be
better informed about the risk of possible dependency.
We know potential determinants for opioid dependency include
gender, age, whether the patient sought treatment for an acute injury
or a chronic condition, and the size of the dosage and duration of the
prescription. \1\
---------------------------------------------------------------------------
\1\ America's Opioid Epidemic. BCBSA.
---------------------------------------------------------------------------
To truly have accurate predictive analytics we need more data
sources. Currently, we find ourselves in data silos across the public
and private healthcare sectors. My recommendation is to open the lines
of communication and pathways to share data for a ``holistic view'' to
help combat this epidemic. The Federal Government has the means and
infrastructure to create an integrated data environment which we can
source from at local and state levels. Having access to such a vast
data repository will enable the creation of robust predictive analytics
that leverages multiple variables such as social determinants of
health, family and medical history, and access to complete episodes of
care. A secure and encrypted data repository would enable our
healthcare informaticists to administer and deploy innovative
technologies to enhance our predictive capabilities. This includes
advanced machine learning algorithms for deeper pattern analyses from
both the provider and patient fronts.
To accomplish this, we simply need access to more substance abuse
data. I ask you all to consider and support the Prescription Drug
Monitoring Act of 2017 (S. 778) which requires any state that receives
Federal grant funding to establish a prescription drug monitoring
program to share their data with other states. In addition, this act
also contains components to help fund a data sharing hub which I spoke
of earlier. I also ask you all to consider supporting the Protecting
Jessica Grubb's Legacy Act (S. 1850) which calls for modernizing Part 2
to align with HIPAA regulations and will grant appropriate sharing of
substance use disorder records to ensure persons with opioid use
disorder and other substance use disorders receive accurate diagnoses
and effective treatment.
Once predictive analytics have identified at-risk individuals for
developing an addiction, we can use prescriptive analytics to offer up
actionable insights. Providers and health plans can predict what may
happen and make the necessary changes to treatment plans.
Using descriptive, diagnostic, predictive, and prescriptive
analytics, we have an opportunity to identify at-risk individuals and
change the course to help address the epidemic.
List of recommendations to consider:
Pass S. 778--Prescription Drug Monitoring Act of 2017
Pass S. 1850--Protecting Jessica Grubb's Legacy Act
Create and enable authorized access to an integrated,
secure data repository for opioid prescriptions, treatments,
overdoses, and individuals at risk
______
The Chairman. Thank you, Mr. Shah, and thanks to each of
you.
We will now have a round of 5 minute questions from
Senators. We have a number of Senators, so if you will try to
keep the questions and answers within 5 minutes, everyone can
participate.
Senator Young.
Senator Young. Mr. Shah, I enjoyed your testimony where you
spoke, quite a bit, about the potential descriptive,
diagnostic, predictive and prescriptive analytics, and their
potential to make it possible to identify individuals who are
at-risk of becoming opioid dependent.
I see limitless opportunities to harness these tools. Not
just in the area of healthcare and improving health outcomes,
but proactive policing. We are starting to see it in various
geographies. Our office is working on child abuse prevention
through the utilization of some of these tools.
What can the Federal Government do now to encourage
exploration, more exploitation of these analytic tools while
ensuring patient protections?
Mr. Shah. Thank you for the question.
Well, there are a couple of things I mentioned in my
testimony here. I think that the Prescription Drug Monitoring
Act of 2017, first of all, allows opening up the doors, if you
will, for states to access data from states that are currently
employed in the Prescription Drug Monitoring Programs. So
sharing of that data will enable opening up some insights that
we can share at local, state, and Federal levels.
In addition to that, I think part of the question also
revolves around privacy and ensuring that we have our
communities protected. When you are looking at this epidemic
and you are looking at patient safety, it is imperative that we
do leverage substance abuse disorder records to identify
patterns, identify deeper analytics, and then share that
amongst communities.
As it relates to safety and privacy, part of that includes
protecting the data and accessing it in a protected environment
and in an encrypted environment, if you will. So I think that
would address some of the concerns from the public as it
relates to sharing some of their data. Again, the focus here is
to really handle the data with care and then ultimately benefit
these communities across the U.S.
Senator Young. Yes, there are some serious privacy
concerns. We need to make sure we do our very best to address,
and not confuse, wherever possible correlation with causation,
as they say, as well. Right?
I see some affirmative nods from our panelists.
Mr. Shah, specifically talking about predictive analytics,
which you brought up, analytics that enable us to leverage data
to anticipate what is to come.
In order to use this tool, you claim we need more data
sources and open communication. We need to break down the data
silos across the private and public healthcare sectors, and
then connect the dots, as it were.
Can you elaborate on what those data silos are and then
tell me why we cannot tear down these silos right now? Does
this have, in part, to do with market power and vendor
interest? Or are there other legal barriers or are there other
dynamics that you would like to speak to, sir?
Mr. Shah. Sure.
Well, there are a lot of stakeholders, and data is very
important to these individual stakeholders. You have the
provider systems. You have the payer systems. You have
pharmaceutical companies. And then, you also have consumer-
created data as well.
A part of the barrier here is just identifying an
environment and creating an environment to access the
information, collaborate.
Part of the concern here is that most organizations are
very protective of their data because it is certainly an asset
for that particular organization.
We are starting to get there, as it relates to sharing some
of our important data from a consumer perspective and it is
also from a private industry perspective. But the challenges
remain and I think we need assistance to help break down those
barriers.
Senator Young. What options, if you have some in mind, do
we have for action at the Federal level to catalyze or
incentivize change in this area that facilitates more data
sharing?
Mr. Shah. One suggestion I would have is to, again, part of
that Prescription Drug Monitoring Act of 2017 is to create an
integrated data source that we can all pull from. It would be a
secure data source leveraging public data that is available.
Senator Young. Yes.
Mr. Shah. Ultimately with the goal to, hopefully, bring in
some of the private data as well so we can start to leverage
this for not only research and development purposes, but also,
as you mentioned, for some predictive capabilities across
various different industries.
Senator Young. Would you sit down with me, obviously after
this hearing, but to dive a little deeper on this issue? I am
not sure, in terms of methodology, how we get there.
Maybe the National Academy of Sciences could help. We could
commission them to establish data standards that, over a period
of years, would be adopted.
Mr. Shah. Sure.
Senator Young. The private sector would understand that.
There, no doubt, would be resistance to this idea. I am Okay
with resistance, if it is the right thing to do.
Would you, or other stakeholders, other panelists, or
people watching these proceedings, I just welcome them to work
with our office on this?
Thanks so much for being here, all of you.
The Chairman. Thank you, Senator Young.
Senator Murray.
Senator Murray. Well, thank you, to all of our panelists
today.
Dr. Mahon, let me start with you.
Throughout our hearings, we have heard about the need for
more options for states' opioid disposal. I was particularly
interested in the drug disposal bags you mentioned during your
testimony, which offer, I assume, individuals a way to dispose
of dangerous drugs on their own.
Tell us a little bit about those bags. Who provides them?
How do they work and whether they could be made more widely
available?
Dr. Mahon. Absolutely.
As part of our disposal bag that we provide to all of our
patients, any time a patient fills a first-time opioid
prescription, we mail them a disposal bag. Express Scripts will
mail the member a disposal bag to their home with instructions
on how to properly, safely dispose their unused medications.
Then we also subsequently offer the consultation by the
specialized pharmacists who can continue to have the
conversation with the member on any questions that they may
have about proper disposal.
The way the bags work, they have activated carbon inside
the bag where the member just simply pours a little bit of
water and their pills in the bag. It immediately renders the
drug deactivated and the bags themselves are biodegradable.
They are safe to be disposed in the member's home.
We really feel that that is the best mechanism to allow
members safe disposal in their home.
Senator Murray. Are you finding that people use them?
Dr. Mahon. Yes. We even are having members respond back to
us. They are writing us letters and notes back.
One, thanking us for the educational letters we are sending
them and basically saying, ``Thanks for the heads up.''
Two, ``Thank you for letting me or giving me large enough
of a bag where I can dispose not just my own medications, but
my family's unused medications,'' to be able to properly get
them out of the homes.
Senator Murray. Is there any way we can make these more
widely available? Do you have any ideas?
Dr. Mahon. What we have seen in our program, what works
really well, is having a targeted, data-driven approach. So not
just giving the disposal bags at random times during the year,
but really, when it matters the most: when the patient is just
leaving the pharmacy counter and they are going home.
We know that they have gone home with that medication. They
are probably going to have some additional meds left; giving it
to them at that time, and then having that correlation with
that specialized pharmacist that is coaching them through the
process, really helps.
Senator Murray. Interesting. Thank you.
Ms. Green, you talked about the potential use of PDMP's to
combat the opioid crisis, but also the need for data standards,
so these programs can be effective.
Can you provide some examples to us about how data and
requirements for maintaining data can be different across
PDMP's, and how that can lead to systems that are not able to
communicate or share information effectively?
Ms. Green. Certainly.
Right now, we have a number of standards about who can
access the data and under what conditions, and those can vary
from state to state.
For example, one of the best options we have with PDMP's is
to facilitate widespread integration of the data into
Electronic Health Records. And yet, we have a number of states
that do not allow the PDMP report to actually be placed into
the Electronic Medical Record, and they have different
standards for access and use of that data, once it is actually
in the medical record.
We need consistent standards for placing the PDMP report in
a medical record and upon placement, allowing all of the same
standards for use and disclosure that apply to other
information in that medical record to apply to the PDMP data.
Those are the kinds of standards we now need to be
reconciling and making more uniform.
Senator Murray. Do we need some single data hub to ensure
interoperability or is there another way to do it?
Ms. Green. We already have 44 states that are actually
sharing data and the others that are in the process of making
legal changes.
But I would suggest, yes, we need a federally funded,
single hub that is based on the interests and the needs of
states and the public officials at the Federal level because
that is what will generate the reconciling and the uniformity
of some of these standards so that we can maintain the
interest.
Some of the differences are occurring in different states
because of some of the particular interests that have been
affecting the laws and policies that go through some of the
states.
If we can create uniformity at the Federal level, have it
be federally funded, then we can create the kind of uniformity
and standards that we are all looking to do at this point in
time. And that would be under the Prescription Drug Monitoring
Act of 2017.
Senator Murray. And Dr. Clark, real quick, I am encouraged
by data sharing, but I am concerned about individual privacy,
especially when people with substance use disorders are worried
that their treatment could impact their job or family, and may
discourage them from getting care.
What issues do we need to be aware of when it comes to
protecting patient privacy?
Dr. Clark. First, we need to distinguish between those
people who are at-risk from those people who already have
developed a substance use disorder problem and are seeking
treatment. Those are two different populations of people.
Predictive analytics work very well for those people who
are at-risk, but for those people who are attempting to present
their treatment, we need to keep in mind they are much more
vulnerable than the former group.
What we do not want to do is to discourage people, who are
trying to get treatment, from postponing that treatment.
Because if they postpone treatment, then they continue their
demand for illicit substances or the misuse of alcohol while
their children, and their employer, and others are trying to
cope with them.
As Sally Satel, M.D. pointed out, ``We must be realistic
about who is getting in trouble with opioid pain medications.
Contrary to popular belief,'' she said, ``It is rarely the
people for whom they are prescribed. Most lives do not come
undone, let alone end in overdose after analgesia for a
specific problem.'' We should not let these different
populations of people----
Perhaps that is what we could use predictive analytics for,
is to differentiate the populations so that we could have
appropriate standards with that.
Senator Murray. Thank you.
The Chairman. Thanks, Senator Murray.
Senator Cassidy.
Senator Cassidy. Thank you all.
Ms. Green, I came in on the tail end of Senator Murray's
criticism of PDMP data, but what I heard, I am thinking,
``Right on.''
You say 44 states--and I am not challenging you, I am just
exploring--44 states share data, but do they share all of each
other or just interstate compact?
Ms. Green. It depends on the states. Some states share
widely across, some states have decided to only share within
their region, and the reason for that----
Senator Cassidy. That is fine.
Ms. Green. Yes, Okay.
Senator Cassidy. We have limited time. I do not mean to be
rude.
Ms. Green. That is all right.
Senator Cassidy. As I know, and I have mentioned before,
Missouri, for example, does not have PDMP.
But it is also my understanding that a lot of states do not
real time put up their data. There is a delay and that most
states do not allow it to be shared with law enforcement. And I
read--I do not know if it is up to date--that in 17 states, the
Veterans Administration does not share data with the PDMP.
Is all of that correct as far as you know?
Ms. Green. Not quite.
Law enforcement is able to access in every state, but the
standard is different. Twenty-eight states allow it based on
bone fide investigation, others use a court ordered subpoena.
Senator Cassidy. But in terms of Mr. Shah's hope that it
can be used proactively, relatively few allow a proactive
sharing.
Ms. Green. That is correct because PDMP laws are very
specific about who can access the system for what purpose, and
that purpose of proactive sharing would have to actually be
written into the laws.
Senator Cassidy. Now, Ms. Mahon, after Hurricane Katrina,
it was amazing. All these patients had been displaced on
chemotherapy, everything else. And somebody flipped a switch,
and every doctor treating a Katrina evacuee had access to their
prescription data. It was amazing.
A doctor in Oklahoma City seeing one of my patients could
access my patient's records and would call me, but he then knew
the Interferon my patient was on, and the complications, et
cetera, etc.
It tells me--and I have actually seen an even more robust
data base than this--that we are futzing around with PDMP's,
but someone like you, Express Scripts, already has a more
robust dataset than PDMP's.
Is that a fair statement?
Dr. Mahon. We have the dataset of the information if the
member is using their pharmacy benefit card at the pharmacy
counter. So if the patient chooses not to use their pharmacy
benefit, and they are paying cash for their prescription, those
are the claims that we would not see.
Senator Cassidy. When I say I have seen a more robust
version, I have seen a robust version of a dataset which now
includes the cash payment. Every Veterans Administration is
real time as in when the pharmacy fills it, it is uploaded.
This is a mechanism to avoid for a compliance with anti-
kickback regulations with government programs.
We are, again, futzing around with PDMP with all its
limitations and we have before us a robust dataset that is even
better than what I saw after Hurricane Katrina.
Mr. Shah, this seems like nirvana for someone like you. You
can sort by provider. You can sort by patient and, I presume,
geolocate within this dataset.
Would you agree?
Mr. Shah. Yes, absolutely. I would definitely agree with
that, especially from an analytic point of view.
When we have a conformed dataset like that, you can slice
and dice from various different factors, get to the root cause
drivers of certain trends.
Certainly to your point, Senator Cassidy, it absolutely
would be ideal.
Senator Cassidy. To believe that this dataset exists and is
compliant with current law, then we should be exploring how to
use it.
By the way, I have a bill in for PDMP because right now,
that is the only weapon you have to fight this war against
opioid abuse. You need to use it, but I keep on saying, we
should go nuclear. We should be using this dataset, not the
PDMP, and I just say to assert.
Dr. Clark, you probably gathered I am a doctor,
hepatologist, treated a lot of patients with liver disease, and
some patients with liver disease got theirs from shooting
drugs. Some are actively shooting drugs.
I say this not to challenge, but again to explore. If you
looked at the history of somebody I was treating, I would have
everything. He shot drugs in the past or he is still shooting
drugs. When did you stop? Did you share a needle? Sexually
transmitted disease. Have you had a blood transfusion? Did your
mother have hepatitis when you were born? All this stuff. What
is your mental health history? Because if I am going to treat
him with Interferon, that is what we were using at the time,
mental health was very important.
Now all that was covered under HIPAA, not under the mental
health provisions. So your sensitivity, I thoroughly respect.
My gosh. If somebody had come for those records, I would have
barred the door and used whatever weapons I could to keep
somebody from using those. But at the same time, you sense that
there should be a greater sensitivity. But I would, again,
point out that I had all that information whether the person
was bipolar, for example.
Knowing that you are the advocate, and not challenging you,
but just to explore. Why would HIPAA not be adequate when,
frankly, I am already getting that data and I am only covered
by HIPAA because I am not a mental health professional?
Dr. Clark. I think we need to be careful about a
presumption of dysfunction. We also need to distinguish
monitoring from surveillance.
If we are not careful, we will wind up viewing patients as
dysfunctional by definition and we will be using healthcare
records for purposes of surveillance for purposes beyond----
Senator Cassidy. Okay. Now that is totally foreign from
what I was saying.
Dr. Clark. No, it is not, sir. I am not just trying to
argue with you.
I am just saying when you start creating larger scale data
bases for the purposes of predictive analytics, you need to be
concerned about surveillance. When you start regarding every
patient as being dysfunctional from the outset, then you need
to be concerned about surveillance, and that is what concerns
me.
One of the things about 42 CFR Part 2 is you inform the
patient. You ask the patient. Dr. Mahon's perspective----
Senator Cassidy. You have to be brief, because the Chairman
is about to start rapping on us.
Dr. Clark. Yes. In Dr. Mahon's perspective, you have the
patient actively involved.
The Chairman. We are over time.
Dr. Clark. The patient's consent is a guarantee.
Senator Cassidy. I yield back. Thank you for your
forbearance.
The Chairman. Thank you, Dr. Cassidy. I am sure we will get
back into that subject.
Senator Bennet.
Senator Bennet. Thank you, Mr. Chairman.
Thank you to the panel for sharing your expertise on this
important issue.
One Coloradan dies every 17 hours from an opioid overdose.
Our state, as a result, is already trying to make strides to
prevent the spread of opioids with technology.
When I recently visited the University of Colorado Health
Emergency Room, I saw how they used Electronic Health Records,
in conjunction with their prescription drug monitoring program,
to obtain the information they need in just one click. Patients
leaving the E.R., as a result of this, are leaving with
prescriptions for pain medications have dropped from 20 percent
of patients to 12 percent over a 3-year period.
Last year, the state also passed a bill to expand provider
access to PDMP, so they can better identify patients at high
risk of doctor shopping or opioid diversion.
Today, I will be introducing the Every Prescription
Conveyed Securely Act along with Senators Warren, Heller, and
Toomey. The bill directs providers to use electronic
prescribing for opioids and other controlled substances
prescribed under Medicare Part D. The aim is to reduce
fraudulent prescriptions, give providers and pharmacists real
time information on opioid use, and streamline prescribing for
both the provider and the patient.
I wonder, Dr. Mahon, if you could say a word about that
bill and what you have seen in states that have required
doctors to e-prescribe controlled substances?
Dr. Mahon. Absolutely, and thank you very much for the work
on this, Senator.
What we have seen specifically, there are seven states
today that currently do utilize electronic prescribing. In
particular, the State of New York mandated not just electronic
prescribing for all prescriptions, but in particular,
controlled substances.
What we have seen in our data, looking at the 2017 data in
our claims that 89.8 percent of all controlled substances are
now being e-prescribed in the State of New York compared to
only 21 percent nationally.
That really tells us that having this information is going
to be critical and crucial in helping identify, track, and
manage these controlled substances that, today, we certainly do
not have the ability to do so.
Senator Bennet. Thank you.
Before I go to Mr. Shah, Mr. Chairman, I wonder whether I
could enter into the record a letter of support for that bill
from a number of organizations, including one represented here.
The Chairman. It will be.
Senator Bennet. Thank you, Mr. Chairman.
The Chairman. Thank you.
Senator Bennet. Mr. Shah, in your testimony, you spoke
about the problems associated with doctor and pharmacy
shopping. You gave an example about a Medicare enrollee that
received 73 prescriptions, I think it was----
Mr. Shah. Yes.
Senator Bennet [continuing]. For opioid drugs from 11
prescribers and filled them at 20 different pharmacies.
Do you think by expanding electronic prescribing, would
that help to reduce these kinds of fraudulent transactions?
Mr. Shah. Yes, absolutely. I mean, there are two factors to
that.
One, prescribers are able to pull up information about
where this particular patient has gone or how many times they
are refilling it in near real time.
Quite importantly, I think what Senator Murray had talked
about a little earlier, is in some states having providers
actually look at the PDMP data bases to identify, ``There is
something going on with a particular individual. They just had
a refill 7 days ago. Maybe I want to consider an alternative
pain therapy or some member education or patient education
options.''
To answer your question, I think that would certainly be
something that would help curtail this doctor, pharmacy
shopping that we are seeing amongst our communities.
Senator Bennet. Thank you. I appreciate that testimony.
I hope, Dr. Clark, that we will be able to overcome our own
presumption of dysfunction in the U.S. Congress and actually
move some of this legislation forward.
Grateful to the panel.
The Chairman. Thank you very much, Senator Bennet.
Senator Isakson.
Senator Isakson. Mr. Shah, is there any convincing evidence
and data that shows how many people overdose on opioids that
were prescribed and how many overdosed on opioids that were
obtained--it might have been prescribed to somebody--but were
obtained illegally in some other mechanism?
Mr. Shah. Sir, your question, I believe is there any
evidence on where individuals that have obtained----
Senator Isakson. Get it illegally.
Mr. Shah. I do not have any of those figures with me right
now, but I know there are studies of individuals that have
obtained prescriptions through legal means, quite frankly, and
then there are also figures in articles that I have read where
individuals are stealing prescriptions or obtaining them
illegally.
I do not, unfortunately, have the statistics to answer your
question right now.
Senator Isakson. But it is true that a lot of legally
obtained opioids are, in fact, sold or otherwise distributed to
people.
Mr. Shah. Absolutely. Yes. One hundred percent.
Senator Isakson. I will tell you a number. My staff is
responsible for the credibility of this number. I am not taking
responsibility for it, although I have a great staff and he is
behind me.
[Laughter.]
Senator Isakson. I am sure he is right, but I could not
believe it when I read my homework last night.
In the State of Georgia, we have over 541 million doses of
opioid circulating in the state. That is 54 doses for each man,
woman, and child living in our state. That is a state of 10.5
million people.
How does that sound to you in terms of accuracy?
Mr. Shah. It does sounds accurate, yes.
Senator Isakson. It is way too much and it is way too many.
A year ago Monday, I had some major surgery. When I became
conscious and started recognizing what was going on post-
surgery, I got into an educational session with my physician
and the pharmacist on opioids, Oxycodone, Hydrocodone, all
kinds of things like that.
Because of being a United States senator, and having a
great Chairman like Lamar Alexander, and people who focus on
things like the opioids, and people like you testifying--even
though I was still recovering from the surgery and anesthetic
that I had--I knew that was dangerous stuff.
I asked him, ``Are there alternatives to Hydrocodone and
other things that I could go ahead and take? I do not want to
run the risk of getting anything bad.''
Basically, I was prescribed 6 Tylenols a day and dealt with
my pain with 6 Tylenols a day. My discomfort, it did not deal
with all the pain.
Do we do a good enough job of aggressively counseling
patients who have procedures that are painful by recommending
alternative sources other than opioids?
Mr. Shah. I have a personal example to share with you as
well. To answer your question, I think not enough of a good
job, but we are getting there.
My father actually had knee surgery in Chicago where, a
very similar situation. An immigrant here, does not speak a lot
of English that well, and the provider had come in and just
said, ``Here are your prescriptions.'' They happened to be
opioid prescriptions, of course, for pain management after the
knee surgery without much follow-up or education in that sense.
So, I think, to answer your question.
Then, there are all these alternatives, but we have to be
careful with those alternatives because of the CDC, I believe,
had released a study here on morphine equivalents which, in
high dosages, can be just as detrimental as what you are seeing
with traditional opioids like you said with the Hydrocodone,
OxyContin, and Percocet, and whatnot.
We are getting there. It is still about education. I think
we continue the education of the providers and our member
communities as well.
Senator Isakson. Well, everybody's testimony has been
fantastic, and I appreciate it a lot, but you have all really,
in one way or another, endorsed the more data, the better.
Better for predictive analytics, which is a great term. It
sounds like I went to Georgia Tech when I say that. I did not
go there, but it sounds good anyway.
We can better cast when somebody would be at-risk and
hopefully get them into a preventive environment before they
ever are tempted with drugs would help us an awful lot. And I
think it would be one of the roles this Committee can take.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Isakson.
Senator Kaine.
Senator Kaine. Thank you, Mr. Chairman.
Thank you to the witnesses.
Here is a question that was suggested to us from my Medical
Society of Virginia physicians. They indicate that in Virginia,
Federal requirements for electronic prescribing software for
opioid medications and other controlled substances are very
onerous, expensive, and they are not easily compatible with
existing e-prescription software so that the Federal
requirement does not match the existing software.
The barriers make many small and medium sized providers
reluctant to e-prescribe controlled substances, leading to gaps
in data and less secure prescriptions.
What regulatory barriers exist to making opioid related e-
prescribing software more affordable and accessible to
providers? What is Express Scripts, or other EHR vendors, doing
to make the opioid e-prescription software more affordable and
more integrated with existing e-prescribing platforms?
Dr. Mahon. Thank you for the question, Senator.
I will start this off with just really understanding the
technology. While certainly there may be some initial humps and
hurdles you have to get through, once the providers are on an
e-prescribing platform, it really is pretty simple to go
through the authentication processes.
This technology has advanced, especially just in the last
12 months. We went from having to require a key fob
authentication to now just requiring your fingerprints to be
scanned to now just even using a smart application to get
through the system. So it really is just moving with the
technology, where it is going, and really allowing providers to
get through the process much more simply.
In terms of other barriers or it could be rural barriers,
lack of Internet access or things like that, we do believe that
those can be overcome as well.
Then in terms of the expense or the cost piece of getting
approved for e-prescribing, it is relatively inexpensive. It is
typically around $100 to get e-prescribing software and
licenses once you are on an e-prescribing platform.
Overall, we definitely see the technology is evolving that
this is really going to become a pretty simple process.
Senator Kaine. Do the other witnesses have anything
additional to add on that?
Mr. Shah.
Mr. Shah. Yes, I will speak to the data interchange issues
that you had alluded to.
To address that, there is certainly technological advances
that are happening every day. Quite frankly, we can work with
some of these private vendors through API's to get data
interchanged in a conformed format. But that requires
collaboration, quite frankly.
To answer your question about some of the challenges, yes,
that is part of the sharing, getting that data from various
different sources unstructured or not. We have the means
through technology to integrate and assimilate that data in a
conformed fashion.
I think that is a barrier that can be easily overcome, but
it will require some collaboration, as I mentioned earlier.
Senator Kaine. Let me ask one other question, and actually,
Dr. Clark, this might be a good question for you, but others
could weigh in too.
In the immediate preceding Congress, Senators Toomey,
Portman, Brown, and I acted together to include a provision to
establish a lock-in program for Medicare Part D for controlled
substances, similar to the lock-in program that was already
existing in Medicare.
These lock-in programs, as you know, prevent inappropriate
prescriptions from crossing the pharmacy counter by locking in
certain beneficiaries at-risk of drug abuse into choosing, and
they get to choose, but then once they choose, they choose a
sole prescriber and pharmacy.
Those who worked on the provision, we were having some real
concerns about the way CMS is approaching it, that they are
taking a very limited approach to the kinds of at-risk
beneficiaries that should be included in the lock-in program in
Medicare Part D.
I wonder if you would talk about what you think are the
benefits and disadvantages of lock-in programs, and what we
might do to make sure that we do it in an effective way.
Dr. Clark. Well, sir, first to your earlier point, I wanted
to point out that we want to make sure that technology does not
change so fast that the practitioners in the field cannot keep
up with it, and that is an essential point. As a physician,
that is something that you struggle with.
That gets to the next question about the lock-in program.
As a senior citizen, I want to make sure I can have access
to geographically accessible and administratively accessible
prescription programs. I do not object to lock-in programs per
se, but we want to make sure that senior citizens are not
precluded from accessing care. I have a 99-year-old mother. She
has limited physical abilities. I am 72 this year myself.
If, in fact, we create programs that prevent people having
access, then basically we get back to my earlier assumption of
the presumption of dysfunction and senior citizens will bear
the burden of that.
Senator Kaine. It is not just senior citizens, because
Medicaid is a similar program.
But are there other comments on lock-in programs quickly?
Ms. Green. Yes, if I can quickly say this.
Lock-in programs are great for reducing the use of specific
drugs, but we need a corresponding increase in support by
public and private payers for non-opioid alternatives for
treatment.
Senator Kaine. Great. Thank you very much.
Thanks, Mr. Chairman.
The Chairman. Thanks, Senator Kaine.
Senator Roberts.
Senator Roberts. Thank you, Mr. Chairman.
Many thanks to you and Senator Murray. I think this is the
fifth hearing that we have had here. Thank you for your
leadership.
I am the co-Chairman of the Senate Rural Healthcare Caucus
and I am particularly concerned with the growing rise of the
opioid epidemic and substance abuse in rural areas.
Senator Donnelly and I introduced legislation last year
that would help our rural areas develop substance abuse
prevention, treatment, and recovery facilities.
Tomorrow, this Committee will mark-up legislation that I
introduced to reauthorize the State Offices of Rural Health.
These offices, obviously, play a very critical role in
strengthening the rural healthcare delivery system by
collecting and disseminating data that helped inform the Senate
to make good decisions.
Ms. Green, how can we ensure that Federal, state, and local
efforts to combat the opioid crisis take into account the
unique situation faced by rural Americans?
Ms. Green. We need to increase our efforts for tele-health
in projects like Project ECHO out of New Mexico, which is
specifically designed to match up practitioners in rural areas
with specialists on opioid addiction at various specialty hubs.
That would be one of the best efforts we can make to ensure
that there are appropriate resources available to address the
opioid problem.
Senator Roberts. What role can state offices of rural
health play in ensuring that the opioid policies are based on
reliable data and sound evidence?
Ms. Green. In terms of getting reliable data, one of the
best things we can do in making sure we have reliable data is
to ensure that there is effective coordination at the state
level, as well as the Federal level, for the types of data,
patient data that we should be consolidating and making
available to different practitioners at different levels--
local, state, and Federal--to be able to address the opioid
crisis.
We do not have enough consolidation of patient data, and
there is no comprehensive patient prescription history or
patient history in any one single source yet.
Senator Roberts. We are at the base of the mountain.
On the Senate Finance Committee, I am interested in the
potential for the electronic authorization--I may be going over
plowed ground here--or e-prior authorization within Medicare
Part D to strike a proper balance between limiting the
unnecessary dispensing of opioids and avoiding overly
burdensome requirements.
Dr. Mahon, you mentioned in your testimony some successful
opioid management initiatives, including the use of prior
authorization for certain prescriptions. But I have
consistently heard from constituents with concerns about the
burdens this practice can place on physicians and patients.
How can e-prior authorization be used by Medicare Part D
and Medicare Advantage plans to help uphold responsible
dispensing of opioids while reducing the physician and patient
burden?
Dr. Mahon. Thank you for the question, Senator.
Certainly, as we have seen in our data in our program that
if a physician absolutely needs to provide more medication to
any given member, they have the ability to request an
authorization, a prior authorization of that drug.
Where our electronic prescribing is going to be critical is
prior to the point of prescribing, the physician will already
know if this particular drug requires the quantity level or a
prior authorization. So they are able to go through that
process pretty quickly without having to do it after the fact,
which is what is really important as we continue to manage this
opioid epidemic.
But in particular, what we saw in our data was that only 4
percent of all providers who initially wrote a prescription for
a 30-day supply--subsequently got reduced to a 7-day supply--
requested an authorization to give the member more than seven.
Senator Roberts. Four percent.
Dr. Mahon. Only 4 percent of doctors requested an
authorization where they basically said, ``Thank you. This
patient only needs a 7-day supply and it is sufficient.''
Senator Roberts. Well, I thank you for that.
The FDA has approved several Abuse Deterrent Formulations,
or the ADF's, in recent years, which have shown effectiveness
in reducing opioid misuse and abuse. However, many patients
still lack the proper access to these drugs due to all sorts of
factors.
What policy should the Federal Government consider to
increase patient access to ADF's and what is the relationship
between the ADF's and prior authorization?
Dr. Mahon. From our standpoint, we do caution you to avoid
allowing more ADF's into the system. The reason for that is
these medications are not necessarily abuse-proof. So they
could be an abuse deterrent, but they are not abuse-proof and
that is really the big difference that individuals can still
continue to overdose on these medications.
There are many different techniques online that you can
just go and look. How do I boil, or cook, or do whatever you
can do from these medications?
It is really critical that we do not rely just on ADF
medications as a single tool. We need to rely on this epidemic
to really solve it from multiple angles. Educating the
physicians, working with the pharmacies, consulting the members
to really solve the problem, and ADF's alone are not going to
be able to do that.
Senator Roberts. I appreciate it.
I yield back, Mr. Chairman. Thank you very much.
The Chairman. Thank you, Senator Roberts.
Senator Smith.
Senator Smith. Thank you very much, Chairman Alexander and
Ranking Member Murray.
I really appreciate this meeting today and all of your
testimony.
We all know, because we have been sitting through these
conversations, that roughly 75 percent of people who began
abusing opioids in the 2000's got there through an opioid
prescription. We are so focused on trying to figure out how we
can tackle this by improving the use of data.
Chairman Alexander, I have a letter from Prime
Therapeutics, which is a company headquartered in Minnesota,
which is also doing some really good work on this.
I would like to ask consent to enter this into the record
on their behalf.
The Chairman. It will be included.
Senator Smith. This letter identifies that Prime has
figured out how to achieve a 71 percent decline in the number
of high risk opioid users through their work which, I think,
gives us some hope in this difficult time.
But Ms. Green, I wanted to ask you, and really, anybody on
the panel, just one more question about this issue of what we
can do at the Federal level to facilitate the sharing of
information.
This is fresh in my mind because I have talked to so many
providers in Minnesota and have really found that our PDMP is
cumbersome, that they have to log-in and then log-out. We do
not require people to do this, in part, because it is so
cumbersome. I am sure there are lots of reasons for this.
But what are the top one or two things that we could do to
facilitate this data sharing?
Ms. Green. In every Federal grant and contract that is let
out, including CDC, the Justice Department, SAMHSA, they all
address trying to improve PDMP's.
We need to include consistent standards in all of those
grants and contracts that indicate, ``The following standards
must be met. There must be comprehensive data sharing, and
there must be data made available for public health
surveillance purposes,'' and all the other purposes that we
need that data made available for, because that is the funding
that is primarily being used now to improve PDMP's.
Senator Smith. Thank you.
Does anybody else want to make any other comment on that?
Dr. Clark?
Dr. Clark. Yes, I want to echo what she said because, in
fact, if we can enhance our PDMP's, which is something we have
been struggling with almost now for 10 years, if we can enhance
the technology.
We do not have the kind of information that people argue
that we need. What we need to know is that the epidemic is
actually subsiding. And so, we want to make sure we do not put
something in place that, as they say, closes the barn door
after the horse is gone.
Senator Smith. Yes.
Dr. Clark. PDMP's have been around. We have known for 10
years what some of the limitations are. We just have not done
much about those limitations. It would be useful if we did
something about those limitations.
Senator Smith. I would like to just change direction a
little bit here.
We have been hearing a lot how technology can help prevent
opioid abuse, which is so important. But I am also really
interested in how technology can help us provide good care to
people who are in the process of recovery.
I have had a chance to talk with some folks in Minnesota
that are working on this. Particularly, we have an example in
Little Falls, Minnesota, rural Minnesota, which is how they
describe it as sort of a hub and spoke strategy, which is
really about coordinating care and providing all of the
services that somebody needs when they are in the middle of
recovery.
I would be very interested to know from this panel, maybe
Dr. Mahon, you could address this because you talked about
patient engagement.
How can we better use technology to coordinate care as we
address this epidemic?
Dr. Mahon. Absolutely. Thank you for the question, Senator.
What we have seen as part of our program, it becomes really
critical to collaborate with the provider. So one of the many
things that Express Scripts is doing is we are actually
communicating with the doctors via the Electronic Health Record
and sending them information at the point of care when the
individual is about to receive the next prescription.
Giving them information, not just on what the morphine
equivalent dose is of that individual, which is really, really
important, but then also giving them recommendations on
subsequent therapy or care.
Whether it is if we see somebody is on 600 mgs of morphine
equivalent, this individual should probably be on a Naloxone,
or giving them additional information on how to properly
counsel them on where else services are available in-network,
whether it is a treatment facility and relaying and sharing
that information within the Electronic Health Record becomes
really, really important. So we definitely see that.
Then the second piece is using telemedicine and virtual
pharmacists, which is what we are leveraging to actually be
communicating with the members as well, and then sharing that
information back to the pharmacy. So the way we view it is
really encapsulating the member within the care continuum of
the pharmacy, their home, and the physician office. It becomes
really important.
Senator Smith. Right. Thank you very much.
Mr. Shah, I can see you are eager to respond, but I am out
of time. So we will look forward to hearing your comments
later.
Thank you.
The Chairman. Thank you, Senator Smith.
Let me operate here as a little bit of a skeptic on the
Federal Government's ability to deal with lots of data. I think
of HealthCare.Gov. I think of the actual mess with Electronic
Healthcare Records that we got into. We ended up having six
hearings on that that we did not plan to have during our 21st
Century Cures.
Vanderbilt University has been trying for years with health
records that Meaningful Use One was helpful; Meaningful Use Two
was Okay; Meaningful Use Three was terrifying. And when the
government tried to combine that with the ability of getting
everybody to change to a method of payment that had to do with
outcome, it became an even bigger difficulty.
I have two questions I would just like to ask you to
comment. One involved e-prescribing. One involves the Federal
data hub.
We have a million doctors out there, many of whom are still
having a hard time with Electronic Health Records. The best way
to get your healthcare record from one hospital to another is
to put it in your suitcase, and carry it over there, and give
it to the doctor, even though we spent more than $30 billion
encouraging people to do that.
Would it not be a good idea on e-prescribing, to the extent
we move ahead, to do it slowly, to try it out? You have, I
think, seven states are already doing it. If the technology is
evolving, why should we not let it evolve before we impose it
on doctors who are already struggling with lots of burdens?
What suggestions would you have about making the movement
to e-prescribing, if that is where we need to go, as something
that we can do in an evolving way? If McDonald's was
introducing a new sausage gravy, they would do it in Dallas and
Nashville and see how it tasted before they imposed it in
14,000 stores. So that is one.
As far as the prescription drug data base, do you really
want that at the Department of Justice or do you really want it
at all?
Why not, instead, establish the standards that states can
use and why not leave room for Amazon, Google, and Delta? We
can do our airline reservations just instantly with these
things. We can order from Amazon, why not let the private
sector come in and offer a way to fill in whatever gap remains
after we have gradually improved the state PDMP's?
Count me as a skeptic. Express Scripts is not a Government
company, and if it were, it would probably not be nearly as
successful.
What would you do about evolving e-prescription and
improving the state PDMP's, but leaving room for the private
sector to fill in the gaps?
Ms. Mahon.
Dr. Mahon. Yes, I will start first.
We certainly understand that there are limitations of
prescribers and I think we can definitely look at what the
State of New York did when they launched the mandated
controlled substance prescribing. They did leave out some
exceptions: long term care facilities, certain situations. So
because we have an epidemic, I do not think we have time to
wait.
Now, what we can do is carefully figure out what are some
of those areas that we could leave some exceptions and give
them extended dates of when they should be ready to be mandated
for controlled substance prescribing.
But certainly, the rest of the physician practices that do
have the ability to do so, we should move on them now.
Ms. Green. The private sector can assist with certain
innovations, but their focus is ultimately market dominance and
competition. That is the nature of the laissez-faire economic
system we have and this is part of the problem we have had with
some of the data systems already. That starts to take hold.
What I am interested in is, yes, the standards but also I
want the Federal Government to maintain those standards that
are appropriate for the public interest.
The Chairman. But standards do not require establishing an
entire Federal hub of data in the Justice Department, does it?
Ms. Green. Well, but it would require it if it were
federally funded.
The Chairman. What makes you think the Federal Government
has that competence?
Ms. Green. Well, first of all, I would say that I never
assume the Federal Government has competence in anything.
The Chairman. Yes, well then, why would you suggest a
Federal hub for all this data in the Justice Department?
Ms. Green. Because the Federal Government is not going to
be maintaining the hub; they are going to be setting out the
Federal funding for it and the standards are going to be within
the Federal funding. So they are not actually going to be,
there is not going to be a Federal agency that is actually
doing the hub.
The Chairman. They did a great job with HealthCare.Gov.
Ms. Green. I agree with you that there were mistakes there,
but what I am suggesting----
The Chairman. It was a disaster.
Ms. Green. There were mistakes there, but what I would
suggest is that we learn from those mistakes.
The Chairman. It took a year and a half to fix it.
Ms. Green. Then what I would suggest is that this body is
the perfect body to heed the lessons learned from health-dot-
com or health-dot-gov and to translate those into the standards
that are actually put in the hub.
The hub that is in the Prescription Drug Monitoring Act
does not suggest that the Federal Government is actually going
to run that. What it does is it says the Federal Government----
I have no particular concerns if it is the Department of
Justice or HHS, but what I am concerned about is that Federal
funding is a mechanism by which to ensure that the standards
for public interest actually are maintained.
The Chairman. Thank you, Ms. Green.
I am out of my own time and I do not want to set a bad
example.
Senator Warren.
Senator Warren. Thank you, Mr. Chairman.
I am actually going to pick up where you are. My view is we
do need data, and we need the data in order to inform better
decisions. The Federal Government collects all kinds of data
right now.
We get the monthly data reports on how many people are
employed and whether the unemployment rate is going up or going
down.
We collect data on education, how many people are in
school, how many college graduates there are, how much student
loan debt is outstanding.
We collect data on highways, and transit, and all kinds of
things because we think it informs making better decisions
going forward. Our alternative is to grope around blindly and
it seems to me that is not the best way to make a decision.
With e-prescriptions, so that the doctor instead of handing
you a piece of paper, which you could lose, which you could
alter, which you could photocopy, particularly where an opioid
is concerned, a doctor who says, ``Wait. I am going into a
secure system. I am doing my authorization. This is how much I
am prescribing,'' it cannot be altered at that point. As Dr.
Mahon says, someone can then come back and even say to the
doctor, ``Really? That is how much you want to prescribe for
somebody who only weights 70 pounds? Or you may want to
consider other concerns or ways to help protect this client.''
I see this exactly the other way that e-prescribing is
something that is enormously valuable.
We are in the middle of a crisis and that, right now, the
latest data I have for 2016--I think some of our panelists may
have later data--that only about 14 percent of doctors are e-
prescribing controlled substances, and that these are the
prescriptions that are most likely to be misused and diverted.
And yet, we are sending them to pharmacies on little pieces of
paper.
I want to ask the question the other way. Dr. Mahon, you
work at Express Scripts, which is one of the largest Pharmacy
Benefit Mangers in the country.
If more doctors were using e-prescribing to write
prescriptions for opioids, would we have a better understanding
of the opioid crisis in America?
Dr. Mahon. Absolutely. One quick comment.
The numbers did go up last year. Now we are at 20 percent
of physicians that are e-prescribing.
Senator Warren. Great.
Dr. Mahon. But still, not enough.
Really, absolutely, we would because one of the biggest
gaps that we have today, as a Pharmacy Benefit Manager, is we
do not have access to cash claims.
Those members who are getting the paper copy prescription,
walking into the pharmacy under the radar, obtaining those
medications, we have no visibility and no ability to intervene
subsequently.
All of the things that we are doing right now with sharing
information with doctors, sending a member a disposal bag,
educating them in their home, we do not have the ability to do
it if it is going under the radar in the cash processing
system.
Giving them the ability to e-prescribe would automatically
give all of us the visibility to these claims, and we would
have the ability to appropriately intervene on these members
when it is most needed in real time.
Senator Warren. In a large sense, it lets us see how many
opioids are being prescribed.
Dr. Mahon. Yes.
Senator Warren. Who is prescribing them, where there are
pockets of use in the country, and that alerts us to problems
as we go through.
I want to ask another part of this, because I think you
have worked on this question.
Does e-prescribing actually have the potential to change
how many opioids doctors prescribe?
Dr. Mahon. Absolutely.
In terms of these limits that we have set from an over-
utilization perspective, the physician would be able to see if
I am limited to, let us say, two 7-day fills within a certain
time period, that would be visible in the system.
Ideally, we would be in a world where anytime a physician
would write a prescription, they would see how are they
adhering to the CDC guidelines, to the state prescribing
requirements of opioids that would ultimately help us limit.
Senator Warren. The advantages to collecting this data in
e-prescribing are not only how we use them from a public health
point of view. From an enforcement point of view, we actually
have some evidence, it makes a difference in the decisions that
doctors make patient by patient in using the best practices in
prescribing opioids.
I am about to run out of time, but I just want to push on
one more part and that is, Ms. Green, you have spoken today
about the need to make sure that the PDMP's in different states
can talk to each other.
Do we also need to make sure that the PDMP's can talk to
Electronic Health Records and e-prescribing systems?
Ms. Green. Yes, all three of the systems need to
efficiently and seamlessly talk to one another so that we can
timely transfer the data and proactively monitor patient and
prescriber behavior, which will allow us to intervene at an
early point to address any problems.
Senator Warren. Good, just powerfully important. Thank you
very much. I see I am out of time, but count me in for more
data.
The Chairman. I already was, Senator Warren.
Thank you.
[Laughter.]
The Chairman. Thank you for your good questioning.
Senator Casey.
Senator Casey. Thank you, Mr. Chairman.
I want to thank you and the ranking member for these
hearings. I guess this is the fifth and we are grateful for
that. This is an epidemic, a challenge that warrants that kind
of attention. I wish every serious subject in the Senate was
the subject of this kind of a review, all these hearings. So we
are grateful for that.
I wanted to start with the challenge. There are lots of
ways to describe this crisis and we are grateful to have the
expertise in the room to help us understand one part of the
challenge.
This is a trauma which is affecting every member of the
American family in one way or the other. It does not matter
where you live. It does not matter what age you are. It does
not matter who you are. It is affecting all of us in some way
or another; everyone from infants born addicted, so-called
Neonatal Abstinence Syndrome, all the way to other members of
the American family.
One of the real telling indicators in my state is rural and
urban. We have data that tells you that in urban America, it
could not be worse. Here is an example.
Overdose deaths in Philadelphia estimated to have reached
1,200 last year with fatal overdose death rate in 2015 of
almost 47 deaths per 100,000. In Chicago, it is a fraction of
that, 15. In New York, it is 11. So Philadelphia at 47,
unfortunately, is a high number.
You can actually make the case that it is worse in rural
Pennsylvania. We have 48 rural counties out of 67. We are told
that the pace of rural deaths is actually faster; a 42 percent
increase year over year of 15 to 16 versus 34 in urban areas.
Fulton County, that is a county of about 14,000 people on
the Maryland border, a small county, a rural county, in 2016,
the opioid death rate was 74 per 100,000. Compare that to what
I thought was a high number of 47 in Philadelphia and much
higher in those other urban areas around the country.
The President declared a so-called public health emergency,
but we have not heard nearly enough from the Administration on
this issue. We need leadership there. It is a big vacuum. Even
as we are here having five hearings here, work being done in
the Congress, we need the President to lead on this because of
the nature of the crisis.
The last point I will make before questions is the
importance of Medicaid, the Medicaid program as well as the
Medicaid expansion.
Pennsylvania, 127,000 people receive treatment via Medicaid
for one of two general conditions: mental health challenges, as
well as the broader category of substance use disorder, not
just the opioid crisis.
We need Medicaid badly and we need Medicaid expansion. So
those who talk about cutting Medicaid had better square that
with what they are saying about the opioid crisis.
I wanted to start with Professor Shah. I worked on a number
of bills that speak to these concerns. We have a grandparents
bill that will be marked up in the Aging Committee tomorrow. I
am working with Senator Collins to create a Federal taskforce
charged with supporting grandparents who are raising
grandchildren and other manifestation of the family trauma.
I worked with Senator McConnell on a bill to deal with this
Neonatal Abstinence Syndrome that I mentioned before. We got
that legislation passed to do two things, really. One is to
have a new strategy to address research and program gaps in the
Federal Government mostly across HHS. The second part of the
bill requires recommendations for preventing and treating so-
called NAS, Neonatal Abstinence Syndrome.
We are told by the ``Philadelphia Inquirer and Daily News''
that the number of drug exposed babies born in Philadelphia and
the four surrounding counties doubled between 2009 and 2016.
Tell us, if you can, in light of the data that hospitals in
Pennsylvania are collecting, tell us how we can use that data
to positively impact what you mentioned in your testimony, the
so-called predictive analytics to reduce either the numbers or
the mortality when it comes to infants.
Mr. Shah. In addition to just actual data collected at
facilities of claims out of EMR data, we have to couple all of
that information together to really identify meaningful
insights.
But then, there is additional data sources that we need to
bring in. Some of the conversations revolved around social
determinants of health data. Where are these individuals
living? What is their income, their education level? These are
all factors that contribute to meaningful and targeted
analytics.
To answer your question, it is a collaboration of various
different institutions to share that data.
Secondly, it is to bring in additional data too and then
break down those data silos. And by having that historical data
and in that context from an analytic perspective, we will be
able to better identify certain instances where there may be an
individual, perhaps a neonatal, or whatever the case may be
that may be headed in that direction. Perhaps identify
opportunities for intervention early to help curb that.
To answer your question, it is, again, revolving around
data and integration.
Senator Casey. Collection of the data is obviously the
foundation of it.
Mr. Shah. That is correct.
Senator Casey. I know I am out of time. I will maybe submit
a question for a couple of the members of the panel.
Ms. Green, I wanted to ask you a question. I will submit in
writing, about the challenge with regard to different states,
especially a state that borders, like ours does where we have
states that are nearby having both different standards and
requirements for the Prescription Drug Monitoring Programs.
But in the interest of time, I will submit that for the
record.
Senator Casey. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Casey.
Senator Murray, do you have additional comments?
Senator Murray. I just have one comment for the record I
want to make clear on that.
That actually the data hub on HealthCare.Gov was the part
that actually worked. And it was responsible for identity
proofing and eligibility verification.
The part that did not work, that failed, was the Web site's
ability to support high traffic and allow enrollees to actually
browse through the options. That was actually a private
contractor, CGI Federal; so just for the record.
But I did want to thank all of the witnesses today. This
was an excellent hearing and very helpful as we work to develop
and pass legislation on this critical topic.
Mr. Chairman, I want to thank you for holding this hearing
today and for remaining very focused on building a bipartisan
effort to address this issue.
Thank you.
The Chairman. Thank you, Senator Murray.
These have been bipartisan hearings, which mean we agree on
them. The witnesses have been very helpful, very good.
I am going to pursue my point a little bit. I have been
around long enough to know that everybody assumes, ``Here is a
great idea. Let us get the Federal Government do it.'' But the
Federal Government lacks the capacity, in many cases, to do
things well.
Do any of you have any suggestions?
A couple of you commented about what to say to doctor. Let
us say 20 percent are e-prescribing now. That means 800,000 are
not. They might say back to you, ``Well, look. You have me all
tied up in a knot on Meaningful Use Three. You have new
regulations on merit-based payment and I am mad about that. And
now, here you come with a whole big set of regulations about
how I am going to do e-prescribing.''
What can you say to that doctor or what can you say to us
about how we can avoid creating an oppressive burden?
Mr. Shah, do you have any suggestions?
Mr. Shah. Going back to your example, the McDonald's
example that you had shared with us, it is about a phased
approach.
I think what we need to do is identify communities and
organizations that are a little bit ahead of the curve from a
technological perspective, and really institute and showcase
the value of the e-prescribing as it relates to curbing this
opioid epidemic.
We talked a little bit about New York and Maine, as an
example, as a success story. I think we need to model that
instance there to a broader community. But, again, that is
doing it in a phased type of approach. That is what I would
recommend to those providers, those that are willing to
participate and then working your way out.
The Chairman. Would there be any merit to saying that if
you do not do it within a certain period of time, the Federal
Government will do it? E-prescribing, obviously, could be
required by states, seven are. Right?
Dr. Clark.
Dr. Clark. I think providing incentives to states to adopt
these strategies would be another approach. That way, you can
phase it in to those jurisdictions that saw the utility of it
and would be early adopters, and then you could move from
there.
You would have states and then perhaps regional endorsers
or adopters of the strategy. That way, you can avoid the
encumbrance of, say, federally mandated strategies. So
incentives versus mandates would be an approach that could
address your concern.
I think practitioners, clinicians, and it is not just
physicians who are prescribers. There are practitioners and
physician assistants who also prescribe, and it is not just
opioids. It is benzodiazepine and other medications.
People would be interested in facilitating better care. As
you are suggesting, people just do not want to have so many
obstacles that it interferes with the ability to provide that
care.
The Chairman. Any other comments?
Dr. Clark, do you have any concerns about a Federal hub of
data in the Justice Department?
Dr. Clark. Yes, sir. I have large concerns about a Federal
hub of data in the Justice Department.
I love our Justice Department. They do a great job, but I
do not think a repository of clinical information belongs in
the Justice Department. As I pointed out, there is a difference
between monitoring and a difference between surveillance, and
the Justice Department is very much interested in surveillance.
What we are trying to accomplish here is enhancing the care
of people and not create an ``I got you'' kind of environment
where practitioners and patients feel that they cannot rely on
the healthcare delivery system.
The Chairman. Thanks to all four of you. This is very
helpful. I agree with Senator Murray. Very useful to us.
You can see that we are about to write a bill, so if you
have very specific suggestions beyond what you have already
discussed or if you want to reiterate something that you said
toady or had in your testimony you would like to make sure we
pay attention to, we would welcome that. That will help us
write a better bill.
The hearing record will remain open for 10 days. Members
may submit additional information for the record within the
time, if they would like.
The Chairman. Our Committee will meet again tomorrow,
Wednesday, February 28 at 9:45 a.m. for an executive session.
Thank you for being here.
The Committee will stand adjourned.
[Whereupon, at 11:45 a.m., the hearing was adjourned.]
[all]