Are you following_the_script may 2015

Polsinelli PC. In California, Polsinelli LLP
Are You Following the Script?
Consequences for Medical
Professionals Who Fail to Check
Pharmacy Registries
Presented By: Edward F. Novak
and Melissa S. Ho

real challenges. real answers. sm
44 Americans die every day from
prescription drug overdose, most
commonly an opioid. (Source: Centers for Disease
Control and Prevention)
As a result, both the DEA and medical
boards throughout the country have taken
an increasingly critical look at prescription
drug providers.

National Prescription Pain Medication
Problem
Prescription and over the counter drugs
are, after marijuana (and alcohol), the
most commonly abused substances by
Americans 14 and over.
Source: National Institute on Drug Abuse

Problem

National Prescription Pain Medication Problem
Most commonly abused:
Opioid Pain Relievers (Vicadin, Oxycontin)
Stimulants to treat ADHD (Adderral,
Concerta, Ritalin)
Central Nervous System depressants for
anxiety (Valium, Xanax)
Cough/Cold Remedies with
dextromethorphan

Purdue Pharma has been investigated and
now sued for one billion dollars by the
Kentucky Attorney General for deceptive
marketing practices related to OxyContin
abuse in the state.
Purdue Pharma had previously settled a
federal criminal case related to
intentionally misleading doctors about
OxyContin’s potential for misuse.

Individual Costs of Addiction

Problem for Individuals
Use of any psychoactive drug which contributes to
impairment results in individual criminal charges for
driving while impaired.
According to National Highway Traffic Safety
Administration’s (NHTSA) 2007 National Roadside
Survey, more than 16 percent of weekend, nighttime
drivers tested positive for illegal, prescription or OTC
drugs.
A 2009 NHTSA study found that 18% of fatally injured
drivers tested positive for at least one illicit, prescription,
or OTC drug (an increase from 13% in 2005).

Victims injured in an accident may seek to
recover monetary damages against those
prescribing.
Healthcare professionals increasingly find
themselves receiving records subpoena or
subpoena to testify in criminal matters.

Prescriber Needs to
Understand what a valid subpoena for
records entails.
Know how to narrow or properly respond
to a request for records.
Have trained office staff on how to
respond.

State Pharmacy Registries
What is a State Pharmacy Registry (aka
Patient Prescription History Reports)?

Missouri Finally Joins in the Fun
For years, Missouri was the only state that
didn’t have a program in place due to
privacy concerns.
As of April this year, the Missouri Senate
approved SB 63 to create a drug
monitoring program.
Kansas has had its program (K-TRACS)
since 2011.

State Pharmacy Registries
Arizona Example:
H.B. 2136 established a Controlled
Substances Prescription Monitoring
Program (CSPMP). The bill required the
Arizona State Board of Pharmacy (ASBP)
to establish a controlled substances
prescription monitoring program.

H.B. 2136 requires pharmacies and
medical practitioners who dispense
controlled substances listed in Schedule II,
III, and IV to a patient, to report the
prescription information to the Board of
Pharmacy on a weekly basis.
See A.R.S. §§ 36-2601 thru 36-2611

Definitions
A.R.S. § 36-2601
(2). "Dispenser" means a medical practitioner or pharmacy that is
authorized to dispense controlled substances.
(3). "Licensed health care provider" means a person who is licensed
pursuant to title 32, chapter 7, 11, 13, 14, 15, 16, 17, 18, 19.1, 21, 25, 29 or
33.
(4). "Medical practitioner" has the same meaning prescribed in section 32-
1901.
(5). "Person" means an individual, partnership, corporation or association
and the person's duly authorized agents.
(6). "Program" means the controlled substances prescription monitoring
program.

A.R.S. 36-2602
Includes a computerized central database
tracking system to track the prescribing,
dispensing and consumption of Schedule II,
III, and IV controlled substances in Arizona.
One of its stated purposes is to assist law
enforcement in identifying illegal activity
related to the prescribing, dispensing and
consumption of these controlled substances.

Mandatory reporting by pharmacies began on
October 17, 2008. The Board began collecting
dispensing practitioner’s data in October 2009.
The purpose of this legislation is to improve the
State’s ability to identify controlled substance
abusers or misusers and refer them for treatment
and to identify and stop diversion of prescription
controlled substance drugs in an efficient and cost
effective manner that will not impede the appropriate
medical utilization of illicit controlled substances.

Who can Search
Authorized persons may request
information from this repository to assist
them in treating patients and identifying
and deterring drug diversion, consistent
with A.R.S. § 36-2604.
Except as otherwise provided in 36-2604
the information submitted is confidential
and not subject to public inspection.

Who can Search/Use Information
Pharmacy Board or its designee. If the board or its designee has reason to believe an act of
unprofessional or illegal conduct has occurred, the board or its designee shall notify the
appropriate professional licensing board or law enforcement or criminal justice agency and
provide the prescription information required for an investigation.
Pharmacy Board may release data to: (1) A person who is authorized to prescribe or dispense a
controlled substance, or a delegate who is authorized by the prescriber or dispenser, to assist that
person to provide medical or pharmaceutical care to a patient or to evaluate a patient. (2) An
individual who requests the individual's own prescription monitoring information pursuant to
section 12-2293. (3) other professional licensing boards only if the requesting board states in
writing that the information is necessary for an open investigation or complaint. (4) local, state or
federal law enforcement or criminal justice agency only if the requesting agency states in writing
that the information is necessary for an open investigation or complaint. (5) The Arizona health
care cost containment system administration only if the administration states in writing that the
information is necessary for an open investigation or complaint. (6) A person who is serving a
lawful order of a court of competent jurisdiction. (7) A person who is authorized to prescribe or
dispense a controlled substance and who performs an evaluation on an individual pursuant to
section 23-1026.

Who Can Use/Search Information Cont’d.
The board may provide data to public or private entities for
statistical, research or educational purposes after removing
information that could be used to identify individual patients or
persons who received prescriptions from dispensers.
For the purposes of this section, "delegate" means a licensed health
care professional who is employed in the office of or in a hospital
with the prescriber or dispenser or an unlicensed medical records
technician, medical assistant or office manager who is employed in
the office of or in a hospital with the prescriber and who has
received training regarding both the Health Insurance Portability and
Accountability Act privacy standards, 45 Code of Federal
Regulations part 164, subpart E, and security standards, 45 Code of
Federal Regulations part 164, subpart C.

What is on the Patient History Report
Patient identifiers (Patient ID, home addresses)
Will give fill date for prescriptions, the quantity,
dosages. Prescriber information (identity and
address), the prescription number.
It will provide the total number of prescriptions.
Pharmacy identifiers, whether the prescription is
active and a morphine equivalent table and
calculation for reference.

What Prompts a Criminal Prosecution?

As mentioned previously: DUIs very
common.
Prosecutions for drug sales (Individual
selling their own prescriptions or soliciting
purchases of prescription medications).
Forgery of scripts being utilized at
pharmacies.

Third-party prosecutions often lead to
subpoenas for documents.
Testimony at Trial.
Sometimes a Board Complaint from a concerned
family member or disgruntled patient.
In worse-case scenarios: Criminal charges for
the prescribing professional themselves.

Prosecution Statistics
Recent figures from the U.S. Government
Accountability Office (2012/2013) notes
7,848 subjects in criminal investigations (25%
were medical facilities and 16% were durable
medical equipment centers. Only 13.8% were
charged, of which 85% were convicted.)
2,339 subjects in OIG civil investigations (20%
hospitals; 18% other medical facilities. 47% of
civil investigations pursued.)

No reliable statistics for state prosecutions
of health care providers/medical groups.
Individual prosecutions could entail a
number of theft or fraud allegations.
An Arizona doctor was charged with
forgery and fraudulent schemes and
artifices for falsely stating he had reviewed
medical records in certifying access to
medical marijuana.

State v. Gear (Division One)
No.1 CA-CR 13-0852
Whether the Arizona Medical Marijuana Act
(AMMA) bars the State from prosecuting a
physician for misrepresenting (negligently or
otherwise) that he had reviewed the last 12
months of a patient’s medical records, including
records from other physicians.
A confidential informant went to see a physician
who completed a DHS Form. No records were
ever provided by the confidential informant.

A grand jury indicted the Doctor on one
count of forgery and one count of
fraudulent schemes and artifices. (All
felonies)
The AMMA requires a written certification
which is more than a physician’s
professional opinion; it requires a
complete assessment of the medical
history.

The Court of Appeals concluded that
AMMA’s physician immunity provision bars
the State’s prosecution, but notes that the
statute does not prevent a professional
licensing board from sanctioning a
physician for failing to properly evaluate a
patient’s medical condition.
It is rumored that the State is going to
appeal this ruling.

Licensing Boards

Professional Licensing Boards
Are typically established by statute.
Members are typically appointed to serve
discrete terms.
Members include practitioners, and a
public members. (The public member is
often an attorney.)
The Executive Director of the Board may
vote on certain matters.

Some boards have their own attorney---
often an Assistant Attorney General.
Most AAGs are not “activist lawyers,”
meaning they advise on legal matters, but
will not provide guidance on how to
resolve a complaint.

Common Sources of Complaints
Patient or family
Other medical provider
Pharmacists
Colleagues
Supervisors
Often prompted by adverse outcomes,
traffic accident or criminal prosecution.

Example Statistics for Arizona Nursing
Board
In 2010: 75 cases opened (2.15% of
nursing population)
7 resulted in Discipline
2 licenses were revoked or suspended
17 were dismissed

Board Hearings
Subject to Open Meeting Laws.
Agendas are posted.
Sensitive Matters go to Executive Session.
The type of Board and the amount of
resources the Board has will determine the
responsiveness of the Investigation.

Most Boards don’t “troll”, i.e., they are
responsive to complaints.
If you are the subject of a complaint, it is
important to report it immediately to your
carrier, employer or business partners.
Board Complaints often carry very short
response times. (2 weeks is not
uncommon)

Board Complaints
Not surprisingly Board Complaints are
one-sided.
The complaining Party is not always the
Patient. It is often a family member or
friend who is “concerned.”
You must provide a response to the Board
within the time frame. Ask for an
extension if you need more time to gather
information.

Board Complaints
The initial letter from the Licensing Board
often comes from an investigator.
The complaint will be attached; a time
frame for responding to the complaint may
be attached.
The Board may issue a subpoena (often
very broad).

Licensing Board
The Licensing Board may do an
Investigative Review
Conduct Interviews
Ask for an Informal Appearance at a Board
Meeting
Ask for a formal Hearing

Board Action
Boards can dismiss the allegations
Continue investigation and request staff to
issue subpoenas
Issue letters of concern
If discipline is warranted, vote to offer a
consent agreement (often drafted with
AAG help)
Ask for formal hearing

Board may be Empowered to
Issue letters of concern
Issue non-disciplinary orders for
continuing education
Issue Decrees of Censure
Fix terms and period of probation
Impose civil penalties
Suspend or Revoke a Respondent’s
License.

What to Do if you Receive a Board
Complaint

Responding to Board Complaints
Retain counsel
Review patient records
If the allegation relates to a prescription
medical issue, request and obtain the
pharmacy registry immediately.
Will insurance Cover?
Will my employer cover the cost?

Reasons for Dismissal
Unable to Substantiate
Anonymous complaint with insufficient information
Allegations were retracted
Allegations that were retaliatory
Single or time limited minor practice issues
Minor injury or minimal risk of harm
Personality disputes
Unfair business practices related to billing or fee
disputes

Common Issues
Oops, I may have forgotten something…

Common Issues
No documentary evidence of pain (x-ray, MRI, etc.)
No pill counts noted
No UAs on file
Agreeing to refill prescriptions for other practitioners
(i.e., you were the substitute doctor for the day, but
you didn’t check the registry)
Forgetting to remind patient to follow up with their
PCP.

How does this Happen?
Too much sympathy for the patient
Don’t want to lose the patient to a pain
clinic
Concern over previous care issues
Reliance on patient’s self-reporting of pain

What if I don’t have time to do all this
checking?
Will my prior spotless record help?

Failure to check the Prescription Drug
Monitoring Programs and a patient’s
history of substance abuse or psychiatric
Issues can be tantamount to negligence
for the prescribing provider.

Be Proactive

Be Proactive
Know what you are prescribing!
Check advisory opinions
Call the Board of Pharmacy
Check urine drug screens, serum levels,
old records and diagnostic labs.

Have a written plan
Just as with HIPAA liability, a key issue in
apportioning blame to a medical practice
or respondent is whether they took
reasonable efforts to prevent harm and
ensure quality.

Make someone responsible for enforcing
the written plan.
For instance how does your office keep
prescriptions for pick up? Does it require
a sign-in sheet and ID check? Are the
prescriptions locked and logged?
Build in redundancies and backup in the
event there is a change in personnel.

Keep immaculate records on your quality
assurance programs.
Double-check the compliance work and
document any issues.
Involve the staff in training and spotting
issues with patients. Particularly in
smaller practices, the medical assistant or
front staff may be first to know of issues.

Due Diligence
Conduct due diligence on vendors; check
their licenses; look for lawsuits and
complaints.
Many insurance programs will require that
pharmaceuticals are sourced from
licensed providers.

Review your informed consent procedures
and patient confidentiality policies.
Have treatment agreement forms and note
in the patient’s records that the patient has
been explicitly told about the potentially
addictive nature of the prescription drugs
and risks even when they are used as
treatment modality.

Makes sure the patient has the ability/willingness
to maintain control and safety of the controlled
drugs (and document this).
Have a clear patient treatment agreement which
specifically outlines: compliance, consequences
of non-compliance, and notice that if there is
abuse suspected, that the patient will be
discontinued in a safe manner and referred for
other pain management programs.

Be able to document the causes of the
chronic pain
Be able to demonstrate that the dosage is
well tolerated by the patient and that
treatment levels have stayed steady.
Don’t forget to have a policy related to the
counting and destroying of post-dated
prescriptions.

Arizona Medical Association (ARMA)
Prescribing Guidelines
Published by the Arizona Department of
Health Services has the following
recommendations

ARMA recommendations
1. When possible, one medical provider should
provide all controlled substances to treat a
patient’s chronic pain.
2. The Controlled Substances Prescription
Monitoring Program should be checked prior to
prescribing controlled substances.
3. The administration of intravenous and
intramuscular controlled substances in the ED
for relief of acute exacerbations of chronic pain
is discouraged.

4. Emergency medical providers should not
provide replacement prescriptions for controlled
substances that were lost, destroyed or stolen.
5. Should not provide replacement doses of
methadone for patients in a methadone
treatment program.
6. Long-acting or controlled-release opioids
(OxyContin, fentanyl patches, methadone)
should not be prescribed from the ED.

7. Prescriptions should state that the patient is
required to provide a government issued picture
identification to the pharmacy filling the
prescription.
8. EDs are encouraged to photograph patients
who present for pain related complaints without
a government issued ID.
9. EDs should coordinate care of patients who
frequently visit the ED using an ED care
coordination program.

10. EDs should maintain a list of clinics that provide pain
management and primary care for patients of all payer
types.
11. EDs should perform screening, brief interventions
and treatment referrals for patients with suspected
prescription abuse problem.
12. For exacerbations of chronic pain, the emergency
medical provider should attempt to contact the primary
controlled substances provider or pharmacy.
Emergency medical provider should prescribe only
enough pills to last until office of patient’s primary
controlled substances prescriber opens.

13. Prescriptions for controlled substance pain
for acute injuries (e.g., fractured bones), in most
cases should not exceed 30 pills with no refills.
14. Screen patients for substance abuse prior to
prescribing controlled substance medication for
acute pain.
15. Emergency physicians are required by law
to evaluate an ED patient who reports pain. Law
allows for use of clinical judgment and does not
require the use of controlled substances.

Additional Resources
State Pharmacy Boards often publish
guidelines for dispensing controlled
substances.
Arizona Department of Health Services
publishes an Arizona Opioid Prescribing
Guideline (other states have similar).

Contact Information
Edward F. Novak, Shareholder
– enovak@polsinelli.com
Melissa Ho, Shareholder
– mho@polsinelli.com
Polsinelli PC
www.polsinelli.com
Follow us on:
– Twitter: @polsinelli
– LinkedIn: https://www.linkedin.com/company/polsinelli?trk=company_logo
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Are you following_the_script may 2015

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