Physician Extender Collaboration & Supervision

Fourth Annual Prescription Drug Abuse Symposium November 1, 2013

Anne M. O’Brien, JDKrieg DeVault

Disclosure The speaker has no financial interests related to

the subject matter except that she spends much of her work-life addressing these laws, rules and related court cases.

Disclaimer This content is provided for general information

purposes and is not intended as legal advice. Competent legal counsel should be sought before taking any action in reliance on this content.

Objectives Understand the responsibilities of the

physician for overseeing the mid-level practitioner’s prescription of controlled substances, and potential outcomes of failing to meet those responsibilities

Discuss the parameters for delegation to a mid-level practitioner

Physician Assistants

Physician Assistants IC 25-27.5-1 et seq.

Statute grants supervising physician or physician designee the authority to delegate tasks or services the physician typically performs and is qualified to perform

Does not grant authority to a physician assistant to function independently of a physician’s supervision

Physician Assistants"Supervision" means overseeing the activities of, and accepting responsibility for, the medical services rendered by a physician assistant Supervising physician or designee is physically present

at location of PAOR Supervising physician or designee immediately available

by phone AND for consultation within 24 hours AND if not in same facility as PA, within a reasonable travel distance to personally ensure proper care of patients

Physician Assistants PA may perform duties and responsibilities

within scope of practice of supervising physician PA may prescribe and dispense drugs Agreement shall specify name or classification of

drug, and protocol for prescribing Agreement shall be submitted to board Any amendment must be resubmitted to board PA may prescribe unless board denies

agreement

Physician Assistants As of July 1, 2013, PA may prescribe and

dispense Schedule II drugs PA must submit new agreement and letter

requesting addition of C-II Verify addition of C-II to CSR at

http://www.in.gov/pla/3119.htm Must request registration update from DEA at

www.deadiversion.usdoj.gov

Physician Assistants Limitation on days supply

PA may prescribe C-II through C-V in an aggregate amount that does not exceed a 30 day supply

Any refill or subsequent prescription must be authorized by the supervising physician and recorded in the patient’s medical record

Physician Assistants Supervising physician or designee must

review PA’s patient encounters within 72 hours 100% for first year of employment 50% for second year of employment 25% for third year and thereafter 100% for first year of authority to prescribe

CS Starts over if PA is employed in different

practice specialty

Physician Assistants PA who is delegated authority to prescribe

must enter on prescription: PA’s signature Initials indicating the credentials awarded to

PA by the NCCPA. PA’s state license number If delegated authority to prescribe CS, must

also include own DEA number

Physician Assistants The legal responsibility for the physician

assistant's patient care activities are that of the supervising physician

A physician may enter into a supervising agreement with more than 2 PA’s, but may not supervise more than 2 at one time

Advanced Practice Nurses

Advanced Practice Nurses An advanced practice nurse shall operate in

collaboration with a licensed practitioner as evidenced by a practice agreement, or by privileges granted by the governing board of a hospital with the advice of the medical staff of the hospital that sets forth the manner in which an advanced practice nurse and a licensed practitioner will cooperate, coordinate, and consult with each other in the provision of health care to their patients.

Advanced Practice Nurses APN’s who meet the requirements

established by the nursing board are authorized to prescribe legend drugs, including controlled substances

APN may be granted authority to prescribe legend drugs only within the scope of practice of the APN and the scope of the licensed collaborating health practitioner

Advanced Practice NursesAPN’s application for prescriptive authority must include:

Proof of collaboration with a licensed practitioner

Written practice agreement stating the manner in which the APN and practitioner will cooperate, coordinate, and consult with each other in the provision of health care to patients

Advanced Practice NursesWritten practice agreement shall include: Description of what limitation, if any, the practitioner has

placed on the APN's prescriptive authority Description of the time and manner of the practitioner's

review of the APN's prescribing practices Description shall include provisions that the APN must

submit documentation of the APN's prescribing practices to the practitioner within 7 days

Documentation shall include, but not be limited to, at least a five percent (5%) random sampling of the charts and medications prescribed for patients

Advanced Practice NursesAPN with authority to prescribe must enter on each prescription form:

The signature of the APN Initials indicating the APN’s credentials The identification number assigned to the

APN by the nursing board indicating the authority to prescribe

Must comply with all applicable state and federal laws concerning prescriptions for legend drugs

Potential Outcomes of Failure to Supervise

Medical Licensing BoardComplaints re: prescribing of CS

Pre-signed prescription pads for use by PA’s or nurses

No H&P or medical records No diagnosis supporting medications

prescribed No referral for alternative modalities or no

consequence for failure to follow through

Medical Licensing BoardComplaints re: prescribing of CS

Urine drug screen inconsistencies No INSPECT reports, or reports showing

multiple prescribers or multiple pharmacies are ignored

Risk factors and co-morbidities making opioid therapy inappropriate

Quantity and types of medications prescribed

Medical Licensing Board Professional incompetence by undertaking

professional activities practitioner is not qualified for – did not know limitations of what PA’s are allowed to prescribe and practice

Failure to keep abreast of current theory and practice

Unfit to practice due to failure to keep abreast of current theory and practice

Medical Licensing Board Allow name or a license issued under this

chapter to be used in connection with an individual who renders services beyond the scope of that individual's training, experience, or competence – allowed PA’s and NP’s to prescribe using physicians DEA and CSR

Assist another in committing act that would be grounds for disciplinary action

Special Cases

Narcotic treatment program – prescribing drugs for maintenance or detox requires additional DEA registration

Drugs prescribed for weight loss – may only be prescribed by physician

Drug Enforcement Administration

DEA Practitioner’s ManualSafeguards for PrescribersIn addition to the required security controls, practitioners can utilize additional measures to ensure security. These include:1. Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use.2. Write out the actual amount prescribed in addition to giving a number to discourage alterations of the prescription order.3. Use prescription blanks only for writing a prescription order and not for notes.

DEA Practitioner’s ManualSafeguards for Prescribers (cont’d)4. Never sign prescription blanks in advance.5. Assist the pharmacist when they telephone to verify information about a prescription order; a corresponding responsibility rests with the pharmacist who dispenses the prescription order to ensure the accuracy of the prescription.6. Contact the nearest DEA field office (see Appendix E) to obtain or to furnish information regarding suspicious prescription activities.7. Use tamper-resistant prescription pads.

DEA Focus Areas

Manufacturer

Wholesaler/Distributor

PharmacyPharmacy

Wholesaler/Distributor

PharmacyPharmacy

Prescriber

FOCUS AREA (Quotas/Suspicious Orders)

FOCUS AREA (Suspicious Orders)

FOCUS AREA (Legitimate Medical Purpose)

Patient Patient Patient Patient Patient Patient Abusing PatientPatient

FOCUS AREA(Legitimate Medical Purpose)

DEA Focus Area “Suspicious Order” Activity

Requires wholesalers and manufacturers to have systems in place to identify “suspicious orders”

Wholesalers will report suspicious order activity to DEA

Has lead to some pharmacies being “cut-off” by wholesalers

DEA Focus AreaLegitimate Medical Purpose

What is a CS Prescription?

An order for a CS drug Issued by an individual state licensed

prescriber Who is registered with the DEA For a “patient” For a legitimate medical purpose in the usual

course of professional treatment In the right “form”

What is NOT A CS Prescription?

An order for a CS drug... that “purports” to BE a prescription...

looks like a prescription has all the right information correct form not a “forgery” from a licensed (registered) prescriber for a “patient”

not issued for a legitimate medical purposes, in the usual course of professional treatment.

“Prescription” defined 21 CFR § 1300.01(b)(35):

An order for medication which is dispensed to or for an ultimate user (non-institutional).

“Form” of a prescription21 CFR § 1306.05

CS prescriptions must be dated and signed when issued, have patient’s name and address, prescriber's DEA number and written in ink, indelible pencil or typewritten.

The pharmacist has a corresponding responsibility to determine that prescriptions are issued in this form.

What is a “legitimate medical purpose”?

How are “legitimate medical purpose” and “usual course of professional practice” defined?

Federal courts have recognized that it is not possible expand on the above phrase to address all the varied situations physicians and pharmacists may encounter.

The creation of guidelines by the DEA is not possible since it is the state medical and pharmacy boards that regulate professional practice.

Courts must engage in a case-by-case analysis to determine final conclusion.

The Pharmacists Manual

The following criteria may indicate that a prescription was not issued for a legitimate medical purpose: The prescriber writes significantly more prescriptions

(or in larger quantities) compared to other practitioners in your area.

The patient appears to be returning too frequently. Prescription which should last for a month in legitimate use, is being refilled on a biweekly, weekly or even a daily basis.

The Pharmacists Manual The prescriber writes prescriptions for antagonistic drugs,

such as depressants and stimulants, at the same time. Drug abusers often request prescriptions for "uppers and downers" at the same time.

Patient appears presenting prescriptions written in the names of other people.

A number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician.

Numerous "strangers," people who are not regular patrons or residents of your community, suddenly show up with prescriptions from the same physician.

The Pharmacists Manual

Note: The quantity of drugs prescribed and frequency of prescriptions filled are not alone indications of fraud or improper prescribing especially if the patient is being treated with opioids for pain management.

Pharmacists should also recognize that drug tolerance and physical dependence may develop as a consequence of the patient’s sustained use of opioid analgesics for the legitimate treatment of chronic pain.

Legitimate Medical Purpose“Red Flags”

Prescribing drug “cocktails” for known in the profession to be used by patients abusing drugs Oxycodone, hydrocodone, alprazolam, carisoprodol

No individualization of dosing by the prescribing physician

Filling multiple prescriptions for the strongest dosages of hydrocodone and alprazolam

Legitimate Medical Purpose“Red Flags”

Requests for early dispensing of refills Refills of patients or doctors located hundreds of

miles away from the pharmacy

Common DEA Questions“Red Flags”

Is the physician located in the same geographical area as the pharmacy?

Does the specialty of the prescriber fit the prescribed medication and the diagnosis?

What does the prescriber’s office look like? Are there patients waiting in line outside of the prescriber’s office?

Common DEA Questions“Red Flags”

Is there a high percentage of cash paying customers in relation to insured patients?

Do patients appear to be selling or trading controlled substances nearby?

Are patients requesting a specific manufacturer or by color or street name?

Avoid “Red Flag” Wide net cast by DEA encompasses

legitimate medical purpose in the usual course of professional treatment

What is a legitimate practitioner to do? Document, document, document

Avoid “Red Flag” Pain management organizations’ guidelines*

suggest treatment is not exclusive to administering CS

*Not endorsed by DEA Recognized modalities include:

pharmacotherapy; psychosocial interventions; rehabilitation techniques; CAM; implantable devices and surgical interventions

Avoid “Red Flag” Include history, detailed treatment and

diagnosis in chart Provide diagnosis to pharmacy Protocol for new patients

History Records PDMP check?

Avoid “Red Flag” INSPECT Statute – IC 35-48-7-11.1

“(k) This section may not be construed to require a practitioner to obtain information about a patient from the data base.”

Medical Licensing Board OrderPhysician and any mid-level practitioners shall review INSPECT report and consider for evidence of abuse or diversion

Federal Law:Corresponding Responsibility

21 CFR 1306.04 Purpose of Issue of Prescription(a) A prescription for a controlled substance to be

effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.

Federal Law:Corresponding Responsibility

The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.

Federal Law:Corresponding Responsibility

An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

Schedule II Prescriptions Must be in writing, except:

emergency situation verbal ok quantity limited to emergency pharmacist reduces to writing within 7 days, prescriber sends written Rx

facsimile may serve as original if: prescription is for infusion therapy patient is resident of LTCF patient enrolled in hospice

Schedule II Prescriptions No refills Partial filling fully authorized

outpatient must fill balance within 72 hours

LTCF or terminal illness must fill balance within 60 days must record each partial filling

Rules are substantially relaxed for institutional pharmacies, where patients are administered drugs by licensed healthcare professionals

Schedule II “Post Dating”

Prescriptions must be dated to reflect the date of issuance

“Post–dating” is NOT permitted Multiple prescriptions can not exceed

a combined total of 90-days supply.

Schedule II “Sequential Dating”

Conditions:(i) RX is for a legitimate medical purpose, issued in the usual course of professional practice;(ii) Instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill the prescription;

Schedule II “Sequential Dating”

Conditions:(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and(v) The individual practitioner complies fully with all other applicable requirements, as well as any additional requirements under state law.

Questions?

Anne M. O’BrienKrieg DeVault30 N. LaSalle Street, Suite 2800Chicago, Illinois 60602(312) 235-1132aobrien@kdlegal.com