1. Physician Extender Collaboration & Supervision Fourth Annual Prescription Drug Abuse Symposium November 1, 2013 Anne M. O’Brien, JD Krieg DeVault

2. 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.

3. 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

4. Physician Assistants

5.  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

6. 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 PA OR  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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Advanced Practice Nurses

14.  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.

15. 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

16. Advanced Practice Nurses APN’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

17. Advanced Practice Nurses Written 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

18. Advanced Practice Nurses APN 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

19. Potential Outcomes of Failure to Supervise

20. Medical Licensing Board Complaints 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

21. Medical Licensing Board Complaints 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

22. 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

23. 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

24. 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

25. Drug Enforcement Administration

26. DEA Practitioner’s Manual Safeguards for Prescribers In 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.

27. DEA Practitioner’s Manual Safeguards 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.

28. DEA Focus Areas Manufacturer Wholesaler/Distributor Pharmacy Wholesaler/Distributor Pharmacy Prescriber FOCUS AREA (Quotas/Suspicious Orders) FOCUS AREA (Suspicious Orders) FOCUS AREA (Legitimate Medical Purpose) Patient Abusing Patient Patient FOCUS AREA (Legitimate Medical Purpose)

29. 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

30. DEA Focus Area Legitimate Medical Purpose

31. 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”

32. 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.

33. “Prescription” defined  21 CFR § 1300.01(b)(35): An order for medication which is dispensed to or for an ultimate user (non-institutional).

34. “Form” of a prescription 21 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.

35. What is a “legitimate medical purpose”?

36. 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.

37. 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.

38. 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.

39. 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.

40. 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

41. Legitimate Medical Purpose “Red Flags”  Requests for early dispensing of refills  Refills of patients or doctors located hundreds of miles away from the pharmacy

42. 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?

43. 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?

44. 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

45. 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

46. Avoid “Red Flag”  Include history, detailed treatment and diagnosis in chart  Provide diagnosis to pharmacy  Protocol for new patients  History  Records  PDMP check?

47. 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 Order Physician and any mid-level practitioners shall review INSPECT report and consider for evidence of abuse or diversion

48. 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.

49. 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.

50. 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.

51. 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

52. 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

53. 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.

54. 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;

55. 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.

56. Questions? Anne M. O’Brien Krieg DeVault 30 N. LaSalle Street, Suite 2800 Chicago, Illinois 60602 (312) 235-1132 aobrien@kdlegal.com