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ChangingChanging LivesLives

AANNUAL NNUAL CCONFERENCE AND ONFERENCE AND TTRADE RADE SSHOWHOW August 25th, 26August 25th, 26thth & 27 & 27thth, 2009, 2009

ChangingChanging LivesLivesHow Pharmacy ComplianceHow Pharmacy Compliance

with the DEAwith the DEA Affects your Bottom LineAffects your Bottom Line

Session 15GWednesday, August 26, 2009

9:45 -11:15 a.m.

6175 Hi-Tek CourtMason, Ohio 45040

www.skilledcare.com

Larry Galluzzo, RPh

Larry Galluzzo has been the President/Owner of Skilled Care Pharmacy since 1980. He was the co-founder of Net-Rx, a purchasing group comprised of owners of privately-held pharmacies, as well as the co-founder of Excel CSO, a group service organization serving the Long Term Care market. He is a member of the American Society of Consultant Pharmacists and the Ohio Pharmacist Association, and an active participant in the Ohio Health Care Association, The Ohio Academy of Nursing Homes, Kentucky Association of Health Care Facilities, Association of Ohio Philanthropic Homes and Housing for the Aging, The American College of Nursing Home Administrators, and the Assisted Living Association of America.

Tracy OvertonCII Compliance Supervisor

Tracy Overton has served as a pharmacy technician in the long-term care industry for the past seven years assuming positions in both staff and supervisory roles. At Skilled Care, Tracy is exclusively responsible for pharmacy and physician compliance with the controlled substance (CII) prescription process per the Drug Enforcement Agency regulatory expectations. Recently, she participated in the successful realignment of the CII process within the pharmacy for which she gained great knowledge and expertise in procedural accountability and facility/physician buy-in.

Angela Sagraves, RPhSenior Pharmacy Manager

Angela Sagraves has served in a pharmacist capacity for 15 years in the long-term care industry. She has assumed positions in multiple settings as staff pharmacist and consultant pharmacist as well as 10 years in institutional pharmacy management. Her responsibilities at Skilled Care include oversight of the order entry, controlled substances, dispensing, prescription verification, and intravenous pharmacy processes encompassing over 100,000 prescriptions per month.

Most recently, in conjunction with her operational duties, she was actively involved in the development and implementation of procedural changes relative to the management of controlled substance prescription acquisition and medication dispensing.

28601 Chagrin BoulevardEton Tower, Suite 500

Beachwood, Ohio 44122Phone 216.831-0042 Fax 216.831.0542

www.meyersroman.com

Winner 2006 & 2007

Mary Louisa L’Hommedieu is experienced in a wide variety of corporate health care, commercial, and employment matters. She has litigated numerous cases in state and federal courts and before administrative bodies. Mary Louisa devotes a substantial portion of her practice to the resolution of business and regulatory disputes in the health care, long-term care and pharmacy industries. She also handles a broad range of other commercial litigation, and has authored and presented seminars on health care, employment and real estate topics.

Prior to joining the firm, Mary Louisa’s practice was focused in

health care, commercial litigation and employment law . She also served as a judicial attorney for the Honorable William B. Hoffman of the Fifth District Court of Appeals, and as judicial attorney for the Honorable Patricia A. Cosgrove of the Summit County Court of Common Pleas. She graduated cum laude from the University of Akron School of Law in 1996, where she was a member and an Associate Editor of the Akron Law Review.

Mary Louisa is a member of the Cleveland and Ohio Bar

Associations, as well as a member of the American Health Lawyers Association, OHCA (where she serves on the Facility Standards Committee) , and AOPHA. She has served as an Executive Board Member of the Youngstown Chapter of Habitat for Humanity, and is a member of the Hudson Chamber of Commerce. Look for her article, “Never Events and the Advent of Value Based Purchasing in Long Term Care” in the September, 2009 edition of Health Lawyer’s News. She lives in Hudson, Ohio with her husband and two children.

Mary Louisa L’Hommedieu

Mark P. McGrievy focuses his practice on business services, real estate, finance (representing both borrowers and lenders) and health care transactions and regulatory issues. Mark is a partner in the firm and serves as Chair of its Health Care Practice Group. He counsels clients on organizational structure; mergers, acquisitions and divestitures; financing; debtor/creditor workouts; licensure; Medicare and Medicaid certification, compliance and regulatory issues. Mr. McGrievy represents a number of health care providers, including; Nursing Homes, Residential Care and Assisted Living facilities, Physicians, Home Health Care and Senior Services companies, Medical Billing companies, Device Manufactures, Oxygen, Ambulance and Therapy companies and other Ancillary Providers, as well as Real Estate companies, Lending Institutions and closely held businesses in a variety of business sectors.

Mr. McGrievy graduated in 1988 from Cleveland-Marshall

College of Law and began his legal career as a law clerk to the Honorable Thomas R. Rumana, JSC, Passaic County N.J. Superior Court. He is admitted to practice in Ohio and New Jersey. Before joining a downtown Cleveland law firm in 1995, he served as Chief Financial Officer and General Counsel for a Nursing Home Management company from 1990 to 1995.

Mark is a member of the Cleveland and Ohio Bar

Associations, as well as a member of the American Health Lawyers Association, Ohio Health Care Association, and Ohio Academy of Nursing Homes. He served as President of the Allied Healthcare Professionals Association, and is involved in several Community organizations; IPMC Treasurer (2002 to present), Fraternal Order of Eagles, and March of Dimes.

Mark P. McGrievyChair, HealthcareGroup

http://www.facebook.com/album.php?profile=1&id=1551922437

ChangingChanging LivesLivesAGENDA

Introduction & BackgroundIntroduction & Background

http://www.cafepress.com/symbolsonstuff.238876413


ChangingChanging LivLivesAGENDA

Introduction & Background

Controlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations






Controlled Substances Act & DEA Regulations

CII Dispensing RulesCII Dispensing Rules








CII Dispensing Rules

CIII through C-V DispensingCIII through C-V Dispensing










CIII through C-V Dispensing

““Agent” of the Practitioner IssuesAgent” of the Practitioner Issues












“Agent” of the Practitioner Issues

Is your Facility at Risk?Is your Facility at Risk?














Is your Facility at Risk?

Penalties, Fines and other RepercussionsPenalties, Fines and other Repercussions
















Penalties, Fines and other Repercussions

Facility & Pharmacy challenges and how to work togetherFacility & Pharmacy challenges and how to work together


















Facility & Pharmacy challenges and how to work together

Compliance challenges and Cost of Non-complianceCompliance challenges and Cost of Non-compliance




















Compliance challenges and Cost of Non-compliance

Question & Answer Session Question & Answer Session





















Compliance challenges and Cost of Non-compliance

Question & Answer Session












ChangingChanging LivesLives WARNINGWARNING

DEA currently has ACTIVE investigationsin Ohio, Michigan, New York , Wisconsin,

West Virginia and Pennsylvania.


ChangingChanging LivesLives WARNINGWARNING

DEA currently has ACTIVE investigationsin Ohio, Michigan, New York , Wisconsin,

West Virginia and Pennsylvania.

Please do not discuss or raisePlease do not discuss or raisequestions regarding particularquestions regarding particular

Facility or Pharmacy issuesFacility or Pharmacy issues


ChangingChanging LivesLivesIntroduction & BackgroundIntroduction & Background

In the last five years, prescription drug abuse has prescription drug abuse has risen more than two-thirds nationwiderisen more than two-thirds nationwide. It is the DEA’s responsibility to work with our law enforcement partners to monitor prescriptions and ensure that legitimate pharmaceuticals are not diverted for illegitimate abuse.

-Special Agent in Charge John P. Gilbride, commenting on a recent case reported on DEA website. 3/22/07




Nearly 7 million Americans are abusing prescription drugs7 million Americans are abusing prescription drugs*—more than the number who are abusing Cocaine, Heroin, Hallucinogens, Ecstasy, and Inhalants, combined. That 7 million was just 3.8 million in 2000, an 80 percent increase in just 6 years80 percent increase in just 6 years.





Methods of acquiring prescription drugs for abuse Methods of acquiring prescription drugs for abuse include “doctor-shopping”, traditional drug-dealing, theft from pharmacies or homes, illicitly acquiring prescription drugs via the Internet, and from friends or relatives.





Misuse of painkillers represents three-fourths of the overall Misuse of painkillers represents three-fourths of the overall problemproblem of prescription drug abuse; Hydrocodone is the most commonly diverted and abused controlled pharmaceutical in the U.S.

From DEA Drug Fact Sheet, on DEA website: http://www.usdoj.gov/dea/concern/prescription_drug_fact_sheet.html

http://www.usdoj.gov/dea/concern/prescription_drug_fact_sheet.html




Pharmacies investigated for common practices generally are regulated by State Boards, but now DEA investigations are on the rise.




Nursing Home, Residential Care and Assisted Livingfacilities have experienced increased investigations and should expect heightened scrutiny!

Pharmacies investigated for common practices generallyare regulated by State Boards, but now DEA investigationsare on the rise.



ChangingChanging LivesLivesControlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations

Controlled Substances Act

Legal foundation of the Federal government’s authority over controlled substances and listed chemicals.






Consolidates more than 50 laws regulating controlled substances and listed chemicals.






Consolidates more than 50 laws regulating controlled substances and listed chemicals.

System of U.S. compliance with international treaties.

Implemented in DEA Regulations: Title 21 CFR 1300 to End



ChangingChanging LiLivesControlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations


“Closed system” of distribution.






Five “schedules” of controlled substances. C-I through C-V






Five “schedules” of controlled substances. C-1 through C-V

Created the Compliance Program (1971) to monitor the legitimate manufacture and distribution of controlled substances.




Closed System of Distribution:

Registrants must maintain DEA registration





Registrants must maintain DEA registration Each registrant involved in a transaction must verify the other registrant’s DEA registration





Registrants must maintain DEA registration Each registrant involved in a transaction must verify the other registrant’s DEA registration Transfer by the end user to any other person is illegal distribution





DEA Registrants (Handlers of Controlled Substances)





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers Distributors (Wholesalers), Exporters





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers Distributors (Wholesalers), Exporters Pharmacies





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers Distributors (Wholesalers), Exporters Pharmacies Narcotic Treatment Programs (NTPs)





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers Distributors (Wholesalers), Exporters Pharmacies Narcotic Treatment Programs (NTPs) Practitioners (MD, DO, DDS, DVM)”





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers Distributors (Wholesalers), Exporters Pharmacies Narcotic Treatment Programs (NTPs) Practitioners (MD, DO, DDS, DVM) Mid-Level Practitioners (PA, ARNP)





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers Distributors (Wholesalers), Exporters Pharmacies Narcotic Treatment Programs (NTPs) Practitioners (MD, DO, DDS, DVM) Mid-Level Practitioners (PA, ARNP) Researchers, Analytical Labs





DEA Registrants (Handlers of Controlled Substances) Importers, Manufacturers Distributors (Wholesalers), Exporters Pharmacies Narcotic Treatment Programs (NTPs) Practitioners (MD, DO, DDS, DVM) Mid-Level Practitioners (PA, ARNP) Researchers, Analytical Labs “Reverse Distributors”





Disposition of Unwanted Controlled Substances:

Return to supplier






Return to supplier Send to “Reverse Distributor”



ChangingChanging LivesLivesControlled Substances Act & DEA Regulations



Return to supplier Send to “Reverse Distributor” Receive permission from DEA to destroy




Long term care facilities such as nursing homes, assisted living facilities, and other institutions providing extended health care to resident patients are exempt from the Registration requirement because they hold prescribed controlled substances in a custodial capacity for their residents.




Some DEA offices have advised that flushing or pouring down the drain are not acceptable methods of destruction.

Under current law long term care facilities who wish to dispose or destroy controlled substances and do not want to just throw them away or flush them down the drain, must submit a letter to the local DEA office for authorization.




Schedule I – No current medical use in the United States, with a Very High potential for abuse:

Heroin

MDMA (Ecstasy)

LSD

Marijuana

Scheduled Substances:

http://www.usdoj.gov/dea/pubs/scheduling.html

http://www.usdoj.gov/dea/pubs/scheduling.html




Schedule II - Legitimate medical use, but with High potential for abuse:

Methamphetamine Dilaudid Cocaine Morphine

Ritalin Percocet Adderall Oxycontin




Schedule III - Legitimate medical use, but with lesser potential for abuse including Narcotic (III), and Non-narcotic (IIIN):

Examples:

Vicodin, Lortab (Hydrocodone) (III)

Tylenol with Codeine (III)

Buprenorphine (Suboxone) (III)

Butorphanol (Stadol) (III)

Anabolic Steroids, Ketamine (IIIN)



Changing LivesControlled Substances Act & DEA RegulationsControlled Substances Act & DEA Regulations

Schedule IV - Low potential for abuse:

Valium Xanax Darvocet Diet Drugs




Schedule V - Lowest potential for abuse

Cough syrups Lyrica Lomotil




DEA Regulations: The Controlled Substances Act of 1970 is the foundation for the body of regulations that governs the production, transfer, and disposal of controlled substances.





Current federal requirements can be found under 21 CFR 1300, et seq.





Current federal requirements can be found under 21 CFR 1300, et seq.

Controlled substances are also regulated at the state level (usually under the State Department of Health)




Federal and State Regulations Healthcare professionals must comply with both federal and state laws and regulations.




Federal and State Regulations Healthcare professionals must comply with both federal and state laws and regulations.

When federal laws or regulations differ from state laws or regulations, the more stringent law applies.




http://www.usdoj.gov/dea/pubs/csa.html

DEA Website lists text of law, with linksto regulations:

http://www.usdoj.gov/dea/pubs/csa.html




DEA Diversion Web Site: www.deadiversion.usdoj.gov

http://www.deadiversion.usdoj.gov/





A prescription for a controlled substance (CII-CV) must be issued for a legitimate medical purpose by an individual medical practitioner “acting in the usual course of his or her professional practice.”






Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner.






Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner.

A “corresponding responsibility rests with the pharmacist who fills the prescription.” 21 CFR 1306.04(a). 21 CFR 1306.03.





All prescriptions for controlled substances must be:

dated as of, and signed on the day issued,

.






dated as of, and signed on the day issued, must bear the full name and address of the patient

.






dated as of, and signed on the day issued, must bear the full name and address of the patient the drug name

.






dated as of, and signed on the day issued, must bear the full name and address of the patient the drug name strength

.






dated as of, and signed on the day issued, must bear the full name and address of the patient the drug name strength dosage form

.






dated as of, and signed on the day issued, must bear the full name and address of the patient the drug name strength dosage form quantity prescribed

.






dated as of, and signed on the day issued, must bear the full name and address of the patient the drug name strength dosage form quantity prescribed directions for use and

.






dated as of, and signed on the day issued, must bear the full name and address of the patient the drug name strength dosage form quantity prescribed directions for use and the name, address and registration number of the practitioner.

21 CFR 1306.05.





Prescriptions must be written with ink or indelible pencil or typewriter

.






Manually signed

.






Manually signed

Prepared by the secretary or agent

.






Manually signed

Prepared by the secretary or agent

Pharmacy may not fill any prescription without all required elements.

21 CFR 1306.05.





Proper Prescriptions for Schedule II Controlled Substances: Written prescription signed by the practitioner

Original written, signed prescription must be presented to the pharmacist for review prior to the actual dispensing

These general rules have specific, limited exceptions.

21 CFR 1306.11(a)

.





Proper Prescriptions for Schedule II Controlled Substances

Exception 1: Faxed CII prescriptions sufficient when: Long term care facility (“LTCF”) resident

Hospice Patient Compounded for certain direct administration

In each of these cases, the facsimile serves as the original written prescription.

21 CFR 1306.11.





Exception 2: Oral authorization permitted in Emergency Situation:

(1) The quantity limited to the emergency period; (&)

.





Exception 2: Oral authorization permitted in Emergency Situation:


(2) Immediate reduction to writing; (&)

.





Exception 2: Oral authorization permitted in Emergency Situation (cont).



(3) Validation; (&)

.








(3) Validation; (&)

(4) Obtain written prescription within 7 days.



Changing Lives



Pharmacist must notify DEA of Doctor’s failure to deliver or face loss of license.

21 CFR 1306

.





Exception 2: Emergency Situations (cont).

Oral authorization in Emergency Situations:

Immediate administration is necessary

.








No appropriate alternative treatment is available, including administration of N-CII drug

.








No appropriate alternative treatment is available, including administration of N-CII drug

Not reasonably possible for the physician to provide a written prescription prior to the dispensing.

21 CFR 1306.11 and § 290.10.





Refilling and Multiple Prescriptions of CIIs:

Prohibited, except:

Where pharmacist is unable to supply the full quantity Partial fills for LTC residents or terminally ill

21 CFR 1306.12

.




CIII, IV & V Dispensing RulesCIII, IV & V Dispensing Rules

SCHEDULE III, IV AND V SUBSTANCES

Prescriptions. Generally, a written prescription is required before dispensing a Schedule III, IV or V controlled substance and may be dispensed only with: a written prescription signed by a practitioner; or a facsimile of a written, signed prescription; or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of the practitioner. 21 CFR 1306.21




CIII, IV & V Dispensing RulesCIII, IV & V Dispensing Rules

SCHEDULE III, IV AND V SUBSTANCES

Refilling of prescriptions for controlled substances listed in Schedule III and IV.

No more than six months after the issue date.

No more than five times.

21 CFR 1306.22 & 21




Dispensing RulesDispensing Rules

Robert J. Compliant, M.D.123 Holly Lane Date: 5/01/09 Hudson, Ohio 44236 Reg. No.: _________________________________________________Patient’s name: ___________________________Address: ________________________________Drug: ___________________________________Disp: #______# (write out quantity)

Sig: __________________________Signature of Individual Medical Practitioner



Is this Correct?

93

Is this Correct?

94

Is this Correct?

95

Is this Correct?

96

Is this Correct?

97



Who is the “Agent,” and why is this causingsuch a controversy?



ChangingChanging LivesLives Is your Facility at RiskIs your Facility at Risk? ?

Just a Pharmacy issue?





Patient Care





Patient Care Nursing Home Resident’s Bill of Rights






Fraud & Abuse issues






Fraud & Abuse issues False Claims Act






Fraud & Abuse issues False Claims Act DEA Investigations, audits, fines






Fraud & Abuse issues False Claims Act DEA Investigations, audits, fines Potential Criminal and Civil liability




WHAT SHOULD YOU BE DOING?

Contact your Pharmacy to discuss issue






Set protocols with your Pharmacy







Assist Pharmacy in dealing with the Resident’s Physicians







Assist Pharmacy in dealing with the Resident’s Physicians

Audit medication requests for compliance



ChangingChanging LivesLivesPenalties, Fines and other RepercussionsPenalties, Fines and other Repercussions

Civil Fines and Criminal Penalties




Civil Fines and Criminal Penalties Litigation & Defense Costs




Civil Fines and Criminal Penalties Litigation & Defense Costs False Claims Act




Civil Fines and Criminal Penalties Litigation & Defense Costs False Claims Act Fraud & Abuse




Civil Fines and Criminal Penalties Litigation & Defense Costs False Claims Act Fraud & Abuse Loss of Provider Agreements




Civil Fines and Criminal Penalties Litigation & Defense Costs False Claims Act Fraud & Abuse Loss of Provider Agreements Five Star Ranking





Recognize potential problems






Appoint Liaison





Appoint Liaison

Recordkeeping


Compliance ChallengesCompliance Challenges

Disruption to Facility




Cost of Compliance




Cost of Compliance

Cooperation between all Parties involved


Question & Answer SessionQuestion & Answer Session

?

? Ask Away

THANK YOUTHANK YOU

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