Physicians, dentists, veterinarians, hospitals, and other persons prescribing or managing practitioners that prescribe controlled substances should require written agreements with staff and others communicating controlled substance prescriptions on their behalf and implement other suitable controls to ensure compliance with Drug Enforcement Administration requirements for prescribing controlled substances according to a new DEA Statement of Policy On Role of Authorized Agents in Communicating Controlled Substance Prescriptions To Pharmacies (Statement) published by the Department of Justice Drug Enforcement Administration (DEA) on October 6, 2010.

The Statement reflects that the DEA is concerned that about practitioners improperly delegating medical need determinations and other responsibilities for prescribing controlled substances. The Statement indicates that practitioners using agents to communicate controlled substance prescriptions should ensure that their delegations are appropriately documented by written agreements with the agents detailing the scope of their authority and implement background checks, monitoring, written and operational policies and procedures governing delegations and other controlled substance prescribing and other controls to appropriately comply with DEA controlled substance prescription mandates.

Under the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA) and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 801-971), a valid prescription issued by a DEA-registered practitioner is required for dispensing a controlled substance.  Existing rules prohibit DEA-registered practitioners from delegating their authority to prescribe controlled substances. To be effective (i.e., valid), a DEA-registered practitioner must issue the required prescription for a controlled substance for a legitimate medical purpose as determined by the practitioner acting in the usual course of professional practice. The registered practitioner actually must make the required determination of legitimate medical purpose underlying a controlled substance prescription. He cannot delegate responsibility for determining the legitimacy of the medical purpose for a controlled substance prescription or other core responsibilities.

While DEA rules prohibit a registered practitioner from delegating his core responsibilities pertaining to prescribing controlled substances to anyone else, DEA rules allow an individual practitioner to authorize an agent to perform a limited role in communicating controlled substance prescriptions to a pharmacy in order to make the prescription process more efficient. The ability to delegate these communication responsibilities is very restricted and requires that the practitioners apply appropriate controls to prevent delegation of core prescribing responsibilities.

In the Statement, the DEA cautions that DEA requires that DEA registered practitioners must be prepared to demonstrate that the registered practitioner alone makes all required medical determinations to prescribe the communicated controlled substances when delegating responsibility to communicate controlled substance prescriptions to pharmacies on their behalf to nurse or other person acting as the practitioner’s agent.  The Statement warns that delegation must be limited to participation in the communication of the prescription in accordance with DEA requirements.  The Statement urges practitioners allowing agents to participate in the communication of controlled substance prescriptions to make those delegations pursuant to written agreements with t he agent and to adopt other safeguards to maintain compliance with DEA rules.  To learn more, see  here

For More Information Or Assistance

If you need assistance reviewing or responding to the DEA prescribing guidance contained in the Statement or addressing other health care related risk management or compliance concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

• CMS Delegated Lead Responsibility For Development of New Affordable Care Act-Required Medicare Self-Referral Disclosure Protocol
• HHS announces Rules Implementing Tools Added By Affordable Care Act to Prevent Federal Health Program Fraud
• OIG: Texas Overbilled Medicaid for Medical Transportation Costs
• DMEPOS Suppliers Face 9/27 Deadline To Meet Tightened Medicare Standards
• Initial EHR Certification Bodies Named
• HHS Announces Adjustments to Federal Medical Assistance Percentage (FMAP) Rates
• CMS Publishes Corrections To Proposed 2011 Physician Fee Schedule Rules
• Medicare Changing How It Pays For Outpatient Dialysis
• Last Call: Today Deadline To Comment on Proposed Edits To CMS Nursing Home Civil Monetary Penalty Regs
• Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case As OCR Moves To Tighten Privacy Rules
• HHS Invites Input On Medicaid Changes To Promote Children’s Health Quality
• CMS Adopts ESRD Facility Prospective Payment System & Proposes New Quality Incentive Program
• CMS Rule Clarifies When Outpatient Services Subject to 3-Day Rule & Finalizes FY 2011 Inpatient Payment Rates
• New Affordable Care Act Mandated High Risk Pre-Existing Condition Insurance Pool Program Regulations Set Program Rules, Prohibit Plan Dumping of High Risk Members
• CMS & ONC To Co-Host 7/22 ONC Certification & Medicare/Medicaid EHR Incentive Program Audio Training
• CMS Proposes Changes To Civil Monetary Penalty Rules For Nursing Homes

For More Information

We hope that this information is useful to you. If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information here. To unsubscribe, e-mail here.

©2010 Solutions Law Press. All rights reserved.

This entry was posted on Tuesday, November 2nd, 2010 at 9:38 am and is filed under Controlled Substances, Corporate Compliance, DEA, Doctor, Electronic Medical Records, Health Care, Health Care Provider, Health Care Quality, Hospital, Licensing, Medical Licensure, Medical Malpractice, Physician, Physician Licensing, Prescription Drugs, Substance Abuse. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.