Merck To Pay $950 Million To Settle Vioxx® Off-Label Marketing Charges

November 27, 2011

American pharmaceutical company Merck, Sharp & Dohme (Merck) will pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx® (rofecoxib).   Merck previously withdrew Vioxx® from the market.

According to a November 23, 2011 joint announcement of the U.S. Departments of Justice (DOJ) and Health & Human Services (HHS), Merck has agreed to plead guilty to one misdemeanor count of engaging in illegal promotional activity and to a $321,636,000 criminal fine to resolve charges that its marketing of Vioxx® violated the Food Drug and Cosmetic Act (FDCA)

Concurrent with the criminal plea agreement, Merck also is entering into a civil settlement agreement under which it will pay $628,364,000 to resolve other allegations of off-label marketing of Vioxx® and false statements about the drug’s cardiovascular safety.   Of the total civil settlement, $426,389,000 will go to the United States, and the remaining share of $201,975,000 be paid to the participating Medicaid states.  The settlement and plea conclude a long-running investigation of Merck’s promotion of Vioxx®, which was withdrawn from the marketplace in September 2004.

Under the provisions of the FDCA, a company is required to specify the intended uses of a product in its new drug application to FDA.   Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – any use not specified in an application and approved by FDA – unless the company applies to the FDA for approval of the additional use.   The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002.   In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.

Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration (FDA).  

The parallel civil settlement covers a broader range of allegedly illegal conduct by Merck.   The settlement resolves allegations that Merck representatives   made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government.   It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx, and that those agencies relied on Merck’s false claims in making payment decisions about the drug.   Finally, like the criminal plea, the civil settlement also recovers damages for allegedly false claims caused by Merck’s unlawful promotion of Vioxx for rheumatoid arthritis.

As part of the settlement, Merck has also agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of HHS that requires it to strengthen the system of reviews and oversight procedures imposed on the company to deter and detect similar conduct in the future with respect to Merck products regulated by the FDA.

The Merck plea agreement and civil resolution agreement show the continuing commitment of DOJ and other federal regulators to investigate and prosecute off-label and other marketing of pharmaceutical products in violation of applicable federal laws.  Pharmaceutical companies and members of their workforce should heed the announcement as another reminder of the need to exercise continuing diligence to comply with these requirements.

For Help With Compliance, Investigations Or Other Needs

If you need assistance providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management 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 24 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 medical privacy and other compliance and risk management policies, to 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/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights 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.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

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OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks

November 9, 2011

The kickoff of a new compliance audit pilot program provides another reason for health care providers, health plans, healthcare clearinghouses and their business associates to get serious about compliance with the privacy, security and data breach requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 

OCR Pilot Audit Program Begins

On November 8, 2011, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) announced that it will begin auditing HIPAA compliance this month under a new pilot program.

As amended by the American Recovery and Reinvestment Act of 2009 in Section 13411 of the HITECH Act, requires HHS to provide for periodic audits to make sure covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards.  To carry out this mandate, OCR is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance between November 2011 and December 2012.

The commencement of OCR HIPAA compliance audits is yet another sign that covered entities and their business associates should get serious about HIPAA compliance. The audit program serves as a new part of OCR’s health information privacy and security compliance program.  While OCR says that it presently views the pilot audits as primarily a compliance improvement tool, this does not mean violators should expect a free walk.

Even before the impending audits, HIPAA Privacy exposures of covered entities for failing to comply with HIPAA already had risen significantly.  Earlier this year, OCR imposed a $4.3 Million Civil Money Penalty (CMP) against Cignet Health of Prince George’s County (Cignet) for violating HIPAA.  Meanwhile, the Department of Justice has secured several criminal convictions or pleas under HIPAA’s criminal provisions. Under amendments made by the HITECH Act, state attorneys general also now are empowered to bring civil lawsuits against covered entities and business associates that commit HIPAA violations that injure citizens in their state under certain circumstances. Eventually, individuals injured by HIPAA violations also will get the right to share in a portion of certain HIPAA recoveries.

These and other audit and enforcement activities send a strong message that covered entities and their business associates need to get serious about HIPAA compliance. As stated by OCR Director Georgina Verdugo when announcing the Mass General Resolution Agreement, “To avoid enforcement penalties, covered entities must ensure they are always in compliance with the HIPAA Privacy and Security Rules,” Verdugo added, “A robust compliance program includes employee training, vigilant implementation of policies and procedures, regular internal audits, and a prompt action plan to respond to incidents.” Learn more here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need assistance monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.

Vice President of the North Texas Health Care Compliance Professionals Association, a member of the American College of Employee Benefit Counsel, Past Chair of the ABA RPTE Employee Benefits & Other Compensation Arrangements Group, 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 extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies.  Ms. Stamer also regularly helps clients deal with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, 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 publications and insights 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.  Her insights on the required “culture of compliance” with HIPAA are frequently included in medical privacy related publications of the Atlantic Information Service, Modern Health Care, HealthLeaders and many others. Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here or may contact her at (469) 767-8872 or via e-mail here.

You can review other selected publications and resources and additional information about the employment, employee benefits and other experience of Ms. Stamer here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources available at www.solutionslawpress.com. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

 

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Posted by Cynthia Marcotte Stamer

Houston Doctor Gets 135 Month Health Care Fraud Sentence

November 6, 2011

Conviction Highlights Growing Fraud Enforcement Risks Reach Broadly

A Houston Federal Court recently sentenced Houston doctor Christina Joy Clardy to 135 months in federal prison for her conviction on charges arising from a health care fraud conspiracy that federal officials charged resulted in false billings to Medicare and Texas Medicaid programs for $45,039,230 over a 2 ½-year-period.  Clardy, who was found guilty of one count of conspiracy to commit health care fraud, 14 counts of health care fraud and three counts of mail fraud on May 27, 2011, after an 18-day trial in front of U.S. District Judge Melinda Harmon, also was ordered to pay $15,626,084.01 in restitution to Medicare and Medicaid.

Federal prosecutors had charged that Clardy was a key player in a massive federal health care fraud scheme under which City Nursing Services of Texas, Inc (City Nursing Services) billed more than $25 million worth of physical therapy services under Clardy’s physician provider numbers between January 2007 and August 2008.

Clardy is the third defendant to be sentenced in this matter.

The charges against Clardy and others convicted in the City Nursing Services action are one of a growing number of health care fraud prosecutions resulting  from the actions of the Medicare Fraud Strike Force that are conducted as part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT).  HEAT is a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.  The joint Department of Justice-HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing.  Since its announcement, the Strike Force has used the combined resources of agents from the FBI, HHS-Office of Inspector General (HHS-OIG), multiple Medicaid Fraud Control Units, and other state and local law enforcement agencies to investigate and prosecute a rising number of organizations and individuals throughout the industry for alleged violations of Federal health care fraud prohibitions.  In their September 7, 2011 announcement, HHS and DOJ credited Strike Force Operations in nine locations with resulting in charges against more than 1,140 defendants who the government charged collectively falsely billed the Medicare program for more than $2.9 billion.  Learn more here.,

The effectiveness of these Federal efforts to deter, find and prosecute false claims and other perceived abuses of Federal health care law has been significantly strengthened since Congress passed the Patient Protection & Affordable Care Act (Affordable Care Act).  Among other things, ACA empowered HHS to:

  • Suspend payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
  • Impose a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
  • Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified  health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
  • Terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
  • Require provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements.

 

Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management 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 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD 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 presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, 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 responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see  here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

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Posted by Cynthia Marcotte Stamer

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

May 17, 2011

On January 14, 2011, a disciplinary panel of the Texas Medical Board (TMB) temporarily suspended the medical license of Julia Renee Ward, M.D. of Houston, after determining that Dr. Ward’s continuation in the practice of medicine presents a continuing threat to the public welfare.   Physicians, pharmacists and others involved in pain treatment should  resist the temptation to allow the allegations of extreme misconduct by Ward, others to blind them to the need for special precautions when prescribing or administering pain management or other controlled substance treatments.

Ward Pain Management Suspension

According to a January 18, 2011 TMB Press Release, TMB issued the Order of Temporary Suspension (Without Notice of Hearing) based on Dr. Ward’s operation of a pain management clinic, Tejas Urgent Care Clinic, without the certification required by law; failure to practice medicine in an acceptable, professional manner; inappropriate prescribing of controlled substances; and unprofessional or dishonorable conduct. The suspension took immediate effect.  Previously, the medical board denied certification of Tejas Clinic in Houston, based on the clinic’s partial ownership by a non-physician.

According to the Press Release, TMB and Texas State Board of Pharmacy investigators staked out the clinic and observed several vehicles, some with out-of-state license plates, dropping off and picking up small groups of patients throughout the day.   TMB says investigators observed four men who appeared to be patrolling the parking lot, directing patients to Tejas Clinic and H&W Pharmacy.  Investigators reported the dropped-off patients would enter the clinic, exit about 20 minutes later, and then go to the pharmacy next door, H&W Pharmacy, to fill their prescriptions. Most of the prescriptions written by Dr. Ward were for hydrocodone, and a large number of prescriptions were for Xanax and Soma as well. The three drugs are a well-known combination commonly abused and diverted for sale to addicts.

According to the TMB Press Release, H&W Pharmacy’s license has since been suspended by the Texas State Board of Pharmacy, as has the license of H&W pharmacist Victor Egbulefu.

The Temporary Suspension Hearing Without Notice took place under the Board’s authority, granted by the Medical Practice Act, to suspend or restrict a physician’s license without notice when it determines the physician’s continuation in practice would constitute a continuing threat to the public welfare. Under TMB procedures, Ward has the opportunity to have a Temporary Suspension Hearing With Notice at least 10 days after notice of the suspension.

Physician Precautions Recommended For Pain Management Activities

Physicians and other health care providers should not allow the egregiousness of allegations underlying suspensions like those alleged committed by Ward to blind them to the importance of exercising special care when engaging in pain management activities.  While medical practitioners, medical boards, the Drug Enforcement Agency, accreditation agencies and others increasingly recognize the appropriateness and need for legitimate pain management, physicians, pharmacies and others prescribing and delivering pain management must conduct these activities in a defensible manner.  Physicians prescribing pain management remain accountable for demonstrating and documenting the therapeutic appropriateness of prescribed management including appropriate procedures to monitor and redress potential concerns about patient medication abuse or addition.  See Texas Medical Board Rules §§ 170.1-170.3.  As many pain management medications both are controlled substances, physicians prescribing these medications often must comply with special prescribing, documentation and other requirements under DEA, state medical board and other rules and ethical standards.  See, e.g, DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing.   

Missteps by providers in the prescription, documentation, or administration of pain management or other controlled substance prescriptions and treatment are frequently the basis of medical board and other disciplinary actions and civil, criminal and administrative enforcement actions by the Justice Department, DEA, Department of Health & Human Services and others. See e.g., Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians; Texas Pain Management Physician and Psychiatrist Arrested on Federal Health Care Fraud Inditement; Pain and The Law.  

To defend against these and other exposures, physicians and practices, pharmacies and pharmacists, and the hospitals and other organizations involved in the operation or management of physicians or pharmacists prescribing or dispensing pain management treatments should implement written delegation policies and other procedures to facilitate their ability to withstand DEA, medical board and other scrutiny and defend against a claim of improper conduct.   As part of these efforts, prescribing practitioners should consider include:

  • Carefully and fully document the therapeutic need and appropriateness of the prescribed treatment including the medical justification, patient counseling, adherence to DEA and other standards and procedures, and monitoring for effectiveness, patient compliance and potential patient abuse.
  • Strictly complying with DEA requirements when prescribing controlled substances;
  • Ensure appropriate and well-documented physician assessment of patient pain and pain management treatment;
  • Abstain from or restrict delegation of pain management assessments or prescription of controlled substance except in strict and clearly documented compliance with DEA rules and all otherwise applicable regulations and care standards;
  • Adopting and following written policies and procedures governing the prescription and handling of pain management and other controlled substances including the scope of allowable delegation of communication functions;
  • Requiring physicians, pharmacists and others participating in pain management or other controlled substance ordering or treatment to participate in specific, documented training and enter into signed written agreements acknowledging knowledge of and agreement to comply with pain management, controlled substance and other relevant policies and requirements;
  • Monitoring of prescribing and other dealings with controlled substances for potential noncompliance;
  • Careful documentation of all activities involved with the prescription and handling of controlled substances or their prescriptions;
  • Carefully restricting the individuals that with or without authorization could participate in the prescription or handling of controlled substance;
  • Requiring drug and alcohol testing of physicians and other staff with involvement in the prescription or handling of controlled substance or who otherwise might be in a position to access the materials used in this process;
  • Conducting appropriate training of DEA-authorized practitioners and their support staff regarding the appropriate procedures for handling and prescribing controlled substances;
  • Conducting periodic background checks of physicians, pharmacists, staff and others who might participate in the prescription of or otherwise be in a position to access controlled substances or the tools for their access or prescription pursuant to written authorizations designed to comply with applicable Federal Trade Commission credit check and other relevant laws;
  • Avoiding relationships and dealings involving prescribers, pharmacies, investors or others with questionable backgrounds or involving relationships that might create heightened exposures or appearances of impropriety; and
  • Investigating and promptly redressing any known or suspected violation of DEA mandated or other policies regarding the prescription or handling of controlled substances.

For Help With Compliance, Investigations Or Other Needs

IIf you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management 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 including her highly popular programs on “Sex Drugs & Rock ‘N Role:  Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others. 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. 

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

 

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: , , , , , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

5/18 Deadline to Register For 5/19 CMS Provider Call on Medicare and Medicaid EHR Meaningful Use Incentive Programs

May 17, 2011

Wish you knew more about how to use electronic health records (EHRs) to earn incentive payments from the Centers for Medicare & Medicaid Services (CMS)?  CMS plans to host a  national provider education call to help you learn more about meaningful use on Thursday, May 19 at 2:30 p.m. EDT.   During the call, CMS plans to discuss:

In order to receive the call-in information, you must register for the call. It is important to note that if you are planning to sit in with a group, only one person needs to register to receive the call-in data. This registration is solely to reserve a phone line, NOT to allow participation. Registration will close at 2:30 p.m. EDT on May 18, 2011, or when available space has been filled. No exceptions will be made, so please be sure to register prior to this time. In order to register, you should:

  1. Visit the registration page.
  2. Fill in all required information and click “Register.”
  3. You will be taken to the “Thank you for registering” page and will receive a confirmation email shortly thereafter. Please save this page in case your server blocks the confirmation emails. (If you do not receive the confirmation email, check your spam/junk mail filter as it may have been directed there.)
  4. If assistance for hearing impaired services is needed, please email medicare.ttt@palmettogba.com no later than three business days before the call.

Prior to the call, presentation materials will be made available in the “Upcoming Events” section of the Spotlight page on the CMS EHR website.

Register for the call today.

Want more information about the EHR Incentive Programs?
Make sure to visit the EHR Incentive Programs website for the latest news and updates on the EHR Incentive Programs.

Sixty-two Regional Extension Centers (RECs) across the nation are prepared to offer customized, on-the-ground assistance for eligible professionals and hospitals registering for the CMS EHR Incentive Programs. To locate an REC near you, visit http://www.healthit.

In addition to the May 10 call, recordings of various other recent health information privacy and data security training offered by agencies within the Department of Health and Human Services also now is avaialble on the web.  For instance, the  National Institute of Standards and Technology (NIST) and the Office for Civil Rights (OCR) are making presentations from the 4th annual conference on “Safeguarding Health Information: Building Assurance through HIPAA Security” co-hosted in Washington, D.C. on May 10 & 11, 2011 available on line for review.  The training is part of a series of continuing efforts by the agencies to outreach to various parties on the Privacy and Security Rules of the Health Insurance Portability & Accountability Act of 1996, as amended (HIPAA).  Meanwhile, OCR’s Susan McAndrew on Monday shared insights on OCR’s HIPAA regulatory and enforcement agenda at a teleconference to be hosted by the American Bar Association Joint Committee on Employee Benefits at Noon Central on May 16, 2011.  Recordings of these presentations are or will be accessible on the sponsoring organizations from their websites.  For details about reviewing the May 10-11 presentations, see the 2011 HIPAA Conference website here.  For details about the May 16 teleconference, see here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need assistance monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management 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 medical privacy and other compliance and risk management policies, to 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.  On May 3, 2011, Ms. Stamer served as the appointed scribe for the ABA Joint Commitee on Employee Benefits Agency meeting with OCR and will moderate a teleconference featuring comments by OCR’s Susan McAndrew for the Joint Committee on Employee Benefits scheduled for May 16.  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/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others..   Her publications and insights 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.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

Leave a Comment » | Academic medicine, ASC, DEA, Disease Management, DME, Doctor, Electronic Health Records, Electronic Medical Records, Employer, Genetic Information, GINA, Health Care Provider, Health IT, Health Plan, HIPAA, HITECH Act, Hospital, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Mental Heatlh, OCR, Physician | Tagged: , , , , | Permalink
Posted by Cynthia Marcotte Stamer

OCR/NIST Share Training Online, OCR’s McAndrew To Speak On May 16 Teleconference

May 10, 2011

The National Institute of Standards and Technology (NIST) and the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) are making presentations from the 4th annual conference on “Safeguarding Health Information: Building Assurance through HIPAA Security” co-hosted in Washington, D.C. on May 10 & 11, 2011 available on line for review.  The training is part of a series of continuing efforts by the agencies to outreach to various parties on the Privacy and Security Rules of the Health Insurance Portability & Accountability Act of 1996, as amended (HIPAA).  Meanwhile, OCR’s Susan McAndrew is scheduled to share insights on OCR’s HIPAA regulatory and enforcement agenda at a teleconference to be hosted by the American Bar Association Joint Committee on Employee Benefits at Noon Central on May 16, 2011. 

 The Security Rule sets federal standards to protect the confidentiality, integrity and availability of electronic protected health information by requiring HIPAA covered entities and their business associates to implement and maintain administrative, physical and technical safeguards. Presentations cover a variety of current topics including updates on HHS health information privacy and security initiatives, OCR’s enforcement of health information privacy and security activities, integrating security safeguards into health IT and security automation, insider threat trends and safeguards, and more.

The conference is designed to explore the current health information technology security landscape and the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, the agencies share their practical strategies, tips and techniques for implementing the HIPAA Security Rule. 

For details about reviewing the May 10-11 presentations, see the 2011 HIPAA Conference website here.  For details about the May 16 teleconference, see here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need assistance monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management 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 medical privacy and other compliance and risk management policies, to 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.  On May 3, 2011, Ms. Stamer served as the appointed scribe for the ABA Joint Commitee on Employee Benefits Agency meeting with OCR and will moderate a teleconference featuring comments by OCR’s Susan McAndrew for the Joint Committee on Employee Benefits scheduled for May 16.  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/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others..   Her publications and insights 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.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

Leave a Comment » | Academic medicine, ASC, DEA, Disease Management, DME, Doctor, Electronic Health Records, Electronic Medical Records, Employer, Genetic Information, GINA, Health Care Provider, Health IT, Health Plan, HIPAA, HITECH Act, Hospital, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Mental Heatlh, OCR, Physician | Tagged: , , , , | Permalink
Posted by Cynthia Marcotte Stamer

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

January 18, 2011

On January 14, 2011, a disciplinary panel of the Texas Medical Board (TMB) temporarily suspended the medical license of Julia Renee Ward, M.D. of Houston, after determining that Dr. Ward’s continuation in the practice of medicine presents a continuing threat to the public welfare.   Physicians, pharmacists and others involved in pain treatment should  resist the temptation to allow the allegations of extreme misconduct by Ward, others to blind them to the need for special precautions when prescribing or administering pain management or other controlled substance treatments.

rd Pain Management Suspension

According to a January 18, 2011 TMB Press Release, TMB issued the Order of Temporary Suspension (Without Notice of Hearing) based on Dr. Ward’s operation of a pain management clinic, Tejas Urgent Care Clinic, without the certification required by law; failure to practice medicine in an acceptable, professional manner; inappropriate prescribing of controlled substances; and unprofessional or dishonorable conduct. The suspension took immediate effect.  Previously, the medical board denied certification of Tejas Clinic in Houston, based on the clinic’s partial ownership by a non-physician.

According to the Press Release, TMB and Texas State Board of Pharmacy investigators staked out the clinic and observed several vehicles, some with out-of-state license plates, dropping off and picking up small groups of patients throughout the day.   TMB says investigators observed four men who appeared to be patrolling the parking lot, directing patients to Tejas Clinic and H&W Pharmacy.  Investigators reported the dropped-off patients would enter the clinic, exit about 20 minutes later, and then go to the pharmacy next door, H&W Pharmacy, to fill their prescriptions. Most of the prescriptions written by Dr. Ward were for hydrocodone, and a large number of prescriptions were for Xanax and Soma as well. The three drugs are a well-known combination commonly abused and diverted for sale to addicts.

According to the TMB Press Release, H&W Pharmacy’s license has since been suspended by the Texas State Board of Pharmacy, as has the license of H&W pharmacist Victor Egbulefu.

The Temporary Suspension Hearing Without Notice took place under the Board’s authority, granted by the Medical Practice Act, to suspend or restrict a physician’s license without notice when it determines the physician’s continuation in practice would constitute a continuing threat to the public welfare. Under TMB procedures, Ward has the opportunity to have a Temporary Suspension Hearing With Notice at least 10 days after notice of the suspension.

Physician Precautions Recommended For Pain Management Activities

Physicians and other health care providers should not allow the egregiousness of allegations underlying suspensions like those alleged committed by Ward to blind them to the importance of exercising special care when engaging in pain management activities.  While medical practitioners, medical boards, the Drug Enforcement Agency, accreditation agencies and others increasingly recognize the appropriateness and need for legitimate pain management, physicians, pharmacies and others prescribing and delivering pain management must conduct these activities in a defensible manner.  Physicians prescribing pain management remain accountable for demonstrating and documenting the therapeutic appropriateness of prescribed management including appropriate procedures to monitor and redress potential concerns about patient medication abuse or addition.  See Texas Medical Board Rules §§ 170.1-170.3.  As many pain management medications both are controlled substances, physicians prescribing these medications often must comply with special prescribing, documentation and other requirements under DEA, state medical board and other rules and ethical standards.  See, e.g, DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing.   

Missteps by providers in the prescription, documentation, or administration of pain management or other controlled substance prescriptions and treatment are frequently the basis of medical board and other disciplinary actions and civil, criminal and administrative enforcement actions by the Justice Department, DEA, Department of Health & Human Services and others. See e.g., Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians; Texas Pain Management Physician and Psychiatrist Arrested on Federal Health Care Fraud Inditement; Pain and The Law.  

To defend against these and other exposures, physicians and practices, pharmacies and pharmacists, and the hospitals and other organizations involved in the operation or management of physicians or pharmacists prescribing or dispensing pain management treatments should implement written delegation policies and other procedures to facilitate their ability to withstand DEA, medical board and other scrutiny and defend against a claim of improper conduct.   As part of these efforts, prescribing practitioners should consider include:

  • Carefully and fully document the therapeutic need and appropriateness of the prescribed treatment including the medical justification, patient counseling, adherence to DEA and other standards and procedures, and monitoring for effectiveness, patient compliance and potential patient abuse.
  • Strictly complying with DEA requirements when prescribing controlled substances;
  • Ensure appropriate and well-documented physician assessment of patient pain and pain management treatment;
  • Abstain from or restrict delegation of pain management assessments or prescription of controlled substance except in strict and clearly documented compliance with DEA rules and all otherwise applicable regulations and care standards;
  • Adopting and following written policies and procedures governing the prescription and handling of pain management and other controlled substances including the scope of allowable delegation of communication functions;
  • Requiring physicians, pharmacists and others participating in pain management or other controlled substance ordering or treatment to participate in specific, documented training and enter into signed written agreements acknowledging knowledge of and agreement to comply with pain management, controlled substance and other relevant policies and requirements;
  • Monitoring of prescribing and other dealings with controlled substances for potential noncompliance;
  • Careful documentation of all activities involved with the prescription and handling of controlled substances or their prescriptions;
  • Carefully restricting the individuals that with or without authorization could participate in the prescription or handling of controlled substance;
  • Requiring drug and alcohol testing of physicians and other staff with involvement in the prescription or handling of controlled substance or who otherwise might be in a position to access the materials used in this process;
  • Conducting appropriate training of DEA-authorized practitioners and their support staff regarding the appropriate procedures for handling and prescribing controlled substances;
  • Conducting periodic background checks of physicians, pharmacists, staff and others who might participate in the prescription of or otherwise be in a position to access controlled substances or the tools for their access or prescription pursuant to written authorizations designed to comply with applicable Federal Trade Commission credit check and other relevant laws;
  • Avoiding relationships and dealings involving prescribers, pharmacies, investors or others with questionable backgrounds or involving relationships that might create heightened exposures or appearances of impropriety; and
  • Investigating and promptly redressing any known or suspected violation of DEA mandated or other policies regarding the prescription or handling of controlled substances.

For Help With Compliance, Investigations Or Other Needs

IIf you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management 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 including her highly popular programs on “Sex Drugs & Rock ‘N Role:  Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others. 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. 

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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 here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

 

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.

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Posted by Cynthia Marcotte Stamer

DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing Functions, Urges Adoption of Written Policies & Agreements

November 2, 2010

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:

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.

Leave a Comment » | 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 | Tagged: , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

NCPDP SCRIPT 10.6 Approved As Medicare Part D/Advantage E-Prescribing Option

July 1, 2010

The Centers for Medicare & Medicaid Services (CMS) today (July 1, 2010) issued an interim final rule (Rule) that permits the voluntary use of the National Council for the Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard, Implementation Guide, Version 10, Release 6 (Version 10.6) (NCPDP SCRIPT 10.6) for conducting certain e-prescribing transactions for the Medicare Part D electronic prescription drug program. Review the Rule here.

Prior to the adoption the Rule, only NCPDP SCRIPT 8.1 was authorized for use in communicating Medicare Part D medication history among sponsors, prescribers and dispensers. The Rule revises Regulation §423.160(b)(4) to specify that entities now may use either NCPDP SCRIPT 10.6 or 8.1 for the communication of Medicare Part D medication history among sponsors, prescribers, and dispensers.

Along with the rule, CMS issued a request for comments on the Rule.  The deadline for interested parties to comment is 5 p.m. Eastern Daylight Time on August 30, 2010.

Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) requires that Prescription Drug Plan (PDP) sponsors, Medicare Advantage (MA) organizations offering Medicare Advantage-Prescription Drug Plans  and other Medicare Part D sponsors (Plans) provide for electronic transmittal the prescribing provider, dispensing pharmacy and the dispenser of information about:

  • Eligibility,
  • Benefits (including drugs included in the applicable formulary, any tiered formulary structure and any requirements for prior authorization),
  • The drug being prescribed or dispensed and other drugs listed in the medication history,
  • The availability of lower cost, therapeutically appropriate alternatives (if any) for the drug prescribed, and
  • Certain other information.

Before the Rule, CMS had approved NCPDP SCRIPT 8.1 for conducting these electronic transmittals.

As a consequence of the Rule, Plans, prescribers and dispensers now may use either NCPDP SCRIPT 10.6 or 8.1 when conducting e-Prescribing to conduct:

  • Get message transaction.
  • Status response transaction.
  • Error response transaction.
  • New prescription transaction.
  • Prescription change request transaction.
  • Prescription change response transaction.
  • Refill prescription request transaction.
  • Refill prescription response transaction.
  • Verification transaction.
  • Password change transaction.
  • Cancel prescription request transaction.
  • Cancel prescription response transaction.
  • Fill status notification transaction.
  • For the communication of Medicare Part D medication history among sponsors, prescribers, and dispensers.

The MMD does not require that prescribers or dispensers implement e-Prescribing, prescribers and dispensers who electronically transmit prescription and certain other prescription-related information for Medicare Part D covered drugs prescribed for Medicare Part D eligible individuals, directly or through an intermediary, must comply with any applicable final standards that are in effect.  The Rule provides new choices on how to accomplish this.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. You can get more information about her health industry experience here.   If you need help with these or other compliance concerns, wish to ask 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:

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.

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.  A popular lecturer and widely published author on health industry and human resources matters, Ms. Stamer continuously advises health industry clients about these and other related concerns.  Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, 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.  For additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.  

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.

Leave a Comment » | Controlled Substances, DEA, Doctor, Electronic Health Records, Electronic Medical Records, Health Care, Health Care Provider, Health IT, Health Plan, Health Plans, Hospital, Hospital, Meaningful Use, Medicare, Medicare Advantage, Pharmacy, Physician, Prescription Drugs, Privacy, Reimbursement, Telemedicine | Tagged: , , , , , , , | Permalink
Posted by Cynthia Marcotte Stamer

DEA/DOJ Release Interim Final E-Prescribing Rules

March 25, 2010

Health care providers wishing to electronically prescribe controlled substance should begin reviewing and updating their practices and technology to comply with requirements of the Interim Final Regulations scheduled for publication in the Federal Register on March 31, 2010. Read details at http://wp.me/ptOGJ-94

An advance copy of the new Interim Final Regulation with Request for Comments released March 24, 2010 by the Drug Enforcement Administration (DEA) and Department of Justice on Electronic Prescribing of Controlled Substance on is posted for review here.

Concurrent with publication of the Interim Final Rule, the DEA is inviting comment on DEA is seeking additional comments on the following issues: identity proofing, access control, authentication, biometric subsystems and testing of those subsystems, internal audit trails for electronic prescription applications, and third-party auditors and certification organizations.

About The Author

If you need assistance with health industry human resources or other management, concerns, wish to inquire about compliance, risk management or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer at cstamer@solutionslawyer.net or (469) 767-8872. 

Nationally and internationally recognized for more than 22 years of work with health industry technology,  privacy and data security, regulatory compliance, reimbursement, workforce and staffing, licensure and accreditation, and other quality, risk management, operations and public policy matters organizations, publications, workshops and presentations and leadership Cynthia Marcotte Stamer has worked extensively with physicians, health systems, specialty and other pharmacy, telemedicine and other health technology, and other health industry clients on a diverse range of operational, product and process development, regulatory, licensure, public policy and risk management protections relating to e-prescribing, telemedicine, interoperable and other electronic health and medicine arrangements and other health care internal controls, process and privacy and technology matters. The publisher of the Solutions Law Press Health Care Update, and Solutions Law Press Health Care Privacy & Technology Update, Ms. Stamer also is a popular speaker and author of these and other health industry topics.  She regularly publishes, speaks and conducts training for health industry and other organizations, the ABA, American Health Lawyers Association (AHLA), Health Care Compliance Association, Institute of Internal Auditors, various medical society and other professional organizations, the Medical Group Management Association, and many other organizations.  Her many publications and programs include“Changing Regulations Will Ease Way for E-Prescribing, But Physicians Shouldn’t Jump the Gun,” “Telemedicine, E-Prescribing & Electronic Health Records: Opportunities & Exposures,” “Telemedicine & E-Prescribing: Evolving Ethical, Licensing & Reimbursement Rules & Realities,” the “Tort & Other Liability” Chapter of the ABA Health Law Section/BNA E-Health & Technology Treatise, “Protecting & Using Patient Data in Disease Management Opportunities, Liabilities and Prescriptions,” Chapter 1: Privacy.” The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks (AHLA 2005) (Contributing Author), “Cybercrime and Identity Theft: Health Information Security beyond HIPAA,” “Privacy & Securities Standards-A Brief Nutshell” and numerous other programs and publications on telemedicine and e-prescribing, HIPAA and other privacy and data security, and other related internal controls and operational matters.   Publishers of her many highly regarded writings on health industry and human resources matters include the Bureau of National Affairs, Aspen Publishers, ABA, AHLA, Spencer Publications, World At Work, SHRM, Business Insurance, James Publishing and many others.  You can review other highlights of Ms. Stamer’s health care experience here, and employment experience here.  Her insights on these and other matters appear in Managed Care Executive, Modern Health Care, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, MDNews, Kentucky Physician, and many other national and local publications.

Other Resources

If you found this information of interest, you also may be interested in reviewing other updates and publications by Ms. Stamer including:

For More Information

We hope that this information is useful to you.  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 Cynthia Marcotte Stamer.  All rights reserved.

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Posted by Cynthia Marcotte Stamer

DEA Seeks Comments on Standardization of Code Number For Institutionally Based Practitioners Dispensing Controlled Substances

September 9, 2009

Midnight on November 9, 2009 is the deadline to respond to request for comments of the Drug Enforcement Administration (DEA) on how best to standardize the specific internal code number associated with each individual practitioner permitted by the hospital  or other institutional practitioner to administer, dispense, or  prescribe controlled substances using that institution’s DEA registration.

DEA is soliciting public input in response to comments received to its Notice of Proposed Rulemaking  “Electronic Prescriptions for Controlled Substances” regarding electronic prescriptions for controlled substances published on June 27, 2008, 73 FR 36722.  In that Notice, DEA proposed:

  • That  pharmacy applications receiving electronic prescriptions for controlled  substances be capable of reading and retaining the full DEA  registration number, including any extensions, or other identification  numbers used under 21 CFR 1306.05(c).
  • That the full number including extensions must be retained in the prescription record.
  • That the pharmacy application must verify that the practitioner’s DEA registration was valid at the time the prescription was signed by checking the DEA CSA database or by having another entity check the DEA CSA database during transmission and indicate on the record that the check has occurred and the registration is valid.
  • That the pharmacy application must reject prescriptions signed by practitioners without valid DEA registrations.    
  • Every person who dispenses controlled substances is required to obtain a DEA registration under the Comprehensive Drug Abuse Prevention  and Control Act of 1970, often referred to as the Controlled Substances  Act (CSA) and the Controlled Substances Import and Export Act (21  U.S.C. 801-971), (CSA).
  • An individual practitioner who is an agent or employee of a  hospital or other institution registered with DEA may use the DEA  registration of that hospital or other institution to administer,  dispense, or prescribe controlled substances in accordance with the  regulations (21 CFR 1301.22(c)). Specifically,  an individual practitioner who is an agent or employee of a  hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe  controlled substances under the registration of the hospital or  other institution which is registered in lieu of being registered  himself if:
  • The dispensing, administering or prescribing is done in the  usual course of his professional practice;  
  • The individual practitioner is authorized or permitted to  do so by the jurisdiction in which he is practicing;    
  • The hospital or other institution by whom he is employed  has verified that the individual practitioner is so permitted to  dispense, administer, or prescribe drugs within the jurisdiction;    
  • The individual practitioner is acting only within the scope  of his employment in the hospital or institution;  
  • The hospital or other institution authorizes the individual  practitioner to administer, dispense or prescribe under the hospital  registration and designates a specific internal code number for each  individual practitioner so authorized consisting  of numbers, letters, or a combination thereof and shall be a suffix  to the institution’s DEA registration number, preceded by a hyphen; and
  • A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner. See 21 CFR  1301.22(c).

In response to the comments on these proposed provisions, DEA has determined standardization of the internal code numbers assigned by institutional  practitioners to the individual practitioners they permit to use their  registration to administer, dispense, and prescribe controlled  substances is essential for DEA to require pharmacy systems to retain this  information.

Since this number has never been standardized, however, DEA anticipates that institutional practitioner registrants have established a variety of internal code number systems. Accordingly, DEA is soliciting information from the regulated  industry and other interested members of the public regarding current methods used and how best to implement industry standardization  in this area. Specifically, DEA seeks the following information:

  • Information regarding formats used by institutional  practitioners when establishing internal code numbers for individual  practitioners permitted to use the institution’s registration number;     
  • Estimates of the number of individual practitioners using  internal code numbers for identification purposes;    
  • Estimates of the number of individual practitioners using  internal code numbers for identification purposes in a particular  institutional practitioner;    
  • Estimates of costs to institutional practitioners if code  numbers for individual practitioners were to be standardized and what  changes would be associated with those costs;  
  • Formats pharmacy applications could accommodate or would  prefer, recognizing that pharmacy applications may need to be  reprogrammed to accept this information;
  • Estimates of the costs to pharmacies and/or pharmacy  application providers for such reprogramming;
  • Comments regarding whether pharmacies have had difficulty obtaining information from institutional practitioners regarding individual practitioners’ internal code numbers and, if so, any proposed solutions.

Persons wishing to address the above topics or provide other information relative to these proposed rules should submit their comments by Midnight on November 9, 2009 in accordance with the instructions contained in the Notice available for review here.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

  • How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
  • Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

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

For More Information

We hope that this information is useful to you.  If you need assistance with auditing or defending health care fraud concerns or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters. 

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 to cstamer@cttlegal.com.

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.

©2009 Cynthia Marcotte Stamer.  All rights reserved.

Leave a Comment » | Controlled Substances, DEA, Doctor, Electronic Health Records, Electronic Medical Records, FDA, Health Care, Health IT, HIPAA, Hospital, Pharmacy, Physician, Physician Licensing | Permalink
Posted by Cynthia Marcotte Stamer

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