Are you following_the_script may 2015

Polsinelli PC. In California, Polsinelli LLP

Are You Following the Script? Consequences for Medical Professionals Who Fail to Check Pharmacy Registries

Presented By: Edward F. Novakand Melissa S. Ho

real challenges. real answers. sm

� 44 Americans die every day from prescription drug overdose, most commonly an opioid. (Source: Centers for Disease Control and Prevention)

� As a result, both the DEA and medical boards throughout the country have taken an increasingly critical look at prescription drug providers.


National Prescription Pain Medication Problem

� Prescription and over the counter drugs are, after marijuana (and alcohol), the most commonly abused substances by Americans 14 and over.

� Source: National Institute on Drug Abuse



Most commonly abused:

� Opioid Pain Relievers (Vicadin, Oxycontin)

� Stimulants to treat ADHD (Adderral, Concerta, Ritalin)

� Central Nervous System depressants for anxiety (Valium, Xanax)

� Cough/Cold Remedies with dextromethorphan


� Purdue Pharma has been investigated and now sued for one billion dollars by the Kentucky Attorney General for deceptive marketing practices related to OxyContin abuse in the state.

� Purdue Pharma had previously settled a federal criminal case related to intentionally misleading doctors about OxyContin’s potential for misuse.


Individual Costs of Addiction


National Prescription Pain Medication Problem for Individuals

� Use of any psychoactive drug which contributes to impairment results in individual criminal charges for driving while impaired.

� According to National Highway Traffic Safety Administration’s (NHTSA) 2007 National Roadside Survey, more than 16 percent of weekend, nighttime drivers tested positive for illegal, prescription or OTC drugs.

� A 2009 NHTSA study found that 18% of fatally injured drivers tested positive for at least one illicit, prescription, or OTC drug (an increase from 13% in 2005).


� Victims injured in an accident may seek to recover monetary damages against those prescribing.

� Healthcare professionals increasingly find themselves receiving records subpoena or subpoena to testify in criminal matters.


Prescriber Needs to

� Understand what a valid subpoena for records entails.

� Know how to narrow or properly respond to a request for records.

� Have trained office staff on how to respond.


State Pharmacy Registries

� What is a State Pharmacy Registry (aka Patient Prescription History Reports)?


Missouri Finally Joins in the Fun

� For years, Missouri was the only state that didn’t have a program in place due to privacy concerns.

� As of April this year, the Missouri Senate approved SB 63 to create a drug monitoring program.

� Kansas has had its program (K-TRACS) since 2011.


State Pharmacy Registries

� Arizona Example:� H.B. 2136 established a Controlled

Substances Prescription Monitoring Program (CSPMP). The bill required the Arizona State Board of Pharmacy (ASBP) to establish a controlled substances prescription monitoring program.


� H.B. 2136 requires pharmacies and medical practitioners who dispense controlled substances listed in Schedule II, III, and IV to a patient, to report the prescription information to the Board of Pharmacy on a weekly basis.

� See A.R.S. §§ 36-2601 thru 36-2611


Definitions

� A.R.S. § 36-2601� (2). "Dispenser" means a medical practitioner or pharmacy that is

authorized to dispense controlled substances.� (3). "Licensed health care provider" means a person who is licensed

pursuant to title 32, chapter 7, 11, 13, 14, 15, 16, 17, 18, 19.1, 21, 25, 29 or 33.

� (4). "Medical practitioner" has the same meaning prescribed in section 32-1901.

� (5). "Person" means an individual, partnership, corporation or association and the person's duly authorized agents.

� (6). "Program" means the controlled substances prescription monitoring program.


A.R.S. 36-2602

� Includes a computerized central database tracking system to track the prescribing, dispensing and consumption of Schedule II, III, and IV controlled substances in Arizona.

� One of its stated purposes is to assist law enforcement in identifying illegal activity related to the prescribing, dispensing and consumption of these controlled substances.


� Mandatory reporting by pharmacies began on October 17, 2008. The Board began collecting dispensing practitioner’s data in October 2009.

� The purpose of this legislation is to improve the State’s ability to identify controlled substance abusers or misusers and refer them for treatment and to identify and stop diversion of prescription controlled substance drugs in an efficient and cost effective manner that will not impede the appropriate medical utilization of illicit controlled substances.


Who can Search

� Authorized persons may request information from this repository to assist them in treating patients and identifying and deterring drug diversion, consistent with A.R.S. § 36-2604.

� Except as otherwise provided in 36-2604 the information submitted is confidential and not subject to public inspection.


Who can Search/Use Information

� Pharmacy Board or its designee. If the board or its designee has reason to believe an act of unprofessional or illegal conduct has occurred, the board or its designee shall notify the appropriate professional licensing board or law enforcement or criminal justice agency and provide the prescription information required for an investigation.

� Pharmacy Board may release data to: (1) A person who is authorized to prescribe or dispense a controlled substance, or a delegate who is authorized by the prescriber or dispenser, to assist that person to provide medical or pharmaceutical care to a patient or to evaluate a patient. (2) An individual who requests the individual's own prescription monitoring information pursuant to section 12-2293. (3) other professional licensing boards only if the requesting board states in writing that the information is necessary for an open investigation or complaint. (4) local, state or federal law enforcement or criminal justice agency only if the requesting agency states in writing that the information is necessary for an open investigation or complaint. (5) The Arizona health care cost containment system administration only if the administration states in writing that the information is necessary for an open investigation or complaint. (6) A person who is serving a lawful order of a court of competent jurisdiction. (7) A person who is authorized to prescribe or dispense a controlled substance and who performs an evaluation on an individual pursuant to section 23-1026.


Who Can Use/Search Information Cont’d.

� The board may provide data to public or private entities for statistical, research or educational purposes after removing information that could be used to identify individual patients or persons who received prescriptions from dispensers.

� For the purposes of this section, "delegate" means a licensed health care professional who is employed in the office of or in a hospital with the prescriber or dispenser or an unlicensed medical records technician, medical assistant or office manager who is employed in the office of or in a hospital with the prescriber and who has received training regarding both the Health Insurance Portability and Accountability Act privacy standards, 45 Code of Federal Regulations part 164, subpart E, and security standards, 45 Code of Federal Regulations part 164, subpart C.


What is on the Patient History Report

� Patient identifiers (Patient ID, home addresses)� Will give fill date for prescriptions, the quantity,

dosages. Prescriber information (identity and address), the prescription number.

� It will provide the total number of prescriptions. Pharmacy identifiers, whether the prescription is active and a morphine equivalent table and calculation for reference.


� What Prompts a Criminal Prosecution?


� As mentioned previously: DUIs very common.

� Prosecutions for drug sales (Individual selling their own prescriptions or soliciting purchases of prescription medications).

� Forgery of scripts being utilized at pharmacies.


� Third-party prosecutions often lead to subpoenas for documents.

� Testimony at Trial.� Sometimes a Board Complaint from a concerned

family member or disgruntled patient.� In worse-case scenarios: Criminal charges for

the prescribing professional themselves.


Prosecution Statistics

� Recent figures from the U.S. Government Accountability Office (2012/2013) notes

� 7,848 subjects in criminal investigations (25% were medical facilities and 16% were durable medical equipment centers. Only 13.8% were charged, of which 85% were convicted.)

� 2,339 subjects in OIG civil investigations (20% hospitals; 18% other medical facilities. 47% of civil investigations pursued.)


� No reliable statistics for state prosecutions of health care providers/medical groups.

� Individual prosecutions could entail a number of theft or fraud allegations.

� An Arizona doctor was charged with forgery and fraudulent schemes and artifices for falsely stating he had reviewed medical records in certifying access to medical marijuana.


State v. Gear (Division One)No.1 CA-CR 13-0852

� Whether the Arizona Medical Marijuana Act (AMMA) bars the State from prosecuting a physician for misrepresenting (negligently or otherwise) that he had reviewed the last 12 months of a patient’s medical records, including records from other physicians.

� A confidential informant went to see a physician who completed a DHS Form. No records were ever provided by the confidential informant.


� A grand jury indicted the Doctor on one count of forgery and one count of fraudulent schemes and artifices. (All felonies)

� The AMMA requires a written certification which is more than a physician’s professional opinion; it requires a complete assessment of the medical history.


� The Court of Appeals concluded that AMMA’s physician immunity provision bars the State’s prosecution, but notes that the statute does not prevent a professional licensing board from sanctioning a physician for failing to properly evaluate a patient’s medical condition.

� It is rumored that the State is going to appeal this ruling.


Licensing Boards


Professional Licensing Boards

� Are typically established by statute.� Members are typically appointed to serve

discrete terms.� Members include practitioners, and a

public members. (The public member is often an attorney.)

� The Executive Director of the Board may vote on certain matters.



� Some boards have their own attorney---often an Assistant Attorney General.

� Most AAGs are not “activist lawyers,” meaning they advise on legal matters, but will not provide guidance on how to resolve a complaint.


Common Sources of Complaints

� Patient or family� Other medical provider� Pharmacists� Colleagues� Supervisors� Often prompted by adverse outcomes,

traffic accident or criminal prosecution.


Example Statistics for Arizona Nursing Board

� In 2010: 75 cases opened (2.15% of nursing population)

� 7 resulted in Discipline� 2 licenses were revoked or suspended� 17 were dismissed


Board Hearings

� Subject to Open Meeting Laws.� Agendas are posted.� Sensitive Matters go to Executive Session.� The type of Board and the amount of

resources the Board has will determine the responsiveness of the Investigation.



� Most Boards don’t “troll”, i.e., they are responsive to complaints.

� If you are the subject of a complaint, it is important to report it immediately to your carrier, employer or business partners.

� Board Complaints often carry very short response times. (2 weeks is not uncommon)


Board Complaints

� Not surprisingly Board Complaints are one-sided.

� The complaining Party is not always the Patient. It is often a family member or friend who is “concerned.”

� You must provide a response to the Board within the time frame. Ask for an extension if you need more time to gather information.


Board Complaints

� The initial letter from the Licensing Board often comes from an investigator.

� The complaint will be attached; a time frame for responding to the complaint may be attached.

� The Board may issue a subpoena (often very broad).


Licensing Board

� The Licensing Board may do an Investigative Review

� Conduct Interviews� Ask for an Informal Appearance at a Board

Meeting� Ask for a formal Hearing


Board Action

� Boards can dismiss the allegations� Continue investigation and request staff to

issue subpoenas� Issue letters of concern� If discipline is warranted, vote to offer a

consent agreement (often drafted with AAG help)

� Ask for formal hearing


Board may be Empowered to

� Issue letters of concern� Issue non-disciplinary orders for

continuing education� Issue Decrees of Censure� Fix terms and period of probation� Impose civil penalties� Suspend or Revoke a Respondent’s

License.


What to Do if you Receive a Board Complaint


Responding to Board Complaints

� Retain counsel� Review patient records� If the allegation relates to a prescription

medical issue, request and obtain the pharmacy registry immediately.

� Will insurance Cover?� Will my employer cover the cost?


Reasons for Dismissal

� Unable to Substantiate� Anonymous complaint with insufficient information� Allegations were retracted� Allegations that were retaliatory� Single or time limited minor practice issues� Minor injury or minimal risk of harm� Personality disputes� Unfair business practices related to billing or fee

disputes


Common Issues

� Oops, I may have forgotten something…


Common Issues

� No documentary evidence of pain (x-ray, MRI, etc.)� No pill counts noted� No UAs on file� Agreeing to refill prescriptions for other practitioners

(i.e., you were the substitute doctor for the day, but you didn’t check the registry)

� Forgetting to remind patient to follow up with their PCP.


How does this Happen?

� Too much sympathy for the patient� Don’t want to lose the patient to a pain

clinic� Concern over previous care issues� Reliance on patient’s self-reporting of pain


� What if I don’t have time to do all this checking?

� Will my prior spotless record help?


� Failure to check the Prescription Drug Monitoring Programs and a patient’s history of substance abuse or psychiatric Issues can be tantamount to negligence for the prescribing provider.


Be Proactive


Be Proactive

� Know what you are prescribing!� Check advisory opinions� Call the Board of Pharmacy� Check urine drug screens, serum levels,

old records and diagnostic labs.


� Have a written plan

� Just as with HIPAA liability, a key issue in apportioning blame to a medical practice or respondent is whether they took reasonable efforts to prevent harm and ensure quality.


� Make someone responsible for enforcing the written plan.

� For instance how does your office keep prescriptions for pick up? Does it require a sign-in sheet and ID check? Are the prescriptions locked and logged?

� Build in redundancies and backup in the event there is a change in personnel.


� Keep immaculate records on your quality assurance programs.

� Double-check the compliance work and document any issues.

� Involve the staff in training and spotting issues with patients. Particularly in smaller practices, the medical assistant or front staff may be first to know of issues.


Due Diligence

� Conduct due diligence on vendors; check their licenses; look for lawsuits and complaints.

� Many insurance programs will require that pharmaceuticals are sourced from licensed providers.


� Review your informed consent procedures and patient confidentiality policies.

� Have treatment agreement forms and note in the patient’s records that the patient has been explicitly told about the potentially addictive nature of the prescription drugs and risks even when they are used as treatment modality.


� Makes sure the patient has the ability/willingness to maintain control and safety of the controlled drugs (and document this).

� Have a clear patient treatment agreement which specifically outlines: compliance, consequences of non-compliance, and notice that if there is abuse suspected, that the patient will be discontinued in a safe manner and referred for other pain management programs.


� Be able to document the causes of the chronic pain

� Be able to demonstrate that the dosage is well tolerated by the patient and that treatment levels have stayed steady.

� Don’t forget to have a policy related to the counting and destroying of post-dated prescriptions.


Arizona Medical Association (ARMA)Prescribing Guidelines

� Published by the Arizona Department of Health Services has the following recommendations


ARMA recommendations

� 1. When possible, one medical provider should provide all controlled substances to treat a patient’s chronic pain.

� 2. The Controlled Substances Prescription Monitoring Program should be checked prior to prescribing controlled substances.

� 3. The administration of intravenous and intramuscular controlled substances in the ED for relief of acute exacerbations of chronic pain is discouraged.



� 4. Emergency medical providers should not provide replacement prescriptions for controlled substances that were lost, destroyed or stolen.

� 5. Should not provide replacement doses of methadone for patients in a methadone treatment program.

� 6. Long-acting or controlled-release opioids (OxyContin, fentanyl patches, methadone) should not be prescribed from the ED.



� 7. Prescriptions should state that the patient is required to provide a government issued picture identification to the pharmacy filling the prescription.

� 8. EDs are encouraged to photograph patients who present for pain related complaints without a government issued ID.

� 9. EDs should coordinate care of patients who frequently visit the ED using an ED care coordination program.



� 10. EDs should maintain a list of clinics that provide pain management and primary care for patients of all payer types.

� 11. EDs should perform screening, brief interventions and treatment referrals for patients with suspected prescription abuse problem.

� 12. For exacerbations of chronic pain, the emergency medical provider should attempt to contact the primary controlled substances provider or pharmacy. Emergency medical provider should prescribe only enough pills to last until office of patient’s primary controlled substances prescriber opens.



� 13. Prescriptions for controlled substance pain for acute injuries (e.g., fractured bones), in most cases should not exceed 30 pills with no refills.

� 14. Screen patients for substance abuse prior to prescribing controlled substance medication for acute pain.

� 15. Emergency physicians are required by law to evaluate an ED patient who reports pain. Law allows for use of clinical judgment and does not require the use of controlled substances.


Additional Resources

� State Pharmacy Boards often publish guidelines for dispensing controlled substances.

� Arizona Department of Health Services publishes an Arizona Opioid Prescribing Guideline (other states have similar).


Contact Information

� Edward F. Novak, Shareholder– [email protected]

� Melissa Ho, Shareholder– [email protected]

Polsinelli PCwww.polsinelli.com

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Are you following_the_script may 2015

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Transcript of Are you following_the_script may 2015