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Title:Michigan Automated Prescription System and State Legislative Updates
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Body:C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS Updates & Opioid Legislation

June 14, 2019 Presented by: Amber Daniels, Analyst danielsa3@Michigan.gov

Department of Licensing and Regulatory Affairs BPL-MAPS@Michigan.gov | 517-241-0166

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

I do not have any relevant financial relationships with any commercial interests or any other conflicts of interest to disclose.

Disclosure

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Established in July 2015 . 10 Occupational Licensing/Regulation Boards . 24 Health Professional Licensing/Regulation Boards . Boards are advisory and determine sanctions . License and regulate over 758,000 individuals . 3 Divisions: Licensing, Investigations & Inspections, Enforcement . Enforcement Division: Administers Pharmacy and Drug Monitoring Section and Michigan Automated Prescription System (MAPS) Section; investigates overprescribing, over dispensing, and drug diversion

Bureau of Professional Licensing

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Total CS prescriptions dispensed % change from previous year

2007 17,007,858

2008 17,400,640 2.31%

2009 17,876,684 2.74%

2010 18,954,172 6.03%

2011 19,763,680 4.27%

2012 20,991,020 6.21%

2013 20,728,216 -1.25%

2014 20,904,764 0.85%

2015 21,472,326 2.71%

2016 21,092,674 -1.77%

2017 19,943,203 -5.45%

2018 17,642,901 -11.53%

Controlled Substance Prescriptions Filled in Michigan by Year

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Opioid Prescriptions Filled in Michigan by Year

Total Opioid Prescriptions Dispensed % Change from Previous Year

2013 9,920,288

2014 10,301,142 3.84%

2015 10,833,681 5.17%

2016 10,507,059 -3.01%

2017 9,670,789 -7.96%

2018 8,223,103 -14.97%

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

The numbers in these tables are drug totals dispensed by number of units (e.g. number of tablets, milliliters, etc.) *2018 numbers are provisional as of 2/14/19

Controlled Substances Filled in Michigan by Drug

Alprazolam 2 mg Alprazolam 1 mg Hydrocodone 10 mg Hydrocodone 7.5 mg

2015 10,227,915 41,499,216 177,326,801 107,776,175

2016 8,618,772 39,040,420 172,038,459 99,473,052

2017 6,939,880 34,379,472 151,080,925 84,705,294

2018* 3,511,238 27,845,017 118,224,505 66,733,496

% Change from 2015 to 2016 -15.73% -5.92% -2.98% -7.70%

% Change from 2016 to 2017 -19.48% -11.94% -12.18% -14.85%

% Change from 2017 to 2018 -49.40% -19.01% -21.75% -21.22%

Carisoprodol 350 mg Oxycodone 30 mg Oxymorphone 40 mg Promethazine with Codeine 2015 13,124,785 16,666,622 1,165,058 41,758,634 2016 10,442,641 14,859,323 1,358,611 34,803,234 2017 7,808,190 12,306,723 1,502,544 28,579,490 2018* 4,903,581 9,450,473 1,040,601 15,967,775 % Change from 2015 to 2016 -20.44% -10.84% 16.61% -16.66% % Change from 2016 to 2017 -25.23% -17.18% 10.59% -17.88% % Change from 2017 to 2018 -37.20% -23.21% -30.74% -44.13%

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Contains over 100 million records . Data maintained for 5 years . Required reporting of CS Schedule 2-5 from:  Prescribers who dispense CS Schedule 2-5  Pharmacists (dispensers)  Veterinarians

MAPS Background

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Who has access to MAPS data: . Prescribers (MD,DO, Nurse Practitioner, Physician Assistant, Dentist, Optometrist, Podiatrist, Veterinarian, Midwife with Prescribing Authority) . Prescriber Delegate (an individual a prescriber elects to gain access to the system on behalf of them) . Dispensers (Pharmacist) . Dispenser Delegate (Pharmacist Intern, Licensed Pharmacy Technician) . Law Enforcement (Conditional upon meeting statutory limitations) . Representative of State Board (Conditional upon meeting statutory limitations) . Health Care Payer/Benefit Provider (Conditional upon meeting statutory limitations) . System Administrators (Department of Licensing and Regulatory Affairs)

MAPS access

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Michigan Statute outlines appropriate uses of Electronic monitoring system data in MCL 333.7333a

Specifically it states (4)"a person that receives data or any other report under subsection (2) containing any patient identifiers of the system from the department shall not provide it to any other person except by order of a court of competent jurisdiction"

MAPS access

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Prescribers, Pharmacists (including delegates requesting the information on their behalf): "A practitioner or pharmacist who requests information and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide current patient"

*There is also allowance for a provider to access information specific to their own prescribing history, to determine if a controlled substance has been dispensed. MAPS access

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Law Enforcement: . " A state, federal or municipal employee or agent whose duty is to enforce the laws of this state or the United States relating to drugs" . "A state, federal or municipal employee who is the holder of a search warrant or subpoena properly issued for records"

Statute goes on to outline the appropriate uses of how that information should be used in stating "....a person shall use information submitted under this section only for bona fide drug-related criminal investigatory or evidentiary purposes....

MAPS access

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Representative of a State Board:

"A designated representative of a board responsible for the licensure, regulation, or discipline of a practitioner, pharmacist, or other person that is authorized to prescribe, administer, or dispense controlled substances"

MAPS access

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Health Care Payer/ Benefits provider:

" The health care payment or benefit provider for the purposes of ensuring patient safety and investigating fraud and abuse"

As defined in MCL 333.7333a (13) (b) "Health care payment or benefit provider means a person that provides health benefits, coverage, or insurance in this state, including a health insurance company, a nonprofit health care corporation, a health maintenance organization, a multiple employer welfare arrangement, a Medicaid contracted health plan, or any other person providing a plan of health benefits, coverage, or insurance subject to state insurance regulation."

MAPS access

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

System Administrators:

"An employee or agent of the department"

MAPS access

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Successfully launched Appriss Health's PMP AWARxE on April 4, 2017 . Added Appriss Health's NarxCare report to MAPS on December 4, 2017 . Response times average 0.4-0.8 seconds . Registered Users:

MAPS Update

As of 04/04/2017 As of 06/03/2019 Increase

Prescribers 9,156 44,675 35,519

Dispensers (Pharmacists) 3,994 8,389 4,395

Delegate Users 1,096 19,388 18,292

Law Enforcement 598 2,034 1,436

Benefit Plan Managers 29 114 85

State Board Reps 0 49 49

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

*Note: Includes online requests and integration requests from MAPS (Michigan) registered users

MAPS - Patient Requests

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

PMP Interconnect States Connected

1. Alabama 2. Arizona 3. Colorado 4. Connecticut 5. Delaware 6. Florida 7. Idaho 8. Illinois 9. Indiana 10. Kansas 11. Kentucky 12. Maine 13. Military Health System (DOD) 14. Minnesota 15. Mississippi

States Pending Connection

1. Iowa 2. Puerto Rico 3. Washington, D.C. 16. Montana 17. Nevada 18. New Mexico 19. New York 20. North Carolina 21. North Dakota 22. Ohio 23. Rhode Island 24. South Carolina 25. South Dakota 26. Tennessee 27. Virginia 28. West Virginia 29. Wisconsin

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS - NarxCare Integrations

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS - NarxCare Report

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS - NarxCare Report (continued)

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS - NarxCare Report (continued)

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS - NarxCare Report (continued)

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS - NarxCare Resources

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS - NarxCare Resources

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Narx Scores and Predictive Risk Scores (overdose) Scores: based on algorithms, including MMEs, number of prescribers and pharmacies Scores: Ranges from 000-999; higher scores equate to higher risk and misuse . Red Flags . Rx Graphs . PDMP Data

MAPS - NarxCare Report

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. If you want to integrate your EMR/pharmacy dispensation system before the statewide funding runs out on August 31, 2019, go to: www.Michigan.gov/bpl >MAPS >Software Integration Resources . Complete the Integration Request Form . Sign the Terms and Conditions . Email the documents to BPL-MAPS@Michigan.gov

Integration Process

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Healthcare professionals can use MAPS integration to meet the specialized registry requirement for Meaningful Use . Healthcare professionals must register to MAPS online and their EMR/EHR must be integrated . Additional information: https://michiganhealthit.org/public-health/maps/ Meaningful Use - Specialized Registry

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Administrative Rule Update

Michigan Board of Pharmacy Administrative Rules

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Effective January 4, 2019 Neurontin (gabapentin) is a Schedule 5 controlled substance in the State of Michigan. Further information about this can be found in the Michigan Board of Pharmacy Administrative Rule 338.3125

Mandatory reporting: When gabapentin is dispensed in excess of a 48-hour supply

Mandatory MAPS review: When it is prescribed in excess of a 3-day supply Michigan Board of Pharmacy Rule Update

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

New Opioid Laws

Legislative Action

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Requires disclosure of opioid information to minors and patients.

. Beginning June 1, 2018, a prescriber shall comply with the following before issuing a new prescription for a controlled substance containing an opioid to a minor:  Discuss with the minor and the minor's parent or guardian the potential risks of addiction and overdose associated with the controlled substance.  Discuss the increased risk of addiction to a controlled substance to an individual suffering from both mental and substance abuse disorders.  Discuss the danger of taking a controlled substance containing an opioid with benzodiazepine, alcohol, or another central nervous system depressant.  Discuss any other information in the patient counseling information section of the label for the prescription. Public Act 246 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Requires the signature of the minor's parent or guardian to consent to the minor's treatment on a "start talking consent form", which is to be filed in the minor's medical record. . The form is to contain:  Signatures of the parties involved.  Information on the name and quantity of the controlled substance.  Acknowledgement that the drug has potential for abuse.  A statement certifying that the prescriber discussed with the minor and the minor's guardian the potential risks of the drug.

. If an adult signing a consent form is not the parent or guardian, the prescriber shall not prescribe more than a single 72-hour supply of the controlled substance to the minor. Public Act 246 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Exceptions to the law in case of emergency:  If it is detrimental to the minor's health.  Certain surgical circumstances.  Specific hospice related instances.  If the minor's parent or guardian is not legally required to consent.

. Beginning June 1, 2018, before an opioid is prescribed to a patient, a prescriber shall provide the following information:  The dangers of opioid addiction.  How to properly dispose of an expired, unused, or unwanted controlled substance.  That the delivery of a controlled substance is a felony under Michigan Law.  If the patient is pregnant or is a female of reproductive age, the short and long term effects of exposing a fetus to an opioid, including but not limited to neonatal abstinence syndrome.

Public Act 246 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. The prescriber shall obtain the signature of the patient or the patient's representative on a form provided by the Department of Health and Human Services, that they were informed of the above requirements. The form can be found at michigan.gov/stopoverdoses under the prescriber tab. . The signed form shall be kept in the patient's medical record.  The requirement does not apply if the controlled substance is prescribed for inpatient use

. Provides sanctions for prescribers for failing to inform minors and their guardians of the risks of opioid abuse.

Public Act 246 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Please note this law was amended with PA 101 of 2018, which extends the effective date to March 31, 2019 unless LARA promulgates rules to provide exceptions to the bona-fide prescriber-patient relationship for prescribing. *Rules were promulgated on January 4, 2019

Requires prescribers to be in bona-fide prescriber-patient relationships prior to prescribing.

. Beginning January 4, 2019, a licensed prescriber shall not prescribe a controlled substance listed in Schedules 2-5 unless the prescriber is in a bona fide prescriber-patient relationship with the patient. . If the prescriber provides a controlled substance, the prescriber shall provide follow-up care to the patient to monitor the efficacy of the use of the controlled substance as a treatment of the patient's medical condition. Public Act 247 of 2017 (PA 101 of 2018)

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. If the prescriber is unable to provide follow-up care, they shall refer the patient to the patient's primary care provider for follow-up care, or if a primary care provider does not exist, another licensed prescriber who is geographically accessible to the patient. . Defines a bona fide prescriber-patient relationship as treatment or a counseling relationship between a prescriber and a patient in which both of the following are present:  The prescriber has reviewed the patient's relevant medical or clinical records and completed a full assessment of the patient's medical history and current medical condition, including a relevant medical evaluation of the patient conducted in person or via telehealth.  The prescriber has created and maintained records of the patient's condition in accordance with medically accepted standards.

Public Act 247 of 2017 (PA 101 of 2018)

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

A licensed prescriber may prescribe a Schedule 2-5 controlled substance without first establishing a bona fide prescriber-patient relationship in the following circumstances:

. The prescriber is providing on-call coverage or cross-coverage for another prescriber who is not available and has established a bona fide prescriber-patient relationship with the patient for whom the on-call or covering prescriber is prescribing the controlled substance. The prescriber, or an individual licensed under Article 15 of the Public Health Code, must review the patient's relevant medical or clinical records, medical history, and any change in medical condition, as well as provide documentation in the patient's medical record in accordance with medically accepted standards of care. . The prescriber is following or modifying the orders of a prescriber who has established a bona fide prescriber-patient relationship with a hospital in-patient, hospice patient, or nursing care facility resident, and provides documentation in the patient's medical record in accordance with medically accepted standards of care. Public Act 247 of 2017 (PA 101 of 2018)

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. The prescriber is prescribing for a patient that has been admitted to a licensed nursing care facility or a hospice, meets the requirements of a bona fide prescriber-patient relationship, in compliance with R 325.20602 or R 325.13302, and provides documentation in the patient's medical record in accordance with medically accepted standards of care. . The prescriber is prescribing for a patient for whom the tasks of reviewing the patient's medical history and current medical condition, including a relevant medical evaluation of the patient, and the creation and maintaining of records of the patient's condition, have been performed by an individual licensed under Article 15 of the Public Health Code, and the prescriber provides documentation in the patient's medical record in accordance with medically accepted standards of care. . The prescriber is treating a patient in a medical emergency. Medical emergency is defined as a situation that, in the prescriber's good-faith professional judgement, creates an immediate threat of serious risk to the life or health of the patient for whom the controlled substance prescription is being prescribed.

Public Act 247 of 2017 (PA 101 of 2018)

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Requires prescribers to be registered to MAPS prior to prescribing or dispensing a controlled substance, and also requires a review of MAPS when prescribing or dispensing in a quantity that exceeds a 3-day supply. . Beginning June 1, 2018, before prescribing or dispensing to a patient a controlled substance in a quantity that exceeds a 3-day supply, a licensed prescriber shall obtain and review a MAPS report concerning that patient. The requirement does not apply in any of the following circumstances:  If the dispensing occurs in a hospital or a freestanding surgical outpatient facility and the controlled substance is administered to the patient in the hospital or facility.  If the patient is an animal, the dispensing occurs in a veterinary hospital or clinic, and the controlled substance is administered to the animal in that hospital or clinic.  If the controlled substance is prescribed by a licensed prescriber who is a veterinarian and the controlled substance will be dispensed by a pharmacist.

. Beginning June 1, 2018, before prescribing or dispensing a controlled substance to a patient, a licensed prescriber shall register with MAPS.

Public Act 248 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Contains provisions for sanction for various violations of the opioid bills package. . Contains many of the provisions of the other bills, as it is being used as a vehicle to correct conflicts in statute created by the package of bills being passed.  Includes the bona fide prescriber-patient relationship language of PA 247 of 2017.  Contains the mandatory MAPS report review language for prescribers contained in PA 248 of 2017, as well as language regarding mandatory registration with MAPS for prescribers. Public Act 249 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Provides penalties for violation of the following:  Beginning March 31, 2019, prescribers failing to adhere to the bona fide prescriber-patient relationship requirements.  Beginning June 1, 2018, prescribers failing to obtain and review a MAPS report, when required, prior to prescribing or dispensing to a patient a controlled substance in a quantity that exceeds a 3-day supply.  Beginning June 1, 2018, prescribers failing to register with MAPS prior to prescribing or dispensing a controlled substance to a patient.  Beginning June 1, 2018, prescribers failing to provide minors, and their parents or guardians, with proper education regarding the risks of opioid abuse. Public Act 249 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Beginning June 1, 2018, if the department has reasonable basis that a licensee failed to obtain and review a MAPS report or failed to register to MAPS, LARA:  Is not required to conduct an investigation.  May issue a letter to the licensee notifying Issue Includes the bona fide prescriber-patient relationship language of PA 247 of 2017.  A letter issued under this section of the law is not considered a disciplinary action.

. Not registering and checking MAPS may result in sanctions as determined by the board. Public Act 249 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Requires the providing of information regarding Substance Use Disorder Services. . Effective March 27, 2018:  A health professional licensee or registrant that treats a patient for an opioid-related overdose is required to provide that patient with information regarding Substance Use Disorder Services.

Public Act 250 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Requires prescribers treating for acute pain, to not prescribe a patient more than a 7-day supply of an opioid within a 7-day period. . Beginning July 1, 2018, if a prescriber is treating a patient for acute pain, that the prescriber shall not prescribe the patient more than a 7-day supply of an opioid within a 7-day period. . Further, beginning March 27, 2018, the legislation provides that a pharmacist, consistent with federal law and regulations on the partial filling of a controlled substance included in Schedule 2, may partially fill in increments, a prescription for a controlled substance included in Schedule 2. Public Act 251 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MAPS review requirements before dispensing or prescribing buprenorphine or methadone. . Effective March 27, 2018.

. Adds the dispensing of a controlled substance at a veterinary hospital or clinic that administers the controlled substance to an animal that is an inpatient, to the following list of exemptions for MAPS reporting requirements:  A hospital.  A health facility or agency if the controlled substance is dispensed by a dispensing prescriber in a quantity adequate to treat the patient for not more than 48 hours. Public Act 252 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Provides that before dispensing or prescribing buprenorphine or a drug containing buprenorphine or methadone to a patient in a substance disorder program, that a prescriber shall obtain and review a MAPS report on the patient. . Additionally, the legislation provides that a prescriber shall report data to MAPS if federal law does not prohibit the reporting of data concerning the patient, to LARA. . The legislation rescinds R 338.3162E from the pharmacy rules, which deals with exemptions to MAPS reporting requirements.

Public Act 252 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Medicaid eligibility for Substance Use Disorder Services. . Effective March 27, 2018.

. Amends the Social Welfare Act to provide that an eligible individual can receive medically necessary treatment for opioid abuse. The bill codifies coverage by Michigan's Medicaid program for detox programs.

Public Act 253 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

PDOAC recommendations for the instruction of pupils on the dangers of opioid abuse. . Requires PDOAC, by July 1, 2018, to develop or adopt for Michigan's Department of Education, recommendations for the instruction of pupils on the dangers of prescription opioid drug abuse.

Public Act 254 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

MDE model programs of instruction on the dangers of prescription opioid drug abuse. . No later than July 1, 2019, the Department of Education shall make available to school districts the model program of instruction on the dangers of prescription opioid drug abuse, developed or adopted by PDOAC. . Beginning in the 2019-2020 School Year, the Department of Education shall ensure that the state model of academic standards for health education includes instruction on prescription opioid drug abuse, including at least the PDOAC recommendations.

Public Act 255 of 2017

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Pushes back the effective date for the bona fide prescriber-patient relationship requirement to 3/31/19; OR . If rules are promulgated to provide alternatives to the prescriber-patient requirement before 3/31/19, on the date on which rules are promulgated is when the change becomes effective.

Public Act 101 of 2018

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

. Individuals seeking additional information regarding the new opioid laws can visit http://www.legislature.mi.gov and do the following: - Select "Public Act (Signed Bills)" among the options under the "Legislature" category on the left of the page. - On the "Public Acts" webpage, enter the Public Act Number, and select a "Public Act Year" below. For example, to find more information regarding Public Act 247 of 2017, Enter "247" in the search box, and select the "Public Act Year" from the dropdown box as "2017". Select "Search" when ready. . A direct link to the above referenced "Public Act (Signed Bills)" search page is as follows: http://www.legislature.mi.gov/(S(gfsic4rztsd0vhcpbmxfjwvy))/mileg.aspx?page=Pub licActs. For Additional Legislative Information

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

For technical assistance, please contact Appriss' customer first center at: . 844-364-4767

For policy or administrative assistance and more information about integrating with MAPS, please contact MAPS support: . 517-241-0166 or BPL-MAPS@Michigan.gov . Info: www.Michigan.gov/bpl, click on MAPS . Integrations: Click on Software Integration Resources

For additional resources for providers and the public, please go to the State website: www.michigan.gov/opioids

Contacts for MAPS

C U S T O M E R D R I V E N. B U S I N E S S M I N D E D.

Thank You!

Questions?