APRN PRACTICE UPDATE LAW AND RULE 2014 2015 Family Practice Review and Reunion February 21, 2015 Douglas Caserta, MSN, FNP-BC, APRN Meets the Category A, 1.5 hour requirement for Ohio Nursing Law and Rules

Objectives Discuss law and rules pertinent to contemporary APRN practice in Ohio including the 2014 update Review the most recent changes in the Ohio Formulary. Briefly review Schedule II Prescribing and OARRS Law and Rule State the requirements for staying compliant with Ohio’s rules for APRN practice and briefly review what the APRN should do if the “board comes knocking?” Predict the Legislative and Practice Future for Ohio APRNs

Law and Rules – Where are they? Title – What is title protection? Review Topics Law and Rules – Where are they? Title – What is title protection? Certificate of Authority COA Components Scope of Practice What is it? APN Decision Tree –New practice and procedures

Review Topics - continued Standard Care Arrangement Collaboration Who signs? Components of the SCA Prescribing Parameters Update Quality Assurance Chart Review: when and who Prescriptive Review: when and who Relicensure – What do I need Primary Source Verification Continuing Education

Review Topics – continued Prescribing Principles and Standards Staying Compliant - Review Pharmacology Hours Licensure Maintenance Keeping the BON Informed SCA Key Points – What’s new? Prescriptive Authority – What’s new? Schedule II – Brief Review Legislative Updates and Future Initiatives

APRN Law and Rules – Where Are They? Ohio Revised Code (ORC) 4723 (Law) Voted and passed by General Assembly Signed by the Governor The Nurse Practice Act (ORC 4723) Ohio Administrative Code (OAC) (Rules) Written by the regulatory boards (BON) Cannot conflict with or expand the law Rules assist to implement the law Nursing Rules 4723-1 through 4723-23 (OAC)

How Do I Find the APRN Law and Rules APRN State Rules http://codes.ohio.gov/oac/4723 APRN State Law http://codes.ohio.gov/orc/4723 APRN Federal Law United States Code of regulations Center for Medicare and Medicaid Services (CMS) Board of Nursing (BON) http://www.nursing.ohio.gov/Practice.htm#AdvancedPractice Board of Medicine – No direct APRN Authority www.med.ohio.gov

Title Protection Provides legal recognition for practice Unless individuals meet the requirements cannot use the title ORC 4723-8-03 Ties reimbursement to the title: RNs cannot bill for physician services, APRNs bill for physician services. Title Change occurred with H.B. 303, 2012: A.P.N initials changed to A.P.R.N. in all Ohio statutes May still use CRNA, CNM, CNS, CNP

Certificate of Authority COA required for APRN to practice: Renews every 2 years with RN license; Must have up to date national certification; primary source verification within 30 days of recertifying, (OAC 4723-8-08) Current national certification: If your national certification lapses by one day, your COA is not active, no grace period, you must cease practice (continuous certification required) At Renewal: submit name and business addresses of collaborating physicians (4723-8-08) May place COA on inactive status (Ref. 4723-8-08 OAC)

Scope of Practice What is your scope of practice? Scope: defined by national certifying organizations, standards of care, parameters of practice NO LAUNDRY LIST IN OHIO OF PERMISSABLE SERVICES HB 303 - 2013 Scope: as defined by ORC 4723.43: CRNPs provide “preventative and primary care services …. OAAPN met with BON and requested they include a CNP scope that was at least consistent with CNS scope that recognizes complexity and illness, not only primary or preventive care. The BON added “provide services for acute illnesses, and evaluate and promote patient wellness within the nurse’s nursing specialty, consistent with the nurse’s education and certification….”

How to determine if a procedure is within my scope? Questions about Scope How to determine if a procedure is within my scope? “Decision-Making Guide for Determining Individual APN Scope of Practice”.. Follow this guideline and ask the BON www.nursing/ohio.gov/PDFS/AdvPractice/APNModelandIntro072406.pdf Are APRNs supervised in Ohio? Rarely: APRN CtP – Externship CRNAs have supervisory language Must a Doctor be on site or sign charts? NO Exception: CtP-E for supervised hours) Must be accessible by telecommunication

Standard Care Arrangement SCA (4723-8-04) Must have one before you practice Articulates the APRN & physician collaborating relationship Must be signed by all collaborators unless it is signed by the “physician’s designated representative” – department director or chair Signed and reviewed once a year (kept on site – don’t send to BON) Must include the PI/PC Arrangement (OAC 4723-9-10) NEW – NEW - NEW

Standard Care Arrangement SCA (4723-8-04) Must have one before you practice: keep on site Includes: broad statement of services; description of prescriptive practice; medications designated per SCA; off label use of medications; incorporation of new procedures; referrals; emergency coverage; plans for infant care; dispute settlement; quality assurance process (4723-8-05); - physician must be involved document physician licensure yearly provisions for in-person physician evaluation if needed. Samples available from OAAPN

Standard Care Arrangement Collaborating Physician - Notify the Board H. B. 303 requires APRN to submit to the BON the name and business address of each of the collaborating physicians/podiatrist no later than 30 days after APRN first engages in practice as an APRN. Must notify BON of any changes in SCA signatories within 30 days after any change takes effect see BON site for forms. Schedule II authority UPDATE SCA FOR PI/PC CATEGORY and PER SCA CATEGORY

SCA: Quality Assurance Measures (OAC 4723-8-05) Is a process for improvement that includes: QA Committee Members: Must include physician – may use committee, physician component need not take part in all QA activity Chart Review: regular (once a year minimum and document outcomes and improvement) Prescriptive review (twice a year minimum and document) inclusive of a representative sampling of schedule II if prescribing schedule II Additional information on the SCA may be found at the OAAPN website: oaapn.org where an one hour CE on the 2014 SCA is available.

Standard Care Arrangement – Clarification of PI/PC BON OAC 4723-9-10 Formulary: previously listed drugs as PI ( physician initiated) or PC ( physician consultation) or, they were categorized as all PC if noted in SCA Physician Initiated (PI): Means the APRN may continue the medication after the physician has examined the patient in accordance with OAC 4723-11-09 and initiated therapy. Physician Consult (PC): Means the APRN may initiate and continue the medication after direct communication with the collaborator and documentation of consult in patient record.

SCA - Formulary Rule Changes LEGEND and Format Changes: all formulary drugs are now categorized as: “may prescribe,” “physician initiated,” “physician consult” or “may not prescribe.” SCA may also include any additional parameters pertaining to the prescribing of drugs indicated in this column. Effective: APRIL 1, 2014 In Accordance with SCA: Means that drugs/drug categories on the formulary under this column, must have the prescribing designations determined jointly by the APRN and CP and specified. See current formulary (9/22/2014).

Formulary Legend Changes: SCA Update – “In Accordance with SCA”: *Use general category approval statement to cover all drugs in this column Example of general statement: “The APRN may prescribe all formulary drugs under “in accordance with SCA category”, per the APRN’s and collaborator’s scopes of practice and within acceptable prescribing practices.” *or address each drug individually in SCA Update – “In Accordance with SCA”: *Use individual drug approval statement, PI, PC or may not prescribe

Formulary Legend *Off-Label Use: : *May prescribe if supported by current peer review literature (which is accessible by the CTP holder),and noted as the standard of care in the SCA *Compounded Drugs: *Combination Drugs: Each component must be “CTP holder may prescribe” Limited conditions: Components must be FDA approved and listed in formulary as may prescribe. SCA must contain verbiage recognizing the approved compounded drugs; if off label, follow rules

Formulary Rule Changes: Schedule II Opioid Analgesics*** All requirements of Section 4723.481 ORC, and more narrow prescribing parameters requiring physician involvement specified in Section 7 of formulary, apply to schedule II Opioid Analgesics SCA must state if initial prescriptions for > 14 day supply require physician initiation or consultation – or are approved by CP for extended initial supply May not change the designation “MAY NOT PRESCRIBE”.

Re-licensure – What do I need for my COA? Continuing Education CE LAW and Rule 4723-14-03 – OAC: 1 hour Category A, law and rule, must be approved by the Ohio BON or offered by OBN approved provider (every 2 years) HB 303, (2012) Ohio APRN may use the CE used for national certification to apply toward CE requirements for renewal of APRN license as RN does if the CE is obtained through a Program approved by the OHIO BON or by a BON approved CE Provider.

Re-licensure & COA Continuing Education Requirements: (OAC 4723-14-05) Licensure Renewal: (every 2 years) *24 hrs. for RN renewal (1 hr. nursing law and rule, Category A) *12 hrs. in Pharmacology Save documentation of all CEs for 6 years *Must have some component addressing controlled substances. TOTAL: 36 hours for COA + CTP Renewal Specialty certification every 5 years See certifying organization for specifics

Prescribing Principles and Standards Prescriptive Authority Must have CtP (CtP – E can prescribe when licensed and if meets supervision requirements). SCA must include prescribing authority of APRN to include off label, Schedule II and per SCA arrangement (OAC 4723-9-10) Within Scope of Practice – congruent with specialty area of physician and APRN May not prescribe any drug/device that induces an abortion Follow Federal and State Laws Sample Drugs Samples within the formulary Provided free of charge, may not repackage No more than 72 hour supply or smallest packaged amount No samples of DEA controlled substances (4723-9-09: 4723-9-08 OAC: 4723.50 ORC)

Prescribing Principles and Standards Prescriptive Authority Stock Medications Dispense or furnish stock medications by site: health department, federally funded primary care clinic, or non profit health care clinic, ( college: student health clinic), maintain safety standards Dispensing stock medications by category: antifungals, antibiotics, contraceptives, prenatal vitamins, scabicides; asthma, antihypertensives, DM meds; antilipidemics 4723-9-08 OAC: 4723.481 ORC

Prescribing Principles and Safety Standards Furnishing Standards: ( must be on formulary – no controlled) Provide directions for Stock Medication use: Affix label & include: name of APN, name of patient, name and strength of drug: directions for use; date furnished Must maintain record of all stock drugs and devices personally furnished by the APN Prescribing Standards: Valid prescriber-patient relationship Assessment/exam, diagnosis, document Current certificate to prescribe, accordance with scope of practice; No friends or family member (additional rules & no controlled meds); Use DEA if prescribing controlled meds, According to APRN SCA & most current BON Formulary

Prescribing Principles and Safety Standards Issuance of a Prescription: (4729-5-30) Must Have: Date, APRN name, address, title, telephone, same identifiers for patient; drug, quantity, strength, directions for use; refills; CtP on every prescription: no refills for schedule II May provide multiple prescriptions for schedule ll DEA for scheduled drugs Fax: not appropriate for schedule II: exception is LTC and Hospice Follow Hospice Patient prescription format (OAC 4729-5-15) All controlled drugs quantity written numerically and alphabetically (4729-5-13) Formulary Use: Confirm Per SCA preference in SCA FDA and Off-Label Use: in accordance with formulary and consistent with SCA Follow formulary review requirements

Board of Medicine: OAC 4731-11-09 Prescribing to persons not seen by the physician/APRN **Not approved, except in institutional settings, on call situations, cross coverage situations, situations involving new patients, protocol situations, situations involving nurses practicing in accordance with standard care arrangements, and hospice settings, as described in paragraphs (D) and (E) of this rule, **A physician shall not prescribe, dispense, or otherwise provide, or cause to be provided, any controlled substance to a person who the physician has never personally physically examined and diagnosed. NOTE: This applies to APRNs.

Prescribing Principles and Safety Standards Approved Delegation of Med Administration/Unlicensed (4723-13-05 OAC, 4723.07 ORC) OTC topical medications OTC eye drops, ear drops Suppository medications, Foot soak treatments Enemas CtP Externship Requirements for Out of State APRNs APNs who prescribed in another state within the last 3 years Included or excluded controlled substances Must complete 2 hour law and rule course specific to prescribing in Ohio (Follow rules 4723-9-08 – 4723-9-10)

Schedule II Brief Review Achieved limited Schedule II Prescriptive Authority – June 2012 Changes to SCA and Quality Assurance Requirements General Pharm CE requirements – 12 pharm hours with some component for controlled substances In course objectives IN COURSE TITLE No specific # of CE required for controlled substances Quality assurance requiring representative sampling of schedule II drugs if prescribed Must adhere to standards & rules OARRS Must be vigilant as new legislation introduced frequently 3 initiatives passed in 2014

Prescribing Schedule II Schedule II prescribing outside of approved site list:  1) Only in terminal condition with degree of medical certainty it is terminal, there can be no recovery 2) CP initially prescribed the substance for the patient 3) The amount does not exceed a 24 hour supply (ORC 4723.481) These current rules on Schedule II do not apply if the Schedule II drug is written from any of the listed locations NO CONVENIENCE CARE CLINICS EVER

Schedule II Brief Review Approved Sites: Hospitals and any entity owned or controlled in whole or part by hospital ORC 3701.07 County Home Chapter 5155 ORC etc. Health care facility operated by department of mental health or developmental disabilities Nursing Home: ORC 3721.02, or 3721.09 ORC Hospice care program ( home, outpatient, inpatient etc.)(3712.01 ORC) Community Mental Health Facility (ORC 5122.01) Ambulatory Surgical Facility 3702.30 ORC Free Standing Birthing Center (ORC 3702.51) FQHC or FQHC look a like (defined in section 1905 (1) (2) (B) of SSA 2264, (1989(. 42 U.S.C. 1396d (1)(2)(B)). 3701.047 ORC Health Care Office/facility operated by ODH or board of health of city/general district 3709.05 ORC Physician owned offices/practices Excludes Convenience Care Clinics

Hospice Program or Hospice Facility? Hospice Program – defined under ORC 3712.01 “Hospice care program” is a coordinated program of home, outpatient and inpatient care and services that is operated by a person or public agency and that provides the following care and services to hospice patients, including services as indicated below to hospice patient’s families, through a medically directed interdisciplinary team, under interdisciplinary plans of care established pursuant to section 3712.06 of the ORC, in order to meet the physical, psychological, social, spiritual, and other special needs that are experienced during the final stages of illness, dying, and bereavement.

Schedule II Rule Changes Amphetamines: CTP Holder may prescribe with formal established diagnosis Per SCA if no formal diagnosis Opioid Analgesics – Schedule II (NEW) 14 day maximum for initial therapy without PI/PC SCA must indicate amount > 14 day supply per institutional protocol or per PI/PC within SCA “In accordance with SCA”

Schedule II Prescribing - Additional Requirements SCA Must Include: *The exact authority to prescribe schedule 2 Example: May prescribe all scheduled drugs per BON formulary: OR May prescribe all schedule II with exception of stimulants: OR May not prescribe schedule II drugs *Quality assurance standards must be inclusive of schedule II drugs, representative sampling review *APRN must follow all of the standards and procedures for the utilization and review of OARRS reports (OAC 4723-9-12)

Schedule II Prescribing - Additional Requirements *Must have DEA with approval to prescribe 2 and 2N noted on the license to prescribe schedule II *May not prescribe an opioid for the treatment of drug addiction (Federal Law). Problem for neonates with abstinence syndrome

APRNS may not prescribe opioids for drug addiction to include neonates

Recap: Prescribing Safely Prescribing Rules: According to SCA Scope of practice Formulary requirements Does not exceed your collaborator Valid-patient prescriber relationship No controlled substances – ever for family DEA must have to prescribe II – V drugs No device or substance that induces an abortion Write CtP on all prescriptions Follow OARRS regulations DO NOT furnish a schedule II to anyone DO NOT prescribe anabolic steroids (C-III) (4723-9-09 OAC)

OARRS – What YOU Need to Know BON: OAC 4723-9-12 Standards and Procedures for review of OARRS OARRS: *Is a prescription monitoring program maintained by the Ohio BOP, assists with med management & serves as screening for abuse. *Makes it easy to obtain a chronologic history of patient use of controlled substances (4729-37-02 OAC) *Pharmacy must report on a weekly basis, by pharmacy or prescriber – if personally furnished or dispensed. *Prescriber: May request report if prescriber-patient relationship Must utilize if: *Currently treating or plan on prolonged use 12 weeks or more *Every year at least as well as the first prescription, initial prescribing *If has reason to believe abuse of drugs (list of examples) 4723-9-12 *Must first review the OARRS report and document review *If you prescribe and review and determine likely abuse, you must document a CP consult before prescribing again. *If the OARRS report is not available – must document in record If you prescribe benzos or opioids - NEW * Hospice patients exempt http://codes.ohio.gov/oac/4723-9-12 https://www.ohiopmp.gov/Portal/images/MedBoardArticle.pdf

LAW AND RULES PERTINENT TO OHIO CONTEMPORARY APRN PRACTICE - NEW Determination & Pronouncement of Death (4723.36 ORC Effective 3/22/2013) CNS, CNP and RN can determine and pronounce death: if respiratory and circulatory functions are not artificially sustained. If individual is in LTC facility; residential care facility, assisted living, county home, If CNP or CNS provides supervision of individual’s care through hospice care program or palliative care, APRN may not complete individual’s death certificate Attending physician must be notified before 24 hrs. has passed.

LAW AND RULES PERTINENT TO OHIO CONTEMPORARY APRN PRACTICE - NEW Hospital Admission Authority (ORC 3737.06) – effective 5/20/2014 *APRNs with collaboration agreement with hospital staff physician *Hospital privileged and credentialed *Must notify CP prior to admitting patient *No change in APRN scope – APRNs make admission decisions, this simply allows them to write the specific order to admit *Bill is much more restrictive than federal admitting rules – another advancement in practice, Hospital bylaws must allow.

New LAWS ORC 4761.11 • APRNS may now supervise certified hyperbaric technologists – Effective 9/4/2014. ORC 4723.486 •ALL PRESCRIBERS of Opioids and Benzodiazepines must check OAARS before prescribing - Effective 9/16/2014 ORC 3712.062 •Requires a licensed hospice care program that provides hospice care and services in a patient's home to establish a written policy & adopt certain practices for preventing the diversion of controlled substances containing opioids – Effective 9/17/2014

ORC 4723-48 • Mandatory Consent for Minors who are prescribed Opioids – Effective 9/17/2014 Go to StartTalking.ohio.gov for sample consent and tips ORC 1751.69 • Prohibits health insurance provided by certain insurers from providing less favorable coverage for orally administered cancer medication than for intravenously administered or injected cancer medications – Effective 9-17-2014 ORC 4730.093 Lyme Disease: a written notice must be given to patients when ordering a test for Lyme disease. Notice is signed by the patient/POA and kept in MR. Form required to make patients aware of difficulty in diagnosing Lyme disease, as symptoms are often non-specific and found in other conditions Effective 9-17-2014 Strategy to repeal started

ORC 4723.488 Naloxone Prescription to a Non-Patient Effective March 11, 2014, APRNs w/ CTP, to personally furnish/ issue naloxone prescription to friend, family member, or other individual in a position to provide assistance to an individual at risk of experiencing an opioid-related overdose; Grants immunity from criminal or civil liability or professional disciplinary action when acting in good faith; Requires health care professional to instruct individual to whom the drug is furnished/prescription is issued to summon EMS immediately before or immediately after administering naloxone.

HB 483 Budget Bill had nurse law changes to include: Permits CNPs and CNSs to be added to a list of professionals who may supervise various Chemical Dependency Counselor professionals when treating gambling disorders and various substance abuse disorders. Permits a prescriber to request OARRS information for mother of a newborn or infant patient, for the purpose of providing medical treatment to the newborn or infant after being diagnosed as opioid dependent.

Current Legislative Initiatives Pink Slip • HB 104 introduced 3/19/13 by Representatives Ruhl & Stautberg; stalled in Senate Civil Justice committee since 12/12/13. • An amendment (G90175) to the bill was sent to Senator Sharon Jones on 7/23/14 for her support. • Amendment includes: A clinical nurse specialist certified as a psychiatric-adult CNS by ANCC; A CNP adult psychiatric-mental health NP by ANCC to be identified amongst those who may “pink slip” Not all APRNs Hope to pass in lame duck!

Delegation Update HB 301 Introduced 10/16/13 ; passed committee, now in House To authorize a person not otherwise authorized to do so to administer certain drugs pursuant to delegation by APRN who a CTP. Requires BON to establish standards and procedures for the delegation of authority to administer drugs Currently there is no opposition to this bill. PA association request that we agree to put 301 into 412 and help them get the bill passed in the lame duck session.

Prescriptive Changes Hydrocodone Combination Products (VICODIN, NORCO)moved from Schedule III to Schedule II Effective October 6, 2014 Tramadol and products containing tramadol moved to Schedule IV controlled substances in Ohio pursuant to a rule adopted by the United States DEA. Effective August 18, 2014

BARRIERS TO PRACTICE – FUTURE PERSPECTIVES Full Practice Authority Committee - OAAPN Represents all APRN Associations Seeks Barrier Free Prescribing and Practice and retirement of mandatory collaboration. Research based strategic action RAND Study completed of the economic benefits realized by Ohio with barrier free APRN practice ONLY INITIATIVE for 2015-2016.

What to do if the board comes knocking. Disciplinary actions on the rise in Ohio. Preventive Action – Most Important Follow the rules of practice for Ohio APRNs Have all documents available for review at your work site and up to date Consult legal counsel – immediately Do not call BON before you call your attorney Don’t represent yourself Know your rights Don’t sign anything

Questions?? Douglas Caserta, MSN, FNP-BC, APRN Treasurer OAAPN Member, Full Practice Authority Committee cen1996@gmail.com 937-670-2745