2015 Family Practice Review and ReunionFebruary 21, 2015

Douglas Caserta, MSN, FNP-BC, APRN

Meets the Category A, 1.5 hour requirement for Ohio Nursing Law and Rules

APRN PRACTICE UPDATE LAW AND RULE 2014

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

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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 3

• Standard Care ArrangementCollaborationWho signs? Components of the SCAPrescribing Parameters Update

Quality Assurance Chart Review: when and whoPrescriptive Review: when and who

Relicensure – What do I needPrimary Source VerificationContinuing Education

Review Topics - continued 4

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

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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)

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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 LawUnited States Code of regulationsCenter 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

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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

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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)

Certificate of Authority 9

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 - 2013Scope: 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….”

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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 – ExternshipCRNAs have supervisory language

Must a Doctor be on site or sign charts? NOException: CtP-E for supervised hours)Must be accessible by telecommunication 11

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 12

Standard Care Arrangement

SCA (4723-8-04) Must have one before you practice: keep on siteIncludes: 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 involveddocument physician licensure yearlyprovisions for in-person physician evaluation if needed.Samples available from OAAPN

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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 14

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.

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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.

Standard Care Arrangement – Clarification of PI/PC

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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).

SCA - Formulary Rule Changes 17

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 Changes:

*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 Legend 20

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”.

Formulary Rule Changes:

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.

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• 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

Re-licensure & COA 23

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)

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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 ORC25

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

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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

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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) 29

Schedule II Brief Review Achieved limited Schedule II Prescriptive Authority – June 2012Changes 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 201430

» 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 recovery2) CP initially prescribed the substance for the patient3) 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

Prescribing Schedule II 31

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

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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.

Hospice Program or Hospice Facility?

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Amphetamines: CTP Holder may prescribe with formal established diagnosisPer 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 Rule Changes 34

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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

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*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

Schedule II Prescribing -Additional Requirements

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APRNS may not prescribe opioids for drug addiction to include neonates

Prescribing Rules:According to SCAScope of practiceFormulary requirementsDoes not exceed your collaboratorValid-patient prescriber relationship No controlled substances – ever for family DEA must have to prescribe II – V drugsNo device or substance that induces an abortionWrite CtP on all prescriptionsFollow OARRS regulationsDO NOT furnish a schedule II to anyoneDO NOT prescribe anabolic steroids (C-III) (4723-9-09 OAC)

Recap: Prescribing Safely 39

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 recordIf you prescribe benzos or opioids - NEW* Hospice patients exempt

http://codes.ohio.gov/oac/4723-9-12https://www.ohiopmp.gov/Portal/images/MedBoardArticle.pdf

OARRS – What YOU Need to Know 40

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.

LAW AND RULES PERTINENT TO OHIO CONTEMPORARY APRN PRACTICE - NEW

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

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» 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.

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 APRNsHope to pass in lame duck!

Current Legislative Initiatives

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

Full Practice Authority Committee - OAAPNRepresents all APRN Associations Seeks Barrier Free Prescribing and Practiceand 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.

BARRIERS TO PRACTICE – FUTURE PERSPECTIVES

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 dateConsult legal counsel – immediatelyDo not call BON before you call your attorney Don’t represent yourself Know your rights Don’t sign anything

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Questions??

Douglas Caserta, MSN, FNP-BC, APRNTreasurer OAAPN Member, Full Practice Authority Committeecen1996@gmail.com937-670-2745

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