RISK MANAGEMENT: MEDICAL RECORDS, COMPLIANCE & TRENDS

Isabelle Bibet-Kalinyak, Esq. McDonald Hopkins LLC

Ohio MGMA Fall Conference September 21, 2018

Columbus, Ohio

7542997

AGENDA

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Content of Medical Records

Authentication and Integrity

Retention, Access, and Releasing

Transfer, Rights to, and Disposal

The Joint Commission

Privacy and Cybersecurity Risks, HIPAA

Robo Text or Repeated Documentation

Medical Necessity

E/M Services Reform

Liability and Consequences

Opioid Epidemic

Prescribing Requirements

Telemedicine

Emerging Compliance Challenges

Definitions for Reference

PURPOSE OF MEDICAL RECORDS

• Continuity of care – same provider over time or transfer

• Quality of care

• Compliance with payer requirements, accreditation requirements, legal requirements, etc.

• Billing and coding

• Litigation: – To prove/defend claims of medical malpractice

– Government investigation

– Disciplinary action (Board, medical staff, etc.)

– Payor or utilization audits

– Discovery issues

• Research, database

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CONTENT OF MEDICAL RECORDS

• SOAP format: – Subjective data from patient: Symptoms, complaints – Objective data from examination – Assessment: Analysis of data gathered, possible diagnosis – Plan of action: Treatment, consultation, hospitalization, further

tests/studies necessary or why not pursued, prescriptions • Beyond the basics:

– Document efforts to contact patient by phone or else – Have staff member present during examination (pelvic exams), note in

records – Note names of other persons/family members present during review of

treatment options – Informed consent before treatment/procedure – AMA – Potential complications

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COMMON PITFALLS

• Omitting required information

• Omitting relevant information

• Inaccurate data or errors

• Professionalism

• Illegible records or signature

• Wrong or too many abbreviations

• Misunderstanding of coding language and standards

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DEFINITION OF MEDICAL RECORDS • 42 C.F.R. § 482.24(c)(2)(i)

Content of record: All records must document […] all practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition.

• Format:

EMR (cloud-based or local)

Paper

Hybrid

• Primary records vs. ancillary records: labs, diagnostic tests and imaging, phone records, emails, texts, 3rd party provider records, medical bills, incident reports, patient portals, etc…

• Audit trails and meta data

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DEFINITION OF MEDICAL RECORD - OHIO

• RC 3701.74(B) Request to examine or obtain copy of medical record Medical record, definition: Data in any form that pertains to patient’s medical history, diagnosis, prognosis, or medical condition and that is generated and maintained by health care provider in process of treatment.

• Griffith v. Aultman Hospital, 2016-Ohio-1138 Fifth District Court (Canton): Maintained by hospital’s medical records dept. &

decision to keep or preserve to further treatment Ohio Supreme Court:

o Only data provider has decided to keep or preserve for treatment o Includes all records generated and maintained, regardless of where or by

which department they are kept Trial court

• Sub H.B. 172 (2017-2018) – Attempts to clarify access to medical records “Designated” by provider instead of “generated and maintained”

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TEXTING

• Medicare (Jan. 2018) and The Joint Commission • No texting of patient orders in hospital settings (CoPs, CfCs) • Texting patient information among members of the hospital

healthcare team permissible, but only from secure, encrypted systems and platforms

• Computerized provider order entry (CPOE) - preferred method • Medicare continues to permit handwritten orders (and verbal

orders, subject to some additional requirements) in the medical records but CPOE preferred, even if provider accesses remotely

• Why? CPOE orders are automatically dated, timed, authenticated, and promptly downloaded into EHR

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STUDENT NOTES IN MEDICAL RECORDS

• Medicare Claims Processing Manual, Change Request # 10412 • Effective March 5, 2018 • Evaluation and Management (E/M) • Prior: Required teaching physicians to re-document certain entries

made by medical students in the medical records. Review of systems and past family and/or social history did not need re-documentation

• New rule: No re-documentation, just verification of all components of E/M services in medical records.

• Requirements: Teaching physician must: – Personally perform or re-perform the physical exam and medical decision

making activities of the E/M service; and – Verify all student documentation and findings in medical records

• Reduces duplication of data entry in medical records

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AUTHENTICATION & INTEGRITY • RC 3701.75 Authenticating health care records

Definition: Any document or combination of documents pertaining to patient medical history, diagnosis, prognosis, or medical condition, generated and maintained in the process of treatment

• Policy permitting use of electronic signatures • Authentication:

– Two-level access control mechanism, unique identifier for each user; or – Biometric access control device

• Safeguards – Unauthorized access – Forgery – Signatory: Must have reviewed content – User certification re: compliance with confidentiality and security policies

• Penalties • Training • Emerging issues: Corruption during software update; patient portals

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MEDICARE SIGNATURE REQUIREMENTS

• Valid signature: – Services provided must be authenticated by ordering practitioner; – Handwritten, electronic, or stamped (only if physical disability) – Legible

• Missing signature: – Cannot add beyond transcription process – No retroactive orders permitted – Submit attestation – If order for tests: Submit signed progress notes showing intent to order specific

tests

• Signature not legible: – OK if original record contains printed signature below illegible signature – Submit signature log or attestation to support identity of illegible signature

• Signature log: Typed listing of providers identifying name with corresponding handwritten signature. – Individual or group log

• Recoupment of overpayment

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RETENTION REQUIREMENTS • State laws

Adults Minors OAC 3701-84-11(E), General Medical Records Requirements: 6 years

from date of discharge

• Federal HIPAA Accounting of Disclosures 45 C.F.R. 164.528: 6 years Medicare CoPs 42 C.F.R. 482.24(b)(1): 5 years Specific record types – example: Labs 42 C.F.R. 493.1105

• Test requisitions and reports 2 years • Pathology test reports 10 years after date of reporting • Blocks: 2 years after examination • Cytology slide preparations: 5 years from examination • Tissue remnants: until diagnosis made

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RETAINING ACCESS TO MEDICAL RECORDS, OTHER CONSIDERATIONS

• Continuing software/EHR licenses and access to metadata

• Statute of limitations, RC 2305.113(A)-(B) Medical Malpractice Actions:

– 1 year after cause of action accrued or after discovered

– Tolling: Notice within 1 year, extra 180 days

– Dismissal and refile within 1 year

– Minors

• Statute of repose, RC 2305.113(C)-(D): 4 years; exceptions

• Wrongful death, RC 2125.02(D): 2 years

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RELEASE OF MEDICAL RECORDS

• Current form ODM 03397 (02/2016), http://medicaid.ohio.gov/Portals/0/Resources/Publications/Forms/ODM03397fillx.pdf

• Proposed* new rule OAC 5160-1-32.1, Standard Authorization Form: Standard forms for use and disclosure of PHI in Ohio – Form ODM 10221 A and B – Standard form and consent for release of SUD data

• Requirement under RC 3798.10 • Meets all requirements of 45 C.F.R. 164.508 and 42 C.F.R. part

2 as applicable • Use of form not mandatory • Only required if authorization required * Comment period, not submitted, looking at 1/1/2019 effective date

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COPIES OF MEDICAL RECORDS • RC 3701.741 Fees for providing copies of medical records • (B)(1) Request from patient or personal representative

– No records search fee – Paper or electronic format: $3.18 per page (first 10 pages); $0.66 per page

(pages 11-50); $0.27 per page (pages 51 and higher) – X-ray, MRI, or CAT scan recorded on paper/film: $2.18 per page – Actual cost of postage

• (B)(2) Request by others – $19.58 records search fee – Paper or electronic format: $1.29 per page (first 10 pages); $0.66 per page

(pages 11-50); $0.27 per page (pages 51 and higher) – X-ray, MRI, or CAT scan: $2.18 per page – Actual cost of postage

• Annual CPI adjustment RC 3701.742, March timeframe • HIPAA Rule, 45 C.F.R. 164.524: Flat fee $6.50 or schedule of costs

based on average allowable labor costs to fulfill standard requests

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TRUMP ERA EHR REFORM TO ENHANCE PATIENT ACCESS TO HEALTH DATA

• MyHealthEData • Changes to Medicare and Medicaid Promoting Interoperability

Programs (Meaningful Use) • Codified in FY 2019 Inpatient Prospective Payment System and

the Long-Term Care Hospital Prospective Payment System Rule, August 2, 2018

• Enhance patients’ access to their health data • Providers must use 2015 Edition Certified EHR Technology

(CEHRT) by 2019 – Technical requirements focused on interoperability – Application programming interfaces (APIs)

• Less burdensome reporting requirements for providers • New opioid prescription measures

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TRANSFER OF MEDICAL RECORDS, TRIGGERS

• Departure of one or more physicians

• Death or retirement of a physician

• Sale of practice

• Lease of practice

• Consolidation into a larger group practice

• Acquisition by health system or private equity

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RIGHTS TO THE MEDICAL RECORDS

• Ownership can be murky

• Providers: Physician vs. medical practice?

Employment agreement or professional services agreement

• Hospitals

• Ambulatory surgical centers

• Patients’ choice

• Patient portals: Secure online website that give patients convenient, 24/7 access to personal health information from anywhere. Example: MyChart (CCF)

• EHR software licenses and IP issues

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DISPOSING OF PAPER RECORDS

• HIPAA: Must properly dispose of paper records containing PHI

• Includes paper, films, and other hard copy media

• Shred or destroy so that PHI cannot be read or reconstructed

• Redaction not sufficient

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DISPOSING OF ELECTRONIC RECORDS

• Office of Civil Rights (OCR) Guidance on Disposing of Electronic Devices and Media, August 7, 2018

• Applies to all covered entities and business associates that store ePHI on desktops, laptops, copiers, cell phones, USB devices and other electronic storage devices

• Risk analysis • Decommissioning devices:

– Erase and destroyed or recycled – Inventory – Privacy protection via proper migration to another system or total destruction

of data

• HIPAA policies and procedures – Address disposal of ePHI • Destruction and disposal to prevent retrieval: Electronic media must be

purged, cleared or destroyed consistent with NIST Special Publication 800-88 Revision 1, Guidelines for Media Sanitization

• https://www.hhs.gov/sites/default/files/cybersecurity-newsletter-july-2018-Disposal.pdf

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THE JOINT COMMISSION – RECORD OF CARE, TREATMENT AND SERVICES

• Plan: – Clinical records components, complete and accurate – Authentication – Timeliness – policy, maximum 30 days post discharge – Audit – Retention

• Implementation: – Care, treatment and services – Operative and other high-risk procedures, use of

sedation/anesthesia, post-operative notes – Verbal orders – Discharge information

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THE JOINT COMMISSION – PROVISION OF CARE, TREATMENT AND SERVICES • Core components: Assessing, planning, providing, coordinating care,

treatment and services • Plan:

– Admission – Assessment and screening – Planning care

• Implementation: – Providing care, treatment and services – Coordinating – Patient education – Primary care medical home

• Special conditions – Special procedures: Surgery, anesthesia/sedation, tissue specimens, ECT – Restraints and seclusion: Cannot be “PRN,” monitoring

• Discharge and transfer: planning and continuity of care • Blood safety

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THE JOINT COMMISSION – MEDICATION MANAGEMENT

• Medication planning and management

• Safety: Look-alike, sound-alike medications

• Selection and procurement

• Storage

• Ordering and transcribing

• Preparing and dispensing

• Administration

• Monitoring

• Evaluation

• Antimicrobial stewardship

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EMERGING AND EVOLVING COMPLIANCE CHALLENGES

• Privacy and cybersecurity risks, HIPAA

• Regulatory challenges: Increased enforcement of laws and regulations, qui tam actions – Robo text/repeated documentation

– Medical necessity

– Plan of care

• Opioid epidemic and compliance with prescribing requirements

• Prescribing via telemedicine

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CONFIDENTIALITY

• Hippocratic oath

• HIPAA

• State statutes

• Psychiatric and Substance Use Disorders (SUDs)

• HIV/AIDS – Ryan White Care Act and state laws

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NEW SAMHSA RULES, 2017 AND 2018

• Substance Abuse and Mental Health Services Administration (SAMHSA)

• Confidentiality of certain substance abuse records

• In addition to HIPAA

• January 13, 2017 – First update since 1987: Electronic records and blanket consent to disclose information to “my treating providers”

• January 3, 2018 – Effective February 2, 2018: Illustrative list of potential types of acceptable disclosures related to payment and health care operations, e.g. billing, quality improvement initiatives, utilization review, underwriting

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USE OF EHR DATA IN CLINICAL RESEARCH

• HHS guidance published July 2018 (not applicable to registries), FDA website • Interoperability and integration of systems

– Data standards: Challenges to interoperability of EHR and Electronic Data Capture (EDC) systems

– Structured data recommended – Validation

• Best practices – Technology certified by Office of National Coordinator for Health Information

Technology (ONC) – Use of EHR systems not certified by ONC – eSource principles for EHRs – Blinded study designs – Informed consent 21 C.F.R. 50.25(a)(5) - Should not promise or imply absolute

confidentiality by FDA; or that FDA needs permission from the subject for access to the records.

• Inspection, record keeping, & record retention 21 C.F.R. part 312: – All records, including EHRs – 2 years (see specifics)

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CYBERSECURITY TRENDS AND HIPAA SECURITY • Trends:

– Cloud computing service providers – Ransomware and phishing – Cyber breaches up vs. coincidental breaches – Recording and photographing (RC 2933.52 and RC 2933.62) – Scams

• HIPAA Security Rule 45 C.F.R. 164 Subpart C • HIPAA Breach Notification Rule 45 C.F.R. 164 Subpart D

– Impermissible use or disclosure that compromises the security or privacy of PHI – Presumption of breach – Unless demonstrate low probability PHI has been compromised via risk

assessment of factors including: • Type of information • Encryption • Likelihood of re-identification • To whom disclosure was made • Mitigation

– Exceptions: good faith, unintentional acquisition or access – Notification: 60 days

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HIPAA PRIVACY RULE

• HIPAA Privacy Rule 45 C.F.R. 164 Subpart E • Permitted uses and disclosures 45 C.F.R. 164.506: Without patient

consent or authorization • Treatment: Provision, coordination, or management of health care and

related services among health care providers (or by health care provider with a third party), consultation between providers regarding patient, or the referral of a patient from one health care provider to another

• Payment: Various activities of health care providers to obtain payment or be reimbursed for services.

• Health care operations of recipient: Administrative, financial, legal, and quality improvement activities of a covered entity that are necessary to run its business and to support the core functions of treatment and payment. Limited to activities listed at 45 C.F.R. 164.501

• Covered entity • Business associate • Business associate agreement

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RANSOMWARE ATTACKS

• HIPAA compliance helps preventing and responding to cyber attacks • OCR recommendations (January 30, 2018) for robust security incident

procedures to respond to ransomware attacks https://www.hhs.gov/sites/default/files/RansomwareFactSheet.pdf – Detect and conduct initial analysis – Contain impact and propagation – Eradicate the instances of ransomware and mitigate or remediate

vulnerabilities that permitted the ransomware attack and propagation – Recover from attack by restoring data lost and returning to “business as

usual” operations – Conduct post-incident activities:

• Deeper analysis of the evidence to determine if the entity has any regulatory, contractual or other obligations: Breach notification under HIPAA

• Incorporating lessons learned into the overall security management process of the entity to improve incident response effectiveness for future security incidents.

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ROBO TEXT OR REPEATED DOCUMENTATION

• Medicare, OIG work plan

• Trends or patterns in which documentation is nearly identical may indicate potential fraud, waste, or abuse

• Documentation identical or nearly identical to documentation for a different date-of-service for the same beneficiary

• Documentation identical or nearly identical to documentation for multiple other beneficiaries.

• Templates permitted but must allow full and complete collection of information

• Ensure providers are creating original, signed, customized and unique records for each patient encounter

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OTHER EHR TECHNOLOGY CONCERNS

• Drop down menus

• Prepopulated templates

• Pull forward

• Integrity of amendments

• Integrity of authorship

• Note fatigue

• Integrity and/or availability of data after software upgrade

• Interoperability, including with other systems such as pathology/lab systems (e.g., CoPath)

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MEDICAL NECESSITY, MEDICARE

• 42 USC 1395y(a)(1)(A) - No payment may be made under part A or part B for any expenses incurred for items or services which […] are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. – Exceptions for preventative care, palliative care and similar types of

services

• CMS Claims Form 1500 certification • Services not clinically indicated per general medical standards

and national or local coverage determinations (NCDs, LCDs) • Inflating the volume (repeat visits) • Inflating the value of a service (up-coding) • High quality documentation and coding compliance

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MEDICAL NECESSITY, OHIO MEDICAID • OAC 5160-1-01 Medical Necessity • Meets generally accepted standards of medical practice; • Clinically appropriate in its type, frequency, extent, duration, & delivery

setting; • Appropriate to adverse health condition for which it is provided and is

expected to produce the desired outcome; • Lowest cost alternative that effectively addresses & treats the medical

problem; • Provides unique, essential, and appropriate information if it is used for

diagnostic purposes; and • Not provided primarily for the economic benefit of the provider nor for

the convenience of the provider or anyone else other than the recipient. • Fact that physician, dentist or other licensed practitioner renders,

prescribes, orders, certifies, recommends, approves, or submits a claim for a procedure, item, or service does not, in and of itself make the procedure, item, or service medically necessary and does not guarantee payment for it.

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DOCUMENTATION, MEDICAL NECESSITY

• Therapy/Rehab services - Documentation must demonstrate: Beneficiary’s condition required the expertise,

knowledge, clinical judgment, decision making and abilities of a qualified therapist for provision of rehabilitative therapy;

Beneficiary’s condition required the expertise, knowledge, clinical judgment, decision making and abilities of a qualified therapist to carry out a safe and effective maintenance program; and

Services were of the appropriate type, frequency, intensity and duration for individual needs of patient

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DOCUMENTATION, PLAN OF CARE • Documentation must demonstrate that service is reasonable

and necessary to support plan of care • Long-term goals must be measurable • Progress report and meeting

– Date of beginning and end of reporting period; – Date report written – Signature and professional identification of qualified professional who wrote

report – Objective reports of the patient’s subjective statements, as relevant – Objective measurements or description of changes in status relative to each goal

addressed in treatment – Assessment of improvement, extent of progress (or lack thereof) toward each goal

listed in plan – Plans for continuing treatment, reference to additional evaluation results, and/or

treatment plan revisions – Changes to long or short term goals, discharge or updated plan of care sent to the

physician/NPP for certification of next interval of treatment – Functional documentation at end of each progress reporting period

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TRUMP ERA REFORM, E/M SERVICES

• “President Trump has made it clear that he wants all agencies to cut the red tape, and CMS is no exception.”

• Proposed new rule, July 12, 2018 • Overhaul of E/M documentation and coding system to reduce time

spent inputting unnecessary information into patient records • E/M visits: 40% of services • Move from 5 levels of patient visits to 2 levels:

– Level 1 (new patients) and single set of RVUs for current levels 2-5

• Add-on payments for certain types of visits with higher resource costs: – Separately identifiable E/M visits furnished in conjunction with a 0-day

global procedure – Primary care E/M visits for continuous patient care – Certain types of specialist E/M visits, including those with inherent visit

complexity

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FALSE CLAIMS ACT LIABILITY

• Criteria: – Knowingly presents, or causes to be presented, a false or fraudulent

claim for payment or approval – Knowingly makes, uses, or causes to be made or used, a false record

or statement material to a false or fraudulent claim – Knowingly makes, uses, or causes to be made or used, a false record

or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government

– Conspires to commit a violation of FCA

• Repayment and treble damages $10,781-$21,563 per claim • Corporate integrity agreement (CIA) • Self-disclosure

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FALSE CLAIMS ACT LIABILITY, EXAMPLE

• Standing order for lab test before surgery without individual review and documentation for medical necessity

• Test: $95

• 500 tests not medically necessary

• Final liability: $5,533,000 – Overpayment x 3: 500 x $95 x 3 = $142,500

– Penalty: $10,781 x 500 = $5,390,500

• Legal costs

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OTHER POTENTIAL LIABILITY • Denial of payment and repayment of overpayments • Medicare 42 C.F.R. 412.46, Medical Review Requirements, Physician

Acknowledgment: – Notice to Physicians: Medicare payment to hospitals is based in part on each

patient’s principal and secondary diagnoses and the major procedures performed on the patient, as attested to by the patient’s attending physician by virtue of his or her signature in the medical record. Anyone who misrepresents, falsifies, or conceals essential information required for payment of Federal funds, may be subject to fine, imprisonment, or civil penalty under applicable Federal laws.

• CMS Claims Form 1500 Certification: – I certify that the services shown on this form were medically indicated and

necessary for the health of the patient and were personally furnished by me or were furnished incident to my professional service by my employee under my immediate personal supervision, except as otherwise expressly permitted by Medicare or CHAMPUS regulations.

• Criminal statutes and state false claims statutes • Medicare debarment • Corporate integrity agreement (CIA)

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OPIOID EPIDEMIC NATIONAL AND LOCAL STATISTICS

• Approximately 64,000 deaths (2016), nearly doubled in 1 year

• 30 deaths per 100,000 individuals (2016)

• Opioids and heroin

• National emergency

• 2017: HHS invested nearly $900 million

• September 2017: Additional $144.1 million awarded in federal grants under Comprehensive Addiction and Recovery Act

• 2016: 4,140 Ohioans died due to unintentional overdose

• 36% increase from 2015

• Montgomery county: Hardest hit county in U.S.

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FEDERAL LAWS: PRESCRIPTION REQUIREMENTS • RX for Controlled Substances:

• Must be dated and signed by the prescribing practitioner on the day issued • Include patient’s name and address, drug, dosage, strength, quantity, and

directions for use • Include name, address, and DEA number of prescribing practitioner • Issued for a legitimate medical purpose • In writing (electronic script permitted) and for a specific patient (21 C.F.R. §§ 1306.04, 1306.05)

• RX for Schedule II drugs • May only be faxed if: Patient is a resident of a long-term care facility or

hospice program and the script is faxed directly to the dispensing pharmacy • Sequential prescriptions up to a 90-day supply of a Schedule II controlled

substance are permitted (21 C.F.R. §§ 1306.11, 1306.12)

• No pre-filled prescriptions under any circumstances

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PRESCRIPTION REQUIREMENTS, PHARMACISTS

• Changes Pharmacist can make to Controlled Substance prescription (except Schedule II): – May add or change patient’s address upon verification – May add of change dosage form, drug strength, quantity,

directions for use, or issue date: • Only after consultation with and agreement with prescribing

provider • Note in prescription and medical records • Compliance with all state and federal laws

• Changes Pharmacist cannot make to any Controlled Substance prescription: – Patient’s name, Controlled Substance prescribed, and

prescriber’s signature

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PRESCRIPTION DRUG MONITORING PROGRAMS AND STATE LAWS

• 50 states have PDMPs as of November 2017 • 11 states have laws regulating pain management clinics • 44 states provide civil immunity to laypersons who administer naloxone • Some states limit dosage and duration of opioid pain relievers • Ohio – OARRS: Ohio Automatic RX Reporting Program • Indiana – INSPECT: Indiana Scheduled Prescription Electronic Collection

& Tracking • Kentucky – KASPER: Kentucky All Schedule Prescription Electronic

Reporting • Michigan – MAPS: Michigan Automated Prescription System • West Virginia – Controlled Substance Automated Prescription Program • Pennsylvania – PDMP: Pennsylvania Prescription Drug Monitoring

Program • Florida: State law

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OHIO OPIOID RX LIMITS FOR ACUTE PAIN (2017) • New rules effective August 31, 2017 • Acute pain only, not chronic pain • Dentists: OAC 4715-6-02 • Medical Board: OAC 4731-11-01, 4731-11-02, 4731-11-13 • Nursing Board: OAC 4723-9-10 • Pharmacy Board: OAC, 4729-5-30, effective December 29, 2017 • 4 key limitations on opioid prescriptions:

– 7 days maximum (adults) – Minors: 5 days maximum & written consent of parent or guardian – Can prescribe above limits if specific reason & document in medical records

– Total morphine equivalent dose (MED) of a prescription cannot exceed 30 MEDs per day, unless exception

• Morphine equivalent dose conversion chart • Prescribers: ICD-10 diagnosis code (first 4 characters) or full procedure code on

all opioid prescriptions • Pharmacists will enter code in OARRS • Track trends and identify high prescribers

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2016 GUIDELINES FOR MANAGEMENT OF ACUTE PAIN • Guidelines: Available at

http://mha.ohio.gov/Portals/0/assets/Initiatives/GCOAT/Guidelines-Acute-Pain-20160119.pdf

• Tools: Available on Ohio Mental Health and Addiction Services website http://mha.ohio.gov/Default.aspx?tabid=828

– Fact sheet

– Summary

– Partner organizations

– Acute Pain Opioid Prescribing Guidelines Infographic

– Patient Education Letter for Acute Pain Treatment

– Patient Education Letter for Chronic Pain Management

– Patient and Provider Responsibilities (National Institute on Drug Abuse)

– Pain Management/Treatment Overview (University of Wisconsin School of Medicine and Public Health)

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OHIO OARRS REQUIREMENTS • Registration

• Applicable to pharmacists & prescribers but some variations

• Rules - minimum standards:

– OAC 4731-11-11 – Physicians

– OAC 4723-9-12 – NPs

• SCA must contain provision re: OARRS

– OAC 4730-2-10 – PAs

– OAC 4715-6-01 – Dentists

– OAC 4725-16-04 – Optometrists

• Short videos about how to obtain and how to read and interpret OARRS reports: Available on Ohio Board of Pharmacy website (home page)at https://www.ohiopmp.gov/Portal/Default.aspx

• Morphine equivalent dose calculator: Available at https://www.ohiopmp.gov/Portal/MED_Calculator.aspx

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WHEN TO OBTAIN AND REVIEW OARRS REPORT?

• Provider must request patient information from OARRS & border state(s), as applicable

WHEN? • Before prescribing or personally furnishing any opioid

analgesic, benzodiazepine, or “reported drug,” unless an exception applies

• Reported drug, definition: See list at OAC 4729-37-02 • All schedule II, III, IV, and V controlled substances • PAs – All dangerous drugs containing tramadol • If any red flags; and • If TX with a reported drug >90 days

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WHEN TO OBTAIN AND REVIEW OARRS REPORT? (cont’d)

• Query period: – Initial review: At least previous 12 months – Subsequent reviews: Period from date of last report – If TX>90 days: Repeat at intervals not exceeding 90 days – At least once per year

• Document receipt and assessment in patient record – Copy of medical record? – Copy to patient? – Copy to anyone?

• Document physician consult, as applicable • If OARRS not available: Document reason & efforts to follow-up (in details) in

patient record • Use of “delegate:” Report can be requested by “delegate but provider must

personally review – To add a delegate:

https://www.ohiopmp.gov/Portal/Documents/AddRemoveDelegate.pdf – Liability

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SIX EXCEPTIONS AND APPLICABILITY

EXCEPTIONS – Drug prescribed or personally furnished

PAs NPs MDs/DOs

To hospice patient or any other patient with terminal DX

Yes Yes Yes

For period not to exceed 7 days Yes Yes Yes

For treatment of cancer or other condition associated with cancer

Yes Yes Yes

Drug is administered in hospital, nursing home, or residential care facility

Yes Yes Yes

*To treat acute pain resulting from surgical or other invasive procedure or a delivery*

N/A N/A Yes

OARRS is not available Yes Yes Yes

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RED FLAGS • Selling prescription drugs

• Forging or altering a prescription

• Stealing or borrowing reported drugs

• Increasing the dosage of reported drugs in amounts that exceed the prescribed amount

• Suffering an overdose, intentional or nonintentional

• Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen

• Having been arrested, convicted, or received diversion, or intervention in lieu of conviction for a drug-related offense while under your care

• Receiving reported drugs from multiple prescribers, without clinical basis

• Traveling with a group of other patients to your office, where all or most of the patients request controlled substances prescriptions

• Traveling an extended distance or from out of state to your office

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RED FLAGS (cont’d) • Having a family member, friend, law enforcement officer or health

care professional express concern related to the patient's use of illegal or reported drugs

• A known history of chemical abuse or dependency • Appearing impaired or overly sedated during an office visit or

examination • Requesting reported drugs by specific name, street name, color, or

identifying marks • Frequently requesting early refills of reported drugs • Frequently losing prescriptions for reported drugs • A history of illegal drug use • Sharing reported drugs with another person • Recurring visits to non-coordinated sites of care, such as emergency

departments, urgent care facilities, or walk-in clinics to obtain reported drugs

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PHYSICIAN CONSULTATION FOR APRNS

• OARRS report and/or red flags • Patient may be abusing or diverting drugs • May prescribe one time • Must consult with physician prior to prescribing at patient’s

next visit • Consultation must include review & documentation of:

– Reasons for suspicion of abuse or diversion – Patient progress toward TX objectives – Patient’s functional status: ADL, AE, analgesia, aberrant

behavior, etc.

• Consultation may include and result in: – Treatment agreement – Consult or referral to substance use disorder specialist

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JOINT COMMISSION REQUIREMENTS

• Effective January 1, 2018 • New and revised pain assessment and management standards

for accredited hospitals • Leadership (LD.04.03.13), Medical Staff (MS.O3.01.03,

MS.05.01.01), Provision of Care (PC.01.02.07), Performance Improvement (PI.01.01.01, PI.02.01.01)

• Leader or leadership team responsible for pain management and safe opioid prescribing

• Patient involvement • Identifying and monitoring high risk patients • Facilitating access to PDMPs • Hospitals must provide non-pharmacologic pain treatment

modalities • Integrative health

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OHIO, MEDICAL MARIJUANA – TOOL IN THE BOX OR PERFECT STORM…?

• Decriminalizes use and possession only

• Does not require employers to permit or accommodate use and possession in the workplace

• Drug policy

• Does not prohibit employer from refusing to hire, discharge, discipline, or otherwise take an adverse employment action against individual because of use, possession, or distribution

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TELEMEDICINE PRESCRIBING RULE

• OAC 4731-11-09 Describes when a physician or PA can prescribe medication to a patient the physician or PA has not personally examined when the patient is at a different location from the prescriber – Applies in all situations where the physician or PA is in one location

and the patient is in another location

– Applicable to PAs OAC 4730-1-06

• General Rule: Cannot prescribe any controlled substance or any prescription drug to a person on whom the physician or PA has never conducted a physical examination

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EXCEPTIONS TO TELEMEDICINE PRESCRIBING RULE

• Can prescribe a prescription drug that is not a controlled substance without a physical examination if: – Establish patient identity and location

– Obtain informed consent for remote treatment

– Forward the patient’s medical record or refer the patient to a health care provider/facility

– Complete an evaluation meeting minimal standards appropriate for patient

– Establish or confirm a diagnosis and treatment plan and document necessity of utilization of drug

– Document in the patient’s medical record

– Provide or recommend follow-up care

– Make medical record of visit available to patient

– Use appropriate technology sufficient to conduct all steps as if the evaluation occurred in-person

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EXCEPTIONS TO TELEMEDICINE PRESCRIBING RULE (cont’d) • Can prescribe a controlled substance without a physical examination in

any of the following situations: – Person is an active patient and the drugs are provided pursuant to an on-call

or cross-coverage arrangement and the physician complies with the steps on the previous slide

– Patient is physically located in a DEA-registered hospital or clinic when treated by an Ohio licensed DEA-registered physician or PA

– Patient is being treated by and in the presence of a DEA-registered physician or PA

– Physician has obtained a special registration from the DEA to prescribe controlled substances in Ohio

– Physician is medical director, hospice physician or attending physician for hospice and: • The controlled substance is provided to a patient enrolled in that hospice program; and • The prescription is transmitted by means compliant with Ohio Board of Pharmacy rules

– Physician is medical director, or attending physician at institutional facility and: • The controlled substance is provided to someone admitted as inpatient or who is a resident of the

facility; and • The prescription is transmitted by a means compliant with Ohio Board of Pharmacy rules

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RECOMMENDATIONS FOR PROVIDERS & EMPLOYERS

• Review and revise protocols

• Policies & procedures for opioid prescriptions

• Training

• Documentation of training

• Self-audits

• Medical Marijuana – Review and revise drug policy

• Telemedicine – Legal complexity

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IMPORTANT DEFINITIONS FOR REFERENCE

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Contact Information

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McDonald Hopkins LLC Isabelle Bibet-Kalinyak (216) 348-5736 IBK@McDonaldHopkins.com

This presentation is intended to provide general information. It is not intended as a form of, or as a substitute for legal advice and analysis. Legal advice should always come from in-house or retained counsel. Moreover, if this presentation in any way contradicts advice of counsel, counsel’s opinion should control over anything written herein. No attorney client relationship is created or implied by this presentation. No reproduction or dissemination without prior written consent from McDonald Hopkins LLC. ©2018 McDonald Hopkins. All rights reserved.