new pharmacy laws: credentialing pharmacists and single pdl · examination -north american pharmacy...

4/4/2018

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JEFF ROCHON, PHARM .D.WASH IN GTO N STATE PHARM A C Y ASSOC IAT IO N

New Pharmacy Laws: Credentialing Pharmacists

and Single PDL

Disclosure

Jeff Rochon has no financial relationships to

disclose. He is employed by the Washington State

Pharmacy Association.

Learning Objectives

At the completion of this program, attendees will be able to:

1. Describe ESSB 5557 and how it includes pharmacists in

provider networks

2. Discuss the best practice guidance of the ESSB 5557

Advisory Workgroup

3. Outline the scope of pharmacy practice and role of the

healthcare team

4. Describe SSB 5883 and Health Care Authority’s plan to

implement a single PDL

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2015 Law Change

ESSB 5557 introduced by Senator Linda Evans Parlette (R-12)

May 11, 2015: Governor Inslee signed bill into law

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Photo permission granted by WSPA

“Every Category of Provider” Law (1995)

� RCW 48.43.045(1) requires health plans in Washington

to include access to every type or “every

category” of licensed medical provider to provide

health care services to care for conditions included in the

basic health plan.

� Pursuant to WAC 284-43-205, “health carriers shall not

exclude any category of provider licensed by the

State of Washington who provide health care services or

care within the scope of their practice for conditions

covered by basic health plan (BPH) services as defined

by RCW 48.43.005(4)

Attorney General Informal Opinion

� In January 2013, WA State AG Ferguson’s office provided the informal opinion confirming:

“Pharmacists are health care providers and must be compensated for services included in the basic health plan that are within the scope of the pharmacist’s practice if the pharmacist agrees to abide by stated standards related to cost containment, management, and clinically efficacious

health services.”

� The informal opinion was not a silver bullet, but reinforced our long held belief that pharmacists are healthcare providers that should be able to provide covered patient care services within provider networks.

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ESSB 5557 Highlights: Pharmacists as Patient Care Providers

� Clarified pharmacists inclusion into existing law RCW 48.43.045

� Health plans must recognize pharmacists the same as other healthcare providers with regard to their role as patient care providers of covered medical benefits

� Adequate number of pharmacists in their networks

� Includes services within scope of practice

� covered services within essential health benefit requirements

� Required for commercial carriers covering large group, small group,

individual and family plans

� Clarified that pharmacies in health plans’ drug benefit networks

DOES NOT satisfy new requirements

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Law Implementation Timeframe

LegislationSigned into law May 2015

Implementation Advisory CommitteeSummer 2015

Deliverables to OICRecommendations due by December 2015

ImplementationJan 2016: Health plans enroll pharmacists in health-

systems with delegated credentialing agreements Jan 2017: Health plans enroll pharmacists in all settings

SB 5557 Highlights:

Advisory Committee Process

� OIC designated a lead organization.

� Lead organization formed Advisory Committee

� Develop best practice recommendations for

standards on credentialing, privileging, billing and

payment.

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SB 5557 Highlights:

Advisory Committee Participants

� Representative(s) from:

� Lead organization facilitator

� State agencies

� Provider associations

� Health carriers

� Health care system that

coordinates care and coverage

� Hospital with internal credentialing

process

� Health facilities with pharmacists providing medical services

� Pharmacy schools

� PBM

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http://clipart-library.com/clipart/191052.htm

Advisory Committee Work

� Intent: � Ensure that pharmacists will be regarded as any other provider as it

relates to:

� health plan billing,

� processing,

� and payment of claims for medical services

� Specific deliverables: � FAQ

� Health Plan Policy Directives

� Pharmacists and Other Provider Expectations

� https://www.insurance.wa.gov/sites/default/files/documents/onehealthport-report-on-essb5557-november2015.pdf

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FAQ Document

� Reflects industry information offering understanding

and context for Policy Directives and Provider

Expectations.

� Includes:� Pharmacist’s scope of practice, licensure requirements, training,

education, and certifications

� Collaborative Drug Therapy Agreements (CDTA)

� Credentialing and Privileging

� Primary care providers or specialty care providers?

� Diagnosis required to bill for services?

� Which billing codes?

� What process billing of medical services?

� Do medical billing standards apply?

� And more

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FAQ Application of Law

Does this legislation apply to services that are

covered under a patient’s medical benefit and

pharmacy-drug benefit?

� This legislation only applies to services covered under a

patient’s medical benefit � i.e. services which may also be performed by a qualified physician,

ARNP, PA, etc., as appropriate to their scope of practice and licensure.

� For services that are covered under patient’s pharmacy-

drug benefit, billing and reimbursement policies and

procedures will not be impacted.

FAQ Training

What training and education do pharmacists receive

to obtain their pharmacy degree?

� Highly focused on the anatomy/physiology, medicinal

chemistry, pharmacology, pharmacokinetics, and

therapeutic applications of medications

� Promotes a strong understanding of medication safety and

efficacy

� Considerable attention in pharmacy curricula (both didactic

and experiential) is devoted to the development of core

ability in communication, leadership, and inter-professional

teamwork

The Pharmacy Degrees

Baccalaureate Pharmacy degree� At least 2 years of prerequisites

� 3 years of pharmacy school curriculum � Didactic and experiential

Doctor of Pharmacy (Pharm.D.) degree � 3-4 years of prerequisites

� 4 years of pharmacy school curriculum � Didactic and experiential

Doctor of Pharmacy degree has been the standard for ACPE accreditation since 2003.

The majority of pharmacy students enter the professional

program with a Baccalaureate or Master’s level college degree.

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FAQ Training continued

� In order to be eligible to become a licensed pharmacist in

the state of Washington, licensure applicants must have

completed a: � Pharmacist degree from the Accreditation Council for Pharmacy

Education (ACPE) accredited pharmacy program.

� Pertains to both Baccalaureate and Doctor of Pharmacy (Pharm.D.) degrees.

� The ACPE is the national agency for the accreditation of

professional degree programs in pharmacy and providers of

continuing pharmacy education.

� The ACPE standards are available at:

https://acpeaccredit.org/pdf/Standards2016FINAL.pdf.

FAQ Training continued

� Postgraduate training (optional)

� Pharmacy residency programs in hospitals, clinics, community pharmacies, administration, and managed care.

� Primary accrediting body American Society of Health-System

Pharmacists (ASHP)

� Pharmacy fellowships in academic/research or industry.

� Not accredited

� Certification/Training programs

� Credentialing Council of Pharmacy (CCP)

� http://pharmacycredentialing.org/

Pharmacist Career Options

• Ambulatory Clinic Pharmacist

• Community Pharmacist

• Consulting Pharmacist

• Hospice & Home Care

• Hospital & Institutional Practice

• Long-Term Care

• Specialized Care

• Uniformed (Public Health) Service

• Academia

• Government Agencies

• Pharmacy Ownership

• Managed Care Pharmacist

• Medical & Scientific Publishing

• Pharmaceutical Industry

• Trade & Professional Associations

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Licensing Requirements in Washington

Washington State Pharmacy Licensure Requirements

(RCW 18.64; WAC 246-861 and WAC 246-863)

Licensure

Requirements

Licensure Application State Licensure Application Form

Education Pharmacy Degree from an Accreditation Council for Pharmacy

Education (ACPE) accredited pharmacy program

Examination -North American Pharmacy Licensure Examination (NAPLEx)

-Multi-state Jurisprudence Examination (MPJE)

Training -1,500 hours of experiential training

-7 hours of HIV training

-3 hours Suicide Prevention training

Renewal 15 hours of continuing education annually

Scope of Pharmacy Practice in Washington State

� In Washington State, the “Practice of Pharmacy” (RCW 18.64.011) includes:

� Dispensing, compounding, labeling and distributing of drugs and devices

� RCW 18.64.011 includes:

� “initiating and modifying drug therapy through written

protocols and guidelines” (Collaborative Drug Therapy

Agreements)

� “administering” of drugs and devices

� “monitoring of drug therapy and use”

Monitoring of Drug Therapy and Use (WAC 246-863-110)

� Collecting and reviewing patient drug use histories;

� Measuring and reviewing routine patient vital signs

� Ordering and evaluating the results of lab tests relating

to drug therapy

� blood chemistries and cell counts,

� drug levels in blood, urine, tissue or other body fluids,

� and culture and sensitivity tests

�when performed in accordance with policies and procedures or

protocols applicable to the practice setting

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FAQ CDTA

Collaborative Drug Therapy Agreement (CDTA)WAC 246-863-100

� Signed agreement between one or more providers with prescriptive

authority and one or more licensed pharmacists.

� It is required in those situations when the pharmacist will exercise prescriptive authority in his or her practice (see RCW 18.64.011(23),

WAC 246-863-100) by initiating or modifying drug therapy in

accordance with written guidelines or protocols previously established and approved for his or her practice by a practitioner authorized to

prescribe drugs.

� Filed with the Pharmacy Quality Assurance Commission (PQAC).

� CDTAs are applicable in all care delivery environments, hospital, clinics,

and community pharmacies.

FAQ CDTA continued

� Per WAC 246-863-100, these agreements shall include:

� A statement identifying the practitioner authorized to prescribe and the

pharmacist(s) who are party to the agreement.

� The practitioner authorized to prescribe must be in active practice, and the

authority granted must be within the scope of the practitioners' current practice.

� Time period not to exceed 2 years during which agreement will be in effect.

� A statement of the type of prescriptive authority decisions which the

pharmacist(s) is (are) authorized to make, which includes:� types of diseases, drugs, or drug categories involved, and the type of prescriptive authority

activity (e.g., modification or initiation of drug therapy)

� procedures, decision criteria, or plan the pharmacist is to follow when making therapeutic

decisions

� activities pharmacist is to follow in the course of exercising prescriptive authority, including

documentation of decisions made, and a plan for communication or feedback to the

authorizing practitioner concerning specific decisions made.

� documentation may occur on the prescription record, patient drug profile, patient medical

chart, or in a separate logbook.

Collaborative Drug Therapy Agreements (CDTA)per WAC 246-863-100)

� A voluntary agreement between pharmacist and a

provider with independent prescribing authority

� Delegates prescriptive authority to a pharmacist a

particular therapy based on a specific protocol

� Authority is not restricted to collaborators patients

� CDTA must be on file with the Pharmacy Commission

prior to implementing

� States differ significantly

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� Enables pharmacists to enter into agreements with prescribers which authorize the pharmacist to: � Identify patients in need of a specific intervention or care,

� Administer the care (including prescribing if needed), and

� Notify the prescriber of the action taken.

� These agreements shall include:

� Practitioner(s) authorized to prescribe and pharmacist(s).

� A time period not to exceed 2 years.

Collaborative Drug Therapy Agreements (CDTA)

per WAC 246-863-100

Collaborative Drug Therapy Agreements (CDTA)

per WAC 246-863-100

� Type(s) of prescriptive authority decisions pharmacist(s)

are authorized to make, including:

�Types of diseases, drugs, or drug categories involved,

�Type of prescriptive authority activity authorized in

each case.

�Procedures, decision criteria, or plan pharmacist(s) are

to follow when making therapeutic decisions.

Collaborative Drug Therapy Agreements (CDTA)per WAC 246-863-100

� Activities pharmacist(s) must follow in the course of

exercising prescriptive authority

�documentation of decisions made,

�a plan for communication or feedback to the

authorizing practitioner concerning specific decisions

made.

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FAQ CDTA continued

When is a CDTA necessary?

� Under current (2015) Washington State prescribing laws, if

a pharmacist will be prescribing medications in the course

of their patient care services, such as for chronic disease

management (adjusting blood pressure medications or

anticoagulation), or initiating new therapies (Take home

naloxone, immunizations), then a CDTA would be necessary

to delegate prescribing authority to the pharmacist.

� For more information on how CDTAs are regulated, see

WAC 246-863-100

Prescriptive Protocols

� A component of the CDTA which outlines the extent of the

prescriptive authority.

� Can be very specific or more broad

� Allow specific collaborative expansion of scope primarily

prescriptive authority

� A provision of the Washington Administrative Code (WAC

246-863-100) specifies the components of the agreements

or protocols which must be present in order to obtain

approval by PQAC .

� Currently 34,000 active CDTAs on file with PQAC

Examples of CDTA Protocol Areas

� Public Health� Immunizations

� Tobacco Cessation Therapy

� Emergency Contraception

� Contraception

� Emergency Preparedness Antiviral Therapy

� Tuberculosis Screening

� Naloxone

� Travel Medications

� Chronic Disease Monitoring and Management� Anticoagulation

� Dyslipidemia

� Diabetes

� Hypertension

� Asthma

� Pain

� Heart Failure

� Comprehensive Medication Reviews

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FAQ Designation

Are pharmacists primary care providers or specialty care

providers?

� The pharmacist is a member of the primary care team, providing

primary care services.

� Many pharmacist-provided services should be regarded as primary care

services

� based on specific examples from ACA provisions

� common medical usage of what constitutes primary care services

� examples: chronic disease medication management, medication

reconciliation, preventive care services

� However, in some patient care situations, certain pharmacist provided

services may be considered specialty services when working in collaboration with other specialty providers.

FAQ Place of Service

� What are the different places of service in which a

Pharmacist may practice?

� Pharmacists practice in a variety of ‘places of service’, e.g.

pharmacy, inpatient hospital, home, nursing facility,

independent clinic, etc.

FAQ Codes

What CPT/HCPCS Codes do pharmacists anticipate

billing? How will they be reimbursed?

� The following types of codes are likely to be used when

billing for medical services. Note: this is not an exhaustive

list, other codes may be billed.

CPT / HCPCS Code Types

� E&M Codes

� MTM Codes

� Medication/Vaccination Codes

� Lab Test Codes

� Diabetes Mellitus Self Management Code

� Potential Harm Reduction

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Billable Interventions

� Preventive Care Services

� Alcohol and Substance Dependency

� HIV Prevention (PreP)

� Immunization

� Medicare Annual Wellness Visit

� Naloxone

� Osteoporosis

� Preventive Medicine Services

� Reproductive Health

� TB Testing

� Tobacco Cessation

� Travel Medicine


� Chronic Care (Drug Therapy Monitoring/Management) � Anticoagulation� Asthma / COPD

� Chronic Kidney Disease

� Congestive Heart Failure� Coronary Artery Disease

� Diabetes

� Hyperlipidemia � Hypertension

� Behavioral/Mental Health

� Obesity � Pain

� Chronic Care Management Services

� Transitional Care Management Services


� Infused, Injectables, And Laboratory Tests

� Infusion and Injectable Medications

� Laboratory Tests

� Medication Therapy Management

� Comprehensive Medication Review

� Other Time-based Services

� Prolonged Services

� Telemedicine/Telehealth

� Telephone Services

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Health Plan Policy Directives

� Identifies policy conditions/requirements that

health plans will have in place to enable the

billing and appropriate reimbursement of

medical services provided by pharmacists:

� Contracting

� Credentialing

� Utilization Management

� Coding/Billing/Reimbursement

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Provider Expectations

� Lists and briefly describes expectations and/or requirements for pharmacists, other providers, and other stakeholders in order to operationalize the reimbursement of pharmacist-provided services: � Applicability

� Contracting � Credentialing

� Privileging� Utilization Management

� Coding/Billing/Reimbursement

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Advisory Committee Documents

� Consensus documents agreed upon by

diverse representation of healthcare

community

� Serve as best practice guidance for health

plans and pharmacists

� Provided needed clarification to address

assumptions and interpretations

http://clipart-library.com/clipart/dc9rgELc7.htm

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SSB 5883 Single PDL

� Budget Bill

� Implement a single, standard medicaid preferred drug list

to be used by all contracted medicaid managed health care

systems, on or before January 1, 2018.

SSB 5883 Single PDL

� Shall be designed to maximize federal rebates and

supplemental rebates and ensure access to clinically

effective and appropriate drug therapies under each class.

� Entities eligible for 340B drug pricing shall continue to

operate under their current pricing agreement, unless

otherwise required by federal laws or regulations.

SSB 5883 Single PDL

� Shall require each managed care organization to use the

established preferred drug list;

� Shall prohibit each managed care organization and any of

its agents from negotiating or collecting rebates for any

medications listed in the state's medicaid single preferred

drug list.

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SSB 5883 Single PDL

� Contracted medicaid managed health care systems shall

provide HCA with drug-specific financial information to

include � the actual amounts paid to pharmacies for prescription drugs dispensed

to covered individuals compared to the cost invoiced to the health plan

� individual rebates collected for prescription drugs dispensed to Medicaid

members

SSB 5883 Single PDL

� Information disclosed to HCA by the manufacturer pursuant

to this provision shall only be used for the purposes of

developing and implementing a single, standard state

preferred drug list in accordance with this provision.

� HCA, medicaid managed care organizations, and all other

parties shall maintain the confidentiality of drug-specific

financial and other proprietary information and such

information shall not be subject to the Washington public

records act.

SSB 5883 Single PDL

� HCA shall provide a report to the governor and appropriate committees

of the legislature by November 15, 2018, and by November 15, 2019, � including a comparison of the amount spent in the previous two fiscal years to expenditures

under the new system by, at a minimum, fund source, total expenditure, drug class, and top twenty-five drugs.

� The data provided to HCA shall be aggregated in any report by the authority, the legislature, or the office of financial management so as

not to disclose the proprietary or confidential drug-specific information,

or the proprietary or confidential information that directly or indirectly identifies financial information linked to a single manufacturer.

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Apple Health PDL

What has changed?

� On January 1, 2018, HCA implemented the Apple Health

PDL that includes some drug classes. HCA will add more

drug classes later this year.

Apple Health PDL

How do managed care plans cover drugs that are not

included in the Apple Health PDL?

� Managed care plans will continue to use their own clinical

criteria and policies for drugs that are not part of the Apple

Health PDL.

� Each plan will continue to use established communication

channels to notify patients and providers

Apple Health PDL

If a drug became non-preferred on January 1, 2018,

was it grandfathered?

� The DUR Board determines which drugs must be

grandfathered for clinical purposes.

� For grandfathered drugs, prescribers will not need to obtain

prior authorization (PA) for patients to continue the

medication they were stabilized on before January 1, 2018.

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Apple Health PDL

Will medical benefit drugs be included in the Apple

Health PDL?

� The primary focus will be drugs that are covered in

outpatient settings. HCA expects to include drugs

traditionally covered in the medical benefit. The timeframe

for including medical benefit drugs hasn’t been set.

Apple Health PDL

How often will drug classes be reviewed and changes

made to the PDL?

� Drug classes will be reviewed at least once a year.

Apple Health PDL

Who makes the final decision as to which drugs

become part of the PDL?

� Washington State’s Medicaid Director, who is a deputy

director within HCA, or her designee, has the final authority

for PDL decisions

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Apple Health PDL

Can plans add drugs to the PDL?

� No. Plans may not add drugs to classes within the Apple

Health PDL. Plans may follow their own PDL for drugs or

drug classes that are not part of the Apple Health PDL.

Apple Health PDL

Do managed care plans use their own prior

authorization criteria?

� The goal is that all plans use the same prior authorization

criteria, step therapy edits, and quantity limits that HCA

develops.

� Beginning January 1, 2018, plans are using the same

preferred status for drugs listed on the Apple Health PDL;

however, they will continue to use their own quantity limits.

� HCA has reviewed each plan’s criteria and will allow the

plans to use their own criteria until a common set has been

established.

Apple Health PDL

� Has the process to obtain prior authorization

changed?

� No. The process is the same.

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Apple Health PDL

Does the Therapeutic Interchange program apply to

the Apple Health PDL?

� The Therapeutic Interchange program only applies to some

drug classes for the Medicaid Fee for Service program.

Apple Health Managed Care Plans do not participate

� The therapeutic interchange program (TIP) will apply to the

30 drug classes included in both the Washington PDL and

the Apple Health PDL. Therapeutic interchange is a service

for Endorsing Practitioners of the Washington PDL.

Apple Health PDL

Will endorsing prescriber status apply to the Apple

Health PDL?

� An endorsing prescriber will continue to have the ability to

override non-preferred status in some drug classes for the

Medicaid Fee for Service program.

Current Apple Health PDL (Jan 1, 2018)

� Can be viewed at: www.hca.wa.gov/apple-health-pdl

Includes:� Anaphylaxis Agents: Epinephrine Self injectables

� Anticoagulants: Factor XA and Thrombin Inhibitors

� Antidiabetics: insulin (long, intermediate, rapid, short-acting and pre-mixed)

� Antiemetics: 5HT3 Receptor Agonists, Substance P/Neurokinin 1 (NK1) Receptor

Antagonists, Other

� Antivirals: HIV

� Asthma/COPD Agents: Anticholinergics, Anti-Inflammatory and Muscarinic Agents,

Beta agonists (long acting, oral, short acting), inhaled corticosteroids/ combinations ,

monoclonal antibodies, Phosphodiesterase 4 inhibitors

� Cytokine and CAM antagonists

� Digestive Enzymes

� Endocrine and Metabolic Agents: Growth hormone

� Multiple Sclerosis Agents

� Substance Use Disorder: Opioid Antagonists/Partial Agonists

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Next up…

� Significantly more classes to be added: � July 1, 2018

� January 1, 2019

� Reports to Governor and committees� November 15, 2018

� November 15, 2019

Questions?Jeff Rochon, Pharm.D.

[email protected]