Attachment D.17 - VA PBM Field Guidance.pdf

PBM Guidance Access to Clinical Pharmacy Services at Contracted Community Based

Outpatient Clinics (CBOCs) and Rural locations

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Background:

Medication management services provided by clinical pharmacist practitioners (CPP) are essential in the primary care setting to improve access and quality of care to our Veteran population as described in the

PBM Fact Sheet Optimizing the Clinical Pharmacy Specialist (CPP) To Improve Access.1 In addition, there is a shortage of VA primary care physicians, estimated at over 400 positions which are currently unfilled.2 These gaps, coupled with the ongoing medication management needs of the population, create an urgency for CPP and clinical pharmacists to assist with caring for the Veteran in the PACT and

Specialty care settings. This issue is apparent at both medical facilities and even more prevalent in rural and CBOC locations. Clinical pharmacy services are provided in a variety of ways at CBOCs and rural locations. Many facilities have CBOC locations where VA employees serve the needs of the patients while other facilities may utilize contracted services. All VA facilities must evaluate their clinical pharmacy staffing ratios as outlined in VHA Handbook 1108.11 Clinical Pharmacy Services3 and using staffing standards outlined in the VHA Handbook 1101.10 Patient Aligned Care Teams (PACT)

Handbook.4

The published staffing ratios related to CPP, coupled with access issues faced by VA, has resulted in contracted clinics serving VA patients hiring clinical pharmacists and/or clinical pharmacy specialists.

This guidance document assists leaders in outlining strong practice recommendations for promoting access to clinical pharmacy services at contracted CBOCs and rural locations.

Discussion

Many facilities utilize contracted CBOC locations to provide primary care services to their patients at outlying clinics, especially in rural areas. Requirements outlined in contracts help to ensure consistency of care between the main facility and the CBOC location. The contracts must be designed to assure that

VA meets the same level of care in the contracted CBOCs as they do in their own internal facilities so that veterans in those locations do not get substandard care. When contracted clinical pharmacy services are utilized, it is imperative that the Chief of Pharmacy at the main facility is involved with oversight for professional practice and responsibilities of the clinical pharmacists.

Prior to determining how clinical pharmacy services are provided it is imperative that a clear understanding of the state practice acts regarding collaborative practice is understood. This will assist the facility and Chief of Pharmacy in determining whether clinical pharmacy services should be provided by VA Clinical Pharmacist or Clinical Pharmacy Specialist (CPP) or contracted pharmacist.

Determining State Practice Acts related to “Scope of Practice”

In determining the scope of practice for the contracted pharmacist, it is important that a review of state pharmacy practice acts be performed in advance. Note that state pharmacy practice acts differ as to the terminology used including collaborative drug therapy management (CDTM), collaborative practice http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPOSharepointLogos/CPPO%20Logo%20Wide.png https://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPO%20Documents/Fact%20Sheet%20-%20Optimizing%20the%20Clinical%20Pharmacy%20Specialist%20To%20Improve%20Access.pdf http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2977 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2977

Pharmacy Benefits Management (PBM) Services Updated January 2023 April 2017-Page 2 agreements (CPAs), and physician delegation.6 As of September 2016, 50 out of the 53 United States territories allow some degree of collaborative prescribing practices within their state practice acts with the exception of Alabama, Delaware, and South Carolina. It is imperative that a review of the state’s pharmacy practice acts be performed in advance of any decisions being made regarding pharmacists scope of practice. Since the contracted pharmacist is not considered a VA employee, they must possess an unrestricted license in the state in which the contracted CBOC resides and adhere to pharmacy practice acts within that state. It is important to remember that state practice acts do not govern scope of practice for VA employees as outlined in VHA Handbook 1108.11.3

Note: State Practice Acts do not govern scope of practice for any VA employee appointed under Title 38, 7405. This includes but is not limited to Full and Part-time Pharmacists, Without Compensation (WOC), and Fee Basis pharmacists.

Contracted Pharmacists may be granted a scope of practice from the parent VA; however it may not exceed what is allowable or outlined in state collaborative practice acts. A VA scope of practice is required for any circumstances in which the contracted pharmacist has patient care activities and serves as a non-physician provider, as part of collaborative medication management, to initiate, modify, renew, or discontinue medication therapy.

The Chief of Pharmacy (or designee) should be aware of pharmacy state practice acts regarding collaborative practice and evaluate these acts based on three main areas:

1. Do the state practice acts include allowance for collaborative practice agreements (or similar patient care activities) for medication management?

a. If no, then the clinical pharmacist may not be granted a VA Scope of Practice. The facility (and Chief of Pharmacy) should re-consider utilizing a contracted clinical pharmacist to provide services at the location.

b. If yes, proceed to number 2.

2. Do the state practice acts allow the clinical pharmacist to have prescriptive authority for medications?

a. If no, then the clinical pharmacist may not have prescriptive authority for medications included in their VA scope of practice. Proceed to number 3.

b. If yes, include medication prescriptive authority in VA scope of practice and proceed to number 3.

3. Do the state practice acts allow the clinical pharmacist ordering ability for labs or other diagnostics tests?

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a. If no, then policy or standard operating procedure must outline how labs will be performed after final approval of the PCP.

b. If yes, include this in the VA scope of practice and proceed to next step. (see Hiring of

Contracted clinical pharmacist)

In the event that state practice acts do not allow for collaborative practice, it is recommended that clinical pharmacy services be provided by other means if possible. This may be achieved in a variety of ways which include, but may not be limited to, hiring a VA clinical pharmacist with a scope of practice to practice at the actual CBOC or rural location or by providing the services via Telehealth or virtual care modalities. In addition, if collaborative practice acts do not exist the contracted clinical pharmacist may provide recommendations for medication management to the PCP for final approval and action.

In the event that state collaborative practice acts exist but are limited (e.g., do not allow for medication prescriptive authority), there are additional avenues to providing comprehensive medication management services. Medication management services may be provided in a variety of ways by a contracted clinical pharmacist to include:

• A CPA may be created and signed between the contracted physicians at the CBOC and the clinical pharmacist (if state allows CPA or protocols but does not allow for autonomous lab or prescriptive ordering ability).

• Medication and laboratory orders are entered by the contracted clinical pharmacist and then signed by the physician after review and approval.

• Progress notes are entered by the contracted clinical pharmacist with recommendations for therapy changes and the PCP is added as an additional signer to progress notes.

Hiring of Contracted Clinical Pharmacists with a Scope of Practice and Determining Initial Competency

Once it has been determined that a contracted clinical pharmacist with a scope of practice will be hired to provide clinical pharmacy services, the Chief of Pharmacy, when possible, and/or VA Contracting

Specialist should be involved in the hiring process. This will ensure that the credentials and competencies of the clinical pharmacist with a scope of practice being hired will be verified prior to the selection being made and are consistent with the level of services expected for the position. Selection and subsequent hiring should be consistent with qualifications outlined in VHA Handbook 5005/5, Pharmacist Qualifications Standards.6 The VA contract may stipulate additional requirements that the clinical pharmacist must meet to qualify for the position beyond those outlined in the qualification standards (e.g., post-graduate residency, board certification). The Medical Director for the contracted

CBOC location and the Chief of Pharmacy will work collaboratively to approve recommendations for appointment and scopes of practice for the contracted clinical pharmacist. All pharmacists hired by the contractor must be registered in the state in which the VA facility resides and meet any requirements outlined in state practice acts. If the clinical pharmacist is required to register their CPA with the state http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPOSharepointLogos/CPPO%20Logo%20Wide.png http://vaww.va.gov/ohrm/directives-handbooks/Documents/5005-55.doc http://vaww.va.gov/ohrm/directives-handbooks/Documents/5005-55.doc

Pharmacy Benefits Management (PBM) Services Updated January 2023 April 2017-Page 4 or be credentialed in accordance with state law for the functions outlined in the VA scope of practice, it is the responsibility of the contracted clinical pharmacist to ensure this is completed. These requirements should be clearly stated in the contract. In addition, the contracted clinical pharmacist must also meet all credentialing requirements outlined in VHA Handbook 1100.19.7

Note: Since the contracted clinical pharmacist is not a VA employee they would not be covered under the

VA liability protection for tort claims.

The VA Chief of Pharmacy (or designee) should assist to evaluate the initial competency of the contracted clinical pharmacist and will provide recommendations in regards to the initial scope of practice and CPA. As stated previously, this is performed in conjunction with the Medical Director for the contracted CBOC location. If there are specific requirements outlined in state practice acts regarding competency assessment, these are required to be followed in addition to any requirements outlined in VA policy. If the Chief of Pharmacy (or designee) determines all areas of competency for the position of been met, the contractor will prepare the Scope of Practice in collaboration with the VA

Chief of Pharmacy and submitted to the Executive Committee of the Medical Staff (ECMS) (or appropriate facility-based governing body) for review and recommendation to the facility Director. The

Scope of Practice should be standardized across the facility for clinical pharmacist with a scope of practice in similar practice settings and meet requirements outlined in the VHA Handbook 1108.113 as well as the PBM Guidance for Pharmacist Scope of Practice.8

If the Chief of Pharmacy or Designee(s) determines areas of deficiencies exist in regards to the clinical pharmacist with a scope of practice competencies, the Contractor and the VA Chief of Pharmacy or

Designee(s) will initiate a Mentorship with evaluation of the clinical pharmacist competency at a pre-set time frame in the future (see VHA Handbook 1108.11, Appendix C).3 It is important to note that a mentorship is not required, but may be warranted if there is insufficient evidence the contracted clinical pharmacist ’s readiness to assume duties outlined in their proposed scope of practice. Once competencies have been acquired for the areas of interest, the process of submitting to the ECMS for a scope of practice will ensue.

Scope of Practice Oversight for Contracted Clinical Pharmacists

If the Contracted Pharmacist is granted a Scope of Practice through the parent facility, the quality of care for a contracted clinical pharmacist must be evaluated in a fashion identical to that of VA employees as well as meet all standards outlined in state practice acts. Professional practice evaluations, both focused and ongoing, should meet requirements in VHA Handbook 1108.113 and PBM

Guidance Pharmacist Professional Practice Evaluations.9 In addition, the following items should be adhered to:

http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPOSharepointLogos/CPPO%20Logo%20Wide.png http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120 https://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPO%20Documents/PBM%20Guidance%20Pharmacist%20Scope%20of%20Practice.pdf http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120 https://dvagov.sharepoint.com/:b:/r/sites/VHAClinicalPharmacy/CPPO%20Documents/PBM%20Guidance%20Professional%20Practice%20Evaluation%20Process.pdf?csf=1&web=1&e=IPygJ1 https://dvagov.sharepoint.com/:b:/r/sites/VHAClinicalPharmacy/CPPO%20Documents/PBM%20Guidance%20Professional%20Practice%20Evaluation%20Process.pdf?csf=1&web=1&e=IPygJ1

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• Clinical care reviews (CCRs) are recommended to be performed on the contracted clinical pharmacist by a VA equivalent pharmacy peer on an ongoing basis as requirement of the scope of practice oversight. The professional practice evaluation (PPE) process should be handled in the same manner as for other VA employees functioning in a similar practice setting, i.e., the VA

PACT CPP.

• Focused and Ongoing Professional Practice Evaluations (FPPE and OPPE respectively) must be completed for the contracted clinical pharmacist by the contracted clinic and must be similar in content to VA employees. The OPPE will be reviewed by the Chief of Pharmacy prior to presentation to the ECMS.

• The Chief of Pharmacy should assist the contractor, as appropriate, in providing trended data that the contractor is unable to obtain.

• The expectations for performance of the contracted clinical pharmacist must be identical to VA employees (e.g. triggers and actions taken on those triggers).

Utilizing VA Employees at CBOC and rural locations

As stated previously, another alternative to providing clinical pharmacy services at CBOC and rural locations will be to assign a VA CPP to practice to the site. If a CPP assumes this role, it is important to note that state practice acts do not apply to the scope of practice since they are serving in their capacity as a VA employee. Clinical Pharmacy services may be provided via Telehealth or virtual care modalities for CBOC patients as well as through traditional modalities (e.g., face to face visits).

Summary of Recommendations:

• Facilities should review state practice acts regarding collaborative practice before determining how clinical pharmacy services will be provided at contracted locations.

• Chief of Pharmacy (or designee) should be involved with selection and hiring of contracted clinical pharmacist

• Chief of Pharmacy should be involved with determining initial and ongoing competency for scope of practice as well as oversight of the professional practice evaluation program.

• Opportunity exists to utilize and expand clinical pharmacy services to address access issues at facilities, contracted CBOC and rural locations.

Questions related to this guidance may be directed to the Clinical Pharmacy Practice Office (CPPO) at

VHAPBH Clinical Pharmacy Practice Office (CPPO) ClinicalPharmacyPracticeOfficeCPPO@va.gov http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPOSharepointLogos/CPPO%20Logo%20Wide.png mailto:ClinicalPharmacyPracticeOfficeCPPO@va.gov

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References:

1. PBM Fact Sheet Optimizing the Clinical Pharmacy Specialist (CPP) To Improve Access, April 2016.

https://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPO%20Documents/Fact%20Sheet%20-

%20Optimizing%20the%20Clinical%20Pharmacy%20Specialist%20To%20Improve%20Access.pdf

2. Oppel and Goodnough, “Doctor Shortage Is Cited in Delays at V.A. Hospitals,” New York Times, 5/29/14 (Accessed July 18, 2014).

3. VHA Handbook 1108.11 Clinical Pharmacy Services; July 1, 2015.

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120.

4. VHA Handbook 1101.10, Patient Aligned Care Team (PACT) Handbook; February 5, 2014.

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2977

5. Hill JD, Hill JM, Gentile, NJ. A review of state pharmacist collaborative practice laws. Am J Health-

Syst Pharm. 2016; 73: 1467-72.

6. VA Handbook 5005 [Staffing], Part II [Appointments], Chapter 3[Title 38 Appointments], And

Appendix II-G15 [Licensed Pharmacist Qualification Standard]. http://vaww.va.gov/ohrm/directives-handbooks/Documents/5005-55.doc

7. VHA Handbook 1100.20, Credentialing of Health Care Providers; September 15, 2021.

file:///C:/Users/VHATVH~2/AppData/Local/Temp/1/MicrosoftEdgeDownloads/47b6c605-d944-

4d59-b028-e0d694a83388/1100_20_D_2021-09-15.pdf.

8. PBM Guidance on Pharmacist Scope of Practice, January 13, 2023.

https://dvagov.sharepoint.com/sites/VHAClinicalPharmacy/CPPO%20Documents/Forms/AllItems.as px?id=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents%2FPBM%20Guidance%20Pharma cist%20Scope%20of%20Practice%2Epdf&parent=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Do cuments

9. PBM Guidance on Professional Practice Evaluations for Pharmacists with a Scope of Practice, January 13, 2023.https://dvagov.sharepoint.com/:b:/r/sites/VHAClinicalPharmacy/CPPO%20Documents/PBM% 20Guidance%20Professional%20Practice%20Evaluation%20Process.pdf?csf=1&web=1&e=IPygJ1 http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPOSharepointLogos/CPPO%20Logo%20Wide.png https://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPO%20Documents/Fact%20Sheet%20-%20Optimizing%20the%20Clinical%20Pharmacy%20Specialist%20To%20Improve%20Access.pdf https://vaww.infoshare.va.gov/sites/ClinicalPharmacy/CPPO%20Documents/Fact%20Sheet%20-%20Optimizing%20the%20Clinical%20Pharmacy%20Specialist%20To%20Improve%20Access.pdf http://www.nytimes.com/2014/05/30/us/doctor-shortages-cited-in-va-hospital-waits.html?_r=2 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2977 http://vaww.va.gov/ohrm/directives-handbooks/Documents/5005-55.doc http://vaww.va.gov/ohrm/directives-handbooks/Documents/5005-55.doc https://dvagov.sharepoint.com/sites/VHAClinicalPharmacy/CPPO%20Documents/Forms/AllItems.aspx?id=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents%2FPBM%20Guidance%20Pharmacist%20Scope%20of%20Practice%2Epdf&parent=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents https://dvagov.sharepoint.com/sites/VHAClinicalPharmacy/CPPO%20Documents/Forms/AllItems.aspx?id=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents%2FPBM%20Guidance%20Pharmacist%20Scope%20of%20Practice%2Epdf&parent=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents https://dvagov.sharepoint.com/sites/VHAClinicalPharmacy/CPPO%20Documents/Forms/AllItems.aspx?id=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents%2FPBM%20Guidance%20Pharmacist%20Scope%20of%20Practice%2Epdf&parent=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents https://dvagov.sharepoint.com/sites/VHAClinicalPharmacy/CPPO%20Documents/Forms/AllItems.aspx?id=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents%2FPBM%20Guidance%20Pharmacist%20Scope%20of%20Practice%2Epdf&parent=%2Fsites%2FVHAClinicalPharmacy%2FCPPO%20Documents https://dvagov.sharepoint.com/:b:/r/sites/VHAClinicalPharmacy/CPPO%20Documents/PBM%20Guidance%20Professional%20Practice%20Evaluation%20Process.pdf?csf=1&web=1&e=IPygJ1 https://dvagov.sharepoint.com/:b:/r/sites/VHAClinicalPharmacy/CPPO%20Documents/PBM%20Guidance%20Professional%20Practice%20Evaluation%20Process.pdf?csf=1&web=1&e=IPygJ1