TJHP - Volume 20 Issue 1

Advancing Pharmacy Practice and Education in Texas

VOLUME 20 | ISSUE 1 | SPRING 2021

A Review of Billing Opportunities for Outpatient Pharmacists in the State of Texas Adenike Atanda, PharmD, BCACP, CDCES Deidra Lee, Pharmacy Student Megan Wesling, PharmD, BCPS, BCACP

Medication Compliance in Enterally-fed Patients with Oral Dosage Forms that Should Not Be Crushed Lauren Goldberg, PharmD

Do Not Crush List Journal of the Texas Society of Health-System Pharmacists

HSV Hepatitis in the Immunocompetent Individual: An Under-Recognized Concern Hongmei Wang, PharmD, Ph.D. Christopher Cruz Namphi Nguyen Tankhoa Dang

New Drug List www.tshp.org/journal

TJHP: Texas Journal of Health-System Pharmacy Journal of the Texas Society of Health-System Pharmacists www.tshp.org/journal Stacey Mather, CAE Executive Director Paige Haines Membership & Communications Specialist Leah Cody Professional Development Manager

About TSHP The Texas Society of Health-System Pharmacists (TSHP) has been supporting health-system pharmacy in Texas since 1949, becoming one of the leading health-system pharmacy societies in the country that fosters leadership and education in pharmacy. What began as a small group of twenty-five dedicated hospital pharmacists coming together to learn and discuss professional issues, has grown to a dynamic health-system pharmacy organization that includes pharmacists, technicians, residents, students, retired pharmacists, educators, industry associates, and others passionate about the mission, vision, and core values of TSHP: Pharmacy Leaders. Transforming Patient Care. For more information on TSHP, please visit www.tshp.org.

TSHP Executive Committee: President Sarah Lake-Wallace, MS, PharmD, FTSHP

KeShana Odom Advocacy & Practice Director

President-Elect Latresa Billings, PharmD, BCPS Immediate Past President Steven Knight, PharmD, BCPS, RPh, CMTM Secretary Mallory Gessner-Wharton, PharmD, MS, BCPS Treasurer & President-Elect Designee Randy Martin, PharmD, BCCCP

TJHP Texas Society of Health-System Pharmacists 3000 Joe DiMaggio Blvd, Ste 30A Round Rock, Texas 78665-3920 (512) 906-0546

TSHP President Sarah Lake Wallace, PharmD TJHP Editor Todd Canada, PharmD TJHP Managing Editor Paige Haines Questions/Comments journal@tshp.org

Volume 20, Issue 1 Released: April 2021 ISSN: 2325-2804 Copyright © 2021 Texas Society of Health-System Pharmacists (TSHP)

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Treasurer-Elect Mary Olumesi, PharmD, BCPS

A very special thank you to the authors and contributors of this special issue, the TSHP Board of Directors, and the members of the 2018-2020 TSHP Editorial Advisory Board for their time and expertise in helping bring back the TJHP better than ever. It is because of you that we can truly advance pharmacy practice and education in Texas.

TSHP Editorial Advisory Board & Peer Reviewers: E. Paul Holder, MS, PharmD, FTSHP Saeed K. Alzghari, MS, MBA (HOM), PharmD, BCPS Tina Beck, PharmD, MSCR, BCPS Latresa Billings, PharmD, BCPS Jacqueline Bozick, PharmD, BCPS Amy Buesing, BS-Pharm, MBA Todd W. Canada, PharmD, BCNSP, BCCCP, FASHP, FTSHP, FASPEN(Chair) Abimbola Farinde, PharmD Caitlin Gibson, PharmD, BCPS Khanh-Hau Moss, MS, PharmD, BCPS Kimberly Nguyen, PharmD Kathryn Pidcock, PharmD, BCPS

Continuing Education Information The Texas Society of Health-System Pharmacists (TSHP) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing education.

To claim credit for CE, the participant must complete the course post-test, and complete a session evaluation using the provided link. Additional information on any available CE within this issue can be found at the end of each applicable article. Completion of this course requires access to an internet-enabled computer. Mozilla Firefox is the preferred browser. For information regarding TSHP’s privacy policy, please visit https://tshp.org/page/privacy_policy. Questions? Contact TSHP at tshp@tshp.org.

Hardware Requirements: Any computer capable of running an A-grade web browser. Typically, a minimum memory of 1GB, and a processor speed of 1Ghz Software Requirements: Any of the following A-grade browsers: Chrome 45+ Edge 38+ Firefox 40+ Opera 15+ Safari 7+ No other plugins are mandatory.

Connectivity: Minimum 1MB/s speed downstream, 512KB/s speed upstream For full CE information (UAN numbers, objectives, CEUs, type), see the end of each applicable article.

TJHP is the official publication of the Texas Society of Health-System Pharmacists (TSHP). TSHP is a membership-driven state society of pharmacists, technicians, students, and professional colleagues who advocate for optimized patient care, professional practice, and public health. Membership in TSHP is open to all pharmacists and others who support TSHP’s mission and values. Annual membership dues are $180, of which $30 is for a subscription to the TJHP. The annual subscription rate (minimum 2 issues) to nonmembers is $40. The cost for single copies is $25.

Payments made to TSHP are not deductible as charitable contributions for federal income tax purposes. However, they may be deductible under other provisions of the IRS up to 33%. TSHP payment processing can be reached at (512) 906-0546 Monday through Friday, 8:00 AM to 5:00 PM Central Time or by contacting tshp@tshp.org.

To view membership status, login at www.tshp.org/login or contact the TSHP office.

TEXAS JOURNAL OF HEALTH-SYSTEM PHARMACY

CONTENTS 5

Message from the TSHP President Sarah Lake-Wallace, MS, PharmD, FTSHP

10 Medication Compliance in Enterally-fed Patients with Oral Dosage Forms that Should Not Be Crushed

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Lauren Goldberg

15 A Review of Billing Opportunities for

Outpatient Pharmacists in the State of Texas Adenike Atanda, PharmD, BCACP, CDCES Deidra Lee, Pharmacy Student Megan Wesling, PharmD, BCPS, BCACP

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HSV Hepatitis in the Immunocompetent Individual: An Under-Recognized Concern Hongmei Wang, Pharm.D., Ph.D. Christopher Cruz Namphi Nguyen Tankhoa Dang

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25 New Drug List 26 Do Not Crush List

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THANK YOU TO ALL OF OUR SPONSORS

Authorship Authorship The Texas Society of Health-System Pharmacists Editorial Advisory Board welcomes manuscripts from any source that are pertinent to the practice of pharmacy in hospitals and health systems. Manuscripts are subject to review by the Editorial Advisory Board and Editor(s) and will be accepted for publication only if they are believed to represent an important contribution to the literature.

Authors should follow the procedure checklist and submission instructions at www.tshp.org/journal. Authors without internet access may mail one (1) copy of their manuscript and a USB flash drive containing the manuscript file and supporting material to TJHP, 3000 Joe DiMaggio Blvd, Ste 30A, Round Rock, Texas 78665-3920. Authors may call (512) 906-0546 for assistance.

Accepted materials may not be published elsewhere without written permission from both the author and TSHP. The Editor(s) reserve the right to revise all manuscripts submitted, if necessary. The publisher assumes no responsibility for the statements and opinions advanced by contributors to the TJHP. For guidance on style, authors should consult the manuscript checklist, recent issues of the TJHP and American Journal of HealthSystem Pharmacy, and Scientific Style and Format: The CBE Manual for Authors, Editors, and Publishers, 6th edition. The AMA’s Manual of Style contain helpful advice on correct usage.

The views expressed by authors of contributions in the TJHP do not necessarily reflect the policy of TSHP or the institution with which the author is affiliated, unless otherwise specified. Authors, reviewers, Editorial Advisory Board Members, and TJHP Editors are required to declare potential conflicts of interest regarding manuscripts submitted for publication.

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A MESSAGE FROM THE TSHP PRESIDENT

W

elcome to the latest edition of the TJHP. In this issue, you will find a focus on Payment for Clinical Services along with other interesting articles.

The one term I hear over and over again is Provider Status.

It comes up with discussions with students or residents. It comes up during discussions about the needs of the pharmacy profession or the biggest challenge that is facing our profession. The term “Provider Status” can be defined in a multitude of ways but being paid for the services pharmacist provide is always in that definition somewhere. The path to achieving consistent payment for clinical services is not going to be straightforward or rely on just one mechanism. It will not be about a legislative fix or a change in coding structure. It is going to take a multifaceted approach. That is why I am so excited to see this kind of work shared. The approach will require an understanding from people in all areas of work from our profession to outside the profession.

These types of publications help tell that story, to help build that understanding. I continue to be struck by the importance of sharing our story.

A story of reducing cost and improving outcomes. A story of collaborations with other healthcare providers and patients. I feel sharing our stories of what we do and the impact it makes is going to be critical to reaching goals such a provider status.

Publications such as TJHP are one way to share a story of research and knowledge and I hope you will find some new thoughts on where you will expand your story.

Thank you to all the authors who contributed to this edition. You are sharing a part of your story, a story of learning and furthering understanding. And sharing at a time when we are working under heavy stress and demands.

Sarah Lake-Wallace, MS, PharmD, FTSHP, TSHP President 2020-2021 at the capitol speaking on behalf of TSHP

None of us know how the next six or even 12 months will progress. We are making strides in returning to something that looks less like a pandemic lock down. We have all been asked to figure out a way to add more or redesign a process. This is hard work. It was hard work before. Yet our members and colleagues have found a way to not let the research, the learning, the sharing get lost in this time. And we can be proud of all the things we have added on and all the things we kept going. This publication is evidence that we are not letting the pandemic be our only story. Thank you to our members for your hard work and dedication. Please know that TSHP is your partner and we want to be here to help you problem-solve.

It only seems appropriate that my outgoing message end like I started my first message with a quote that fits my mindset from the 90’s political drama “The West Wing” (seriously it’s been a year, you haven’t even gone to watch one episode?)

"It's Not The Battles We Lose That Bother Me, It's The Ones We Don't Suit Up For." - Toby Ziegler (West Wing)

Sarah Lake-Wallace, MS, PharmD, FTSHP TSHP President 2020-2021 VOLUME 20 | ISSUE 1

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Medication Compliance in Enterally-fed Patients with Oral Dosage Forms that Should Not Be Crushed Lauren Goldberg, PharmD PGY2 Health-System Pharmacy Administration Resident at University of Texas at MD Anderson Cancer Center

Key Words:

Purpose: The division of pharmacy identified hospitalized patients with tube

Patient safety Tube feeding Enteral nutrition Medication administration

Introduction The two main types of specialized nutrition support in which patients can receive their caloric and protein requirements are enteral nutrition (EN) or parenteral nutrition (PN).

PN is the delivery of calories and nutrients into a vein while EN is any method of feeding that uses the gastrointestinal (GI) tract to deliver part or all of a person’s caloric requirements. EN can include an oral diet, liquid supplements, or use

feeding (TF) devices who were ordered medications on the Institute for Safe Medication Practices (ISMP) Do Not Crush List. The purpose of this research was to evaluate a tertiary academic cancer center’s compliance with the ISMP Do Not Crush List.

Summary:

A daily workbench report was created utilizing the electronic

health record to retrieve all admitted hospitalized patients with TF orders along with a medication order on the ISMP Do Not Crush List. A pharmacist-initiated communication occurred with the patient’s nurse to determine if the patient could tolerate oral medications despite the TF device. If the patient could not tolerate oral medications, the ordering provider was contacted by a pharmacist to change the medication to an appropriate dosage form for delivery via a TF device. The report was evaluated for 30 days in which 315 medication orders for 166 patients with TF orders were identified. Of the total number of medication orders, 22.5% were ordered with an oral route of administration despite active TF orders. A pharmacist communicated with the patient’s nurse to discover 19.7% of ordered oral medications were not able to be administered orally and this represented a total of 4% of the 315 medication orders.

Conclusion:

This evaluative study of our institution’s compliance with the ISMP Do Not Crush revealed areas to improve patient safety; however, only a relatively small percentage (4%) of the medication orders required the medication to be changed to an appropriate dosage form.

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of an enteral access device to deliver an enteral feeding formulation. It is preferred when the patient’s GI tract is functional and used preferentially over PN. Enteral access devices, also known as tube feeding (TF) devices, are used for feeding that bypasses 2 the oral cavity. In the United States, a TF device is used in approximately 250,000 hospitalized patients annually. These devices can be used in infants, as well as adults, and in any kind of setting including acute, subacute, rehabilitation, long-term care, and home settings. A TF device may be inserted orally, nasally, or percutaneously and the distal tip may be in the stomach, 3 duodenum, or jejunum. There are various types of EN administration including gastric (or bolus), continuous, intermittent, 6

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or cyclic feeding in which the location of the tip of the TF 4 device dictates, as well as patient tolerance. In cancer patients with intestinal obstructions, a nasogastric or gastrostomy TF device may also be used to suction gastric contents and are not used for delivery of EN. Frequently, TF devices are also used for medication administration in patients who cannot swallow safely.

However, all of these TF devices are prone to complications due to medication administration.

Occlusion of the TF device has a reported incidence up to 35% and is usually attributed to viscous EN feeding formulation, improperly administered medications, inadequate flushing, and small lumen (e.g., < 10 French) TF devices.5 Particular medications are often not designed to be administered via TF devices due to their composition (e.g., extended-release capsules that contain beads or pellets, capsules filled with enteric-coated granules).6 There is a potential for an altered clinical response if an inappropriate medication (e.g., extendedor delayed-release) is crushed and administered via the TF device. This type of medication administration can result in potentially lower or higher initial blood levels leading to lack of efficacy or increased adverse effects.

Another potential complication, as previously mentioned with improperly administered medications is occluded tubes. Once a tube is occluded, a replacement may be required, which can lead to increased costs, risks for infections, and loss of EN delivery.7,8 In order to minimize the chances of complications

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occurring with medication administration via TF devices, the Institute of Safe Medication Practices (ISMP) published its first list in 1975 focusing on medications that should not be crushed for a wide variety of reasons all revolving around improving patient safety. ISMP most recently published its list in 2020 which includes 386 oral dosage forms that should not be crushed and administered via TF devices. 9 The University of Texas MD Anderson Cancer Center (MDACC) is a 700-bed tertiary academic comprehensive cancer center located in Houston, Texas, where the division of pharmacy identified patients with TF devices who were receiving medications on the ISMP Do Not Crush List. The purpose of this study was to evaluate our compliance with the ISMP Do Not Crush List by reviewing medications ordered with an oral route for hospitalized patients with TF devices that could not tolerate oral medications.

Methods Study Design: This was an evaluative study to determine MDACC’s compliance with the ISMP Do Not Crush List.

Approval was obtained by the Quality Improvement Assessment Board at our institution. A daily workbench report was created by the pharmacy informatics team utilizing Epic, the institution’s electronic health record (EHR), to retrieve all admitted hospitalized patients with TF orders along with a medication order on the ISMP Do Not Crush list. The report included information such as

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the patient’s demographics (name, age, gender, medication record number), location within the hospital, type of TF device, and details of the medication order such as strength, route of administration, nursing administration instructions, and the ordering provider’s name. In order to successfully retrieve the appropriate medications, the RxNorm codes for each medication strength and dosage form on the ISMP Do Not Crush List was gathered utilizing the U.S. National Library of Medicine website, RxNav. 10 Procedure: An inpatient pharmacist ran the workbench report on a daily basis and identified medications ordered with an oral route since these medications were a concern for administration as an active TF order suggested the patient could not tolerate oral food or medications. The pharmacist then determined if the medication could or could not be crushed based on the ISMP Do Not Crush List or the medication’s package insert. If it was determined the medication should not be administered via a TF device, the pharmacist contacted the patient’s nurse to determine if the patient could tolerate oral medications. If the patient could not tolerate oral medications and their medications were being crushed, the pharmacist then contacted the ordering provider to change the order if the medication was not appropriate for crushing. The intervention was documented as accepted via an i-Vent in the patient’s profile (Figure 1).

Figure 1

Outcome: The primary endpoint was to determine the number of pharmacist-initiated interventions required within 30 days of running the workbench report. Pharmacist intervention was defined as the patient’s nurse confirming the patient cannot tolerate oral medications and the medication order needing to be changed to an appropriate dosage form for crushing/delivery via a TF device. The secondary endpoint was to determine whether or not the medication had appropriate nursing administration instructions associated with the medication order. We defined appropriate nursing administration instructions as the EHR medication order indicating the medication should not be crushed, broken, chewed, swallowed (if sublingual), or dissolved.

Results: Between December 13th, 2019 and January 23rd, 2020, the workbench report was run 30 times in which 345 different medication orders were collected for 166 patients with active TF orders along with a medication on the ISMP Do Not Crush List. However, after reviewing the orders, it was found that 30 of the RxNorm codes were associated with medication orders that were not on the ISMP Do Not Crush List, so they were removed from the analysis leaving a total of 315 medication orders. Of the total number of medication orders, 22.5% (71 out of 315) were ordered with an oral route of administration despite active TF orders. A pharmacist communicated with the patient’s nurse to discover 19.7% (14 out of 71) of the ordered oral medications were not able to actually be administered orally because of the need for a TF device and this encompassed 4% of the 315 medication orders. This resulted in a pharmacist contacting the provider to change the medication to an appropriate form to be administered via the TF device. This implied 80.3% (57 out of 71) of

Figure 1. Procedure followed by the pharmacist to determine whether the medication order required an intervention to ensure patient safety for patients with TF devices. (EHR: electronic health record)

the ordered medications with an oral route could be tolerated by the patient without an intervention required (Figure 2). Of the 315 medication orders identified, 36 different medications were then analyzed for the EHR nursing administration instructions.

Each medication had various strengths, but the EHR nursing administration instructions were the same for each of the medication strengths. Of the 36 different medications, nine (25%) different medications encompassing 12.4% (39 out of 315) of the medication orders did not have appropriate EHR nursing administration instructions for patients receiving through a TF device (Figure 3).

[1] RxNorm provides normalized names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software, including those of First Databank, Micromedex, and Gold Standard Drug Database.

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Discussion

Figure 2

Figure 2. Analysis of the medication order routes to determine the number of medications ordered with an oral route in which hospitalized patients could not tolerate oral medications.

Figure 3

Figure 3. Analysis of the nursing administration instructions associated with the 36 medications.

This evaluative study found that MDACC has reasonable compliance (80.3%) with physicians ordering medications for patients restricted to TF devices not on the ISMP Do Not Crush List. However, there were areas identified to improve patient safety, namely with education and nursing administration instructions. Initially, our pharmacy informatics team focused on our EHR in order to remove inappropriate medication delivery routes, such as oral, for a patient with an active TF order, but as the data showed, 57 of the 71 medications ordered with an oral route was in fact appropriate since the patient could still tolerate oral medications (Figure 2). Patients may require a TF device in order to receive all of their nutritional requirements, but if they can tolerate partial oral intake, it is preferred to utilize the GI tract and administer medications via an oral route vs. a TF device.11 An area for opportunity to improve patient safety starts with education for inpatient pharmacists responsible for verifying medication orders. Each medication order should have the appropriate route selected, especially if the medication is on the ISMP Do Not Crush List. As part of the verification process, the pharmacist must review the patient’s access devices from the EHR (i.e., TF devices, central intravenous (IV) line, peripheral IV line, etc.) along with diet or TF orders to determine whether the patient is receiving EN through their TF device. If a patient has TF orders, it is suggested that the patient cannot tolerate oral foods or medications. In order to determine whether the patient can tolerate oral medications, the pharmacist is required to confirm with the nurse to determine if the patient can tolerate oral medications.

Along with verifying the route of the medication order, the pharmacist should ensure the EHR nursing administration instructions are appropriate. Particular medications (e.g., extended- or delayedrelease) should not be crushed and administered via TF devices

because this action can alter the efficacy of the drug and lead to adverse effects with higher blood levels. Another example is 6 enteric-coated medications formulated to be released in the small intestine (e.g., higher pH) so less GI irritation occurs.

The pharmacy department can help minimize the number of medications inappropriately administered by ensuring nurses have the proper instructions for each medication such as stating when to not crush, break, chew, swallow (if sublingual) or dissolve particular medications.

Limitations of this evaluative study include a short, defined period in which the workbench report was employed. The number and types of medication orders vary throughout the year, and this study only analyzed patients with TF devices and medication orders on the ISMP Do Not Crush List for 30 days. In order to best determine the compliance of an institution, a longer period such as 12 months would be beneficial in order to capture the various prescribing patterns occurring throughout the year. Another limitation of this study was no intervention was performed in order to determine if there was an improvement in compliance or reduction in adverse effects. Additionally, we did not evaluate the number of occluded tubes. Future steps of this project include education of inpatient pharmacists and ensuring EHR nursing administration instructions are appropriate for each medication on the ISMP Do Not Crush List. After the above interventions are implemented, a comparison of the workbench report can be completed to determine improvement in compliance for medication orders on the ISMP Do Not Crush List in hospitalized patients with TF devices and avoidance of occluded TF devices. In addition, EHRs require ongoing maintenance, so it is recommended that

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hospitals review their medication build processes to ensure that appropriate routes and administration instructions are included. Additionally, while our results did not reveal a problem at this time, we would recommend hospitals reviewing this in an ongoing fashion to correct any build or practice issues that may arise in the future.

Conclusion This evaluative study of our institution’s compliance with the ISMP Do Not Crush List revealed areas to improve patient safety; however, only a relatively small percentage (4%) of all medication orders were inappropriately ordered for an oral route when they were being administered by a nurse through a TF device. We were able to identify nine medications with missing EHR nursing instructions to better assist with medication administration through a TF device.

References 1.Kirby D, Parisian K. Enteral and parenteral nutrition. American College of Gastroenterology, 2011. https://gi.org/topics/enteral-and-parenteral-nutrition/ Accessed September 7, 2020.

2.Bankhead R, Boullata J, Brantley S, Corkins M, Guenter P, Krenitsky J, et al. Enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr.

2009;33:122-167.

3.Kumpf VJ, Mulherin DW. Enteral nutrition. In: DiPiro JT, Yee GC, Posey L, Haines ST, Nolin TD, Ellingrod V. eds. Pharmacotherapy: A Pathophysiologic Approach, 11e. McGraw-Hill; https://accesspharmacy-mhmedical-com.ezproxy.lib.utexas.edu/content.aspx?bookid=2577&sectionid=237536227.

4.Boullata JI, Carrera AL, Harvey L, Escuro AA, Hudson L, Mays A, McGinnis C, et al. ASPEN safe practices for enteral nutrition therapy. JPEN J Parenter Enteral Nutr. 2017;41:15-103.

5.Dandeles LM, Lodolce AE. Efficacy of agents to prevent and treat enteral feeding tube clogs. Ann Pharmacother. 2011;45:676-680.

6.Williams NT. Medication administration through enteral feeding tubes. Am J Health Syst Pharm. 2008;65:2347-2357.

7.van de Bemt PM, Cusell MB, Overbeeke PW, Trommelen M, van Dooren D, Ophorst WR, et al. Quality improvement of oral medication administration in patients with enteral feeding tubes. Qual Saf Health Care. 2006;15:44-47.

8.Li T, Eisenhart A, Costello J. Development of a medication review service for patients with enteral tubes in a community teaching hospital. Am J Health Syst Pharm. 2017;74(11 Suppl 2):S47-S51.

9.Institute for Safe Medication Practices. Oral dosage forms that should not be crushed. https://www.ismp.org/recommendations/do-not-crush.

10.U.S. National Library of Medicine. https://mor.nlm.nih.gov/RxNav/.

11.Wang K, McIlroy K, Plank LD, Petrov MS, Windsor JA. Prevalence, outcomes, and management of enteral tube feeding intolerance: a retrospective cohort study in a tertiary center. JPEN J Parenter Enteral Nutr. 2017;41:959-967.

Renewing is now easier than ever!

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DID YOU KNOW? TSHP awards more than $17,000 annually to pharmacy and pharmacy technician students and residents.

Because of donors like you, many students each year are able to venture through their schooling without having to worry as much about their financial status.

Meet Baneen! She is an amazing addition to our TSHP community and was offered a scholarship through the R&E Foundation.

That was all made possible because of people like you!

Open your phone camera and point at the QR code below to be brought to the donation webpage.

For more information please email tshp@tshp.org.

Scan the QR code to donate!

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A Review of Billing Opportunities for Outpatient Pharmacists in the State of Texas Adenike Atanda, PharmD, BCACP, CDCES

Deidra Lee

Megan Wesling, PharmD, BCPS, BCACP

Assistant Professor, University of North Texas System College of Pharmacy

Pharmacy Student, University of North Texas System College of Pharmacy

Assistant Professor, University of North Texas System College of Pharmacy

Purpose:

To review select existing avenues for pharmacist-reimbursed outpatient clinical services in the state of Texas and identify benefits and potential barriers to their implementation.

Summary:

Pharmacists play a pivotal role in the optimization of drug therapy management and serve as integral members in interdisciplinary health care teams. Outpatient pharmacists are equipped to address gaps in healthcare delivery and improve patient outcomes. However, barriers to pharmacist integration are underpinned by limitations in financial support for services rendered.

Conclusion:

The state of Texas and recent legislation promotes opportunities for pharmacists to overcome historical barriers to integration and compensation by strengthening the infrastructure to billing and reimbursement for pharmacist-directed outpatient clinical services.

Keywords: pharmacist, billing, chronic care management, reimbursement, provider status The positive impact of pharmacists’ intervention on patient outcomes and the benefits of collaborative practice has been well documented in the 1-3 literature. Despite favorable patient outcomes and the benefit of pharmacy presence in interdisciplinary teams, the integration of pharmacists into health organizations has been limited by barriers in service reimbursement and lack of recognition of pharmacists as national providers by the Centers for 4,5 Medicare and Medicaid Services (CMS). Traditionally, the pharmacist's role in the outpatient setting has involved medication dispensing, patient 6,7 counseling, immunization, and optimizing drug regimens via Medication Therapy Management (MTM) services.

Pharmacist-directed clinical services in the outpatient setting have been primarily delivered in two settings: community pharmacies and outpatient clinics (hospital or physician-based clinics). Reimbursement for these services has also been predominantly through government-funded payers like Medicare and Medicaid. However, some services can be reimbursed by commercial health plans, self-insured employers, or directly by patients. Recently, billing opportunities for pharmacists have expanded to include incident-to billing, chronic care management (CCM), Medicare annual wellness visits (AWV), transitional care management (TCM), and diabetes self-management training and education (DSMT/E).

Advancements to pharmacy practice in the state of Texas have provided additional avenues for pharmacists to positively impact patient care and create sustainable practice models. In May 2019, House Bills 1757 (HB 1757) and 3441 (HB 3441) were signed by Governor Greg Abbott to amend the insurance code for commercial health plans.8,9 The bills amend the insurance code for commercial health plans issued or renewed on or after January 1, 2020, and allow an insured beneficiary to select a pharmacist as a provider for services within the scope of the pharmacist’s license. The amendment also prohibits commercial health plans from denying reimbursement for appropriate services provided by licensed pharmacists. Another notable advancement in pharmacy practice in the state of Texas is the signing of Senate Bill 1056-Collaborative Practice Clarification (SB 1056) in May 2019. SB 1056 allows a physician to delegate to properly qualified and trained pharmacists, drug therapy management “implementation and modification” utilizing a collaborative practice agreement.10 Several avenues exist for pharmacists to bill for direct patient care services in the outpatient setting. As a result, it is important for pharmacists to be aware of the specific criteria required for these services, to allow for appropriate billing and reimbursement. This article will review select existing avenues for pharmacist-reimbursed outpatient clinical services that may not be well known or utilized, and identify benefits and potential barriers to their implementation.

Pharmacist Provider Status and Collaborative Practice in the State of Texas Through the passing of HB 1757 and HB 3441, Texas joined states like Washington and Tennessee in the recognition of pharmacists as approved providers 11 to be included and equitably reimbursed for appropriate services covered by commercial health plans. With this accomplishment, outpatient pharmacists became eligible to receive reimbursement from commercial health plans for clinical services like chronic disease management, MTM and

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Clinical Laboratory Improvement Amendments (CLIA) waived tests. Pharmacists in the community setting are well-positioned to offer point-of-care testing (POCT) services to increase accessibility and address gaps in patient care that may exist especially in rural areas. Relevant CLIA-waived tests that can be performed in the outpatient setting by pharmacists include but are not limited to: prothrombin time and international normalized ratio (PT/INR), 12,13 lipid panel, liver function tests, hemoglobin A1c and SARS-CoV 2.

Collaborative practice agreements (CPA) between pharmacists and physicians have positively impacted patient outcomes and the delivery of patient care by interdisciplinary health care teams.14-18 The passing of SB 1056 amends the occupations code in the state of Texas as of December 1, 2019, and allows pharmacists practicing in a hospital, hospital-based clinic, or academic health care institution, to enter into collaborative practice agreements with physicians and establish protocols for drug therapy management including implementation or modification of a patient’s drug therapy.10 Furthermore, House Bill 2425 (HB 2425) amends the occupations code in the state of Texas as of September 1, 2019, to provide prescriptive authority, under a physician’s delegation, to pharmacists in federally qualified health centers (FQHC) as well as hospitals, hospital-based clinics or academic health care institutions.

10 Pharmacists performing drug therapy management under a physician’s delegation will need to establish a collaborative drug therapy management (CDTM) protocol agreement that contains a statement identifying the authorizing physician(s), authorization for the pharmacist(s) to dispense drugs and engage in drug therapy management as a delegate to the physician, a statement identifying the approved drug therapy management decisions, disease conditions, drugs and assessments or procedures that can be performed by the pharmacist and a statement detailing the activities, mechanism and time frame for the pharmacist to execute the responsibilities outlined in the protocol. The pharmacist is required to notify and provide a copy of the written CDTM protocol to the Texas State Board of Pharmacy (TSBP) prior to the signing of any prescription and complete a board-approved application that is to be signed and updated annually. Following approval of the protocol, TSBP will post the name and license number of the practicing pharmacist, the name and address of the approved delegating physician(s), and the expiration date of the protocol. Lastly, pharmacists will need to provide evidence of at least six hours of continuing education approved by the Accreditation Council for Pharmacy Education (ACPE) relating to drug therapy management or engage in drug therapy management as allowed by existing laws for initial approval. Pharmacists will also be required to engage in 6 hours of ACPE approved continuing education annually and keep all records of the CDTM protocol for at least two years. Additional requirements for collaborative practice 10 agreements can be found in the Texas Administrative Code.

Pharmacists can leverage their expertise to improve relevant health outcomes and quality metrics as a revenue source within their clinical service.

Performance metrics including but not limited to medication adherence, medication reconciliation, transitions of care, diabetes care (hemoglobin A1C control and nephropathy), hypertension management, and disease prevention screenings (breast cancer, colorectal cancer, and osteoporosis) can be significantly impacted by pharmacists’ intervention and ultimately result in cost savings/avoidance for the institution.

2,19,20

Incident-To Billing As inferred, ‘incident-to is defined as a service that is furnished incident-to a supervising physician when the service is considered “an integral, although incidental, part of the physician’s personal professional 21 services in the course of diagnosis or treatment of an injury or illness.”

Implementation of incident-to requires the achievement of specific criteria under the supervision of the physician. Other Medicare Part B recognized non-physician practitioners (i.e. physician assistants, nurse practitioners, or certified clinical nurse specialist) may supervise incidentto services; however, reimbursement will be 85% of the Medicare physician fee schedule (PFS) for the level of service or Current Procedural Terminology (CPT) code submitted.

Licensed pharmacists have the option of billing “incident-to” a supervising physician or qualified non-physician practitioner for disease state management as an “auxiliary personnel” (or analogous terminology of “clinical staff” or “auxiliary staff”) authorized by the provider. Although pharmacists are not specifically listed as auxiliary personnel in the incident-to billing code, CMS released a statement in response to a query by the American Academy of Family Physicians (AAFP) clarifying that pharmacists can utilize incident-to billing as long as all billing requirements are met and all state laws are observed.22 Incident-to billing requirements include:23 1. The service is provided by the pharmacist to an established patient of the eligible provider with an established diagnosis and only after a course of treatment (i.e. care plan) is defined.

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2. The service is conducted in compliance to supervision rules by a physician or qualified non-physician practitioner. a. If services delivered are associated with a physician’s office, the pharmacist must abide by “direct supervision” rules. i.Direct supervision is defined by the availability of the eligible provider in the office suite and immediately able to assist if needed.24 ii.In a group practice, eligible providers may cross cover for one another and maintain adherence to incident-to direct supervision requirements. b. As detailed in the 2020 CMS Final Rule, if services delivered are associated with a hospital outpatient therapeutic service, the supervising provider must comply with “general supervision” rules. 25 i.General supervision is defined by the furnishing of services under the physician’s direction and control, but the physician’s presence is not required during the performance of the service.

3.

The physician must see the patient at a frequency that reflects active involvement in the care of the patient and their course of treatment for the established problem.

4.

A valid financial agreement must be in place by the same entity between the eligible billing provider and the pharmacist.

5. The service provided by the pharmacist is within the pharmacist’s scope of practice as defined by the Texas Pharmacy Rules.

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6. The pharmacist must provide the required documentation for incident-to services in the patient’s record and clearly link services to the supervising provider. a. Identify the individual who rendered the service (i.e. pharmacist) b. Supervision at the time of service is documented. c. Demonstrates supervising providers initiation and continued active involvement in the management and care plan of the individual patient.

Pharmacists meeting incident-to billing requirements in a hospital or health system outpatient setting (facility-based) may use ambulatory payment classification (APC) code 5012 with Healthcare Common Procedure Coding System (HCPCS) code G0463 as part of the hospital outpatient prospective payment system (HOPPS) facility fee for billing and reimbursement. Historically, pharmacists in the physician-based office (non-facility fee) have sought the use of CPT evaluation and management (E/M) codes (level 1 to level 5) when conducting incident-to services. However, controversy has plagued the consistent implementation of incident-to billing of CPT E/M codes due to inconsistent interpretation of the payment policies under the Physician Fee Schedule (PFS). The Medicare Administrative Contractors (MACs), private health care insurers responsible for processing claims for Medicare Part A and Part B, have had differing interpretations of the incident-to rules using CPT E/M codes for pharmacist-directed services. Some MACs have stated that, as auxiliary personnel, pharmacist-directed services would result in physicians or other qualified non-physician practitioners billing no higher than the lowest level of CPT E/M codes (i.e., 99211) while other MACs have not offered specifications and/or restrictions to incident-to billing to the highest E/M level attained by the pharmacist-led services (99212 - 99215). With pressure from national pharmacy associations to clarify ruling and as of CY2021 Final Rule, CMS has responded stating that because newly constructed CPT E/M codes, by the American Medical Association, for levels 2 through 5 (99212-99215) are to be directly furnished and billed by physicians and qualified non-physician practitioners, pharmacists do not meet the criteria of such qualified healthcare provider and incident-to based billing may not exceed CPT 26 E/M level 1 (99211).

For incident-to billing of CPT E/M level 1 or other qualifying CPT codes discussed below, it is important to note that the pharmacist will not be eligible to bill as the primary provider for the incident-to services. The claim will be billed as if the Medicare recognized provider personally rendered the services. If specific contracts are not established with an individual commercial health plan as allowed by the above Texas rules and regulations, the billing mechanisms for pharmacist-directed services will default to mimic CMS regulations. Reimbursement for incident-to services varies based on year, CPT billing code, locality, and payer billed.

The current reimbursement rate in Fort Worth, Texas for non-facility pricing for an established patient E/M for level 1 service (CPT 99211) is $22.89, based on the 2021 physician fee schedule.27 Potential barriers to incident-to as a billing and reimbursement mechanism include coordination of services between the pharmacist and billing “incident-to” provider as they are responsible for initiating the care plan for the given diagnosis and providing attestation that they were present in the clinic during the time of the pharmacist-directed service in a physician-based service. Ultimately, this may limit service availability

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and integration. Consequently, the supervising provider will be the listed billing provider for the service. Alternative mechanisms will be required such as the pharmacist being listed as the secondary provider to facilitate tracking and reimbursement for the clinical service directed by the pharmacist. Claim submission for incident-to services by the pharmacist on the same day as a physician-directed evaluation and management service will result in CMS selecting and paying the lesser of the two billed services as the primary reimbursement code for the patient. In addition, the change in ruling for incident-to billing of CPT E/M will significantly impact the financial feasibility of certain pharmacists providing complex, comprehensive medication management. Lastly, the absence of a collaborative practice agreement between the pharmacist and eligible providers may limit the pharmacist’s scope of practice and require physician intervention for medication changes, laboratory tests, and other appropriate diagnostic and screening tests.

Chronic Care Management As of 2014, 66% of Medicare beneficiaries were identified to have two or more chronic conditions with 99% of Medicare spending targeted at care and management of these conditions.28 To optimize the management of chronic disease states, CMS developed the chronic care management (CCM) service as a Medicare Part B benefit. This service includes establishing and maintaining a comprehensive care plan, provision of comprehensive and transitional care management with 24/7 access to care and structured data recording, and maximization of continuity of care among an interdisciplinary team for patients meeting chronic condition eligibility criteria. Beneficiaries are eligible for enrollment into this monthly service if they have two or more chronic health conditions that are (1) expected to last at least 12 months or until the death of the patient, and (2) the chronic conditions place the patient at significant risk of death, acute exacerbation, decompensation or functional decline. A single eligible billing provider may submit for reimbursement of CCM services per calendar month.29 Licensed pharmacists may perform and bill for CCM services (face-toface or non-face-to-face care) as “clinical staff” utilizing and applying incident-to billing rules under “general supervision” of a qualified health professional (i.e. physician, physician assistant, nurse practitioner).

Billing and reimbursement of CCM services are based on length (in minutes) and complexity of decision-making or care plan on a monthly basis. Where applicable, there are four CPT E/M codes for CCM services that pharmacists may submit for reimbursement. CPT code 99490 will be applied for non-complex CCM services that amount to at least 20 minutes of clinical staff time.29 As of 2021, CMS has added CPT 99439 that may be added to 99490 to account for each additional 20 minutes of clinical staff time per calendar month. 99439 may be added up to a maximum of two times within a calendar month to account for additional time spent. CPT code 99487 may be billed for complex CCM services of more than 60 minutes of clinical staff time and decision-making is of moderate or high complexity. CPT code 99489 may be applied to complex CCM for each additional 30 minutes of clinical staff time spent on a monthly 26,30 basis.

The current reimbursement in Fort Worth, Texas for CMS non-facility pricing is $40.78 for non-complex CCM services, $37.26 for each additional 20 minutes of time spent on non-complex CCM, $91.25 for complex CCM

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services and $43.48 for additional 30 minutes of time spent on complex CCM. There have been reports of pilot programs detailing the implementation of CCM practice models in the community and ambulatory care pharmacy services. However, return on investment and related metrics from pharmacist-led CCM services are limited. RxClinic in Charlotte, NC entered into a contractual and team-based partnership to pilot a CCM program leveraging the community pharmacist to conduct and bill for CCM services of assisted living seniors overseen by a physician provider. This program described the clinical value of pharmacist-delivered services but discretely noted the benefit in supporting the financial sustainability of additional pharmacists in this service model. 30 In addition, a 10-month, single-site 31 study conducted within a geriatric clinic evaluated CCM services led by clinical pharmacists and medical providers for 36 Medicare patients meeting enrollment criteria with primary submission for reimbursement of CPT 99490 (20 minutes). A total of 95 claims were submitted by the pharmacists spending an average of 45 minutes and a subsequent average reimbursement rate of $30.83 ($21.15-107.90) per patient. Although this study represented revenue generation of a CCM model, it failed to demonstrate cost-effectiveness. The study also did not represent current reimbursement rates with newly integrated CPT codes by CMS in 2017 for complex CCM care. which would anticipate increased estimated reimbursement of $93 per patient and, subsequently, improvement in the financial feasibility of pharmacist integration and delivery of the CCM model in an outpatient clinic. 31 A Mathematica Policy Research Group report evaluated the global diffusion and impact of CCM services. The study found a reduction of $74 in total Medicare expenditure perbeneficiary-per month (PBPM) over a period of 18 months following CCM enrollment. This was largely driven by a reduction in inpatient hospital and skill nursing services. The study also noted a reduction in hospital admission for specific “ambulatory care sensitive conditions” including diabetes mellitus and heart failure. Overall, the study estimated a net savings to Medicare of $36 million over a 12-month period of time following receipt of CCM services. 32 Potential barriers to the implementation of pharmacist-directed CCM service and billing model vary little from those identified for incident-to billing. In addition, CCM services may meet resistance based on interprofessional participation as service initiation requires face-to-face enrollment during an annual wellness visit, evaluation and management visit (level 2 to 5), initial preventative physician examination, or transitional care management visit by the Medicare-eligible provider.

Other barriers include access to a shared, certified electronic health record (EHR) if CCM services were being provided outside of the physician’s office. In consideration of the patient, co-payment requirements, unless the patient has qualified dually eligible insurance coverage, may limit patient willingness to participate.

Medicare Annual Wellness Visits Annual Wellness Visits (AWVs) are benefits to a Medicare Part B recipient for the provision of Personalized Prevention Plan Services

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(PPPS). Services covered include the initial preventive physical examination (IPPE) also known as the “Welcome to Medicare” visit provided by a physician or a qualified non-physician practitioner with the purpose of reviewing the patient’s medical and social health history and preventive services education. Subsequently, the Medicare beneficiary will have available annual wellness visits to develop or update personalized prevention plans and perform health risk assessments (HRA). These visits are commonly referred to as the “initial annual wellness visit” or the “subsequent annual wellness visit.”

Although a pharmacist cannot deliver the IPPE exam, as a “medical professional” under direct supervision by a provider, they are eligible to provide initial and subsequent AWVs. The AWV would require the following components to be established or updated by the licensed pharmacist to meet billing requirements: Health Risk Assessment (HRA), list of current providers or suppliers, medical/family history, risk of depression (initial only), functional ability and level of safety (initial only), vitals, assessment of cognitive function, written screening schedule, list of risk factors with interventions, health advice, and advanced care planning services.33 In addition to addressing defined elements of an AWV, the following criteria to bill for an AWV must be met, which include (1) all “incidentto” billing rules are applied, (2) the AWV is not billed within the first 12 months of the beneficiaries Medicare Part B coverage period, and (3) it has been 12 months or more since the patient’s IPPE exam or last AWV. Upon meeting these criteria, the licensed pharmacist may use the HCPCS codes G0438 for the initial AWV and G0439 for subsequent AWVs. Alternatively, G0468 would be submitted for licensed pharmacists furnishing AWV services at an FQHC. Additional CPT codes may be billed with a modifier for significant, separate, medically necessary evaluation and management (E/M) services that are provided during the AWV. 33 The current reimbursement in Fort Worth, Texas for CMS non-facility pricing is $167.90 for initial AWV services and $132.31 for subsequent AWVs. 27 In an accountable care organization (ACO), clinical pharmacists generated $22,340 in revenue from AWV billing (codes G0438 and G0439) during a three-month period. An additional $36,379 was generated from other services (i.e. mammograms, laboratory testing, vaccinations) performed during the visits. Unfortunately, the study was limited in calculating a total net gain. An 8-month, financial analysis of pharmacist-led AWVs was conducted in a large family medicine practice in North Carolina that was supported by 17 physicians, 5 pharmacists, and additional professional learners. Assuming a 50% utilization rate of AWV services by Medicare patients within the practice, the revenue generated for 10% initial AWVs (G0438) and 90% subsequent AWVs (G0439) demonstrated revenue generation of $338,220, which would provide salary support of pharmacy services in a medium- to large-sized physician practice.35 Potential barriers to AWV services include pharmacist integration into a clinical structure where AWVs are already established into workflow and managed by other health care providers. 36 Other limitations include those previously described and identified for incident-to billing provided by a pharmacist.

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Transitional Care Management Transitional care management (TCM) is a benefit afforded to Medicare beneficiaries and includes service provided during a patient’s transition from the inpatient to a community setting. This includes the transition of care from hospitals (acute care, long-term care, and psychiatric), skilled nursing facilities, and inpatient rehabilitation facilities. The service involves initial contact with the patient, which can be done by face-to-face visits or via telephone and email communication, within 2 days of discharge. Patients should be provided face-to-face services with a billing provider within 7 days (patients requiring high complexity decision making) or 14 days (patients requiring moderate complexity decision making) of discharge. 37 Licensed pharmacists can perform non-face-to-face TCM services as “an auxiliary staff member” utilizing incident-to billing under the direct supervision of a qualified health professional. Pharmacists can also participate in the face-to-face visit and perform medication reconciliation services. However, the required face-to-face visit must be performed and billed by the physician or non-physician-qualified health professionals.

Non-face-to-face services can be provided by the pharmacist under “general supervision”. Appropriate non-face-to-face services include but are not limited to initial communication within two days of inpatient discharge, communication with agencies and community service providers, patient education, medication assessment, and facilitation of access to community and health resources.37 There are two CPT E/M codes that can be submitted for TCM services.

CPT code 99495 may be used for moderate complexity TCM services and 99496 for high complexity TCM services. Billing providers have 30 days from inpatient discharge to provide and bill for TCM services.

Reimbursement for TCM services varies based on billing code, geographic location and payer billed. The current reimbursement in Fort Worth, Texas for CMS non-facility pricing is $206.26 for moderate complexity TCM and $279.30 for high complexity TCM.27 TCM services are reimbursed at a higher cost than CPT 99214 or 99215 incident-to-billing codes for appropriate patients.

A one-year pilot study evaluating the impact of pharmacist involvement in a preexisting telehealth transitional care management program reported a relative risk reduction of 36.8% for 30-day hospital readmission for patients with high-risk medications contacted by the TCM pharmacist and resolution of 108 medication-related problems (MRPs). The cost avoidance for the 108 MRPs identified by the TCM pharmacist during the pilot was estimated at $31,676.40 for the sixty-six patients enrolled. A pharmacistcoordinated multidisciplinary transition of care program was piloted in the University of North Carolina Internal Medicine Clinic in 2012. The program successfully billed Medicare for TCM services and reported a 65% reduction in 30-day readmission rates. 39 Potential barriers to the provision and billing of TCM services by pharmacists include those discussed under the provision of incident-to billing and the required direct intervention from physicians and nonphysician providers, which can make quantifying payment for pharmacist time challenging. Organizations can leverage the difference between incident-to-billing codes and TCM codes to compensate for

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pharmacist time as TCM services and coordination can be timeconsuming for billing providers.

Diabetes Self-Management Training and Education (DSMT/E) Diabetes self-management training and education (DSMT/E) services provide patients with the necessary skills, knowledge, and resources for comprehensive self-management of diabetes. It is an ongoing service provided by accredited education programs to foster shared decision-making, appropriate self-care skills, and collaboration with healthcare providers to improve health outcomes relating to diabetes care. 40 DSMT/E programs are accredited by the American Diabetes Association (ADA) or the Association of Diabetes Care and Education Specialist (ADCES) formerly known as the American Association of Diabetes Educators (AADE). The service involves individual and/or group education sessions comprised of two or more participants.

CMS and commercial health plans provide reimbursement for DSMT/E services. 41,42 CMS will reimburse for 10 hours of initial DSMT/E services within 12 consecutive months and 2 hours of DSMT/E follow-up per year (outside calendar year of initial DSMT/E). The first hour of the initial DSMT/E can be used for individual services but the remaining 9 hours must be used for group services unless no DSMT/E group is available for 2 months or longer from the date of referral, the referring provider indicates that the beneficiary has a barrier to group learning or the referring provider 41 indicates that the beneficiary needs additional insulin training.

Licensed pharmacists, including those in community pharmacies, can develop, provide, and directly bill for DSMT/E services as a professional member of an accredited DSMT/E program. Pharmacists will need to meet the individual requirements for accreditation. A referral from a prescribing provider describing the type of diabetes, treatment plan, and reason for referral is required for reimbursement and the DSMT/E program will need to maintain timely communication with the referring provider.

Pharmacists may use HCPCS code G0108 for billing of individual DSMT/E services (per 30 minutes) or G0109 for group services (per 30 minutes). Reimbursement for DSMT/E services vary based on billing code, geographic location, and payer billed. The current reimbursement in Fort Worth, Texas for CMS non-facility pricing is $15.65 for group services and $55.76 for individual services.

27 Pharmacists will need to confirm with individual health plans about requirements for DSMT/E billing for commercial health plans.

A pharmacist-led DSMT/E service in a rural hospital reported a significant reduction in A1C of 1.3% (P< 0.001) with more than 50% of patients achieving an A1C goal of ≤ 7%.43 Of note, only 21.7% of reported interventions were related to medication initiation or titration.44

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A second study evaluating the effectiveness of a pharmacist-administered diabetes education and management service reported a significant A1C reduction of 1.7% with 38% of patients experiencing a greater than 1% reduction in A1C from baseline. The authors estimated savings of $820 for each 1% A1c reduction resulted in a calculated total cost avoidance of $59,040 for the health care system.44 Potential barriers to the provision and billing of DSMT/E services by a pharmacist include accreditation costs, requirements, and training of personnel, limited patient participation due to copay and deductible requirements, marketing of services, and maintenance of communication with referring providers. Pharmacists can leverage improvement in outcomes that affect quality metric determination (e.g. STAR ratings, MIPS) to market DSMT/E services.

Conclusion Modifications to the insurance and occupation codes in the state of Texas have expanded the opportunities for pharmacists to deliver clinical services, elevated the recognition of pharmacists as valued members of the interprofessional healthcare team, and supported the remuneration of these pharmacist-directed services. SB 1056 and HB 2425 enable more pharmacists to enter into collaborative practice agreements to leverage existing billing avenues and provide quality-driven clinical services. HB 1757 and HB 3441 include licensed pharmacists as approved providers for beneficiaries within commercial health plans. Pharmacists can utilize contractual agreements between commercial health plans or billing providers to develop sustainable practice models furnished by incident-to billing, chronic care management, Medicare annual wellness visits, transitional care management, and diabetes self-management training and education.

Inconsistent and inadequate reporting of revenue generation, return on investment, and cost-avoidance gained from pharmacist-provided clinical services remain significant barriers to the integration of pharmacists into healthcare organizations. There is also a limited understanding of approved pharmacist billing opportunities by pharmacists and healthcare administrators. Subjectivity applied to the CMS billing rules by Medicare Administrative Contractors (MACs) may deter billing and reimbursement for pharmacist-provided services. Furthermore, pharmacists that are not integrated into commercial health plan provider networks may need to rely on indirect billing mechanisms for reimbursement.

Although lack of national provider status for pharmacists remains an inhibitory factor for many, the state of Texas has instituted initial infrastructures for pharmacists to further explore opportunities for revenue generation. As pharmacy organizations advocate for the recognition of pharmacists as providers nationwide, increased access to pharmacist-driven services and initiatives regionally will provide evidence to justify reimbursement for value-based care and subsequent improvement in patient outcomes.

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Key Points 1. Barriers to pharmacist integration is underpinned by limitations in financial support for services rendered and lack of national recognition of pharmacists as healthcare providers by the Centers for Medicare and Medicaid services. However, existing literature has detailed positive implications upon incorporation of pharmacists into healthcare organizations. The benefits described include positive impact on patient outcomes and benefits of collaborative practice agreements between pharmacists and supervising providers.

2. The state of Texas instituted significant infrastructures for pharmacists to further explore opportunities for revenue generation within outpatient practice. House Bills (HB) 1757 and 3441 allows pharmacists to be added to the provider network of a commercial health plan and inhibits insurers from denying reimbursement for pharmacistprovided services. HB 2425 permits a physician to delegate prescriptive authority to pharmacists in federally qualified health centers and Senate Bill 1056 authorizes a physician to delegate drug therapy management to pharmacists using a collaborative practice agreement.

3.

Pharmacists can advocate for the billing and reimbursement of services rendered in the outpatient clinical practice setting. This may be achieved by leveraging existing avenues for pharmacist-reimbursed outpatient clinical services that may not be well known or utilized. These billing opportunities include but are not limited to: incident-to billing, chronic care management (CCM), Medicare annual wellness visits (AWV), transitional care management (TCM) and diabetes selfmanagement training and education (DSMT/E) to develop sustainable practice models.

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References 1.Scott MA, Heck JE, Wilson CG. The integral role of the clinical pharmacist practitioner in primary care. North Carolina Medical Journal. 2017;78(3):181-185. doi:10.18043/ncm.78.3.181 2.Quinones ME, Pio MY, Chow DH, et al. Impact of clinical pharmacy services on outcomes and costs for indigent patients with diabetes. Am J Manag Care. 2016;22(4):e147-52.

3.Hitch B, Parlier AB, Reed L, et al. Evaluation of a team-based, transition-of-care management service on 30-day readmission rates. N C Med J. 2016;77(2):87-92. doi:10.18043/ncm.77.2.87 4.Provider status: what pharmacists need to know now. Pharmacist.com website. https://www.pharmacist.com/provider-status-what-pharmacists-need-know-now. Published August 2013. Accessed June 2019.

5.Dietrich E, Gums JG. Incident-to billing for pharmacists. J Manag Care Spec Pharm. 2018;24(12):1273-76 6.Exploring pharmacists’ role in a changing healthcare environment. Avalere Health LLC website. http://avalere-health-production.s3.amazonaws.com/uploads/pdfs/1400680820_05212014Exploring_Pharmacists_Role_in_a_Changing_Healthcare_Environment.pdf. Published May 2014. Accessed June 2019 7.Pharmacist billing for ambulatory pharmacy patient care services in a physician-based clinic and other non-hospital- based environments- FAQ. American Society of Health-System Pharmacists website https://www.ashp.org/-/media/assets/ambulatory-care-practitioner/docs/sacp-pharmacist-billing-for-ambulatory-pharmacy-patient-care-services.pdf. Published May 2014. Accessed June 2019.

8.HB 1757. 86th Leg., R.S., Tex.(2019). Texas Legislature Online website. https://capitol.texas.gov/BillLookup/BillNumber.aspx. Published 2019. Accessed June 2019.

9.HB3441. 86thLeg., R.S.,Tex.(2019). Texas Legislature Online website. https://capitol.texas.gov/BillLookup/BillNumber.aspx. Published 2019. Accessed June 2019.

10. 22 Tex. Admin. Code § 295.13 (2020). Texas Board of Pharmacy website. http://txrules.elaws.us/rule/title22_chapter295_sec.295.13. Published 2019. Accessed June 2019.

11.Texas pharmacist now providers in private health plans. Pharmacist.com website. https://www.pharmacist.com/article/texas-pharmacists-now-providers-private-health-plans. Published July 18, 2019. Accessed September 23, 2020.

12.US Department of Health & Human Services, Office of the Assistant Secretary for Health. Guidance for licensed pharmacists, COVID-19 testing, and immunity under the PREP Act. https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html. Published April 8,2020. Accessed September 27, 2020.

13.Waived tests. Centers for Disease Control and Prevention website. https://www.cdc.gov/labquality/waived-tests.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fclia%2Fwaived-tests.html. Updated December 16, 2019. Accessed September 23, 2020.

14. Monte SV, Slazak EM, Albanese NP, et al. Clinical and economic impact of a diabetes clinical pharmacy service program in a university and primary care-based collaboration model. J Am Pharm Assoc (2003).

2009;49(2):200-208. doi:10.1331/JAPhA.2009.08160 15. Rodgers S, Avery AJ, Meechan D, et al. Controlled trial of pharmacist intervention in general practice: the effect on prescribing costs. Br J Gen Pract. 1999;49(446):717-720.

16.Hayhoe B, Cespedes JA, Foley K, et al. Impact of integrating pharmacists into primary care teams on health systems indicators: a systematic review. Br J Gen Pract. 2019;69(687):e665-e674. doi:10.3399/bjgp19X705461 17.Chaudhri K, Hayek A, Liu H, et al. General practitioner and pharmacist collaboration: does this improve risk factors for cardiovascular disease and diabetes? A systematic review protocol. BMJ Open.

2019;9(8):e027634. doi:10.1136/bmjopen-2018-027634 18. McAdam-Marx C, Dahal A, Jennings B, et al. The effect of a diabetes collaborative care management program on clinical and economic outcomes in patients with type 2 diabetes. J Manag Care Spec Pharm.

2015;21(6):452-468. doi:10.18553/jmcp.2015.21.6.452 19.Markov model of the cost-effectiveness of pharmacist care for diabetes in prevention of cardiovascular diseases: evidence from Kaiser Permanente Northern California. J Manag Care Pharm. 2013;19(2):102-114. doi:10.18553/jmcp.2013.19.2.102 20.Altowaijri A, Phillips CJ, Fitzsimmons D. A systematic review of the clinical and economic effectiveness of clinical pharmacist intervention in secondary prevention of cardiovascular disease. J Manag Care Pharm.

2013;19(5):408-416. doi:10.18553/jmcp.2013.19.5.408 21.“Incident to” and the initial visit-evaluation & management service guidelines. Novitas Solutions. https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00004947. Mar 9, 2017.

Accessed Sept 23, 2020.

22.Taverna CM. Center for Medicare and Medicaid Services response to AAFP MTM billing letter [letter]. American College of Clinical Pharmacy website. https://www.accp.com/docs/positions/misc/CMS%20Response%20to%20AAFP%20MTM%20Billing%20Letter.pdf. Published March 25, 2014. Accessed Sept 23, 2020.

23.Incident to services in the office setting. Novitas solutions website. https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00150920 Updated February 21, 2019. Accessed September 23, 2020.

24.“Incident to” services. Centers for Medicare and Medicaid services website. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se0441.pdf. Updated August 23, 2016. Accessed September 23, 2020.

25. Centers for Medicare & Medicaid Services (CMS). Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule [Final Rule]. Available at https://www.federalregister.gov/documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other. Accessed September 25, 2020.

26.Centers for Medicare & Medicaid Services (CMS). Medicare Program; CY 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions from the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19. Available at https://public-inspection.federalregister.gov/2020-26815.pdf. Accessed December 11, 2020.

27.Physician fee schedule search. Centers for Medicare and Medicaid Services website. https://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx Updated January 20, 2021. Accessed March 23,2021.

28.Roulac H, Oswald M, Marshall A, et al. Understanding and promoting the value of chronic care management services [presentation]. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2017-02-21-CCM-Presentation.pdf. Published February 21, 2017. Accessed September 23, 2020.

29.Chronic care management services. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-NetworkMLN/MLNProducts/Downloads/ChronicCareManagement.pdf. Published July 2019. Accessed September 23, 2020.

30.Bonner L. Finding the right fit: Chronic care management is more flexible than you might think. Pharmacy Today. 2018; 24(11): 26-29.

31.Fixen DR, Linnebur SA, Parnes BL, et al. Development and economic evaluation of a pharmacist-provided chronic care management service in an ambulatory care geriatrics clinic. Am J Health-Syst Pharm. 2018; 75:1805-11.

32.Schurrer J, O’Malley A, Wilson C, et al. Evaluation of the diffusion and impact of the chronica care management (CCM) services: final report. https://innovation.cms.gov/files/reports/chronic-care-mngmtfinalevalrpt.pdf. Published November 2, 2017. Accessed March 20, 2021.

33.Annual wellness visit. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-NetworkMLN/MLNProducts/Downloads/AWV_Chart_ICN905706.pdf. Published August 2018, Accessed September 23, 2020.

34. Alhossan A, Kennedy A, Leal S. Outcomes of annual wellness visits provided by pharmacists in an accountable care organization associated with a federally qualified health center. Am J Health Syst Pharm.

2016:73(4):225-228. doi: 10.2146/ajhp150343 35.Park I, Sutherland S, Ray L, et al. Financial implications of pharmacist-led Medicare annual wellness visits. J Am Pharm Assoc. 2014;54(4):435-40.

36.Clark CM, LaValley SA, Singh R, et al. A pharmacist-led pilot program to facilitate deprescribing in a primary care clinic. J Am Pharm Assoc. 2020; 60:105-11.

37.Frequently asked questions about transitional care management (TCM). American Academy of Family Physicians [pdf]: DPA17061167 Accessed June 2019.

38.Cole J, Wilkins N, Moss M, et al.Impact of pharmacist involvement on telehealth transitional care management (TCM) for high medication risk patients. Pharmacy. 2019; 7(4):158.

39.Cavanaugh JJ, Jones CD, Embree G, et al. Primary care-based multidisciplinary readmission prevention program. J Gen Intern Med. 29(5):798-804.

40.Funnell MM, Brown TL, Childs BP, et al. National standards for diabetes self-management education. Diabetes Care. 2008;31(Supplement 1):S97.

41.Outreach and education. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/DSMT-Fact-Sheet909381.pdf. Published 2018. Accessed June 2019.

42. DSMES toolkit. Centers for Disease Control and Prevention website. https://www.cdc.gov/diabetes/dsmes-toolkit/reimbursement/medicare.html Published 2018. Accessed June 2019.

43.Meade LT, Tart RC, Buzby HL. Evaluation of diabetes education and pharmacist interventions in a rural, primary care setting. Diabetes Spectrum. 2018; 31(1): 90-95.

44.Ragucci KR, Fermo JD, Wessell AM, et al. Effectiveness of pharmacist-administered diabetes mellitus education and management services. Pharmacotherapy. 2005; 25:1809–1816.

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What you can expect to find in the Membership Guide:

Open your phone camera and tap the QR code to be brought to the 20202021 Membership Guide

The 2020-2021 Membership Guide could not have been completed without the help of the Membership Retention and Recruitment Committee. We would like to say our thanks to those that have dedicated their time during such a busy year. We are greatly appreciative for your committement to TSHP.

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Find your community Connect with your local chapter Get Involved Learn about TSHP Find opportunities Become a leader Transform your industry

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HSV Hepatitis in the Immunocompetent Individual: An Under-Recognized Concern 1

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Hongmei Wang, Pharm.D., Ph.D., Christopher Cruz, Namphi Nguyen, Tankhoa Dang

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1. Department of Pharmacy Practice, Texas Southern University, Houston, Texas, United States

Herpes simplex viruses (HSV) are endemic worldwide, with approximately 70% of the population under age 50 estimated as infected. 1 Herpes simplex virus hepatitis (HSVH) is a rare complication of HSV infection, only accounting for one percent of acute liver failure (ALF) episodes and two percent of viral ALF.2 The diagnosis of HSVH is often not straight forward, and can rapidly progress to ALF leading to fulminant hepatic failure (FHF), liver transplantation, disseminated intravascular coagulation, renal failure, or death. 3 HSVH can occur in apparently immunocompetent patients, leading to FHF with mortality rates of more than 70%.

HSV most commonly affects immunocompromised individuals but also affects a significant proportion of individuals who are seemingly immunocompetent. In a retrospective study of 137 patients with HSVH, 24% were considered immunocompetent.2 Yokoi et al analyzed the clinical laboratory findings of hepatitis in 57 immunocompetent patients and found an extremely high mortality rate of 86.7% in postsurgical patients compared to 71.4% in nonsurgical patients. 4 Causes remain unclear for the dissemination of viruses resulting in severe

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hepatitis in immunocompetent individuals. Proposed theories include large HSV viral load upon first infection, an occult impairment in cellular immunity, reinfection of a second strain of HSV that reactivates latent virus, and greater disease-causing tendency in some virus strains.5 In rare case reports, substances with immunosuppressive effects have been suggested to cause the reactivation of latent HSV, including inhalants and anesthetic agents such as enflurane, isoflurane, desflurane and nitric oxide.6 Similarly, HSV can be reactivated later in pregnancy with a three-fold likelihood for the appearance of symptoms versus non-pregnant patients.7 HSVH patients present with a wide variety of non-specific gastrointestinal, respiratory, neurological, or urogenital symptoms making timely diagnosis difficult and often delays treatment. Signs and symptoms include fever, nausea, vomiting, diarrhea, and abdominal pain. Herpetic lesions present in less than 50% of the HSVH patients at initial presentation (or admission) or during hospitalization. If 4 healthcare providers are made aware of this rare yet severe infection, diagnosis should not be difficult. HSV DNA polymerase chain reaction (PCR) utilizing a blood sample has displayed

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rapid results, with higher specificity and sensitivity in comparison to serologic antibody testing. Liver biopsy can be considered, though it is generally not recommended due to its invasive nature, in order to confirm the diagnosis of HSVH; however, risks and benefits need be evaluated due to elevated bleeding risk associated with liver failure. The most typical 9 findings appear to be hemorrhagic in nature. Radio-diagnostic tests are useful to rule out hepatitis but are generally unspecific for early diagnosis of HSVH. The appropriate treatment of HSVH is parenteral acyclovir therapy administered at 10mg/kg intravenously every 8 hours for 14 to 21 days. 10 Resistance to acyclovir has been reported in 0.27% of immunocompetent individuals.4 Quantitative PCR could be useful to evaluate the effectiveness of antiviral therapy during follow up to promptly identify those with refractory viruses. In such cases, foscarnet and cidofovir have proven successful as treatment alternatives, but use of foscarnet in those with decreased renal function must be monitored closely due to nephrotoxic effects (Table 1).11 Liver transplant remains the last resort if fulminant HSVH is unresponsive to antivirals.

In conclusion, HSVH is a rare but potentially life-threatening disease. It is crucial that HSVH be included in the differential diagnosis for ALF patients with unknown etiology. Given its high mortality rate and the relatively minimal side effect profile of acyclovir treatment, early empirical therapy should be initiated when HSVH is suspected pending confirmation of lab results.

References 1. World Health Organizations. Herpes simplex virus website. https://www.who.int/news-room/factsheets/detail/herpes-simplex-virus World Health Organization (WHO). Accessed August 27, 2019.

2. Norvell JP, Blei AT, Jovanovic BD, Levitsky J. Herpes simplex virus hepatitis: an analysis of the published literature and institutional cases. Liver Transpl. 2007;13:1428-34.

3. Arkin LM, Castelo-Soccio L, Kovarik C. Disseminated herpes simplex virus (HSV) hepatitis diagnosed by dermatology evaluation. Int J Dermatol. 2009;48:1020–1.

4. Yokoi Y, Kaneko T, Sawayanagi T, et al. Fatal fulminant herpes simplex hepatitis following surgery in an adult. World J Clin Cases. 2018;6:11-19.

5. Miyazaki Y, Akizuki S, Sakaoka H, et al. Disseminated infection of herpes simplex virus with fulminant hepatitis in a healthy adult. A case report. APMIS. 1991;99:1001-7.

6. Noor A, Panwala A, Forouhar F, Wu GY. Hepatitis caused by herpes viruses: a review. J Dig Dis. 2018;19:446-455.

7. Jacques SM, Qureshi F. Herpes simplex virus hepatitis in pregnancy: a clinicopathologic study of three cases. Hum Pathol. 1992;23:183-7.

8. Beersma MFC, Verjans GM, Metselaar HJ, et al. Quantification of viral DNA and liver enzymes in plasma improves early diagnosis and management of herpes simplex virus hepatitis. J Viral Hepat 2011;18:e160–6.

9. Levitsky J, Duddempudi AT, Lakeman FD, et al. Detection and diagnosis of herpes simplex virus infection in adults with acute liver failure. Liver Transpl. 2008;14:1498-504.

10. Norvell JP, Blei AT, Jovanovic BD, et al. Herpes simplex virus hepatitis: an analysis of the published literature and institutional cases. Liver Transpl. 2007;13:1428–1434 11. Chaudhary D, Ahmed S, Liu N, Marsano-Obando L. Acute liver failure from herpes simplex virus in an immunocompetent patient due to direct inoculation of the peritoneum. ACG Case Rep J. 2017;4:e23.

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Abbreviated New Drug Application (ANDA) Approvals This report includes original ANDA approvals (applications for generic drug) during the selected month(s) Source: Drugs@FDA-Approved Drugs, https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm; March 15 - April 1; Accessed on April 2nd, 2021

*Visit the FDA US Food & Drug Administraiton website for additional disclaimers

Download Drugs@FDA Express for free

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Do Not Crush List The List of Oral Dosage Forms That Should Not Be Crushed, commonly referred to as the "Do Not Crush" list, contains medications that should not be crushed because of their special pharmaceutical formulations or characteristics, such as oral dosage forms that are sustained-release in nature.

Source: Institute of Safe Medication Practices (ISMP); https://www.ismp.org/; Accessed on April 5th, 2021

*View C-Z at https://www.ismp.org/recommendations/do-not-crush.

This list is adapted by ISMP with permission from Echaiz, T. A. (Ed.).Oral Dosage Forms That Should Not Be Crushed 2021 [wall chart]. St. Louis, MO: Thomas Land Publishers, Inc. Copyright (C) 2021 Thomas Land Publishers

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Thank you for attending TSHP's Virtual

2021 Annual Seminar We can't wait to see you next year!