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16 th National Conference on Anticoagulation Therapy October 28-30, 2021 Anticoagulation Service – The New Normal Session Chairs Allison Burnett, PharmD, CACP University of New Mexico Health Sciences Center Scott Kaatz, DO, MSc, SFHM Henry Ford Hospital

Anticoagulation Service – The New Normal

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16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Anticoagulation Service – The New NormalSession Chairs

Allison Burnett, PharmD, CACPUniversity of New Mexico

Health Sciences Center

Scott Kaatz, DO, MSc, SFHMHenry Ford Hospital

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Anticoagulation Service: The New Normal

Moving the Needle: IHI and Anticoagulation Safety & StewardshipFrank Federico, RPhInstitute for Healthcare Improvement

Arthur Allen, PharmD, CACPVA Salt Lake City Health Care System

Mark Crowther, MD, MScMcMaster University

Staying Relevant: Practice Innovations & the Clinic of the Future

Andrea Van Beek, RN, DNP, AGPCNP-BCVisalia Medical Clinic/Kaweah Health Medical Group

Daniel Witt, PharmD, FCCP, BCPS, CACPUniversity of Utah

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Staying Relevant: Practice Innovations & the Clinic of the Future

Presenters:

Arthur Allen, PharmD, CACPVA Salt Lake City Health Care System

Mark Crowther, MD, MScMcMaster University

Andrea Van Beek, RN, DNP, AGPCNP-BCVisalia Medical Clinic/Kaweah Health Medical Group

Daniel Witt, PharmD, FCCP, BCPS, CACPUniversity of Utah

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Faculty DisclosuresArthur Allen, PharmD, CACP

• Speakers Bureaus:• Janssen Pharmaceuticals• Alexion Pharmaceuticals

• Scientific Advisory Boards:• Boehringer-Ingelheim Pharmaceuticals• Bristol-Meyers Squibb Pharmaceuticals• Pfizer Pharmaceuticals• Roche Diagnostics

Dan Witt, PharmD, FCCP, BCPS• Research Funding

• Roche Diagnostics• AHRQ (R18 HS027960-01)

Mark Crowther, MD, MSc• Personal Funding/Advisory Boards

• Hemostatis Reference Laboratories• Syneos Health• Walters Kluwer

• Educational Materials• Pfizer• SCL Behring

• Other• University of Toronto• Peerview Press• Meridian HealthComms• American Society of Hematology• Saudi Society of Hematology• The Anticoagulation Forum• The Canadian Medial Protective Association• McMaster University

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

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XIa inhibitors… Just when we were getting used to our current anticoagulants

Mark Crowther, MD, MSc

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Objectives

• To understand in a few slides the rationale for development of the next generation of anticoagulants

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

• All anticoagulants that are current available reduce the risk of first and recurrent thrombosis at the expense of increased bleeding

• Presumable since they inhibit both physiological and pathological clots

• Although DOACs are probably pushing this relationship a bit there is no doubt the cost of anticoagulation is bleeding

• Factor XII deficiency is NEVER, and Factor XIa deficiency is NOT USUALLY associated with bleeding

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

• Inhibition of XIa may specifically block pathological thrombosis without impacting physiological hemostasis

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Where are we?• A variety of therapies are currently in evaluation

• siRNAs• Antibodies• Parenteral agents• Oral agents

• What is their niche ?• Hard to show that they are better than DOACs in

general populations so will need, at least initially, to be tested in selected patients

• May be particularly useful in patients with device associated thrombosis

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Summary

• Early days but promising results• Will initially be used in very selected patients

but may gain broader use depending on results

• Likely to initially be a parenteral agent with later introduction of oral agents

• May uncouple pathological and physiological bleeding

• Watch this space for more news

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

12

Population HealthArthur Allen, PharmD, CACP

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Population Health

VS

Traditional Model

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

What if we could use technology to DAILY review every patient prescribed a DOAC, handing us only those with following scenarios?

• Dose inappropriate for indication and patient-specific factors

• Separate “call out” for patients prescribed standard dose Rivaroxaban/Apixaban for >180 days for VTE

• Notable laboratory changes (Hgb/Plt/LFTs)• Drug-Drug Interactions

• Divided by “critical” DDIs & concomitant NSAIDs

• Patients of childbearing potential• Patients with ICD code for mechanical valve

• Patients with ICD code for bariatric surgery• DOAC med renewal due within 30 days• Potential nonadherence to therapy (> 30

days overdue for med fill)• Overdue for routine laboratory monitoring• Patients “lacking indication” for DOAC (no

ICD code for AF or VTE)• Patients placed “under review” by AC

provider

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

VA’s DOAC Population Management Tool (PMT): Overview

• The home screen provides an overview of the number of flags currently in play for each area of concern.

• This allows the healthcare team to prioritize and filter flags based on the reason for clinical concern.

• Each number serves as a hyperlink to the expanded PMT interface where patients are grouped based on the flag for a focused intervention.

• When a hyperlink number is clicked, it will expand and provide a more in-depth review of clinically relevant factors and the reason the patient is flagging.

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

DOAC PMT: Expanded Single-Patient View

• Each blue hyperlink allows the user to review the report in more detail or adjust monitoring frequencies.

• Patient Name provides additional patient-specific detail (e.g., refill history, flag dismissal history).• Diagnosis provides a comprehensive list of patient diagnoses and gives the reviewer the ability to remove a

diagnosis from being included in the report.• Edit allows the reviewer to adjust monitoring frequency (CBC and Scr)• Clinical Concerns box includes the active flags (as hyperlinks) that require review. For the example provided,

the patient is flagging for a potential dosing issue. After they have reviewed and addressed the concern, the user can dismiss the flag with one click.

• The Click to Place Under Review function marks a patient for further review at a future date.

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Benefits of the VA’s DOAC PMT

• Valencia et al: DOAC PMT model vs. clinic-based model (SOC)• Significant interventions made per patient encounter

• 0.55 (PMT) vs. 0.2 (SOC), P <0.001• 75% reduction in mean time to intervention

• 16 min (PMT) vs. 64 min (SOC)

• Rossier et al: 20 PMT high-use VA sites vs. 20 non-use sites (SOC)• DOAC PMT use was associated w/ 4.3% absolute risk reduction in

questionable dosing rates• 13.2% (PMT), vs. 17.5% (SOC) P < 0.001• In AF subgroup, rates of questionable dosing was nearly twice as

high in the SOC group• 5.3% (PMT) vs. 10.4% (SOC) , P < 0.001

Annals of Pharmacotherapy 2019; 53(8), 806–811.J Thromb Thrombolysis. 2020 Nov 22. doi: 10.1007/s11239-020-02341-y.

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

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Billing and CodingAndrea Van Beek, RN, DNP, AGPCNP-BC

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Billing basics• At present, MD’s, PA’s, and NP’s can bill for anticoagulation services provided to

patients• Office visits• Televisits• Telephone calls with INR results (labs drawn at a lab, or with a home INR

monitor)• Training on home INR monitors

• Billing for Pharmacists is more complicated

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Office Visit Billing• E/M codes for office visits – 99211-99215• As of January 1, 2021, you can bill based on the total time spent caring for your

patient• Time spent preparing to see the patient (chart review)• Time spent with the patient• Time spent coordinating care with another provider• Time spent charting in the EMR

• G2212 for prolonged time• For each 15 minutes beyond the length of the 99215 visit (54 minutes)

• Point of Care INR test: CPT 86510 (for CLIA waived, add modifier “CW”) – use when patient comes for an office visit and has INR checked the same day

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

INR interpretation with notification of patient• CPT code: 93793: Anticoagulation management for patients taking warfarin, must include

review and interpretation of a new home, office, or lab international normalized ratio (INR)test results, patient instructions, dosage adjustment (as needed), and scheduling of additional test (s), when performed

• Do not report 93793 the same day as an E/M service

• G0250: Only used for home testing of INR: Physician review, interpretation, and patient management of home INR testing for a patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; includes face-to-face verification by the physician that the patient uses the device in the context of the management of the anticoagulation therapy following initiation of the home INR monitoring; not occurring more frequently than once a week

Source: https://codingintel.com/anticoagulation-management/

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Home INR monitor training• CPT code: 93792: Patient/caregiver training for initiation of home international normalized ratio

(INR) monitoring under the direction of a physician or other qualified healthcare professional, face-to-face, including use and care of the INR monitor, obtaining blood sample, instructions for reporting home INR test results, and documentation of patient’s/ caregiver’s ability to perform testing and report results

• G0248: Demonstration, prior to initiation of home INR monitoring, for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria, under the direction of a physician; includes: face-to-face demonstration of use and care of the INR monitor, obtaining at least one blood sample, provision of instructions for reporting home INR test results, and documentation of patient’s ability to perform testing and report results

Source: https://codingintel.com/anticoagulation-management/

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Billing for Pharmacists• More complicated

• CMS does not recognize Pharmacists as providers – so can not bill Medicare part B• On a state level: some states allow pharmacists to bill as providers

• Some 3rd party payers recognize, some do not• Some allow pay parity, some reimburse at a lower rate compared to MD/PA/NP’s• Pharmacists can use ToC billing codes if the infrastructure is in place (need to be seen by a

recognized provider within the 7-14 day time frame)• Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 2759/S.1362)

• ASHP has been the biggest proponent• AC Forum signed a letter to congress in July 2021

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

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Patient Self-ManagementDaniel Witt, PharmD, FCCP, BCPS, CACP

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

For patient receiving anticoagulation therapy...the ASH guideline panel suggests using specialized AMS care rather than care provided by the patient’s usual health care provider (conditional recommendation).

For patients receiving maintenance [warfarin] therapy...the ASH guideline panel suggests using home point-of-care INR testing (patient self-testing [PST]) over any other INR testing approach except patient self-management (PSM) in suitable patients (those who have demonstrated competency to perform PST and who can afford this option) (conditional recommendation).

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

For patients receiving maintenance [warfarin] therapy...the ASH guideline panel recommends using point-of-care INR testing by the patient at home and self-adjustment of [warfarin] dose (PSM) over any other management approach, including PST in suitable patients (those who have demonstrated competency to perform PSM and who can afford this option) (strong recommendation).

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Q: How many patients in Europe are engaged in warfarin PSM?

A: Well over 400,000.

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Q: What proportion of patients receiving warfarin in the US healthcare system are currently practicing PSM?

A: Less than 1%!!

Q: Why is that?

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Pharmacotherapy. 2005;25(2):265-269

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Shared Decision Making

CLINICIANSCommunicate

disease-related information &

evidence-based information about

treatment risks and benefits

PATIENTSCommunicate

information about their values, needs, and preferences

“I don’t mind dying from a heart attack. I can take having a heart attack, but I don’t want to have a stroke. I have seen people with a stroke and they were not able to be rehabbed. And that is not the way I choose to spend the rest of my life. So I guess that’s what’s most important to me, to continue on as I am. If that means a blood thinner, then whatever is necessary.” - Actual AF Patient

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Shared Decision Making-The Future of Anticoagulation Management Services?• SDM is particularly useful when there are no clear “best” options (i.e.,

when there is “clinical equipoise”) and where decisions are value laden and complex.

• Models of informed consent and SDM emphasize the importance of presenting the risks and benefits of all treatment options (including no treatment) to patients.

• How many situations in the typical anticoagulated patient’s journey are consistent with these points?

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021

Examples• Which anticoagulant is best for me?• Should I continue anticoagulation beyond 3 months after VTE?• Should I use bridge therapy for my upcoming procedure?• Should I resume anticoagulation therapy following my recent GIB?• What system of warfarin management is best for me?• Should I (or my family members) get hypercoagulability testing?• Should I be taking aspirin with oral anticoagulation therapy?

16th National Conference on Anticoagulation TherapyOctober 28-30, 2021