the role of pharmacists in vaccination ... - annual.ascp.com

10/22/21

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2021 Annual Meeting & ExhibitionNovember 4-7, 2021 | San Diego, California

The Role of Pharmacists in Vaccination Decision Making and Delivery to Older Adults in Long-

Term Care, the Medically Complex, and Other At-Risk or Hesitant Populations

Nancy L. Losben, R.Ph., CCP, CGChief Quality Officer

Omnicare, a CVS Health company

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Part 4: Operations and business advice for pharmacists and pharmacies on how to implement successful immunization programs.Nancy L. LosbenChief Quality OfficerOmnicare, a CVS Health Company

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Biography• Chief Quality Officer,

Omnicare, a CVS Heath company

• Certified Consultant Pharmacist

• Certificate in Gerontology• ASCP Richard S. Berman

Award• Eli Lilly/ASCP award for

Excellence in Education• Volunteer of the Year Award

from the American Medical Directors Association, 2011

• ASCP President’s Business Leader Award

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Disclosure

I have no actual or potentially relevant financial relationship to disclose and no conflict of interest in relation to this activity

Nancy L. Losben

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Objectives

• Implement best practices as mass immunizer in skilled nursing homes, assisted living, and communal housing facilities

• List the requirements for billing vaccines and vaccine administration to Medicare and other payers

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What is a mass immunizer?A mass immunizer offers seasonal influenza virus vaccination, pneumococcal

vaccination, or both to a large number of individuals. A mass immunizer may be atraditional Medicare provider or supplier or a non-traditional provider or supplier(such as a senior citizens’ center, a public health clinic, or a community pharmacy).

Mass immunizers must submit claims for immunizations on roster bills and mustaccept assignment on both the vaccine and its administration. A mass immunizershould enroll with the Medicare Administrative Contractor (MAC) prior to eachinfluenza season.

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Does Medicare Part A Cover Pneumococcal, Seasonal influenza and Zoster Vaccines?

If a skilled nursing facility resident receives a flu vaccine or other preventative vaccine during a covered Part A stay, the SNF itself is responsible for billing Medicare for the vaccine. Even though the Consolidated Billing requirement makes the SNF itself responsible for billing Medicare for a preventive or screening service furnished to its Part A resident, the SNF would not include the service on its Part A bill, but would instead submit a separate bill for the service. This is because the Part A SNF benefit is limited to coverage of “diagnostic or therapeutic” services.

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What vaccines are covered by Medicare Part B?

A Provider may bill Medicare Part B for Seasonal Influenza vaccine, Pneumococcal Vaccine, Hepatitis B Vaccine and vaccines directly related to the treatment of an injury or direct exposure to a disease or condition

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What vaccines does Medicare Part D cover?

Medicare part D covers preventative vaccinations including Seasonal Influenza vaccine, Pneumococcal Vaccine and Shingles Vaccine. Except for vaccines covered under Medicare Part B, Medicare Part D plans cover all commercially available vaccines as long as the vaccine is reasonable and necessary to prevent illness.

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Does Medicare Part D pay for the administration of vaccines?

The Part D Program covers vaccine administration costs as a component ofthe negotiated price for a Part D vaccine, which includes: Dispensing fee (ifapplicable), Sales tax (if applicable), Vaccine administration fee , Vaccineingredient cost.

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Other Coverage

https://www.hhs.gov/immunization/get-vaccinated/pay/index.html

Private health insuranceMost insurance plans are required to cover recommended vaccines without charging you. That means you can usually get vaccines at no cost to you.• Military insurance, TRICARE, covers all of the recommended vaccines for people currently serving in

the military and their dependents (family members they support). Depending on your plan, there may be a copay or a fee for getting vaccinated.

MedicaidMedicaid covers all of the recommended vaccines for children and some vaccines for adults. There may be a copay or fee for getting vaccinated, depending on what state you live in and the doctor you see to get vaccinated.

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U.S. government increased Medicare reimbursement rates for COVID-19 vaccines to $40 per single-shot from $28, and $80 for two-dose vaccine from about $45.

https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment

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https://www.hhs.gov/immunization/get-vaccinated/pay/index.html

https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment

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Billing for COVID-19: Medicare Highlights• You must be a Medicare-enrolled provider to bill Medicare for administering COVID-19 vaccines to Medicare patients.

• You can bill on single claims for administering the COVID-19 vaccine, or submit claims on a roster bill for multiple patients at a time.

• When you choose the Place of Service (POS) code for your Part B claims, carefully consider where you provided the vaccine.

• If you administer additional vaccine doses on or after August 12, 2021, to immunocompromised Medicare patients, consistent with the FDA’s updated emergency use authorizations, acknowledge and document (e.g., in the medical record) your patient’s self-reported qualifying conditions for the additional dose and bill the appropriate billing code for administering an additional dose.

• If you administer booster doses on or after September 22, 2021, to certain Medicare patients, consistent with the FDA’s updated emergency use authorizations, bill the appropriate billing code for administering the booster dose.

• When the government provides COVID-19 vaccines at no cost, only bill for the vaccine administration. Don’t include the vaccine codes on the claim when the vaccines are free.

https://www.cms.gov/medicare/covid-19/medicare-billing-covid-19-vaccine-shot-administration13

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Review Question

Which of the following questions regarding Medicare coverage of vaccinations is true?1. Medicare Part A patients have to wait until their 100-day benefit

expires to obtain a vaccine 2. Medicare Part B will cover vaccines directly related to the treatment

of an injury or direct exposure to a disease or condition3. Medicare Part D pays for the administration of a vaccine

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https://www.cms.gov/medicare/definitions

https://www.cms.gov/medicare/covid-19/medicare-billing-covid-19-vaccine-shot-administration

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Getting Started: Leadership and a Business PlanCustomers Skilled, Assisted Living, Independent Living, Community

Vaccines and Supplies Access to vaccines, ability to pay for vaccines, store vaccines, ship vaccines, Medical Supplies, emergency kits, documents, sharps

Capital $$$, investors, marketing, tuition, continuing education, PPE, transportation, shipping; hardware, tables, carts, chairs, posters, placards, temperature devices

Human Resources Certified pharmacists, nurses, certified technicians; training, job descriptions

Clinical Knowledge Vaccine information, vaccine ingredients, Vaccine schedules

Regulations State Board of Pharmacy rules and regulations

Policies & Procedures Operational policies, customer policies, if applicable, Job aids

Liability Insurance Corporate, individual

Billing Capabilities Coverage, payment, co-pays, electronic billing

Reporting & Record Keeping

Software, spread sheets, laptops, connectivity

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Types of Clinics and Covered ServicesSkilled Nursing FacilitiesDispensing OR Dispensing and AdministrationAssisted Living Communities

Dispensing and AdministrationIndependent Living

Dispensing and AdministrationGroup Homes

Dispensing and AdministrationHospiceDispensing OR Dispensing and Administration

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YOU can become a mass vaccinator!

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What Kind of Clinic Should We Offer?

Individual site capability

Environmental conditions, and

Consider populations to be served,

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Types of Clinics

• Appointment-only temporary clinics held in schools, churches, and pharmacies. • Smaller clinics can be laid out more efficiently and serve fewer people to help reduce

exposure risk for staff and patients. • Large-scale clinics, particularly those held indoors• Curb-side, Drive-through, MobileClinic Modeling• Walk-through clinics with line queues • Clinic flow should be one way starting with greeting to post vaccination monitoring..• Consider using online or phone options for scheduling appointments and completing

admissions and payment paperwork• Such processes should include registration, obtaining insurance information, and billing

(if needed), screening for contraindications and precautions, and texting or emailing vaccine information statements (VISs) or emergency use authorization (EUA) forms

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https://www.cdc.gov/vaccines/hcp/admin/mass-clinic-activities/index.html

Staff Functions Vaccination Clinic Day

Administer vaccine

Communicate with non-

English-speaking patients.

Direct clinic flowEducate patients

about the vaccine.

Greet patients

Implement infection control

measures

Monitor logistical, administrative, IT,

and financial activities

Monitor vaccine temperatures

before, during, & after the clinic.

Provide emergency

medical services.Provide security

Register patients, insurance

information, fees, as appropriate.

Report vaccines administered to the jurisdiction

Screen for vaccine eligibility &

contraindications and precautions.

Manage vaccines, storage, handling and transport to clinic if

necessary.

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Registration insurance Billing Consent

Screening Contra-indications Precautions Questionnaire

EducationVaccine

Information Sheets

Additional forms Q&A

Administrative workflow

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Location of Clinics

Indoor clinic such as one in a school, church, auditorium, theater, pharmacy, or inside a medical facility in a hallway, classroom, or cafeteria

Curbside or drive-through clinicOutdoor walk-through clinic or clinic in an outdoor tent outside a medical facility Mobile clinic

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https://www.cdc.gov/vaccines/hcp/admin/mass-clinic-activities/curbside-vaccination-clinics.html

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Physical Layout of an Indoor Vaccination Clinic

• Accommodate weather if it is a walk-through, curbside, drive-through, or mobile clinic• Accessible restrooms, waiting areas• Accessible and adequate entry and exit points, including the one-way clinic flow• Adequate heating and cooling, lighting• Capacity to adhere to infection prevention, equipment specifications, and public safety

regulation requirements and protocols• Compliance with Americans with Disabilities Act (ADA) standards, along with ease of

accessibility by the elderly and those with disabilities and mobility issues• Enough power outlets• Proximity to populations and mass transit• Space for clinic functions such as screening, registration, vaccine storage and

preparation, vaccination, holding areas to monitor for adverse reactions after vaccination, and emergency care

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Enter

Greet

RegisterConsent

EducateAnd Screen

Vaccinate

Observe

Emergent Care

Exit

Wait

Clinic Layout - Logistics

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Review Question

Which of the following will cause you to cancel a clinic and inconvenience patients?1. The vaccine did not arrive at the clinic2. The vaccine arrived, but is tainted3. The vaccination team arrived at wrong facility4. The team forgot consent forms and Vaccine Information Sheets5. All of the above

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In Summary : The Three Constants of Providing Vaccination Clinics

Communication

Coordination

Checklists

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Safety Is Your Finest Product!

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Ten Principles for Holding Safe Vaccination Clinics

1. Keep vaccines at the correct temperature at all times using proper procedures for vaccine transport, handling and storage. Document temperature monitoring at appropriate intervals during all stages. For further guidance: www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

2. Clinic: Have vaccine shipped directly to the site. If direct shipment is not possible, transport vaccine using correct storage and handling guidelines.

3. Train staff to perform CPR and treat medical emergencies, including anaphylaxis. Ensure supplies are on site, including an emergency medical kit and infection control supplies, as well as enough Vaccine Information Statements (VISs).

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http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf2.%20Pre-2

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4. Always check for medical contraindications and allergies beforevaccinating anyone. Provide Vaccination Information Sheets for all patients or guardians. 5. Follow manufacturers’ instructions and Advisory Committee on Immunization Practices guidelines for correct age and intervals for vaccines that require more than one dose. 6. Follow manufacturers’ instructions for injection dose, site, and route.7. Only use vaccines that are not damaged, not expired, at the correct temperature, and prepared using aseptic technique.

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8. Follow safe handling of needles and syringes, including using a new needle and syringe for every injection. Dispose of all sharps in a sharps container.

9. Document every vaccination and give patients a copy.

10. Keep patient information secure and private. Record vaccinations in jurisdictional vaccination information systems

Ten principles for safe vaccination clinics at satellite ,temporary, or off-site locations. National Adult and Influenza Immunization Summit; Updated January 25, 2019 https://www.izsummitpartners.org/content/uploads/2017/04/Ten-principles-for-safe-vac-clinics-1-pg-sum.pdf

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https://www.izsummitpartners.org/content/uploads/2017/04/Ten-principles-for-safe-vac-clinics-1-pg-sum.pdf

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Review Question

What competency would you add to your staff education regarding vaccination safety?1. Processes for temperature monitoring before and during a clinic2. How to properly eat lunch when administering vaccines3. HIPAA and Confidentiality rules have been waived for vaccination

clinics

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2021 Annual Meeting & ExhibitionNovember 4-7, 2021 | San Diego, California 32

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Vaccine Delivery

• Have vaccine(s) shipped directly to the clinic site instead of transporting them from another facility. • a location with on-site equipment that can secure and store vaccines at appropriate

temperatures. • Plans must be in place to ensure staff can check the shipment immediately upon arrival

to ensure there has been no temperature excursion, place the vaccines in storage unit(s), and regularly monitor vaccine temperatures.

• If direct shipment is not possible, plans must be made to ensure vaccines can be handled safely and the cold chain can be maintained during transport and throughout the clinic workday. • plans must include regular monitoring of vaccine temperature before, during, and after

the clinic.• Vaccines cannot be administered if they are not kept at appropriate

temperatures based on information in manufacturer package insert and CDC guidance.

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CDC Vaccine Checklist: Instructions1. A staff member who will be at the vaccination clinic should be designated as the clinic coordinator/supervisor. This person will be responsible for completing the steps below and will be referred to as “you” in these instructions. 2. Review this checklist during the planning stage of the vaccination clinic—well in advance of the date(s) when the clinic will be held. This checklist includes sections to be completed before, during, and after the clinic. 3. Critical guidelines for patient safety and vaccine effectiveness are identified by the stop sign icon: If you check “NO” in ONE OR MORE answer boxes that contain a , DO NOT move forward with the clinic. Follow your organization’s protocols and/or contact your state or local health department for guidance BEFORE proceeding with the clinic. Do not administer any vaccine until you have confirmed you can move forward with the clinic. 4. Contact your organization and/or health department if you have any concerns about whether vaccine was transported, stored, handled, or administered correctly, whether patients’ personal information was protected appropriately, or other responses that you have marked as “NO” in rows that do not have the .

5. This checklist should be used in conjunction with CDC’s Vaccine Storage and Handling Toolkit:https://www.izsummitpartners.org/content/uploads/2019/02/off-site-vaccination-clinic-checklist.pdf

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https://www.izsummitpartners.org/content/uploads/2019/02/off-site-vaccination-clinic-checklist.pdf

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Vaccine Clinic Checklist: Before the ClinicVACCINE SHIPMENT YES NO NA

VACCINE TRANSPORT

RECOMMENDED TEMPERATURES MAINTAINED

VACCINE STORAGE AND HANDLING

CLINIC PREPARATION AND SUPPLIES

A CONTINGENCY PLAN IS IN PLACE IN CASE VACCINES NEED TO BE REPLACED.

ALL VACCINATION PROVIDERS AT THE SITE ARE CERTIFIED IN CARDIOPULMONARY RESUSCITATION

THERE IS A DESIGNATED AREA AT THE SITE FOR MANAGEMENT OF PATIENTS WITH URGENT MEDICAL PROBLEMS ADEQUATE INFECTION CONTROL SUPPLIES ARE PROVIDED, INCLUDING BIOHAZARD CONTAINERS AND SUPPLIES FOR HAND HYGIENEADEQUATE SUPPLIES ON HAND ALCOHOL WIPES SYRINGES, NEEDLES, BANDAGES, ETC.

IF USING A STANDING ORDER PROTOCOL, THE PROTOCOL IS CURRENT AND AVAILABLE AT THE CLINIC/FACILITY SITEA PROCESS FOR SCREENING FOR CONTRAINDICATIONS AND PRECAUTIONS

A SUFFICIENT NUMBER OF VACCINE INFORMATION STATEMENTS 35

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Data Collection and Reporting

• Data collection and management strategy based on site capability (manual processes must be planned for temporary sites lacking specific infrastructure)

• Internet access• Access to vaccination history (if applicable)• Reporting to an IIS or electronic health record (EHR)

https://www.immunize.org/guide/pdfs/vacc-adults-step7B.pdf

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https://www.immunize.org/guide/pdfs/vacc-adults-step7B.pdf

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Vaccination Data Reporting

• Data May Include:• Provider information• Patient name, address• Date of birth, race• Insurance information• Date of vaccination(s), or refusal• Vaccination product(s), manufacturer, lot #, Expiration date• Site and route of administration

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CMS COVID-19 Provider Toolkithttps://www.cms.gov/covidvax

COVID-19 Vaccine Policies & GuidanceWe’re giving you the information you need to provide the COVID-19 vaccine. We have many resources about coverage and billing for providers, state Medicaid plans, and private health plans.

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https://www.cms.gov/covidvax

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Billing for Covid-19 VaccinationsYou must be a Medicare-enrolled provider to bill Medicare for administering COVID-19 vaccines to Medicare patients.• You can bill on single claims for administering the COVID-19 vaccine, or submit a roster bill for

multiple patients • When you choose the Place of Service (POS) code for your Part B claims, care fully consider where

you provided the vaccine. Payment is based on the Place of Service• If you administer additional vaccine doses on or after August 12, 2021, consistent with the FDA’s

updated emergency use authorizations, acknowledge and document your patient’s self-reported qualifying conditions for the additional dose (3rd Dose)

• When the government provides COVID-19 vaccines at no cost, only bill for the vaccine administration. Don’t include the vaccine codes on the claim when the vaccines are free.

• If you have temporary billing privileges because of the public health emergency (PHE) and you have 1 National Provider Identifier (NPI) tied to multiple Provider Transaction Access Numbers (PTANs), use the taxonomy code on your claim to help you assign the correct PTAN.

• Use the ICD-10 diagnosis code Z23 (encounter for immunization) on the claim.• Until the PHE ends, you should include modifier CR on your claim only if you administer the COVID-

19 vaccine at a temporary location that isn’t considered your actual practice location

Enrollment for Administering COVID-19 Vaccines. Enrollment for Administering COVID-19 Vaccines | CMS.Accessed September 12, 2021

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Provisional Enrollment for COVID-19 VaccinationAdministration

• Medicare grants billing privileges through the Medicare Provider Enrollment Hotline on a provisional basis because of the public health emergency (PHE). These billing privileges are temporary.

• When the COVID-19 PHE ends, Medicare Administrative Contractors (MAC) will contact providers and suppliers to request a complete enrollment application to establish full Medicare billing privileges.

If no response within 30 days of the MAC’s request, the MAC will deactivate your temporary billing privileges.

If you provide services while you have deactivated billing privileges, Medicare can’t pay you

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https://www.cms.gov/medicare/covid-19/enrollment-administering-covid-19-vaccines

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Medicare Enrollment

• If you’re not a Medicare provider, you must qualify and enroll as a Mass Immunizer or other Medicare provider type that allows billing for administering vaccines. Enrolling over the phone is easy and quick. You will need:

• Valid Legal Business Name (LBN)• National Provider Identifier (NPI)• Tax Identification Number (TIN)• Practice location• State license, if applicable

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Centralized Billing

• If you’re a mass immunizer, use centralized billing to send all of your COVID-19 vaccine roster bill claims, to a single MAC

• Estimate of how many patients to whom you expect to administer the COVID-19 vaccine

• Approximate dates of vaccines• List of states for COVID-19 vaccination clinics• Type of services you generally deliver other than preventive vaccinations,

if any• Whether you employ nurses who will administer the COVID-19 vaccine or

if you hired them specifically to give these vaccines• Names and addresses of all entities operating under your application• Contact information for your centralized billing program

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Billing for Flu Vaccine

• Get payment allowances & effective dates for the 2021-2022 season

• Find the right HCPCS, CPT, & ICD-10 codes• You may use roster billing or submit individual claims• All providers who administer the flu shot must accept

assignment• Entities, like local health facilities, must get a national provider

identifier if they’ve never submitted Medicare claims• Learn about roster billing, mass immunizers, & centralized

billing

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Valid Types of Bills for Roster Billing12X Hospital Inpatient

13X Hospital Outpatient

22X Skilled Nursing Facility (SNF) covered Part A stay (paid under Part B) & Inpatient Part B

23X SNF Outpatient72X Independent and Hospital-based Renal Dialysis Facility75X Comprehensive Outpatient Rehabilitation Facility81X Hospice (nonhospital based)82X Hospice (hospital based85X Critical Access Hospital34X Home Health (Part B Only)

Roster Bill: A way for you to submit multiple claims for COVID, flu, and pneumococcal vaccines. Entities enrolled as Mass Immunization Roster Billers must use roster billing. Must bill each type of vaccine on a separate roster bill. You can’t combine COVID, flu, and pneumococcal vaccine codes on the same roster bill. https://www.cms.gov/medicare/definitions

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https://www.cms.gov/medicare/definitions

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Review Question

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If you are not currently enrolled as a Medicare Provider, is there a way to provide COVID-19 Vaccines during this pandemic?1. No, the provider door is closed 2. Yes, I can apply for a Medicare provisional status3. Yes, I can ask each patient to pay cash

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Marketing

• Social Marketing practice is guided by ethical principles. • Seeks to integrate research, best practice, theory, audience and partnership

insight, to inform the delivery of programs that are effective, efficient, equitable and sustainable.

• Benefits of Vaccinations• Heavy use of symbols or symbolic messaging

• “Smokey the Bear”• “Your Brain on Drugs”

• Promotes your brand awareness

Tapp, A., Brophy. R., Carausan, M., Carruthers, J., Peattie, S., Revill, S., Chamberlain, M., Lee, N., Sherif, S., Beall, T., Morgan, W., Lellig, C., Suggs, L.S., & French, J Social marketing practice. (2013). Endorsed by iSMA, ESMA, AASM

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Questions? Thank you!

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