Strategies for Obtaining Pharmaceuticals

1
Strategies for Obtaining Pharmaceuticals

• Eric Meininger, M.D., M.P.H.
• Staff Physician, Community-University Health Care
  Center
• Staff Physician, Southside Community Health
  Services
• Aaron Petersen, L.C.S.W.
• Pharmacy Programs Coordinator, Heartland Health
  Outreach
• Andrew Draper, Pharm.D., M.S.A.
• Pharmacy Manager, 4th Street Pharmacy

National Health Care for the Homeless Annual
Conference Hyatt Regency Phoenix, Arizona June
12, 2008
2
Overview of presentation

• Introduction of speakers
• Discussion of medication procurement strategies
• HCH on-site pharmacies
• Other models to provide medications to patients
• Working with medication procurement programs
• Deciding the best program for your clinic
• Questions/Answers

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Learning Objectives

• 1. Gain better understanding of Patient Assistant
  Programs (PAPs) and how they can be utilized 
• 2. Gain better understanding of how HRSAs
  Federal 340B medication program, designs, and
  rules can be utilized 
• 3. Examine historical reasoning for onsite
  pharmacies at HCH programs 
• 4. Examine different models for obtaining and
  dispensing pharmaceuticals for homeless patients
  (not just at HCH on-site pharmacies). 
• 5. Discuss use of PAPs, 340B programs, and
  samples for either on-site or off-site
  acquisition of pharmaceuticals (adding samples).

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Lack of Insurance Can Have a Significant Impact
on Health

• Nearly 3 in 5 uninsured adults have gone without
  coverage for at least two years
• More than 50 of uninsured adults report that
  they or a member of their household have skipped
  medical treatment due to cost, compared to only
  25 of insured adults
• 1 in 3 uninsured people dont fill their
  prescriptions due to costs
• 60 of people with chronic conditions skip
  medicines if uninsured

Result The Uninsured Wait Until Conditions
Become Critical and More Complicated and
Costly to Treat
Sources Income, Poverty, and Health Insurance
Coverage in the US 2005, August 2006 Kaiser
Family Foundation, The Public on Health Care
Costs, December 2005 Urban Institute and Kaiser
Commission on Medicaid and the Uninsured
estimates based on the Census Bureau's March 2005
and 2006 Current Population Survey (CPS Annual
Social and Economic Supplements) Commonwealth
Fund Biennial Health Insurance Survey 2003.
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Medication Access Strategies

• Medication Samples
• 340B Drug Pricing Program
• In-house pharmacy
• Patient Assistance Programs

• Glenn ZM. Program Development Consultant. HRSA
  Pharmacy Services Support Center presentation.
  2008

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Samples Heartland Health Outreach

• Avoid dependence on samples through Reps
• Bulk sampling through Merck
• Eli Lilly sampling through internet (insulin)
• Only sampling products that are available through
  PAP

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The PHS 340B DrugPricing Program

• Established in 1992
• Provides discounts on outpatient drugs to covered
  entities
• Manufacturers that participate in Medicaid must
  also sign an agreement to participate in 340B
  Drug Pricing Program

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Who are the Covered Entities

• Consolidated Health Centers
• AIDS clinics and drug programs
• Black Lung Clinics
• Federally Qualified Health Center Look-a-likes
• Disproportionate Share Hospitals

• Hemophilia treatment centers
• Native Hawaiian health centers
• Urban Indian clinics/638 tribal centers
• Title X family planning clinics
• STD clinics
• TB clinics

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Why 340B?

• Reduce prescription drug expenditures by safety
  net providers in order to
• Expand health services access to
• Low-income individuals/families
• Vulnerable populations
• Reduce taxpayer burden
• Average savings 25-50 for covered medications
  (NACHC Survey)

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340B definitions

• Covered outpatient drugs (42 USC 340B(b))
• Prescription drugs, over-the-counter drugs that
  are prescribed
• Excludes vaccines and inpatient drugs.
• A patient of a covered entity (61 FR 55156)
• Receives a range of health care services from a
  practitioner employed by the entity such that the
  entity remains responsible for the care of the
  patient
• Grantee entities care must be within the scope
  of the grant
• Health records maintained by the entity
• Getting prescription services not enough to make
  you a patient.

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Diversion to non-patients

• Section 340B makes it illegal to sell or provide
  340B-priced drugs to persons who are not patients
  of a covered entity.
• Entities are responsible for having procedures to
  prevent this and records to prove it.
• Does not require separate inventories.
• Subject to audit by the manufacturer or the
  Secretary.

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340B Price Determination

• Brand name drugs 340B price for each unit of the
  drug cannot exceed Average Manufacturer Price
  (AMP) (as reported to CMS under Medicaid rebate
  program) minus rebate percentage
• Minimum discount on branded drugs AMP minus 15
• Generic and prescribed OTC drugs AMP minus 11
• Ceiling price deeper discounts can be
  negotiated
• 340B Prime Vendor Program
• Studies show average savings of 51 below AWP
• No list of the 340B price exists

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CHC 340B In-House Pharmacy How it works

• Entity establishes pharmacy according to state
  law.
• Entity buys covered drugs at the 340B price (or
  lower if Prime Vendor or entity-negotiated with
  the manufacturer) through their wholesaler
• Outpatients with 3rd party prescription coverage
  Co-pay and pharmacy reimbursement according to
  the insurers policy
• 340B does not prescribe how the savings must be
  used or spent
• Medicaid patients entity must choose a procedure
  that prevents duplicate discounts
• Uninsured patients what patient pays determined
  by the entity, often on a sliding scale,
  subsidized by 340B savings from other patient
  transactions.

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340B Contract Pharmacy (Final guidelines 61 FR
4359, August 23, 1996)

• Allows an entity to contract with a pharmacy to
  dispense 340B drugs and provide pharmacy services
  to the entitys patients.
• One contracted pharmacy per eligible entity site
• Pharmacy must provide entity with reports
  consistent with customary business practices
• Entity and pharmacy subject to audits
• Entity and pharmacy must comply with all Federal
  and State laws
• Does NOT require dual physical inventory

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Resources for 340B implementation

• The Bridge to 340B Comprehensive Pharmacy
  Services Solutions in Underserved Populations
• Implementing a Comprehensive 340B Contracted
  Pharmacy Service
• Interactive Contract Pharmacy Financial Model
  Spreadsheet (Excel)
• Interactive In-House Pharmacy Financial Model
  Spreadsheet (Excel)

http//pssc.aphanet.org/resources.htm
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Assessing Program Components

• Formulary management
• Samples
• Patient assistance programs
• Pharmacy service option
• In-house
• Contract
• Other

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Alternative Method Demonstration Projects

• Goal is to demonstrate and evaluate new methods
  of accessing 340B drug discounts to serve greater
  numbers of indigent and uninsured people
• Non-funded projects
• No application deadlines/funding cycles
• Multiple contracted pharmacies
• Contracted pharmacy supplement to in-house
  pharmacy

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Accessing the 340BProgram Pricing
Prime Vendor Program (Apexus)
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Prime Vendor Program

• Improve access to affordable medications for
  covered entities and their patients
• Primary goals
• Lower participants supply costs by expanding the
  current PVP portfolio of sub-340B priced products
  
• Provide covered entities with access to efficient
  drug distribution solutions to meet their
  patients needs
• Provide access to other value added products and
  services meeting covered entities unique needs
• Vaccines, prescription vials, syringes, diabetic
  supplies, pharmacy technology/automation, etc.

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Prime Vendor Program Benefits

• A benefit to all HRSA grantees with no risk or
  cost to participate
• Ensures compliance with 330 grant requirements
• Immediate reduction of pharmacy expenditures
• All covered entities have realized savings
  joining program
• Choice of pharmacy distributor with low fees
• National purchasing program to secure steepest
  discounts on drugs and other pharmacy related
  products
• Accurate and transparent pricing via secure
  website
• Longer term contracts to base formulary decisions
  and minimize budget fluctuations

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Prime Vendor Participation Agreement

• Verification of enrollment in 340B program on
  HRSA Office of Pharmacy Affairs database
• Complete prime vendor agreement with Apexus Inc.
  (formerly HealthCare Purchasing Partners
  International/HPPI)
• www.340bpvp.com
• Toll Free Number 1-888-340B PVP
• Chris Hatwig at [phone] or
  chatwig_at_340bpvp.com

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Getting Help The Pharmacy Services Support Center

• Overseen by Office of Pharmacy Affairs
• Established September 2002
• Contract between HRSA and the American
  Pharmacists Association
• Harry Hagel, RPh, MS
• Senior Director
• Facilitate development of clinical and
  cost-effective pharmacy services

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PSSC Improving Access to Pharmacy Services

• Organize and manage information
• Promote value of pharmacy services
• Support programs to enhance access
• Manage technical assistance program

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PSSC Technical Assistance

• Team of consultants with knowledge and experience
  in clinical and cost-effect pharmacy services in
  340B entity settings
• FREE TA provided to eligible entities
• Assistance provided on-site, by phone or via
  e-mail
• Larry Brandt, Director

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Optimizing the 340B Program

• Strong PT Committee
• Good representation
• Meet regularly
• Formulary Management is Imperative
• Inventory Control
• Check 340B prices on purchases
• Use wholesaler programs to access lowest price

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Optimizing the 340B Program

• Use wholesaler to automatically update the 340B
  quarterly price changes
• Utilize the Prime Vendor Program
• Medications
• Supplies (printer cartridges, vials, labels)
• Pfizer Share the Care Program
• In-house Pharmacies
• Maximize use of extremely low price items (0.01
  items)

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Optimizing the 340B Program

• Utilize PAP programs that you need
• Limit the use of manufacturer samples to the ones
  that you need
• Participate in 3rd Party Plans
• Participate in Medicare Part D Plans
• Solidify Medical Home for patients
• Prevent loss of patients
• Additional revenue

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Optimizing the 340B Program

• Charge a dispensing fee for each medication
  dispensed
• PAP
• Pfizer Share the Care
• Work closely with Schools of Pharmacy
• Get FREE help from PSSC as needed!

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Resources

• HRSA Pharmacy Services Support Center
• 1-800-628-6297
• E-mail pssc_at_aphanet.org
• Web page http//pssc.aphanet.org/
• PSSC Technical Assistance
• www.pharmta.net
• The 340B Prime Vendor Program
• www.340bpvp.com
• Toll free [phone]

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340B where does NHCHC stand as a group?

• NHCHC 111 member entities analyzed
• 88 of 111 (79) entities eligible and enrolled in
  the 340b program
• These 88 entities represent a total of 469 sites
• Of 469 total sites, 382 are enrolled in Prime
  Vendor Program (PVP)
• Of 87 sites not enrolled in PVP, 41 of the
  entities are represented

340b PVP data analysis, May 2008
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Formulary Planning

• Formulary rationale for Phillips Neighborhood
  Clinic
• Stock medications to treat conditions most
  prevalent among PNC clients.
• Stock a first line agent as well as 1-2
  alternatives that may be used.
• Address the cost of the individual medications
  when choosing what to include in the formulary.

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Example Inventory Data
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HCH on-site pharmacies
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Historical background of Fourth Street Clinic

• Federally Qualified Health Center
• Began operating at current site in Salt Lake
  City, Utah in 1993
• Became independent, nonprofit organization in
  1998
• Present location is easily accessible to
  residents of area shelters and close to sister
  agencies.
• 6 outreach sites (Overflow, E-beds, St Vincents,
  Street Outreach, VOA Detox, Peds Offsite)

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Fourth Street Clinic

• Services provided to homeless patients
• Over 25K medical visits annually for over 5700
  patients
• 40 medical/behavioral health professionals,
  support staff, and administration personnel.
• More than 30 medical volunteers and 20 pharmacy
  volunteers
• Services provided in over 15 specialties

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Fourth Street Pharmacy
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Historical background of Fourth Street Pharmacy

• 1997 Executive director and Dr. Ken Buchi,
  medical director, felt an on-site pharmacy needed
• Local college of pharmacy approached, but no real
  agreement reached
• Considered automated dispensing machine
• First full-time physician in clinic, Scott
  Stevens, developed relationship with Pfizer to
  obtain pharmaceuticals through Sharing the Care
  (STC)

41
Fourth Street Pharmacy inception

• Without financing, the clinic jumped into
  part-time on-site pharmacy operation
• 2001 Pharmacy licensed with DEA and state
  pharmacy board
• Solicited pharmacist help from community
• Part-time pharmacy manager not adequate
• 2005 Pharmacy expansion doubled size
• 2006Formal hiring was done for Patient
  Assistance (PA) advocate

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Fourth Street Pharmacy expansion

• 2006-7 Funding was obtained for full-time
  pharmacy manager
• Expanded to Monday-Friday effective July 2007
• Typically dispense gt2500 Rxs/month
• Budget 100K annually
• PA, Pfizer Sharing-the-Care meds valued at nearly
  1M annually
• Work with over 30 pharmaceutical companies for PA
  medications

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Formulary

• Formulary developed to be lean, yet adequate
• Reviewed at least annually
• modifications made as drugs become available
  generically or pricing discounts are offered
• Limited controlled substances for specific
  circumstancesno narcotics
• Formulary exceptions are worked through on a
  case-by-case basis

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Eligibility

• Patients eligible for services at the clinic may
  receive their medications if they do not have 3rd
  party insurance
• We work closely with patients who have 3rd party
  insurance to minimize copays and insure
  continuity of care
• Staff emphasize 3rd party prescriptions are a
  step toward health care self-sufficiency

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Funding

• State primary care funding
• Federal HCH funding
• Corporate funding (American Express,
  Intermountain Healthcare)
• Philanthropy (Eccles Foundations, United Way)
• No copays for medications (slide all patients to
  zero because lt100 Federal Poverty level)
• No billing of 3rd parties
• Financial evaluation completed to determine
  feasibility

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Philosophy

• Provide respectful, comprehensive pharmaceutical
  care
• Strive to give patients benefit of doubt and help
  out however we canmanagement supportive
• Administer PA programs to ? medication costs
• Bring patients into mainstream healthcare
• Free up providers for other clinical tasks
• Financial benefits direct access to 340b
  pricing, direct control over formulary/drug
  spending

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Establish pharmaceutical care as integral part of
clinic
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What is pharmaceutical care?

• Pharmaceutical care is a patient-centered,
  outcomes-oriented pharmacy practice that requires
  the pharmacist to work in concert with the
  patient and the patients other health care
  providers to promote health, to prevent
  diseaseto optimize the patients health-related
  quality of life and achieve positive clinical
  outcomes.

American Pharmacists Association, 1995
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Operating model

• Operational, clinical skills are blended
• Patients have a relationship with a clinic
  provider before prescriptions are issued
• Prescriptions are issued
• Eligibility for pharmacy services is determined
  patients with 3rd party insurance are directed to
  outside pharmacy

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Operating model (2)

• Prescriptions are filled as in a regular pharmacy
• Prescription entered in computer database
• Screening for drug interactions, therapeutic
  duplication, dosing, accuracy
• Emphasis placed on basic counseling, open
  interaction/patient questions, and taking
  responsibility for own healthcare
• Pharmacy staff triage patients for med refills
• Medications are prepared for evening and weekend
  outreach clinics
• Pharmacist operates with technicians and PA
  clerks in accordance with state/federal
  regulations

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Operating model (3)

• Patients are signed up for PA at the time of
  initial dispensing
• PA advocates rapidly determine documentation
  lacking
• Medications are prioritized
• Decisions driven by data
• Medication supplies are sometimes restricted
• Work with outsourced workers on-site
  (DWSMedicaid, Social Security) for documentation
• Samples, generic meds are used to begin therapy

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Operating model (4)

• Staffing overseen by pharmacy manager
• Intermountain Healthcare donates pharmacist time
• Community Volunteers also provide pharmacist time
  and expertise
• Technicians seeking pharmacy experience also
  volunteer both in PA and pharmacy

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Operating model (5)

• Pharmacy manager
• Interfaces with pharmacist volunteers and
  providers in pharmacy day-to-day operations (a
  health care professional and not a technician)
• Resolve important details/patient issues
• Improve cohesiveness with provider team
• Oversees operation of the PA program
• Coordinates formulary with preferred PA
• Directs PA/pharmacy personnel on program
  direction
• Directs procurement of medication samples and
  documentation
• Participates on organizational leadership team
  and provider meetings

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Work closely with provider staff

• Back door medicine pharmacy connects with
  clinic for frequent cross-talk both ways
• Formulary changes therapeutic substitutions
  working with outside pharmacies, providers and
  agencies.
• Electronic Health Records (EHR)/Electronic
  Prescribing
• Drug information and interaction resource for
  providers
• Access to patient chart and health information to
  resolve patient issues

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Administer PA programs

• Technician, part-time pharmacist initially
• May 06brought on PT PA advocate, added another
  PA advocate in Jun 07
• Hours increased at beginning of 2008 for both PA
  advocates
• Increase pt access
• Meet increased volume
• Real-time forms processing

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Integrated pharmaceutical care vs. provider
dispensing

• Additional documentation, safety, oversight
• Pharmacist monitors
• correct medication use
• drug side effects
• drug interactions
• patients responsibility for own health
• Additional distinct interaction with another
  health care professional adds great value to the
  overall healthcare encounter.

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Some Fourth Street Pharmacy Facts and Figures

• First 4 months 2007
• 7,665 prescriptions
• 27,174 expenditures
• Raw Per Rx cost 3.55
• First 4 months 2008
• 11,273 prescriptions
• 32,236 expenditures
• Raw Per Rx cost 2.86
• Operating hours increased by nearly 100
• 47 increase in volume, only 19 increase in cost
  (includes gt10 annual increase in pharmaceuticals
  costs)

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Some Fourth Street Pharmacy Facts and Figures,
cont.

• Value of patient assistance medications/ Sharing
  the Care (STC)
• 2006 values 128K Pfizer STC, 793K PA/Samples
• 2007 values 192K Pfizer STC, 978K PA/Samples
• Spent additional 49K on PA personnel, pharmacist
  personnel salaries annually
• Bottom line Greatly improve patient access to
  pharmaceutical services AND quality of patient
  encounters in the pharmacy

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Other pharmacies that are now providing on-site
pharmacy services

• Once youve seen one health care for the
  homeless program, youve seen one health care for
  the homeless program.
• each site unique
• Individual facilities should tailor their
  medication procurement strategies to local
  funding, physical facility, and community support
  constraints.

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Albuquerque Health Care for the HomelessPharmacy
highlights (NM)

• Pharmacy located in the middle of the HCH clinic
• Relationships with University of New Mexico
  (UNM), medical students, community providers
• UNM, ValueOptions are alternate med sources
• 1 full-time RPh, 2 full-time techs, student
  support Fall 2008 through grant
• Pfizer, 8 pharmaceutical companies for PA

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Albuquerque Health Care for the Homeless Pharmacy
highlights (2)

• No controlled substances
• Samples managed through pharmacist in charge
  (physicians known in area)
• Operates a refill program
• Prescriptions are processed using commercial
  software
• Fill for Outreach clinics (4) as well as Saturday
  clinic
• No billing of 3rd parties

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Saint Vincent de Pauls Pharmacy (LA)

• Originally established next to a clinic
• Full time pharmacist full time pharmacy
  technician, pharmacy managerhalf of pharmacist
  hours by volunteers pharmacy receptionists greet
  customer
• Part time (4 days/wk) PA representative
• No 340b pricing samples from nursing homes, MD
  offices, other donations

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Saint Vincent de Pauls Pharmacy (2)

• Refills delivered to medication drop off points
  approximately once weekly
• Volunteers do screening for eligibilityletters
  from halfway house/shelter for eligibilityalso
  help with sample management
• Freestanding pharmacy, affiliated with
  Association for Free Pharmacies/Clinics in LA
• Works through Saint Vincent de Paul network to
  garner community support and financial support

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Closed door pharmacy models

• (Texas) Healthcare for the Homeless-Houston
• Pharmacist assisted in development of formulary
  through organizations PT3 clinics plus dental
  clinic
• No direct access for patients to pharmacy
• (Mississippi) Coastal Family Health Center
• 8 clinics feed prescriptions to the pharmacy
• Pharmaceutical donations after Hurricane Katrina
• Deliver medications back to patient with info
• Use Pfizer STC, 340b pricing

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Conclusion

• HCH leaders can benefit from the expertise of a
  pharmacist
• Set up/run pharmacy operations
• Access medications
• Dispense prescriptions
• Manage formulary
• Counsel/educate patient
• Decrease risks of adverse effects
• Decrease clinic expenditures for meds/health care

Dent LA et al. J Am Pharm Assoc
200242(3)497-507.
66
Working with Patient Assistance (PA) medication
procurement programs

• General Patient assistance programs
• Rxassist.org
• Others Needymeds.com, IndiCare.com,
  themedicineprogram.com, PPARx.org
• Multiple individual pharmaceutical companies
• Pfizer Providing different programs to help
  provide medications for homeless patients
  Pfizer Helpful Answers
• Connection to care, Sharing the Care, Others

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Access to Prescription Medicines for the Uninsured
.
.
1-888-4PPA-NOW ? www pparx org
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Connection to Care Application
69
Tools You Can Find Online
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Experience with Pfizer Helpful Answers

• Responsive to our needs when issues arrive or new
  products are added
• Easy to reach a customer service representative
• Voucher program works smoothly for replenishment
• Electronic vouchering and other programs are
  available

71
Working with medication procurement programs

• Other PAPs
• Electronic maintenance of PAPs
• Staffing for PAP paperwork

72
Outcomes for providing medications to homeless
patients

• Analyzed both Cholesterol and Hemoglobin A1c of
  all clinic patients before and after
  implementation of PAP.
• Both were lowered considerably.
• General increase in patient compliance and
  commitment to their own health with ability to
  access to prescribed medications.

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Putting it all together

• Picking the model that works best for your
  specific situation (or blending the models)
• People to contact to start the process of
  obtaining medications for patients, or modifying
  your current process

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Questions?
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Group Discussion

• Barriers/cost savings of PAPs
• How were some of roadblocks removed?
• Which PAPs were easiest to work with?
• Which PAPs programs do you recommend working with?

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Group Discussion

• Barriers/cost savings of 340b
• Why would we not want to participate in the 340b
  program?
• What might we do if a pharmacy we approach does
  not want to contract with us?
• If I participate in 340b pricing currently but do
  not access the prime vendor program, what do I do?

77
Group Discussion

• Barriers/cost savings of on-site pharmacies
• What are benefits of on-site pharmacies? 
• How do I go about establishing an on-site
  pharmacy?
• How do we comply with legal requirements for
  state, federal licensure?
• How do we set up contracts with 340b and PVP
  programs, plus drug wholesalers?
• How do I set up PA programs?

78
Group Discussion

• Barriers/cost savings of on-site pharmacies
• Muster community supportRPhs in general have
  been very willing to donate time
• Consult colleges of pharmacy, local pharmacy
  associations, pharmaceutical representatives
• Consider hiring a pharmacist to do the setup
  process for youcomputer system setup
• Decide what your goals are
• Hours of operation, staffing, programs to work
  with, etc
• Conduct financial analysis

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Contact information

• Eric Meininger
• meininger_at_iname.com
• Aaron Petersen
• apetersen_at_heartlandalliance.org
• Andrew Draper, Pharmacy Manager
• andrew_at_fourthstreetclinic.org

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Questions