SlideShare a Scribd company logo
1 of 30
Michol Bobb, CPhT
mbobb1@umbc.edu
Intern
Maryland Medicaid Pharmacy Program
May 2013
 To identify a way for State Medicaid
Agencies to recognize 340B priced claims in
order to avoid inappropriate rebate
processing
 340B is a Federal Discounted Drug Pricing Program that resulted
from the enactment of Public Law 102-585
1
(the Veterans Health
Care Act of 1992).
 This Act came about as a means of controling the prices that
specified government agencies
2
paid for purchasing
pharmaceuticals.
 The intent of this program is to expand access to affordable
medications in low income populations and help support the
operations of safety net organizations.
 The 340B price is a ceiling price set by drug manufactures that is
less than the Medicaid price of an eligible outpatient drug.
 Apexus: Responsible for negotiating prices
below the 340B ceiling price and improving
access to affordable medications through a
distribution network
 Helps to offset the federal and state costs for
most outpatient prescription drugs dispensed to
Medicaid patients.
 Requires drug manufacture’s to enter into a
national rebate agreement with the Secretary of
DHHS
4
(known as the Medicaid Drug Rebate
Agreement5
) in exchange for State Medicaid
coverage of the manufacture’s drugs.
 This agreement holds manufacture’s responsible
for paying a rebate each time one of their drugs
is dispensed to a Medicaid patient
 HRSA
6
: Regulator
 OPA
7
: Regulator
 Medicaid: Payer
 Contract Pharmacies: Providers
 A 340B patient is defined as:
◦ Someone who receives healthcare services from a
covered entity that maintains health records for the
patient.
◦ Someone who is prescribed medications that are for the
treatment of a received outpatient service at a covered
entity.
◦ Someone referred for care within a covered entity (from
a non-covered entity) becomes eligible as a 340B patient
if the continuum of care is within the 340B covered entity
 340B covered entities are organizations
(facilities/programs) that provide medical
services to the patient and are listed in the
340B Statute as eligible to purchase drugs
through the 340B Program and appear on
the Office of Pharmacy Affairs Database.
 Federally Qualified Health Centers (FQHC)
 Comprehensive Hemophilia Treatment Centers
 Ryan White Programs (Parts A, B, C, D)
8
 Sexually Transmitted Disease/Tuberculosis Programs
 Title X Family Planning Clinics
9
 Urban / 638 Tribal Programs
10
 Federally Qualified Health Center Look-Alikes (FQHC-LA)
 Disproportionate Share Hospitals (DSH)
 Children’s Hospitals
 Free Standing Cancer Hospitals
 Critical Access Hospitals
 Sole Community Hospitals
 Rural Referral Centers
 Contract pharmacies work with covered
entities to fill 340B prescriptions for 340B
eligible patients. The covered entity is
responsible for maintaining health records
for the patient and the pharmacy is
responsible for maintaining medication
records for the patient with access to the
patients health records.
 1. Hospital: The hospital must be eligible for 340B and registered with the 340B
program.
 2. Patient: Patient must be seen in an outpatient facility or service area which
is “integral” to the hospital (i.e., whose costs are listed on the reimbursable
section of the hospital’s latest Medicare Cost Report-records each institution's
total costs and charges associated with providing services to all patients).
 3. Provider: Patient must be seen by a provider who is employed
by, contracted by, or through other arrangements (such as a referral for
consultation). “Other arrangements” are applicable if the prescriptions captured
are “proximate in type and time” to the care patients receive at the hospital.
 4. Records of Care: The record of care and responsibility of care must reside
with the hospital
 5. Pharmacy: Patient must obtain their prescription at the hospital’s pharmacy
or from one of its 340B contracted pharmacies.
 Ship-to Bill-to Method: With contract
pharmacies, the 340B drugs get billed to the
covered entity and shipped to the pharmacy
address
 Virtual inventories: It is managed by software
from a third party company (Ex. SunRx). It
limits the risk of diversion because it accounts
for every 340B script that is filled.
 Replenishment Systems: Easier to maintain
when using a virtual inventory because the
third party automatically replenishes the
pharmacy’s stock without the actual pharmacy
needing to keep track of used medications
 Covered drugs:
◦ Outpatient Prescription drugs
◦ Over-the-counter drugs (accompanied by
prescription)
◦ Clinic administered drugs within eligible facilities
 Non-covered drugs:
◦ Vaccines
◦ In-patient drugs
 1. Use 2 McKesson accounts, use parenthesis around drug
name to identify 340B
 2. Use dual inventory system, created NRX13
system, use
asterisk around product name to identify 340B, use ship-to
bill-to
 3. Use electronic inventory, uses patients to identify
 4. Wrong contact person
 5. Uses CaptureRx
 6. Referred to another person in charge of CHAMP14
program
 7. Doesn't participate, 340B is to confusing
 8. Clinic does everything and replaces drugs used in
pharmacy
 9. (had a 340B contact person listed that was in charge of
multiple sites) Doesn’t participate in MD
 10. Two separate inventories and 2 separate accounts with
wholesaler
 11. One store participates, uses 3rd party to identify
340B scripts (would not disclose name of 3rd party)
 12. Told me to address any questions to the covered
entity, doesn’t know much about 340B
 13. Four 340B hospitals out of 10
 14. Mixed-use = carve in, retail = carve out, uses
replenishment model, uses virtual inventory system to
track usage (does not identify drugs at shelf level)
 15. Use ship-to bill-to, doesn’t use any inventory system
 16. One program in MD, virtual inventory
system, retail pharmacy contract, bill-to
ship-to replacement method
 * Results: HRSA website contained
inconsistencies with contact name, contact
number, and participating information
 Use Provider NPI
15
 Use HRSA Exclusion File: contact providers
to ensure participation
 Use an agency created exclusion file and
audit that against HRSA exclusion file
 Use NCPDP
16
Transaction Strings: basis of
cost and 340B indicator fields
 Monthly Claims Audit is required from 340B
pharmacies: monitors that discount is being
passed on to Medicaid
 340B providers have different ID numbers
 Dual inventory systems
 Avoiding Duplicate Discounts:
◦ Exclude all claims from entities on HRSA
exclusion file in rebate processing, encourage
providers to be all in or all out.
 Charge no more than actual acquisition cost
+ dispensing fee
 Use Usual and Customary pricing: to
identify 340B claims on invoices
 Pay dispensing fees up to $12.00
 *data was obtained from 42 states*17
 The 340B ceiling prices are calculated according to a formula
that is based on information generated in connection with the
Medicaid drug rebate program
 Manufacturers are required to report to the Centers for
Medicare & Medicaid Services (CMS) each quarter the average
manufacturer price (AMP) for each of their drugs
 CMS uses AMP and other data to calculate a unit rebate
amount (URA) that serves as a basis for the rebate amounts
paid by manufacturers
 The AMP and URA used in the 340B ceiling price formula are
based on the smallest dispensable unit of each drug
 The 340B ceiling price is based on these components and is
essentially equal to the AMP reduced by the URA
 The 340B ceiling prices per package are
calculated as follows:
◦ [(AMP) - (URA)] * drug’s package size
 Can’t identify by pharmacy: purchase 340B and
non 340B drugs
 Can’t identify by patient: they bring in the
prescription (unless entity fills all 340B scripts)
 Can’t identify by prescriber: may work at 340B
and non 340B entity
 Can’t identify by NDC
19
: 340B and non 340B
dugs have same NDC (some places put a
unique identifier in the NDC)
 Have provider differentiate 340B claims at time
of submission
 Split billing software to differentiate 340B claims
 Implementing audit forms
 *after verifying all information is accurate* -
Require all participating entities on the HRSA
exclusion file to purchase and bill all Medicaid
drugs under 340B pricing
 Include a line in the NCPDP transaction that
codifies a 340B claim
 Recommend that state Medicaid Agencies
come together and petition for HRSA to
release 340B prices
1.Limitation on prices of drugs
2. US Department of Veterans Affairs: (Big 4) Department of Veterans Affairs, the
Department of Defense, Public Health Service/Indian Health Service, and the Coast
Guard. These government agencies receive special pricing discounts on pharmaceuticals
in accordance with public law 102-585.
3. Partnership between CMS, State Agencies, and participating drug manufactures
4. Department of Health and Human Services
5. Medicaid Drug Rebate Agreement: http://www.medicaid.gov/Medicaid-CHIP-Program-
Information/By-Topics/Benefits/Prescription-
Drugs/Downloads/ManufacturerContactForm.pdf
6. Health Resources and Services Administration
7. Office of Pharmacy Affairs
8. Ryan White Programs: http://www.hab.hrsa.gov/abouthab/aboutprogram.html
9. Title X Family Planning Clinic:
http://www.hrsa.gov/opa/eligibilityandregistration/specialtyclinics/familyplanning/index.
html
10. Urban/Tribal Programs:
http://www.hrsa.gov/opa/eligibilityandregistration/healthcenters/tribalurbanindian/inde
x.html
11. SunRx:
http://www.ihaonline.org/imis15/Images/IHAWebPageDocs/upcomingevent/handouts/a
m/wednesday/W3%20-
%20Improving%20Pharmaceutical%20Access,%20Understanding%20the%20340B%20
Program%20-%20David%20Hardman.pdf
12. Health Resources and Services Administration
13. Electronic system created to manage 340B inventory
14. Maryland Child Abuse Providers at the University of Maryland
Children’s Hospital (Part of the University of Maryland Medical Center)
15. National Provider Identifier
16. National Council for Prescription Drug Programs
17. Nebraska, Ohio, New York, Minnesota, Washington, Alaska, Alabama,
Arizona, Arkansas, California, Connecticut, Delaware, Iowa, Louisiana,
Maine, Massachusetts, Mississippi, Montana, Illinois, Nevada, Oklahoma,
Missouri, New Hampshire, New Mexico, Oregon, Rhode Island, New
Jersey, South Carolina, South Dakota, North Dakota, Tennessee, Texas,
Utah, Colorado, Florida, Georgia, Michigan, Kentucky, Wisconsin, West
Virginia, Virginia, Pennsylvania
18. Office of the Inspector General, 2006
19. National Drug Code
 Apexus 340B University. (2013, April). 340B Glossary of Terms. Retrieved
April 26, 2013, from
https://docs.340bpvp.com/documents/public/resourcecenter/glossary.pdf
 Public Law 102-585. (2012, October 12). In United States Department of
Veterans Affairs. Retrieved April 26, 2013, from
http://www.fss.va.gov/faqs/publicLaw102585.asp
 Review of 340B Prices. (2006, July). In Office of the Inspector General.
Retrieved May 3, 2013, from http://oig.hhs.gov/oei/reports/oei-05-02-
00073.pdf
 HRSA FAQ :http://www.hrsa.gov/opa/faqs/
 340B Drug Pricing Program: http://www.hrsa.gov/opa/
 340B Prime Vendor Program: https://www.340bpvp.com/controller.html
 Office of Pharmacy Affairs (OPA)
Phone: 301-594-4353
Mailing Address: Office of Pharmacy Affairs, HRSA
5600 Fishers Lane
Parklawn Bldg, Room 10C-03
Rockville, Maryland 20857
Pharmacy Support Services Center: 1-800-628- 6297

More Related Content

What's hot

Regulatory guidelines of Australia
Regulatory guidelines of AustraliaRegulatory guidelines of Australia
Regulatory guidelines of Australia
nandiniwarier93
 
Hospital pharmacy institiutional section
Hospital pharmacy institiutional sectionHospital pharmacy institiutional section
Hospital pharmacy institiutional section
Homa Saad
 

What's hot (20)

Drug Distribution system & Hospital formulary
Drug Distribution system & Hospital formulary Drug Distribution system & Hospital formulary
Drug Distribution system & Hospital formulary
 
Counterfeit medicine1
Counterfeit medicine1Counterfeit medicine1
Counterfeit medicine1
 
FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure...
FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure...FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure...
FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure...
 
ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES
ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINESICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES
ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES
 
Drug accountability
Drug accountabilityDrug accountability
Drug accountability
 
Investigational product management
Investigational product management Investigational product management
Investigational product management
 
Pharmacy and therapeutics committee
Pharmacy and therapeutics committeePharmacy and therapeutics committee
Pharmacy and therapeutics committee
 
OOS.pptx
OOS.pptxOOS.pptx
OOS.pptx
 
Post marketing surveillance (PMS)
Post marketing surveillance (PMS)Post marketing surveillance (PMS)
Post marketing surveillance (PMS)
 
Hospital and its organisation, BUDGET AND pHARMACY AND tHERAPEUTIC COMMITTEE
Hospital and its organisation, BUDGET AND pHARMACY AND tHERAPEUTIC COMMITTEEHospital and its organisation, BUDGET AND pHARMACY AND tHERAPEUTIC COMMITTEE
Hospital and its organisation, BUDGET AND pHARMACY AND tHERAPEUTIC COMMITTEE
 
Introduction to post marketing drug safety surveillance fda 2-11-14
Introduction to post marketing drug safety surveillance fda 2-11-14Introduction to post marketing drug safety surveillance fda 2-11-14
Introduction to post marketing drug safety surveillance fda 2-11-14
 
Hospital pharmacy management
Hospital pharmacy managementHospital pharmacy management
Hospital pharmacy management
 
Institutional review Board (IRB) by Mr. Rushikesh Shinde.pptx
Institutional review Board (IRB) by Mr. Rushikesh Shinde.pptxInstitutional review Board (IRB) by Mr. Rushikesh Shinde.pptx
Institutional review Board (IRB) by Mr. Rushikesh Shinde.pptx
 
Investigational use of drugs
Investigational use of drugsInvestigational use of drugs
Investigational use of drugs
 
Pharmaneek's Process Flow Chart & Description
Pharmaneek's Process Flow Chart & DescriptionPharmaneek's Process Flow Chart & Description
Pharmaneek's Process Flow Chart & Description
 
Regulatory guidelines of Australia
Regulatory guidelines of AustraliaRegulatory guidelines of Australia
Regulatory guidelines of Australia
 
Role of pharmacist in interdepartmental communication and community health ed...
Role of pharmacist in interdepartmental communication and community health ed...Role of pharmacist in interdepartmental communication and community health ed...
Role of pharmacist in interdepartmental communication and community health ed...
 
Hospital pharmacy institiutional section
Hospital pharmacy institiutional sectionHospital pharmacy institiutional section
Hospital pharmacy institiutional section
 
Imp management at site (UA)
Imp management at site (UA)Imp management at site (UA)
Imp management at site (UA)
 
Medical Coding textbook for beginners
Medical Coding textbook for beginnersMedical Coding textbook for beginners
Medical Coding textbook for beginners
 

Similar to 340 b presentation 5.31.13

5b_ BS3B MJenkins [Friday]
5b_ BS3B MJenkins [Friday]5b_ BS3B MJenkins [Friday]
5b_ BS3B MJenkins [Friday]
Melissa Jenkins
 
ACCC 340B Sherer and Guide Article May 2011
ACCC 340B Sherer and Guide Article May 2011ACCC 340B Sherer and Guide Article May 2011
ACCC 340B Sherer and Guide Article May 2011
Matt Sherer
 
Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011
Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011
Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011
Matt Sherer
 
Concerns Persist about the 340B Program
Concerns Persist about the 340B ProgramConcerns Persist about the 340B Program
Concerns Persist about the 340B Program
Nan Myers
 
Compliance Today article March 2015
Compliance Today article March 2015Compliance Today article March 2015
Compliance Today article March 2015
Cristine Vogel
 
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docx
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docxCase 13340B Drug Pricing Program OversightSection 602 of the Vet.docx
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docx
keturahhazelhurst
 
What to Expect During an HRSA 340B Audit
What to Expect During an HRSA 340B AuditWhat to Expect During an HRSA 340B Audit
What to Expect During an HRSA 340B Audit
Travis Leonardi
 

Similar to 340 b presentation 5.31.13 (20)

5b_ BS3B MJenkins [Friday]
5b_ BS3B MJenkins [Friday]5b_ BS3B MJenkins [Friday]
5b_ BS3B MJenkins [Friday]
 
ACCC 340B Sherer and Guide Article May 2011
ACCC 340B Sherer and Guide Article May 2011ACCC 340B Sherer and Guide Article May 2011
ACCC 340B Sherer and Guide Article May 2011
 
Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011
Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011
Guidi Sherer Everything You Wanted to Know About 340B Oncology Issues 2011
 
340B Discount Drug Program: Updates and Changes Affecting Contract Pharmacies�
340B Discount Drug Program: Updates and Changes Affecting Contract Pharmacies�340B Discount Drug Program: Updates and Changes Affecting Contract Pharmacies�
340B Discount Drug Program: Updates and Changes Affecting Contract Pharmacies�
 
Concerns Persist about the 340B Program
Concerns Persist about the 340B ProgramConcerns Persist about the 340B Program
Concerns Persist about the 340B Program
 
Navigating manufacturer designations for 340 b contract pharmacies compliatric
Navigating manufacturer designations for 340 b contract pharmacies compliatricNavigating manufacturer designations for 340 b contract pharmacies compliatric
Navigating manufacturer designations for 340 b contract pharmacies compliatric
 
Navigating manufacturer designations for 340 b contract pharmacies compliatric
Navigating manufacturer designations for 340 b contract pharmacies compliatricNavigating manufacturer designations for 340 b contract pharmacies compliatric
Navigating manufacturer designations for 340 b contract pharmacies compliatric
 
Compliance Today article March 2015
Compliance Today article March 2015Compliance Today article March 2015
Compliance Today article March 2015
 
340B Piece Final
340B Piece Final340B Piece Final
340B Piece Final
 
The 340B Program and Implications of the Mega Guidance
The 340B Program and Implications of the Mega GuidanceThe 340B Program and Implications of the Mega Guidance
The 340B Program and Implications of the Mega Guidance
 
Alice Valder Curran's 340B Presentation at the American Institutes for Research
Alice Valder Curran's 340B Presentation at the American Institutes for ResearchAlice Valder Curran's 340B Presentation at the American Institutes for Research
Alice Valder Curran's 340B Presentation at the American Institutes for Research
 
Translating compliance requirements into action items 340B
Translating compliance requirements into action items 340BTranslating compliance requirements into action items 340B
Translating compliance requirements into action items 340B
 
Translating compliance requirements into action items 340B
Translating compliance requirements into action items 340BTranslating compliance requirements into action items 340B
Translating compliance requirements into action items 340B
 
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docx
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docxCase 13340B Drug Pricing Program OversightSection 602 of the Vet.docx
Case 13340B Drug Pricing Program OversightSection 602 of the Vet.docx
 
Sun Rx Overview Presentation
Sun Rx Overview PresentationSun Rx Overview Presentation
Sun Rx Overview Presentation
 
Identifying & resolving 340b duplicate discounts Kalderos
Identifying & resolving 340b duplicate discounts Kalderos Identifying & resolving 340b duplicate discounts Kalderos
Identifying & resolving 340b duplicate discounts Kalderos
 
2023 Compliatric Webinar Series - 340B ESP Overview from a Participating CE
2023 Compliatric Webinar Series - 340B ESP Overview from a Participating CE2023 Compliatric Webinar Series - 340B ESP Overview from a Participating CE
2023 Compliatric Webinar Series - 340B ESP Overview from a Participating CE
 
What to Expect During an HRSA 340B Audit
What to Expect During an HRSA 340B AuditWhat to Expect During an HRSA 340B Audit
What to Expect During an HRSA 340B Audit
 
HRSA Audits What You Need to Prepare For 2016-06-01-final
HRSA Audits What You Need to Prepare For 2016-06-01-finalHRSA Audits What You Need to Prepare For 2016-06-01-final
HRSA Audits What You Need to Prepare For 2016-06-01-final
 
The 340B Drug Pricing Program
The 340B Drug Pricing ProgramThe 340B Drug Pricing Program
The 340B Drug Pricing Program
 

Recently uploaded

THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
DR SETH JOTHAM
 
Sonia Journal club presentation (2).pptx
Sonia Journal club presentation (2).pptxSonia Journal club presentation (2).pptx
Sonia Journal club presentation (2).pptx
palsonia139
 

Recently uploaded (20)

PREPARATION FOR EXAMINATION FON II .pptx
PREPARATION FOR EXAMINATION FON II .pptxPREPARATION FOR EXAMINATION FON II .pptx
PREPARATION FOR EXAMINATION FON II .pptx
 
180-hour Power Capsules For Men In Ghana
180-hour Power Capsules For Men In Ghana180-hour Power Capsules For Men In Ghana
180-hour Power Capsules For Men In Ghana
 
Presentació "Advancing Emergency Medicine Education through Virtual Reality"
Presentació "Advancing Emergency Medicine Education through Virtual Reality"Presentació "Advancing Emergency Medicine Education through Virtual Reality"
Presentació "Advancing Emergency Medicine Education through Virtual Reality"
 
Cervical screening – taking care of your health flipchart (Vietnamese)
Cervical screening – taking care of your health flipchart (Vietnamese)Cervical screening – taking care of your health flipchart (Vietnamese)
Cervical screening – taking care of your health flipchart (Vietnamese)
 
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
THORACOTOMY . SURGICAL PERSPECTIVES VOL 1
 
Pharmacology of drugs acting on Renal System.pdf
Pharmacology of drugs acting on Renal System.pdfPharmacology of drugs acting on Renal System.pdf
Pharmacology of drugs acting on Renal System.pdf
 
SURGICAL ANATOMY OF ORAL IMPLANTOLOGY.pptx
SURGICAL ANATOMY OF ORAL IMPLANTOLOGY.pptxSURGICAL ANATOMY OF ORAL IMPLANTOLOGY.pptx
SURGICAL ANATOMY OF ORAL IMPLANTOLOGY.pptx
 
Gallbladder Double-Diverticular: A Case Report المرارة مزدوجة التج: تقرير حالة
Gallbladder Double-Diverticular: A Case Report  المرارة مزدوجة التج: تقرير حالةGallbladder Double-Diverticular: A Case Report  المرارة مزدوجة التج: تقرير حالة
Gallbladder Double-Diverticular: A Case Report المرارة مزدوجة التج: تقرير حالة
 
BMK Glycidic Acid (sodium salt) CAS 5449-12-7 Pharmaceutical intermediates
BMK Glycidic Acid (sodium salt)  CAS 5449-12-7 Pharmaceutical intermediatesBMK Glycidic Acid (sodium salt)  CAS 5449-12-7 Pharmaceutical intermediates
BMK Glycidic Acid (sodium salt) CAS 5449-12-7 Pharmaceutical intermediates
 
DIGITAL RADIOGRAPHY-SABBU KHATOON .pptx
DIGITAL RADIOGRAPHY-SABBU KHATOON  .pptxDIGITAL RADIOGRAPHY-SABBU KHATOON  .pptx
DIGITAL RADIOGRAPHY-SABBU KHATOON .pptx
 
Sonia Journal club presentation (2).pptx
Sonia Journal club presentation (2).pptxSonia Journal club presentation (2).pptx
Sonia Journal club presentation (2).pptx
 
Video capsule endoscopy (VCE ) in children
Video capsule endoscopy (VCE ) in childrenVideo capsule endoscopy (VCE ) in children
Video capsule endoscopy (VCE ) in children
 
TEST BANK For Huether and McCance's Understanding Pathophysiology, Canadian 2...
TEST BANK For Huether and McCance's Understanding Pathophysiology, Canadian 2...TEST BANK For Huether and McCance's Understanding Pathophysiology, Canadian 2...
TEST BANK For Huether and McCance's Understanding Pathophysiology, Canadian 2...
 
Factors Affecting child behavior in Pediatric Dentistry
Factors Affecting child behavior in Pediatric DentistryFactors Affecting child behavior in Pediatric Dentistry
Factors Affecting child behavior in Pediatric Dentistry
 
Scleroderma: Treatment Options and a Look to the Future - Dr. Macklin
Scleroderma: Treatment Options and a Look to the Future - Dr. MacklinScleroderma: Treatment Options and a Look to the Future - Dr. Macklin
Scleroderma: Treatment Options and a Look to the Future - Dr. Macklin
 
Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)Integrated Neuromuscular Inhibition Technique (INIT)
Integrated Neuromuscular Inhibition Technique (INIT)
 
5cladba raw material 5CL-ADB-A precursor raw
5cladba raw material 5CL-ADB-A precursor raw5cladba raw material 5CL-ADB-A precursor raw
5cladba raw material 5CL-ADB-A precursor raw
 
5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now
5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now
5CL-ADB powder supplier 5cl adb 5cladba 5cl raw materials vendor on sale now
 
Multiple sclerosis diet.230524.ppt3.pptx
Multiple sclerosis diet.230524.ppt3.pptxMultiple sclerosis diet.230524.ppt3.pptx
Multiple sclerosis diet.230524.ppt3.pptx
 
Hepar Sulphuris Remedy, Homoeopathic Materia Medica, HMM, 1st BhMS
Hepar Sulphuris Remedy, Homoeopathic Materia Medica, HMM, 1st BhMSHepar Sulphuris Remedy, Homoeopathic Materia Medica, HMM, 1st BhMS
Hepar Sulphuris Remedy, Homoeopathic Materia Medica, HMM, 1st BhMS
 

340 b presentation 5.31.13

  • 1. Michol Bobb, CPhT mbobb1@umbc.edu Intern Maryland Medicaid Pharmacy Program May 2013
  • 2.  To identify a way for State Medicaid Agencies to recognize 340B priced claims in order to avoid inappropriate rebate processing
  • 3.  340B is a Federal Discounted Drug Pricing Program that resulted from the enactment of Public Law 102-585 1 (the Veterans Health Care Act of 1992).  This Act came about as a means of controling the prices that specified government agencies 2 paid for purchasing pharmaceuticals.  The intent of this program is to expand access to affordable medications in low income populations and help support the operations of safety net organizations.  The 340B price is a ceiling price set by drug manufactures that is less than the Medicaid price of an eligible outpatient drug.
  • 4.  Apexus: Responsible for negotiating prices below the 340B ceiling price and improving access to affordable medications through a distribution network
  • 5.  Helps to offset the federal and state costs for most outpatient prescription drugs dispensed to Medicaid patients.  Requires drug manufacture’s to enter into a national rebate agreement with the Secretary of DHHS 4 (known as the Medicaid Drug Rebate Agreement5 ) in exchange for State Medicaid coverage of the manufacture’s drugs.  This agreement holds manufacture’s responsible for paying a rebate each time one of their drugs is dispensed to a Medicaid patient
  • 6.  HRSA 6 : Regulator  OPA 7 : Regulator  Medicaid: Payer  Contract Pharmacies: Providers
  • 7.  A 340B patient is defined as: ◦ Someone who receives healthcare services from a covered entity that maintains health records for the patient. ◦ Someone who is prescribed medications that are for the treatment of a received outpatient service at a covered entity. ◦ Someone referred for care within a covered entity (from a non-covered entity) becomes eligible as a 340B patient if the continuum of care is within the 340B covered entity
  • 8.  340B covered entities are organizations (facilities/programs) that provide medical services to the patient and are listed in the 340B Statute as eligible to purchase drugs through the 340B Program and appear on the Office of Pharmacy Affairs Database.
  • 9.  Federally Qualified Health Centers (FQHC)  Comprehensive Hemophilia Treatment Centers  Ryan White Programs (Parts A, B, C, D) 8  Sexually Transmitted Disease/Tuberculosis Programs  Title X Family Planning Clinics 9  Urban / 638 Tribal Programs 10  Federally Qualified Health Center Look-Alikes (FQHC-LA)  Disproportionate Share Hospitals (DSH)  Children’s Hospitals  Free Standing Cancer Hospitals  Critical Access Hospitals  Sole Community Hospitals  Rural Referral Centers
  • 10.  Contract pharmacies work with covered entities to fill 340B prescriptions for 340B eligible patients. The covered entity is responsible for maintaining health records for the patient and the pharmacy is responsible for maintaining medication records for the patient with access to the patients health records.
  • 11.  1. Hospital: The hospital must be eligible for 340B and registered with the 340B program.  2. Patient: Patient must be seen in an outpatient facility or service area which is “integral” to the hospital (i.e., whose costs are listed on the reimbursable section of the hospital’s latest Medicare Cost Report-records each institution's total costs and charges associated with providing services to all patients).  3. Provider: Patient must be seen by a provider who is employed by, contracted by, or through other arrangements (such as a referral for consultation). “Other arrangements” are applicable if the prescriptions captured are “proximate in type and time” to the care patients receive at the hospital.  4. Records of Care: The record of care and responsibility of care must reside with the hospital  5. Pharmacy: Patient must obtain their prescription at the hospital’s pharmacy or from one of its 340B contracted pharmacies.
  • 12.  Ship-to Bill-to Method: With contract pharmacies, the 340B drugs get billed to the covered entity and shipped to the pharmacy address  Virtual inventories: It is managed by software from a third party company (Ex. SunRx). It limits the risk of diversion because it accounts for every 340B script that is filled.  Replenishment Systems: Easier to maintain when using a virtual inventory because the third party automatically replenishes the pharmacy’s stock without the actual pharmacy needing to keep track of used medications
  • 13.  Covered drugs: ◦ Outpatient Prescription drugs ◦ Over-the-counter drugs (accompanied by prescription) ◦ Clinic administered drugs within eligible facilities  Non-covered drugs: ◦ Vaccines ◦ In-patient drugs
  • 14.  1. Use 2 McKesson accounts, use parenthesis around drug name to identify 340B  2. Use dual inventory system, created NRX13 system, use asterisk around product name to identify 340B, use ship-to bill-to  3. Use electronic inventory, uses patients to identify  4. Wrong contact person  5. Uses CaptureRx
  • 15.  6. Referred to another person in charge of CHAMP14 program  7. Doesn't participate, 340B is to confusing  8. Clinic does everything and replaces drugs used in pharmacy  9. (had a 340B contact person listed that was in charge of multiple sites) Doesn’t participate in MD  10. Two separate inventories and 2 separate accounts with wholesaler
  • 16.  11. One store participates, uses 3rd party to identify 340B scripts (would not disclose name of 3rd party)  12. Told me to address any questions to the covered entity, doesn’t know much about 340B  13. Four 340B hospitals out of 10  14. Mixed-use = carve in, retail = carve out, uses replenishment model, uses virtual inventory system to track usage (does not identify drugs at shelf level)  15. Use ship-to bill-to, doesn’t use any inventory system
  • 17.  16. One program in MD, virtual inventory system, retail pharmacy contract, bill-to ship-to replacement method  * Results: HRSA website contained inconsistencies with contact name, contact number, and participating information
  • 18.  Use Provider NPI 15  Use HRSA Exclusion File: contact providers to ensure participation  Use an agency created exclusion file and audit that against HRSA exclusion file  Use NCPDP 16 Transaction Strings: basis of cost and 340B indicator fields
  • 19.  Monthly Claims Audit is required from 340B pharmacies: monitors that discount is being passed on to Medicaid  340B providers have different ID numbers  Dual inventory systems  Avoiding Duplicate Discounts: ◦ Exclude all claims from entities on HRSA exclusion file in rebate processing, encourage providers to be all in or all out.
  • 20.  Charge no more than actual acquisition cost + dispensing fee  Use Usual and Customary pricing: to identify 340B claims on invoices  Pay dispensing fees up to $12.00  *data was obtained from 42 states*17
  • 21.  The 340B ceiling prices are calculated according to a formula that is based on information generated in connection with the Medicaid drug rebate program  Manufacturers are required to report to the Centers for Medicare & Medicaid Services (CMS) each quarter the average manufacturer price (AMP) for each of their drugs  CMS uses AMP and other data to calculate a unit rebate amount (URA) that serves as a basis for the rebate amounts paid by manufacturers  The AMP and URA used in the 340B ceiling price formula are based on the smallest dispensable unit of each drug  The 340B ceiling price is based on these components and is essentially equal to the AMP reduced by the URA
  • 22.  The 340B ceiling prices per package are calculated as follows: ◦ [(AMP) - (URA)] * drug’s package size
  • 23.  Can’t identify by pharmacy: purchase 340B and non 340B drugs  Can’t identify by patient: they bring in the prescription (unless entity fills all 340B scripts)  Can’t identify by prescriber: may work at 340B and non 340B entity  Can’t identify by NDC 19 : 340B and non 340B dugs have same NDC (some places put a unique identifier in the NDC)
  • 24.  Have provider differentiate 340B claims at time of submission  Split billing software to differentiate 340B claims  Implementing audit forms  *after verifying all information is accurate* - Require all participating entities on the HRSA exclusion file to purchase and bill all Medicaid drugs under 340B pricing
  • 25.  Include a line in the NCPDP transaction that codifies a 340B claim  Recommend that state Medicaid Agencies come together and petition for HRSA to release 340B prices
  • 26.
  • 27. 1.Limitation on prices of drugs 2. US Department of Veterans Affairs: (Big 4) Department of Veterans Affairs, the Department of Defense, Public Health Service/Indian Health Service, and the Coast Guard. These government agencies receive special pricing discounts on pharmaceuticals in accordance with public law 102-585. 3. Partnership between CMS, State Agencies, and participating drug manufactures 4. Department of Health and Human Services 5. Medicaid Drug Rebate Agreement: http://www.medicaid.gov/Medicaid-CHIP-Program- Information/By-Topics/Benefits/Prescription- Drugs/Downloads/ManufacturerContactForm.pdf 6. Health Resources and Services Administration 7. Office of Pharmacy Affairs 8. Ryan White Programs: http://www.hab.hrsa.gov/abouthab/aboutprogram.html 9. Title X Family Planning Clinic: http://www.hrsa.gov/opa/eligibilityandregistration/specialtyclinics/familyplanning/index. html 10. Urban/Tribal Programs: http://www.hrsa.gov/opa/eligibilityandregistration/healthcenters/tribalurbanindian/inde x.html 11. SunRx: http://www.ihaonline.org/imis15/Images/IHAWebPageDocs/upcomingevent/handouts/a m/wednesday/W3%20- %20Improving%20Pharmaceutical%20Access,%20Understanding%20the%20340B%20 Program%20-%20David%20Hardman.pdf
  • 28. 12. Health Resources and Services Administration 13. Electronic system created to manage 340B inventory 14. Maryland Child Abuse Providers at the University of Maryland Children’s Hospital (Part of the University of Maryland Medical Center) 15. National Provider Identifier 16. National Council for Prescription Drug Programs 17. Nebraska, Ohio, New York, Minnesota, Washington, Alaska, Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Iowa, Louisiana, Maine, Massachusetts, Mississippi, Montana, Illinois, Nevada, Oklahoma, Missouri, New Hampshire, New Mexico, Oregon, Rhode Island, New Jersey, South Carolina, South Dakota, North Dakota, Tennessee, Texas, Utah, Colorado, Florida, Georgia, Michigan, Kentucky, Wisconsin, West Virginia, Virginia, Pennsylvania 18. Office of the Inspector General, 2006 19. National Drug Code
  • 29.  Apexus 340B University. (2013, April). 340B Glossary of Terms. Retrieved April 26, 2013, from https://docs.340bpvp.com/documents/public/resourcecenter/glossary.pdf  Public Law 102-585. (2012, October 12). In United States Department of Veterans Affairs. Retrieved April 26, 2013, from http://www.fss.va.gov/faqs/publicLaw102585.asp  Review of 340B Prices. (2006, July). In Office of the Inspector General. Retrieved May 3, 2013, from http://oig.hhs.gov/oei/reports/oei-05-02- 00073.pdf  HRSA FAQ :http://www.hrsa.gov/opa/faqs/  340B Drug Pricing Program: http://www.hrsa.gov/opa/  340B Prime Vendor Program: https://www.340bpvp.com/controller.html
  • 30.  Office of Pharmacy Affairs (OPA) Phone: 301-594-4353 Mailing Address: Office of Pharmacy Affairs, HRSA 5600 Fishers Lane Parklawn Bldg, Room 10C-03 Rockville, Maryland 20857 Pharmacy Support Services Center: 1-800-628- 6297

Editor's Notes

  1. 340B Prime Vendor Program: http://www.hhs.gov/opa/pdfs/340b-prime-vendor-programs-slides.pdf
  2. - (OIG, 2006)