Transcript The Ryan White Program and 340B Pharmacies

The Ryan White Program and
340B Pharmacies
Britten Pund, Senior Manager, Health Care Access
Emily McCloskey, Manager, Policy and Legislative Affairs
Agenda
 340B Drug Pricing Program Overview
 Coordinating with other 340B entities
 Policy updates
Overview
 Authorized by the Veterans Health Care Act of 1992 and is
administered by the Health Resources and Services Administration
(HRSA).
 Provides discounts on covered outpatient drugs to certain safety-net
covered entities - average savings of 25-50%
 Manufacturers participating in Medicaid agree to charge
covered entities a price that will not exceed the 340B
“ceiling price”.
 The “ceiling price” is calculated based on data obtained
from the Centers for Medicare & Medicaid Services (CMS).
Overview
(continued)
 The 340B Drug Pricing Program provides outpatient drugs
at a reduced price to safety-net providers
– The drugs can be directly purchased at the discounted
rate or programs can receive rebates using a pharmacy
network purchasing system
 It is designed to provide a pricing benefit to safety-net
providers with the intent that providers use the savings to
reinvest in their programs and enhance medical services to
uninsured patients.
Intent of the 340B Program
Permits eligible safety net providers “to
stretch scarce Federal Resources as
far as possible, reaching more eligible
patients and providing more comprehensive
services.”
H.R. Rep. No. 102-384(II), at 12 (1992)
Program Benefits
 Covered entities benefit when the covered entity is able to
bill the patient’s insurer (if insured) at a negotiated rate
that is higher than the 340B price paid to obtain the drug.
 HRSA has no statutory authority to dictate how entities use
the savings generated by the 340B program.
Eligible Entities

Ryan White HIV/AIDS Program Grantees
– Ryan White Part A & B Clinics, AIDS Drug Assistance Programs
(ADAPs), Ryan White Part C Early Intervention Services Grantees

Health Centers
– Federally Qualified Health Centers, Federally-Qualified Health Center
Look-Alikes, Native Hawaiian Health Centers, Tribal / Urban Indian
Health Centers

Hospitals
– Children’s Hospitals, Critical Access Hospitals, Disproportionate Share
Hospitals, Free Standing Cancer Hospitals, Rural Referral Centers, Sole
Community Hospitals

Specialized Clinics
– Black Lung Clinic Programs, Comprehensive Hemophilia Diagnostic
Treatment Centers, Title X Family Planning Clinics, Sexually
Transmitted Disease Clinics, Tuberculosis Clinics
Eligible Entities
(continued)

ADAPs are categorically eligible, meaning all ADAP clients are eligible for
340B priced drugs

All other entities must abide by the patient definition:
1. The covered entity has established a relationship with the individual,
such that the covered entity maintains records of the individual’s
health care; and
2. The individual receives health care services from a health care
professional who is either employed by the covered entity or provides
health care under contractual or other arrangements (e.g., referral
for consultation) such that responsibility for the care provided
remains with the covered entity; and
3. The individual receives a health care service or range of services from
the covered entity which is consistent with the service or range of
services for which grant funding or Federally-qualified health center
look-alike status has been provided to the entity. Disproportionate
share hospitals are exempt from this requirement.
Registration and Enrollment
 http://opanet.hrsa.gov/opa/Default.aspx
Annual Recertification
 Required by Statute
– ADAP recertification - January 2015
 Ensure program integrity, compliance, transparency and
accountability
 Ensure accuracy of covered entity information in the 340B
database
 It is the covered entity’s responsibility to ensure the
accuracy of the information in the 340B database
 Entities must self-disclose programmatic violations
340B Database
 Entities are not eligible for the program unless listed in the 340B
database
 Entities are required to keep their information up to date on the
database and ensure sites are properly listed
 Includes the Medicaid Exclusion File
Requirements
 It is a covered entity’s responsibility to immediately inform
HRSA of a change in eligibility status – entity should stop
purchasing
 Entities should also report non-compliance to HRSA
 All offsite outpatient facilities and subgrantee sites are
required to enroll and be listed on the 340B database
Patient Definition

1996 HRSA Patient Definition Guidelines
– Covered Entities (CEs) Other Than ADAP
 CE maintains records of individual’s health care and
 Individual receives health services from health care professional
employed by CE or under contract or other arrangements such
that responsibility for care provided remains with CE
– Service must be more than dispensing of a drug for selfadministration or administration in the home setting
– Additional Criterion for Non-ADAP HRSA Grantees
 Individuals receives health care service(s) from CE which is
consistent with range of services covered by HRSA grant
– ADAPs Only
 An individual registered in state-operated or funded ADAP that
receives Ryan White funding is considered a patient of the ADAP if
registered as eligible by the State program.
Patient Definition
(continued)

HRSA intended to address patient definition in “mega-reg”

Widely differing perspectives on future of patient definition
– 340B Coalition
 Basic construct of current definition is sound
 Specific terms should be defined to avoid confusion by
stakeholders
 HRSA should release new guidance or regulation in
proposed form, so that the public has opportunity to
comment
– PhRMA
 Limit to “uninsured individuals”
 Physician must be employee or independent contractor
 Patient must receive “ongoing care”
340B Compliance and the Current
Enforcement Environment
 Increase in HRSA audits and inquiries
 Increase in manufacturer inquiries
 Annual recertification for all CEs
 HRSA plans to issue new guidance in many program areas
Coordinating with Other 340B Entities
 An individual may be considered a patient of both the ADAP
and another covered entity
 Both the ADAP and the covered entity would be eligible for
the 340B Drug Pricing Program discount/rebate
 Only one entity can claim the 340B price for a patient’s
prescription
Policy Updates
 The Office of Pharmacy Affairs (OPA) intended to release a
“mega-regulation,” which would codify previous 340B
Program guidances, policy releases and FAQs
 Due to legal issues with OPA’s rule on orphan drugs, the
release of the mega-regulation and all other OPA
regulations have been postponed indefinitely
 HRSA has stated that it will release a proposed guidance in
2015 and proposed rules civil monetary penalties for
manufacturers, calculation of the 340B ceiling price, and
administrative dispute resolution.
Policy Updates
(continued)
 The 340B Drug Pricing Program could be a target for the
114th Congress
 PhRMA is advocating for a change to the patient definition
that would require patients to be uninsured
– This could cause issues for Ryan White Program
grantees
Contact Information
Britten Pund
Senior Manager, Health Care Access
[email protected]
(202) 434-8044
Emily McCloskey
Manager, Policy and Legislative Affairs
[email protected]
(202) 434-8067
www.NASTAD.org