An In Depth Look at the 2015

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Transcript An In Depth Look at the 2015

Legislative Issues of Concern
 SCPhA’s lobbyists constantly track
legislation that may be harmful to the
 Includes such legislation as:
 Vending machines dispensing top 150
 Nurses dispensing,
 Remote pharmacists doing final check for
multiple pharmacies.
Unresolved Legislative Issues
 Compounding Legislation
 Rep. Kit Spires (R-Lexington)
 Sen. Ronnie Cromer (R-Newberry)
 This legislation would update the Pharmacy
Practice Act to include current standards
regarding pharmacy compounding instead
of just being guidance.
 The SC Board of Pharmacy currently has no
authority to enforce guidance through fines.
 This legislation was set aside in the Senate
due to pharmacy’s opposition to two
amendments to this bill.
Immunization Authority Expansion
 Expands a pharmacist’s ability to provide all
CDC-approved adult immunizations without a
prescription for individuals 12 years and older.
 Includes all future CDC-recommended
vaccinations for adults and adolescents
including travel vaccines.
 Authorizes student interns to immunize under the
direct supervision of a certified immunizing
Immunization Authority Expansion
 Authorization to administer travel-related vaccines will only be
given to pharmacists who have successfully completed a
course of training that includes travel vaccine certification
accredited by a health authority or professional body
approved by the Board of Pharmacy and the Board of Medical
 Requires that all written protocols be completed no later than
180 days after the enactment of the law granting this
expansion of authority.
 Legislation is already opposed by SC Pediatricians.
Other potential opponents include: SC Medical Society, SC
Family Practitioners and SC Nurses Association.
Scope of Practice Expansion
 Redefines ‘Drug Therapy Management’ to say:
“… that practice of pharmacy which provides
the expertise of the pharmacist in a
collaborative effort with the practitioner and
other health care providers to optimize
therapeutic outcomes for patients. Drug therapy
management includes, but is not limited to,
Drug therapy outcomes for patients,
Drug therapy reviews,
Therapy consults and management,
Interpretation of laboratory results, and
Health and wellness programs.
Scope of Practice Expansion
 Redefines a ‘Health Care Provider’
 Includes a pharmacist who is authorized to
provide health care services within the
pharmacist’s scope of practice pursuant to
state law and regulation as regulated by the
Board of Pharmacy and in accordance with
Code of Regulations, Chapter 69-22.
Scope of Practice Expansion
 Redefines ‘Pharmacist Care’ (formally Pharmacy Care)
‘Pharmacist Care’ is the direct provision of post diagnostic drug
therapy, disease management, medication outcomes and other
pharmacy care services through which pharmacists, as part of a
patient’s integrated health care team and in collaboration and
cooperation with the patient, the patient’s practitioner(s) and
other health care providers, design, implement, monitor, and
manage therapeutic plans for the purpose of improving a
patient’s quality of life.
Objectives include cure of disease, elimination or reduction of a
patient’s symptomatology, arresting or slowing a disease
process, or prevention of a disease or symptomatology.
Scope of Practice Expansion
 This process includes, but not limited to, the following
primary functions:
Identifying potential and actual drug-related problems,
Resolving actual drug-related problems,
Preventing potential drug-related problems,
Ordering, interpreting and monitoring lab and other diagnostic
tests for diseases to be managed,
Obtaining and reviewing patent medical and social history,
Initiating, adjusting and discontinuing drug therapy in
collaboration with other health care providers,
Administering drugs and/or devices,
Formulating clinical assessments and developing therapy plans
including medications, nutrition and life style changes, and
Participating in comprehensive integrated health care teams in
patient centered care.
Why is Scope Expansion
Important to Pharmacy?
 It will have a direct impact on a pharmacy’s/pharmacist’s
ability to participate in a patient’s medical home.
 It will have a direct impact on a pharmacy’s ability to
participate in future Medicaid/Medicare pharmacy
 If a pharmacy is not helping, or worse, hurting a health
plan’s ‘star ratings’, that plan may not want you in the
pharmacy network.
 It may provide a future source of income for pharmacies
beyond the filling process.
CMS Triple Rated ‘Star Ratings’
 As
measured against ADA standards (e.g.
A1C’s = to or < 7.0)
Blood Pressure
These account for 45% of a
health plan’s star rating.
MAC Transparency Legislation
Maximum Allowable
Multiple Source Drug
Network Providers
Pharmacy Benefit
MAC Transparency Legislation
A pharmacy benefit manager must not place a
drug on a list unless:
The drug has at least three or more nationally available,
therapeutically equivalent, multiple source generic drugs
with a significant cost difference and is generally
available for purchase by network providers domiciled in
this state.
The products are listed as therapeutically and
pharmaceutically equivalent or “A” or “AB” rated in the
Food and Drug Administration’s (FDA) most recent version
of the Orange Book.
The product must be available for purchase without
limitations by all pharmacies in the state from national or
regional wholesalers and not obsolete or temporarily
MAC Transparency Legislation
A PBM must:
Ensure that all drugs on a list are generally available for purchase by
pharmacies domiciled in this state from national and regional wholesalers.
Ensure that all drugs on the list are not obsolete, unavailable, or temporarily
Make available to each network provider at the beginning of the term of the
network provider’s contract, and upon renewal of the contract, the sources
used to determine the maximum allowable cost pricing.
Make a list available within 5 business days to a network provider upon request
in a format that is readily accessible to and usable by the network provider.
Update its MAC list every seven (7) calendar days and make the updated lists,
including all changes in the price of drugs consistent with pricing changes in
the marketplace, available to network providers in a readily accessible and
usable format.
Maintain a procedure to eliminate products from the list of drugs subject to
such pricing or modify MAC rates within three (3) business days when such
drugs do not meet the standards and requirements of this ACT as set forth in
order to remain consistent with pricing changes in the marketplace.
MAC Transparency Legislation
Insurer (Plan Sponsor) Disclosures:
 If
a PBM utilizes a multi-source generic drug list
for drugs dispensed at retail but does not utilize a
similar list for drugs dispensed at mail, this must
be disclosed to the plan sponsor in writing either
in the contract or no later than twenty-one (21)
business days from the implementation of the
MAC Transparency Legislation
Appeals Process:
All contracts between a PBM, a contracted pharmacy or, alternatively, a PBM and a
pharmacy’s contracting representatives or agent such as a Pharmacy Services
Administrative Organization (PSAO) shall include a process by which a network
provider can appeal, investigate, and resolve disputes regarding multi-source generic
drug pricing.
A network provider has 7 business days upon discovery, but no more than 60 days to
appeal a MAC price if the reimbursement for the drug is less than the net amount that
the network provider paid to the supplier of the drug.
At the beginning of the term of the network provider’s contract, and upon
renewal, a PBM must provide the following to network providers:
A telephone number at which a network provider can contact the PBM and speak with
an individual who is responsible for processing appeals; and
A final response to an appeal of a maximum allowable cost within seven (7) business
days of submission.
If an appeal is denied, the PBM shall provide the reason for the denial and identify the
national drug code (NDC) or the UDI of the product that is generally available and
may be purchased by network providers domiciled in South Carolina at a price that is
equal to or less than the maximum allowable cost.
If the appeal is sustained, the PBM must make a price adjustment to its list effective the
date that the PBM makes the determination. Such price adjustment must be effective
for all network providers.
H.R. 4190
Pharmacists as Providers
H.R. 4190
 H.R.
4190 – Pharmacists as Providers
 Introduced
Guthrie (R-KY), G.K. Butterfield (D-NC)
and Todd Young (R-IN)
 Authorizes
a licensed pharmacist to bill for
Medicare Part B services as long as the
provision of those services are within your
scope of practice.
 Does
not supersede state practice act
H.R. 4190
Millions of Americans lack adequate access
to primary health care in the U.S.
Forty-three (43) of South Carolina’s forty-six
(46) counties have been designated as
“medically underserved.”
There are over 7,700 registered pharmacists
in SC.
Most South Carolina residents on Medicare
do not have access to important services
provided by pharmacists.
H.R. 4190
There are 123 cosponsors of H.R. 4190 in the U.S. House of
68 are Democrats; 55 are Republicans
 South Carolina has 7 Congressmen
 Only 1 is a cosponsor: Rep. Joe Wilson (R-2nd Dist.)
 Those who need to be contacted and asked:
Rep. Mark Sanford (R-1st – Charleston area)
Rep. Jeff Duncan (R-3rd – Anderson/Laurens area)
Rep. Trey Gowdy (R-4th – Greenville/Spartanburg area)
Rep. Mick Mulvanie (R-5th – Rock Hill/Gaffney/Sumter area)
Rep. James Clyburn (D-6th – Columbia/Florence/Santee
Rep. Tom Rice (R-7th – Myrtle Beach area)
H.R. 4190
 Pharmacist
 Chronic
 Drug
billable services include:
disease management
therapy management
 Preventive
screenings and related
counseling and education, including
pressure, and
H.R. 4190
According to the Association of American
Medical Colleges:
By 2020, there will be 91,000 FEWER doctors than
needed to meet demand.
The impact will be most severe in medically
underserved communities.
In view of this anticipated shortage, pharmacists
are in a position to play a greater role in the
delivery of health care services.
H.R. 4190
Underserved Community Defined
According to the U.S. Department of Health
& Human Services’ Health Resources
Services Administration (HRSA), a medically
underserved area is:
Those geographic areas that have too few primary
care providers, high infant mortality rates, high
poverty, and high elderly populations.
H.R. 4577
Ensuring Seniors Access to
Local Pharmacies Act
H.R. 4577
Introduced by:
 H.
Morgan Griffith (R-VA)
Currently, there are 80 co-sponsors
representing 34 states
South Carolina has two co-sponsors:
 Rep.
Tom Rice (R-SC)
 Rep.
Joe Wilson (R-SC)
H.R. 4577
CMS had this concept in it’s 2015 call letter for
the Medicare Part D program.
 Additionally, the call letter would have defined
what could be included as a MAC drug. It also
defined AWP, WAC, etc. It provided for some
PBM transparency.
 PCMA immediately went to Congress to
pressure CMS to withdrawal these new
 NCPA has identified members of Congress in
both houses to introduce legislation to make
these changes law.
Craig Burridge, CEO
SC Pharmacy Association
[email protected]