Transcript Michigan Society Talk

ASHP Update:
Trends, Developments and Future Implications
David Chen, B.S.Pharm, MBA
Director, Pharmacy Practice Sections
Overview
Provider Recognition
Medication Safety and Compounding
Drug Shortages
New ASHP Strategic Plan
Task Force on Organizational Structure
Pharmacy Practice Model Initiative
Provider Recognition
Provider Recognition
President Lyndon Johnson signing the Medicare Act in 1965 Photo: Library of Congress
What is Provider Status?
Becoming a “provider” means
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Pharmacists can participate in the Medicare program and
bill for services that are within their state scope of practice
to perform
Becoming a provider at the federal level will not expand
pharmacists’ scope of practice
What is Provider Status?
 Being listed in section 1842 or 1861 of the Social Security
Act (SSA) as a supplier of “medical and other health
services”, which includes:
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Physicians’ services
Nurse practitioner
Physician assistant
Certified nurse midwife services
Qualified psychologist services
Clinical social worker services
Certified nurse anesthetist
Qualified speech-language pathologist
Qualified audiologist
Registered dietitian
Physical therapist
Provider Recognition
 Essential to recognize pharmacists as patient-care providers
 Pharmacists provide distinct direct patient-care:
 Pharmacists improve patient medication-use outcomes when included
on the patient-care teams1
 Report to the Surgeon General by the Office of the Chief Pharmacist of
the U.S. Public Health Service - compelling case for using pharmacists
more effectively in the care of patients2
 Services provided should be eligible for recognition and payment by:
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Medicare
Medicaid
Other third-party payers (including states and private health plans)
Sources:
1) Jack BW, Chetty VK, Anthony D, Greenwald JL et al. A Reengineered Hospital Discharge Program to Decrease
Rehospitalization. Ann Intern Med. 2009;150:178-187.
2) Giberson S, Yoder S, Lee MP. Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. A
Report to the U.S. Surgeon General. Office of the Chief Pharmacist. U.S. Public Health Service. Dec 2011.
Brief History
2001—Provider Status Coalition Co-Founded by ASHP
and ACCP
2001—Senator Tim Johnson Introduces the Medicare
Pharmacist Services Coverage Act, S.974
2001—Representative Pallone Introduces the
Medicare Pharmacist Services Coverage Act of 2001,
HR 2799
The Estimated Cost (in 2001 dollars) of S.974/H.R.
2799 was $13.12 billion over 10-years (average of $1.3
billion annually)
History
2002—Representative Pickering Introduced
Medicare Medication Therapy Management Services
Coverage Act of 2002, HR 5539
2003—Senators Johnson and Cochran Introduced
Medication Therapy Management Act of 2003, S.
1270
2003—Medicare Modernization Act Enacted
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Part D prescription drug benefit includes Medication
Therapy Management requirement (with conditions and
no explicit payment)
History
2006– Senator Cochran Introduces the Pharmacist
Access and Recognition in Medicare (PHARM) Act of
2006, S.2563
2008—Representative Wilson Introduced the
Medicare Clinical Pharmacist Practitioner Services
Coverage Act of 2008, H.R. 5780
History
 2010—Affordable Care Act
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MTM Definition, Accountable Care Organizations, MTM Grant
Program, Center for Medicare & Medicaid Innovation, ValueBased Purchasing Program
 2010—Representative Heinrick Introduced the Medicare
Clinical Pharmacist Practitioner Services Coverage Act of
2010, H.R. 5389
 2010-Present—Affordable Care Act Implementation
 2012—National Pharmacy Organizations Begin Discussions
on Reinitiating Provider Status Campaign
Provider Recognition
Advocacy Efforts
 What will it require:
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Massive grassroots effort
 Individual pharmacy practitioners
 Affiliated state societies
Educate lawmakers about the value pharmacists bring to patient care
Strong and cohesive national coalition
 Pharmacy associations
 Patient and consumer groups
 Other health care organizations
Multi-year strategy; achieving provider status is a marathon not a sprint
 ASHP’s efforts:
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2012: Legislative Day; ASHP members met with their representatives on Capitol Hill
2013: CEOs of the national pharmacy organizations to meet to discuss working together
to pool resources and collective energies
Pharmacy stakeholder principles developed.
It’s About Patients
Achieving provider status is about giving patients
consistent access to care that improves safety,
quality, outcomes, and decreases costs
Why Do Pharmacists Want Provider Status When Fee-ForService is Going Away?
 Now and in the future traditional fee-for-service will likely be phased out
and replaced with new payment systems that emphasize quality, outcomes,
and shared risk/savings/bundled payments
 Pharmacists are focusing on their roles on interdisciplinary teams
collaborating with others throughout the continuum of care
 However, section 1861 of the SSA remains the reference point for which
practitioners are eligible to participate in new and emerging delivery
systems and payment models (e.g., ACOs and Medical Homes)
 Therefore, to efficiently participate in new and current delivery and
payment systems, pharmacists need to be listed in the SSA
Current Provider Status Efforts
Pharmacy Stakeholder Group Renews Discussion
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Recognize the pharmacist’s role in improving patient
health.
Three principles:
 Improve opportunities for patients to receive
pharmacists’ services
 Improve opportunities for health care teams to include
pharmacists
 Improve patients’ experiences, health system
efficiencies, and control costs through pharmacist
patient care services
Current Provider Status Efforts
January 2012—ASHP Board Approves Initial
$500,000 for Provider Status Efforts
Spring 2012—Pharmacy Organizations and other
Pharmacy Stakeholders Convene to Discuss Provider
Status Interests
Summer 2012—Pharmacy Stakeholders Develop
Provider Status Principles
Current Provider Status Efforts
Fall/Winter 2012—Pharmacy Stakeholders Finalize
Principles and Agree that Medicare Part B Should be
the Focus
Winter/Spring 2013—Pharmacy Stakeholders Work to
Develop, Narrow, and Negotiate Legislative Request
Summer/Fall 2013—Various Legislative Options
Developed
Potential Legislative Options
***Not Officially Endorsed or Supported by Any Organization***
1) Pharmacists as providers in Medicare Part B (SSA
Section 1861)
2) Pharmacists’ services approved by the Secretary of
the Department of Health and Human Services for cost
effectiveness and improved quality and outcomes (SSA
Section 1861)
3) Pharmacists as ACO professionals (SSA Section 1899)
Potential Cost Limiters
***Not Officially Endorsed or Supported by Any Organization***
Physician Referral
Collaborative Drug Therapy Management Agreement
Eligible Patient Population (e.g., medically
underserved)
Limiting the Number of Services
Pricing services as a percent of the physician fee
schedule
Likely Next Steps for Pharmacy Stakeholders
1) Select a legislative option (i.e., “the ask”)
2) Formalize a coalition
3) Advocate
Provider Status High-Level Strategy
National coalition with multiple stakeholders
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Will NOT be successful with a national strategy alone
Major leadership by states
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Grassroots—letter writing, calls…
Grasstops—Relationships with key lawmakers
Practice site visits—Showing how and where it’s
happening
Consensus building and formation of state coalitions
Outreach to local media
Presence at political events and fundraisers
Efforts to expand state scope of practice
Medication Safety
The Issue of Compounding
Medication Safety
The Issue of Compounding
WHAT IS NEEDED?14
1) Stronger communication and collaboration between state boards of pharmacy
and the FDA
2) Granting the FDA the resources it needs to perform serious and meaningful
regulatory oversight of entities that are potentially engaged in manufacturing
3) A defined distinction between traditional pharmacy compounding and
manufacturing
Source:
14) ASHP Testifies to Senate Committee about Compounding, http://www.ashp.org/menu/News/NewsCapsules/Article.aspx?id=455 , November 2012
States in Which Facilities Received CSPs from NECC that
Was Later Recalled
www.cdc.gov/hai/outbreaks/meningitis.html
Case Count as of September 6, 2013
www.cdc.gov/hai/outbreaks/meningitis.html
Medication Safety
The Issue of Compounding
 ASHP’s Efforts:
 Testified before Senate and House Committees
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Worked with Senators, Representatives, and Committee
Staff on draft legislation to address issues around
compounding
Continue to meet with policymakers and regulators
Continue to help to educate the public and serve as
subject matter expert to various media outlets
 New York Times
 Wall Street Journal
 Fox23.com
 The Tennessean
 Health Leaders Media
ASHP Sterile Compounding Resource Center
 http://www.ashp.org/sterilecompounding
Main Advocacy Points/Goals
 To protect patients from receiving contaminated sterile products like
the ones at the New England Compounding Center
 To clarify federal and state oversight responsibilities for pharmaceutical
compounding activities
 Intent is to ensure a regulatory framework that recognizes an evolving
pharmaceutical marketplace that has arisen to meet demands for
specialized products not commercially available
 Give our members the assurance they need that if they outsource for
compounded products, the outsourcer is preparing products in
accordance with proper requirements
Compounding: S. 959
 Bipartisan bill developed by the Senate Health, Education, Labor and
Pensions (HELP) Committee
 Would create a 3rd category of registration, not a pharmacy but not a
manufacturer; “compounding manufacturer”
 Compounding manufacturers would be licensed and regulated by FDA,
would rely on user fees for funding
 Hospitals and health systems were carved out of the category and
considered traditional pharmacy compounders subject to state board
 ASHP supported the bill, testified before HELP
 Bill was passed out of committee
Compounding: H.R. 3089
 H.R. 3089 by Reps Griffith (R-Va), DeGette (DColo), Green (D-Tx)
 Bill defines traditional pharmacy compounding:
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Pursuant to a Rx
Anticipatory compounding can be done based upon
historical demand and a history of prescriptions
generated solely with an established relationship
between the pharmacist and physician
Compounding for office use without a prescription is
allowed so long as the drug is administered within the
physician’s office, hospital or other health care setting
However must supply valid prescription or patient names
within 7 days after drug was administered; also interstate
shipment cannot account for more than 5 percent of total
inventory
Compounding: Final Bipartisan/Bicameral
Agreement, H.R. 3204
Late September, House and Senate reach
bipartisan/bicameral agreement on compounding
Largely stripped down from S. 959, H.R. 3089
Reaffirms that Section 503A of the Food, Drug and
Cosmetic Act is the law of the land (originally
passed in 1997)
Severs the unconstitutional provisions from the
original section 503A
Creates a new section, 503B, outsourcing facility
with voluntary FDA registration
Would include risk-based FDA inspections, user fees
Section 503A
 Defines compounding to NOT include: mixing,
reconstituting, other acts in accordance with
labeling/manufacturer directions
 Section 503A does not apply to compounding pursuant
to Rx
 Section 503A allows compounding from bulk if USP
compliant
 Section prohibits compounding if on FDA list of
products removed from the market
 Cannot compound “regularly or in inordinate amounts
drug products that are essentially copies of
commercially available drug products”
 Does not mention “office use”, leaves it to the states
Section 503A, Cont’d.
 A drug product may not be compounded if it is
demonstrably difficult to compound, as determined by FDA
 Allows for anticipatory compounding in “limited” quantities
and must be based upon historical relationships
 Section 503A limits amount of compounded drugs to be
distributed out of state to no more than 5% of total
prescription orders dispensed. Unless…
 Memorandum of Understanding (MOU) between states and
FDA is created to address inordinate amounts of
compounded drugs distributed out of state
 Again, if under the 5% of total drugs dispensed, no MOU is
necessary. If No MOU, then cannot exceed 5% distribution
out of state.
Section 503B, New Section
Outsourcing Facility—Definition
 Engaged in compounding of sterile drugs
 Has elected to register as an outsourcing
facility [with the FDA]
 Complies with all requirements under 503B
 Is NOT required to be a licensed pharmacy
 May or may not obtain prescriptions for
identified individual patients
Section 503B, Cont’d
Section 503B defines compounding:
combining, mixing, diluting, pooling,
reconstitution… to create a drug.
Outsourcers must be under supervision of
pharmacist
Must report adverse events
Comply with labeling requirements (notice
it’s a compounded drug)
H.R. 3204
Requires enhanced communication between FDA
and state boards
States can report to FDA that a compounding
pharmacy may be acting contrary to Section 503A
FDA notifies state boards upon receiving
registration from an outsourcing facility or,
FDA determines that a pharmacy is acting contrary
to Section 503A
No more confusion!
Within 36 months, GAO must report to Congress on
regulatory efforts to ensure safe compounding
Compounding: Final Bipartisan/Bicameral Agreement,
H.R. 3204
ASHP would have liked to see the bill go
farther, but nonetheless we are supportive
House passed via voice vote on September
28
Senate passed by unanimous consent on
November 18
Signed into law (P.L. 113-54) by President
Obama on Nov. 27
FDA Oversight of Compounding
 November 27, 2013 - President Obama signed the Drug
Quality and Security Act (DQSA)
 December 2, 2013 – FDA Releases three Proposed Rules
and three Draft Guidance Documents
 Proposed Rules
 List of drugs/drug categories that are demonstrably
difficult to compound
 List of bulk ingredients for compounding (503A)
 List of bulk ingredients for compounding (503B)
 Draft Guidance
 Registering as an outsourcing facility
 Registering products compounded
 Withdrawal of 1998 and 2002 CPGs, release of new
guidance for traditional compounding under 503A
Going Forward
 Reacquaint with Section 503A, summaries on our
website:
 http://www.ashp.org/DocLibrary/Advocacy/HR3204Section503A.pdf
 http://www.ashp.org/DocLibrary/Advocacy/HR3204Section503B.pdf
 Hospitals may look at the voluntary registration with
FDA as a criteria in selecting an outsourcer
 State board activity
 Testing labs are receiving attention
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Could be something to look at in the future?
http://www.ashp.org/sterilecompounding
Drug Shortages: Where Are We
Now and
What’s Next?
Drug Shortages
FDA Safety and Innovation Act
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GAO Study due January 2014
FDA Task Force submitted Strategic Plan to Congress
Guidance on hospital repackaging within health system
Continued Congressional Interest
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Gray Market
Economic Factors (ASP+6%)
National Drug Shortages
New Shortages by Year
January 2001 to September 30, 2013
300
267
250
211
200
150
100
204
149166
129
120
88
109
73
58
74 70
50
0
01 02 03 04 05 06 07 08 09 10 11 12 13
Note: Each column represents the number of new
shortages identified during that year.
University of Utah Drug Information Service
Shortage
National Drug Shortages –
Active Shortages by Quarter
Active Shortages
350
300
239
250
200
150
152
188
176
167
246 256
282
273 260
211
299 295 299 294
Note that these are
snapshot data; the
# of active
shortages could
change daily as we
process up to 20
updates a day.
Shortages
100
50
0
Note: Each column represents the number of active shortages on the last day
each quarter. Q3-13 are data through 9/30/13.
University of Utah Drug Information Service
Active Shortages
Top 5 Drug Classes
Active Shortages 9/30/13
60
50
40
30
20
10
0
50
39
31
34
26
University of Utah Drug Information Service
Active Shortages
Common Drug Classes in Short Supply
50
45
40
35
30
25
20
15
10
5
0
46
35
29
2426
23
1517
11
10
34 35
23
15 17
23
16 14 16
1515 13
910 711
9
Source: University of Utah Drug Information Service
2010
2011
2012
Reasons for Shortages – 2012
Reason Determined by University of Utah Drug
Information During Shortage Investigation
Unknown 44%
Manufacturing 36%
Supply/Demand 8.3%
Discontinued 7.8%
Raw Material 3.9%
Source: University of Utah Drug Information
Service
So Where Do We Go from Here?
 Full effect of the Food and Drug Administration
Safety and Innovation Act (FDASIA) legislation
remains to be seen
Analyses of economic and other factors are
expected
ASHP is committed to addressing this issue
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Ongoing activities with summit co-conveners and other
stakeholders
Ongoing collaboration with FDA staff
Upcoming member surveys
New Strategic Plan
New ASHP Strategic Plan
New integrated
strategic plan released
January 2013
http://www.ashp.org/
DocLibrary/AboutUs/St
rategic Plan.pdf
New Strategic Plan
Built from New ASHP Vision
ASHP’s vision is that medication use will be optimal,
safe, and effective for all people all of the time.
Includes three strategic priorities
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Patients and Their Care
Members and Partners
People and Performance
New Strategic Plan
Revised ASHP Mission
The mission of pharmacists is to help people achieve
optimal health outcomes. ASHP helps its members
achieve this mission by advocating and supporting the
professional practice of pharmacists in hospitals,
health systems, ambulatory clinics, and other settings
spanning the full spectrum of medication use. ASHP
serves its members as their collective voice on issues
related to medication use and public health.
ASHP Task Force on
Organizational Structure
What is the Purpose of the Task Force?
 The Task Force will assess the following areas at a
minimum:
 The membership structure of ASHP and
membership classifications as defined in the
governing documents;
 The role and structure of ASHP state affiliates,
Sections, and Forums within ASHP both in terms of
governance and policy;
 The ASHP policy development process
Priority Issues to Tackle
 Revisit of the existing Sections/Forums are structured to
maximize a sense of identity/community among
members
 Identify key membership segments and assess current
services for these groups
 Enhance state affiliate’s role and support of ASHP
 Identify ways for technology to improve membership
satisfaction
 Consider different models of membership
 Study the current governance model as it relates to ASHP
leadership cultivation
Goal: Pharmacy Technicians
Explore long term vision for technicians and role
within ASHP
Study if ASHP has sufficient appeal to grow and
maintain a large technician membership core
Assess how resources should be allocated to
support the technician workforce
Goal: Enhance ASHP’s state affiliates
Create a closer alignment of ASHP and its state
affiliates
Determine the best ways for ASHP to support state
affiliates
Identify partnership opportunities/models between
ASHP and state affiliates
Goals of Policy Process
To evaluate and make recommendations to
ASHP on ways to improve the policy-making
process
To ensure that policy development is timely,
efficient, effective, responsive to member needs,
forward-thinking, and engages the expertise of a
variety of ASHP members and groups including
Sections and Forums
Policy Process
Current
Process
Proposed
Process
Remains
the Same
Development and
approval is an
annual process
Development and
approval is an
ongoing process
(i.e. quarterly)
Policy Week
(With enhanced
Section role)
All policies voted
on at annual HOD
Session
Expedited
electronic and
virtual approval
process
Regional Delegates
Meetings (May host
a virtual RDC on
focused topics)
Input from
members late in the
policy process
Input from members
early and
throughout policy
process
House of Delegates
Session at Summer
Meeting
ASHP Guidelines
 ASHP currently publishes
about 7 new or revised
guidelines each year.
 ASHP maintains
 40 Guidelines
 10 Therapeutic
Position Statement
 4 Therapeutic
Guidelines
 ~25 Guidelines that
are slated for revision
Pharmacy Practice Model Initiative
PPMI – Profession’s Consensus
on Setting the Course
Additional Resources for Strategic Planning
Ambulatory Care Conference and Summit
State Affiliate Grants
http://www.ashpfoundation.org/MainMenuCateg
ories/Education/PPMI-State-Affiliate-Tool-Kit
Ongoing Feedback Opportunities
ASHP Connect Community and Discussion Threads
Specific requests to member segments (i.e. surveys)
Face-to-Face member meetings (i.e. Affiliate
Executives Meeting, Regional Delegate Meetings,
Summer Meeting)
Members of the Task Force, ASHP leaders, and staff
Beverly Black
Director, Affiliate Relations Division – ASHP
[email protected]
301-664-8864