ASHP Update: Trends, Developments and Future Implications
David Chen, B.S.Pharm, MBADirector, Pharmacy Practice Sections
Overview
Provider RecognitionMedication Safety and CompoundingDrug ShortagesNew ASHP Strategic PlanTask Force on Organizational StructurePharmacy 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 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:
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: 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 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
History2010—Affordable Care Act
MTM Definition, Accountable Care Organizations, MTM Grant Program, Center for Medicare & Medicaid Innovation, Value-Based 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 RecognitionAdvocacy Efforts
What will it require: 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: 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-For-Service 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 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 Will NOT be successful with a national strategy alone
Major leadership by states 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 SafetyThe Issue of Compounding
Medication SafetyThe 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 SafetyThe Issue of Compounding
ASHP’s Efforts: Testified before Senate and House Committees
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 (D-Colo),
Green (D-Tx) Bill defines traditional pharmacy compounding:
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. 3089Reaffirms 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 RxSection 503A allows compounding from bulk if USP
compliantSection prohibits compounding if on FDA list of products
removed from the marketCannot 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 eventsComply 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/HR3204-Section503A.pdf
http://www.ashp.org/DocLibrary/Advocacy/HR3204-Section503B.pdf
Hospitals may look at the voluntary registration with FDA as a criteria in selecting an outsourcer
State board activityTesting labs are receiving attention
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 GAO Study due January 2014 FDA Task Force submitted Strategic Plan to Congress Guidance on hospital repackaging within health system
Continued Congressional Interest Gray Market Economic Factors (ASP+6%)
National Drug Shortages New Shortages by Year
January 2001 to September 30, 2013
01 02 03 04 05 06 07 08 09 10 11 12 130
50
100
150
200
250
300
12088
73 58 74 70
129149 166
211
267
204
109 Shortage
Note: Each column represents the number of new shortages identified during that year.University of Utah Drug Information Service
National Drug Shortages – Active Shortages by Quarter
Q1-10
Q2-10
Q3-10
Q4-10
Q1-11
Q2-11
Q3-11
Q4-11
Q1-12
Q2-12
Q3-12
Q4-12
Q1-13
Q2-13
Q3-13
0
50
100
150
200
250
300
350
152167176188
239246256273260
211
282299295299294
Active Shortages
Shortages
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
Note that these are snapshot data; the # of active shortages could change daily as we process up to 20 updates a day.
Active Shortages Top 5 Drug Classes
Antimicr
obial
s
Chemoth
erapy
Cardiov
ascu
larCNS
E-Lytes
, Nutr
ition
0102030405060
3931
26
50
34
Active Shortages 9/30/13
Active Shortages
University of Utah Drug Information Service
Common Drug Classes in Short Supply
Antibio
tics
Chemoth
erapy
Autono
mic
Cardiov
ascu
larCNS
Electro
lytes
EENT GI
Hormon
e0
10
20
30
40
50
23 24
15 15
34
23
137
14
35
26
1723
46
159 11 9
29
11 1017
35
1510
16 16 201020112012
Source: University of Utah Drug Information Service
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 Ongoing activities with summit co-conveners and other
stakeholders Ongoing collaboration with FDA staff Upcoming member surveys
New ASHP Strategic Plan
New integrated strategic plan released January 2013
http://www.ashp.org/DocLibrary/AboutUs/Strategic Plan.pdf
New Strategic Plan
Built from New ASHP VisionASHP’s vision is that medication use will be optimal,safe, and effective for all people all of the time.
Includes three strategic priorities Patients and Their Care Members and Partners People and Performance
New Strategic Plan
Revised ASHP Mission
The mission of pharmacists is to help people achieveoptimal health outcomes. ASHP helps its members
achieve this mission by advocating and supporting theprofessional practice of pharmacists in hospitals,
health systems, ambulatory clinics, and other settingsspanning the full spectrum of medication use. ASHPserves 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
Development and approval is an
annual process
All policies voted on at annual HOD Session
Input from members late in
the policy process
Proposed Process
Development and approval is an
ongoing process (i.e. quarterly)
Expedited electronic and virtual approval
process
Input from members early and
throughout policy process
Remains the Same
Policy Week (With enhanced
Section role)
Regional Delegates Meetings (May host
a virtual RDC on focused topics)
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/MainMenuCategories/Education/PPMI-State-Affiliate-Tool-Kit
Ongoing Feedback Opportunities
ASHP Connect Community and Discussion ThreadsSpecific 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
Questions
Beverly BlackDirector, Affiliate Relations Division – ASHP