ASHP Update: Trends, Developments and Future Implications

ASHP Update: Trends, Developments and Future Implications

David Chen, B.S.Pharm, MBADirector, Pharmacy Practice Sections

http://www.ashp.org/default.aspx


Overview

Provider RecognitionMedication Safety and CompoundingDrug ShortagesNew ASHP Strategic PlanTask Force on Organizational StructurePharmacy Practice Model Initiative


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



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



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



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




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



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 Strategic Plan



New ASHP Strategic Plan

New integrated strategic plan released January 2013

http://www.ashp.org/DocLibrary/AboutUs/Strategic Plan.pdf

http://www.ashp.org/DocLibrary/AboutUs/Strategic%20Plan.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

[email protected]

mailto:[email protected]
