Transcript States - South Carolina Society of Health

“WE THE PEOPLE”
Advocating for Health-System
Pharmacy
South Carolina Society of
Health-System Pharmacists
March 10, 2008
Kevin Colgan, President-elect ASHP
Dedication
 50th Anniversary of the South Carolina Society of
Health-System Pharmacists & my good friend,
Robert Spires, their President
 125th Anniversary of the University of Wisconsin
College of Pharmacy
 William Zellmer, ASHP Deputy Executive Vice
President
 Brian Colgan, Legislative Assistant, United
States Representative Judy Biggert (R-IL)
Agenda
• What’s Advocacy?
• Key Advocacy Issues Facing Pharmacy
• Advocating for Health-System Pharmacy
• Healthcare Platforms of the Presidential
Candidates
Constitution of the United States
“We the People of the United States, in Order to form a more
perfect Union, establish Justice, insure domestic
Tranquility, provide for the common defense, promote
general Welfare, and secure the Blessings of Liberty to
ourselves and our Prosperity, do ordain and establish this
Constitution of the United States.”
Advocacy
•
Active participation in the government
 Voting
 Calling, writing, or visiting to share your views with those
elected and governmental regulatory agencies
•
The basic quality of an advocate is the wish to
be one – requires courage, order & logic, voice
•
Democracy needs citizens to participate – you
have tremendous power to change the way
government acts
Advocacy Role of the Nonprofit
Professional Pharmacy Organization
1. Promote the interest of Pharmacy
2. Shape the social contract we have with the
citizens of our county, state, and country
3. Engage in public discussions about
governmental policies
4. Join members together to nurture values and
provide programs and services that strengthens
public health within their communities
Imperatives for Advocacy
• Patients are still being harmed from medication use
in hospitals and health systems
• Pharmacists are not universally recognized for the
value they bring to health care
• Imagine what a strong and effective policy effort
would accomplish
• Imagine how it would enhance our ability to fulfill
SCSHP & ASHP’s mission
Key Advocacy Issues Facing
Pharmacy
1. Medicaid NDC Reporting
2. Technician Education and Training
3. Provider Status
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4.
5.
6.
7.
Advanced Practice Licensure
Follow-on Biologicals - Biosimilars
FDA Agency Funding
PGY2 Residency Funding
Federal Loan Forgiveness
Medicaid NDC Reporting
• Deficit Reduction Act
– requires state Medicaid programs to collect 11-digit NDC numbers on
all “physician administered” drugs
• CMS defined “physician administered” to include
hospital outpatients
• Creates tremendous burden on hospitals
– Implementation complex and difficult
– CMS cost estimate per claim is $0.09
– Survey of hospitals showed an estimated cost of $10.90 vs. $0.09
Medicaid NDC Reporting
Three Approaches  Legislative, Regulatory, Judicial
• Lobby for a delay
– 17 state Medicaid programs have received a delay
• Ask Congress to define “physician administered”
– Risky - may not receive the answer you want
– Congressional Budget Office would have to score a change and the
estimated savings would need to come from somewhere else
– Randy Kuiper, ASHP member from Montana met with Senate Finance
Committee Chair’s staff (Senator Max Baucus D-Mont)
• Litigation – file a suit over the definition
– ASHP is involved with SNHPA (Safety Net Hospitals for
Pharmaceutical Access)
Technician Education and Training
• March 30, 2007 20/20 Report – Auburn University
Study of Drug Store Chains in Four States
– Technicians misleading patients in signing their rights away to patient
counseling
– Patient counseling only offered on 27 of every 100 prescriptions
– Only 8 of 25 Coumadin users were provided warnings of OTC’s
– 22% error rate, but no wrong medications dispensed
– Too many, too few pills
– Missing label instructions, child-proof caps
Technician Education and Training
•
USA Today Series – Week of February 11, 2008
“Inside a Pharmacy Where a Fatal Error Occurred”
– 46 year old roofing contractor with chronic neuropathic pain
– In 2001, died of a methadone overdose  label with incorrect dosing
instructions
– Busy Pharmacy – 380 Rx’s dispensed that day – mixed accounts on
whether the volume was too much for the pharmacist to handle
– Technician who made the error was a part-timer who had failed the
PTCB Certification Exam
Technician Education and Training
•
USA Today Series – Week of February 11, 2008
“Rx for errors: Drug error killed their little girl ”
– Rainbow Babies and Children’s Hospital: 2 year old girl named Emily
treated for a curable abdominal tumor
– Received last of 4 chemotherapy treatments mixed in 23.4% saline
mixed by a pharmacy technician – pharmacist did not catch the mistake
– Technician spent time on internet planning her wedding in the lull
before the error
– Legislation for mandatory technician education and training has drawn
resistance from pharmacy lobbyists in Ohio
– Emily’s bill submitted in the US House by Rep. LaTourette
Technician Education and Training
ASHP Policy Statement 0412
Uniform State Laws and Regulations Regarding
Pharmacy Technicians
1. Completion of a nationally accredited standardized
program of education and training as a prerequisite to
technician certification
•
•
Interim measure – one year experience vs. education program
112 accredited programs – only 4 in health-systems
2. Mandatory PTCB Certification
•
•
Included in regulations of 30 state boards of pharmacy
¾ Americans assume tech’s are required by law to be trained &
certified
3. Registration by state boards of pharmacy
Provider Status
• 43 states, the Department of Veterans Affairs, and
the Indian Health Service all recognize the value
of collaborative medication management
• Senators Tim Johnson (D-SD) and Thad Cochran
(R-MS) introduced the Medication Therapy Act of
2003 – supported by the Pharmacist Provider
Coalition
• Medicare Modernization Act of 2003 required
PDP’s to offer MTM services
Provider Status
• February, 2005 – Application made for
Pharmacist MTM codes to be added to CPT codes
• January, 2008 – New codes effective (99605,
99606, 99607)
• ASHP supports pharmacists as providers under
Medicare Part B
• ASHP also supports payment for pharmacist
services as part of MTM under Medicare Part D
How did Nurse Practitioners obtain
Provider Status?
•
•
•
•
The Facts
Over 300 accredited post graduate training
programs – most are 2 year MS programs
Five specialty certification exams
Medicare reimburses NP’s at 85% of MD’s rate
and 100% on incident-to billing – private
insurance varies
Most states allow collaborative Rx authority &
some allow independent practice
Am J Health-Syst Pharm. 2003;60:2301-07
How did Nurse Practitioners obtain
Provider Status?
• 20 years of incremental legislative & policy
victories
• Research indicating that NP primary care
decisions and outcomes were equivalent to MD’s
N Engl J Med. 1994;330:211-4
JAMA. 2000;283:59-68
• Laying the Foundation
– 14 RN’s completed RWJ Health Policy Fellowship and worked on
health care issues in congressional offices
– Grass roots activism – seminars teaching NP’s to communicate
with legislators
– Coalitions of NP organizations  American College of Nurse
Practitioners (1973  1993)
Am J Health-Syst Pharm. 2003;60:2301-07
How did Nurse Practitioners obtain
Provider Status?
• Rallying the troops (1993 – 1997)
– testimonials, case studies, demonstration projects, & intense
communication with Congress
• In 1997, 18 Senators & 58 Representatives
cosponsored the NP legislation that became part
of the Balanced Budget Act of 1997
Am J Health-Syst Pharm. 2003;60:2301-07
Optometrist Licensure: Authorization
to Prescribe Medications
• Board of Examiners includes medications in
examination of Treatment & Management of
Ocular Disease
• Medication exam can be administered separately
• State boards of optometry vary in the level of
scope of practice they allow for optometrists
• Variation is primarily around the use of
medications for Dx and Tx purposes
• Being an optometrist is not consistent within a
state or between states ≈ 1 – 3 levels of practice
Optometrist Licensure: Authorization
to Prescribe Medications
• Oklahoma – 1 license
– All must be licensed to use topical and nontopical
pharmaceutical agents
• Maryland – 2 licenses
– Diagnostic Pharmaceutical Agent Certification
– Therapeutic Pharmaceutical Agent Certification
• New Mexico – 3 licenses
– Diagnostic Certification
– Topical Certification
– Oral Certification
Provider Status & Advanced Practice
Licensure: Lessons for Pharmacy
• Best to have uniformity with little state-to-state
variation in scope of practice/licensure
• Collect and present research that provides
evidence of value
• Establish standards in education and credentialing
• Use professional organizations  many voices
supporting common cause – Pharmacist Provider
Coalition
• Have a passionate, persistent commitment to the
cause - advocate
Follow-on Biologicals - Biosimilars
• Bills being introduced to provide a framework
to approve abbreviated applications for
follow-on biological products deemed
“comparable”
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–
–
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No meaningful clinical differences in products
Same mechanism of action
Same route of administration
Same dosage form and strength
• Biosimilar regulation has already been
enacted in Europe and Australia
• Issues  market exclusivity (none to 14 years) &
safety (Risk Evaluation and Mitigation Strategy)
FDA Funding
• Montgomery County, MD > larger budget
than the FDA
• 2007 FDA Science Board Report Outlined
deficiencies within the FDA
– IT upgrade needed
– More trained scientists needed
• PDUFA (Prescription Drug User Fee Act)
reauthorized in September, 2007
– REMS & Postmarketing Surveillance were key elements of bill
– $80M in new user fees + $50M from Appropriations Committee in
President’s budget
• ASHP is a member of the Alliance for a
Stronger FDA
PGY2 Residency Funding
• CMS discontinued funding in 2004, but left
door open in future
• ASHP is seeking a legislative fix
• Current budget situation is tough with deficit
– $7M funding request
• Issue is important for hospitals and academia to
recruit staff and faculty
•Where are we now?
Residency Program Growth in the ASHP Accreditation Process
1990 to 2007
1200
980
1000
853
800
750
668 705
Pharmacy Practice programs
623
600
547
435
400
234 245 249
275
310 326
350
571
Specialized programs
totals
471
380
October 2003 CMS removes
funding from Specialized
Residencies
July 2007 change to
PGY1 & PGY2
200
0
1990
1995
2000
2005
2007
Federal Loan Forgiveness
• National Health Service Corps Loan
Repayment Program for those willing to work in
underserved communities & rural areas
• Includes MD’s, NP’s, PA’s, Nurse-midwife,
Dentists, & Dental Hygienists
• Requires two years of full time service (40
hrs/week)
• ASHP is advocating for inclusion of
Pharmacists
– Submitted language to the House of Representatives
– Senate Committee Report supports inclusion of Pharmacists
Advocating for Health-System Pharmacy
• ASHP board is not happy with the pace of
change
• We have the capacity to be bolder in
fostering needed changes
What do members want?
They want ASHP and their state society of healthsystem pharmacy to advocate effectively on their
behalf for changes that are important to them.
Five Parts to New Advocacy Program
1.
2.
3.
4.
5.
Build capacity for advocacy
Advocacy teams
Expand practice standards
Research
Communications
1. Build capacity
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Reimbursement specialist
Health policy analyst
Quality improvement
Grassroots / PAC coordinator
Survey research
(Practice standards facilitator)
2. Advocacy teams
1. Payment, clinical services  David Chen
2. State requirements for pharmacy
technicians  Doug Scheckelhoff
3. Funding residency training  Brian Meyer
3. Expand practice standards
Policy Development
 Practice Standards
 Policy Positions
Policy Implementation (Advocacy)
 Practitioners
 Pharmacy Stakeholders
 External Stakeholders
External stakeholders
• Groups outside of ASHP who need to be
persuaded to take action or make a
change that members want
– Quality-improvement organizations (NQF, PQA, AHQA)
– Federal regulatory agencies (CMS, FDA, HRSA)
– States (Dept of Health, Medicaid, National Alliance of
State Regulators)
– Health care organizations (AHA, TJC)
– Congress (Key Health Committees)
Key Health Committees - Senate
• Health, Education, Labor & Pensions Committee
– Health Care Jurisdiction: Aging, Biomedical R&D, Public Health
– Ted Kennedy (MA) Chair, Michael Enzi (WY), The Ranking Member
– Members: Barack Obama (IL), Hillary Rodham Clinton (NY)
• Finance Committee
– Health Care Jurisdiction: Health Programs under the Social Security
Act and health programs financed by specific tax or trust fund
– Max Baucus (MT) Chair, Chuck Grassley (IA), The Ranking Member
– Subcommittee on Health Care  John Rockefeller, IV (WV) Chair,
Orrin Hatch (UT), The Ranking Member; Members: Debbie Stabenow
(MI)
Key Health Committees - House
• Energy and Commerce Committee
– Health Care Jurisdiction: Health Care for Senior Citizens & Children,
Protect the Safety of Food and Drugs
– John Dingell (MI), Chair & Diana DeGette (CO), Vice Chair
– Members: Bart Stupak (MI), Charlie Melancon (LA), Mike Rogers (MI)
• Ways and Means Committee
– Health Care Jurisdiction: National Social Security Programs
– Charles Rangel (NY), Chair; Members: Sander Levin (MI), Jim McCrery
(LA), Dave Camp (MI)
– Subcommittee on Health – Pete Stark (CA), Chair; Member: Dave
Camp (MI)
4. Research
• Evidence of value in pharmacists
providing clinical services
• Closing gaps identified by frontline
advocates
• Partnership with ASHP Foundation
• Fund research projects that allow ASHP
to advance its advocacy agenda
5. Communications
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Web site for all advocacy activity
NewsLink for advocacy efforts
InterSections
Board member, officer, staff speeches
and reports
• “Health Policy Alerts”
Communicating with Congress
• Officials
– Senate: Lindsey Graham (R-SC), James DeMint (R-SC)
– House: Henry Brown Jr. (R-01), Joe Wilson (R-02),
Gresham Barrett (R-03), Bob Inglis (R-04),
John Spratt (D-05), James Clyburn (D-06)
• Offices (District/Capital) & Office Structure
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Chief of Staff
Scheduler
Legislative Director
Legislative Assistant
• Congressional Schedule
• Political Action Committee
Meetings with Congress
1. Pre-arrange meeting ( 7-14 days) & identify topic
2. Arrive early
3. Practice 5 minute message
“My name is__________. I take care of _______
patients at __________hospital in your district. I am
hear to talk with you about ___________. I would ask
you to support ___________ for the following reasons
________. Arguments against include ________”
4. Leave information behind in a file with your card
attached
5. Ask for a response and preferred follow-up, when
appropriate
6. Ask him/her to visit when in the district
7. Write a thank you note
Writing Congress
1. Form letters, blitz faxes, postcard campaigns don’t
work!
2. Success is in getting to the right person, at the right
time, and in the right way  “grass tops”
3. Tips
• Use www.congress.org to determine what member
cares about – put message in that context
• Communicate by letter or Web Form
• Include address – be specific in what you ask
• Link to practice standards, talking papers, etc.
• Offer to be a resource
Healthcare Platforms
October 11, 2007
Stated Goal
Provide access to affordable healthcare for all by
paying only for quality healthcare, having insurance
choices that are diverse and responsive to individual
needs, and encourage personal responsibility
Sources: Kaiser Family Foundation & www.johnmccain.com
Healthcare Platforms
May 29, 2007
Stated Goal
Affordable and high-quality universal coverage through
a mix of private and expanded public insurance
Sources: Kaiser Family Foundation & www.barackobama.com
Healthcare Platforms
May 24, 2007 for cost
August 23, 2007 for quality
September 17, 2007 for coverage
Stated Goal
Affordable and high-quality universal coverage through
a mix of private and public insurance
Sources: Kaiser Family Foundation & www.hillaryclinton.com
Healthcare Platforms
October 11, 2007
Overall Approach
1.
2.
3.
4.
Tax credit to increase incentive for insurance coverage
Remove favorable tax treatment for employer-sponsored plans
Insurance competition – transparency for outcomes, quality, & price
Contain costs through payment changes to providers
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Care coordination
Non-payment for preventable medical errors or mismanagement
5. Innovative delivery systems, such as clinics in retail outlets – flexibility
in permitting appropriate roles for nurse practitioners, RN’s, and MD’s
6. Cheaper generic versions of drugs & biologicals – safety protocols to
permit re-importation
7. Tort reform to eliminate frivolous lawsuits & excessive damage awards
Healthcare Platforms
May 29, 2007
Overall Approach
1.
2.
3.
4.
5.
6.
7.
8.
9.
Required coverage for children – coverage thru parents plan up to age 25
Expanded eligibility for Medicaid
Employers must provide plan or contribute %age of payroll to nat’l plan
Income-related subsidies for private plan, new public plan, & federal
subsidies for catastrophic health care costs
National Health Insurance Exchange - create rules & standards for plans
Comparative effectiveness reviews/research – drugs, devices, procedures
Hospitals & plans required to report quality data for disparity populations
Direct negotiation of prices with drug companies for Gov’t programs
Allow drug reimportation if drugs safe & prices lower
Healthcare Platforms
May 24, 2007 for cost
August 23, 2007 for quality
September 17, 2007 for coverage
Overall Approach
1.
2.
3.
4.
Every American required to have coverage
Large employers must provide plan or contribute
Income-related tax subsidies available to make coverage affordable
Private and public plan options to individual through a new Health Choices
Menu operated by the Federal Employee Health Benefits Program
5. Insurance reform – guarantee issue, auto renewal, rate protection,
minimum stop-loss ratios
6. Chronic care management programs, such as “medical homes”
7. Allow Medicare to negotiate drug prices, create pathway for biogenerics,
more generic competition, oversight for PhRMA/provider relationships
Final Thought
“You can’t expect Government to
do what’s right for pharmacy,
unless you advocate for what’s
right for pharmacy!”