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Legislative and Regulatory Update:
DC Perspective
Montana Pharmacy Association Winter CE & Ski
Big Sky, MT • January 11, 2013
Marcie Bough, PharmD
Senior Director, Government Affairs
American Pharmacists Association
Learning Objectives
Professional Resources & Business Development
At the completion of this knowledge-based activity, pharmacists
will be able to:
1. Describe new federal legislative activity that will impact
the practice of pharmacy.
2. Describe new federal regulations that will affect the
practice of pharmacy.
3. Highlight activities of the Center for Medicare and
Medicaid Innovation.
American Pharmacists Association (APhA)
• Largest and oldest national professional society for pharmacists
• Represents over 62,000 pharmacists, student pharmacists,
pharmaceutical scientists and pharmacy technicians
• APhA members provide care in all practice settings, including:
community pharmacies, hospitals, long-term care facilities,
community health centers, managed care organizations,
hospice settings and the uniformed services
Legislative Update
Overview
• Election Impact
• Federal Budget and Debt Debate
• Congressional Activity
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Senate Community Pharmacy Caucus
Prescription Drug User Fee Reauthorization Act (PDUFA)
Safe Doses Act
Medication Therapy Management (MTM)
Other Hot Topics
2012 Election Impact
• Pharmacy
– Not much change but some losses/retirees
– New members of key Senate and House Committees to be
determined
• Health care issues – the Affordable Care Act
– Health care reform survived two near-death experiences
• Supreme Court
• Election
– House Republicans may still try to repeal parts of the law but
Senate Democrats would not let such bills go through Senate
– By 2014
• States to implement insurance exchanges and need to discuss Medicaid
expansions
• Most people will have to be insured, subsidies should help
Federal Debt Debate
Federal Budget and Debt
• “Fiscal Cliff” and debt ceiling discussions ongoing
• Year-end budget deal delayed cut by 2 months
• Sequestration and debt debate to be determined…
– $1.2 trillion in defense and non-defense budget cuts if no fix
– Potential cuts: Medicare providers $11 billion, NIH $2.5
billion, and FDA $320 million
• Multiple bipartisan “debt commissions” discussed
potential solutions in the past
– Generally recommended combination of new revenues and
spending cuts
• Entitlement programs linked to debt discussion
Budget, Debt and Health Costs
• Health care entitlement programs are a significant portion
of the federal budget
– In 2011 budget terms, generally 21% of budget is Medicare,
Medicaid, and Children’s Health Insurance Program
• Sustainable Growth Rate (SGR) – “Doc Fix”
– Formula for Medicare payment to physicians
– 2013 significant cuts delayed by 1 year in budget deal, still
need to fix SGR
– Expect an extension with the goal of more hearings and
discussions on a new Medicare payment model
• Overall Medicare payment reform discussions ongoing
Congressional Activity
U.S. Senate Community Pharmacy Caucus
• Formed in 2011
• Caucus co-chairs, Senators Jon Tester (D-MT) and Jerry
Moran (R-KS), held an educational briefing March 28, 2012
– “The Role of Pharmacists in Rural America”
– MPA’s Eric Beyer presented
• Focus:
– Role of pharmacists on the health care team and in providing
patient care
– How pharmacists are key to proving accessible health care in
rural communities
– How pharmacists are utilizing technology, such as
telepharmacy, to increase access to services
Prescription Drug User Fee Act (PDUFA)
Reauthorization
• Reauthorization required every 5 years of the Prescription Drug
User Fee Act – PDUFA V
• The Food and Drug Administration Safety and Innovation Act
(FDASIA; P.L. 112-144) signed into law July 2012
• User fees from manufacturers provide resources for FDA’s drug
review process, in addition to Congressional appropriations
– PDUFA IV was included as part of the FDA Amendments Act of 2007
(FDAAA)
– FDA held ongoing meetings with industry and stakeholders to
gather input
– FDA submitted proposal to Congress in January 2012
• Included FDA and manufacturer agreement
PDUFA Reauthorization Provisions
• Law also includes manufacturer user fees for generics, biologics
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and medical devices
Law addresses:
– General program improvements
– Increased communication between FDA and manufactures during
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review process
Authorization to develop guidance on standards for
interoperability of prescription drug monitoring programs
Authorization to study drug labeling by electronic means
Increased manufacturer-level track-and-trace provisions
Requirements related to drug shortages
• Early notification by manufacturers to FDA of potential shortages
• HHS-maintained public list of all drugs experiencing shortages
PDUFA Agreement
• PDUFA agreement between FDA and manufacturers outlines
how user fees are intended to be spent, including:
– Improvements to risk evaluation and mitigation strategies (REMS)
– Improved programs for post-market surveillance and adverse event
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tracking (Sentinel Initiative)
Enhanced management of biomarker and pharmacogenomic
details
• Improvements to REMS reflects APhA’s advocacy efforts
PDUFA and REMS Improvements
• REMS improvements include:
– Earlier dialogue about REMS in drug review process
– Improved standardization and integration into existing and
evolving medical and pharmacy practice technologies and
workflows
• Examples: Use of electronic health records, pharmacy operating
systems, etc.
– Continued strategy/timeframe for FDA to gather public input and
host stakeholder meetings
– Develop guidance on:
• Assessing REMS effectiveness, impact on patient access, and burden
on the health care system
• Applying statutory criteria for when a REMS is required
PDUFA Related Dialogue
• Remaining PDUFA provisions not included in final law that continue to
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have Congressional discussion
– Track and trace requirements to pharmacy and patient level
(pedigree)
– Addressing prescription drug abuse/diversion through
reclassification of hydrocodone from Schedule III to II
FDA Advisory Committee hearing on January 24-25, 2013 to discuss
rescheduling of hydrocodone containing products
‒ APhA on health professionals panel to present pharmacy issues for
Committee members to consider related to impact, logistics, state
issues, and pharmacists role in working with pain patients
‒ FDA will consider recommendation from the Committee; FDA to
make final recommendation to DEA
Safe Doses Act
• The Safe Doses Act became law in October (P.L. 112-186)
• Provisions include:
– Fight medical theft and distinguish from theft of other
products
– Increases medical theft sentences and penalties
– Protect patients from receiving stolen and mishandled
medical products resold in marketplace (often gray- or
black-market channels)
– Increases restitution to victims injured by stolen medical
products
– Provide resources/tools to law enforcement
Medication Therapy Management
(MTM) Improvement Legislation
• Bills introduced in Senate (S. 274) and House (H.R. 891)
• Sen. Hagan (D-NC) bill in the Senate and Rep. McMorris-Rodgers (RWA) bill in the House
• Positioned as “common sense” reform with broad bipartisan support
• Provisions:
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Broadens Medicare Part D MTM eligibility
Requires MTM for Dual Eligibles
Appropriate reimbursement
Pay for performance incentives
Data collections and performance measures
• Continue discussion with Congressional staff and pharmacy
organizations
• Consider revisions to bills if reintroduced in 2013
Compounding Activity
• Ongoing investigation of fungal meningitis tragedy in October 2012
• Rep. Markey (D-MA) issued report October 2012
– Compounding Pharmacies Compounding Risk
• Senate and House held hearings
• Discussion focus on defining compounding versus manufacturing
and regulatory authority between states and FDA
• Senate Health, Education, Labor & Pension (HELP) Committee
requested comments from stakeholders twice
– Questions on compounding prior to hearing
– Response to FDA’s testimony at hearing
• In November, 11 pharmacy organizations released a joint statement
in support of compounding
Compounding Continued…
• Legislation introduced
– Verifying Authority and Legality in Drug Compounding (VALID) Act of 2012
(H.R. 6584) by Rep. Markey (D-MA)
– Support Access to Formulated and Effective (SAFE) Compounded Drugs Act of
2012 (H.R. 6638) by Rep. DeLauro (D-CT)
• HELP Committee and House Energy & Commerce Committee staff
are meeting with stakeholders, including pharmacy
• FDA held stakeholder meetings with pharmacy and others in
December
• FDA held public hearing with the states on December 19
• Expect continued activity and focus on compounding regulations
and better defining compounding versus manufacturing
• FDA continues to support traditional compounding and is seeking to
better regulate manufacturing
Other Legislative Hot Topics
• Including pharmacists in Congressional discussions on
Medicare provider payment reform and evolving payment
models
– Moving away from fee-for-service and toward pay-forperformance (quality and outcomes)
– Payment models for integrated care and risk sharing models
• Pursuing and obtaining Medicare Part B provider status for
pharmacists
• Pharmacy organization discussions and initiatives
– APhA, ASHP, ACCP, NCPA, and others
– Pharmacy Stakeholders group (14 national organizations)
Regulatory Update
Overview
• Center for Medicare and Medicaid Services (CMS)
– Health care reform implementation, state focus areas, Medicare
Part D, other hot topics
• White House Office of National Drug Control Policy (ONDCP)
– Drug abuse/diversion policy
• Food and Drug Administration (FDA)
– Risk evaluation and mitigation strategies (REMS), potential
revisions to the drug paradigm, other hot topics
• Drug Enforcement Administration (DEA)
– Disposal and enforcement issues
• Public Health Service (PHS)
– Report to Surgeon General
Centers for Medicare and Medicaid
Services (CMS)
CMS: Health Care Reform Implementation
Health Care Reform Implementation
• The Affordable Care Act (ACA; P.L. 111-148) also
referenced as health care reform
• APhA’s Goals:
– Influence stakeholders on role of pharmacists on the health
care team
– Advance the profession by making meaningful strides to
scale-up patient care services
– Explore all opportunities for pharmacists to be recognized,
utilized and compensated
– Utilize APhA’s MTM Resources
– Continue to lead the Pharmacy Stakeholder group
– Focus on CMS Innovation Center activities
CMS Innovation Center (CMMI)
• CMMI is part of the Centers for Medicare and Medicaid
Services (CMS)
• Focusing in readmissions and transitions of care
‒ Community Based Care Transitions Program
• Tests models for improving care transitions from the hospital
to other settings and reducing readmissions for high-risk
Medicare beneficiaries
‒ Partnership for Patients Initiative
• Tests models for improving care transitions in order to reduce
hospital readmissions
• Formation of Affinity Groups focused on sharing successful
program information, networking, and utilizing Hospital
Engagement Networks (HENS)
• Pharmacists playing a key role in Medication Affinity Group
Medication Reconciliation Resources
• APhA and the American
Society of Health-System
Pharmacists (ASHP)
collaborating to improve
transitions of care resources
– March 2012 White Paper
available online
– October 2012 survey of
transitions of care
announced 8 best practice
profiles
• Other submissions (nearly
80) will also be highlighted
in future publication
CMMI Activities Continued…
• Accountable Care Organization (ACO) Initiatives
‒ Shared Savings Program, Pioneer ACOs, Advance Payment,
Learning Sessions
‒ Expect to see expansion of CMMI funded programs through
initiative in 2013
• Million Hearts Initiative
‒ Lead by Department of Health and Human Services (HHS)
‒ Goal: Prevent 1 million heart attacks and strokes over the
next five years
Accountable Care Organizations (ACOs)
• November 2, 2011 CMS released final rule
• Shared savings program payment model
• Eligible programs continue to receive fee-for-service payment
through Medicare Parts A & B
• Also eligible for additional Medicare payments if meet specific
quality and savings requirements (shared percentage of savings
generated) on A & B but not D
• Opportunities for pharmacists working in health-systems
forming ACOs
• Challenges remain with linking to community pharmacy
HCR Implementation and the States
• Medicaid and Maintenance of Effort
– On January 1, 2014, states will be required to provide Medicaid
coverage to all individuals with income below 133% of the
federal poverty level who are not eligible for Medicare
– 16 Million new enrollees in 2014
– Opportunity for pharmacists to help care for new patients as
part of the evolving health care model
• Essential Health Benefits (EHB)
– Health insurance exchanges (HIEs)
– State Exchanges must implement a payment structure that
provides incentives for medication and care compliance
activities
– Providing a meaningful set of benefits that are also affordable
– CMS Released guidance notice of its plan to implement EHB that
delegated EHB to States
EHB Continued…
• Required categories to cover in states plans:
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Ambulatory patient services
Emergency services
Hospitalization
Maternity and newborn care
Mental health and substance use disorder services, including behavioral
health treatment
Prescription drugs
Rehabilitative and habilitative services and devices;
Laboratory services
Preventive and wellness services and chronic disease management, and
Pediatric services, including oral and vision care
• Work with states to see if benchmark plan covers pharmacists
services
• CMS working on more regulations
HCR Take Away Points
• Pharmacy needs to be proactive and advocate for role in
evolving health care system
• The number of issues affecting the practice of pharmacy is
increasing (HCR and other regulations)
• HCR is an opportunity but implementation is key
• Transitions of care and medication reconciliation are focus areas
to pharmacists
• Federal and state programs are targeted to find savings and
improve care
• Payment for services is moving away from fee for service:
– Pay for performance
– Risk sharing and shared savings in ACO’s or other integrated care models
– Public/private payment models are being referenced
CMS: Medicare Part D
Medicare Part D
• Medicare Part D MTM Improvements
– Effective 2013
– Requires Part D plans to offer MTM services to targeted
beneficiaries that include, at a minimum, services to improve
adherence:
• Annual comprehensive medication review (CMR), person-toperson or using telehealth technologies
• Provided by licensed pharmacist or other qualified provider
• CMR to result in recommended medication action plan
(MAP), written/printed summary, and personalized
medication record
Medicare Part D
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Part D MTM (continued)
– PDP sponsor must have a process to
• Assess, at least quarterly, the medication use of individuals
who are at risk but not enrolled in the MTM program, including
individuals who have experienced a transition in care
• Automatically enroll targeted beneficiaries, including those
identified a chronic care improvement program
– Enrollment criteria for targeted beneficiaries
– Review of outcome and quality measures:
• Medication adherence, diabetes treatment, and high risk
medication measures
Medicare Part D
• Additional program revisions in 2013
– Improve transparency of preferred or non-preferred
pharmacy networks
– Short-cycle dispensing in long-term care facilities
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14 day or less dispensing with some drugs excluded
Aims to reduce waste
Effective 2013
Continued concerns over costs related to implementation,
dispensing fees, technology, delivery, etc.
• CMS considering independence of consultant pharmacists
working in long-term care facilities
Medicare Part D Communications
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Standardized pharmacy notice of prescription coverage denial
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Dispense written notice to beneficiary versus use of poster in
pharmacy
Increasing MTM awareness
– CMS included MTM reference in the 2012 and 2013 Medicare and
You Handbook, CMS’ annual official guide to Medicare mailed to
all beneficiaries and posted online
– Reference to MTM also appears online in the Part D Section of the
Medicare Web site www.Medicare.gov
– Plan ratings to include MTM program information in 2014
• Additional information of interest on Medicare.gov
– Ask Medicare initiative which provides information helpful to caregivers
• Focus on access to local services and resources related to Medicare
Other CMS Hot Topics
• Electronic health records
– Stage 2 meaningful use criteria for incentive payments
– Stage 3 meaningful use criteria being drafted
– Pharmacy e-HIT Collaborative leads efforts to integrate
pharmacy into EHRs
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Durable medical equipment requirements
Fraud, waste and abuse
Audits
Immunizations
White House Office of
National Drug Control Policy
(ONDCP)
ONDCP Focus Areas
• 2011 Prescription Drug Abuse Action Plan
– Education of prescribers and patients
• Tied to FDA Opioid REMS prescriber education
• Support for required prescriber education for DEA registration
– Prescription Drug Monitoring Programs (PDMPs)
• Expand to all states, ensure interconnectivity between states
– Medication disposal
• Tied to DEA improving options for disposal of controlled substances
(DEA regulations being drafted)
– Enforcement
• Focus on pill mills and doctor shopping
• 2012 National Drug Control Strategy
– Strengthens efforts to prevent drug abuse
– Reinforces efforts on PDMPs and prescription return/take-back and
disposal programs
Food and Drug Administration
(FDA)
Risk Evaluation and
Mitigation Strategies (REMS)
• Why are REMS programs important?
– REMS are intended to mitigate risks to improve patient safety
• Example: iPLEDGE program for isotretinoin products
– Allows access to drugs that would otherwise not be approved or
remain on the market
– FDA does not have the authority to regulate the practice of
medicine or pharmacy but FDA’s decisions and actions impact
these practices every day
– Pharmacists and prescribers are responsible for implementing
REMS in their practices
– REMS could impact patient access
– The number of REMS continues to increase
– Opioid REMS has driven dialogue with FDA and other stakeholders
and increased awareness
• Approved REMS listed online at: www.FDA.gov
REMS: Beneficial Contribution to
Prescription Drug Safety Continuum
REMS
Approved drugs
for
which a
REMS is
unnecessary
Drugs that would not
receive FDA approval
or be allowed to
remain on the market
because the
risk outweighs the
benefit
Average Risk of Drug
Prescription drugs that would not be FDA approved
or remain on the market without a REMS
Source: APhA 2011
REMS White Paper
REMS: Effective Provider Interventions
REMS
Burden Too
Excessive
Average
Burden of
Intervention
Target
REMS
Activity
Ideal
REMS
Activity
Average Effectiveness of Intervention
Source: APhA 2011
REMS White Paper
Ongoing REMS Activity
• PDUFA V reauthorization includes improvements to REMS programs
• Class-wide REMS continue to drive dialogue to improve
standardization, integration and efficiency into workflow, and use of
single-shared systems
– Extended-Release and Long-Acting and Extended Release (ER/LA)
Opioid products
– Transmucosal Immediate-Release Fentanyl (TIRF) products
• Education and CE credit part of ER/LA REMS
• November 2011 final MedGuide/REMS guidance clarifies distribution
and inclusion in REMS
• White House efforts to address prescription drug abuse helping to
drive REMS discussions
APhA’s REMS Resources
FDA: Nonprescription Safe Use
Regulatory Expansion (NSURE) Initiative
FDA Nonprescription Safe Use Regulatory
Expansion (NSURE) Initiative
• February 2012 FDA announced it is considering ways to improve
public health and patient access to certain medications
• Potential revisions to the drug classification paradigm
• Generally, FDA looking to make definitions of prescription and
OTC less rigid so that certain nonprescription medications
could be available through “conditions of safe use”
• March 22-23, 2012 – FDA hosted public hearing
– “Using Innovative Technologies and Other Conditions of Save Use
to Expand Which Drug Products Can Be Considered
Nonprescription”
– FDA Web page: www.fda.gov/drugs/newsevents/ucm/289240
NSURE Initiative: Conditions of Safe Use
• Conditions of safe use could include:
‒ Intervention by a pharmacist or other health care provider
‒ Use of innovative technologies prior to the purchase of the
product
‒ Potential label/approval as prescription and nonprescription with conditions of safe use in place
• Process would be driven by a manufacturer’s interest in
pursuing use of conditions of safe use
• Manufacturer would submit application to FDA for review
through FDA’s nonprescription regulatory pathway
Conditions of Safe:
Opportunities for Pharmacists
• Leverage patients’ access to pharmacists to safely increase the
availability of certain medications as pursued by
manufacturers
• Reconnect and refer patients back into the health care system
‒ Much like pharmacists do today for OTCs and prescriptions
• Communicate and collaborate with the medical community to
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improve team-based care
Pharmacists are well qualified to perform interventions as
required through conditions of safe use
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Conditions of Safe:
Opportunities for Pharmacists
• Build upon the success of existing pharmacist-provided
patient care services provided through:
‒ Immunizations
‒ Collaborative practice agreements
‒ Successful models used by the U.S. Public Health Service
and others
‒ Chronic disease state management programs
‒ Medication adherence programs
‒ OTC self-care programs
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NSURE: Conceptually Similar to REMS
• FDA’s potential new drug paradigm fits into the overall drug
safety continuum much like risk evaluation and mitigation
strategies (REMS)
– REMS programs are a risk management tool that improves
access to certain high risk prescription medications
• Medications requiring a REMS would not be approved or be
allowed to remain on the market without a REMS program due
to the risks associated with their use
• Similarly, certain low risk medications may have an
opportunity to be approved as nonprescription provided that
conditions of safe use are in place as an additional safety step
– See next slide
Potential New Drug Paradigm Being Considered by FDA:
Creating More Flexibility on the Drug Safety Continuum to
Benefit Patients and Public Health
OTCs
Draft
New
FDA
Idea
(NSURE)
Prescription
drugs
REMS
Drugs that would not
receive FDA approval
or be allowed to
remain on the market
because the
risk outweighs the
benefit
Average Risk of Drug
Source: American
Pharmacists Association
Drugs that would
remain prescription
absent “conditions of
safe use” being
considered by FDA
Prescription drugs that
would not be FDA approved
or remain on the market
without a REMS
Additional Key Focus Areas for
Success of NSURE
‒ Science-driven application process
‒ Public input for conditions of safe use applications
‒ Uniform and standardized processes
‒ Efficient and effective communication using HIT
‒ Conditions of safe use interventions being based on consensusdriven, best-practice algorithms
‒ Billing mechanisms must be standardized and in place for a viable
business model
‒ Pharmacists are well qualified to provide safe use conditions
‒ FDA establishing regulatory pathway with existing authority
NSURE Conditions of Safe Use:
Effective Provider Interventions
Intervention
Burden Too
Excessive
Average
Burden/Cost
of Intervention
Target
Activity
Ideal Intervention
Activity
Average Effectiveness of Intervention
Source: American
Pharmacists Association
NSURE Final Thoughts
• Conditions of safe use can improve access and public health
• A more flexible process also requires communication and
collaboration of the health care team
• Many logistics, payment, challenges, and other uncertainties
about any potential new paradigm can we worked out in the
future and are not significant enough to stop this initiative from
moving forward
• APhA aims to work with and be a resource for FDA,
manufacturers, and other stakeholders to help ensure this
concept becomes a reality
Other FDA Hot Topics
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Patient Medication Information (PMI)/MedGuides
Drug Shortages
Safe Use Initiative
MedWatch Reporting
Drug Safety Alerts
Sentinel Initiative
Track and Trace/Supply Chain Security/Counterfeit
Acetaminophen
Antibiotics
Biosimilars
Drug Enforcement Administration
(DEA)
DEA Activities
• Disposal of controlled substances
– Drafting regulation to improve process
• National Drug Take-Back Days
– In conjunction with state Attorney Generals and local law enforcement
– DEA will continue to host until disposal regulations are final
• Constructive transfer issues
– Delivery of a patient-specific controlled substance prescription to a
prescriber for administration to patient
– Issues with DEA definition/interpretations of delivery of controlled
substance to the “ultimate user” – the patient
• Bath salts (synthetic cathinones)
– Public safety issue and drug abuse have lead to scheduling
• Refill reminder letters from pharmacy to physicians
– Can no longer be pre-populated
Public Health Service (PHS)
Summary of PHS Report to
the Surgeon General
• Issued December 2011
• “Improving Patient and Health System Outcomes through
Advanced Pharmacy Practice. A Report to the U.S.
Surgeon General, 2011”
• Four focus points:
‒ Integration of pharmacists as health care providers that
already exists
‒ Recognition of pharmacists as health care providers via
legislation and policy
‒ Compensation mechanisms commensurate with the level of
services provided
‒ Evidence supporting the alignment of this model with health
reform goals
PHS Report Continued…
• Discusses three demands that pharmacist-delivered
patient care can help meet:
‒ Providing care for chronic diseases
‒ Increasing access to care
‒ Supplementing the primary care provider workforce
• Great opportunity for the profession to use this report as
a resource
• Available on PHS Web site at:
http://www.usphs.gov/corpslinks/pharmacy/sc_comms_sg_report.aspx
Wrap Up
Overall Take Away Points
• Continue to advocate for the role of pharmacists as part of the
integrated health care team
• Look at all avenues for payment for services
• Continue to highlight the current successes of pharmacy
practice and make them scalable
• CMS Innovation Center will continue to play a key role in
advocacy efforts and in pharmacist opportunities within
transitions of care activities
• Medicare Part D MTM improvements continue to evolve
• Improvements to REMS programs is ongoing
• FDA NSURE Initiative looking at opportunities to improve
patient access to certain medications through
• Compounding will remain a focus point in Congress, FDA,
states, and pharmacy organizations
APhA Resources
• Access information on APhA’s Web page at
www.pharmacist.com
• Read CEO Tom Menighan’s Blog
• Read policy articles on pharmacist.com and in Pharmacy
Today
• Follow APhA on Twitter and Facebook
• Be a resource for APhA
Self-Assessment Questions
1. Which of the following are addressed in the law
reauthorization PDUFA V?
A. Drug shortages and early notification by manufacturers to FDA of
potential shortages
B. Manufacturer-level track and trace provisions
C. Authorization for study of drug labeling by electronic means
D. All of the above
E. None of the above
Self-Assessment Questions
2. What is a significant focus area of the Center for Medicare
and Medicaid Innovation (CMMI) as part of health care
reform implementation?
a. To expand access to patient care services.
b. To perform cost effectiveness research.
c. To encourage states to adopt public health initiatives for
underserved populations.
d. To share successful care models reducing hospital readmissions
and improving transitions of care.
Self-Assessment Questions
3. Which of the following statements about FDA’s NSURE
Initiative and potential revisions to the drug paradigm is true:
a. It would create a new category of drugs.
b. The new paradigm would allow certain drugs that would
otherwise require a prescription to be sold without a
prescription under conditions of safe use.
c. Any final recommendations for modifying the drug paradigm
must be voted on by Congress.
d. The program would implement greater standardization to REMS
programs.
Questions
Self-Assessment Answers: 1(d), 2(d), 3(b)
Thank You!
APhA Headquarters in Washington, DC
Contact Information
Marcie Bough, PharmD
Senior Director, Government Affairs
American Pharmacists Association
Washington, DC
[email protected]
Office: 202-429-7538
Cell: 703-232-9337