Download Managing Compliance, Performance, and Outcomes Slides

Managing Compliance,
Performance, and Outcomes
Sarah J Steinhardt, PharmD, JD, MS
Objectives
•
•
•
•
•
•
•
•
Define compliance within the context of pharmacy practice
Explain the differences between a law and a regulation
Explain the differences between a standard and a guideline
Define a star rating and HEDIS and describe why they are
important to pharmacy practice
Describe the terms metric, adherence, baseline, and
process indicator
Explain the difference between a process indicator and an
outcome
List four different health care outcomes
Discuss the importance of having a manager for compliance
and medication safety in the pharmacy
Compliance & Pharmacy
• Practicing pharmacists must be compliant
with the laws and regulations of the
profession – they follow the rules!
• Accordingly, pharmacies must operate in
compliance
– Compliance: When the policies, procedures, and
activities for operation of the pharmacy are
consistent with the laws, rules, regulations,
standards, and guidelines established for
pharmacy practice
Areas of Regulation for Pharmacy
Practice
• Federal and state pharmacy and health care
laws and regulations
• Professional standards and guidelines for
treatment and care
• Performance of important functions
• Managing clinical & economic patient
outcomes
Who is Responsible in the Pharmacy?
• Leadership is responsible for recognizing the
importance of compliance and creating
infrastructure to accomplish compliance
• Assessment of processes and results of how well
the pharmacy is meeting their compliance goals
should be reported to leadership
• Key Responsible Parties in Hierarchical Order:
–
–
–
–
Chief Pharmacy Officer
Director of Pharmacy
Pharmacy Manager
Lead Pharmacist
Pharmacy & Law
• Pharmacy managers must be knowledgeable
on:
– Federal & State general health care laws &
regulations that affect pharmacy
– Federal & State laws & regulations specific to
drugs and pharmacy practice
•
Hierarchy of Law
US Constitution
– Federal and state laws may not violate the Constitution; if they are determined to violate the
Constitution they are invalidated and declared unconstitutional
•
Federal Statutes & Regulations
–
–
–
–
–
Federal laws preempt (take precedence over) state law
State law may be stricter than federal law, but it may not be more lenient
Federal law is generally broader; state law is generally stricter
If a state law is broader or contradicts federal law, the federal law controls
Regulations are authorized by statutes meaning first a statute is created by the legislature and
the statute grants an agency authority to create detailed regulations to carry out the broader
directive of the statute
•
•
Florida pharmacy statutes are generally much broader than the detailed Florida regulations
State Constitution
– Similar to state laws, state constitutions may be more detailed than the federal constitution
•
State Legislation & Regulations
– State laws should not violate the state constitution, federal law, and the US Constitution
– Some state laws are made that violate federal law (marijuana laws); citizens would not be
prosecuted on the state level, but on the federal level
•
Ordinances (local government laws)
– Apply to everyone in the county or municipality (city or town) limits
Statutes
(Legislative Branch)
• Statutes are created by the
legislature
Federal statutes passed here in the US Capitol
Building in Washington D.C. by the House & Senate
– Congress at the federal level
– State legislature at the state
level
• Statutes give authority to
agencies to create
regulations
– So you cannot have a
regulation without a statute
first being passed to give the
agency permission to create
the regulation
Florida state statutes passed here in the state capitol building
in Tallahassee, Florida by the Florida House & Senate
Regulations
(Executive Branch)
• Regulations are created by
agencies
• Agencies are under
departments which are part
of the executive branch of
government
– Federally under the
Department of Health and
Human Services (HHS)
• Examples of agencies:
– Food & Drug Administration
– Center for Medicare &
Medicaid Services
– State level under the Florida
Department of Health (DOH)
• Board of Pharmacy
Summary of Differences Between Statutes
and Regulations
• Statutes are laws created by the legislature (Congress and the state
legislature)
– They are broad directives
– They give authority for an agency to create (promulgate) a regulation
– They are created through the legislature using the process of “How a Bill
Becomes a Law”
– Codified (arranged and catalogued) in the United States Code (USC)
• New laws are added to or amend the USC
• Regulations are created by agencies (federal and state agencies)
– Agencies are considered content experts
– Regulations are more specific and detailed than statutes; agencies create
detailed regulations to carry out the objectives outlined broadly in a statute
– Agencies work with interest groups and scientific experts to create regulations
through the notice and comment process
– Codified (arranged and catalogued) in the Code of Federal Regulations (CFR)
• New regulations are added to or amend the CFR
Overview of Important Laws Affecting
Pharmacy Practice
• Food, Drug, and Cosmetic Act of 1938
– Primary federal statute affecting manufacture,
preparation, distribution, and use of drugs in the United
States
– Law passed so that no new drug could be marketed until it
was 1) proven safe for use under the conditions described
on the label and 2) approved by the FDA
– Many major amendments to law added to FDCA
• Examples:
– Durham Humphrey Amendment (Prescription Drug Amendment): 2
classes of drugs – OTC & Prescription; authorizes oral prescriptions and
refills of prescription drugs
– Kefauver Harris Amendment (Drug Efficacy Amendment): New drugs
cannot be marketed unless proven safe and effective; established Good
Manufacturing Practices requirements for drug manufacturing
Overview of Important Laws Affecting
Pharmacy Practice
• Food and Drug Administration Modernization Act
of 1997
– Created fast track approval process for new drug
applications for drugs treating serious or lifethreatening diseases
– Replaced federal legend with “Rx Only”
– Exemption to allow pharmacists to compound drugs
for patients; describes parameters for what is
compounding and what is manufacturing
– Allows manufacturers to distribute peer-reviewed
journal articles on off-label indications
Overview of Important Laws
Affecting Pharmacy Practice
•
Controlled Substances Act
– Manufacture, distribution, labeling, storage, record keeping, and dispensing of controlled
substances
•
Health Insurance Portability & Accountability Act (HIPAA)
–
–
•
Establishment of national standards for electronic health care transactions and national provider identifier
(NPI) numbers
Rules on security and privacy of health care information
•
•
Security – protects information (confidentiality and availability)
Privacy – patients’ rights and how their information may be used
Omnibus Budget & Reconciliation Act (OBRA 90)
– Requires pharmacists to use drug utilization review to ensure safe and effective drug therapy
– Pharmacist must make an offer to counsel patients
•
Not a requirement to counsel, it is a requirement to make an offer to counsel
– Standards vary in states: some may require counseling for new prescriptions only; some
require counseling for new prescriptions and refills; some require the pharmacist to offer,
others allow a technician to offer, but in all states pharmacists must perform the counseling
•
Medicare Modernization Act of 2003
– Established Medicare Part D drug benefit
– Created provisions for Medication Therapy Management (MTM) and pharmacist
reimbursement for drug therapy management of patients with multiple chronic diseases
taking multiple covered medications who are expected to exceed annual spending limit
Overview of Important Laws
Affecting Pharmacy Practice
• Prescription Drug User Fee Act of 1992
– Requires manufacturers to pay fees for New Drug Applications (NDAs) and
supplements when the FDA reviews clinical studies for prescription drugs; this
provides funding to hire more reviewers and speed up the process
– Reauthorized every five years
– There are now acts establishing user fees for generics and biologics
• Prescription Drug Marketing Act of 1987
– Bill enacted to place more controls on distribution of prescription drug
products and samples
• Patient Protection and Affordable Care Act
– Major health care legislation passed to increase quality and affordability of
health insurance, reduce the numbers of uninsured through expansion of
public and private insurance coverage and reduction of health care costs for
individuals and the government
• 340B Federal Drug Discount Program
– Expands access to affordable medications to low income populations by
supporting the operations of health care safety net providers
State Laws & Regulations
• State statutes
• State regulations from the Board of Pharmacy
• General health department rules and
regulations
Employment Law
• Pharmacy leaders and managers will deal with
employment law on a daily basis
– Should be in contact with their human resources
departments for questions on compliance
Overview of Key
Employment Law
• Americans with Disabilities Act (ADA)
– Civil rights legislation prohibiting discrimination against people with
disabilities and providing for equal opportunity in employment and other
areas
• Age Discrimination in Employment Act (ADEA)
– Prohibits employment discrimination against persons 40 years of age or older
• Fair Labor Standards Act (FLSA)
– Establishes minimum wage, overtime pay, recordkeeping, and child labor
standards for employees of both the government and the private sector
• Family and Medical Leave Act (FMLA)
– Entitles employees of covered employers to have unpaid, job-protected leave
for specific family and medical reasons with health insurance coverage
provided during the leave
• Twelve workweeks of leave in a year for certain situations including birth of child or care
of a newborn child within one year of birth or to care for employee’s spouse, child, or
parent with a serious health condition
• Twenty-six workweeks of leave in a year for military caregiver leave
Standards and Guidelines
•
The Pharmacist Standard of Care is the ethical and legal duty of a pharmacist to
practice with care, diligence, and skill in accordance with established professional
codes of practice as the reasonable and prudent pharmacist would practice
– The standard of care is defined as “what a reasonable, prudent pharmacist would have done
under the same circumstances”
– It is not what the best or most highly functioning, perfect pharmacist would have done, but
the ordinary, average pharmacist
•
Standards are developed by pharmacy organizations (e.g. accrediting
organizations, professional associations, etc) to allow for the measurement of the
quality and reliability of services provided and ensure the practice site is meeting
established levels of quality & reliability for the profession
– Organizations who do not meet standards may lose certification and have their failure to meet
standards potentially sued against them in a quasi legal
•
Guidelines are recommendations and not requirements
– Best practices are considered guidelines; not all pharmacies will be using best practices
Performance
•
•
Performance is managed by measurement
How is performance measured?
– Metric – what is being measured?
•
Example: how much pharmacy counseling is occurring
– Benchmarks – a normal value used to compare facilities
•
Example: 100% of patients with new and refill prescriptions should be counseled unless they refuse
counseling
– Compliance – a determination on whether a law, regulation, standard, guideline, or best
practice has been met
•
Example: OBRA 90 requires offer to counsel; Florida law requires offer to counsel on both new and
refill prescriptions and the pharmacy has incorporated workflow to provide that these requirements
are met 100% of the time to be in compliant with the law
– Intervention – an action, treatment or test performed to improve health care
•
Example: Pharmacist holding a counseling session with patient specifically for medication adherence
– Process/Performance Indicator – intermediate measure between the intervention and an
outcome
•
Example: Pharmacist counsels on medication adherence (intervention) -> Patient adheres to
medication (process/performance indicator) -> Patient health outcomes improve (outcomes measure
= fewer seizures, lower cholesterol)
Medicare Star Ratings
•
•
The federal government offers health insurance plans to cover prescriptions under
Medicare Part D and has an option for beneficiaries to select Medicare Advantage
Plans under Medicare Part C through private insurance to cover their prescriptions
and health care costs
In order to rate and compare the quality of these plans, Medicare developed a Five
Star Quality Rating System
– Five is the highest score and one is the lowest score
– It is used to compare different plans, so beneficiaries can make an informed decision
•
•
33 accountable care measures covering 4 domains: 1) patient/caregiver
experience, 2) care coordination/patient safety, 3) preventative health, and 4) atrisk populations for specific diseases
The 33 measures are calculated using different rating systems including:
–
–
–
–
–
•
HEDIS (Healthcare Effectiveness Data and Information Set)
CAHPS (Consumer Assessment of Healthcare Providers and Systems)
CMS (Centers for Medicare and Medicaid Services)
HOS (Health Outcomes Survey)
IRE (Independent Review Entity)
17 of the 33 measures involve medication management
Medicare Star Ratings
Medicare Star Ratings
•
What do the Star Ratings mean?
– For plans paying for health services, the quality score reflects the plan’s quality of services in
these five categories:
•
•
•
•
•
Staying healthy: screenings, tests, and vaccines. Includes whether members got various screening
tests, vaccines, and other check-ups that help them stay healthy.
Managing chronic (long-term) conditions: Includes how often members with different conditions got
certain tests and treatments that help them manage their condition.
Member experience with the health plan: Includes ratings of member satisfaction with the plan.
Member complaints and changes in the health plan’s performance: Includes how often Medicare
found problems with the plan and how often members had problems with the plan. Includes how
much the plan’s performance has improved (if at all) over time.
Health plan customer service: Includes how well the plan handles member appeals.
– For plans covering drug services, the score reflects quality of services in 4 topics
•
•
•
•
Drug plan customer service: Includes how well the plan handles member appeals.
Member complaints and changes in the drug plan’s performance: Includes how often Medicare found
problems with the plan and how often members had problems with the plan. Includes how much the
plan’s performance has improved (if at all) over time.
Member experience with plan’s drug services: Includes ratings of member satisfaction with the plan.
Drug safety and accuracy of drug pricing: Includes how accurate the plan’s pricing information is and
how often members with certain medical conditions are prescribed drugs in a way that is safer and
clinically recommended for their condition.
– For plans covering both health and drug services, the overall score for quality of those services
covers all of the topics above
HEDIS Measures
• Used by 90% of insurance plans to measure
performance on important dimensions of care
and service
• 75 measures across 8 domains; 29 of them
involve medication management
• Forward thinking pharmacies should strive to
adhere to the HEDIS measures in anticipation
of providing quality services that are
reimbursable
Outcomes
• Four Types of Outcomes that are evaluated in pharmacies and health care
organizations
– Clinical Outcomes
• Concerned with effectiveness of therapy
• Lab tests are not considered clinical outcomes; lab tests are process indicators or
intermediate steps utilized to ascertain the clinical outcome
• Examples: Morbidity & Mortality, decrease in the number of seizures, improved
respiratory function, etc
– Utilization Outcomes
• Use of facilities and providers: number of physician visits, emergency room visits, or
hospitalizations
• Amount of medication used
– Economic Outcomes
• Cost of care – decreased or increased?
– Humanistic Outcomes
• Quality of Life
• Patient Satisfaction
Medication Adherence
• Pharmacists should set a goal to improve medication adherence
• Medication adherence is a process or intermediary indicator and
not an outcome measure
• But it leads to improvements in clinical functioning and reduced
health care utilization
• A study showed medication adherence generated improved
outcomes for four chronic conditions that are major drivers of drug
spending: diabetes, hypercholesterolemia, hypertension, and
congestive heart failure
– For all four conditions, patients who were 80 to 100% adherent to
their medications were significantly less likely to be hospitalized as
compared to non adherent patients; hospitalization rates were lowest
for patients who had the highest medication adherence
– Medical costs were lowered for diabetes, hypertension, and
hypercholesterolemia in highly adherent patients
The Joint Commission
(TJC)
• Famous accreditation organization
• Accredits hospitals, home health agencies, long term care
facilities, hospice
• Health care organizations that achieve accreditation prove to
patients and the marketplace that their facility meets the
standards set by the accreditation organization, so consumers
know the services they are receiving meet a particular
standard of care as determined by an independent
assessment body
• There are many Joint Commission standards; the Medication
Management standards are especially significant to pharmacy
and the National Patient Safety Goals are highlighted
standards that concern the entire health care organization