Omnibus Budget Reconciliation Act (OBRA-90)
Goal
To save money
OBRA-90
Recognizes a public expectation of
pharmacists that goes beyond oversight of
drug distribution to include the detection and
resolution of problems with drug therapy.
Basic Framework of OBRA-90
Three major areas
 Rebates
 Demonstration Projects
 DUR
Rebates
Manufactures required to provide
pharmaceuticals to Medicaid at their “best
price”
Demonstration Projects
Goal
To determine if patient outcomes improve and
cost decrease if pharmacists paid to provide
DUR services
Drug Use Review
Retrospective Review
 Educational Programs
 Prospective Review
The 3 functions are all elements of a
continuous quality improvement cycle
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Retrospective Review
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Board reviews drug use and compares with
criteria for use
Identifies area(s) for improvement
Recommend educational programs
Educational Programs
Goal
To improve medication use
Prospective Review
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Screen of prescriptions prior to dispensing
Patient counseling by the pharmacist
Pharmacist documentation of relevant
information
Counseling Standards
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Name and description of medication
Dosage form, dosage, route of administration, and
length of therapy
Directions and precautions
Common/severe side effects
Techniques for self monitoring
Storage
Refill information
What to do if dose missed
Health Insurance Portability and
Accountability Act
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Seeks to improve portability and continuity of
health insurance coverage
To prohibit discrimination in health coverage
HIPAA
Targets 4 aspects of health information
 Transactions and code sets
 National provider identities
 Security
 Privacy
Medicare
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Title XVIII
Part A provides hospitalization insurance
without any charge to eligible beneficiaries
Part B insures beneficiaries against medical
expenses
Medicare Prescription Drug
Improvement and Modernization Act
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Adds a voluntary prescription drug benefit to
Medicare beginning 2006
Provides coverage for disease management
programs, termed medication therapy
management (MTM) programs
Medicare--Hospital
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A pharmacist must supervise the compounding, packaging, and
dispensing of drugs
Drugs and biologicals must be kept in a locked storage area
Outdated products must be made unavailable
No pharmacist, only designated personnel may remove drugs from
pharmacy
Stop order policy
Drug administration errors, adverse drug reactions, and
incompatibilities must be reported
Abuses and losses of controlled substances must be reported
Information relating to drug therapy must be available to professional
staff
Formulary system must be established by the medical staff to ensure
the availability of quality pharmaceuticals at reasonable costs.
Medicaid
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Title XIX
Provides for the health care costs of certain
categories of indigents, including
Blind
Disabled
Aged
Members of families with dependent children
Long-Term Care
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Self-administration of medications allowed
No unnecessary drugs
in excessive dose (including duplicative therapy)
for excessive duration
without adequate monitoring
without adequate indications for its use
in the presence of adverse consequences that
indicate the dose should be reduced or discontinued
any combination of these reasons
Long-Term Care
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No antipsychotic drugs given unless necessary to
treat specific condition diagnosed and documented
in the clinical record
Residents on antipsychotic must receive gradual
dose reductions and behavioral interventions, unless
clinically contraindicated
Facility must ensure that it is free on medication
error rates of 5 % or greater
Residents must be free of any significant medication
errors
Long-Term Care--Pharmacy
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Pharmacy services
Pharmacist consultant
Drug regimen review
Labeling of drugs and biologicals
Storage of drugs and biologicals
Federal Antitrust Laws
Sherman Antitrust Act
 Makes unlawful every contract, combination,
or conspiracy in restraint of trade
 Prohibits monopolies, attempts to
monopolize, or conspiracies to monopolize
 Purpose to protect competition
Types of Per Se Violations
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Price fixing
Boycotting
Tying Arrangements
Exclusive Contracts Joint
Joint Ventures
Robinson-Patman Act
Makes it unlawful for sellers to discriminate in
price between purchasers of like products
when the effect of the discrimination may
substantially injure competition, unless the
discrimination is cost justified