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

Retrospective Review

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

Screen of prescriptions prior to dispensing Patient counseling by the pharmacist Pharmacist documentation of relevant

information

Counseling Standards

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

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

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

Adds a voluntary prescription drug benefit to Medicare beginning 2006

Provides coverage for disease management programs, termed medication therapy management (MTM) programs

Medicare--Hospital

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Drugs and biologicals must be kept in a locked storage area Outdated products must be made unavailable No pharmacist, only designated personnel may remove drugs from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

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

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

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

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

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