Omnibus Budget Reconciliation Act (OBRA-90)

1. Omnibus Budget Reconciliation Act (OBRA-90) Goal To save money

2. 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.

3. Basic Framework of OBRA-90 Three major areas • Rebates • Demonstration Projects • DUR

4. Rebates Manufactures required to provide pharmaceuticals to Medicaid at their “best price”

5. Demonstration Projects Goal To determine if patient outcomes improve and cost decrease if pharmacists paid to provide DUR services

6. Drug Use Review • Retrospective Review • Educational Programs • Prospective Review The 3 functions are all elements of a continuous quality improvement cycle

7. Retrospective Review • Board reviews drug use and compares with criteria for use • Identifies area(s) for improvement • Recommend educational programs

8. Educational Programs Goal To improve medication use

9. Prospective Review • Screen of prescriptions prior to dispensing • Patient counseling by the pharmacist • Pharmacist documentation of relevant information

10. 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

11. Health Insurance Portability and Accountability Act • Seeks to improve portability and continuity of health insurance coverage • To prohibit discrimination in health coverage

12. HIPAA Targets 4 aspects of health information • Transactions and code sets • National provider identities • Security • Privacy

13. Medicare • Title XVIII • Part A provides hospitalization insurance without any charge to eligible beneficiaries • Part B insures beneficiaries against medical expenses

14. 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

15. 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the compounding, packaging, and dispensing of drugs • Drugs and biologicals must be kept in a locked storage area • Outdated products must be made unavailable • No pharmacist, only designated personnel may remove drugs from pharmacy • Stop order policy • Drug administration errors,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.

16. Medicaid • Title XIX • Provides for the health care costs of certain categories of indigents, including • Blind • Disabled • Aged • Members of families with dependent children

17. 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

18. 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

19. Long-Term Care--Pharmacy • Pharmacy services • Pharmacist consultant • Drug regimen review • Labeling of drugs and biologicals • Storage of drugs and biologicals

20. 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

21. Types of Per Se Violations • Price fixing • Boycotting • Tying Arrangements • Exclusive Contracts Joint • Joint Ventures

22. 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