1. Federal Regulation of Pharmacy Practice
OBRA-90
HIPAA
Medicare
Medicaid
Long-Term Care
Federal Antitrust Laws

2. OBRA-90 Omnibus Budget Reconciliation Act of 1990
First Federal law to address practice standards for pharmacists
Changed practice (slowly)
Acknowledges pharmacists role in assuring safe and effective drug use

3. OBRA-90 Requirements Drug use review (DUR)
Pharmacist must review patient’s drug regimen
Must identify and resolve problems
Goals:
increase chances of desired outcomes
Decrease chance of adverse effects, ineffective Rx

4. OBRA-90 Bottom line – save $$ for the Federal Govt!
Better use of drugs = lower costs
Also added requirement to review medications of LTC residents

5. OBRA-90 Three major provisions Rebates Demonstration project funding
States pay lowest price offered by manufacturer
Demonstration project funding
To see if pharmacists can reduce drug costs and/or improve patient outcomes
Drug Use Review
Retrospective (data mining looking for patterns)
Prospective (individual patient with new Rx)
Educational Programs (to “educate” prescribers)

6. Prospective DUR Review of patients entire drug regimen
Biggest impact on individual RPh’s
Requires patient medication counseling
Documentation of RPh comments
Types of problems to assess:
Therapeutic duplication
Drug-disease contraindications
Incorrect dose or duration
Drug allergies
Clinical abuse/misuse

7. OBRA-90 Expected outcomes: Identify problems then correct them
Call prescriber and/or talk to patient
Document actions
Problems with OBRA 90…
No pay for pharmacists to do this
Often overlooked in busy pharmacies
Beginning to see reimbursement for specific areas

8. Medication Counseling
RPh must “offer to discuss”:
Name and description of medication
Dosage form, dose, route, duration
Special directions
Common, severe side effects
Techniques for self-monitoring
Storage
Refill information
What to do if a dose is missed
Product identification (not in Federal law)

9. Medication Counseling
Counseling is specific to the patient, not the drug
Patient may refuse counseling
Counseling must be offered by RPh (not technician or clerk)
Pharmacy must have system to identify Rx that require counseling
Advisable to have written waiver for those who refuse

10. Pharmaceutical Care OAR 855-041-0100
(1)Patient Counseling and Monitoring:
Prior to dispensing all new prescriptions, the pharmacist or pharmacist intern shall review the patient's record, and initiate and provide oral counseling to the patient or to the patient's agent or caregiver in all ambulatory care settings and for discharge medications in hospitals unless:
(A) counseling is refused, or
(B) counseling in a form other than oral counseling is provided pursuant to Board rules.

11. Pharmaceutical Care OAR 855-041-0100
(b) Counseling on refill prescriptions shall be such counseling as a reasonable and prudent pharmacist would provide and may include:
(A) monitoring for compliance,
(B) intended or expected outcomes,
(C) adverse drug reaction,
(D) inquiries about over-the-counter medications,
(E) generic changes, and
(F) the accuracy of the medication.

12. Pharmaceutical Care OAR 855-041-0100
(c) A pharmacist may provide counseling in a form other than oral counseling when a reasonable and prudent pharmacist would determine in the particular circumstances that a form of counseling other than oral counseling would be more effective.
(d) Patient counseling shall be in person whenever practicable. Whenever the prescription is delivered outside the confines of the retail drug outlet by mail or other third party delivery, counseling shall be in writing and by free access to the pharmacist by phone.

13. Pharmaceutical Care OAR 855-041-0100
(e) Before providing professional advice to the patient or patient's agent, the pharmacist shall, when applicable:
(A) assess the patient, including age, sex, height and weight, chronic medical conditions, medication history, allergies, drug reactions and drug idiosyncrasies, other disease states of the patient, and, when the prescription is a refill, whether the drug has been taken according to the prescriber's directions, therapeutic response and adverse events; and
(B) perform a drug utilization review as defined by Board rule in OAR

14. Pharmaceutical Care OAR 855-041-0100
(f) When providing professional advice during oral counseling, the pharmacist shall provide such information as a reasonable and prudent pharmacist would provide in the circumstances, which may include:
(A) the name and description of the drug;
(B) the dosage form, dose, route of administration, and duration of drug therapy;
(C) the intended use of the drug and expected outcomes;
(D) special directions and precautions for preparation, administration, and use by the patient;

15. Pharmaceutical Care OAR 855-041-0100
(E) common severe side effects, common severe adverse effects, common severe interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
(F) the possible dangers of taking the drug with alcohol, or taking the drug and then operating a motor vehicle or other hazardous machinery;
(G) techniques for self-monitoring drug therapy;
(H) proper storage;
(I) prescription refill information;
(J) action to be taken in the event of a missed dose; and
(K) any other information a reasonable and prudent pharmacist would provide relevant to the patient's drug therapy, including information specific to the patient or the drug.
(g) Counseling shall be initiated and provided confidentially.

16. Authority for Counseling Rules
ORS “Practice of pharmacy” defined. The “practice of pharmacy” means the interpretation and evaluation of prescription orders; the compounding, dispensing, labeling of drugs and devices (except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs and devices); the administering of vaccines and immunizations pursuant to ORS ; the administering of drugs and devices to the extent permitted under ORS ; the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records therefor; the responsibility for advising, where necessary or where regulated, of therapeutic values, content, hazards and use of drugs and devices; the monitoring of therapeutic response or adverse effect to drug therapy; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy. [1979 c.777 §4; 1999 c.350 §3]

17. OBRA-90: Documentation
RPh must make “reasonable effort” to obtain and record at least:
Name, address, phone #, DOB, age, gender
Disease states, allergies, reactions, medication list (profile), devices
Pharmacist’s comments on drug therapy

18. HIPAA Health Insurance Portability and Accountability Act of 1996
Intended to improve insurance continuity
Prohibits discrimination
Regulates privacy and security of health information
DHHS writes rules to implement this law

19. HIPAA Protection of privacy and security of health information from:
Unauthorized access
Alteration
Deletion
Transmission
All healthcare entities (pharmacies, hospitals, clinics, insurers, etc.) must develop P&Ps, train employees

20. HIPAA Covered entities Protected Health Information (PHI)
Anything that can identify the patient (prescriptions, payment/insurance information)
Notice of Privacy Practices
Must be provided to all patients and posted in pharmacy and on internet (if applicable)
Written acknowledgement of receipt

21. HIPAA Protected Health Information (PHI) Specific rules for disclosure
Treatment, payment, operations (TPO)
Communication with other healthcare professionals involved in patient’s care
Transferring prescriptions
Board of Pharmacy, other regulatory agencies
May only disclose “minimum necessary” info
Patient may authorize additional disclosure

22. HIPAA Incidental disclosure De-identification of PHI
Can happen, but try to avoid!
Patient counseling and confidentiality
Has been a big problem for pharmacies
Must make effort to protect confidentiality
De-identification of PHI
Can remove all identifiable information and use
See p. 237 for list of “identifiable” information

23. OAR 855-041-0103 Confidentiality
(1) No licensee or registrant of the Board who obtains any patient information shall disclose that information to a third party without the consent of the patient.
(2) Section (1) of this rule does not apply to:
(a) any disclosure made to the Board;
(b) any disclosure made to a practitioner or to another pharmacist when the pharmacist reasonably believes that disclosing such information is necessary to protect the patient's health or well being; or
(c) to a third party when disclosure is otherwise authorized or required by law.

24. HIPAA Use of PHI Teaching - OK Public health, legal disclosures - OK
Marketing - NOT OK!!

25. A Bad Example from 2002
NEW YORK (AP) - A 16-year-old boy was among southern Florida residents who received unsolicited samples of the antidepressant drug Prozac in the mail in a much-criticized and highly unorthodox marketing campaign.
"I was livid," said the boy's mother, Sue Grinstead of Palm Beach. "My son knew enough not to take it, but what about the other kids?"
A spokesman for the Walgreen Co. drugstore chain, Michael Polzin, confirmed the family's account that a month's supply of Prozac was sent to 16-year-old Michael Grinstead. He said the boy's name was among others sent by a local doctors' office to a Walgreen's in Palm Beach with instructions to send them the drug samples.

26. The Grim Reality!

27. HIPAA - Penalties for Violations
Unintentional – up to $25,000 per year
Intentional – up to $50,000 and/or up to one year in prison!
If fraud involved – up to $100,000 and/or up to five years in prison !
If for personal gain – up to $250,000 and/or up to ten years in prison!

28. Medicare Federal program enacted in 1965
Provides insurance for people over 65 yrs and people with certain disablities
Part A – hospitalization
Part B – other medical expenses (except drugs until 2006)
Drug “discount” cards until 2006 (voluntary program)

29. Medicare Hospitals must comply with “conditions of participation”
CMS can inspect hospitals to assure compliance
Many requirements for pharmacy services in hospitals
JCAHO certification usually suffices for evidence of compliance

30. Medicare Part D
AKA: Medicare Prescription Drug, Improvement, and Modernization Act
Medication Therapy Management (MTM) required for certain patients:
at least two chronic medical conditions
take at least two Part-D-covered medications
are likely to spend more than $4000/year

31. Medication Therapy Management (MTM)
A pharmacist or other qualified professional, such as a nurse, can provide MTM
Drug plans (“insurance company”) to determine the education, skills, and experience of MTM providers
National Council for Prescription Drug Programs (NCPDP) codes can be used for billing of pharmacist professional services
Not fully known how this will impact profession

32. Medicaid Programs administered by each state For “medically indigent”
Funded by both state and federal govts
Federal requirements must be met to get funding
“Oregon Health Plan” is Oregon Medicaid
Received waiver from Federal “no rationing” requirement
Not going so well!!

33. Medicare/Medicaid Fraud
Prohibits “kickbacks” for goods or services provided to Medicaid patients
Ex: Pay $100 for drug, charge Medicaid $110, receive $50 rebate from manufacturer
You gain $60!
(plus a $25,000 fine and 5 years in prison)
Ex: MD’s can not own a lab and refer all patients to it

34. Long-Term Care Facilities
Nursing Homes, Adult Foster Care, Assisted Living Facilities, etc.
Characteristics to both community and hospital pharmacy services
Many federal (and State) requirements
All facilities must have a “consultant pharmacist”
Residents may self-administer or facility staff may administer medications

35. Long-Term Care Facilities
Consultant pharmacist
Responsible for all aspects of pharmaceutical care services at facility
Must provide drug regimen review at least monthly
Report recommendations to MD and director of nursing
MD may disagree

36. Long-Term Care Facilities
Dispensing and Storage
Residents may choose own pharmacy
Unit dose system or traditional bottles
Must lock up DEA C-II medications separately

37. Federal Antitrust Laws
Lots of financial “mysteries” in pharmaceutical market
The “players” (and they all want a “piece of the action”)
Manufacturers
Wholesalers (primary, secondary, etc)
Hospitals
Pharmacies
Group Purchasing Organizations (GPOs)
Health Maintenance Organizations (HMOs)
Preferred Provider Organizations (PPOs)
Prescribers

38. Federal Antitrust Laws
Oregon figures prominently!
Sherman Antitrust Act
Designed to protect competitive markets
Many violations are not challenged
Requires two competitors to make a violation

39. Sherman Antitrust Act Types of violations Price fixing Boycotting
Tying arrangements (two or more products/services)
Exclusive contracts
Joint ventures
Pharmaceutical Services Administration Organizations (PSAOs)
Purchasing cooperatives

40. Robinson-Patman Act Passed in 1936
Prohibits discrimination in price between purchasers of like products (unless it can be cost-justified)
“Preferential pricing” in hospitals/HMOs
Justified based on competitive pressure & formularies
Hospitals/HMOs prohibited from selling in competition with retail pharmacies
Portland Retail Druggists Association (PRDA) vs. Abbott Laboratories (p. 258)
“Own Use” Doctrine