Federal Regulation of Pharmacy Practice

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 patients 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
• 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 RPhs
• 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 CareOAR 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 CareOAR 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 CareOAR 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 CareOAR 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 855-006-0005.

14
Pharmaceutical CareOAR 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 CareOAR 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 689.015Practice 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 689.645 the
  administering of drugs and devices to the extent
  permitted under ORS 689.655 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
• Pharmacists 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 PPs, 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 patients care
• Transferring prescriptions
• Board of Pharmacy, other regulatory agencies
• May only disclose minimum necessary info
• Patient may authorize additional disclosure

22
HIPAA

• Incidental disclosure
• 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 MDs 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