Transcript Federal Regulation of Pharmacy Practice

Federal Regulation of Pharmacy Practice
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OBRA-90
HIPAA
Medicare
Medicaid
Long-Term Care
Federal Antitrust Laws
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
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
OBRA-90
• Bottom line – save $$ for the Federal
Govt!
• Better use of drugs = lower costs
• Also added requirement to review
medications of LTC residents
OBRA-90
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Three major provisions
1. Rebates
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States pay lowest price offered by manufacturer
2. Demonstration project funding
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To see if pharmacists can reduce drug costs
and/or improve patient outcomes
3. Drug Use Review
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Retrospective (data mining looking for patterns)
Prospective (individual patient with new Rx)
Educational Programs (to “educate” prescribers)
Prospective DUR
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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:
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Therapeutic duplication
Drug-disease contraindications
Incorrect dose or duration
Drug allergies
Clinical abuse/misuse
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
Medication Counseling
• RPh must “offer to discuss”:
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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)
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
Pharmaceutical Care
OAR 855-041-0100
(1)Patient Counseling and Monitoring:
(a) 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.
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.
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.
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;
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(B) perform a drug utilization review as defined by
Board rule in OAR 855-006-0005.
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;
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.
Authority for Counseling Rules
ORS 689.015
“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
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]
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
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
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
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
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
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
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.
HIPAA
• Use of PHI
– Teaching - OK
– Public health, legal disclosures - OK
– Marketing - NOT OK!!
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 muchcriticized 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.
The Grim Reality!
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!
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)
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
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
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
Medicaid
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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!!
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
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
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
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
Federal Antitrust Laws
• Lots of financial “mysteries” in pharmaceutical
market
• The “players” (and they all want a “piece of the
action”)
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Manufacturers
Wholesalers (primary, secondary, etc)
Hospitals
Pharmacies
Group Purchasing Organizations (GPOs)
Health Maintenance Organizations (HMOs)
Preferred Provider Organizations (PPOs)
Prescribers
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
Sherman Antitrust Act
• Types of violations
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Price fixing
Boycotting
Tying arrangements (two or more products/services)
Exclusive contracts
Joint ventures
Pharmaceutical Services Administration
Organizations (PSAOs)
– Purchasing cooperatives
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