Current through Register Vol. 46, No. 12, March 20, 2024
(b) The following definitions shall apply to
this Part unless the context requires otherwise:
(1) Affiliate or affiliated person means any
person having an overt, covert or conspiratorial relationship with another,
such that either of them may directly or indirectly control the other or such
that they are under a common control. For example: persons with an ownership or
control interest in a provider; agents and managing employees of a provider;
subcontractors; and wholly owned suppliers of a provider with whom the provider
has significant business transactions--are considered affiliated with each
other. Similarly, providers sharing a common ownership or control interest are
affiliated with each other.
(2)
Fraud shall mean an intentional deception or misrepresentation made with the
knowledge that the deception could result in same unauthorized benefit to the
person or another person, and includes the acts prohibited by section 547-k of
the Executive Law.
(3) Abuse shall
mean practices that are inconsistent with sound fiscal business or generally
accepted pharmacy practice and result in unnecessary costs to the
program.
(4) Agent means a person
who has actual or apparent authority to obligate or to act for
another.
(5) Pharmacy-applicant is
any pharmacy which has submitted an application for enrollment.
(6) Application for enrollment or application
means any document submitted by a person for the purpose of enrolling in the
program.
(7) Conviction or
convicted means that a plea of guilty or no contest or a verdict of guilty has
been entered in a Federal, State or local court, regardless of whether an
appeal from the judgment is pending or whether a certificate of relief from
civil disabilities has been granted.
(8) Contractor means the State fiscal
intermediary responsible for enrollment of providers and making payments under
the program.
(9) Enrollment or
enrolling is the process by which a pharmacy-applicant contracts to participate
in the program as a provider of prescription drugs.
(10) Furnishes means the provision of
prescription drugs either directly or indirectly by supervising the provision
thereof.
(11) Indirect ownership
interest means an ownership interest in an entity that has an ownership
interest in a provider. This term includes an ownership interest in any entity
that has an indirect ownership interest in a provider.
(12) Indictment means an indictment has been
handed down by a grand jury, or an accusatory instrument charging a crime which
would be a felony under New York State law has been filed.
(13) Managing employee means a general
manager, business manager, administrator, director, or other person who
exercises operational or managerial control of a provider, or who directly or
indirectly conducts the day-to-day operation of a provider.
(14) Medicaid is the program of
State-administered medical assistance established by title XIX of the Social
Security Act.
(15) Medical
assistance program means the program of medical assistance for needy persons
provided for in title 11 of article 5 of the Social Services Law.
(16) Medicare is the program of hospital and
medical insurance established under title XVIII of the Social Security
Act.
(17) Ownership interest means
possession of equity in the capital, the stock or the profits of a
provider.
(18) Participation is the
ability and authority to furnish prescription drugs to eligible participants
and to receive payment from the program.
(19) Person includes natural persons,
corporations, partnerships, associations, clinics, groups and other
entities.
(20) Person with an
ownership or control interest means a person who:
(i) has an ownership interest totalling five
percent or more in a provider;
(ii)
has an indirect ownership interest equal to five percent or more in a
provider;
(iii) has a combined
direct and indirect ownership interest equal to five percent or more in a
provider;
(iv) owns an interest of
five percent or more in any mortgage, deed of trust, note or other obligation
secured by the provider if that interest equals at least five percent of the
value of the property or assets of the provider;
(v) is an officer or director of a provider
that is organized as a corporation; and
(vi) is a partner in a provider that is
organized as a partnership.
(21) Covered drug means a drug dispensed
subject to a legally authorized prescription pursuant to section
6810 of
the Education Law, and insulin, an insulin syringe or an insulin needle, as
more fully defined in Part 9960 of this Title.
(22) Program means the Program for Elderly
Pharmaceutical Insurance Coverage as provided for by article 19-K of the
Executive Law.
(23) Provider is any
person who has enrolled as a provider of prescription drugs under the
program.
(24) Significant business
transaction means any business transaction or series of transactions that,
during any one fiscal year, exceed the lesser of $25,000 or five percent of a
provider's total operating expenses.
(25) Subcontractor means any person to which
a provider has contracted or delegated some of its management functions or
responsibilities for providing covered drugs.
(26) Supplier means a person from whom a
provider purchases goods and services used in carrying out its responsibilities
under the program.
(27) Wholly
owned supplier means a supplier whose total ownership interest is held by a
provider or a person with an ownership or control interest in a
provider.
(28) Common ownership
means:
(i) ownership by a person or group of
persons who have a combined direct or indirect ownership interest of 50 percent
or more in two or more providers; or
(ii) two or more providers with any common
ownership where common purchasing is practiced.
(29) 24-hour emergency prescription services
means a service in which a pharmacist is available to fill or refill a
prescription at any time of the day or night, to treat the existence of any
condition requiring the alleviation of severe pain or which threatens to cause
disability or take life if not promptly treated.
(30) Emergency delivery service at no cost to
the consumer means a participant is able to obtain free emergency delivery
service, within a five-mile radius of the pharmacy, during operating hours, to
treat the existence of any condition requiring the alleviation of severe pain
or which threatens to cause disability or take life if not promptly
treated.
(31) Maintain a patient
profile means each pharmacist shall maintain a patient medication profile. Such
medication profile shall include, but not be limited to, the patient's name,
address, telephone number, gender, date of birth or age, known allergies and
drug reactions, chronic diseases, a comprehensive list of medications and
relevant devices and other information reported to the pharmacist which is
appropriate for counseling an individual regarding use of prescription and
over-the-counter drugs. Pharmacists shall conduct a prospective drug review
before each prescription is dispensed or delivered to a patient or person
acting on behalf of the patient. Such review shall include screening for
potential drug therapy problems due to therapeutic duplication, drug-drug
interactions, including serious interactions with over-the- counter drugs,
incorrect drug dosage or duration of drug treatment, drug-allergy interactions,
and clinical abuse or misuse.
(32)
Direct patient consultation with each prescription shall mean pharmacists
providing prescription services shall offer to discuss with each patient,
recipient or caregiver of such patient, (in person, when ever practicable, or
by telephone, or for pharmacies engaged primarily in the mail order delivery of
prescriptions, through access to a telephone service which is toll-free for
long-distance calls) who presents a prescription, matters which in exercise of
the pharmacist's professional judgment, the pharmacist deems significant,
including the following:
(i) the name and
description of the medication;
(ii)
dosage form, dosage, route of administration and duration of drug
therapy;
(iii) special directions
and precautions for preparation, administration and use by the
patient;
(iv) common severe side or
adverse effects or interactions and therapeutic contraindications that may be
encountered, including their avoidance, and the action required if they
occur;
(v) techniques for
self-monitoring drug therapy;
(vi)
proper storage;
(vii) prescription
refill information; and
(viii)
action to be taken in the event of a missed dose.
If the offer to counsel is accepted, the pharmacist, or
registered pharmacy intern shall counsel the person presenting the prescription
to the extent the pharmacist deems appropriate in the pharmacist's professional
judgment. Such counseling may include subparagraphs (i)-(viii) of this
paragraph. In the event a patient chooses not to supply information necessary
for maintenance of a medication profile, or not to accept counseling, a
pharmacist may fill a prescription as presented, without having violated this
regulation, provided the refusal to provide such information or accept
counseling is documented in the records of the pharmacy. Patient medication
profiles shall be maintained in a retrievable form for five years following the
date of the most recent entry.