New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle KK - Program for Elderly Pharmaceutical Insurance Coverage › Part 9800 - Enrollment Of Pharmacies › Section 9800.1 - Policy and scope

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The
				policy of the State is to assist elderly persons with low income to meet the
				cost of their prescription drug expenditures. In pursuit of this goal, the
				State will contract with only those pharmacies which can demonstrate that they
				are qualified to provide prescription drugs and which can provide reasonable
				assurance that public funds will be properly utilized. Only qualified and
				responsible pharmacies may be enrolled as providers under the Program for
				Elderly Pharmaceutical Insurance Coverage.
(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.