N.Y. Comp. Codes R. & Regs. tit. 9 § 9800.1

Current through Register Vol. 46, No. 45, November 2, 2024

Section 9800.1 - Policy and scope

(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.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 9800.1