New York Codes, Rules and Regulations
Title 18 - DEPARTMENT OF SOCIAL SERVICES
Chapter II - Regulations of the Department of Social Services
Subchapter E - Medical Care
Article 3 - Policies and Standards Governing Provision of Medical and Dental Care
Part 505 - Charges For Professional Health Services
Section 505.3 - Drugs
Universal Citation: 18 NY Comp Codes Rules and Regs ยง 505.3
Current through Register Vol. 46, No. 39, September 25, 2024
(a) Definitions.
(1)
Compounded prescription means one in which two or more
ingredients are mixed by the dispensing pharmacist. Medical assistance
reimbursement for compounding is limited to the following:
(i) a combination of any two or more legend
drugs found on the list of Medicaid reimbursable prescription drugs;
or
(ii) a combination of any legend
drugs included on the list of Medicaid reimbursable prescription drugs and any
other item(s) not commercially available as an ethical or proprietary
product(s); or
(iii) a combination
of two or more products which are labeled "Caution: For Manufacturing Purposes
only." The reconstitution of a commercially available drug is not a compounded
prescription.
(2)
Drug means both prescription and nonprescription
drugs.
(3)
Drug acquisition
costs means the invoice price to the pharmacy of a prescription drug
dispensed to a Medicaid recipient, minus the amount of all discounts and other
cost reductions attributable to such dispensed drug.
(4)
Nonprescription drug
means any drug for which a prescription is not required under section 6810 of
the Education Law, including over the counter, pre-packaged items.
(5)
Practitioner means a
person licensed, authorized or otherwise permitted to write a
prescription.
(6)
Prescription drug means any drug for which a prescription is
required under section 6810 of
the Education Law.
(7)
Written order or fiscal order are terms which
are used interchangeably in this section and refer to any original, signed
written order of a practitioner including any faxed transmitted order which
requests a pharmacy to provide a drug to a medical assistance recipient. All
written orders and fiscal orders shall comply with the provisions of section 21
of the Public Health Law and regulations promulgated thereunder or contained in
this section including but not limited to requirements for prescribing brand
necessary drugs.
(b) Written order required.
(1)
Drugs may be obtained only upon the written order of a practitioner, except for
non-prescription emergency contraceptive drugs as described in subparagraph (i)
of this paragraph, and for telephone and electronic orders for drugs filled in
compliance with this section and 10 NYCRR Part 910.
(i) Non-prescription emergency contraceptive
drugs for females may be obtained without a written order subject to a
utilization frequency limit of 6 courses of treatment in any 12-month
period.
(ii) The
ordering/prescribing of drugs is limited to the practitioner's scope of
practice.
(iii) The
ordering/prescribing of drugs is limited to practitioners not excluded from
participating in the medical assistance program.
(2) All orders for drugs must show the
ordering practitioner's name, address, telephone number, United States Drug
Enforcement Agency (DEA) number (if applicable), and either the practitioner's
MMIS provider identification number, the practitioner's license number or the
certification number of the facility in which the drugs were ordered. All
orders must also contain the name of the recipient for whom ordered.
(3) When used in the context of an order for
a prescription drug, the order must also meet the requirements for a
prescription under section 6810 of
the Education Law and 10 NYCRR Part 910. When used in the context of a
nonprescription drug, the order must also contain the following information:
name of the drug; quantity ordered; strength or dosage; ingredient information,
as necessary; directions for use; date ordered; and number of refills, if
any.
(4) Telephone orders and for
prescription drugs permitted to be filled by subdivision (4) of section 6810 of
the Education Law and non-prescription drugs are permitted.
(5) A telephone order must be recorded by the
pharmacy in the format required by subdivision (4) of section 6810 of
the Education Law, recording the time of the call and the initials of the
person taking the call and the dispenser, prior to dispensing the drug. The
pharmacist must label the drug as he/she would a written prescription, and make
a good faith effort to verify the practitioner's identity, and validity of the
prescription if the practitioner is unknown to the pharmacist. The practitioner
must expressly state whether substitution is permitted or prohibited.
(6) Effective April 1, 2005 an order which
requests a pharmacy to provide a drug to a medical assistance recipient may be
electronically transmitted unless otherwise prohibited by law or regulation.
All written orders and all orders which are electronically transmitted must
comply with the relevant provision of the State Education Law and all
regulations promulgated thereunder. It is the responsibility of the pharmacist
to make a good faith effort to verify the practitioner's identity and validity
of the prescription if the practitioner is unknown to the pharmacist.
(7) On or after June 1, 2005 and after the
department has provided advance written notice to appropriate providers, all
claims for payment of drugs provided under this section and submitted to the
Medical Assistance Program shall contain the serial number of the official New
York State prescription form. Additionally, where serial numbers are available
on official NYS prescription forms for items not required to be ordered or
prescribed on such forms, the billing pharmacy provider must enter such serial
numbers on pharmacy claims submitted for payment to the MA program.
(c) Where obtained.
Drugs may be obtained only from pharmacies which are properly registered by the State in which the pharmacy is located, or from the ordering practitioner. A pharmacy must keep on file the signed written order of the practitioner for audit by the department, or other authorized agency, for six years from the date of payment for any drug dispensed. A practitioner must annotate the patient record to reflect the dispensing of the drug and the quantity, dose, directions for use and number of refills, if any.
(d) Prescription refills.
(1) A written order may not
be refilled unless the practitioner has indicated the number of allowable
refillings on the order.
(2) No
written order for drugs may be refilled more than twelve months after the date
of issuance, nor more than eleven times within a twelve-month period.
(3) Refills must bear the prescription number
of the original written order.
(e) Prescribed quantities.
(1) Drugs must be ordered in a quantity
consistent with the health needs of the patient and sound medical
practice.
(2) Dispensing limits for
drugs.
(i) Except as provided in subparagraph
(ii) of this paragraph, the maximum quantity of drugs dispensed is limited to
the larger of:
(a) a 30-day supply;
or
(b) 100 doses. One hundred doses
is 100 units of a solid formulation.
(ii) The dispensing limit does not apply to
long-term maintenance drugs. Long-term maintenance drugs are:
(a) drugs ordered or prescribed with one or
more refills in quantities of a 30-day supply or greater. The quantity ordered
or prescribed must be based on generally accepted medical practice. The
ordering practitioner must be contacted if dispensing the supply specified in
the prescription would result in the medical assistance recipient receiving a
quantity of drugs which exceeds the manufacturer's labeling indications;
or
(b) drugs ordered or prescribed
without refills in quantities of a 60-day supply or greater. The quantity
ordered or prescribed must be based on generally accepted medical practice. The
ordering practitioner must be contacted if dispensing the supply specified in
the prescription would result in the medical assistance recipient receiving a
quantity of drugs which exceeds the manufacturer's labeling indications;
or
(c) drugs ordered or prescribed
for family planning purposes. The quantity ordered or prescribed must be based
on generally accepted medical practice. Prescription contraceptives for family
planning purposes may be dispensed in a 12-month supply at one time;
or
(d) prescriptions written and
dispensed on the official New York State prescription form for up to a
three-month supply when written in conformity with the Controlled Substance Act
(title IV of article 33 of the Public Health Law).
(f) Payment for drugs.
(1) The reimbursement amounts
are payment in full.
(2) Drugs
provided by a practitioner and billed separately will be paid for at the actual
cost to the practitioner.
(3) The
department will pay each pharmacy enrolled in the MA program a dispensing fee
for each prescription drug claim. Dispensing fees include routine delivery
charges. The department will pay an additional compounding fee of $.75 for each
compounded prescription drug claim. The additional dispensing fee for a
compounded prescription drug claim will not be paid when a manufacturer's
specialty drug is reconstituted or when a nonmedical or nontherapeutic agent is
added to the prescription drug.
(4)
Each pharmacy enrolled in the Medicaid program shall provide the department, in
such manner, for such periods, and at such times as the department may require,
with the drug acquisition costs, as defined in paragraph (a)(3) of this
section, of prescription drugs.
(g) Limitations.
(1) The department will pay for therapeutic
vitamins and specific vitamin preparations only when ordered by a physician for
the treatment of deficiency states or pathological conditions requiring
increased vitamins.
(2) The
department will pay for amphetamine and amphetamine-like substances (congeners)
only when used in outpatient treatment of conditions other than obesity or
weight reduction.
(3) No payment
will be made for any drug which has weight reduction as its sole clinical use.
Payment for drugs used to promote fertility is limited to bromocriptine,
clomiphene citrate, letrozole and tamoxifen, when receiving services pursuant
to section
505.1(a)(1)(iii)
of this Part, and subject to the FDA recommended and/or compendia-supported
uses and limitations.
(4) From time
to time the department may limit the frequency or the amount of drugs which may
be ordered. The department may require prior approval or prior authorization of
drugs. The department may allow for exceptions to prior approval or prior
authorization requirements in emergency circumstances. Emergency circumstances
for purposes of this paragraph means any condition requiring alleviation of
severe pain or which threatens to cause disability or take life if not promptly
treated. The department will advise practitioners and pharmacies in writing
before any reduction in frequency or amount, prior authorization or prior
approval is imposed on any drug.
(h) Utilization threshold.
(1) This subdivision describes the
utilization threshold that the department has established for pharmacy
services. Part 503 of this Title authorizes the department to establish a
utilization threshold for specific provider service types, including pharmacy
services. Part 503 also describes the application of the utilization threshold,
services and procedures excluded from the utilization threshold for all
provider service types subject to a threshold, the method for obtaining an
exemption from or increase in the utilization threshold, notices, and the right
to a fair hearing in certain situations.
(2) General rules.
(i) Federally nonparticipating persons.
Payment will be made for up to 43 pharmacy service formulary codes in a benefit
year for persons who belong to a group listed in section
360-3.3(a)(1) or
(b)(7) of this Title.
(ii) Federally participating persons. Payment
will be made for up to 60 pharmacy service formulary codes in a benefit year
for persons who belong to a group listed in section
360-3.3(a)(2)-(6),
(b)(1)-(6) or (3) of this Title.
(3) Formulary codes.
As used in this subdivision, a formulary code is defined as follows:
(i) for prescription drugs,
the first time a prescription is filled is one formulary code; each refill of
the original prescription is also one formulary code; and
(ii) for nonprescription drugs and medical
and surgical supplies, each initial fiscal order for the drug or supply is one
formulary code; each refill of the fiscal order is also one formulary
code.
(i) The department may, after completing a competitive request for proposal (RFP) process, contract with mail-order pharmacies or their corporate owners to supply prescription and nonprescription drugs and medical/surgical supplies by mail to medical assistance (MA) recipients. The department may elect to offer mail-order pharmacy services in one or more social services districts through a contractor selected after completion of the RFP process. Individuals who are furnished MA by such districts who are not restricted in their access to drugs or medical/surgical supplies and who are not patients in residential health care facilities or any other facilities which have pharmaceuticals included in their medical assistance payments may choose to receive long-term maintenance drugs, excepting drugs prohibited pursuant to article 33 of the Public Health Law, nonprescription drugs and medical/surgical supplies by mail from contractors selected through the RFP process to provide such drugs and supplies.
Disclaimer: These regulations may not be the most recent version. New York may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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