New Jersey Administrative Code › Title 10 - HUMAN SERVICES › Chapter 167A - PROVISION OF PHARMACEUTICAL SERVICES UNDER THE PHARMACEUTICAL ASSISTANCE TO THE AGED AND DISABLED PROGRAM (PAAD) › Subchapter 1 - REQUIREMENTS FOR PROVISION OF PHARMACEUTICAL SERVICES › Section 10:167A-1.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms, when used in this chapter,
				  shall have the following meanings unless the context clearly indicates
				  otherwise:
"Active pharmaceutical ingredient" means any substance or
				  mixture of substances intended to be used in the manufacture of a drug product
				  and that, when used in the production of a drug, becomes an active ingredient
				  of the drug product.
"Annual income" means all income from whatever source
				  derived, actually received or anticipated.
"Applicant" means an individual who applies or reapplies for
				  PAAD, either personally or through an authorized agent.
"Beneficiary" means an individual who has been found eligible
				  for PAAD benefits.
"Bulk drug substance" means a bulk drug substance as defined
				  in 21 CFR
				  207.3(a)(4), that includes
				  any substance that is represented for use in a drug and that, when used in the
				  manufacturing, processing, or packaging of a drug, becomes an active ingredient
				  or finished dosage form of the drug. "Bulk drug substance" does not include
				  intermediates used in the synthesis of such substances.
"Calendar year" means a year beginning January 1 and ending
				  on December 31. It is the base period utilized to determine annual income and
				  PAAD eligibility.
"Centers for Medicare and Medicaid Services (CMS)" means the
				  agency of the Federal Department of Health and Human Services which is
				  responsible for the administration of the Medicare program in the United
				  States. CMS was formerly known as the Health Care Financing Administration
				  (HCFA).
"Commissioner" means the Commissioner of the Department of
				  Human Services.
"Current year" means the calendar year in which a person
				  applies or reapplies for PAAD.
"Department" means the Department of Human Services.
"Division" or "DMAHS" means the Division of Medical
				  Assistance and Health Services in the New Jersey Department of Human
				  Services.
"Durable Medical Equipment, Prosthetics, Orthotics and
				  Supplies (DMEPOS)" means a type of Medicare Part B coverage that applies to
				  certain types of medical equipment and supplies. Pharmacies enrolling as
				  Medicare Part B suppliers for the purpose of PAAD's Medicare Recovery
				  initiative must enroll under DMEPOS.
"Electronic Data Interchange (EDI) Enrollment Form" means an
				  agreement signed by a Medicare Part B Supplier authorizing PAAD to bill
				  Medicare electronically on its behalf for claims that are eligible under both
				  PAAD and Medicare.
"Electronic Media Claim" or "EMC" means an electronic media
				  claim processed by the State's fiscal agent, including claims submitted as
				  real-time claims via modem or electronic bulletin board through the World Wide
				  Web (www), in an electronic format that complies with the standards of the
				  National Council on Prescription Drug Plans (NCPDP), DCPDP D.0/1.2 Payer Sheet,
				  version D.0, which is incorporated herein by reference, as amended and
				  supplemented. The NCPDP standards can be obtained from the NCPDP at 9240 East
				  Raintree Drive, Scottsdale, Arizona 85260-7516, or by accessing the Pharmacy
				  NCPDP-HIPAA Payer Sheet at
http://www.njmmis.com/downloadDocuments/NJ_D-0_NCPDP_Payer_Sheet.pdf
.
"Excipient" means an ingredient that does not contribute
				  therapeutically to a compound, including, but not limited to, fillers,
				  diluents, wetting agents, solvents, emulsifiers, preservatives, flavors,
				  absorption enhancers, sustained-release matrices, and coloring agents.
"Expiration date" means the date when a beneficiary's PAAD
				  eligibility ends.
"Initial Prescription Claim" means a PAAD claim for a drug
				  not previously paid by the State during the 200-day calendar period immediately
				  preceding the service date of a claim being considered for payment; or a PAAD
				  claim that exceeds a time period based on the service date of the previously
				  paid PAAD claim.
"Interchangeable drug product" means those drug products,
				  with therapeutic equivalence ratings of "A," identified in the publication of
				  the Office of Generic Drugs in the Office of Pharmaceutical Science of the
				  Center for Drug Evaluation and Research of the Food and Drug Administration
				  (FDA) of the United States Department of Health and Human Services, Approved
				  Drug Products with Therapeutic Equivalence Evaluations, 34th Edition,
				  incorporated herein by reference, as amended and supplemented, commonly known
				  as the "Orange Book," promulgated pursuant to the Federal Food, Drug, and
				  Cosmetic Act, at
				  21
				  U.S.C. §
										355(j)(7); and
				  those drug products approved by the FDA with therapeutic equivalence ratings of
				  "A" that appear on the FDA's "Drugs@FDA" website, bearing formal internet
				  address
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
,
				  incorporated herein by reference, as amended and supplemented. The Orange Book
				  can be obtained by contacting the United States Government Printing Office at
				  PO Box 979050, St. Louis, MO 63197, or at (866) 512-1800, or it is available
				  on-line at
http://www.accessdata.fda.gov/scripts/cder/ob/
.
"Legend drug" means any approved drug product which by
				  Federal law cannot be dispensed without a prescription and bears the statement
				  on the label: "Caution: Federal law prohibits dispensing without a
				  prescription."
"Medicare" means medical assistance provided to certain aged
				  and disabled persons as authorized under Title XVIII (Medicare) of the Social
				  Security Act.
"Medicare Part B Supplier" means a supplier of Medicare Part
				  B (Medical Insurance) services to Medicare beneficiaries including Durable
				  Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS).
"Medicare Prescription Drug Program" or "Medicare Part D"
				  means the prescription drug coverage program established under the Federal
				  Medicare Prescription Drug, Improvement, and Modernization Act of 2003,
				  Pub. L.
				  108-173 (
				  42 U.S.C. §
										1395w-101 et seq.)
"National drug code" or "NDC" means the three-segment
				  identification number for a specific drug product issued by the U.S. Food and
				  Drug Administration pursuant to
				  21 U.S.C. §
										360 of the Federal Food, Drug and Cosmetic
				  Act.
"National Provider Identifier" or "NPI" means a national
				  identifier issued to a healthcare provider by the National Plan and Provider
				  Enumeration System (NPPES) established pursuant to 45 CFR Part 162, Subpart
				  D.
"National Supplier Clearinghouse (NSC)" means the entity that
				  issues Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
				  supplier authorization numbers nationwide to Medicare Part B Suppliers for the
				  Centers for Medicare and Medicaid Services (CMS). The National Supplier
				  Clearinghouse is located at P.O. Box 100142, Columbia, SC 29202-3142.
"NSC Supplier Number" means the authorization number issued
				  by the National Supplier Clearinghouse (NSC) to a Medicare Part B Supplier of
				  Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) for
				  the Centers for Medicare and Medicaid Services (CMS).
"Pharmacy" means any pharmacy located in New Jersey,
				  operating under a valid permit from the Board of Pharmacy of the State of New
				  Jersey, which has filed an application and agreement of participation, which
				  has been approved by the New Jersey Medicaid Program. The term "pharmacy" also
				  includes any volunteer prescription drug mail-order program or specialty
				  pharmacy in a Medicare Part D plan provider network or a mail order
				  prescription drug program required by a PAAD beneficiary's primary
				  payer.
"Prescription drugs" means all approved legend drugs,
				  including any interchangeable drug products and in conformance with the
				  provisions of the "Prescription Drug Price and Quality Stabilization Act," and
				  insulin, insulin syringes, and insulin needles when prescribed.
1. The term "prescription drugs" includes:
i. Any drug product which by Federal law cannot be dispensed
				  unless ordered by a physician, dentist or podiatrist;
ii. Every product considered to be a legend prescription
				  drug;
iii. Insulin, insulin syringes and insulin needles. While not
				  legend drugs, these items are covered by this program when prescribed;
				  and
iv. Syringes and needles for injectable medicines.
2. The term "prescription drugs" excludes cosmetic drugs as
				  indicated at
				  10:167A-1.15 unless medically
				  necessary.
"Previous year" means the calendar year preceding the year in
				  which the person is applying or reapplying for PAAD. For example, 1995 is the
				  "previous year" when referring to an application which is dated between January
				  1, 1996 through December 31, 1996, inclusive.
1. If a person, who is required to submit a Federal, State
				  and/or City Income Tax return, applies for PAAD at the beginning of a calendar
				  year but has not yet filed an income tax return for the previous year, the last
				  year for which the person filed a tax return is considered to be the "previous
				  year" when completing the PAAD application.
"Provider" means any individual, partnership, association,
				  corporation, institution, or any other public or private entity, agency, or
				  business concern, meeting applicable requirements and standards for
				  participation in the New Jersey Medicaid Program, and the Pharmaceutical
				  Assistance to the Aged and Disabled Program, and where applicable, holding a
				  current valid license, and lawfully providing medical care, services, goods and
				  supplies authorized under
				  30:4D-1 et seq. and amendments
				  thereto.
"Refill Prescription Claim" means a PAAD claim for a
				  previously paid prescription in which the time period between claims is less
				  than or equal to two times the days supply reported by the previously paid PAAD
				  claim for the same prescription. A refill prescription claim may have the same
				  or different prescription number.
"Resident" means "one legally domiciled within the State (of
				  NJ) for a period of 30 days immediately preceding the date of application for
				  inclusion in the PAAD Program. Mere seasonal or temporary residence within the
				  State, of whatever duration, does not constitute domicile." (See
				  10:167-6.4 for residence
				  requirements.)