N.J. Admin. Code § 10:51-1.13

Current through Register Vol. 56, No. 24, December 18, 2024

Section 10:51-1.13 - Non-covered pharmaceutical services

(a) The following classes of prescription drugs or conditions are not covered under the Medicaid or NJ FamilyCare fee-for-service programs. For beneficiaries in the Medically Needy component of the New Jersey Care... Special Medicaid Programs, pharmaceutical services are not available to the aged, blind, nor the disabled who are residing in a long-term care facility (except a nursing facility) or in the community. For information on how to identify a covered person, see N.J.A.C. 10:49, Administration.

1. Prescriptions which are not for medically accepted indications as defined in Section 1927(k)(6) of the Social Security Act;

2. Antiobesics and anorexiants, with the exception of lipase inhibitors, when used in treatment of obesity (see N.J.A.C. 10:51-1.14, Prior authorization); coverage of lipase inhibitors shall be limited to obese individuals with a Body Mass Index (BMI) equal to or greater than 27 kg/m2 and less than 30 kg/m2 with co-morbidities of hypertension, diabetes or dyslipidemia; and obese individuals with a BMI equal to or greater than 30 kg/m2 without comorbidities;

3. Drug products for which adequate and accurate information is not readily available, such as, but not limited to, product literature, package inserts and price catalogues;

4. Experimental drugs;

i. Exception: Drugs available only for treatment through an Investigational New Drug (IND) application shall be prior authorized;

5. Medication furnished by a prescriber or an employee of a prescriber;

6. Medication prescribed for hospital inpatients;

7. Non-legend drugs other than antacids; contraceptive devices and contraceptive supplies; diabetic testing materials; over-the-counter (OTC) family planning supplies; inhalation devices (pharmaceutical); insulin; and insulin needles and/or syringes;

i. Exception: Non-legend drugs described in N.J.A.C. 10:51-1.11, for beneficiaries under 21 years of age.

8. Prescriptions written and/or dispensed with nonspecific directions;

9. Food supplements, milk modifiers, infant formulas, therapeutic diets, special liquid or powdered diets used in the treatment of obesity;

i. Exception: Enteral nutritional products and electrolyte replacement supplements;

10. Methadone in any form (tablets, capsules, liquid, injectables, or powder) when used for drug detoxification or addiction maintenance;

11. Drug products for which final orders have been published by the Food and Drug Administration, withdrawing the approval of their new drug application (NDA);

12. Drugs or drug products not approved by the Food and Drug Administration, when such approval is required by Federal law and/or regulation;

13. Radiopaque contrast materials (for example, Telepaque);

14. Drug Efficacy Study Implementation (DESI) drugs and identical, similar and related drugs (see N.J.A.C. 10:51-1.21);

15. Drugs not covered by rebate agreements as defined in Section 4401 of OBRA '90 and Section 1927(a) of the Social Security Act (see N.J.A.C. 10:51-1.22);

16. Erectile dysfunction drugs for individuals who are registered on New Jersey's Sex Offender Registry;

17. Any bundled drug service (see N.J.A.C. 10:51-1.23);

18. Preventive vaccines, biologicals, and therapeutic drugs distributed to hospital clinics and/or community health centers by the New Jersey Department of Health; and

19. Drugs provided primarily for the treatment of infertility or which may be used to treat other conditions related to infertility, including fertility preparations and gonadotropic (follicle stimulating and luteinizing) hormones.

i. When a drug is provided that is ordinarily considered an infertility drug, but is provided for conditions unrelated to infertility, the claim must be sent with supporting documentation for medical review and approval of payment to the Division of Medical Assistance and Health Services, Office of Medical Affairs and Provider Relations, PO Box 712, (Mail Code #14), Trenton, New Jersey 08625-0712.

(b) Otherwise reimbursable products shall be excluded from payment, under the following condition(s):

1. Products whose costs are found to be in excess of defined costs outlined in N.J.A.C. 10:51-1.5, Basis of payment;

2. Drug products in dosage forms whose labeling, prescription or promotional material indicate the primary use is cosmetic in nature; for example, hair restoration;

3. Drug products available in unit-dose and/or unit-of-use packaging and dispensed to residents in a boarding home, residential care setting, alternative family care (AFC) home or other community type setting. Other community type settings shall not include certain assisted living settings, including assisted living residences (ALRs) or comprehensive personal care homes (CPCHs) licensed by the Department of Health and Senior Services.

i. Drug products commercially available only as a unit-dose packaged product are covered in all settings when not otherwise marketed as a chemically equivalent product. The potency of the equivalent products may or may not equal the potency of the unit-dose-packaged product.

4. Prescriptions refilled too soon, as described in N.J.A.C. 10:51-1.19(a)5; and

5. Drug products denied payment based on point-of-sale (POS) and prospective drug utilization review (PDUR) standards adopted by the Medicaid or NJ FamilyCare program. (see N.J.A.C. 10:51-1.26)

(c) Reimbursement shall not be made for any claim submitted by a provider which involves a beneficiary restricted to another pharmacy, except for an emergency situation (see N.J.A.C. 10:49, Administration).

N.J. Admin. Code § 10:51-1.13

Amended by 48 N.J.R. 2785(a), effective 12/19/2016