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-1.15 - Non-covered pharmaceutical services

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

2. 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;

3. Experimental drugs;

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

5. Medication prescribed for hospital inpatients;

6. Non-legend drugs other than insulin; insulin needles and/or syringes; and syringes and needles for injectable medicines for the treatment of multiple sclerosis;

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

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

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

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

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

12. Drugs for which Federal Financial Participation (FFP) is not available, including:

13. Any bundled drug service, except drug product cost which is a component of a bundled drug service (see 10:167A-1.23);

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

15. If the provider has a delivery service, he or she may waive or discount delivery charges to the recipient but is prohibited from charging more than his or her usual and customary charge to the general public for delivery;

16. Diabetic testing materials;

17. Vitamins;

18. Cough and/or cold medications;

19. Drugs used for the treatment of erectile dysfunction;

20. Drugs used for alopecia, hair removal or hair restoration, eyelash growth, weight loss, and skin conditions; and

21. Active pharmaceutical ingredients, bulk drug substances, and excipients that are not a covered outpatient drug as defined in the Social Security Act at 42 U.S.C. § 1396r-8(k)(2).

1. Products whose costs are found to be in excess of defined costs outlined in 10:167A-1.7, Basis of payment;

2. Manufacturers and distributors may request the review of a denial of reimbursement for products under this subsection by providing supportive information not previously submitted, within 30 days of the date of the denial. Agency decision after review of support material is final;

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

4. A prescription refilled too soon as described in 10:167A-1.20(a)5;

5. Drug products denied payment based on point-of-sale (POS) and prospective drug utilization review (PDUR) standards adopted by the PAAD program. (See N.J.A.C. 10:167A-1.28);

6. Drugs prescribed by practitioners not assigned a National Provider Identifier;

7. Drugs prescribed by excluded practitioners, as defined under the Patient Protection and Affordable Care Act regulations at 42 CFR Part 455;

8. Adjudicated claims for drugs not dispensed within 14 calendar days;

9. Brand-name drug dispensing at the request of a PAAD beneficiary when the substitution and reimbursement requirements of N.J.A.C. 10:167A-1.21 apply;

10. Drug products subject to the medical exception process that do not receive authorization in accordance with N.J.A.C. 10:167A-1.29; and

11. Legend drugs distributed by a manufacturer that has not entered into a rebate agreement with the Department as required by N.J.A.C. 10:167A-1.30.