N.J. Admin. Code § 10:51-1.23 - Bundled drug service

(a) "Bundled drug service" means a drug or service that is marketed or distributed by the manufacturer or distributor as a combined package which includes in the cost the drug product and ancillary services such as, but not limited to, case management services and laboratory testing.

(b) Bundled drug service shall not be eligible for reimbursement by the Medicaid or NJ FamilyCare program.

1. This provision may be waived at the discretion of the Commissioner if the Commissioner determines that a bundled drug service is less than or equal to the total cost of the unbundled components if reimbursed separately; or

2. The Commissioner may waive the provisions for reasons of medical necessity for a bundled drug or in accordance with terms approved by the Department as follows:

i. Those instances where discontinuation, withdrawal, or elimination of the use of the bundled drug by someone who has been receiving a bundled drug would result in the deprivation of the lifesaving or life prolonging benefits of the drug or would cause potential harm or serious exacerbation of the illness being treated; or

ii. Those instances where use of the bundled drug has shown marked improvement in the beneficiary's clinical status reflected in alleviation of symptoms, and elevation of level of function and independence.

(c) In order to determine eligibility for reimbursement, manufacturers, or distributors of a bundled drug service shall submit complete product information, including the cost to the programs of the total bundled drug service, discrete costs of each component of the bundled drug service, cost benefit analyses, and other information as requested by the Department, to the Chief Pharmaceutical Consultant, Division of Medical Assistance and Health Services, Mail Code #20, PO Box 712, Trenton, New Jersey 08625-0712.

1. If the Commissioner determines that a bundled drug is eligible for reimbursement under this section, Medicaid or NJ FamilyCare beneficiaries shall receive or continue to receive the bundled drug service if prior authorization is requested and approved. Prior authorization shall be obtained by completing the appropriate "Request for Authorization Form" requesting medication management authorization and providing sufficient documentation to establish that it is medically necessary to continue the bundled drug services. Mail all the information to:

Assistant Director

Office of Utilization Management

Division of Medical Assistance and Health Services

Mail Code #15

PO Box 712

Trenton, NJ 08625-0712

Notes

N.J. Admin. Code § 10:51-1.23

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