N.J. Admin. Code § 11:24C-2.8

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

Section 11:24C-2.8 - Department review: minimum standards for designation

(a) An applicant shall possess a pharmacy permit issued by the New Jersey Board of Pharmacy pursuant to N.J.A.C. 13:39-4, which may be a specialized permit issued in accordance with N.J.A.C. 13:39-4.1 6.

1. With respect to the applicant's pharmacy permit, at least some portion of the applicant's pharmacy services shall be dedicated to the provision of services and supplies specifically for the treatment of hemophilia.

(b) If the applicant's blood products include cryoprecipitate, the applicant shall possess a blood bank license issued by the Department in accordance with N.J.S.A. 26:2A-2 et seq., and rules promulgated pursuant thereto, specifically N.J.A.C. 8:8.

(c) An applicant shall be either a health care service firm registered with the New Jersey Department of Law and Public Safety, Division of Consumer Affairs, in accordance with N.J.A.C. 13:45B-14, or a health care provider licensed pursuant to N.J.S.A. 26:2H-1 et seq., or the applicant shall have a contract with one or more other persons having such a registration or license that has the ability to assure the provision of in-home nursing services when needed by a covered person.

(d) The applicant shall be in good standing with respect to all of its registrations, licenses and permits, as shall be the pharmacists employed by or contracted with the applicant, and other persons, if any, contracted with the applicant in accordance with (c) above.

(e) The applicant shall demonstrate to the Department's satisfaction that the applicant meets the requirements of N.J.A.C. 11:24C-2.5(b), including, but not limited to, the following:

1. The applicant shall demonstrate that it has at least one year of experience in the management of bleeding episodes, with at least one year of experience with home treatment of bleeding episodes associated with hemophilia, addressing the needs of at least 10 individuals diagnosed with hemophilia;

2. The applicant shall demonstrate its ability to actively participate in both Class I and Class II drug recalls, both in terms of receiving or obtaining information from multiple sources and disseminating information to clients, including covered persons to whom services have been rendered;

3. The applicant shall have a policy of accepting assignment of benefits when the applicant is not under contract with a carrier or other payer and assignment of benefits is an available option;

4. The applicant shall have knowledge and experience in third party billing of carriers, Medicare, Medicaid and other payers, and in obtaining successful reimbursement;

i. The applicant may rely upon the demonstrated experience of a billing agent under contract with the applicant;

ii. The applicant's knowledge and experience shall include coordination of benefits between and among government programs and other forms of health benefits plans and self-funded agreements;

5. The applicant shall have a policy against presentation of any bill to or the collection of any monies from a covered person of a carrier with which the applicant has an agreement for the provision of services and supplies for the home treatment of bleeding episodes associated with hemophilia, except as may be appropriate to collect the copayments, deductibles or coinsurance amounts the covered person is required to pay under the terms of his or her health benefits plan(s), and the applicant shall agree not to hold such a covered person liable for any monies (other than copayments, deductibles or coinsurance amounts) for which the carrier is responsible pursuant to the terms of the covered person's health benefits plan(s) and the agreement between the carrier and the applicant, regardless of whether the applicant believes the carrier has fulfilled its obligations;

6. At a minimum, the applicant's written policy regarding discontinuation of services shall specify that:

i. The applicant shall continue to provide services and supplies to an individual, notwithstanding that the individual ceases to be able to assure payment for some or all of the costs of services and supplies, until the individual obtains an alternate source of services and supplies, up to at least four months after the occurrence of one of the following: loss of coverage under a health benefits plan; ineligibility for benefits or exhaustion of benefits under a health benefits plan; a requirement to satisfy deductibles, coinsurance, co-payments or other cost-sharing requirements or liability for excess costs or excluded items of expense;

ii. The applicant shall continue to provide services and supplies to an individual in the event the applicant and the covered person's carrier terminate the agreement which includes among its terms, the provision of services and supplies to a covered person for home treatment of bleeding episodes associated with hemophilia, for at least four months, or until the individual obtains an alternate source of services and supplies, whichever occurs first, except when termination is the result of the health care provider losing designation as a home treatment health care provider, or for breach, fraud or a determination by the carrier's medical director that the health care provider is an imminent danger to one or more covered persons, whether such breach, fraud or imminent harm is related to the provision of services or supplies for home treatment of bleeding episodes associated with hemophilia, or other services and supplies for which the carrier and health care provider have an agreement;

iii. The applicant shall refer the individual to the Hemophilia Association of New Jersey to obtain help and information about resources as soon as possible following the occurrence of the situations described in (e)6i or ii above; and

iv. The applicant shall provide the policies and procedures to a covered person in writing prior to the applicant's initial provision of services to the covered person, and to covered persons and carriers upon request; and

7. The applicant's staff credentialing program shall require primary source verification of licenses and permits, and shall require recredentialing at least every three years.

(f) If, in the Department's opinion, the applicant does not meet the standards for designation, the Department shall provide a written notice of that determination, with an explanation therefor, to the applicant.

1. An applicant may appeal the Department's determination, and request a hearing in accordance with the Administrative Procedures Act, N.J.S.A. 52:14B-1 et seq., and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1, but shall not be entitled to enter into any agreement with a carrier for the provision of home treatment for bleeding episodes associated with hemophilia until and unless a final decision in favor of the applicant has been obtained.

2. An applicant shall have the right to make a new application consistent with the requirements of N.J.A.C. 11:24C-2.4 without regard to whether the applicant has requested a hearing and the request has been granted.

(g) If, in the Department's opinion, an applicant meets the standards for designation, the Department shall provide written notice to the applicant, confirming the applicant's designation.

N.J. Admin. Code § 11:24C-2.8