907 KAR 3:205. Hemophilia treatment reimbursement and coverage via the 340B drug pricing program

      Section 1. Definitions. (1) "340B drug pricing program" means a federally-established drug discount program available for covered entities under 42 U.S.C. 256b(a)(4).

      (2) "340B drug pricing program ceiling price" means the highest price allowed by federal law for a drug or factor product available via the 340B drug pricing program.

      (3) "Comprehensive hemophilia diagnostic treatment center" or "CHDTC" means a center pursuant to 42 U.S.C. 256b(4)(g).

      (4) "Department" means the Department for Medicaid Services or its designee.

      (5) "Factor product" means a blood clotting agent used to treat hemophilia.

      (6) "Federal financial participation" is defined in 42 C.F.R. 400.203.

      (7) "Recipient" is defined in KRS 205.8451(9).

 

      Section 2. Participation Requirements. (1) To qualify for reimbursement via the department’s 340B drug pricing program, a comprehensive hemophilia diagnostic treatment center shall:

      (a) Be currently receiving a grant via 42 U.S.C. 701(a)(2);

      (b) Submit the following to the United States Department of Health and Human Services (USDHHS), Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA):

      1. A request to participate in the 340B drug pricing program; and

      2. The entity’s Medicaid billing information; and

      (c) Be approved by the department and the USDHHS HRSA OPA for participation in the 340B drug pricing program.

      (2) A CHDTC participating in the department’s 340B drug pricing program shall:

      (a) Ensure that current information, including business name and address, are always provided to the United States Department of Health and Human Services, Health Resources and Services Administration, Office of Pharmacy Affairs; and

      (b) Comply with 42 U.S.C. Chapter 6A, Subchapter II, Part D, subpart vii, 256b(a)(5) and (7).

      (3) A CHDTC qualifying for reimbursement via the department’s 340B drug pricing program pursuant to subsection (1) of this section shall be eligible for the reimbursement established in Section 4 of this administrative regulation on the first day of the calendar quarter following approval for participation. For example, a CHDTC approved for the department’s 340B drug pricing program participation on January 10, 2009, shall be eligible to receive reimbursement via the program effective April 1, 2009.

 

      Section 3. General Provisions. for Hemophilia Treatment Coverage and Reimbursement for Treatment Provided by a 340B Drug Pricing Program Entity. For the department to reimburse for hemophilia treatment provided by a CHDTC participating as a 340B drug pricing program entity, including a factor product, for a recipient:

      (1) The recipient shall be a current recipient; and

      (2) The factor product shall be:

      (a) Medically necessary for the recipient;

      (b) Approved by the Food and Drug Administration; and

      (c) Prescribed for an indication that has been approved by the Food and Drug Administration or for which there is documentation in official compendia or peer-reviewed medical literature supporting its medical use.

 

      Section 4. Hemophilia Treatment Reimbursement Via the 340B Drug Pricing Program. The department shall reimburse for hemophilia treatment, including a factor product, provided by a CHDTC participating as a 340B drug pricing program entity:

      (1) Exclusively via the department’s 340B drug pricing program;

      (2) Not via the department’s pharmacy reimbursement provisions established in 907 KAR 1:018; and

      (3) At the 340B drug pricing program ceiling price for the factor product pursuant to 42 U.S.C. 256b plus a dispensing fee of twelve and one-half (12 1/2) cents per unit dose.

 

      Section 5. Hemophilia Treatment Coverage and Reimbursement if Provided by a Non-340B Drug Pricing Program Entity. (1) The department’s coverage and reimbursement for hemophilia treatment shall not be restricted to hemophilia treatment provided by an entity participating in the 340B drug pricing program.

      (2) A recipient shall:

      (a) Not be restricted to only receive hemophilia treatment via a 340B drug pricing program entity; and

      (b) Shall have freedom of choice of provider.

      (3) Hemophilia treatment coverage, of hemophilia treatment provided by an entity not participating in the 340B drug pricing program, shall be in accordance with the department’s pharmacy coverage provisions established in 907 KAR 1:019.

      (4) Hemophilia treatment reimbursement, for hemophilia treatment provided by an entity not participating in the 340B drug pricing program, shall be in accordance with the department’s pharmacy reimbursement provisions established in 907 KAR 1:018.

 

      Section 6. Federal Financial Participation. A provision established in this administrative regulation shall be effective contingent upon the department’s receipt of federal financial participation for the respective provision.

 

      Section 7. Appeal Rights. A CHDTC may appeal a department decision associated with this administrative regulation in accordance with 907 KAR 1:671.

      (2) A recipient may appeal the department’s denial, suspension, reduction, or termination of a covered drug or decision regarding the amount of a drug dispensed based upon an application of this administrative regulation in accordance with 907 KAR 1:563. (35 Ky.R. 492; Am. 1233; 1483; eff. 1-5-2009.)

Notation

      RELATES TO: 42 U.S.C. 256b; 42 U.S.C. 701(a)(2)

      STATUTORY AUTHORITY: KRS 194A.030(2), 194A.050(1), 205.520(3), 205.560(2), 42 U.S.C. 256b

      NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health and Family Services, Department for Medicaid Services has responsibility to administer the Medicaid Program. KRS 205.520(3) authorizes the cabinet, by administrative regulation, to comply with a requirement that may be imposed, or opportunity presented by federal law for the provision of medical assistance to Kentucky's indigent citizenry. This administrative regulation establishes the department’s reimbursement, coverage, and other provisions related to hemophilia treatment reimbursed via the 340B drug pricing program and does not affect the coverage and reimbursement provisions available under 907 KAR 1:018 and 1:019 for hemophilia treatment provided by an entity not participating in the 340B drug pricing program.