Mo. Code Regs. tit. 13 § 70-20.030

Current through Register Vol. 49, No.12, June 17, 2024

Section 13 CSR 70-20.030 - Drugs Covered by the MO HealthNet Pharmacy Program

PURPOSE: The purpose of this amendment is to update the rule to reference the federal guidelines.

PURPOSE: This rule implements recent changes in drug coverage as mandated by the Centers for Medicare & Medicaid Services (CMS).

(1) Drugs covered under the MO HealthNet Pharmacy Program must meet the definition of a covered outpatient drug as defined in the Social Security Act, section 1927(k)(2) and section 1927(k)(3), as amended.

"Such term also does not include any such drug or product for which a National Drug Code number is not required by the Food and Drug Administration or a drug or biological used for a medical indication which is not a medically accepted indication."

(2) Participating Manufacturers- The MO HealthNet Division identifies those manufacturers who have entered into a rebate agreement according to the Social Security Act, section 1927(a)(1), as amended. All products marketed by participating manufacturers are reimbursable, with the following exceptions: those products identified as Drug Efficacy Study Implementation (DESI) drugs by the federal Food and Drug Administration (FDA); products considered by the federal FDA to be similar, identical or related to a DESI product; products identified in 13 CSR 70-20.031; and products not meeting the definition of drug in sections 505, 506, and 507 of the federal Food, Drug and Cosmetic Act.

13 CSR 70-20.030

AUTHORITY: section 208.152, 208.153, and 208.201, RSMo. 1994.* This rule was previously filed as 13 CSR 40-81.010. Original rule filed Jan. 21, 1964, effective Jan. 31 , 1964. Amended: Filed March 30, 1964, effective April 10, 1964. Amended: Filed April 27, 1965, effective May 7, 1965. Amended: Filed Dec. 7, 1966, effective Dec. 17, 1966. Amended: Filed Oct. 11 , 1967, effective Oct. 21, 1967. Amended: Filed Oct. 19, 1967, effective Oct. 29, 1967. Amended: Filed Jan. 22, 1968, effective Feb. 2, 1968. Amended: Filed Aug. 24, 1968, effective Sept. 4, 1968. Amended: Filed April 16, 1970, effective April 26, 1970. Amended: Filed Feb. 16, 1971, effective Feb. 26, 1971. Amended: Filed Jan. 3, 1973, effective Jan. 13, 1973. Amended: Filed Feb. 6, 1975, effective Feb. 16, 1975. Amended: Filed March 9, 1977, effective June 11 , 1977. Amended: Filed June 13, 1977, effective Oct. 1, 1977. Amended: Filed March 13, 1978, effective June 11 , 1978. Amended: Filed Feb. 1, 1979, effective May 11 , 1979. Emergency amendment filed July 26, 1979, effective Aug. 1, 1979, expired Oct. 10, 1979. Amended: Filed July 16, 1979, effective Oct. 11 , 1979. Emergency amendment filed Aug. 11 , 1981, effective Aug. 21, 1981, expired Nov. 11 , 1981. Amended: Filed Aug. 11 , 1981, effective Nov. 12, 1981. Emergency amendment filed Dec. 21, 1981, effective Jan. 1, 1982, expired April 10, 1982. Emergency amendment filed Jan. 21, 1982, effective Feb. 1, 1982, expired April 10, 1982. Amended: Filed Dec. 21, 1981, effective April 11 , 1982. Emergency amendment filed July 22, 1982, effective Aug. 1, 1982, expired Nov. 10 , 1982. Amended: Filed July 22, 1982, effective Nov. 11 , 1982. Emergency amendment filed Sept. 30, 1982, effective Oct. 10, 1982, expired Jan. 28, 1983. Amended: Filed Jan. 14, 1983, effective May 12, 1983. Amended: Filed July 13, 1983, effective Oct. 13, 1983. Emergency amendment filed Dec. 21, 1983, effective Jan. 1, 1984, expired March 30, 1984. Emergency amendment filed March 21, 1984, effective March 31, 1984, expired July 11 , 1984. Amended: Filed March 21, 1984, effective July 12, 1984. Emergency amendment filed April 20, 1984, effective May 1, 1984, expired July 11 , 1984. Amended: Filed June 13, 1984, effective Sept. 14, 1984. Amended: Filed Sept. 12, 1984, effective Jan. 12, 1985. Amended: Filed Jan. 15, 1985, effective April 11 , 1985. Amended: Filed April 16, 1985, effective July 11 , 1985. Amended: Filed Oct. 2, 1985, effective Jan. 1, 1986. Amended: Filed April 16, 1986, effective July 1, 1986. Amended: Filed Sept. 17, 1986, effective Dec. 1, 1986. Amended: Filed Nov. 14, 1986, effective Feb. 12, 1987. Emergency amendment filed Dec. 18, 1986, effective Jan. 1, 1987, expired Feb. 11 , 1987. Amended: Filed Feb. 18, 1987, effective May 1, 1987. Amended: Filed April 17, 1987, effective July 1, 1987. Amended: Filed June 16, 1987, effective Sept. 1, 1987. Amended: Filed Aug. 18, 1987, effective Nov. 12, 1987. Amended: Filed Dec. 1, 1987, effective Feb. 11 , 1988. Amended: Filed April 4, 1988, effective July 1, 1988. Amended: Filed July 15, 1988, effective Oct. 13, 1988. Amended: Filed Sept. 15, 1988, effective Dec. 11 , 1988. Amended: Filed April 4, 1989, effective July 1, 1989. Amended: Filed June 6, 1989, effective Sept. 1, 1989. Amended: Filed June 30, 1989, effective Oct. 1, 1989. Amended: Filed Nov. 15, 1989, effective Feb. 1, 1990. Amended: Filed Feb. 16, 1990, effective May 1, 1990. Amended: April 18, 1990, effective June 30, 1990. Amended: Filed Aug. 10, 1990, effective Dec. 31, 1990. Emergency amendment filed Dec. 21, 1990, effective Jan. 1, 1991, expired April 30, 1991. Emergency rescission and rule filed March 21, 1991, effective March 31, 1991, expired July 28, 1991. Emergency rescission filed April 2, 1991, effective April 12, 1991, expired Aug. 9, 1991. Emergency rule filed April 2, 1991, effective April 13, 1991, expired Aug. 10, 1991. Emergency amendment filed June 21, 1991, effective July 1, 1991, expired Aug. 10, 1991. Emergency rescission filed July 31, 1991, effective Aug. 11 , 1991, expired Dec. 6, 1991. Rescinded: Filed March 21, 1991, effective Sept. 30, 1991. Emergency rule filed July 31, 1991, effective Aug. 11 , 1991, expired Dec. 7, 1991. Readopted: Filed July 15, 1991, effective Jan. 13, 1992. Emergency amendment filed Sept. 23, 1991, effective Oct. 3, 1991, expired Dec. 7, 1991. Emergency rule filed Nov. 27, 1991, effective Dec. 8, 1991, expired April 5, 1992. Emergency amendment filed March 24, 1992, effective April 1, 1992, expired July 29, 1992. Emergency amendment filed June 16, 1992, effective July 1, 1992, expired Oct. 28, 1992. Amended: Filed March 24, 1992, effective Sept. 6, 1992. Emergency amendment filed Sept. 21, 1992, effective Oct. 1, 1992, expired Jan. 28, 1993. Emergency amendment filed Jan. 15, 1993, effective Jan. 29, 1993, expired May 28, 1993. Amended: Filed June 16, 1992, effective April 8, 1993. Emergency amendment filed March 19, 1993, effective April 1, 1993, expired July 29, 1993. Emergency amendment filed June 18, 1993, effective July 1, 1993, expired Oct. 28, 1993. Amended: Filed April 6, 1993, effective Dec. 9, 1993. Rescinded and readopted: Filed Oct. 15, 1993, effective June 6, 1994. Amended: Filed June 29, 2000, effective Dec. 30, 2000.

Amended by Missouri Register March 1, 2019/Volume 44, Number 5, effective 4/30/2019

*Original authority: 208.152, RSMo 1967, amended 1969, 1971, 1972, 1973, 1975, 1977, 1978, 1981, 1986, 1988, 1990, 1992, 1993; 208.153, RSMo 1967, amended 1973, 1989, 1990, 1991 and 208.201, RSMo 1987.