Covered Outpatient Drug definition

Covered Outpatient Drug shall have the meaning as set forth in Sections 1927(k)(2), (k)(3) and (k)(4) of the Act as implemented by 42 C.F.R. 447.502.

Covered Outpatient Drug means a drug that meets the Centers for Medicare and Medicaid Services (CMS) covered outpatient drug definition as outlined in 42 CFR 447.502. The following provisions also apply:

Covered Outpatient Drug will have the meaning as set forth in Sectionsections 1927(k)(2), (k)(3) and (k)(4) of the Act, and with respect to the Manufacturer includes all such drug products meeting this definition. For purposes of coverage under this agreement, all of those Covered Outpatient Drugs are identified by the Manufacturer's labeler code segment of the NDC number. Certain Covered Outpatient Drugs, such as specified by Section 1927 (d) ( 1) (3) of the Act, may be restricted or excluded from Medicaid payment at State option but shall be included by the Manufacturer for purposes of this agreement. as implemented by 42 CFR 447.502.

Examples of Covered Outpatient Drug in a sentence

• The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 defines a Specified Covered Outpatient Drug (SCOD) as a covered outpatient drug for which a separate APC has been established and that is either a radiopharmaceutical agent, or a drug or biological for which payment was made on a pass-through basis on or before December 31, 2002.

• The Contractor shall comply with all requirements found in the Social Security Act section 1927 and all changes made to the Covered Outpatient Drug Section of the Patient Protection and Affordable Care Act (PPACA) found in 42 C.F.R. Part 447 [CMS 2345-FC].

• In order to comply with CMS’s Medicare requirements in the Medicaid program, the plans shall substitute the terms, Medicaid Covered Outpatient Drug and MCP, for the terms, part D drug and plan sponsor, respectively, and are not required to include members who are experts regarding the care of elderly or disabled individuals.

• Instilled Covered Outpatient Drug (COD) Status: A category that identifies how a product meets the statutory definition of a covered outpatient drug in accordance with sections 1927(k)(2) to 1927(k)(4) of the Social Security Act.

• Covered Outpatient Drug — A brand name drug, a generic drug, or an OTC drug which: • Is approved by the FDA; • Is distributed by a manufacturer that entered into a Federal Drug Rebate Program Agreement with the CMS; • Is compensable under the MA Program; • May be dispensed only upon prescription in the MA Program; • Has been prescribed or ordered by a licensed prescriber within the scope of the prescriber’s practice; and • Is dispensed or administered in an outpatient setting.

• The percentage of "working" patients who are "on sick leave" or "on disability" at one year and two years after implantation will be reported with the corresponding confidence interval.

• Nevertheless, Defendants reported false information to CMS regarding these products, representing that they met the definition of a Covered Outpatient Drug to make them ostensibly eligible for Medicaid reimbursement.

• A Covered Outpatient Drug must: (1) be a drug, (2) for which an NDC is required, (3) used for a medically accepted indication.

• The Defendants’ submissions included a false representation that their levothyroxine drugs met the definition of a Covered Outpatient Drug, and in many instances contained a false FDA approval date.

• Federal law enacted well before the Medicaid Rebate Program was established in 1990 expressly precludes payment for such DESI-LTE drugs (42 U.S.C. § 1396b (i)(5); 42 U.S.C. § 1395y(c); 42 C.F.R. §441.25) and the definition of Covered Outpatient Drug in the Medicaid Rebate Program legislation, 42 U.S.C. § 1396r-8(k)(2)(A)(iii), expressly excludes such drugs.

More Definitions of Covered Outpatient Drug

Covered Outpatient Drug has the same meaning as set forth in 42 U.S.C.§1396r-8 (k)(2)- (4), et seq., and with respect to the Manufacturer/Labeler includes all such drug products meeting this definition. For purposes of coverage under this Agreement, all of those Covered Outpatient Drugs are identified by the Manufacturer’s/Labeler’s labeler code segment of the NDC number. HHSC may restrict or exclude from payment certain Covered Outpatient Drugs.

Covered Outpatient Drug will have the meaning as set forth in 42 U.S.C. 1396r-8(k)(2),(k)(3) and (k)(4) and regulations promulgated by CMS thereto, if any, as such statute or regulations may be amended from time to time.

Covered Outpatient Drug means a drug approved for safety and effectiveness as a prescription drug under the federal Food, Drug, and Cosmetic Act, which is used for a medically accepted indication, and is not subject to the exceptions under WAC 388-530-1150, Noncovered drugs and pharmaceutical supplies.

Covered Outpatient Drug will have the meaning as set forth in 42 U.S.C. § 1396r-8(k)(2),(k)(3) and (k)(4).

Covered Outpatient Drug means a drug that meets all of the following criteria: