Medicaid Drug Rebate Agreement definition

Medicaid Drug Rebate Agreement means the agreement in place between the Pharmaceutical Manufacturer and the U.S. Secretary of Health and Human Services, pursuant to Section 4401 of the Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508). CMS is the agency within HHS having the delegated authority to operate the Medicaid Program.
Sample 1Sample 2Sample 3
Medicaid Drug Rebate Agreement means the agreement in place between (name of manufacturer) and the Secretary of Health and Human Services, pursuant to Section 4401 of the Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508). CMS is the agency within HHS having the delegated authority to operate the Medicaid program. 1.11 "Medicaid Recipient" shall mean any person enrolled inthe State Medicaid Program and eligible to receive prescription drug benefits under a fee for service arrangement. 1.12 "Net Cost" shallmean theprescription drug ingredient reimbursement calculated as (AWP -_%) minus the sum of all rebates paid by (name of manufacturer) to the State for the Covered Product for the calendar quarter. Inthe event of any change to thecalculation used by the Stateto determine drug ingredient reimbursement paid by the Stateto Pharmacy providers, theapplicableterms of this Agreement shall be amended toreflect such change. 1.13 "Pharmacy" shall mean a facility licensed to dispense legend drugs, and enrolled as a State Medicaidprovider.1.14 "Preferred Drug List" shall mean a document listing various pharmaceutical products covered by the State Medicaid Program for the purpose of guiding the prescribing, dispensing and acquisition of pharmaceutical products. The Preferred Drug List shall not prevent beneficiaries from obtaining access to medically necessary drugs of manufacturers that participate in the OBRA 90 Medicaid Dug Rebate Program. 1.15 "State Medicaid Program" shall mean the joint federal and state medical assistance program as established and defined pursuant to Title 42 U.S.C. 1396, et seq., that provides reimbursement for or coverage of prescription drug products to Medicaid Recipients. 1.16· "State Supplemental Rebate" shall mean an amount paid on a calendar quarter basis by (name of manufacturer) to State for utilization under State's fee for service Medicaid program pursuant to this Agreement which renders at the option of the State, either (a) a Net Cost of Covered Products that is less than or equal to the cost of the competitive product for each quarter covered by the terms of this contract; or (b) a Net Cost that is comparatively low or that is the lowest Net Cost to an equivalent therapeutic dose of Covered Product to become a preferred drug in the drug class. 1.17 "Unit" means a single CMS unit of Covered Product. 1.18 "USC" means the United States Code. All references to this agreement to USC chapters or sections shall include any successor, amended, or replacem...
Sample 1

Examples of Medicaid Drug Rebate Agreement in a sentence

  • The Department and Manufacturer have entered into this Agreement for the purpose of establishing a State Supplemental Rebate for utilization of the Manufacturer’s Preferred and Recommended Product(s) by the Medicaid Population, which will be in addition to rebates received under the National Medicaid Drug Rebate Agreement, pursuant to 42 U.S.C. § 1396r-8.

  • It is the intent of this Agreement that the Department will receive a Supplemental Rebate for Medicaid population, in addition to rebates received under the Medicaid Drug Rebate Agreement, pursuant to Section 1927 of the Social Security Act (42 USC 1396r-8), for the Manufacturer’s Covered Product(s) quarterly utilization in the Maine Medicaid Program.

  • Upon entering into the Medicaid Drug Rebate Agreement, the Group agreed to make rebate payments to state Medicaid agencies with respect to certain products in ADVANZ PHARMA North America.

  • MedPAC has expressed concern about under-reporting of these data and has recommended that all Part B drug manufacturers be required to report data to CMS regardless of whether they have Medicaid Drug Rebate Agreement.

  • Pursuant to its separate CMS Medicaid Drug Rebate Agreement and CMS CPI Agreement, Manufacturer will calculate and provide CMS rebates to OHA for the Covered Product(s), which includes the CMS Basic Rebate and the CMS CPI Rebate, as appropriate.

  • This can be contrasted with a term in the Medicaid Drug Rebate Agreement, which requires manufacturers “[t]o comply with the conditions of 42 U.S.C. section 1396s, changes thereto and implementing regulations as the Secretary deems necessary and specifies by actual prior notice to the manufacturer.” Rebate Agreement Between the Secretary of Health and Human Services and Manufacturer, Enclosure A § II(c).

  • CMS notes that the HHS Office of the Inspector General found that for the third quarter of 2012, out of 45 manufacturers who are not required to submit ASP for Part B drugs, only 22 voluntarily provided such data, and at least 74 of the manufacturers with a Medicaid Drug Rebate Agreement (out of 207) did not submit all required data.

  • I understand that there are drugs that a state can restrict or exclude from coverage even though I have been led to believe that ALL my drugs will be covered by the states when I sign the CMS Medicaid Drug Rebate Agreement.

  • Pursuant to its separate CMS Medicaid Drug Rebate Agreement and CMS CPI Agreement, Manufacturer will calculate and provide CMS rebates to DMAP for the Covered Product(s), which includes the CMS Basic Rebate and the CMS CPI Rebate, as appropriate.

  • Pursuant to its separate CMS Medicaid Drug Rebate Agreement and CMS CPI Agreement, Manufacturer will calculate and provide CMS rebates to Agency for the Covered Product(s), which includes the CMS Basic Rebate and the CMS CPI Rebate, as appropriate.

Related to Medicaid Drug Rebate Agreement

  • Medicaid program means the Kansas program of medical

  • Medicaid Provider Agreement means an agreement entered into between a state agency or other such entity administering the Medicaid program and a health care provider or supplier under which the health care provider or supplier agrees to provide services for Medicaid patients in accordance with the terms of the agreement and Medicaid Regulations.

  • Federal-Aid Contract means a contract in which the United States (federal) Government provides financial funding as so designated in the Information for Bidders.

  • Medicare Provider Agreement means an agreement entered into between CMS or other such entity administering the Medicare program on behalf of CMS, and a health care provider or supplier under which the health care provider or supplier agrees to provide services for Medicare patients in accordance with the terms of the agreement and Medicare Regulations.

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • Medicaid means that government-sponsored entitlement program under Title XIX, P.L. 89-97 of the Social Security Act, which provides federal grants to states for medical assistance based on specific eligibility criteria, as set forth on Section 1396, et seq. of Title 42 of the United States Code.

  • Medicare cost report means CMS-2552-10, the cost report for electronic filing of

  • Medicare Levy Surcharge means an extra charge payable by high income earners beyond the standard Medicare Levy if they do not have qualifying private hospital insurance coverage. This charge is assessed as part of an individual or family’s annual tax return.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Medicaid Regulations means, collectively, (i) all federal statutes (whether set forth in Title XIX of the Social Security Act or elsewhere) affecting the medical assistance program established by Title XIX of the Social Security Act and any statutes succeeding thereto; (ii) all applicable provisions of all federal rules, regulations, manuals and orders of all Governmental Authorities promulgated pursuant to or in connection with the statutes described in clause (i) above and all federal administrative, reimbursement and other guidelines of all Governmental Authorities having the force of law promulgated pursuant to or in connection with the statutes described in clause (i) above; (iii) all state statutes and plans for medical assistance enacted in connection with the statutes and provisions described in clauses (i) and (ii) above; and (iv) all applicable provisions of all rules, regulations, manuals and orders of all Governmental Authorities promulgated pursuant to or in connection with the statutes described in clause (iii) above and all state administrative, reimbursement and other guidelines of all Governmental Authorities having the force of law promulgated pursuant to or in connection with the statutes described in clause (ii) above, in each case as may be amended, supplemented or otherwise modified from time to time.

  • Medicaid Certification means a certification by a state agency or other entity responsible for certifying Medicaid providers and suppliers that a health care provider or supplier is in compliance with all the conditions of participation set forth in the Medicaid Regulations.

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Centers for Medicare and Medicaid Services or “CMS” means the federal office under the Secretary of the United States Department of Health and Human Services, responsible for the Medicare and Medicaid programs.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Managed Care Plans means all health maintenance organizations, preferred provider organizations, individual practice associations, competitive medical plans and similar arrangements.

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • Nonprescription drug or "over-the-counter drug" means any

  • Medicare means the “Health Insurance for the Aged Act,” Title XVIII of the Social Security Amendments of 1965, as then constituted or later amended.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Drug addiction means a disease characterized by a

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.