42 C.F.R. §447.502 - Definitions
| Cite as | 42 C.F.R. §447.502 |
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15 cases
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State v. Abbott Labs.
...§ 447.512(b). The regulations define EAC as the “best estimate of the price generally and currently paid by providers for a drug.” 42 C.F.R. § 447.502. Whenever states change their reimbursement policies, they must seek CMS approval to institute the new plan. See Douglas, 132 S.Ct. at 1208.......
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Mallinckrodt Ard LLC v. Verma
...outpatient drug that is produced or distributed under an original NDA approved by FDA and has an approved NDA number issued by FDA." 42 C.F.R. § 447.502. The regulations further state that "[f]or purposes of this definition and the MDR program, an original NDA means an NDA, other than an AN......
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Vanda Pharm. v. Ctrs. for Medicare & Medicaid Servs.
...identifying drugs that may be line extension drugs. Id. CMS next proposed to define “line extension” and “new formulation” at 42 C.F.R. § 447.502. Specifically, CMS proposed to define “line extension” to mean, “for a drug, a new formulation of the drug, but ... not including] an abuse deter......
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United States ex rel. Streck v. Bristol-Myers Squibb Co., CIVIL ACTION NO. 13-7547
...behalf of the manufacturer." Id. The final rule adopted four years later retained the four-part definition of bona fide service fees. 42 C.F.R. § 447.502 (2016). It defines excludable bona fide service fees as fees paid by a manufacturer to "an entity" that: (1) "represent fair market value......
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4 firm's commentaries
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In Latest Medicaid Rule, CMS Aims to Define Line Extensions
...Extension as a “New Formulation” Consistent with the statutory language, CMS is proposing to adopt a definition of “line extension” at 42 C.F.R. § 447.502 to mean “for a drug, a new formulation of the drug, but does not include an abuse-deterrent formulation of the drug (as determined by th......
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New Risks, New Rewards, New Exposure
...that a manufacturer may choose to blend or submit separate AMPs. Unfortunately, the regulatory definition of ‘authorized generic’ at 42 C.F.R. § 447.502 is so broad as to define almost any ‘second’ drug sold under a different labeler/package code to be an authorized generic—“any drug … that......
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Final Rule on VBP, Patient Assistance and Line Extensions Presents Opportunity and Risk for Drug Manufacturers
...release formulation or other change in release mechanism, a change in dosage form, strength, route of administration, or ingredients.” 42 C.F.R. §447.502 (emphasis added). The Proposed Rule also had included new combination drugs, new drug/device combinations, and new indications in its red......
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In Latest Medicaid Rule, CMS Aims to Define Line Extensions
...Extension as a “New Formulation” Consistent with the statutory language, CMS is proposing to adopt a definition of “line extension” at 42 C.F.R. § 447.502 to mean “for a drug, a new formulation of the drug, but does not include an abuse-deterrent formulation of the drug (as determined by th......
4 provisions
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SB 139 – Modifies provisions relating to health care
...multiple source drug", "noninnovator multiple source drug", and "single source drug" shall have the same meanings as defined in 42 CFR 447.502, as updated and amended.208.790. 1. The applicant shall have or intend to have a fixed place of residence in Missouri, with the present intent of ma......
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Chapter 598, SB 844 – AN ACT Relating to the price of prescription drugs; creating new provisions; and amending ORS 646A.689
...in accordance with an abbreviated new drug application approved under 21 U.S.C. 355(j);(b) An authorized generic as defined by 42 C.F.R. 447.502; or(c) A drug that entered the market before 1962 that was not originally marketed under a new drug application.(2) The Prescription Drug Affordab......
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Chapter 240, SB 175 – Prescription Drug Affordability Review Board
...means the all-payer health claims database described in section 25.5-1-204.(4) "Authorized generic drug" has the meaning set forth in 42 CFR 447.502.(5) "Biological product" has the meaning set forth in 42 U.S.C. sec. 262 (i)(1).(6) "Biosimilar drug" means a prescription drug that is produc......
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Chapter 547, SB 380 – Revises provisions governing the reporting of data concerning the prices of prescription drugs
...as defined in NRS 639.0085, or a pharmacist; or(c) A wholesaler.2. The term does not include a bona fide service fee, as defined in 42 C.F.R. § 447.502.Sec. 2. "Third party" means:1. An insurer, as that term is defined in NRS 679B.540;2. A health benefit plan, as that term is defined in NRS......