Clinical Episode definition

Clinical Episode means the following family of related MS-DRGs for a clinical condition to be tested through an Episode of Care under Model 4: DRG 000 Xxxxxxxx Xxxxxx w/ PTCA w/ XXX* XXX 000 Xxxxxxxx Xxxxxx w/ PTCA w/o MCC* DRG 233 Coronary Bypass w/ Cardiac Cath w/ XXX* XXX 000 Xxxxxxxx Xxxxxx w/ Cardiac Cath w/o MCC* DRG 235 Coronary Bypass w/o Cardiac Cath w/ MCC* DRG 236 Coronary Bypass w/o Cardiac Cath w/o MCC* *MCC = major co-morbidities or complications
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Clinical Episode means the period of time described in Article 5.2 initiated on the first day of an Anchor Stay or an Anchor Procedure, during which all Medicare FFS expenditures for allnon-excluded items and services furnished to a BPCI Advanced Beneficiary are bundled together as a unit for purposes of calculating the Target Price and for purposes of Reconciliation. Clinical Episodes may be initiated only during the Agreement Performance Period.
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Clinical Episode means a family of related MS-DRGs for a clinical condition to be tested through an Episode of Care under Model 4. All Clinical Episodes that will be subject to the terms and conditions of this Agreement will be identified in the Awardee Profile (Attachment C) for each Episode Initiator. The Clinical Episodes will include, without limitation, the family of related MS-DRGs for the clinical condition to be tested and a set of exclusions based on MS-DRGs and International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes, which is referred to in Attachment A.
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Examples of Clinical Episode in a sentence

  • A goal of the BPCI Advanced Model is to promote seamless, patient-centered care throughout each Clinical Episode, regardless of who is responsible for a specific element of that care.

  • For Physician Group Practices (PGPs), the registry will calculate the measure as specified at individual hospitals, then the CMS Innovation Center will weight measure performance based on PGP Clinical Episode volume for each ACH where a PGP triggers an episode.

  • A BPCI Advanced Beneficiary must meet this definition for the full duration of the Clinical Episode.

  • For Physician Group Practices (PGPs), the CMS Innovation Center will calculate the measure as specified at the hospital level, then weight the measure based on PGP Clinical Episode volume for each ACH where a PGP triggers an episode.

  • A BPCI Advanced Beneficiary must meet this definition for the full duration of the Clinical Episode and the 90-day lookback period.

  • BPCI Advanced bases the PGP’s Benchmark Price for each Clinical Episode upon the Benchmark Price specific to the ACH where services were furnished during the Anchor Stay or Anchor Procedure that initiated that Clinical Episode, with adjustments for the following: (1) differences in the PGP’s efficiency relative to the ACH where the Anchor Stay or Anchor Procedure occurred; and (2) differences in PGP patient case mix relative to that of each ACH where the Anchor Stay or Anchor Procedure occurred.

  • The item or service is furnished directly to the BPCI Advanced Beneficiary during a Clinical Episode by the Participant, a Participating Practitioner, Downstream Episode Initiator, NPRA Sharing Partner, or NPRA Sharing Group Practice Practitioner.

  • However, to ensure continuity of care for BPCI Advanced Beneficiaries who are in a Clinical Episode at the time the Participation Agreement is terminated or expires, the waiver will continue to apply until completion of the last Clinical Episode initiated during the Agreement Performance Period.

  • For arrangements that meet all of the preceding conditions, the waiver period will start on the date of this Notice and end upon completion of the last Clinical Episode initiated during the Agreement Performance Period.

  • As such, the road transport stakeholders need to permit access to their inspection systems in bridge areas that could be reached by human inspectors.


More Definitions of Clinical Episode

Clinical Episode means the period of time described in Article 5.2 initiated on the first day of an Anchor Stay or an Anchor Procedure, during which all Medicare FFS expenditures for all non-excluded items and services furnished to a BPCI Advanced Beneficiary are bundled together as a unit for purposes of calculating the Target Price and for purposes of Reconciliation. Clinical Episodes may be initiated only during the Agreement Performance Period defined in Article 1.3.
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Related to Clinical Episode

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.