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 defined in Article 1.3.
Sample 1
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.
Sample 1

Examples of Clinical Episode in a sentence

  • On a monthly basis, provided that the Participant has a fully executed and approved Data Request and Attestation form, CMS will provide the Participant with data files that have been de-identified in accordance with HIPAA requirements that describe Medicare FFS spending data at a high level of aggregation, including data regarding the number of Clinical Episodes attributed to each Episode Initiator and the total average Medicare FFS spending for each such Clinical Episode.

  • For each Clinical Episode, a volume-weighted quality score will be determined for each quality measure for which the Participant and its Downstream Episode Initiators and Participating Practitioners are responsible pursuant to Article 4.3 and Appendix D of the Agreement.

  • ARC approval must be obtained prior to constructing a chicken coop or pen.

  • If, on the other hand, the AFP for a Clinical Episode is less than the final Target Price for that Clinical Episode, the result is a Positive Reconciliation Amount.

  • If, during the semi-annual Reconciliation, the AFP for a Clinical Episode exceeds the final Target Price for that Clinical Episode, the result is a Negative Reconciliation Amount.

  • An ACH Episode Initiator will receive its own Target Price for each Clinical Episode based on the ACH’s baseline spending, subject to certain adjustments.

  • The Composite Quality Score (CQS) is calculated at the Episode Initiator level by summing the volume-weighted scores scaled for each Clinical Episode attributed to the Episode Initiator.

  • This update is applied separately for each applicable setting that is part of the Clinical Episode, including inpatient hospital, Part B claims, skilled nursing facility, hospice, home health, inpatient rehabilitation facility, and all other services.

  • A preliminary Episode Initiator-specific benchmark price for the Post-Episode Spending Monitoring Period will be calculated in the same manner as for the Episode Initiator-specific Target Prices calculated for each Clinical Episode, as described above.

  • 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.


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.
Sample 1

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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Clinical Trial means any human clinical trial of a Product.

  • 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 Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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 human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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 the JDC 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.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.