Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Video

Updated: Mar 21, 2026

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
07:00

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

8.7K

Maintaining qualification for 340B.

Robert F Gricius, Douglas Wong

    Healthcare Financial Management : Journal of the Healthcare Financial Management Association
    |May 18, 2016
    PubMed
    Summary
    This summary is machine-generated.

    Related Concept Videos

    Renal Failure: Dose Adjustments01:11

    Renal Failure: Dose Adjustments

    570
    In patients with renal impairment, drugs undergo significant changes in their pharmacokinetics, which require dosage adjustments to ensure safe and effective therapy.
    Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
    However, dosage adjustments...
    570
    Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

    Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

    236
    Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
    236
    Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant01:25

    Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant

    298
    In patients with renal disease, dosage adjustments are necessary to maintain therapeutic plasma drug concentrations and prevent toxicity or subtherapeutic exposure. Renal impairment alters drug pharmacokinetics, especially in conditions like uremia, where changes such as prolonged elimination half-life and altered apparent volume of distribution can significantly affect drug disposition. These changes require careful modification of the dosing regimen to achieve the desired clinical...
    298
    Rational Dosage Regimen: Maintenance Dose and Loading Dose01:24

    Rational Dosage Regimen: Maintenance Dose and Loading Dose

    5.8K
    A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
    In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
    5.8K
    Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

    Pharmacokinetics in Pediatric Patients: Drug Excretion

    368
    In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
    368
    FDA Approved Drugs: Changes to Approved Drugs01:26

    FDA Approved Drugs: Changes to Approved Drugs

    316
    Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
    316

    You might also read

    Related Articles

    Articles linked to this work by shared authors, journal, and citation graph.

    Sort by
    Same author

    Fast track to 340B.

    Healthcare financial management : journal of the Healthcare Financial Management Association·2016
    Same author

    PET-based compartmental modeling of (124)I-A33 antibody: quantitative characterization of patient-specific tumor targeting in colorectal cancer.

    European journal of nuclear medicine and molecular imaging·2015
    Same author

    Mechanical temporal fluctuation induced distance and force systematic errors in Casimir force experiments.

    Journal of physics. Condensed matter : an Institute of Physics journal·2015
    Same author

    DSH payment under the ACA. Steps to receiving your fair share.

    Healthcare financial management : journal of the Healthcare Financial Management Association·2015
    Same author

    Synergistic enhancement in the co-gelation of salt-soluble pea proteins and whey proteins.

    Food chemistry·2013
    Same author

    (124)I-huA33 antibody PET of colorectal cancer.

    Journal of nuclear medicine : official publication, Society of Nuclear Medicine·2011

    Hospitals must actively manage patient eligibility for the 340B Drug Pricing Program, focusing on Medicare and Supplemental Security Income (SSI) enrollment. This proactive approach ensures continued qualification and avoids disruptions in program participation.

    Area of Science:

    • Health policy
    • Healthcare administration
    • Pharmaceutical economics

    Background:

    • The 340B Drug Pricing Program provides significant financial benefits to eligible healthcare organizations.
    • Maintaining eligibility requires ongoing monitoring of patient demographics and payer mix.
    • Changes in healthcare policy and patient enrollment can impact disproportionate share hospital status.

    Purpose of the Study:

    • To outline strategies for hospitals and health systems to maintain eligibility for the 340B Drug Pricing Program.
    • To emphasize the importance of proactively managing patient qualification criteria.
    • To highlight the role of patient enrollment in Medicare and Supplemental Security Income (SSI) in sustaining 340B status.

    Main Methods:

    • Review of 340B Program requirements and eligibility criteria.

    More Related Videos

    Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples
    08:54

    Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples

    Published on: May 19, 2020

    8.3K
    Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
    11:17

    Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

    Published on: August 30, 2018

    13.5K

    Related Experiment Videos

    Last Updated: Mar 21, 2026

    Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
    07:00

    Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

    Published on: August 11, 2017

    8.7K
    Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples
    08:54

    Validated LC-MS/MS Panel for Quantifying 11 Drug-Resistant TB Medications in Small Hair Samples

    Published on: May 19, 2020

    8.3K
    Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
    11:17

    Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

    Published on: August 30, 2018

    13.5K
  • Analysis of patient enrollment data, particularly for Medicare and SSI.
  • Monitoring of disproportionate share hospital status and SSI Ratio.

    • Main Results:

    • Proactive management of the SSI Ratio is crucial for preventing declines in the Medicare patient base within the 340B program.
    • Continuous tracking of patient eligibility for Medicare and SSI is essential, even amidst Medicaid expansion.
    • Failure to monitor and manage these factors can jeopardize 340B program participation.

    Conclusions:

    • Hospitals must implement robust processes for monitoring patient eligibility and payer status to maintain 340B Drug Pricing Program participation.
    • Strategic management of patient enrollment, particularly for Medicare and SSI, is key to long-term program success.
    • Sustained qualification requires a proactive approach to healthcare policy and patient demographic tracking.