100 episodes

Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.

K&L Gates Health Care Triage K&L Gates

    • Business
    • 4.0 • 10 Ratings

Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.

    OIG Updates Work Plan to Include Audits of COVID-19 Related Reimbursement and CARES Act Funding

    OIG Updates Work Plan to Include Audits of COVID-19 Related Reimbursement and CARES Act Funding

    Matt Hubbell and Stephen Bittinger discuss the addition of two new items to the Department of Health and Human Services Office of the Inspector General (OIG) work plan: auditing of COVID-19 related reimbursement, and auditing of CARES Act provider relief funds. The hosts discuss the ways in which OIG is likely to scrutinize the use of CARES Act and other funding received by health care providers during the COVID-19 public health emergency, and how providers should prepare for OIG inquiries.

    • 15 min
    K&L Gates Triage: Rutledge v. Pharmaceutical Care Management Association

    K&L Gates Triage: Rutledge v. Pharmaceutical Care Management Association

    In this episode of Triage, Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association, including its potential impact on nearly forty state laws that regulate the conduct of pharmacy benefit managers (PBMs) and at least nine state laws prohibiting PBMs from engaging in two-tier pricing models in regard to the 340B Drug Pricing Program.
    Presenters: Leah D’Aurora Richardson, Victoria K. Hamscho

    • 8 min
    COVID-19 and Social Determinants of Health -- A Closer Look at the Disparate Impact of COVID-19 on Ethnic and Racial Minorities

    COVID-19 and Social Determinants of Health -- A Closer Look at the Disparate Impact of COVID-19 on Ethnic and Racial Minorities

    In this episode, Mary Beth Johnston and Nora Becerra discuss recent COVID-19 federal data and the disparate impact of the disease on ethnic and racial minorities; they examine the data through the lens of social determinants of health and propose potential solutions moving forward.

    • 12 min
    Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

    Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

    FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On this week’s episode, Lindsey Rogers-Seitz and Kenneth Kennedy discuss the scope of FDA’s clinicaltrials.gov reporting requirements, as well as the penalties responsible parties may face for failing to meet them.

    Presenters: Lindsey Rogers-Seitz and Kenneth Kennedy

    • 10 min
    K&L Gates Triage: HIPAA: Do Hospitals Need a Business Associate Agreement with their Health System Parent Corporation?

    K&L Gates Triage: HIPAA: Do Hospitals Need a Business Associate Agreement with their Health System Parent Corporation?

    In this week’s episode, Rebecca Schaefer and Hannah Maroney discuss a string of recent HIPAA enforcement actions which demonstrate that the HHS Office of Civil Rights (OCR), the agency tasked with enforcing HIPAA, is increasingly focused on ensuring that affiliated hospitals within a health system, typically comprising an Affiliated Covered Entity (ACE), have HIPAA business associate agreements in place with the parent corporation to allow for the lawful exchange of PHI.

    • 10 min
    340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

    340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

    In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B Drug Pricing Program. In particular, the presenters discuss the implications of the recent D.C. Circuit decision in American Hospital Association v. Azar, as well as certain provisions of the new OPPS proposed rule released by CMS on August 4, 2020.

    • 8 min

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