K&l Gates Health Care Triage



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, three to ten minute 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.


  • Stark Law and the Anti-Kickback Statute Under the False Claims Act

    12/01/2023 Duration: 21min

    In this episode, Norman Acker, Nora Becerra, and Katherine Rippey discuss the False Claims Act as it relates to Stark Law and the Anti-Kickback Statute. They analyze the Wheeling Hospital case and the Catholic Medical Center case and discuss key takeaways from the cases as they relate to the False Claims Act.  

  • Recent Developments to the 340B Drug Pricing Program

    15/12/2022 Duration: 11min

    In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court’s decision earlier this year overturning 340B hospital reimbursement cuts, the agency’s proposed rule with respect to hospital outpatient reimbursement, and some considerations for hospitals when reviewing Medicare Advantage contracts.

  • The Information Blocking Rule's "Glide Path" - Compliance with the Information Blocking Rule After the Limitation on the Scope of EHI is Lifted

    29/11/2022 Duration: 26min

    In this episode, Gina Bertolini and Stephen Page discuss the most recent Information Blocking Rule compliance deadline. Using a recent letter from several health care providers and other stakeholders to the Office of the National Coordinator for Health IT (ONC) that outlines concerns related to the Information Blocking regulations, Gina and Stephen discuss the definition of electronic health information, the implication of technical changes to certified electronic health record technology, and application of some of the Information Blocking Rule’s exceptions as well as offer recommendations for compliance.

  • New Data Available Under the Hospital Price Transparency Rule

    14/11/2022 Duration: 17min

    In this episode, Darlene Davis, Andrew Ruskin, and Lauren Norris Donahue review data that is now available in light of the hospital price transparency rule. They discuss the recent increase in compliance among hospitals, benefits of hospital price transparency data, antitrust considerations, and suggestions for hospitals to implement guidelines for clients when accessing data.

  • Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

    26/09/2022 Duration: 16min

    In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.

  • Cybersecurity & HIPAA: NIST’s Practical Guidance Updates for Covered Entities and Business Associates

    29/08/2022 Duration: 12min

    In this episode, Rebecca Schaefer and J.D. Koesters review key components of the recent National Institute of Standards and Technology (NIST) revised publication regarding cybersecurity. They highlight how this resource incorporates NIST security lessons from other industries and maps the guidance to compliance requirements under the HIPAA Security Rule.

  • Genesis Healthcare and the 340B Program Patient Definition

    09/08/2022 Duration: 09min

    In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the Health Resources and Services Administration’s definition of a 340B eligible patient in light of recent developments in the 340B Program and this year’s upcoming election.

  • Medicare Advantage False Claims Act Developments

    02/08/2022 Duration: 18min

    In this episode, Stephen Bittinger and Nathan Huff discuss the growth of Medicare Part C (Medicare Advantage), new enforcements for Medicare Advantage Organization fraud, recent cases of False Claims Act liability, and key takeaways for Medicare Advantage Organizations and providers.

  • Hospitals, Physician Practices, and Labs – Are You Ready to Report Private Payor Rates for Laboratory Tests?

    05/07/2022 Duration: 14min

    In this episode, Gabriel Scott and Darlene Davis analyze the private payor rates reporting requirements under the Protecting Access to Medicare Act. They discuss the type of entities required to report, potential penalties for failing to report, and provide some suggestions for how to initiate the reporting process.

  • The Drive to Align ESG and Health Equity Priorities With Medicare Reimbursement Models

    07/06/2022 Duration: 11min

    Steve Pine and Alexa Sengupta address the Centers for Medicare and Medicaid Services’ emerging focus on ESG and health equity priorities, and how these priorities are impacting health data collection and Medicare value-based reimbursement models.

  • Regulatory, Contractual, and Governance Considerations for Data Transactions

    10/05/2022 Duration: 28min

    In this episode, Rebecca Schaefer and Gina Bertolini discuss the incredible value of health care data and how providers can harness the power of data transactions to drive innovation, discovery, and advancements in medical therapies.

  • Medical Laboratories Under the Microscope

    22/04/2022 Duration: 20min

    In this episode, Myla Reizen, John Lawrence, and Bobby Higdon analyze the increase in governmental scrutiny around laboratory investigations and enforcement. They discuss the Eliminating Kickbacks Recovery Act (EKRA), trends in enforcement surrounding Operation Double Helix, guidance for medical labs, and the importance of outside counsel for compliance.

  • Navigating the Independent Dispute Resolution Process Under the No Surprises Act

    30/03/2022 Duration: 15min

    In this episode, Steven Pine and Gary Qualls discuss the arbitration provision under the federal No Surprises Act, controversy around the qualifying payment amount (QPA), a recent decision in a Texas federal court that impacts the QPA, and new developments around the independent dispute resolution process.

  • 2021 Health Care Employment Law Year in Review and a Look Forward

    23/03/2022 Duration: 23min

    In this episode, Lou Patalano, Jacqueline Hoffman, and Spencer Hamer discuss employment law and the health care sector. They give a review of highlights from 2021, as well as developments that will impact employment law and the health care sector in 2022, including vaccine mandates, non-competes, and diversity, equity and inclusion.

  • Medicare Reimbursement for Community Hospital Residency Programs

    31/01/2022 Duration: 11min

    Andrew Ruskin and Gabriel Scott discuss how Centers for Medicare & Medicaid Services (CMS) has recently promulgated rules implementing the provisions of the Consolidated Appropriations Act that affect a very large number of community hospitals. Specifically, due to CMS’s interpretation of Medicare graduate medical education reimbursement rules, many community hospitals are no longer eligible for these payments and don’t even know it. This episode discusses the dilemma that community hospitals might be facing and emphasizes the importance of meeting a 1 July 2022 deadline CMS has imposed that may allow these hospitals to press the reimbursement “reset button.”

  • Data Security Breaches in the Health Care Sector

    20/01/2022 Duration: 22min

    Desiree Moore, Gina Bertolini, and Jackie Hoffman discuss the increasing impact of data security incidents and security breaches on the health care sector. They define what qualifies under HIPAA as a protected health information breach, discuss the importance of outside counsel in security incidents, review the timeline of reporting a breach to the Office for Civil Rights (OCR), and provide a road map on to how to manage a security incident from start to finish.

  • What Health Care Providers Should Expect in an FDA Inspection

    28/10/2021 Duration: 14min

    In this week’s episode, Richard Church interviews Michael Hinckle about FDA inspections of health care providers. They discuss why an inspection might come up, what providers should expect, the do’s and don’ts of inspection day, and the action items health care providers should implement post-inspection.

  • An Update on the CMS Hospital Price Transparency Rule

    21/10/2021 Duration: 10min

    In this week’s episode, Darlene Davis interviews Andrew Ruskin about updates to the CMS Hospital Price Transparency rule now that it has been in effect for almost one year. The presenters discuss the expanded scope of pricing information that should be provided, the increased potential and severity of fines and enforcement actions CMS can take in cases of non-compliance, and steps hospitals should take if they are contacted by CMS.

  • FTC Reminds Vendors of Personal Health Records of Breach Rule Obligations

    07/10/2021 Duration: 17min

    In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors of personal health records. The presenters discuss the requirements of the FTC Rule, when it applies relative to HIPAA, and the implications of the policy statement for digital health companies and health IT developers. Gina and Desiree also provide practical takeaways for both health care providers and health app vendors.

  • No Surprises: New Balance Billing Regulations for Health Care Providers

    16/09/2021 Duration: 10min

    In this week’s episode, Don Walker and Macy Flinchum discuss new regulations stemming from the No Surprises Act and the new parameters for health care providers around balance billing, including for example, requirements for adequate notice and consent. Our presenters explain when these requirements apply, who is responsible for providing notice and consent in various situations, and how the new regulations may impact reimbursement and arbitration moving forward.

page 1 from 5