K&L Gates Healthcare Triage
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K&L Gates Healthcare 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 podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, i...
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RWI in Healthcare M&A: Part 2
In part two of this two-part series, Matt Miller and Andrew Lloyd analyze representations and warranties insurance (RWI) in the health care M&A landsc...
RWI in Healthcare M&A: Part 1
In part one of this two-part series, Matt Miller and Andrew Lloyd analyze representations and warranties insurance (RWI) in the healthcare M&A landsca...
Veterans Day Special Episode: Combating Traumatic Brain Injury
In this special Veterans Day episode of Triage, Matt Miller is joined by The Davis Focus Project’s Brandon Davis, a former Black Hawk instructor pilot...
Corporate Practice of Medicine: New Relevance in a Changing World
In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old healthcare regulatory doctrine that has new rel...
Health System Cybersecurity Risks: Part Two
In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks...
Health System Cybersecurity Risks: Part One
In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks...
Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast
In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as...
FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations....
Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations
In this episode, Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by health care organizations and a new federal research agen...
Unpacking CMS's Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement
In this episode, Darlene Davis, Leah Richardson, and Andrew Ruskin unravel CMS’s proposed rule for the remedy for Medicare payments for drugs purchase...
The End of Continuous Medicaid Enrollment—What Health Systems Should Know
In this episode, Alexander Chu and Ashley Davis review the end of the continuous Medicaid enrollment condition as a result of the Consolidated Appropr...
Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities?
In this episode, Macy Flinchum talks with Limo Cherian and Steven Pine about some of the major takeaways, challenges, and successes that providers hav...
Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. Th...
2022 Health Care Employment Law Year in Review
In this episode, Sarah Carlins and Spencer Hamer discuss employment law and the health care sector. They review highlights from 2022, as well as deve...
Rural Emergency Hospitals — Transformative Change or Limited Impact?
In this episode of Triage, Andrew Ruskin, Darlene Davis, and Gabriel Scott discuss key provisions associated with conversion to CMS’s new rural emerge...
Stark Law and the Anti-Kickback Statute Under the False Claims Act
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 Statut...
Stark Law and the Anti-Kickback Statue Under the False Claims Act
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 Statue...
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Recent Developments to the 340B Drug Pricing Program
In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effec...
The Information Blocking Rule's "Glide Path" - Compliance with the Information Blocking Rule After the Limitation on the Scope of EHI is Lifted
In this episode, Gina Bertolini and Stephen Page discuss the most recent Information Blocking Rule compliance deadline. Using a recent letter from sev...
New Data Available Under the Hospital Price Transparency Rule
In this episode, Darlene Davis, Andrew Ruskin, and Lauren Norris Donahue review data that is now available in light of the hospital price transparency...
Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory ove...
Cybersecurity & HIPAA: NIST’s Practical Guidance Updates for Covered Entities and Business Associates
In this episode, Rebecca Schaefer and J.D. Koesters review key components of the recent National Institute of Standards and Technology (NIST) revised...
Genesis Healthcare and the 340B Program Patient Definition
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 Ge...
Medicare Advantage False Claims Act Developments
In this episode, Stephen Bittinger and Nathan Huff discuss the growth of Medicare Part C (Medicare Advantage), new enforcements for Medicare Advantage...
Hospitals, Physician Practices, and Labs – Are You Ready to Report Private Payor Rates for Laboratory Tests?
In this episode, Gabriel Scott and Darlene Davis analyze the private payor rates reporting requirements under the Protecting Access to Medicare Act. T...
The Drive to Align ESG and Health Equity Priorities With Medicare Reimbursement Models
Steve Pine and Alexa Sengupta address the Centers for Medicare and Medicaid Services’ emerging focus on ESG and health equity priorities, and how thes...
Regulatory, Contractual, and Governance Considerations for Data Transactions
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...
Medical Laboratories Under the Microscope
In this episode, Myla Reizen, John Lawrence, and Bobby Higdon analyze the increase in governmental scrutiny around laboratory investigations and enfor...
Navigating the Independent Dispute Resolution Process Under the No Surprises Act
In this episode, Steven Pine and Gary Qualls discuss the arbitration provision under the federal No Surprises Act, controversy around the qualifying p...
2021 Health Care Employment Law Year in Review and a Look Forward
In this episode, Lou Patalano, Jacqueline Hoffman, and Spencer Hamer discuss employment law and the health care sector. They give a review of highligh...
Medicare Reimbursement for Community Hospital Residency Programs
Andrew Ruskin and Gabriel Scott discuss how Centers for Medicare & Medicaid Services (CMS) has recently promulgated rules implementing the provisions...
Data Security Breaches in the Health Care Sector
Desiree Moore, Gina Bertolini, and Jackie Hoffman discuss the increasing impact of data security incidents and security breaches on the health care se...
What Health Care Providers Should Expect in an FDA Inspection
In this week’s episode, Richard Church interviews Michael Hinckle about FDA inspections of health care providers. They discuss why an inspection might...
An Update on the CMS Hospital Price Transparency Rule
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 effec...
FTC Reminds Vendors of Personal Health Records of Breach Rule Obligations
In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regardi...
No Surprises: New Balance Billing Regulations for Health Care Providers
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...
CMS’s Proposal for New Remote Therapeutic Monitoring Codes under the 2022 Medicare Physician Fee Schedule
In the recent Medicare Physician Fee Schedule proposed rule for CY 2022, CMS has proposed adding a new category of reimbursable digital health service...
Key Considerations for Officers and Directors of Distressed Companies
In this week’s episode, Andrea Cunha outlines some of the key considerations directors and officers should assess when their company is approaching in...
Cybersecurity Risk in the Health Care Industry
As health care providers are increasingly relying on complex and integrated electronic medical record systems, the health care industry has rapidly be...
When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives
In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initi...