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Triage

Triage: Rapid Legal Lessons for Busy Health Care Professionals is a podcast created by the K&L Gates health care practice group to inform our clients and friends of the firm about the latest developments in health law. If you would like to provide feedback or would like to suggest a topic for a future episode of Triage, please contact us. Catch up on past episodes by visiting our program page.

Use the icons below to subscribe to Triage via your favorite podcast app to have our episodes delivered directly to you as they become available.

23 October 2020
COVID-19: K&L Gates Triage: CMS Cease and Desist Letters to COVID Labs and Reimbursement Dispute

Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services have been sent to 171 facilities testing for COVID-19 without proper CLIA certifications.

21 October 2020
COVID-19: K&L Gates Triage: State and Federal Developments in the Regulation of Long-Term Care Facilities

Myla Reizen and Jackie Hoffman discuss recent developments on the state and federal level related to the operation of long-term care facilities in light of the ongoing COVID-19 public health emergency.

8 October 2020
K&L Gates Triage: ACO Quality Reporting in 2021: Key Changes from the Medicare Physician Fee Schedule Proposed Rule

Limo Cherian, Steve Pine, and Macy Flinchum discuss some of the key changes for Accountable Care Organizations in the recent Medicare Physician Fee Schedule proposed rule.

2 October 2020
K&L Gates Triage: The Preventing Harm Exception to the ONC Information Blocking Rule

Gina Bertolini, Lindsey Rogers-Seitz and Maggie Power discuss the Preventing Harm Exception to the Information Blocking Rule, which was recently finalized in the Office of the National Coordinator for Health Information Technology final rule implementing the Interoperability, Health IT Certification and Information Blocking requirements under the 21st Century Cures Act. 

28 September 2020
K&L Gates Triage: Updates to Mental Health Parity in California and Nationwide

Carla DewBerry and Kelsey Jernigan discuss issues in mental health parity in the context of recent California legislation. 

18 September 2020
COVID-19: K&L Gates Triage: 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 during the public health emergency, and auditing of CARES Act provider relief funds.

10 September 2020
K&L Gates Triage: Rutledge v. Pharmaceutical Care Management Association

Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association.

4 September 2020
COVID-19: K&L Gates Triage: 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.

27 August 2020
K&L Gates Triage: 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.

20 August 2020
K&L Gates Triage: HIPAA: Do Hospitals Need a Business Associate Agreement with their Health System Parent Corporation?

Rebecca Schaefer and Hannah Maroney discuss a string of recent HIPAA enforcement actions which demonstrate that the HHS Office of Civil Rights is increasingly focused on ensuring that affiliated hospitals within a health system have HIPAA business associate agreements in place with the parent corporation to allow for the lawful exchange of PHI.

13 August 2020
K&L Gates Triage: 340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System of drugs purchased under the 340B Drug Pricing Program. 

6 August 2020
K&L Gates Triage: Michael P. v. BCBS of Texas

In this week’s episode, Gary Qualls discusses a recent case decided in the Western District of Louisiana, which highlights how the application of the arbitrary and capricious standard as applied to payor coverage determinations can, in some instances, favor the patient.

23 July 2020
K&L Gates Triage: Recent Developments in the 340B Drug Pricing Program

Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program.

17 July 2020
COVID-19: K&L Gates Triage: COVID Audits

In this week’s episode, Stephen Bittinger discusses the impending resumption of Medicare error-based audits, which were temporarily suspended following the onset of the COVID-19 crisis.

1 July 2020
COVID-19: K&L Gates Triage: Alternative Payment Models: Tied to an Improved COVID-19 Response?

Gabe Scott and Steve Pine discuss recent data showing how health systems participating in Alternative Payment Models compare to other health systems in responding to the COVID-19 crisis, and discuss the future of APMs.

25 June 2020
COVID-19: K&L Gates Triage: United States vs Australia-Future of Nursing Homes and Long Term Care Facilities and What it Will Take to Succeed

Myla Reizen and Paris Petranis are joined again by Bruce Spurlock, President and CEO of Cynosure Health, and Judi Coombe, a Senior Operations Consultant at Ansell Strategic, to continue their discussion of the effects of the COVID-19 pandemic on nursing homes and long term care facilities in the United States and Australia.

11 June 2020
COVID-19: K&L Gates Triage: Nursing Homes and Long Term Care Facilities in the COVID-19 Environment: Huge Disparity between United States and Australia

Myla Reizen and Paris Petranis are joined by Bruce Spurlock, President and CEO of Cynosure Health, and Judi Coombe, a Senior Operations Consultant at Ansell Strategic, to discuss the effects of the COVID-19 pandemic on nursing homes and long term care facilities in the United States and Australia.

9 June 2020
COVID-19: K&L Gates Triage: Responding to the Unimaginable: Legal Challenges for Nursing Homes & Long-Term Care Facilities in a COVID-19 Enforcement Environment

John Lawrence, Myla Reizen and Mark Rush discuss the devastating effects COVID-19 has had on nursing homes and long term care facilities in the United States and potential civil and criminal liability that may stem from how nursing homes and long term care facilities have responded.

4 June 2020
COVID-19: K&L Gates Triage: Considerations for Behavioral Health Providers in the COVID-19 Environment and Beyond

Carla Dewberry, Sarah Carlins, and Cheryl Choice discuss the ways in which the COVID-19 emergency has changed the landscape of behavioral health in the United States.

28 May 2020
COVID-19: K&L Gates Triage: Workplace Safety Highlights from the CDC's May 2020 "Ten Ways Healthcare Systems Can Operate Effectively During the COVID-19 Pandemic" Guidance

Leann Walsh identifies key takeaways for hospitals and other health care employers from a guidance document recently published by the Centers for Disease Control entitled “Ten Ways Healthcare Systems Can Operate Effectively during the COVID-19 Pandemic.”

21 May 2020
COVID-19: K&L Gates Triage: Telehealth Expansions During the COVID-19 Emergency - What Providers Need to Know

Gina Bertolini, Lindsey Rogers-Seitz and Leah Richardson discuss a number of efforts undertaken by Congress and the U.S. Department of Health and Human Services in recent weeks to expand the availability of telehealth services for the U.S. patient population in order to prevent unnecessary patient-provider contact and help combat the spread of COVID-19.

7 May 2020
COVID-19: K&L Gates Triage: Value-Based Payment Arrangements

In this week’s episode, Limo Cherian, Carla Dewberry and Steven Pine discuss recent changes to value-based health care payment arrangements triggered by the current COVID-19 emergency.

9 April 2020
COVID-19: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests for additional flexibilities to help them respond to the pandemic, particularly as it relates to eligibility requirements under the 340B Program.

2 April 2020
COVID-19: K&L Gates Triage: COVID-19 Stark Waivers

In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain financial and compliance burdens on health care providers seeking agility in responding to the crisis.

26 March 2020
COVID-19: K&L Gates Triage: FDA Facilitates Diagnostic Testing and Heightens Public Safety Efforts Amid Outbreak

In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak.

09 March 2020
COVID-19: K&L Gates Triage: HIPAA Concerns in the Context of Novel Coronavirus

In this week’s episode, Hannah Maroney, Cheryl Choice and Steven Pine provide some background on COVID-19 and discuss challenges health care providers may face with respect to the disclosure of protected health information related to COVID-19 patients under HIPAA, as well as recent guidance issued by the Department of Health and Human Services Office of Civil Rights (OCR) related to such disclosures.

5 March 2020
K&L Gates Triage: Health Care Provider v. Payor Disputes Simplified: Getting Around ERISA Preemption

In this week’s episode, Gary Qualls discusses the recent Louisiana federal district court decision in Crescent City Surgical Centre vs.

27 February 2020
K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that addresses the ways in which the Allina decision augmented notice and comment rulemaking requirements with respect to certain types of regulatory guidance issued by CMS.

20 February 2020
K&L Gates Triage: EKRA - New Fraud and Abuse Considerations for Clinically Integrated Networks

In this week's episode, Limo Cherian, Carla Dewberry, and Steve Pine discuss EKRA - the 'Eliminating Kickbacks in Recovery Act of 2018,' which introduces new criminal penalties for kickbacks associated with referrals to recovery homes, clinical treatment facilities, and laboratories.

13 February 2020
K&L Gates Triage: ONC Signals Federal Health IT Priorities with 2020-2025 Strategic Plan

In this week’s episode, Ryan Severson discusses the Federal Health IT Strategic Plan, which was recently released by the Office of the National Coordinator for Health Information Technology (“ONC”).

30 January 2020
K&L Gates Triage: 340B Update: CMS Issues Guidance for Avoiding Duplicate Discounts in Medicaid

In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to avoid duplicate discounts in Medicaid Fee-for-Service and Medicaid Managed Care Organization programs.

23 January 2020
Triage in 2020: Health Care Topics to Watch in the New Year

In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year.

19 December 2019
K&L Gates Triage: Looking Ahead to 2020: Developing Issues in Pharmacy Law and the 340B Drug Pricing Program

In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient Prospective Payment System and the ongoing litigation challenging the cuts, 340B state action on discriminatory pricing, drug pricing reform, International Pricing Index and Safe Drug Importation Action Plan, and pharmacists’ provider status under Medicare.

25 October 2019
K&L Gates Triage: IPPS-Excluded Hospitals May Now Have IPPS-Excluded Units

Beginning October 1, 2019, hospitals that are excluded from the Medicare Inpatient Prospective Payment System (IPPS), including psychiatric hospitals, children’s hospitals, and cancer hospitals, may now have IPPS-excluded rehabilitation or psychiatric units, provided these units meet the applicable Medicare rules for excluded units.

17 October 2019
K&L Gates Triage: Quality Payment Program Updates in the CY2020 Physician Fee Schedule Proposed Rule - Part 3

In this week’s episode, Steve Pine presents the last installment of our three part series addressing the CMS Quality Payment Program (QPP) updates in the CY2020 Physician Fee Schedule (PFS) Proposed Rule.

16 October 2019
K&L Gates Triage: Modernizing Confidentiality Rules for Substance Use Disorder Records (Again): 2019 Proposed Changes to 42 CFR Part 2 - Part 2

This week’s episode is the second in an ongoing series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R.

8 October 2019
K&L Gates Triage: The Opioid Epidemic & the Confidentiality of Substance Use Disorder Records: an Update on 42 CFR Part 2 - Part 1 of 2

This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R.

4 October 2019
K&L Gates Triage: Quality Payment Program Updates in the CY2020 Physician Fee Schedule Proposed Rule - Part 2

In this week’s episode, Kathy Barger presents the second in a three part series addressing the CMS Quality Payment Program (QPP) updates in the CY2020 Physician Fee Schedule (PFS) Proposed Rule.

26 September 2019
K&L Gates Triage: Quality Payment Program Updates in the CY2020 Physician Fee Schedule Proposed Rule - Part 1

In this week’s episode, Limo Cherian presents the first segment of a three part series addressing the Centers for Medicare & Medicaid Services (CMS) Quality Payment Program (QPP) updates in the CY2020 Physician Fee Schedule (PFS) Proposed Rule.

18 September 2019
K&L Gates Triage: Five Key Questions for Academic Medical Centers About Patent Ownership and Enforcement

On this week’s episode, George Summerfield and Kelly Plummer explore five key questions academic medical centers often face with respect to patent ownership and enforcement.

11 September 2019
K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program, including discussion of the ongoing federal litigation challenging reimbursement cuts on 340B drugs under the Medicare Outpatient Prospective Payment System (OPPS), the status of the Health Resources and Services Administration’s (HRSA’s) 340B Civil Monetary Penalties (CMP) Rule and Ceiling Price Site, and recent developments in the litigation between HRSA and Genesis Health Care.

6 September 2019
K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 1

In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy regulation on a national level, including a discussion of the Trump Administration’s proposed International Pricing Index (IPI) Model, the recently announced FDA Safe Drug Importation Plan, and developments in ongoing litigation surrounding CMS’ price disclosure rule for direct-to-consumer drug advertisements.

29 August 2019
K&L Gates Triage: Activation of Validation Edits for OPPS Providers with Multiple Service Locations

*UPDATE* Since initial publication of this episode, CMS has delayed implementation of this policy until April 2020.

27 June 2019
K&L Gates Triage: Recent Developments in Provider v. Payer Litigation - <i>Encompass v. Blue Cross</i>

In this episode, Gary Qualls provides an overview of a recent case out of the Fifth Circuit Court of Appeals, Encompass Office Solutions, Inc. v. Louisiana Health Service & Indemnity Company d/b/a BlueCross BlueShield of Louisiana.

31 May 2019
K&L Gates Triage: Time’s Up Healthcare: The Current Climate of Sexual Harassment in Healthcare and Important Considerations of the Future - Part 2

In Part Two of this two-part series on the current climate of sexual harassment within the healthcare industry, Leann Walsh and Kristi Nickodem discuss important considerations and practical tips for health care employers in light of the National Academies of Sciences, Engineering and Medicine’s recent report on Sexual Harassment of Women: Climate, Culture and Consequences in Academic Sciences, Engineering and Medicine.

23 May 2019
K&L Gates Triage: Time’s Up Health Care: The Current Climate of Sexual Harassment in Health Care and Important Considerations of the Future - Part 1

With the recent launch of Time's Up Health Care and the publication of the National Academies of Sciences, Engineering and Medicine’s Sexual Harassment of Women: Climate, Culture and Consequences in Academic Sciences, Engineering and Medicine (“National Academies’ Report”), sexual harassment continues to be an important topic of conversation within the health care industry.

16 May 2019
K&L Gates Triage: Digital Health Update: ONC Information Blocking Proposal Aims to Remove Barriers to Data Sharing

The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic health information (EHI).

28 February 2019
K&L Gates Triage: A Discussion of Labor and Employment Issues in the Health Care Industry

In this episode, Richard Church and Spencer Hamer discuss key takeaways for the health care industry upon certain developments in labor and employment law over the past year.

14 February 2019
K&L Gates Triage: When the Feds Come Knocking on Your Door

In this episode, Michael McKay and Carla DewBerry discuss the practical implications of responding to an investigative inquiry by governmental officials.

7 February 2019
K&L Gates Triage: Important Takeaways from Omega Hospital, LLC v. United Healthcare Services, Inc.

In this episode, Gary Qualls discusses a recent development in payer litigation which implicates a number of recurring issues often raised in Employee Retirement Income Security Act (ERISA) cases.

30 January 2019
K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals,Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on health care in 2019.

19 December 2018
K&L Gates Triage: 340B Program: A Conversation with Chris Hatwig, Apexus President Part 3

This is the final episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC.

13 December 2018
K&L Gates Triage: 340B Program: A Conversation with Chris Hatwig, Apexus President Part 2

This is the second episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC.

4 December 2018
K&L Gates Triage: 340B Program: A Conversation with Chris Hatwig, Apexus President Part 1

This is the first episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC.

26 November 2018
K&L Gates Triage: Internal & External Health Care Investigations Part 3

In Part 3 of our series on health care investigations, Mark Rush and John Lawrence discuss the process for external investigations conducted by federal and state governmental agencies, including in the context of qui tam actions arising under the False Claims Act.

26 November 2018
K&L Gates Triage: Internal & External Health Care Investigations Part 2

In Part 2 of our series on health care investigations, Mark Rush and John Lawrence continue the discussion on internal investigations.

25 October 2018
K&L Gates Triage: Internal & External Health Care Investigations

In this episode, Mark Rush and John Lawrence discuss the federal government’s expectations related to health care organizations conducting internal investigations and demonstrating a commitment to compliance.

13 September 2018
K&L Gates Triage: Medicare Overpayment Recoupment Halted by Court

In a recent decision, the Northern District of Texas, Dallas Division, granted a health care provider a preliminary injunction to prevent the Centers for Medicare & Medicaid Services ("CMS") from withholding Medicare payments due to an alleged overpayment while the provider awaits its Administrative Law Judge ("ALJ") hearing on the issue.

31 August 2018
K&L Gates Triage: A New Proposed Pathway for the Medicare Shared Savings Program Part 2, in a 2-Part Series

The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part II of the two-part series on the proposed MSSP changes, Steve Pine discusses changes to ACO benchmarking, beneficiary notifications, and EHR certifications.

23 August 2018
K&L Gates Triage: Sales of Healthcare Businesses in Chapter 11– The Basics

A sale of a business under Section 363 of the U.S.

16 August 2018
K&L Gates Triage: A New Proposed Pathway for the Medicare Shared Savings Program Part 1, in a 2-Part Series

The Centers for Medicare & Medicaid Services (“CMS”) recently proposed a major redesign of its Medicare Shared Savings Program (“MSSP”) under a new plan it calls “Pathways to Success.” In this Part I of a two-part series on the proposed MSSP changes, Limo Cherian discusses the structural changes included in the proposal and how these changes would affect current risk-sharing models. About 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.

2 August 2018
K&L Gates Triage: Accidental Domination and Interference with “Labor Organizations” by the Modern Health Care Employer

In light of the recent #MeToo movement and ongoing public discourse regarding workplace culture, employers in the health care industry are increasingly seeking creative ways to improve their own workplace culture, such as organizing internal committees to boost employee morale and to create a safe space for employees to voice concerns.

26 July 2018
K&L Gates Triage: Recent Developments in Provider v. Payer Litigation -- Medicare Advantage Disputes

In this episode, Gary Qualls discusses a recent development in payer litigation, regarding a provider’s recovery of Medicare Advantage payments pursuant to a Medicare Advantage contract.

19 July 2018
K&L Gates Triage: 2018 Health Care Fraud Takedown

Recently, the U.S.

12 July 2018
K&L Gates Triage: Artificial Intelligence in Health Care

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in various industries today.

14 June 2018
K&L Gates Triage: Update: CMS’s Application of the Statutory Requirement that Hospitals Be “Primarily Engaged” in Providing Services to Inpatients

In September 2017, the Centers for Medicare & Medicaid Services (CMS) released a Survey and Certification memo which created interpretive guidelines for compliance with the statutory requirement that hospitals be “primarily engaged” in providing inpatient care.

7 June 2018
K&L Gates Triage: Proposed Changes to the Federal Satellite Facility Rules

The Centers for Medicare & Medicaid Services (“CMS”) recently proposed certain changes to the existing satellite facility rules in its Inpatient Prospective Payment System (“IPPS”) and Long Term Acute Care Hospital (“LTCH”) Prospective Payment System proposed rule for fiscal year 2019.

17 May 2018
K&L Gates Triage: Pharmacy Gag Clauses & Clawbacks

Pharmacy Benefit Managers (PBMs) are increasingly utilizing gag clauses in pharmacy contracts as a means of prohibiting pharmacies from telling customers that paying for drugs out of pocket would cost them less than if they used their insurance and paid their copays.

10 May 2018
K&L Gates Triage: ACO Improvements in the Bipartisan Budget Act of 2018 (Part 2)

In the second segment of this two-part series discussing recent program changes introduced by the Bipartisan Budget Act of 2018 for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP), Kathy Barger discusses new improvements in telehealth coverage for certain ACOs and new beneficiary incentive opportunities for qualifying primary care services.

3 May 2018
K&L Gates Triage: ACO Improvements in the Bipartisan Budget Act of 2018 (Part 1)

The Bipartisan Budget Act of 2018 recently introduced three noteworthy program improvements for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP) aimed at increasing program flexibility.

25 April 2018
K&L Gates Triage: 340B Update: State Medicaid 340B Billing Requirements

In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace.

17 April 2018
K&L Gates Triage: Ride Sharing and Health Care Regulatory Considerations

Transportation is often cited as one of the top barriers to health care for individuals in the United States.

12 April 2018
K&L Gates Triage: Protecting Patient Information in Bankruptcy Cases

In this episode, Margaret Westbrook discusses privacy issues that may affect health care providers when filing proofs of claim in the bankruptcy court.

4 April 2018
K&L Gates Triage: Sexual Harassment in Healthcare: #MeToo and Beyond

In this episode, Bridget Blinn-Spears discusses sexual harassment issues for health care employers in the wake of the #MeToo movement.

27 March 2018
K&L Gates Triage: The Opioid Epidemic: FDA’s Role in Addressing the Opioid Crisis

In the seventh episode of our series on the national opioid crisis, Erica Jackson discusses efforts by the U.S.

16 March 2018
K&L Gates Triage: The Opioid Epidemic: Federal and State Requirements on Medication-Assisted Treatment for Substance Abuse Disorders

In the sixth episode of our series on the national opioid crisis, Lauren Perry discusses some of the legal obligations for providers who prescribe controlled substances as treatment for substance abuse disorders.

8 March 2018
K&L Gates Triage: The Opioid Epidemic: DEA’s Role in Regulating Individuals and Entities Handling Controlled Substances

In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including opioids.

1 March 2018
K&L Gates Triage: The Opioid Epidemic: Medicaid Reimbursement and Other Funding Opportunities

In the fourth episode of our series on the national opioid crisis, Ruth Granfors and Tracy Lawless discuss how opioid treatment is reimbursed under Medicaid and other public programs.

23 February 2018
K&L Gates Triage: Opioid Epidemic: Update on Policy Issues in Washington, DC.

In the third episode of our series on the national opioid crisis, Amanda Makki and Corbin Santo provide an overview of how the Trump Administration and Congress may address the opioid epidemic this year.

15 February 2018
K&L Gates Triage: Opioid Epidemic: Recent HIPAA Guidance – What Does It Mean?

In the second episode of our series on the national opioid crisis, Gina Bertolini discusses the overlay of recent guidance concerning privacy laws such as the Health Insurance Portability and Accountability Act (HIPAA) and the Confidentiality of Substance Use Disorder Patient Records (Part 2) regulations and how they are interpreted with regard to opioid treatment.

9 February 2018
K&L Gates Triage: The Opioid Epidemic: Laws Impacting Prescribers and Care Givers

This is the first episode in a series focused on the legal issues surrounding the nationwide opioid crisis.

31 January 2018
K&L Gates Triage: Triage in 2018: Health Care Topics to Watch in the New Year

We expect 2018 to be another year of rapid change within the health care industry.

20 December 2017
K&L Gates Triage: 2017 Updates to the OIG’s Active Work Plan Items & Related Audit Experience

In this episode,Hilary Bowmansummarizes recent updates to the U.S.

15 December 2017
K&L Gates Triage: FDA & Health Care Update: The Use of Real-World Data and Real-World Evidence in Medical Product Development

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and their development.

30 November 2017
K&L Gates Triage: Changes in Marijuana Laws for Health Care Employers

This episode of Triage provides an overview for employers of the current state law landscape and federal enforcement priorities regarding marijuana use for recreational and medical purposes.

21 November 2017
K&L Gates Triage: Drones and Disruption in the Health Care Field

In this latest episode on drones in health care, Tom DeCesar discusses how an increase in the prevalence of drone use may complicate existing health care operations, particularly through the disruption of air ambulances and the protection of patient privacy in and around health care facilities.

16 November 2017
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

In this episode, Richard Church and Ryan Severson discuss the recent decision by the Centers for Medicare and Medicaid Services (CMS) to substantially decrease reimbursement under the Outpatient Prospective Payment System (OPPS) for Medicare Part B drugs purchased pursuant to the 340B Drug Discount Program beginning January 1, 2018.

31 October 2017
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, D.C.

In this episode of Triage , Amanda Makki and Corbin Santo of the K&L Gates Public Policy and Law practice group discuss several fundamental issues that are currently at the center of the health care debate in Washington, DC.

27 October 2017
K&L Gates Triage: Emergency Preparedness and Response in Long Term Care - Part III

In the final episode of our three-part series on emergency preparedness and response in long term care, Kimi Gordy sits down with Sara Hamm, Senior Vice President of Successful Aging & Health Services for Lifespace Communities, to discuss disaster recovery and fostering resilience in long term care communities.

20 October 2017
K&L Gates Triage: Using Drones in Medicine

Unmanned aircraft, commonly known as “drones,” are gaining traction as a tool used by many industries today, including health care.

12 October 2017
K&L Gates Triage: Emergency Preparedness and Response in Long Term Care - Part II

This is the second episode in a three-part series on emergency preparedness and response in long-term care.

4 October 2017
K&L Gates Triage: Emergency Preparedness and Response in Long Term Care

This is the first episode in a three-part series on emergency preparedness and response in long-term care.

28 September 2017
K&L Gates Triage: Cyber Insurance Issues for the Healthcare Industry

This episode provides an overview of the major cyber security issues affecting the health care industry.

18 September 2017
K&L Gates Triage: Substantial Payment Reductions Proposed in CY 2018 for Hospital Outpatient Departments Subject to the Site-Neutral Payment Rule

This episode explains the proposed changes to the site-neutral payment rule for off-campus hospital outpatient departments for CY 2018, as discussed in both the recent Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) proposed rules.

7 September 2017
K&L Gates Triage: Reading the Fine Print: A Closer Look at the Proposed Regulation over Arbitration Clauses in Long-Term Care Resident Agreements

This episode discusses a recent policy shift by the Centers for Medicare & Medicaid Services (CMS) regarding binding pre-dispute arbitration clauses in long-term care resident agreements over the course of the past year.

25 August 2017
K&L Gates Triage: Avoiding the Risks Associated with Mandatory Vaccination Programs

This episode discusses the risks associated with mandatory employee vaccination programs and practical tips for health care entities on how to minimize these risks from an employment law perspective.

9 August 2017
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program

This episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B program.

26 July 2017
K&L Gates Triage: Emerging Themes for Emergency Departments: What to Know About Treating Psychiatric Patients Under EMTALA

This episode discusses some of the emerging themes and challenges that many hospitals are facing with the increasing number of psychiatric patients presenting to their emergency departments.

20 July 2017
K&L Gates Triage: Independent Contractors: DOL’s Withdrawal of Guidance

This episode discusses the U.S. Department of Labor’s recent decision to withdraw agency guidance on independent contractors in June 2017.

13 July 2017
K&L Gates Triage: Primary Impacts to Secondary Research through Revisions to the Common Rule

This is the third episode in a series on recent revisions to the Federal Policy for the Protection of Human Subjects, better known as the “Common Rule.” This episode focuses on secondary research, when it is subject to the Common Rule as finalized, and how institutions may utilize the broad consent option to authorize such secondary research to be conducted in the future.

5 July 2017
K&L Gates Triage: Human Subject Research and Revisions to the Common Rule – Informed Consent and Single IRB Requirements

This is the second episode in a series on recent revisions to the Federal Policy for the Protection of Human Subjects, better known as the “Common Rule.” This episode discusses changes to informed consent requirements for human subject research and what types of research may be exempt from such requirements.

22 June 2017
K&L Gates Triage: How the Fourth Circuit’s New Joint Employer Test May Impact Healthcare Employers

This is the second segment in a Labor, Employment and Workplace Safety series discussing the creation of a new “Joint Employer Test” by the Fourth Circuit Court of Appeals and how it impacts health care entities in North Carolina, South Carolina, Maryland, Virginia and West Virginia.

8 June 2017
K&L Gates Triage: Proposed Changes to the Federal Hospitals-Within-Hospitals Rule

This episode explores the proposed changes to the hospital within a hospital (“HwH”) rules, which were published in the Federal Register on April 14, 2017 as part of the Fiscal Year 2018 Medicare Hospital Inpatient Prospective Payment System and Long Term Acute Care Hospital Prospective Payment System Proposed Rule.

1 June 2017
K&L Gates Triage: Revising, Repealing or Replacing the ACA: Legislative Update (May 2017)

This is the third segment in a series on Revising, Repealing or Replacing the ACA.

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