最佳L Gates播客 (2024)

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Veterans Day Special Episode: Combating Traumatic Brain Injury 27:55

19d ago27:55

27:55

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. Brandon shares his experience in the military and how it led him to start The Davis Focus Project, an organization dedicated to supporting veterans to overcome traumatic brain injuries, PTSD, and ot…

1
Corporate Practice of Medicine: New Relevance in a Changing World 28:55

8M ago28:55

28:55

In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old health care regulatory doctrine that has new relevance in a post-COVID world, where the delivery of care via telemedicine and other remote models has become heavily adopted: Corporate Practice of Medicine, or “CPOM.” As more and more health care c…

1
Health System Cybersecurity Risks: Part Two 22:49

8M ago22:49

22:49

In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The Department of Health and Human Servi…

1
Health System Cybersecurity Risks: Part One 11:23

8M ago11:23

11:23

In this two-part Triage series, Gina Bertolini, Sarah Carlins, and Jianne McDonald analyze two recent HHS initiatives that address cybersecurity risks to hospitals and health systems nationwide. Cybersecurity events involving our nation’s health care providers have precipitously risen in the past five years. The Department of Health and Human Servi…

1
Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast 15:54

9M ago15:54

15:54

In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance document, the impacts of FDA’s final…

1
FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors 15:05

1y ago15:05

15:05

In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.…

1
Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations 13:07

1y ago13:07

13:07

In this episode, Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by health care organizations and a new federal research agency initiative to help create security tools to protect the US health care system from cyberattacks.

1
Unpacking CMS's Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement 17:45

1+ y ago17:45

17:45

In this episode, Darlene Davis, Leah Richardson, and Andrew Ruskin unravel CMS’s proposed rule for the remedy for Medicare payments for drugs purchased under the 340B Program and reimbursed as hospital outpatient services. The discussion includes background of the unlawful 340B drug reimbursement policy, as well as CMS’s proposed remedy. They also …

1
The End of Continuous Medicaid Enrollment—What Health Systems Should Know 5:51

1+ y ago5:51

5:51

In this episode, Alexander Chu and Ashley Davis review the end of the continuous Medicaid enrollment condition as a result of the Consolidated Appropriations Act, 2023. They discuss potential impacts of the disenrollment process for health care providers and provide helpful tips for health systems to navigate this change.…

1
Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities? 22:29

1+ y ago22:29

22:29

In this episode, Macy Flinchum talks with Limo Cherian and Steven Pine about some of the major takeaways, challenges, and successes that providers have experienced in navigating the new regulatory flexibilities for value-based arrangements announced in 2020.

1
Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials 15:56

1+ y ago15:56

15:56

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical trials, as well as notable planning considerations and regulatory requirements for both the industry sponsors and the academic medi…

1
2022 Health Care Employment Law Year in Review 22:09

1+ y ago22:09

22:09

In this episode, Sarah Carlins and Spencer Hamer discuss employment law and the health care sector. They review highlights from 2022, as well as developments that will impact employment law and the health care sector in 2023, including vaccine mandates, telehealth regulations, pay equity, and health care staffing regulations.…

1
Rural Emergency Hospitals — Transformative Change or Limited Impact? 17:14

1+ y ago17:14

17:14

In this episode of Triage, Andrew Ruskin, Darlene Davis, and Gabriel Scott discuss key provisions associated with conversion to CMS’s new rural emergency hospital provider type. They review the purpose of the new provider type, considerations and requirements for converting, as well as the benefits and drawbacks of a transition to a rural emergency…

1
Stark Law and the Anti-Kickback Statute Under the False Claims Act 21:46

2y ago21:46

21:46

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.…

1
Recent Developments to the 340B Drug Pricing Program 11:10

2y ago11:10

11:10

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…

1
The Information Blocking Rule's "Glide Path" - Compliance with the Information Blocking Rule After the Limitation on the Scope of EHI is Lifted 26:42

2y ago26:42

26:42

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…

1
New Data Available Under the Hospital Price Transparency Rule 17:42

2y ago17:42

17:42

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…

1
Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight 16:11

2y ago16:11

16:11

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 i…

1
Cybersecurity & HIPAA: NIST’s Practical Guidance Updates for Covered Entities and Business Associates 12:10

2+ y ago12:10

12:10

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…

1
Genesis Healthcare and the 340B Program Patient Definition 9:56

2+ y ago9:56

9:56

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 P…

1
Medicare Advantage False Claims Act Developments 18:26

2+ y ago18:26

18:26

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.

1
Hospitals, Physician Practices, and Labs – Are You Ready to Report Private Payor Rates for Laboratory Tests? 14:27

2+ y ago14:27

14:27

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.…

1
The Drive to Align ESG and Health Equity Priorities With Medicare Reimbursement Models 11:57

2+ y ago11:57

11:57

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.

1
Regulatory, Contractual, and Governance Considerations for Data Transactions 28:29

2+ y ago28:29

28:29

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.

1
Medical Laboratories Under the Microscope 20:00

2+ y ago20:00

20:00

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 compl…

1
Navigating the Independent Dispute Resolution Process Under the No Surprises Act 15:27

2+ y ago15:27

15:27

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.…

1
2021 Health Care Employment Law Year in Review and a Look Forward 23:32

2+ y ago23:32

23:32

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.…

1
Medicare Reimbursement for Community Hospital Residency Programs 11:22

3y ago11:22

11:22

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, man…

1
Data Security Breaches in the Health Care Sector 22:51

3y ago22:51

22:51

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…

1
What Health Care Providers Should Expect in an FDA Inspection 14:23

3y ago14:23

14:23

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.…

1
An Update on the CMS Hospital Price Transparency Rule 10:34

3y ago10:34

10:34

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 c…

1
FTC Reminds Vendors of Personal Health Records of Breach Rule Obligations 17:13

3y ago17:13

17:13

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 …

1
No Surprises: New Balance Billing Regulations for Health Care Providers 10:42

3y ago10:42

10:42

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 an…

1
CMS’s Proposal for New Remote Therapeutic Monitoring Codes under the 2022 Medicare Physician Fee Schedule 6:58

3+ y ago6:58

6:58

In the recent Medicare Physician Fee Schedule proposed rule for CY 2022, CMS has proposed adding a new category of reimbursable digital health services with new CPT codes classified as remote therapeutic monitoring (RTM). In this episode, Leah D’Aurora Richardson and Sarah Staples explain what RTM is, how it is different from remote physiologic mon…

1
Key Considerations for Officers and Directors of Distressed Companies 6:14

3+ y ago6:14

6:14

In this week’s episode, Andrea Cunha outlines some of the key considerations directors and officers should assess when their company is approaching insolvency, including how to evaluate financial distress of the company, the fiduciary duties they owe to the company, considerations for avoiding personal liability, and the maintenance of adequate ins…

1
Cybersecurity Risk in the Health Care Industry 19:47

3+ y ago19:47

19:47

As health care providers are increasingly relying on complex and integrated electronic medical record systems, the health care industry has rapidly become one of the most frequent and often vulnerable targets for cybersecurity threat actors. In this week’s episode, partners Gina Bertolini, John Lawrence, and David Rybicki discuss why health care pr…

1
When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives 14:38

3+ y ago14:38

14:38

In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining research, the regulatory requirements for research, and HIPAA exemptions to the Common Rule.…

1
OFCCP Enforcement in the Health Care Space 30:15

3+ y ago30:15

30:15

Health Care partners Sarah Carlins and Jackie Hoffman interview Labor, Employment, and Workplace Safety partner Craig Leen in this episode of Triage, recorded in collaboration with our Working Wise podcast. As the former director of the Office of Federal Contract Compliance Programs (OFCCP) at the U.S. Department of Labor, Craig shares engaging ins…

1
Understanding OIG and CMS Audits 12:57

3+ y ago12:57

12:57

Richard Church interviews Stephen Bittinger about the scope and authority of OIG and CMS audits, outlining the similarities and differences between the two from a provider perspective. The presenters discuss the key distinctions in the mechanics of the different types of audits that providers should be aware of, as well as strategies for preparing …

1
The Power of Health Care: Renewable Energy Transactions from the Health Care Perspective 13:58

3+ y ago13:58

13:58

Businesses across all industries are experiencing a drive toward sustainability. Companies want to be at the forefront of this movement, not only out of ethical considerations, but also because it is in their financial interests to do so. In this episode, Richard Church interviews Teresa Hill, a partner in our energy practice, about the history and…

1
Health Care Audit and Reimbursement Trends and Challenges 18:51

3+ y ago18:51

18:51

In this week’s episode, Richard Church interviews Stephen Bittinger about current trends and points of concern in the areas of health care reimbursement and integrity audit activity. The presenters discuss increases in provider audits, the potential for collaboration between the government and private payors, changes in the extrapolation process, a…

1
Long-Term Care: Exploring Lessons from the Past Year and Current Topics Facing the Industry 20:53

3+ y ago20:53

20:53

In this week's episode, Myla Reizen interviews Bruce Spurlock, quality expert and President and CEO of Cynosure Health, about long-term care facilities focusing on lessons learned over the past year with COVID-19, with a deep-dive into a recent survey of California nursing homes and key take-aways. The presenters also address current issues facing …

1
Health Care Transactions Trends in 2021 and Beyond 32:41

3+ y ago32:41

32:41

In this week’s episode, Josh Skora interviews Rick Giovannelli and Ken Marlow about current trends in health care transactions, with a particular focus on how COVID-19 has affected pricing considerations and the appetite for mergers, acquisitions, and joint ventures for traditional health care providers and private equity firms alike. The presenter…

1
340B Drug Pricing Program 2021 Outlook 14:00

3+ y ago14:00

14:00

In this episode, Richard Church and Andrew Ruskin discuss recent developments in the landscape of the 340B Drug Pricing Program in 2020, and forecast some of the major areas of focus and potential change for 340B covered entities under the new administration in 2021 and beyond.

1
Health Care and Employment Law: 2020 Year in Review and Looking Ahead 32:53

3+ y ago32:53

32:53

In this episode, Jackie Hoffman interviews Spencer Hamer about recent developments in employment law that have impacted the health care industry. This episode touches on various topics, including COVID-19 screening at the workplace, vaccination requirements, family member and whistleblower claims, physician non-competes, and racism as a public heal…

1
What to Expect in Health Care in 2021 20:24

4y ago20:24

20:24

In this week’s episode, Richard Church and Mary Beth Johnston discuss a number of critical issues in the health care industry that are likely to be points of focus in the coming year, including the COVID-19 pandemic, False Claims Act cases, the Affordable Care Act, health care consolidation, and more.…

1
What AMCs May Expect in Health Care Policy Priorities from the New Congress and the Biden Administration 12:03

4y ago12:03

12:03

In this episode, Health Care partner Rebecca Schaefer interviews Karishma Page, partner of the firm’s Public Policy and Law practice group, on what is likely to be coming down the pike in the health care policy landscape of particular interest to academic medical centers vis-à-vis regulatory and legislative action in 2021.…

1
Information Blocking Considerations for Providers Under the CMS Interoperability and Patient Access Final Rule 22:08

4y ago22:08

22:08

In this week’s episode, Gina Bertolini discusses two important aspects of the CMS Interoperability and Patient Access Final Rule that directly relate to health care providers, and how those aspects of the Final Rule will intersect with health care providers’ obligations under the ONC Information Blocking Rule. Specifically, Gina discusses CMS’ publ…

1
Recent District Court Decision Highlights the Importance of Adequate Behavioral Health Claims Processing Guidelines for ERISA Plans 11:23

4y ago11:23

11:23

On this week’s episode, Carla DewBerry and Sarah Carlins discuss a recent California Federal District Court decision in David Wit v. United Behavioral Health, in which the court found that the defendant insurer violated ERISA by improperly denying behavioral health claims submitted by over fifty thousand beneficiaries. The presenters discuss the wa…

1
340B Update: HRSA Moves Forward with 340B ADR Rule as Covered Entities Challenge Contract Pharmacy Actions 12:41

4y ago12:41

12:41

In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug manufacturer contract pharmacy actions where they are requesting, among other things, for the Health Resources and Services Adminis…

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