Payers, Providers, and Patients – Oh My!

In this episode, hosts Payal Nanavati and Savanna Williams talk to Paul Pollock and Wayne Pryor about how private equity (PE) got its start in the health care industry, current trends in PE regulation, and where listeners can expect to see PE to continue investing in the industry.    This podcast episode features the following speakers: Paul Pollock is a partner in Crowell’s New York office and concentrates his practice on mergers, and acquisitions, and corporate finance, specifically in the health care industry. Wayne Pryor is Managing Director in VMG Health’s Financial Due Diligence Division in the Nashville office.  He has over 30 years of experience in the health care industry with a focus on transaction surfaces.  Wayne has worked on over 450 buy-side and sell-side transactions in every sub sector of the industry, ranging from $1 million to $10 billion deals.

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions’ white paper* on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity. This podcast episode features the following speakers: Jodi Daniel is a Managing Director of Crowell Health Solutions and also is a partner in Crowell’s DC office, who leads the firm’s Digital Health Practice. She previously spent 15 years at the Department of Health and Human Services (HHS). Cara Tenenbaum is a Consultant with Crowell Health Solutions, leads Strathmore Health, and has extensive experience in health policy and patient advocacy. She worked at the U.S. Food and Drug Administration (FDA) for six years. Ben Moscovitch leads Amazon Web Services (AWS) healthcare and life sciences public policy efforts and focuses on policy reforms to improve health data interoperability and clinical research. Devon Adams is a Senior Policy Analyst at the American Cancer Society Cancer Action Network, the nonpartisan advocacy affiliate of the American Cancer Society. He works on policy related to cancer research, device and drug development, precision medicine, and clinical trials. Noah Goodson, Ph.D. is the Principal of Strategy & Advisory at THREAD Research. He spends his day supporting pharmaceutical, biotech, and medical device companies in the design and execution of clinical trials. White Paper: https://www.crowell.com/a/web/vFgM2vJzbE4wsuVyJ5o1py/advancing-adoption-of-decentralized-clinical-trials-rationale-current-state-and-policy-recommendations.pdf  

In this episode, hosts Payal Nanavati and Megan Beaver talk to Chris Flynn and Alice Hall-Partyka regarding the proposed updates to the regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). We discuss the current regulatory environment, enforcement, and key takeaways from the proposed rule. For further reading, please see: New Proposed MHPAEA Rule Builds on NQTL Comparative Analysis Standards (https://www.crowell.com/en/insights/client-alerts/new-proposed-mhpaea-rule-builds-on-nqtl-comparative-analysis-standards) Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Joe Records and Payal Nanavati talk to Rebecca Baskin regarding her recently-published article analyzing the true costs to companies of becoming the subjects of False Claims Act or Anti-Kickback Statue investigations.  We discuss the article’s methodology, findings, and key takeaways.    Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Joe Records, Payal Nanavati, and Jodi Daniel talk to three members of the health information industry regarding the Trusted Exchange Framework and Common Agreement (TEFCA) published by the Office of the National Coordinator for Health Information Technology (ONC). This episode features Jay Nakashima (Executive Director of eHealth Exchange), Nichole Sweeney (General Counsel and Chief Privacy Officer of CRISP Shared Services), and Erica Galvez (CEO of Manifest MedEx), who each share their experiences in the health information exchange industry and their expectations of TEFCA. Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Joe Records and Payal Nanavati talk to Kelly Hibbert and Jed Wulfekotte about how Medicare plan sponsors and Medicaid Managed Care Organizations can structure an affirmative recovery program to prevent and detect fraud, waste, and abuse -- among other things.   Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Joe Records and Payal Nanavati talk to Michelle Chipetine and Stacie Heller about recent developments regarding the nondiscrimination requirements of Section 1557 of the Affordable Care Act, including new rules proposed by the Biden Administration and litigation around the issue of discrimination on the basis of sex.   Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, host Payal Nanavati talks to Shelley Rosenberg and Joe Records about changes to the medical loss ratio (MLR) requirements impacting commercial coverage, particularly the limitations on what expenses issuers can include in their MLR numerators. Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, Joe Records and Payal Nanavati talk to Scott Douglas and Charlotte Freed about the mental health provisions in the federal gun safety legislation. The new law included billions in federal funds to support mental health care—a huge investment likely to have major impacts on the industry. Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

This episode is the second part in a miniseries with Crowell Health Solutions, which is a strategic consulting firm that Crowell & Moring launched earlier this year to help healthcare organizations and technology companies transform health care by improving patient care and health outcomes, advancing health equity, and lowering health care costs through solutions like digital health innovations and value-based healthcare models. In this episode, Janet Walker and Roma Sharma interview three leaders working at Ascension, which is one of the nation’s largest not-for-profit health systems with more than 2,600 sites of care, about how Ascension has prioritized health equity and population health initiatives, including its framework “ABIDE,” which is built upon the hallmarks of Appreciation – Belongingness – Inclusivity – Diversity – Equity.  The interviewees are Dr. Stacy Garrett-Ray (Senior Vice-President and Chief Community Impact Officer), Pamela Mitchell Boyd (Senior Director of ABIDE), and Nicole Commodore (Director, Community Impact and Advocacy).   Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.   For more information, please see: Crowell & Moring Unveils Crowell Health Solutions

In this episode, host Joe Records talks to Gary Baldwin about the regulation of shared-risk arrangements in the state of California. They discuss the history of shared-risk arrangements in California, how the Department of Managed Health Care (DMHC) approaches these kinds of arrangements, and the kinds of issues entities should consider in approaching shared risk.   Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

This episode is the first part in a miniseries with Crowell Health Solutions, which is a strategic consulting firm that Crowell & Moring launched earlier this year to help healthcare organizations and technology companies transform health care by improving patient care and health outcomes, advancing health equity, and lowering health care costs through solutions like digital health innovations and value-based healthcare models. In this episode, Troy Barsky interviews Michael Meng (the CEO of Stellar Health) about how technology has impacted, and continues to impact, health care delivery in light of regulatory changes focused on advancing value-based care.  Michael Meng is the CEO and co-founder of Stellar Health, which is a healthcare technology company focused on enabling success across the value-based care continuum by bridging the incentive gap between providers and payors. Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. For more information, please see: Crowell & Moring Unveils Crowell Health Solutions Stellar Health

In this episode, hosts Payal Nanavati and Joe Records talk to Katy Raffensperger, Todd Rosenberg, and Alexis Gilman about expectations for healthcare transactions in 2022.   The discussion captures how transactions involving health care companies may respond to legal, economic, and market circumstances, including lasting care delivery changes spurred by the COVID pandemic, antitrust scrutiny by federal regulators, inflation, and rising interest rates.   Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Payal Nanavati and Joe Records talk to Matt Vicinanzo about developments in False Claims Act litigation – including materiality, scienter, and government dismissal authority, among others – and how those developments may have a unique impact on companies in the health care industry. For more information please see: "The Top FCA Developments of 2021," Government Contracts Bullet Points (February 25, 2022). Contacts: Brian Tully McLaughlin, Lyndsay A. Gorton, Nkechi Kanu, Payal Nanavati, Matthew Vicinanzo. "Payers, Providers, and Patients – Oh My!: FCA Dismissals Under the Granston Memo," Podcast: Payers, Providers, and Patients – Oh My! (June 26, 2019). Contacts: John T. Brennan Jr., Joe Records, Payal Nanavati. "Payers, Providers, and Patients – Oh My!: Data Analytics and FCA Investigations," Health Care Alert (January 21, 2021). Contacts: Michael Shaheen, Joe Records, Payal Nanavati. Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Payal Nanavati and Joe Records talk to Troy Barsky and Roma Sharma about their reflections on the first year of implementation of new regulations implementing the major fraud and abuse statutes — the Stark Law and Anti-Kickback Statute (AKS) — including discussing challenges, opportunities, and outstanding questions about the new exceptions and safe harbors for value-based care.   For more information please see: "CMS Issues Sweeping Reform to Modernize the Stark Law: Part I," Health Care Alert (November 30, 2020). Contacts: Troy A. Barsky, John T. Brennan Jr., Lidia Niecko-Najjum, Roma Sharma. "OIG Issues Final Rule to Update AKS Safe Harbors: Part II," Administrative Law Alert (February 25, 2021). Contacts: Troy A. Barsky, Jodi G. Daniel, Michael Shaheen, Lidia Niecko-Najjum, Joe Records, Matthew Vicinanzo.   Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Payal Nanavati and Joe Records talk to Jodi Daniel and Savanna Williams about the latest developments in interoperability, including challenges of implementing recent CMS and ONC regulations and expectations about potential enforcement of these rules.  For more information please see: "HHS Finalizes Sweeping Regulations on Interoperability of Health Information and Information Blocking"  "Balancing The New Interoperability Rules With Existing Privacy Laws: Challenges for Payers"  "CMS Expands on Patient Access and Interoperability Requirements for Health Plans"  Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, hosts Payal Nanavati and Joe Records talk to Janet Walker and Mercy Care’s CEO, Lorry Bottrill about the ways in which the government and health plans are addressing the social determinants of health (SDOH), which are the conditions in which people are born, live, learn, work, play and age and they affect a wide range of health, functioning, and quality-of-life outcomes.    Lorry has been a leader in Arizona’s health care community for more than 25 years.  In this episode, she shares recent examples of Mercy Care’s efforts to address SDOH through collaboration with the Arizona Health Care Cost Containment System (AHCCCS or “ACCESS”), Arizona’s Medicaid agency.    For more information please see: Mercy Care CDC Notice of Funding Opportunity: Closing the Gap with Social Determinants of Health Accelerator Plans CMS Innovation Center Strategy Refresh AHCCCS Whole Person Care Initiative   Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. You can follow Lorry Bottrill here.

In this episode, hosts Payal Nanavati and Joe Records talk to Lidia Niecko-Najjum and John Brennan about the legal issues that investors, providers, and innovators should be prepared to navigate when considering offering Ketamine-assisted treatment, including the federal and state laws and regulations related to the practice of medicine, licensure, and many other issues.  Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors.

In this episode, host Payal Nanavati talks to Joe Records about recent enforcement activities under the Mental Health Parity and Addiction Equity Act (MHPAEA), including federal agencies’ requests for insurers to submit comparative analyses of their non-quantitative treatment limitations.  Payers, Providers, and Patients – Oh My! is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. Materials discussed in this episode: H.R.133 - Consolidated Appropriations Act, 2021 Department of Labor, Self-Compliance Tool "COVID Relief and Appropriations Legislation Includes Mental Health Parity Compliance and Oversight Requirements," Health Care Alert (December 23, 2020). Contacts: Michael W. Lieberman, Lauren R. Nunez, Joe Records.

In this episode, hosts Payal Nanavati and Joe Records talk to partner Steve McBrady, who led the Crowell & Moring team that represented Maine Community Health Options in the long running Affordable Care Act §1342 “risk corridors” litigation that ended with U.S. Supreme Court decision in favor of Maine and companion insurers.  Materials discussed in this episode: Client Alert: Supreme Court Rules in Favor of Health Plans in Landmark $13 Billion Affordable Care Act Case Firm News: Maine Community Health Options Wins U.S. Supreme Court Ruling Enforcing Government Payment Obligation Under Affordable Care Act ‘Risk Corridor’ Cases