K&L Gates Health Care Triage

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 landscape.   They discuss the process of finding and securing an insurance underwriter, practical tips for structuring and negotiating RWI policies, how to navigate a claim after the policy is in place, and future trends in the RWI market.

In part one of this two-part series, Matt Miller and Andrew Lloyd analyze representations and warranties insurance (RWI) in the health care M&A landscape. They discuss the benefits of RWI for buyers and sellers, policy structures, premiums, and strategies to ensure effective coverage. The conversation also highlights RWI's role in health care transactions, insights on carriers providing coverage, and tips for securing favorable quotes and deal terms.

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 other physical and psychological wounds they have incurred in the line of duty.

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 companies look for innovative ways to deliver healthcare, it can be easy for seasoned healthcare professionals and newcomers alike to discount or dismiss CPOM. While on its face it is a straightforward prohibition, it is important to understand the doctrine's underlying philosophy and to appreciate its complexity, particularly how it varies from state to state. This is particularly the case where telehealth has become an established method for the delivery of care, and many new companies are entering the health care space. As health care entities, health IT solutions providers, and other companies seek to deliver care in one or more states, there are many health care regulatory considerations to consider, but CPOM should be at the top of the list.  In part one of this series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton offer a brief primer on CPOM, answer some practical questions about its impact, and elaborate on its present-day relevance for health care providers and other companies.

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 Services' Office for Civil Rights (OCR) reports a nearly 300% increase in large data breaches that involve ransomware reported to OCR from 2018 to 2022. Interoperability remains a major government priority, and as remote care models continue to proliferate and the need intensifies for big data to feed increasingly complex technologies, risks to health care providers will continue to abound.   In part two, Gina Bertolini and Sarah Carlins discuss HHS's “Healthcare Sector Cybersecurity” report, which outlines HHS's strategy for securing the digital infrastructure of our nation's health care system. HHS's strategy includes increased funding for support and enforcement of HIPAA's Security Rule and the implementation of voluntary Cybersecurity Performance Goals, and HHS projects changes to HIPAA's Security Rule coming in the Spring of 2024.

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 Services' Office for Civil Rights (OCR) reports a nearly 300% increase in large data breaches that involve ransomware reported to OCR from 2018 to 2022. Interoperability remains a major government priority, and as remote care models continue to proliferate and the need intensifies for big data to feed increasingly complex technologies, risks to health care providers will continue to abound.   In part one of this series, Sarah Carlins and Jianne McDonald discuss recent OCR recommendations for healthcare providers and patients on cybersecurity measures when providing and receiving care via telehealth. They also discuss the federal government's view that effective communication regarding the privacy and security of electronic health information is an important component of quality care in the telehealth setting. 

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 rule on IRB waivers of consent, the IRB review of individual patient expanded access submissions, and the potential effects of the new proposed rule for lab developed tests.

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.

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.

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 discuss the way in which CMS suggests that it will adjust future payments as a purported countermeasure for its remedy payments, as well as the implications for ongoing Medicare Advantage plan disputes on the same issues.

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.

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.

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 medical centers, research institutions and other providers participating in clinical studies. 

 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.

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 hospital. 

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.  

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.”

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.

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.

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.

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.

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.

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 monitoring (RPM), and the uncertainty regarding which practitioners will be able to furnish and bill for RTM services.

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 insurance coverage.

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 providers in particular are being targeted by threat actors, how providers can help protect themselves against this risk, and how providers should react in the event a cybersecurity attack occurs.

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.

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 insights about OFCCP enforcement in the health care industry and what health care entities can do to ensure compliance with OFCCP requirements, including affirmative action and non-discrimination.

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 for and managing an audit, reporting considerations, and the role of the OIG work plan.

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 structure of power purchase agreements and the opportunities that these transactions can bring for the health care industry.

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, and how providers can be proactive to avoid major audit issues.

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 the industry including top-of-mind concerns with vaccine hesitancy, potential litigation, and patient concerns when entering long-term care moving forward.

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 presenters also discuss how changes in the political landscape, funding, and other trends in the provision of health care may affect deal structures moving forward.

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.

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 health threat. This episode of Triage is recorded in collaboration with our Working Wise podcast. For more information on this topic, please read our related client alert, “Employment Law Developments That Will Impact the Health Care Industry in 2021,” authored by members of our Labor, Employment, and Workplace Safety practice.

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.

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. 

 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’ public reporting requirements for clinicians and hospitals who make attestations under the CMS Promoting Interoperability Program related to information blocking, and the new Medicare Condition of Participation which will require hospitals to send electronic patient event notifications in certain instances.

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 ways in which the insurer’s inadequate internal guidelines for the processing of behavioral health treatment claims led to the decision, and what this might mean for the design of behavioral health claims processing guidelines under ERISA regulated health plans in the future.