K&L Gates Health Care Triage: Recent Episodes
K&L Gates
Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.
In this episode, Gabe Scott, Natalia Nino, and Darrell White discuss the Drug Supply Chain Security Act following the FDA's warning letter to a medical spa over Botox products. Their conversation explores what the enforcement action reveals about the agency's compliance expectations, what it may signal about the FDA's priorities, and the steps dispensers should be taking now to mitigate risk and stay compliant.
In this episode, Gabe Scott, Kevin Alonso, and Cindy Laura Ortega Ramos unpack recent updates to the federal independent dispute resolution (IDR) process under the No Surprises Act. They discuss the operational changes introduced in May by the Departments of Health and Human Services, Labor, and the Treasury, along with the Office of Personnel Management, and what these updates mean for how payment disputes are processed and resolved.
In this episode, Gabe Scott, Sarah Carlins, and Myia Pretty discuss two significant proposed HIPAA rulemakings, including updates to the HIPAA Security Rule and proposed modifications to the HIPAA Privacy Rule. They outline the key policy changes and their underlying rationale, as well as what stakeholders should watch for as these processes move forward.
In this episode, Limo Cherian and Nora Becerra focus on key issues faced by in-house counsel and compliance teams as they address attorney-client privilege concerns. Their discussion focuses on the complexities of privilege that arise during healthcare investigations, specifically those involving fraud and abuse.
In this episode, Limo Cherian, Andy Ruskin, and Sarah Staples-Carlton unpack the Consolidated Appropriations Act of 2026 and its impact on provider-based clinics. They explain what provider-based status means, why mandatory attestations are back, and what hospitals and health systems must do to stay compliant and protect Medicare reimbursement.
In this episode, Gabriel Scott, Kevin Alonso, and Kennedy Caldwell break down the new Long Term Enhanced ACO Design (LEAD) Model and its impact on accountable care. They provide background on the model, outline key new features, and discuss five issues that Accountable Care Organizations and providers should consider as they evaluate participation.
In this episode, Gabriel Scott, Mark Ogunsusi, and Amanda Smith take a focused look at the 340B Drug Pricing Program, with particular attention to recent developments related to proposals for a 340B rebate model. They discuss why stakeholders may support or oppose a rebate‑based approach to 340B pricing and highlight key considerations relating to such a model.
In this episode, Limo Cherian, Rebecca Schaefer, and Clarita Sullivan break down the Department of Health and Human Services' (HHS) recent Request for Information on Accelerating the Adoption and Use of Artificial Intelligence (AI) as part of Clinical Care. They discuss why HHS is seeking input from both AI innovators and those facing adoption barriers, what the agency hopes to achieve with this feedback, and how it could shape future regulations, reimbursement policies, and research priorities. If you are an in-house attorney navigating the evolving AI landscape, tune in for practical insights on regulatory trends, federal priorities, and what's next for AI in healthcare. As mentioned in the episode, you can view HHS's consolidated responses and copies of schedules here.
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 healthcare 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 healthcare transactions, insights on carriers providing coverage, and tips for securing favorable quotes and deal terms.
In this special Veterans Day episode, Matt Miller is joined by Brandon Davis, of The Davis Focus Project and former Black Hawk instructor pilot in the 160th Special Operations Aviation Regiment. 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. They discuss the impact of traumatic brain injuries on special forces veterans and explore the latest advancements in treatment methods and emerging science for these complex conditions.
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, Alex 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 some 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 Statue. 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, Norman Acker, Nora Becerra, and Katherine Rippey discuss the False Claims Act as it relates to Stark Law and the Anti-Kickback Statue. 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.
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 Administration (HRSA) to promulgate 340B administrative dispute resolution regulations, which HRSA recently sent to the Office of Management and Budget for review.
In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are joined by Robin Cyr, Vice Provost for Research Administration at Northeastern University, who shares her frontline perspective and insights on the impact of COVID-19 on research programs at the institution and the types of relief that would help mitigate.
On this week’s episode, John Lawrence, Leah Richardson, and John Rothermich discuss compliance requirements associated with federal funding provided to health care providers through the CARES Act Provider Relief Fund, as well as the potential for forthcoming enforcement actions under the Federal False Claims Act (FCA). In particular, the presenters discuss the general confusion surrounding the gradual release of information regarding CARES Act funding compliance, and ways in which providers can prepare for potential government or private party actions alleging the misuse of CARES Act funds.
In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under applicable FDA Emergency Use Authorizations (EUAs), as well as what manufacturers and health care providers alike can learn from this trend.
In this episode, Jackie Hoffman addresses the challenges of providers, and those who advise providers, to identify available resources and maximize reimbursement in the face of the costs of care of uninsured and underinsured patients with COVID-19, or where providers generally face reimbursement challenges due to the pandemic environment.
In this episode, Rebecca Schaefer and Victoria Hamscho provide an update on next month’s Supreme Court oral arguments in California v. Texas, a case in which the Court will be reviewing the constitutionality of key parts of the Affordable Care Act (ACA). The presenters discuss the potential impact of the Supreme Court’s decision on health care providers and other stakeholders as well as the current Republican and Democratic plans to address its impact in case the entire ACA or major parts of the law are overturned.
Presenters: Rebecca Schaefer, Victoria Hamscho
In this episode, Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services (CMS) have been sent to 171 facilities testing for COVID-19 without proper CLIA certifications. Stephen outlines the impact of these cease and desist letters to the facilities, including potential implications for reimbursement of COVID-19 testing.
Presenter: Stephen Bittinger
In this week’s episode, 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. In particular, the presenters discuss recent federal regulatory and executive actions, as well as important state developments in Florida and Texas.
Presenters: Myla Reizen and Jackie Hoffman
In this week’s episode, Limo Cherian, Steve Pine, and Macy Flinchum discuss some of the key changes for Accountable Care Organizations (ACOs) in the recent Medicare Physician Fee Schedule proposed rule. In particular, the presenters discuss the implications and potential challenges for ACOs if the proposed changes to quality reporting and the metrics on which ACOs are scored are finalized for 2021.
In this week’s episode, 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 (ONC) final rule implementing the Interoperability, Health IT Certification and Information Blocking requirements under the 21st Century Cures Act. The presenters begin by providing some general background on the ONC Information Blocking Rule, then discuss how the Preventing Harm Exception may protect certain lawful practices engaged in by health care providers that may otherwise constitute information blocking under the new Information Blocking Rule.
In this week’s episode, Carla DewBerry and Kelsey Jernigan discuss issues in mental health parity in the context of recent California legislation. In particular, the presenters discuss how a new California bill has sparked a renewed discussion on parity for mental health and substance use disorder treatment and how it should work in practice. The presenters further address trends across the federal landscape and the interplay with the COVID-19 pandemic.
In this week’s episode, 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. The presenters discuss the ways in which OIG is likely to scrutinize the use of CARES Act and other funding received by health care providers during the COVID-19 public health emergency, and how providers should prepare for OIG inquiries.
In this episode of Triage, Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association, including its potential impact on nearly forty state laws that regulate the conduct of pharmacy benefit managers (PBMs) and at least nine state laws prohibiting PBMs from engaging in two-tier pricing models in regard to the 340B Drug Pricing Program.
Presenters: Leah D’Aurora Richardson, Victoria K. Hamscho
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; they examine the data through the lens of social determinants of health and propose potential solutions moving forward.
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. On this week’s episode, Lindsey Rogers-Seitz and Kenneth Kennedy discuss the scope of FDA’s clinicaltrials.gov reporting requirements, as well as the penalties responsible parties may face for failing to meet them.
Presenters: Lindsey Rogers-Seitz and Kenneth Kennedy
In this week’s episode, Rebecca Schaefer and Hannah Maroney discuss a string of recent HIPAA enforcement actions which demonstrate that the HHS Office of Civil Rights (OCR), the agency tasked with enforcing HIPAA, is increasingly focused on ensuring that affiliated hospitals within a health system, typically comprising an Affiliated Covered Entity (ACE), have HIPAA business associate agreements in place with the parent corporation to allow for the lawful exchange of PHI. The presenters discuss the circumstances in which a business associate agreement may be required, and address several questions regarding related ACE organizational considerations.
Presenters: Rebecca Schaefer, Hannah Maroney
In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B Drug Pricing Program. In particular, the presenters discuss the implications of the recent D.C. Circuit decision in American Hospital Association v. Azar, as well as certain provisions of the new OPPS proposed rule released by CMS on August 4, 2020.
Presenters: Andrew Ruskin, Darlene Davis, Gabe Scott
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. Mr. Qualls discusses how this case was decided and what providers can learn from the court’s reasoning.
In this episode, Richard Church, Andrew Ruskin, and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent actions by drug manufacturers to limit contract pharmacy access to 340B pricing and impose new reporting requirements on 340B covered entities, as well as a new legislative proposal that would temporarily waive 340B hospital eligibility requirements.
Presenters: Richard Church, Andrew Ruskin, Victoria Hamscho
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. Mr. Bittinger discusses the different forms of audits that are set to resume, potential focus points that auditors may target, and measures providers should take to prepare.
Download Presentation Materials
In this week's episode, 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.
Presenters: Steve Pine, Gabe Scott
In this week’s episode, 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. This week, the presenters focus on the ways in which regulatory authorities and industry leaders in the United States and Australia may adapt and change the face of long term and aged care as the COVID-19 pandemic continues, and beyond.
Presenters: Myla Reizen and Paris Petranis
Download Presentation Materials
In this week’s episode, Carla DewBerry is joined by with Carlos Olivares, Executive Director of the Yakima Valley Farm Workers Clinic, a community based health center in the Pacific Northwest serving low-income, migrant and seasonal farm workers and communities of color for over 40 years. Ms. DewBerry and Mr. Olivares discuss how the COVID-19 pandemic has impacted the organization and community at large, as well as the innovative projects the Yakima Valley Farm Workers Clinic has undertaken, and potential changes in the health care delivery system in years to come.
Presenter: Carla DewBerry
In this week’s episode, 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. The presenters discuss the full scope of issues COVID-19 has created for the long term and aged care industries to date, and the ways in which regulatory authorities and industry leaders are addressing these issues in both the United States and Australia.
Presenters: Myla Reizen and Paris Petranis
Download Presentation Materials
On this week’s episode, 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. In particular, the presenters discuss guidance the United States government has provided to nursing homes and long term care facilities for handling the COVID-19 pandemic, areas of potential exposure to criminal and civil actions for nursing homes and long term care facilities related to their response to the pandemic, and what protective measures such facilities can take to prevent or defend against such civil and criminal actions.
In this week’s episode, 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. The presenters address the ways in which the COVID-19 emergency has affected behavioral health providers and the ways in which they offer behavioral health services, as well as how some of these changes may continue to affect the field of behavioral health into the future.
Presenters: Carla Dewberry, Sarah Carlins, Cheryl Choice
In this week’s episode, Leann Walsh identifies key takeaways for hospitals and other health care employers from a guidance document recently published by the Centers for Disease Control (CDC) entitled “Ten Ways Healthcare Systems Can Operate Effectively during the COVID-19 Pandemic.” In particular, Ms. Walsh discusses CDC guidance related to worker safety and support, patient service delivery, data streams for situational awareness, facility practices, and communication plans.
Presenters: Leann Walsh
Download Presentation Materials
Presenters: Gina Bertolini, Leah Richardson, Lindsey Rogers-Seitz
In this week’s episode, 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 (HHS) 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. The presenters discuss the scope and intended outcome of these efforts, as well as how these changes in access to telehealth services might continue going forward.
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. In particular, the presenters discuss changes implemented by CMS to the Quality Payment Program (QPP), the Merit-based Incentive Payment System (MIPS), and the Medicare Shared Savings Program (MSSP), as well as additional considerations for commercial value-based arrangements.
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.
Presenters: Richard Church, Victoria Hamscho
Download Presentation Materials
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. In particular, the presenters address the Stark Law compliance waivers issued by the Secretary of the Department of Health and Human Services related to the COVID-19 outbreak, and discuss the effect of a Self-Referral Disclosure Protocol submission in the context of CMS’ recently announced expansion of its Accelerated and Advanced Payment Program for various types of providers.
Download Presentation Materials
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. In particular, Mr. Kennedy discusses several unprecedented measures FDA has taken with respect to laboratory test approval, as well as some important regulatory actions aimed at protecting the public health.
Presenters: Kenneth Kennedy
Download Presentation Materials
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.
Presenters: Hannah Maroney, Cheryl Choice, and Steven Pine
Download Presentation Materials
In this week’s episode, Gary Qualls discusses the recent Louisiana federal district court decision in Crescent City Surgical Centre vs. United Healthcare of Louisiana, in which the court found that an out-of-network provider’s claim against a third party payer was not subject to preemption under the Employee Retirement Income Security Act (ERISA) and was properly heard in state court. Mr. Qualls highlights the implications of this decision, including how it may prevent future ERISA preemption of similar claims related to payment for out-of-network services.
Presenters: Gary Qualls
Presentation Materials
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. In particular, Mr. Cooper discusses the ways in which the Allina decision and the CMS memorandum may limit CMS’ ability to cite certain regulatory guidance as a basis for enforcement actions.
Presenters: Adam Cooper
Download Presentation Materials
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. The presenters discuss how EKRA differs from the Federal Anti-Kickback statute, recent criminal litigation, and the role EKRA may play when structuring CIN arrangements.
Presenters: Limo Cherian, Carla DewBerry, Steve Pine
Download Presentation Materials
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”). Mr. Severson discusses several key aspects of the Strategic Plan, which offers both insight into the direction the ONC and other federal agencies may take with respect to health IT regulation in the coming year, and an opportunity for stakeholders to engage with the federal government on matters of health IT.
Presenter: Ryan Severson
Download Presentation Materials
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. The guidance largely lays out existing duplicate discount prevention strategies. However, it contains some recommendations that could greatly impact covered entities, such as using state plan amendments to limit the ability of some or all covered entities and/or contract pharmacies to use 340B drugs for Medicaid beneficiaries. As states implement these strategies, operational and compliance challenges may arise for covered entities, particularly for those that are filling prescriptions for Medicaid beneficiaries in multiple states with potentially differing requirements for identifying duplicate discounts.
Presenters: Macy Flinchum, Victoria Hamscho
Download Presentation Materials
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. Among these issues, Ms. Rogers-Seitz discusses the potential impacts of the 2020 presidential campaign, the health care industry's continued struggle against the opioid crisis, shifts in major regulatory structures, and overall trends in the business of health care.
Presenters: Lindsey Rogers-Seitz
Download Presentation Materials
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.
Presenters: Ryan Severson, Victoria Hamscho
Download Presentation Materials
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. In this episode, Darlene Davis discusses the impact of new guidance from the Centers for Medicare & Medicaid Services (CMS) related to this change and how CMS intends to recognize these units moving forward.
Presenters: Darlene Davis
Download Presentation Materials
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. In this episode, Mr. Pine explains a number of Advanced Alternative Payment Models (APM) proposals, including new incentive structures and changes to applicable reporting requirements.
Presenters: Steven G. Pine
Download Presentation Materials
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. Part 2 (Part 2) regulations related to the confidentiality of substance use disorder treatment records in light of challenges posed by the opioid epidemic. In this episode, Gina Bertolini and Steve Pine discuss SAMHSA’s recent proposed rule that seeks to modernize Part 2 by aligning the regulations with recent advances in the delivery of health care, while retaining important privacy protections for individuals with substance use disorders (SUDs).
For additional information related to this episode of Triage, please see our accompanying client alert.
Presenters: Gina L. Bertolini and Steven G. Pine
Download Presentation Materials
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. Part 2 (Part 2) regulations related to the confidentiality of substance use disorder treatment records in light of challenges posed by the opioid epidemic. In this episode, Gina Bertolini provides some background on the Part 2 regulations themselves and how the opioid epidemic has affected their enforcement. Ms. Bertolini also touches on recent efforts by Congress and SAMSHA to modernize Part 2 in response to stakeholder input.
Presenters: Gina L. Bertolini
Download Presentation Materials
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. In this episode, Ms. Barger discusses several additional key Merit-Based Incentive Payment System (MIPS) proposals presented in the proposed rule, including those related to the weighting of performance categories and updates to MIPS performance thresholds.
Presenters: Kathy G. Barger
Download Presentation Materials
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. Ms. Cherian presents an overview of the QPP and discusses CMS’ newly proposed framework for Merit-based Incentive Payment System (MIPS) participation, the MIPS Value Pathways.
Presenters: Limo T. Cherian
Download Presentation Materials
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. Their discussion covers a number of issues, including the development of an effective intellectual property policy, intellectual property assignments, dealing with start-ups, ownership issues with respect to inventions developed in collaboration with other institutions, and the rights requirements for patent enforcement.
Presenters: George C. Summerfield and Kelly A. Plummer, Ph.D.
Download Presentation Materials
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.
Presenters: Richard Church and Ryan Severson
Download Presentation Materials
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.
Presenters: Richard Church and Ryan Severson
Download Presentation Materials
UPDATE Since initial publication of this episode, CMS has delayed implementation of this policy until April 2020.
The Centers for Medicare and Medicaid Services (CMS), recently announced that it plans to activate systematic validation edits for Outpatient Prospective Payment System (OPPS) providers with multiple service locations that will verify whether the address listed on each claim matches the address in CMS’ Provider Enrollment, Chain and Ownership System (PECOS) database. In this episode, Gabe Scott provides some background on why CMS is making this change, why it is important, and what providers with off-campus provider-based locations might do to address this issue.
Presenters: Gabriel Scott
Download Presentation Materials
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. This episode discusses the issues raised by an unconventional provider of surgical equipment and staff necessary for in-office outpatient surgeries related to the denial of separate claims it submitted under out-of-network ERISA plans. This episode also outlines the analysis of the court as well as key takeaways, particularly including the importance of plan language for interpretation of ERISA plans.
Presenters: Gary S. Qualls and Zachary W. Ernst
Download Presentation Materials
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. This episode includes key takeaways from this report and general steps organizations can take to improve their organizational climate and prevent harassment.
Presenters: Leann Walsh and Kristi Nickodem
Download Presentation Materials
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. In Part One of this two-part series, Leann Walsh and Kristi Nickodem discuss some of the findings in the National Academies’ Report and the current climate of sexual harassment in the health care industry.
Presenters: Leann Walsh and Kristi Nickodem
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). In this episode, Ryan Severson provides an overview of the federal government’s proposal with a particular focus on proposed changes to the scope of information blocking practices.
Presenters: Ryan Severson
Download Presentation Materials
The U.S. Department of Health and Human Services recently released a notice of enforcement discretion announcing changes in how the agency will assess civil monetary penalties for violations of the Health Insurance Portability and Accountability Act (HIPAA). In this episode, Rebecca Schaefer discusses the impact of this revised regulatory interpretation, how the new standard may impact pending disputes, and overall trends affecting HIPAA judgments and settlements.
Presenters: Rebecca Schaefer and Eric Matava
Download Presentation Materials
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. Specifically, this episode provides an overview of recent developments that are particularly important to health care employers, including issues surrounding employee resistance to vaccination requirements, workplace violence, employee use of marijuana, and anti-harassment laws inspired by the #MeToo movement.
In addition to this episode, K&L Gates’ Employment Law in the Health Care Industry 2018 Year in Review can be found here.
Presenters: Richard P. Church and Spencer Hamer
Download Presentation Materials
In this episode, Michael McKay and Carla DewBerry discuss the practical implications of responding to an investigative inquiry by governmental officials. In particular, entities that find themselves as the subject of a potential investigation should be prepared to cooperate as needed with any governmental inquiries while retaining the rights of any affected employees or patients.
Presenters: Michael D. McKay and Carla M. DewBerry
Download Presentation Materials
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. Specifically, a federal district court recently upheld a Louisiana assignment statute over an anti-assignment provision in a provider’s health plan contract and payer’s challenge of preemption.
Presenters: Gary S. Qualls
Download Presentation Materials
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.
Presenters: Hilary Bowman
Download Presentation Materials
This is the final episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor under the 340B Program, including by providing technical assistance and compliance tools to assist stakeholders in running their 340B operations. This last episode discusses how to effectively manage and staff 340B compliance efforts and tools available to covered entities in this regard.
Presenters: Richard Church and Ryan Severson
Download Presentation Materials
This is the second episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor under the 340B Program, including by providing technical assistance and compliance tools to assist stakeholders in running their 340B operations. This second episode discusses manufacturer inquiries into 340B purchasing, including best practices for handling these requests and trends 340B manufacturer inquiries.
Presenters:Richard Church and Ryan Severson
Download Presentation Materials
This is the first episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor in administering the 340B Program, including by publishing guidance and compliance tools to assist stakeholders in running their 340B operations. This first episode discusses best practices for resolving non-compliance under the 340B Program, how to determine whether an issue is a “material breach” of 340B requirements, HRSA’s self-disclosure process, and some of the most common compliance issues that arise.
Presenters:Richard Church and Ryan Severson
Download Presentation Materials
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. The episode provides an overview of the actions that may be taken by governmental agencies when conducting an investigation, and how the subjects or targets of these investigations may be requested to respond through Civil Investigative Demands (CIDs), subpoenas, or search warrants.
Presenters: Mark A. Rush and John H. Lawrence
Download Presentation Materials
In Part 2 of our series on health care investigations, Mark Rush and John Lawrence continue the discussion on internal investigations. Specifically, the episode walks through how to conduct an internal investigation, including the recommended process for collecting key documents, conducting employee interviews, giving Upjohn warnings, drafting a written report of the findings, taking corrective action, and making the requisite disclosures when necessary.
Presenters: Mark A. Rush and John H. Lawrence
Download Presentation Materials
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. The episode also addresses key questions that organizations should consider when identifying overpayments, investigating credible allegations of overpayments, and conducting internal investigations regarding the same.
Presenters: Mark A. Rush and John H. Lawrence
Download Presentation Materials
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. In this episode, Susan Hackney discusses the appeals process for Medicare claim disputes, how the district court reached its decision in this case, and what effects this outcome may have on the process going forward.
Presenters: Susan K. Hackney
Download Presentation Materials
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. He also summarizes CMS’ request for information on methods to facilitate care coordination and modify Medicare fraud and abuse waivers.
Presenters: Steven G. Pine
Download Presentation Materials
A sale of a business under Section 363 of the U.S. Bankruptcy Code or through Chapter 11 can provide the best possible title to the purchaser and may be an appropriate avenue for selected assets or complex and valuable going concern businesses such as healthcare businesses. In this episode, Margaret Westbrook provides a basic overview of the Chapter 11 sales process and how this process can be utilized as an advantageous method of buying and selling healthcare businesses.
Presenters: Margaret R. Westbrook
Download Presentation Materials
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.
Presenters: Limo T. Cherian
Download Presentation Materials
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this requirement. In this episode, Michael Hinckle summarizes current requirements for single shared system (SSS) REMS and explains how the new guidance documents may assist generic drug applicants negotiating SSS issues with brand competitors.
Presenters: Michael H. Hinckle
Download Presentation Materials
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. While these goals are laudable, if not carefully constructed and managed, such a committee may unintentionally constitute an unfair labor practice under the National Labor Relations Act (“NLRA”).
In this episode, Leann Walsh provides a practical reminder for health care employers of the risks involved under the NLRA with employer-created labor organizations.
Presenters: Leann M. Walsh
Download Presentation Materials
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. Specifically, a recent federal case from California is among the first to clarify that providers may sue a Medicare Advantage insurer under state law contract claims for underpayments without being required to exhaust administrative remedies and follow the federal Medicare Advantage administrative appeals process for each individual patient claim at issue.
Presenters: Gary S. Qualls and Zachary W. Ernst
Download Presentation Materials
Recently, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced its largest ever national health care fraud takedown, resulting in charges against 601 diverse defendants including health care entities and individual providers. In this episode, Mark Rush and John Lawrence discuss some of the major trends of the takedown, including a focus on unlawful distribution of opioids and other prescription narcotics and a focus on holding individuals accountable, as well as practical takeaways from the takedown for those in the health care industry.
Presenter: Mark A. Rush and John H. Lawrence
Download Presentation Materials
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. Specifically in health care, AI systems are increasingly utilized to help streamline certain diagnosis, treatment, and administration procedures. In this episode, Ryan Severson discusses some of the key legal issues associated with AI and how the landscape is expected to change over the next few years.
Presenter: Ryan Severson
Download Presentation Materials
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. In this episode, Joe Leahy provides an update on recent enforcement activity stemming from CMS’s application of the statutory requirement and the implications for Medicare-certified hospitals.
For more information on the background of the “primarily engaged” requirement and the interpretive guidelines, please see our prior alert, U.S. District Court Upholds CMS’s Application of the Statutory Requirement that Hospitals Be “Primarily Engaged” in Providing Services to Inpatients.
Presenter: Joe Leahy
Download Presentation Materials
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. In this episode, Darlene Davis discusses the effect of these changes, if implemented as proposed, on the current separateness and control requirements for satellite facilities and the similarities between this proposal and CMS’ changes to the hospital within a hospital rules effective in 2017.
Presenters: Darlene S. Davis
Download Presentation Materials
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. Critics argue that this practice results in artificially inflated prescription drugs costs.
In this episode, Richard Church and Ryan Severson discuss recent litigation stemming from these gag clauses, as well as various state and federal efforts to prohibit PBMs from using gag clauses in their pharmacy contracts, including a proposal in President Trump’s recently released drug pricing plan.
Presenters: Richard P. Church and Ryan J. Severson
Download Presentation Materials
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.
Presenter: Kathy G. Barger
Download Presentation Materials