One year ago, on October 30, 2023, President Joe Biden signed an executive order laying the groundwork both for how federal agencies should responsibly incorporate artificial intelligence (AI) within their workflows and how each agency should regulate the use of AI in the industries it oversees.
What has happened in the past year, and how might things change in the next?
On this episode, Epstein Becker Green attorneys Lynn Shapiro Snyder, Eleanor Chung, and Rachel Snyder Good reflect on what is new in health care AI as a result of the 2023 executive order and discuss what industry stakeholders should be doing to comply and prepare for future federal regulation of AI in health care.
Workplace violence in health care settings is on the rise, capturing the attention of both state and federal lawmakers.
As awareness grows, so too does legal scrutiny and the push for new regulations and enforcement. In these seemingly critical times, what should health care employers be thinking about and incorporating into their comprehensive strategies to prevent and address workplace violence?
On this episode, Epstein Becker Green attorneys Sharon Peters, Eric Neiman, and Avery Schumacher dissect the legal landscape surrounding health care workplace violence, examining the steps being taken at various levels of government and what they mean for health care providers and institutions. Join us as we explore the legal frameworks, emerging policies, and broader compliance implications for health care employers.
The game has changed—are you positioned to adapt? Over the past 12 months, the federal government has been heavily regulating private investment in health care entities.
Simultaneously, multiple states have enacted or introduced new laws restricting or requiring approval of such investments. The question arises: What do you do if you already have investments in these health care entities?
On this episode, Leslie Norwalk, Strategic Counsel at Epstein Becker Green (EBG), joins EBG attorneys Josh Freemire, Tim Murphy, and Ted Kennedy, Jr., to discuss how health care entities, investors, and board members should be responding to an evolving political and regulatory environment that has increased the scrutiny of private investment in health care entities.
Read the letter submitted by Leslie in response to a joint “Request for Information on Consolidation in Health Care Markets” issued by the U.S. Department of Justice, the U.S. Department of Health and Human Services, and the Federal Trade Commission.
Under the Biden administration, the Centers for Medicare & Medicaid Services published a health equity framework that drastically changed the playing field for health plans and other risk-bearing entities.
In the wake of these changes, how can health plans, accountable care organizations, and other similar stakeholders successfully create and administer social determinants of health interventions as a means to advance health equity?
On this episode, Epstein Becker Green attorneys Jackie Selby, Kevin Malone, and Marjorie Scher discuss the recent national focus on health equity, the actionable interventions behind the concept, and the responsibility of stakeholders in making care delivery more equitable.
What trends in state laws and regulations have emerged in the post-public health emergency (PHE) era, and how do these changes impact telehealth stakeholders?
At the federal level, many telehealth-related flexibilities have been extended through December 31, 2024, whereas, at the state level, there are wide variations in approach. Many states have continued to push the boundaries of existing telehealth policies, yet no two states are exactly alike in their approach to defining and regulating telehealth.
On this episode, Epstein Becker Green attorneys Amy Lerman, Audrey Davis, and Avery Schumacher discuss emerging trends in state laws and regulations post-PHE as well as federal regulatory and enforcement developments that set the stage for states.
From wholesale revisions of the merger guidelines to significant amendments to the Hart-Scott-Rodino premerger notification forms, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) have proposed significant changes that, if adopted, will have profound effects on merger review and enforcement for the foreseeable future.
What might these changes mean for hospitals, health systems, and other stakeholders in the health care industry?
On this episode, Epstein Becker Green attorneys Trish Wagner, John Steren, Jeremy Morris, and Will Walters dive into the latest developments in health care antitrust law and analyze the FTC’s and DOJ’s views on mergers in health care markets.
In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).
How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest Sylvia Yu, Vice President and Senior Counsel of Federal Programs at PhRMA.
Sylvia and Epstein Becker Green attorneys Connie Wilkinson and Alexis Boaz discuss the recent updates on the quickly moving implementation of the drug pricing provisions under the IRA and the industry’s response.
The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization one year ago overturned 50 years of legal precedent protecting the constitutional right to abortion in the United States, leaving the question of whether and how to regulate abortion to individual states.
What has happened since and what is to come?
On this episode, Epstein Becker Green attorneys Amy Dow, Erin Sutton, and Jessika Tuazon examine how the Dobbs decision has impacted the legal landscape for patient access to abortion, discuss the challenges facing the health care industry, and explore how industries can manage their compliance efforts moving forward as the legal landscape continues to evolve.
Like the diversity of the industry itself, merger and acquisition (M&A) transactions in health care take many forms, varying in size and complexity.
While buyers tend to focus on several things as part of those transactions, securing key employees post-closing is an important but sometimes overlooked issue.
What are some important factors to consider when entering a transaction in a human capital-intensive industry like health care? On this special crossover episode of Diagnosing Health Care and Spilling Secrets, Epstein Becker Green attorneys Kate Rigby, Erik Weibust, Dan Fahey, and Tim Murphy talk about the different types of health care M&A transactions and the importance of securing key employees post-closing.
On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of mifepristone—and the U.S. Food and Drug Administration’s authority to approve new drugs—will continue to be debated on appeal.
On this episode, Epstein Becker Green attorneys Erin Sutton, Delia Deschaine, and Avery Schumacher analyze the ongoing legal battle over mifepristone and discuss implications for industry stakeholders, including drug manufacturers, distributors, providers, and patients.
The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.
What key compliance issues must industry stakeholders consider as these provisions are put into effect?
On this episode, Epstein Becker Green attorneys Leslie Norwalk, Connie Wilkinson, and Alexis Boaz discuss key considerations for the health care and life sciences industry as the Centers for Medicare & Medicaid Services works its way through the initial stages of implementation of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program under the IRA.
The Federal Reserve’s steady increase of interest rates and the slowed economic growth have increased fiscal pressure on health care providers, leaving many to look for ways to bridge budget shortfalls through injections of capital, asset sales, or other strategic transactions.
What options are there for providers moving forward?
On this episode, Epstein Becker Green attorneys John Tishler, Ryan Cochran, and Tim Murphy discuss how the changing economic climate has impacted the 2023 deal cycle and forecast the trends we expect to see this year.
The Medicare Shared Services Program (MSSP) offers significant benefits for patients, providers, AND payers. But there are substantial hurdles to implementation.
The Biden administration has announced its ambitious goal of “having all people with Traditional Medicare in an accountable care relationship with a health care provider by 2030.” Achieving this goal will require short- and long-term changes for a broad spectrum of healthcare professionals. To help you understand what’s happening - and what’s GOING to happen - HealthExecWire has teamed up with two top Washington attorneys on a new interactive webinar: MSSP, ACOs and You.
Philo and Kevin will be answering these questions and more:
- What are the latest changes to the MSSP?
- How does CMS get us from the current system to an all-ACO model?
- What does this mean for providers in current Medicare value-based payment models?
- In what ways will the present ACO REACH program change?
- Will the patient experience be impacted?
- Integration of specialty care into ACOs – how will this be accomplished?
Changes are on the horizon for provisions of the Program of All-Inclusive Care for the Elderly (PACE) that haven’t been updated in over a decade.
What exactly is PACE and how will new proposed rule modifications affect PACE plans moving forward?
On this episode, hear from special guest Wendy Edwards, Director of Internal Operations at BluePeak Advisors.
Wendy and Epstein Becker Green attorneys Lynn Shapiro Snyder, Kevin Malone, and Helaine Fingold explore the ins and outs of PACE, the changes in recent years that have made PACE available to for-profit companies, and the specifics of the provisions in the pending federal proposed rule.
With the recent midterm elections changing the composition of Congress, and the Biden administration’s first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key health care developments to watch out for in 2023?
On this episode, Epstein Becker Green attorneys Ted Kennedy, Jr.; Alexis Boaz; and Philo Hall discuss the current landscape of health care policy from both the legislative and regulatory perspectives and analyze which key health care issues may arise.
Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, some states have banned abortion in all or most circumstances and many more have enacted new restrictions or enforced old ones.
What must providers and health care leaders understand about this patchwork of laws, the ongoing enforcement activity, and protecting their organization’s interests?
On this episode, Epstein Becker Green attorneys Jenny Nelson Carney, Stuart Gerson, Erin Sutton, and Dan Fahey discuss the post-Dobbs legislative landscape as well as the ongoing enforcement actions in the states that prohibit all or most abortions and abortion-related services.
We’re looking at how the past 50 years of health law will impact health care in the next 50 years. On this episode, Epstein Becker Green attorneys Mark Lutes; Lynn Shapiro Snyder; Ted Kennedy, Jr.; and Nivedita Patel talk about the past, present, and future solutions to a fundamental question: How can the United States manage health care spending while continuing to provide access to high-quality health care products and services?
Since the beginning of 2022, prices for construction services and materials have seen significant increases. How have these increases impacted the advancement of both new and ongoing health care construction projects?
On this episode of our Owner’s Outlook series, hear from special guest Clint Russell, Vice President of Capital Deployment – Construction and Equipment at HCA Healthcare.
Clint and Epstein Becker Green construction attorney Chris Dunn talk about where costs are increasing, what might lie ahead, and how owners and providers can navigate a way forward for projects in the health care market.
In the past decade, certified electronic health records (EHRs) have been instrumental in transforming medical records from paper to digital formats.
What obstacles are currently preventing providers from sharing patient data with each other or patients from sharing health information from their personal devices with their providers? In this episode of our special series on interoperability, hear from Tomaž Gornik, founder and CEO of Better.
Tomaž and Epstein Becker Green attorneys Karen Mandelbaum and Nivedita Patel talk about openEHR and emerging data solutions and pathways for U.S. businesses.
Staffing challenges and cost inflation are seriously impacting health care construction as well as other sectors of the U.S. construction economy.
On this episode of our Owner’s Outlook series, hear from special guest Mike Noli, founder of the NoliWhite Group, and one of the health care industry’s leading providers of construction management and equipment planning services.
Mike and Epstein Becker Green construction attorney Chris Dunn break down which projects are at greatest risk and how to successfully manage these projects amid the current market pressures.
Listen to the first episode in the series: “Owner’s Outlook: Vaccine Mandate for Construction Workers at Health Care Facilities.”
What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to succeed, the regulatory challenges they have faced, and how current events are shaping the future of the industry.
Joining our special guests are Epstein Becker Green attorneys Robert Wanerman and Rachel Weisblatt, who address how biotech leaders, entrepreneurs, and investors can best navigate the complex legal issues that arise along the path from product development to thriving business.
The interoperability and information-blocking rules have imposed new regulations and requirements on health information exchanges (HIEs). How are HIEs responding to these new regulations in a space they have been in for decades? In this episode of our special series on interoperability, hear from Dan Paoletti, CEO of the Ohio Health Information Partnership.
Dan and Epstein Becker Green attorneys Allen Killworth and Nivedita Patel discuss the role of HIEs in the interoperability landscape and the impact of the information-blocking rules on HIEs.
One of the long-term goals of the interoperability and information-blocking rules is to give health care providers a much more comprehensive view of a patient’s entire continuum of care.
In this episode, Andrea Darby, the Vice President of IT Integration – Applications for OhioHealth, offers a provider’s perspective on their role in a health care ecosystem that is striving to achieve much-needed interoperability.
Epstein Becker Green attorneys Jenny Nelson Carney and Nivedita Patel also discuss how providers are tackling the compliance challenges associated with the interoperability and information-blocking rules.
The 21st Century Cures Act kicked off a major paradigm shift in the approach to accessing and sharing patient data. How will the health care industry adapt to this new way of thinking? In the first episode of our special series on interoperability, Steve Yaskin, the CEO and Co-Founder of Health Gorilla, and Epstein Becker Green’s Nivedita Patel discuss why interoperability is so important for patients and all stakeholders within the health care ecosystem.
Steve and Nivedita also provide a recap of how various regulations and government actions have led to the market demand for innovative solutions to meet the interoperability requirements.
What are the key healthcare business issues and trends for 2022, and how can you best position for them? Attend the Twentieth Annual Future Care Web Summit, which addresses these topics and more.
Noted national healthcare expert speaker Mark Lutes, the Chair of Epstein Becker Green, will address these three pivotal regulatory and policy questions: Where are primary care incentivization and delivery models going? Will digital health innovations find payment success? What will CMS and payor response be to genetic and other breakthrough therapies ?
National thought leader Paul Keckley takes us on a journey through key selected trends impacting such topics as healthcare private equity, inflation and pricing, the value-based agenda and more Paul Keckley is an intense observer of that change, diving deep into the trends, tipping points, intended and unintended consequences to bring clients and opinion leaders the unvarnished truth.
Chris Sukenik, Principal, BDC Advisors will highlight key market dynamics that will reshape the healthcare landscape in 2022 and beyond for payers and providers. Chris is a proven consulting leader and trusted advisor to senior healthcare executives with a focus on provider and payer healthcare markets.
The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and self-pay patients scheduling appointments for services or upon request.
On this episode of Diagnosing Health Care, attorneys Helaine Fingold, Robert Hearn, and Alexis Boaz discuss the good faith estimate, what it entails, who needs to provide it, and updates regarding enforcement.
Additionally, you’ll hear about what “substantially in excess” means and how the provider-patient dispute process works.
The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second interim final rule. In addition to describing how the NSA interacts with the plan external review procedures, the second interim final rule describes the independent dispute resolution (IDR) process and how the IDR’s determination is made.
On this episode of Diagnosing Health Care, attorneys Helaine Fingold, Lesley Yeung, and Alexis Boaz dive into how these changes impact entities subject to the NSA’s balance billing prohibitions.
We’re beginning to see how mergers and acquisitions in the hospital industry are being impacted by President Biden’s executive order promoting competition in the American economy. The Federal Trade Commission recently announced policy changes, and the Department of Justice has been asked to consider policy changes, that boards of directors and C-suite officers must take into account when weighing transactions.
On this episode of Diagnosing Health Care, special guest Dr. Subramaniam (Subbu) Ramanarayanan, Managing Director at NERA Economic Consulting, and Epstein Becker Green attorneys John Steren, Patricia Wagner, and Dan Fahey discuss what leaders need to know about the government’s heightened antitrust scrutiny in the hospital market.
As 2021 nears a close, acute care hospitals and health systems are facing a host of financial, regulatory, and legislative challenges. In this special episode of Diagnosing Health Care, Rick Pollack, President and CEO of the American Hospital Association, and Epstein Becker Green’s Ted Kennedy, Jr., discuss the ways in which the industry is working with the Biden administration and Congress to shape policy around critical issues, such as surprise billing, coverage expansion, value-based care, and telehealth.
Rick and Ted look at how these policy issues relate to broader mark.
Epstein Becker Green’s Helaine Fingold and Bob Hearn help stakeholders sort through the No Surprises Act with guidance on compliance and discussion of the issues, implications, and resulting opportunities, in the HealthcareWebSummit event: Making Sense of the No Surprises Act and Interim Final Rules.
In this session, Epstein Becker Green’s Helaine Fingold and Bob Hearn help to make sense of the Act, examine the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces, and discuss specific and “operationalized” guidance to providers, facilities, and health plans on complying with the Act, including its challenging interaction with state balance billing laws. Their insights are based on experience in this arena and are rededicated to deciphering the complex interaction between state law and the new federal law.
The COVID-19 pandemic spurred record growth in the dietary supplement industry in 2020. With this heightened consumer interest and many new entrants to the market, important questions have emerged about the adequacy of the current regulatory framework for dietary supplements. Are current controls adequately protecting consumers from supplement products that are unsafe? What is the right level of regulation and enforcement for these products?
In this episode of Diagnosing Health Care, Epstein Becker Green attorneys Delia Deschaine, Jack Wenik, and Bonnie Odom discuss recent trends that are shaping business decisions and compliance in the dietary supplement industry.
On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final rule in order to implement this act, which will go into effect on January 1, 2022. While the goal is to protect patients from surprise billing, the law will also impose significant compliance burdens on plans, providers, and facilities.
Epstein Becker Green attorneys Helaine Fingold, Bob Hearn, and Alexis Boaz discuss the key areas health care companies need to keep in mind as they prepare to comply with the No Surprises Act.
Although the COVID-19 pandemic exposed cybersecurity vulnerabilities across sectors, it has particularly challenged the resilience of information systems for health care and life sciences companies. Because ransomware attacks have the potential to cripple access to important data, expose patient health records, and shut down machinery and life-saving equipment, it’s no surprise that health care executives continue to lose sleep thinking about potential ransomware or other similar malicious attacks.
Epstein Becker Green attorneys Alaap B. Shah and Jessika Tuazon are joined by Andrew Morrison, principal at Deloitte & Touche LLP and Cyber Risk Services Strategy, Defense & Response solution leader for Deloitte Risk & Financial Advisory. Together, they discuss the impact of ransomware attacks on the health care and life sciences industries, and considerations for companies to strengthen their cybersecurity posture.
The Departments of Labor, Health and Human Services, and the Treasury jointly released a set of frequently asked questions (“FAQs”) related to recent changes made to the Mental Health Parity and Addiction Equity Act effective as of February 10, 2021, and enacted by the Consolidated Appropriations Act at the end of 2020. Accordingly, health plans and insurers must ensure that they understand, and are prepared to provide regulators with documentation of their compliance with, parity requirements on at least a small group of specific non-quantitative treatment limits.
Special guest Henry Harbin, MD, Health Care Consultant and former CEO of Magellan Health Services, and Epstein Becker Green attorneys Kevin Malone, David Shillcutt, and Tim Murphy discuss how stakeholders can gain key insights into the federal enforcement approach on parity from the new set of FAQs, including where the government might get the most return on investment for enforcement.
Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has broadened its net to target businesses making claims that their products can treat specific conditions, a growing number of states have passed bills that, among other things, legalize adult-use cannabis. Epstein Becker Green attorneys Delia Deschaine, Nathaniel Glasser, and Megan Robertson discuss how developments in 2021 impact the cannabis industry and why all players, including employers, health care providers and retailers, and businesses operating in the cannabis space, need to pay close attention to the different nuances between federal and state laws.
The vaccine passport has been a major topic of discussion as businesses and governments consider how to balance privacy and safety through the rollout of the COVID-19 vaccine. Epstein Becker Green attorneys Patricia Wagner, Alaap Shah, and Jessika Tuazon discuss the privacy and security concerns companies must weigh as they consider developing or implementing vaccine passports, such as the collection and use of an individual's personal health information. As state governments and the private sector take the lead on developing vaccine passport initiatives, it is imperative that businesses implement better privacy and security practices to mitigate or manage risk.
Since the start of the COVID-19 pandemic, many jurisdictions have enacted protections from COVID-19-related liability claims through legislation and executive orders. These liability shields, however, may give health care businesses a false sense of security and offer little protection when it comes to employment claims. Epstein Becker Green attorneys Denise Merna Dadika, Gregory Keating, and Elena Quattrone discuss the unintended liability consequences health care employers must consider as they transition more employees back to in-person work and the ways to mitigate increasing whistleblower and retaliation risks.
The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces.
The Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services have at last published their long-awaited companion final rules advancing value-based care. The rules present significant changes to the regulatory framework of the federal physician self-referral law (commonly referred to as the “Stark Law”) and to the federal health care program’s Anti-Kickback Statute, or “AKS.” Epstein Becker Green attorneys Anjali Downs, Jennifer Michael, Lesley Yeung, and Paulina Grabczak give an overview of the final rules and point out key issues health care companies should carefully consider as they take advantage of these value-based care safe harbors and exceptions.
The $1.9 trillion coronavirus relief package, the American Rescue Plan, includes money for rural hospitals, billions of dollars for COVID-19 testing and contact tracing, and extra subsidies to help people buy health coverage through an Affordable Care Act ("ACA") plan. Epstein Becker Green attorneys Mark Lutes, Philo Hall, and Tim Murphy discuss the health-specific portions of the legislation, including increased funding for federal oversight activities, changes to public insurance programs, and what these changes might mean for stakeholders.
The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces.
The Biden administration has invoked the Defense Production Act ("DPA") to speed up the production of vaccines and increase the domestic production of COVID-19 tests, personal protective equipment (or “PPE”), and other essential supplies. Epstein Becker Green attorneys Neil Di Spirito, Constance Wilkinson, and Bonnie Odom discuss the administration's reliance on the DPA as it continues to operationalize its pandemic response, and the challenges these actions are likely to present for medical product suppliers.
This Diagnosing Health Care episode focuses on the legal history of the current immunization delivery system for vaccines in the United States. The system is complex and requires the coordination of many players, from manufacturers and distributors in the supply chain to health care facilities that provide administration, down to public health centers that track the doses. Special guest Richard Hughes IV, Vice President of Public Policy at Moderna, and Epstein Becker Green attorneys Victoria Vaskov Sheridan and Jessika Tuazon discuss the factors impacting an individual’s decision to get vaccinated and the ways that policies and practices at the federal, state, local, and tribal levels can support equity, transparency, accountability, availability, and access to COVID-19 vaccines.
The 117th Congressional health care agenda, including COVID-19 related action, will require 60 votes in the Senate or passage through budget reconciliation. Attorneys Mark Lutes, Philo Hall, and Timothy Murphy discuss the prospects for additional coronavirus relief and what that would mean for stakeholders, as well as the possibility for coverage expansion through changes to the Affordable Care Act or Medicaid.
This Diagnosing Health Care episode dives into the growth of physician practices accepting risk-based payments from health plans and examines why these practices are attractive to investors. Special guest Jason Madden, Managing Director at Accordion, and Epstein Becker Green attorneys Joshua Freemire, Jason Christ, and Tim Murphy, discuss the health regulatory considerations investors must assess when evaluating investment opportunities with physician practices accepting risk-based payments.
Diagnosing Health Care Podcast - Episode 15: The Biden Administration's first 100 days in office will bring forth executive orders, regulations, and new legislation with noteworthy health care policy implications that health care organizations must watch. Member of the Firm Ted Kennedy, Senior Counsel Philo Hall, and attorney Paulina Grabczak discuss the Biden Administration's priorities, including their COVID-19 response plan, and examine which "midnight rules" put in place by the Trump Administration could be intercepted or retained.
The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces.
Diagnosing Health Care Podcast - Episode 14:
This Diagnosing Health Care episode examines the fraud and abuse enforcement landscape in the telehealth space and considers ways telehealth providers can mitigate their enforcement risks as they move into the new year. Hear how the uptick in enforcement warrants close consideration by telehealth providers, especially those that are new to the space and have not yet built their compliance infrastructures.
The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces.
Epstein Becker Green Diagnosing Health Care Podcast - Episode 13: Contact tracing will continue to play a big role in fighting the COVID-19 pandemic, especially in understanding the impact of vaccines. Attorneys Michelle Capezza, Karen Mandelbaum, and Jessika Tuazon look at the privacy issues health care companies and employers across industries should consider when implementing contact tracing technologies.
Oral arguments in California v. Texas offer a glimpse at how the Supreme Court might rule in deciding the fate of the Affordable Care Act (“ACA”). In this Epstein Becker Green Diagnosing Health Care Podcast - Episode 12, Attorneys Stuart Gerson and Tim Murphy also look at what Justice Amy Coney Barrett’s recent appointment means for the ACA and other health law decisions in the upcoming term.
The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces.
On this Diagnosing Health Care episode, “On the Ballot 2020: Health Care Policy Outlook,” dive into the prospects of coverage expansion following the 2020 elections and also examine three major health care policy reform issues that have bipartisan support and could see traction regardless of who wins on November 3. The episode features Members of the Firm Ted Kennedy, Jr., and Lynn Shapiro Snyder as well as Senior Counsel Philo Hall, and is hosted by attorney Tim Murphy.
On this Diagnosing Health Care episode, “Key Considerations for Reshoring U.S. Drug Manufacturing,” dive into the key business, policy, and legal considerations for reshoring active pharmaceutical ingredient (or “API”) and finished drug product manufacturing to the United States. The episode features Members of the Firm Delia Deschaine and Neil Di Spirito and is hosted by attorney Bonnie Scott.
On this Diagnosing Health Care episode, “Product Launching in the Era of COVID-19,” look at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing COVID-19 pandemic.
The episode offers holistic perspectives from across Epstein Becker Green’s offices and features Members of the Firm Julie Lampley and Lauren Sullivan, Strategic Advisor for EBG Advisors Machelle Dunavant Shields, and host Jessika Tuazon.
On this Diagnosing Health Care episode, “Holding Pattern: Cannabis Industry Waits for FDA Regulatory Rulemaking,” get a status update on the Food and Drug Administration’s plan for regulating cannabis and cannabis-derived products and what actions the agency has taken recently to make progress. The episode features Delia Deschaine and is hosted by Megan Robertson, both attorneys in Epstein Becker Green’s Washington, DC, office.
Health Plans continue to be subject to advanced persistent threats from organized hacking groups, and payers need to adopt and update in-depth strategies and comprehensive incident response plans to thwart or mitigate these attacks. These protective countermeasures should be part of the organization’s formalized information security program designed to anticipate, prevent, detect and respond to future similar attacks targeting any organization.
Attendees to this presentation will learn about current cybersecurity trends impacting health plans, best practices to consider for health plan risk management response preparedness, and the importance of increasing Board and C-Suite visibility and awareness of these issues and responsibilities.
A physician group should conduct extensive “reverse due diligence” before entering into a private equity (PE) partnership.
Important things to consider include:
- the PE firm’s financial ability to close the transaction with the physician group;
- the physicians’ comfort level with the PE firm’s experience, integrity, culture, vision, and fit as a partner for the group;
- and the PE partner’s specific experience and track record investing in physician services – in terms of both working well with physicians and achieving substantial value enhancement.
You should speak directly with multiple physicians who have partnered with the investor in the past to assess all of these factors.
Physician groups can keep their practice competitive–and on the “cutting edge”—by partnering with a private equity (PE) platform. The health care marketplace is evolving, and it takes substantial investment in infrastructure, such as IT, to stay ahead and continue be successful and profitable.
A PE investor provides capital to acquire important strategic initiatives, like cutting-edge medical equipment and technologies, advanced electronic medical record capabilities, data analytics, new offices, and new and/or expanded ancillary services. The PE investor’s existing corporate infrastructure may immediately provide some of these benefits.
A private equity (PE) transaction can give a physicians group more room to focus on clinical care as they relinquish much of the administrative and practice management duties. A PE partnership allows physicians access to the PE platform’s seasoned and sophisticated management team and capital.
The team can provide managed-care contracting expertise, advanced electronic medical record capabilities, excellent billing and collection teams, financial management, HR executives, compliance staff, and more. Not only will significant cost savings be enjoyed, but operations will be improved and expanded.
On the flipside, PE investors don’t want to tell physicians how to practice medicine. In fact, in many states, interference of that kind is illegal. PE investors will keep their focus on improving the business aspects of the practice.
A private equity (PE) transaction can help physicians “hedge” the uncertain future of private medical practices in an ever-changing and regulated industry. Uncertainty in the industry includes changing reimbursement models, the prospect of “Medicare for All,” increasing regulation/compliance, and the need for advanced IT and other infrastructure investments.
With a PE investment, some of this risk is mitigated because PE brings in an experienced and sophisticated management and “C-suite” team and the ability to be part of a large platform with hundreds of other physicians in the same specialty, experience in value-based care, and significant economies of scale for expensive EMR and other infrastructure. But not all uncertainty can be eliminated. For example, when the PE partner eventually “exits” its investment who will the new buyer be? How will it impact the practice? However, stability can be its own hedge. Any new buyer will likely be wary of changing a well-run and managed enterprise without the continued support of its physicians.
Provides a thorough examination of the legal, regulatory and corporate structural implications, issues, and challenges for healthcare organizations that are exploring and evaluating offering telehealth services.
In this current environment, healthcare organizations not already providing telehealth services are faced with critical decisions regarding developing such capabilities for the populations they serve. However, there are myriad legal and regulatory complexities in doing so, particularly at the state level.
Topics include:
- Key legal and regulatory telehealth issues
- Corporate formation and corporate practice of medicine considerations
- Implications of applicable telehealth modalities to deploy
- Potential regulatory developments in the current environment
Partnering with a private equity (PE) investor can help physicians monetize the value of their practice. Why treat your practice differently than other assets in your retirement portfolio?
A PE transaction will provide an up-front cash payment and/or rollover equity in the PE platform. Up-front cash, usually 70-80% of the “real value” of your practice, is calculated on a multiple of the practice’s free cash flow or earnings before interest, taxes, depreciation, and amortization (or “EBITDA”). The remaining balance of purchase price (20%-30%) is usually paid in the form of rollover equity.
Rollover equity converts to additional cash payments upon a secondary sale to another investor down the road. Further, many PE transactions are structured so that if a physician retires, becomes disabled, or dies, his/her rollover equity is purchased at its then fair market value.
Private equity (PE) investment in physician groups has steadily grown over the last several years, with 219 physician group deals being announced or closed last year. This trend leaves some groups wondering, is PE for us? There are five critical factors that physician groups should consider:
- “Monetizing” the value of your ownership in your practice
- Hedging future risk in light of increasing uncertainty in the health care industry
- Increasing efficiencies in practice management to allow the physicians to focus on clinical care
- Having access to capital to invest in better infrastructure and growth
- Assessing the experience, financial track record, and culture of the PE partner
Stephanie W. Kanwit examines the provisions, complexities, challenges, implications and outcomes of the CMS Hospital Price Transparency Final Rule.
Topics Include:
- The provisions set forth in the CMS Hospital Transparency Final Rule
- The complexities surrounding the scope of the Final Rule
- The challenge of making a hospital’s negotiated rates “consumer friendly”
- Illustrative examples in the application of risk adjustment
- Practical implications and outcomes for hospitals, consumers, and regulators
$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total recoveries. That’s 87% of all FCA judgments and settlements. $678 million of the health care recoveries came from DOJ initiated enforcement actions. $1.9 billion of the health care recoveries were generated by cases brought by whistleblowers who filed qui tam actions. Qui tam actions remain a principal driver of FCA enforcement in the health care space.
Enforcement targeted pharmaceutical and medical device companies, managed care entities, hospitals, pharmacies, hospice organizations, laboratories, and physicians. The recoveries also reflect DOJ’s intent to hold individuals, not only corporations, accountable in FCA cases.
What does the coming year and new decade hold for healthcare? What are the key healthcare business issues and trends for 2020 that will impact you and your organization, and how can you best position for them? Attend this web summit event and get 2020 vision for your healthcare organization. The Eighteenth Annual Future Care Web Summit addresses key future trends and also focuses on several important cutting-edge healthcare business topics, including:
- Forces of Change: The Future of Healthcare into 2040
- The Legal, Regulatory and Policy Landscape for 2020
- Social Determinants of Health Program & Policy Developments for 2020
- On-Demand Sessions: Transformation Through Digitally Enabled Care, MSSP Pathways to Success
Explore key healthcare innovations and trends that will be highly impactful on healthcare stakeholder this year; gain a sense of the critical legal, regulatory and policy issues impacting healthcare in 2019; and ascertain the implications of the state of value based care in 2019.
What are the key healthcare business issues for 2018 that will impact you and your organization, and how can you best position for them? The Sixteenth Annual Future Care Web Summit addresses key trends and also focuses on several important cutting-edge healthcare business topics.
Where are Quality Payment Programs established under MACRA headed in 2018? What is the role that Medicare Advantage and other Medicare and Medicaid managed care programs can play in future years of the QPP, and the criteria that such plans must meet to be considered an Advanced APM? What is the CMS perspective for Medicare Quality Payment Programs in 2018?
Sessions include: Key Healthcare Legal, Regulatory and Policy Issues for 2017; The Employer Role in Healthcare Transformation 2017; and Top Ten Trends for Healthcare Marketing 2017
Discussion of a range of issues and considerations under the final rule implementing Medicare physician payment reforms included in the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”).
A brief overview of the proposed rule, timing for the final rule, and implementation timelines will be discussed, and Implications of the MIPS scoring proposal will be addressed.
This session provides an overview of CPC+ program details and examines the new model's implications, strategies and issues for stakeholders.
Sessions include: Top Healthcare Trends and Issues for 2016; Key Healthcare Legal, Regulatory and Policy Issues for 2016; and Reference Pricing - Coming soon to a health plan near you?
This session will address the relevant details of the Medicaid Managed Care Proposed Rule, as well as highlight key implications of the major provisions for stakeholders, and what overall level of revisions might be expected with issuance of the Final Rule.
A discussion of the specifics of the provisions that participating ACOs under the Next Generation model will be subject to, as well as further-reaching implications for all ACO stakeholders with respect to the impact the new model will have on the Medicare ACO program as a whole, and the entire Accountable Care movement.
Sessions include: Top Health Industry Issues for 2015; Key Healthcare Legal, Regulatory and Policy Issues for 2015; and ICD-10 as a Strategic Enabler in 2015.
Issues and considerations that stakeholders need to address regarding ACO consolidation and antitrust issues in the marketplace.
Detailed provisions and stakeholder implications of CMS FFE guidance.
Expert discussion and analysis of the policy and regulatory implications of the 2012 elections, with time allotted for questions and answers.
A discussion of the legal, regulatory, policy, fiscal and operational implications for ACOs, their sponsors and other stakeholders regarding the Medicare Shared Savings Program Proposed Rule:
The 2010 Accountable Care Web Summit included three faculty presentations:
- Piedmont Physicians Group Accountable Care Pilot Program - James C. Sams, MD, Medical Director, Piedmont Physicians Group
- The ACO Legal and Regulatory Environment: An Update for 2011 - Doug Hastings, Chair of the Board of Directors, Epstein Becker & Green, P.C.
- ACO Payment and Contracting Issues for 2011 - Terri L. Welter, Principal, ECG Management Consultants, Inc.