Expanding the Use of Telehealth Amid the Coronavirus Pandemic
The coronavirus outbreak has generated a frenzy of activity related to telehealth. Given that coronavirus symptoms can vary from very mild to severe and that the virus spreads through close contact, telehealth can be a powerful tool in combating the crisis. Healthcare providers, supported by states and payers, have scaled their telehealth capabilities at an incredibly fast pace to triage, diagnose and treat patients while protecting healthcare workers and reducing the spread of the disease. States, which have broad authority as payers, regulators and stewards of public health, are playing a key role in driving the use of telehealth as a method of treatment by implementing novel reimbursement policies that enable providers to offer virtual care services to patients. In addition, the Centers for Medicare & Medicaid Services (CMS) has implemented a wide range of new flexibilities in telehealth, rapidly expanding coverage and reimbursement. Other federal agencies, such as the Federal Communications Commission (FCC) and the Health Resources and Services Administration (HRSA) also have expanded their efforts around telehealth.
How Manatt Can Help: With extensive experience in the telehealth space, Manatt can assist states in developing and revising their telehealth policies; payers in understanding federal and state telehealth policies and designing their own coverage and reimbursement approaches; and providers in understanding the landscape of federal funding options for telehealth infrastructure, creating and quickly deploying telehealth programs, and assessing reimbursement potential across all payers.
For More Information: Contact Jared Augenstein, director, Manatt Health, at firstname.lastname@example.org or 212.790.4597.
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Addressing the Added COVID-19 Challenges That Long-Term Care Faces
The nation’s nursing homes, assisted-living facilities, inpatient rehabilitation centers and home care providers are at the forefront of the COVID-19 crisis. Caring for those at highest risk of contracting COVID-19—and experiencing severe cases and dying—long-term care (LTC) providers are faced with overwhelming challenges and difficult decisions. They must protect and care for their patients while keeping their workers safe and their businesses operating efficiently and in compliance with evolving federal and state rules.
About 2.5 million seniors and medically fragile Americans are in congregate care settings, with Medicaid paying 62% of costs. More than 10 million need assistance at home or in their communities, with Medicaid as the primary payer. Given these statistics, state Medicaid programs, working in partnership with providers and health plans, are at the forefront of efforts to mitigate the spread of the virus.
How Manatt Can Help: Manatt helps states, providers and health plans address current COVID-19 challenges, as well as plan and prepare for future emergencies. Manatt can help enhance telemedicine access to reduce risk for both LTC recipients and providers, identify funding opportunities to support provider sustainability, ease regulatory barriers that may inhibit access to public coverage of critical benefits, and assist with maintaining capacity and quality while protecting and incentivizing the LTC workforce.
For More Information: Contact Stephanie Anthony, senior advisor, Manatt Health, at email@example.com or 212.7904505.
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Navigating the COVID-19 Pandemic’s Impact on Employers
The coronavirus pandemic presents unique concerns for employers as they navigate and plan for its impact on business operations. While different industries will be affected in different ways, there are some issues that all employers share. For example, every organization faces the challenge of balancing employees’ medical privacy against the need to protect employees, customers and vendors from contracting this highly infectious disease in the workplace—all while attempting to mitigate the potential and economic impacts of widespread business disruption.
How Manatt Can Help: Manatt can draw on integrated resources from its labor and employment, healthcare regulatory, and employee benefits practices to advise employers on the state and federal laws that should shape their responses to the coronavirus pandemic. We can provide experienced guidance to address employers’ key concerns during the COVID-19 crisis, including ensuring employers’ medical inquiries of workers are consistent with the Americans with Disabilities Act; providing a safe workplace and paid or unpaid leave, as required by state or federal law; avoiding discrimination on the basis of race or national origin; planning for and managing telecommuting; and taking appropriate steps if widespread disruption requires that portions of a workforce be laid off, including continuation of employee benefit plans. Manatt also can provide guidance to ensure employers are in compliance with state and federal privacy laws.
For More Information: Contact Esra Hudson, partner, Employment and Labor, at firstname.lastname@example.org or 212.790.4568 or Esra Hudson, partner, Employment and Labor, at email@example.com or 310.312.4381.
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Understanding Data Privacy Requirements in the Age of COVID-19
Section 1135 of the Social Security Act authorizes the Department of Health & Human Services (HHS) to waive the requirements of certain healthcare laws when the agency declares a public health emergency (PHE) under Section 319 of the Public Health Service Act and the President declares an emergency or disaster under the Stafford Act. In response to the coronavirus outbreak, HHS declared a nationwide PHE retroactive to January 27, 2020. President Trump declared an emergency under the Stafford Act on March 13, 2020.
In the privacy sphere, Section 1135 waivers may cover the imposition of penalties under the following Health Information Portability and Accountability Act (HIPAA) requirements: (i) the need to obtain a patient’s consent to speak with family members about the patient’s medical care; (ii) the duty to honor a patient’s request to be excluded from a facility directory; (iii) the distribution of privacy notices; and (iv) the obligation to process patient requests for restrictions on the use of their health information and their receipt of confidential communications. Section 1135 waivers are not issued automatically, however, when HHS and the President declare an emergency. Healthcare providers must request waivers from HHS (typically through the regional office of the Centers for Medicare & Medicaid Services (CMS) or the state health department) based on their particular circumstances and needs.
How Manatt Can Help: Manatt can assist providers in preparing and submitting Section 1135 waiver requests. We also can help clients understand and navigate the complex slate of state and federal laws governing privacy and data sharing to ensure they remain compliant while effectively treating patients and coping with the crisis.
For More Information: Contact Robert Belfort, partner, Manatt Health, at firstname.lastname@example.org or 212.830.7270.
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Responding to the Crisis With New Flexibilities in Medicaid
During the COVID-19 crisis, states have the opportunity to request added flexibilities that can broaden coverage and reduce enrollment documentation. For example, states can request new flexibilities to support eligibility and enrollment or a special enrollment period for exchange plans.
The COVID-19 pandemic also brings states a wide range of new challenges. Even among covered individuals, increases in utilization may raise costs. For non-covered individuals, utilization increases could strain safety net providers, affecting their ability to provide care to Medicaid enrollees for both COVID-19 and unrelated conditions. Further, as fiscal pressures rise, states are rapidly trying to stitch together federal funding streams that will sustain their Medicaid provider workforces and provide adequate COVID-19 testing and treatment to their residents.
How Manatt Can Help: As a trusted advisor to state policymakers, Medicaid agencies, providers and plans on Medicaid regulatory, policy and operational matters, Manatt brings the deep knowledge to support all stakeholders in the Medicaid program as they respond to the impacts of COVID-19. Serving as a technical advisor to CMS Medicaid and CHIP Coverage Learning Collaboratives, Manatt supported the development of disaster preparedness toolkits and inventory checklists created to guide effective responses to hurricanes, floods and wildfires. Manatt is now developing an updated set of toolkits and advising state Medicaid agencies on how to adapt these proven strategies to the COVID-19 pandemic to ensure timely access to care, address a compromised provider workforce, leverage telehealth to treat Medicaid and CHIP enrollees remotely, and leverage federal funding to address state fiscal constraints. Central to our technical assistance support to states are our understanding of and sensitivity to state needs and pressures, and our ability to think strategically and creatively to provide support during crises. We also guide health plans on strategies to streamline operations in the event of workforce diminishment, and to transition core Medicaid eligibility and enrollment functions to remote, technology-supported solutions.
For More Information: Contact Kinda Serafi, partner, Manatt Health, at email@example.com or 212.790.4625.
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Facing New Pressures From COVID-19 in Commercial Health Insurance
Health plans are facing new and growing pressures from the coronavirus pandemic. Limitations on cost-sharing and utilization review, demands to pay claims during extended premium grace periods, and expanded use of telehealth are just a few of the emerging issues challenging plans. In areas where COVID-19 care has overwhelmed existing provider networks, health plans are covering out-of-network care, and consumers may face surprise medical bills. Deferred care is reducing current claims payments for some insurers, leading to provider demands for insurers to make interim payments.
Insurers and regulators will be challenged on 2021 rate review given the many unknowns, including COVID-19-related costs, pent-up demand and coverage transitions in the economic downturn. Thoughtful use of risk adjustment, reinsurance and risk corridors may help stabilize health insurance markets. States are limited by federal ERISA pre-emption, which leaves regulation of self-insured health plans to the federal Department of Labor.
How Manatt Can Help: With a team of former state and federal regulators and insurance experts, Manatt has the firsthand knowledge to support all stakeholders in effectively addressing the impact of COVID-19 on plans, consumers and providers. Manatt has deep experience in coverage issues, including advising states and providers on creating and implementing best practices for ensuring adequate coverage during crises, such as the opioid epidemic. We are now helping plans, states and providers tailor those strategies to respond to the rapid regulatory and operational changes triggered by COVID-19. Manatt can provide support and guidance across a range of critical areas, including cost-sharing waivers for testing and screening, telehealth coverage, prior authorization and other utilization reviews, provider network adequacy and out-of-network access, off-formulary prescription coverage and relaxed limits on drug refills, consumer communications, declarations of emergency, funding, vaccination coverage, travel insurance, and more.
For More Information: Contact Joel Ario, managing director, Manatt Health, at firstname.lastname@example.org or 518.431.6719 or Troy Oechsner, partner, Manatt Health, at email@example.com or 518.431.6714.
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Complying With New Obligations in the Medicare Advantage, Part D and Medicaid Managed Care Sectors
Managed care plans operating under Medicare Advantage, Part D and Medicaid must navigate many of the same new obligations that apply to commercial insurers in response to the COVID-19 pandemic. These health plans must serve their members while complying with requirements to cover new services—such as COVID-19-related services and antibody testing, often at no cost sharing—that did not exist earlier this year. Compounding this challenge are unique requirements that apply to government health insurance programs and the fact that the populations served by these programs are often particularly vulnerable to COVID-19. Medicare Advantage, Part D and Medicaid managed care plans must address new issues, such as changes in risk adjustment rules, quality reporting requirements and obligations to provide funding to hard-hit providers.
How Manatt Can Help:With extensive experience in Medicare Advantage, Part D and Medicaid managed care requirements, Manatt can assist plans in tracking the latest rules applicable to their businesses and provide guidance on how those rules impact each plan’s specific product offerings. Manatt also can alert plans to new plan flexibilities—such as those around food deliveries and telehealth—that can be vital to members in the time of a pandemic. With a team that includes former CMS and Medicaid officials, Manatt brings an agency perspective that complements its legal and strategic advice.
For More Information: Contact Michael Kolber, partner, Manatt Health, at firstname.lastname@example.org or 212.790.4568; Alex Dworkowitz, partner, Manatt Health, at email@example.com or 212.790.4605; or Adam Finkelstein, counsel, Manatt Health, at firstname.lastname@example.org or 202.585.6557.
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Helping Providers Navigate the Complex Business, Strategy, Legal and Regulatory Implications of COVID-19 Today and Far Into the Future
The COVID-19 pandemic has put a spotlight on both the strengths and vulnerabilities of our health system. The pandemic has introduced tremendous financial, workforce, supply chain and compliance pressures across all providers. The delivery system must navigate the enormous challenges inherent in leading the frontline clinical and public health response while at the same time advancing efforts to rebuild public confidence, resume broader healthcare operations and support regional efforts to restart the economy—all while grappling with unprecedented revenue and cost pressures.
Many organizations across all provider types are focused on short-term liquidity when they evaluate potential restructuring options. As they look to what comes next, providers must also safely resume nonemergency procedures, optimize federal and state funding opportunities, design new care models that leverage digital health capabilities, build on the successes of telehealth efforts and the provision of care in alternate settings, rapidly identify and reach vulnerable and high-need populations, rebuild academic and research programs, and develop strategies to proactively manage legal and compliance risks in an increasingly complex regulatory landscape.
How Manatt Can Help: Manatt Health integrates legal, policy/regulatory and consulting expertise to better serve the complex needs of the healthcare delivery system. We actively track and provide rapid response insights on the implications of evolving federal and state guidance and funding developments, including key compliance considerations. In addition, we help provider organizations assess and respond to legal risks. We also support providers in evaluating their near-term and longer-term strategic responses.
Manatt Health brings the perspective and strategic guidance of regulatory leaders, as well as seasoned administrative and clinical leaders who have been in the trenches running health systems, academic medical centers, and home health and other provider organizations. The Manatt team can help providers clarify their key questions and proactively address the mounting strategic, financial and organizational challenges that COVID-19 presents.
For More Information: Contact Randi Seigel, partner, Manatt Health, at email@example.com or 212.790.4567, or Brenda Pawlak, managing director, Manatt Health, at firstname.lastname@example.org or 202.585.6523.
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Dealing with the Inevitable: In the Midst of COVID-19, the Only Certainty Is That There Will Be Litigation
In this uncertain time—with the entire healthcare system in the midst of a novel pandemic, legal and regulatory guidance changing daily, and all stakeholders racing to adapt—litigation is inevitable. This will be true for every industry, but it will be particularly true for healthcare. A barrage of ever-changing and sometimes-conflicting guidance will raise issues of first impression on topics like jurisdiction, standing, and preemption. And the normal challenges of healthcare litigation will be compounded by nationwide court closures and reductions in services. Litigators will need to stay on top of all of these issues and move as quickly as the changing landscape.
How Manatt Can Help: Manatt’s nationally recognized Healthcare Litigation Group has a deep bench of litigators who come pre-armed with substantive and procedural expertise. For years they have been on the front lines of healthcare litigation on behalf of both providers and payers. Thanks to their close integration into Manatt Health, they are up-to-date on the latest developments and ready to spring into action as litigation becomes necessary.
For More Information: Contact Greg Pimstone, partner, Manatt Health, at email@example.com or 310-312-4133 or Joe Laska, partner, Manatt Health, at firstname.lastname@example.org or 415-291-7446.
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Seeking FDA Authorization for Technologies Used to Respond to COVID-19
Many in the medical device, digital health and diagnostics industries already are actively involved in developing solutions to address the current unmet medical needs presented by the COVID-19 crisis. From ramping up production of personal protective equipment (PPE) to developing antibody and diagnostic testing capabilities to mass producing new ventilators, navigating the Food and Drug Administration’s (FDA) regulatory requirements efficiently plays an important role in addressing critical needs rapidly. FDA has been working very quickly to review new Emergency Use Authorization (EUA) requests and, in some cases, has removed prospective EUA requirements.
At the same time, not all technologies needed to respond to the current healthcare crisis fall within existing EUA policies. To alleviate those challenges, FDA has issued a series of guidance documents allowing companies to make certain changes or introduce new functionality to address needs such as physiological monitoring in the home setting. Understanding these policies as they rapidly evolve is crucial to companies seeking to address important unmet needs.
How Manatt Can Help: As a trusted advisor to many digital health and medtech companies, as well as diagnostic laboratories and manufacturers, Manatt is actively helping our clients navigate FDA’s quickly evolving policies. From supporting EUA requests for ventilators and diagnostic tests to assisting companies in understanding FDA’s new guidance documents, we are already at the forefront of major issues. Additionally, we are actively helping a number of companies that are seeking expedited marketing authorization outside the EUA process for new technologies. We welcome opportunities to share our experience and assist our clients in developing solutions to some of the most challenging healthcare resource problems.
For More Information: Contact Yarmela Pavlovic, partner, Manatt Health, at email@example.com or 415.291.7457.
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Helping Life Science Companies Understand Coverage and Payment for COVID-19 Treatments and Vaccines by Patient Care Setting
Life sciences companies have responded quickly to the COVID-19 pandemic by initiating clinical trials for nearly 150 treatments and 90 vaccines, developing diagnostic tests, and designing new technologies to solve the challenges emerging from the crisis. Whether it is leveraging existing in-line products, repurposing compounds, creating new antibodies to fight the disease, searching for a vaccine, developing diagnostic tests, manufacturing ventilators, producing new home monitoring solutions or developing predictive analytic software to aid in managing intensive care units (ICUs), the life sciences sector has innovated to address the public health emergency (PHE) in unprecedented ways.
As new products enter the market, understanding the coverage and payment landscape during this PHE will be key. Medicare, Medicaid and commercial payers are rapidly evolving policies to accommodate the pandemic, and it is important to understand how that landscape is shifting.
How Manatt Can Help: Manatt Health is uniquely positioned to guide life sciences companies through a changing healthcare environment, including helping them understand and navigate emerging coverage, payment, regulatory and operational complexities. Manatt has undertaken analyses for life science companies working on possible COVID-19 treatments and vaccines by helping them understand Medicare, Medicaid and commercial payer coverage and payment issues for multiple patient settings of care: hospital inpatient, hospital outpatient, physician’s office and home settings for healthcare professional (HCP) and self-administered products. For example, we are analyzing Medicare MS-DRG payments in the current COVID-19-modified environment. Additionally, we are helping clients understand the regulatory and operational complexities of shifting patients from physicians’ offices setting to home settings.
For More Information: Contact Sandy W. Robinson, managing director, Manatt Health, at firstname.lastname@example.org or 571-550-0691.
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