Health Innovation Law
Food is Health (Food as Medicine)
Foodcare is a foundational element of improving and sustaining population health. PLA understands the complexities of navigating the coordination of health and human services at the federal and state levels. Food as Health programs highly rely on telehealth delivery, and these programs allow for creative value based program (VBP) design.
Corporate Practice of Medicine
State laws vary regarding which types of services may be performed through a general business corporation or a limited liability company. In some cases, an MSO-PC model is prudent to ensure compliance with these laws and avoid other regulatory issues, such as anti-kickback and fee splitting prohibitions.
Remote Patient Monitoring
Modern health care delivery increasingly relies on the use of devices and data platforms to collect and monitor patient data and information. It is critical to understand the requirements for offering RPM and RTM to patients and the conditions for reimbursement for these services.
Compliance Assessment and Monitoring
Federal and state governments, commercial health plans, and other third party payors require providers and technology vendors to implement a comprehensive Compliance Program and perform ongoing monitoring and at least annual updates.
Licensing and Scope of Practice
Related to the Corporate Practice of Medicine, state laws vary regarding the scope of practice allowed for different provider types. In addition, the requirements for licensure vary by both state and practice type. Given the growth of Telehealth services across state lines and the increased use of clinical staff for non face-to-face services, ensuring proper licensure for all services in all states is critical.
HIPAA, TCPA, and Privacy
There are multiple federal laws related to the privacy and security of data and how providers communicate with patients. Also, most states have related laws (sometimes, even more restrictive) that apply across the continuum of care. The increased use of Artificial Intelligence has cast a spotlight on this area.
Fraud, Waste, and Abuse Prevention
A comprehensive Compliance Program is a great start to minimizing the risks of audits and findings of FWA. The key to an effective FWA Prevention plan is a company's approach to operationalizing the Compliance Program. One critical piece of this plan is having legal counsel that understands both the legal issues and a deep understanding of the company's business and operations.
Fractional General Counsel
It is not uncommon for companies to use different legal teams and other advisors for specific areas or matters. Whether a company has dedicated in-house legal counsel or not, having an outside fractional counsel often adds significant value. Fractional GCs provide focused and targeted advice while considering the broader implications and maximizing alignment with company goals and strategy.
Health Care Advisory Services
Given the complexity and dynamic nature of health care innovation, providers and vendors often desire complementary services to the core legal offerings. We offer consulting, analytics, and business advice to help companies design their strategic and tactical approaches. Some representative examples include analyzing CMS Innovation Models, Medicaid Waivers, USDA SNAP funding, and related state and federal programs.
Payor Contracting and Credentialing
One of the most challenging areas for providers and suppliers to actually start performing services is establishing network status with health plans and other third party payors. Outside of traditional Medicare and cash pay services, payor contracting and credentialing can delay the start of services and strain financials for newer companies. Understanding the flow of events, the timelines, and how to approach discussions with payors can vastly reduce the friction and speed up the process.
Medicaid and Medicare Billing and Reimbursement
There are often different coverages, codes, and rates across health care lines of business. Some treatments covered by original Medicare, for example, are not covered by commercial plans or state Medicaid plans. The requirements also tend to change on annual basis, and new coverages are added each year. It is important to understand the billing requirements for each payor and how to maximize reimbursement for services rendered.
Audit Support and Defense
Almost all providers will encounter some form of audit from a health plan or payor. Some of these audits are pre-payment audits or proof of compliance audits even during the contracting stage (which are less intrusive if the company responds appropriately). Other audits can be accusatory in nature with allegations of wrongdoing and/or a demand for repayments. Regardless of the nature of the audit, PLA can help.
Healthcare Lawyer
About Pappas Legal & Advisory PLC
Pappas Legal & Advisory, PLC is a full-service legal and advisory firm specializing in health care innovation and the associated legal, compliance, and business matters. Our goal is to help our clients improve population health by providing them with a strong pillar of legal support and a balance of business and practical advice. We work with clients of all sizes, ranging from pre-revenue startups to Fortune 100 companies. Some of the representative client focus areas include:
- Food is Health (Food as Medicine)
- Care Coordination and Access to Care
- Remote Patient Monitoring (RPM and RTM)
- Functional Medicine
- Lifestyle Medicine
- Behavioral Health
- Whole Person Care
- Telehealth and Technology Platform Services (including MSO-PC models)
- Value-based Payment Strategy and Design
We work with clients providing care locally, regionally, and nationwide. We regularly negotiate health plan and third party payor contracts (Medicare, Medicaid, Commercial, and Self-funded plans), and we help our clients tailor compliance programs to meet legal, policy, and contractual requirements. We also collaborate with venture capital firms and other investors to assess potential investments, conduct due diligence, and complement corporate due diligence teams.
Healthcare Legal Team
Meet the team
Pappas Legal & Advisory is focused on health care innovation. After spending 20 years in legal, consulting, and advisory leadership roles in the health care innovation sector, Mike found that the most effective support stemmed from applying a combination of legal expertise, business acumen, and a collaborative approach. PLA is well-connected with leaders of trade associations, industry groups, and other experts to maximize the value that we provide to our clients.
