Healthcare Law Services
Smart – Efficient – Legal Solutions
At McDonough Law Group, we provide legal services designed specifically for healthcare providers, including doctors and medical practitioners. We understand the unique challenges faced by the healthcare industry and offer comprehensive business and regulatory support. Our experienced attorneys ensure that your practice remains compliant, protected, and optimized for growth.
Our clients span the healthcare spectrum, including:
- Healthcare Providers: Physicians, dentists, behavioral providers, group practices, and independent practitioners.
- Healthcare Facilities: Hospitals, long-term care facilities, ambulatory surgery centers, and clinics.
- Healthcare Businesses: Medical device companies, health tech start-ups, and healthcare product manufacturers.
- Healthcare Insurers and Plans: Group health plans, third-party administrators, and managed care organizations.
We help you with…
Business Support for Healthcare Practices & Start-Ups
We help doctors and medical professionals establish and structure their practices, guiding them through the essential legal aspects of starting and operating a business. From choosing the right corporate structure to drafting partnership agreements, we can also assist with mergers, acquisitions and buy-sell agreements.
• Practice formation (PCs, PLLCs, LLCs, etc.)
• Mergers, acquisitions, and joint ventures
• Partnership and shareholder agreements
• Facility development and leasing transactions
• Creation of Management Services Organizations (MSOs) to provide non-clinical administrative services to healthcare practices.
Regulatory Compliance Services
Navigating the constantly evolving landscape of healthcare regulations is critical for any medical practice. Our team provides guidance to ensure compliance with federal, state, and local laws, helping you avoid penalties and maintain your practice’s reputation. Key services include:
• HIPAA Compliance: Risk assessments, privacy policy drafting, and breach response assistance.
• Medicare and Medicaid Compliance: Addressing billing and coding regulations, fraud and abuse issues, and audit responses.
• No Surprises Act: Ensuring compliance with patient billing transparency rules and resolving out-of-network billing disputes.
• Stark Law and Anti-Kickback Statute Compliance: Structuring agreements and advising on compliance with federal fraud and abuse laws.
• Corporate Practice of Medicine (CPOM) Compliance: Structuring entities to comply with CPOM laws in various states.
• Telehealth Regulations: Advising on multi-state licensure, reimbursement policies, and data privacy.
• FDA Compliance: Ensuring adherence to Food and Drug Administration regulations for medical devices and pharmaceuticals.
• Healthcare Antitrust Issues: Guidance on group purchasing arrangements, mergers, and other competitive practices.
• Medical Record Retention and Access: Ensuring compliance with state and federal requirements.
Contract Negotiations and Drafting
Effective contract management is essential for healthcare professionals. We offer comprehensive support in negotiating, drafting, and reviewing various contracts to protect your interests. Our services include:
- Employment agreements and independent contractor agreements
- Vendor and supplier contracts
- Managed care and payer contracts
- Non-compete and confidentiality agreements
- Software as a Service (SaaS) Agreements
- Business Associate Agreements (BAAs)
- Data Protection Agreements (DPAs)
- Technology Licensing Agreements
- Cloud Hosting and IT Agreements
Licensing and Credentialing
We simplify the complex process of obtaining and maintaining professional licenses, credentials, and board certifications. Our attorneys help streamline the paperwork and administrative requirements so that you can focus on practicing medicine. We assist with:
- State medical licensing applications and renewals
- Hospital and healthcare facility credentialing
- Representation in licensure disputes
HIPAA Compliance Services
HIPAA compliance is a critical aspect of operating a healthcare practice. We provide tailored support to help you safeguard patient data and meet all HIPAA requirements. Our services include:
- Conducting HIPAA risk assessments
- Drafting and implementing privacy and security policies
- Responding to HIPAA audits and breach investigations
- Designing and delivering legally required training
We are dedicated to providing proactive legal solutions to help your practice thrive. Whether you are setting up a new medical business, negotiating contracts, or ensuring regulatory compliance, our team stands ready to support you at every step.
Group Health Plan and Payor Services
We provide comprehensive legal support to ensure group health plans and payor services comply with state and federal regulations. Our expertise spans all aspects of plan design, self-funding implementation, and administration, helping employers, plan sponsors, and insurers avoid costly penalties and legal challenges.
Plan Document Compliance:
- Drafting and reviewing Summary Plan Descriptions (SPDs), Summary of Benefits and Coverage (SBCs), Wrap Plan Documents, and Section 125 Cafeteria Plan/Flex Plan Documents.
Regulatory Compliance:
- Adhering to key laws, including ERISA, ACA, PHSA, COBRA, MSP, MHPAEA, and the No Surprises Act (NSA).
- Addressing privacy and security obligations under HIPAA.
- Complying with wellness regulations (EEOC) and IRS High Deductible Health Plan (HDHP) rules.
Required Notices and Communications:
- Preparing and distributing required notices, such as those for COBRA, ACA, HIPAA, and plan changes or special enrollments.
Compliance Program Development:
- Ensuring ongoing compliance with federal and state requirements through audits, gap analyses, and risk assessments.
Medicare Issues and Appeals
We assist healthcare providers, organizations, and individuals with:
- Claim appeals at all levels, including denials and reimbursement disputes.
- Medicare enrollment and eligibility, including Parts A, B, C, and D.
- Overpayments and audits, including RAC and ZPIC audits.
- Compliance with Medicare conditions of participation and payment rules.
- Medicare Advantage and Part D disputes and contracting.