Regulatory Compliance

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Medicare & Medicaid reimbursement rules for:

• Long-term acute care hospitals (LTCHs)
• Inpatient rehabilitation facilities (IRFs)
• Inpatient psychiatric facilities (IPFs)
• Outpatient rehabilitation agencies and clinics
• Outpatient behavioral health and substance use disorder (SUD) settings
• Skilled nursing facilities (SNFs)
• Home health agencies (HHAs)
• Hospices 

Waivers and relief from program requirements due to public health emergencies, such as the COVID-19 pandemic and extreme weather events

State licensure requirements, applications and approvals

State certificate of need requirements, applications and approvals

Change of ownership notifications, applications and approvals

Medicare and Medicaid certification requirements, including assistance with applications and approvals

Counseling on Medicare conditions of participation and accrediting organization standards, including advice on effective responses to survey deficiencies and plans of correction

Qualifications for exemption from the inpatient hospital prospective payment system (IPPS) for LTCHs, IRFs and IPFs

Specific requirements for hospitals-within-hospitals (HwH or HIH), satellite facilities, remote locations, hospital units, and provider-based entities

Document review and interviews to confirm compliance of acquisition targets with federal and state regulatory requirements, including Medicare and Medicaid reimbursement, licensure, certification, accreditation, certificate of need

Notifications, applications and approvals in connection with changes of ownership, including written analysis of same and summary chart with all timeframes to successfully coordinate transfer to new owner

Advice on how to properly structure new and existing arrangements to meet a safe harbor or otherwise comply with federal and state fraud and abuse laws, including the principal federal laws:

• Anti-kickback statute
• Physician self-referral ("Stark") law
• Civil monetary penalties law
• OIG exclusion authority
• Federal False Claims Act (FCA)

Represent clients in investigations conducted by The Department of Health & Human Services (HHS), the HHS Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal health care programs, including responses to subpoenas, legal analysis of issues, defense, and negotiated settlements

Assist providers with negotiating corporate integrity agreements and alternatives with the OIG

Assistance with structuring or amending corporate compliance programs for hospitals and other health care providers

Advise corporate compliance officers and departments regarding internal audits and complaints, and any necessary corrective actions

Conduct legally privileged external audits of compliance issues and advise clients on corrective actions, including disclosures and repayments

Assistance with enrollment and reporting requirements for health care quality reporting programs, including the Medicare quality reporting programs for health care providers

Advise directors of quality management and other quality staff regarding internal reports and reviews to check compliance with quality reporting program requirements and institute effective strategies to minimize violations

Conduct legally privileged external audits of quality reporting in advance of reporting deadlines to identify issues that may lead to agency determinations of non-compliance

Advise clients on privacy and confidentiality requirements, agreements, and requests under federal privacy laws including: 

• Privacy Act of 1974
• Freedom of Information Act (FOIA)
• Health Insurance Portability and Accountability Act of 1996 (HIPAA)

We draft language to include in federal securities filings for public companies and counsel health care clients on information to disclose