Clay’s practice focuses on assisting national hospital chains, nursing homes, community hospitals, ambulatory surgery centers, private physician practices, solo practitioners, pharmacies, mental healthcare provider, dental providers and laboratories with their corporate, transactional, and regulatory compliance matters.
Clay’s services these providers in a variety of ways, including compliance with Medicare and Medicaid Conditions of Participation and Coverage; Stark and Anti-Kickback issues; reimbursement issues including assistance with overpayment investigations, repayments, self-disclosures, and administrative appeals of agency overpayment determinations; skilled nursing facility compliance, survey support, and administrative appeals; Department of Behavioral Health and Developmental Services’ compliance; scope of practice issues; e-discovery management and response; Office of Inspector General investigations and self-disclosures; and Board of Pharmacy and Drug Enforcement Agency compliance. Additionally, Clay assists all types of providers and other entities regarding healthcare transactional matters and represents providers in administrative appeals.
Clay writes and presents frequently on pressing healthcare issues regarding regulatory compliance such as survey deficiencies and responses, excluded providers, social media, e-discovery, advance directives, controlled substances regulation, and scope of practice.
Experience
- Represented numerous providers in successful administrative appeals of Medicare and Medicaid reimbursement issues.
- Represented a mental health provider in successful administrative appeal regarding human rights regulations.
- Represented numerous assisted living facilities and skilled nursing facilities in informal dispute resolutions.
- Performed internal compliance investigations regarding various matters involving Stark and Anti-Kickback concerns.
- Counseled clients on compliance matters and prepared CMS and OIG Self-Disclosures.
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University of Richmond School of LawJD
magna cum laude, General Assembly Editor, Journal of Law and the Public Interest
2010 - Virginia Commonwealth UniversityMPA2005
- College of CharlestonBAUnited States History1999
American Health Lawyers Association.
- Author, Senior Living Alert: HIPAA Security Rule Compliance for Senior Living Facilities, McGuireWoods Legal Alert, July 26, 2024
- Author, Ounce of Prevention: Are You Keeping Track of Your Business Associate Agreements’ Requirements?, McGuireWoods Legal Alert, May 28, 2024
- Author, Ounce of Prevention: Do Your Business Associate Agreements Have All Required Provisions?, McGuireWoods Legal Alert, May 21, 2024
- Author, Ounce of Prevention: Do You Have Business Associate Agreements With Every Required Party?, McGuireWoods Legal Alert, May 14, 2024
- Author, Ounce of Prevention: Is It Time to Perform a Security Risk Assessment?, McGuireWoods Legal Alert, April 5, 2024
- Author, Office for Civil Rights Settlement May Signal Increasing Scrutiny for Ransomware Attacks, McGuireWoods Legal Alert, November 21, 2023
- Author, CMS Increases Oversight and Scrutiny of Hospices, McGuireWoods Legal Alert, September 1, 2023
- Author, Private Equity in Healthcare – An Updated Review of Selected Niche Investment Areas, McGuireWoods Legal Alert, August 7, 2023
- Author, CMS Proposes 36-Month Rule for Medicare-Enrolled Hospices, McGuireWoods Legal Alert, July 19, 2023
- Author, HIPAA Privacy Rule Changes Coming in 2023: Five Steps to Prepare, McGuireWoods Legal Alert, May 3, 2023
- Author, Outdated Medicare Enrollment Data? Caution: CMS Verifying Ownership, McGuireWoods Legal Alert, April 26, 2023
- Author, HIPAA Enforcement Discretion Ends When Public Health Emergency Expires on May 11, McGuireWoods Legal Alert, April 19, 2023
- Author, Considerations for Healthcare Entities and Employers After Roe v. Wade Reversal, McGuireWoods Legal Alert, July 8, 2022
- Author, OCR Continues to Crack Down on Right of Access Violations, Password Protected, February 9, 2021
- Author, State Governors’ “Stay-at-Home” and Prohibition on Elective Procedures Orders, McGuireWoods Legal Alert, October 13, 2020
- Co-author, "Representing Hospitals and Health Systems Handbook," American Health Lawyers Association, September 2016
- Co-author, "The Rise of Drug-Seeking Behavior in the ED and Strategies to Manage Such Behavior," ED Legal Letter, January 2016
- Author, "The Supreme Court Upholds Binding Arbitration Agreements in Nursing Home Contracts But Questions Remain," Virginia Health Care Association, 2012
- Author, "Binding Arbitration in Nursing Homes: Pitfalls with Responsible Parties," American Health Lawyers LTC-SIR Advisor, July 2011
- Author, "Nursing Home Binding Arbitration Agreements and Responsible Parties in Virginia," Virginia Health Care Association, 2011
- Author, "Wyeth v. Levine: What Does It Mean and Where Do We Pharmaceutical Companies Go From Here," 13 RICH. J.L. & PUB. INT. 271 , 2010
- Author, "Davis v. Federal Election Commission: Constitutional Right to Campaign Finance Advantage," 12 RICH. J.L. & PUB. INT. 77, 2008
- Virginia
- Moderator, "Investments in Outpatient Behavioral Health Therapies," 18th Annual Healthcare Private Equity & Finance Conference, February 17, 2022
- Speaker, "Best Practices for Responding to Medicare Claims Audits and OIG Compliance Audits," Healthcare Litigation and Compliance Webinar Series, March 22, 2018
- Speaker, "Government Enforcement Actions Against Providers," Healthcare Litigation and Compliance Webinar Series, July 19, 2018
- Co-presenter, "EMTALA: Navigating Behavioral Health and the Opioid Crisis," Virginia Hospital and Healthcare Association, September 22, 2016
- Presenter, "The Evolving World of Social Media in the Long Term Care Setting," Virginia Health Care Association Annual Meeting, September 13, 2016
- Co-presenter, "Everything You Always Wanted to Know about Exclusions but Were Afraid to Ask," Health Care Compliance Association webinar, January 25, 2016
- Co-presenter, "The Documentation Journey: A Roadmap to Good ALF Documentation," Virginia Health Care Association/Virginia Center for Assisted Living 2015 Assisted Living Symposium, July 23, 2015
- Co-presenter, "Addressing Shortages through Physician-Extenders and Telehealth," West Virginia Hospital Association Critical Access Hospital Network, April 30, 2015
- Co-presenter, "Don’t Let Your Keyboard Fail You: Charting and Documentation to Ensure Accurate Reimbursement and Protect Against Government Audits and Investigations," Virginia Health Care Association Documentation Program, March 31, 2015
- Presenter, "Dental Recordkeeping, Billing, and Audit Procedures," Suffolk Dental Study Committee, December 2, 2014
- Presenter, "Advance Directives and the CMS Grievance Process," George Mason University Regulatory Compliance for Health Systems, June 23, 2014
- Co-presenter, "Managing Government Subpoena Responses in the E-Discovery World," American Health Lawyers Association Long Term Care and the Law Conference, February 25, 2013
- Co-presenter, "You’ve Got Mail: Responding to Letters from the Government," Virginia Health Care Association 2012 Annual Convention, October 3, 2012