ALISSA SMITH HELPS HEALTH CARE ORGANIZATIONS COMPLETE STRATEGIC TRANSACTIONS AND ADDRESS A WIDE RANGE OF REGULATORY MATTERS THAT AFFECT THEIR BUSINESS.
Alissa represents health systems, hospitals, pharmacies, specialty pharmacies, wholesale distributors, pharmacy benefit managers, long-term care providers, vendors in the health care industry, home health agencies, medical practices, individual providers, as well as nonprofit and other organizations. Alissa’s practice involves health law transactional work, federal and state health law regulatory compliance advice, and administrative advocacy before state and federal agencies.
Alissa’s transactional practice includes counseling clients in the health care industry on all aspects of affiliations, ranging from contractual arrangements to joint ventures to mergers and acquisitions.
Alissa’s regulatory practice includes the interpretation and application of state and federal fraud and abuse laws, Medicare and Medicaid rules including payment rules, Medicare Part D regulations, and provider-based regulations, tax-exemption laws, HIPAA and privacy laws, EMTALA laws, licensing and accreditation matters, employment laws, governmental audits and open records and open meetings matters. She also assists with corporate and health system governance issues, including the preparation of policies and procedures, the revision and negotiation of medical staff bylaws, establishing corporate existence including preparing operating agreements and other governance documents, and in assisting in all aspects of participation in accountable care organizations including assisting with the legal structures, policies and procedures and the application process required for participation in the Medicare Shared Savings Program.
Alissa also assists with hospital-provider relations such as co-management arrangements and other professional service agreements, peer review investigations and medical staff fair hearings.
Alissa’s administrative practice includes representing health care providers in negotiation with a variety of state and federal agencies, such as negotiations with: the DOJ, OIG and DEA in self-disclosures and other health care investigation matters; CMS and OIG in EMTALA matters; CMS and their fiscal intermediaries and other contractors in healthcare payment issues and meaningful use audits; and state licensing and certifying bodies. Additionally, Alissa regularly represents health care providers before the Iowa State Health Facilities Council in Certificate of Need hearings; representing healthcare providers seeking to have their applications approved, and representing those who oppose projects before the Council.
- Represented skilled nursing facility in sale of facility to real estate investment trust as well as transition of operations to a new operator.
- Represented physician clinic in overhaul of contract templates.
- Represented chiropractic clinic in analysis and drafting of office lease and employment agreements.
- Represented chiropractic clinic in termination of leasing and partnership arrangement.
- Represented nursing facility in independent informal dispute resolution process in response to deficiencies and denial of payment for new admissions.
- Represented hospital in negotiating exclusive professional services arrangement with multi-specialty physician practice.
- Represented health system as new member in a member substitution agreement for an independent hospital.
- Represented municipal hospital in sale of assets to a regional health system.
- Represented hospital in member substitution agreement with a health system.
- Represented hospital in certificate of need hearing to add new health service.
- Represented health system related to self- disclosure of arrangement that implicated the anti-kickback statute.
- Represented pharmacy benefit manager in administrative proceedings with state boards of pharmacy.
- Represented a large hospital in acquiring the operations of a health system under an operating agreement.
- Represented a joint venture of a non-profit health system and a for-profit publically traded company in obtaining Certificate of Need approval for a 50-bed rehabilitation hospital.
- Represented a hospital in obtaining Certificate of Need approval to add a new obstetrics program.
- Represented a hospital in obtaining Certificate of Need approval to add a new skilled nursing unit.
- Represented a long term care community in obtaining Certificate of Need approval to add NF/SNF beds.
- Represented a long term care community in obtaining Certificate of Need approval to add a SNF unit and a dementia unit.
- Successfully represented several hospitals in opposing applications for certificates of need.
- Represented hospital in the sale of substantially all of its assets to an unrelated health system.
- Represented several health care providers in the internal investigation of billing compliance matters and the repayment process to third party payors.
- Represented an 83 bed NF/SNF in successful acquisition of a Certificate of Need to add additional beds.
- Represented a continuing care retirement community in the successful acquisition of a Certificate of Need to build a new 40-bed nursing facility on campus.
- Represented four hospitals in a successful challenge to the Certificate of Need application of a free-standing birthing center in a rural community.
- Represented a large pharmacy chain in the acquisition of a national specialty pharmacy company.
- Represented a pharmacy chain in the acquisition of numerous retail pharmacies.
- Represented numerous hospitals in the acquisitions of physician practices.
- Represented numerous hospitals in the establishment of co-management arrangements with oncologists, orthopedic physicians, surgeons and cardiologists.
- Represented numerous hospitals, pharmacies and long-term care providers in investigations by the Office for Civil Rights related to alleged violations of HIPAA.
- Represented numerous hospitals in investigations by CMS related to alleged violations of EMTALA and Conditions of Participation, including the development of plans of correction and the negotiation with OIG regarding civil monetary penalties.
- Represented numerous hospitals, pharmacies and long term care providers in the negotiation with the Office of Inspector General over civil monetary penalties related to the employment of excluded providers.
- Represented hospitals in the negotiation with the Office of Inspector General over civil monetary penalties related to incentives offered to induce Medicare and Medicaid beneficiaries.
News & Resources
News & Press Mentions
- “Overpayments, Internal Investigations and an Update on the Implied Certification Theory Three Years Post-Escobar,” Iowa Society of Healthcare Attorneys Spring Meeting, May 23, 2019.
- “Health Insurance Portability and Accountability Act: HIPAA for Lawyers,” Iowa State Bar Association, May 8, 2019.
- “Legal Updates that Impact Your Organization,” LeadingAge Iowa Spring Conference, May 2, 2019.
- “Health Care Fraud and Abuse Overview; Practical Tips to Stay out of the Enforcement Crosshairs,” Physician Leadership Education: Regulatory and Compliance Issues in Healthcare, Mercy Medical Center, April 27, 2019.
- “Health Insurance Portability and Accountability Act (HIPAA): Breach Notification Rule,” Iowa State Association of Counties, April, 18, 2019.
- “Iowa Hospital Association Governance Webinar Series,” Iowa Hospital Association
- “Fiduciary Responsibilities of Hospital and Health System Board Members,” June 20, 2018
- “Understanding Federal Laws and Enforcement Agencies,” August 2, 2018
- “Laws Affecting Tax-Exempt Status and Public Meetings,” October 2, 2018
- “Understanding Health Care Fraud, Waste and Compliance Programs,” December 2, 2018
- “Public Private Partnership for a Community Health Care Solution for Wrangell,” 2018 Alaska Municipal Attorneys Association Conference, Anchorage, Alaska, November 12, 2018.
- “Drug Donation and Safety Net Pharmacy Programs: A Model for the Country,” American Society for Pharmacy Law, Hilton Head, South Carolina, November 2, 2018.
- “Fiduciary Duties of Hospital Board Members,” Spencer Municipal Hospital Board of Trustees Meeting, June 28, 2018.
- “Combatting the Opioid Epidemic: Hospital and Pharmacy Perspectives on Iowa’s New Opioid Law,” Co-Presenter, Iowa Hospital Association Webcast, June 21, 2018.
- “Fiduciary Duties of Non-Profit Hospital and Health System Board Members,” Co-Presenter, Iowa Hospital Association Governance Webinar Series, June 20, 2018.
- “Legal Updates in Long Term Care; Social Media and Personal Devices in Facilities,” LeadingAge Iowa Spring Conference, May 2, 2018.
- “HIPAA and Privacy Rights Enforcement” Drake Law School, Privacy and Information Security Seminar, April 21, 2018.
- “HIPAA and Privacy Rights Enforcement” Iowa State Association of Counties, Spring HIPAA Training, April 19, 2018.
- “What Has the Legal Response Been? Legal Developments in the Fight Against Opioid Abuse” Co-Presenter, Minnesota CLE Seminar: The Opioid Epidemic: Legal, Medical and Policy Perspectives from the Front Lines, February 16, 2018.
- “The Dangers of Social Media and Personal Technology in the Workplace,” Iowa Hospital Association, webinar, November 16, 2017.
- “HIPAA Compliance Training: What’s New in 2017,” Iowa State Association of Counties, webinar, November 8, 2017.
- “What to Know Before Offering Employee Incentives: Tax Rules, Employment Laws, and Fraud and Abuse Laws to Consider in Structuring Sign-On Bonuses, Educational Assistance, and Other Recruitment and Retention Programs ,“ Iowa Hospital Association, Annual Meeting, October 11, 2017.
- “MACRA Update for Providers: MIPS and Advanced APMs”, Iowa Hospital Association Summer Leadership Summit, June 7, 2017.
- “The ACA and the New Administration: Changes So Far and What to Expect,” Iowa Hospital Association, May 19, 2017.
- “Healthcare IT Contracting for Providers: Legal Issues, Tips and Best Practices,” Annual Meeting of the Iowa Society of Hospital Attorneys, May 4, 2017.
- “Merit-Based Incentives and Alternative Payment Models: Positioning for Success,” Iowa Hospital Association, Annual Meeting, October 18, 2016.
- “Off-Campus Provider Based Locations: A Changing Landscape,” Iowa Hospital Association, webinar, June 22, 2016.
- “2016 Healthcare Federal Fraud and Abuse Update,” Iowa Society of Healthcare Attorneys, Annual Meeting, May 10, 2016.
- “2016 HIPAA Update,” Iowa State Association of Counties, Spring Meeting, April 14, 2016.
- “501(r) IRS Regulations for Section 501(c)(3) Private and Governmental Hospitals.” Minnesota Hospital Association-Healthcare Financial Management Association’s Fall Conference, “Preparing for the Transformation of Health Care Finance.” Oct. 8-9, 2015.
- “Contracting with Managed Care Organizations 101: Key Terms to Watch for and Best Practices as Iowa Medicaid Transitions to Managed Care”, LeadingAge Iowa Fall Leadership Conference, September 17, 2015.
- “2015 Legal Update for Long Term Care Providers,” LeadingAge Iowa, May 7, 2015.
- “New IRS Regulations for Private and Governmental Tax-Exempt Hospitals,” Iowa Hospital Association, April 29, 2015.
- “HIPAA and Patient Privacy Workshop for Counties and Regions,” Iowa State Association of Counties, April 16, 2015.
- “EMTALA Staff Training,” Lucas County Health Center, January 29, 2015.
- “Volunteers In Your Facility: A Discussion of Legal Issues and Best Practices,” LeadingAge Iowa webinar, December 18, 2014.
- “Cybersecurity Symposium,” co-presenter, Dorsey & Whitney LLP, Des Moines Botanical Center, November 12, 2014.
- “Health Data Privacy: Biggest Risk Areas, Data Breaches and Compliance Next Steps,” Iowa State Association of Counties, October 23, 2014.
- “Health Data Breaches: The Potential Risks and Lessons Learned in Regulatory Enforcement and Class Action Litigation,” Iowa Hospital Association Annual Meeting, October 8, 2014.
- “Health Data Breaches: HIPAA and Beyond - A Discussion of HIPAA, State Law, and the AvMed Class Action Settlement and Implications for Future Data Breach Litigation,” Association of Corporate Counsel - Iowa Chapter, August 21, 2014.
- “Volunteers in Your Facility: Legal Best Practices for Risk Management,” LeadingAge Iowa Spring Meeting, May 7, 2014.
- “Health Privacy Seminar: In-Depth Work Session on Select Federal and State Health Privacy Laws,” Iowa State Association of Counties, May 1, 2014.
- “HIPAA Workforce Training for Public Health Departments,” Cerro Gordo County Department of Public Health, April 16, 2014.
- “Overview of the Health Insurance Portability and Accountability Act and Select State Privacy Laws," Iowa State Association of Counties Spring School, March 13, 2014.
- "Data Security: What Does It Mean and Why Should I Care?”, Association of University Professors of Ophthalmology Annual Meeting, January 30, 2014.
- “HIPAA Training for Hospital Workforce Members," Skiff Medical Center, December 16 & 18, 2013.
- “HIPAA Training for Hospital Workforce Members," Lucas County Health Center, November 13-14, 2013.
- “Health Care Reform for Employers," Iowa Hospital Association Annual Meeting, October 9, 2013.
- “Nursing Home Compliance Programs: 2013 Update," LeadingAge Iowa Annual Meeting, October 9, 2013.
- "The HIPAA Final Rules, Part II: Drill Down on Specific Compliance Activities," LeadingAge Iowa, August 27, 2013.
- “The HIPAA Final Rules are Finally Here: Will you Be Ready?”, LeadingAge Iowa, July 17, 2013.
- “Hospital Compliance Programs," Broadlawns Medical Center, May 30, 2013.
- “EMTALA Compliance Update," Wheaton Franciscan Healthcare-Iowa, May 22, 2013.
- “The New HIPAA Rules: Are you Ready for Compliance?”, American Association of Healthcare Administrative Management, Iowa Hawkeye Chapter, May 16, 2013.
- “The HIPAA Final Rules are Finally Here: Will You Be Ready?", Iowa Hospital Association, co-presentation with Sarah Mick, February 28, 2013, and March 7, 2013.
- “IT Contract Negotiations and Related Privacy and Regulatory Issues,” Genesis Health System, co-presentation with Ed McIntosh and Rhona Schmidt, February 19, 2013.
- “Hospital Construction Projects: Digging Through the Regulatory and Financing Morass," co-presenter, Iowa Hospital Association, Annual Meeting, October 9, 2012.
- “Iowa Open Meetings and Open Records Laws," Board of Directors Presentation, Spencer Municipal Hospital, August 29, 2012.
- “The New Regulations and Guidance Under GINA and the ADAAA," Health Enterprises of Iowa Human Resources Roundtable, February 9, 2012.
- “Your Health Plan and Health Care Reform: Changes, Costs and Compliance 2011-2013," co-presenter, Iowa Hospital Association, Annual Meeting, October 4, 2011.
- "Peer Review in Iowa: An Update on Recent Cases and Discussion of Applicable Law and Strategies for Protecting Information in the Peer Review Process," Iowa Society of Healthcare Attorneys Health Law Conference, Panel Discussion, May 17, 2011.
- "EMTALA Compliance for Hospitals and Physicians," Hospital and Medical Staff Presentation and In-Service Training, Marengo Memorial Hospital, March 28, 2011.
- "Federal Laws to Combat Identity Theft: The Red Flag Rules," Iowa Society of Certified Public Accountants' Exempt Organizations Annual Conference, November 5, 2010.
- "An In-Depth Discussion: Meaningful Use Criteria," Iowa Hospital Association, webinar, October 14, 2010.
- "Meaningful Use Gap Analysis," 6th Annual Iowa E-Health Summit: Meaningful Use - Not If, When?, Iowa Foundation for Medical Care, August 5, 2010.
- "2009 Federal and Iowa Employment Law Update," Iowa Society for Healthcare Human Resources Administration Spring Conference, April 30, 2009.
- "The American Recovery and Reinvestment Act of 2009: Changes to HIPAA, Incentives for the Adoption of Electronic Health Records, and Whistleblower Provisions," Iowa Hospital Association Audio Conference Presentation, March 25, 2009.
- "Practical Advice for Implementing a Red Flag Identity Theft Program," Webinar, October 29, 2008.
- "An Overview of Federal Health Care Fraud and Abuse Laws," Board of Directors Presentation, Skiff Medical Center, April 23, 2008.
- "EMTALA Compliance for Hospitals and Physicians," Co-Presenter, Medical Staff Presentation, Skiff Medical Center, October 8, 2007.
- "Hospital and Physician Compliance with the Emergency Medical Treatment and Active Labor Act," Medical and Hospital Staff In-Service Training, Marengo Memorial Hospital, February 1, 2007.
Industries & Practices
- Cybersecurity, Privacy & Social Media
- Digital Health
- Healthcare Transactions & Regulations
- Pro Bono
Professional & Civic
Member, Polk County Bar Association
- Member, Iowa Bar Association
Member, Illinois Bar Association
Member, American Health Lawyers Association
Member, Iowa Hospital Association
Adjunct Assistant Professor, University of Iowa, College of Public Health, Department of Health Management and Policy
- Board Member, Iowa Organization of Women Attorneys, 2011-2016; Member, 2016-present
- Board Member, Iowa Hospital Association’s Iowa Society of Healthcare Attorneys, 2014-present; Member, 2004-present
- Co-Chair, Iowa State Bar Association’s Health Law Section, 2015-present; member, 2004-present