Compliance Programs after The Affordable Care Act Angela Mattie, JD, MPH Teresa Tai, PhD, MA Quinnipiac University, School of Business, Department of Healthcare Management & Organizational Leadership November 18, 2014

Agenda Overview of compliance program mandates as part of Patient Protection and Affordable Care Act Analyze impact of these mandates on healthcare organizations Identify steps to implement changes

What We Know About The Patient Protection and Affordable Care Act of 2010 (PPACA)? Key Federal provisions included in the ACA: Expand access to insurance Increase consumer protections Emphasize prevention and wellness Improve quality and system performance Expand the health workforce Curb rising health care costs

ACA Mandates: Lesser Known Change from voluntary to mandatory requirements for compliance programs

ACA Mandates: Lesser Known Change from voluntary to mandatory requirements for compliance programs PPACA § 6401, all Medicare and Medicaid providers-shall establish a compliance program PPACA § 6102 applies to Medicare skilled nursing facilities and Medicaid nursing facilities

Core Elements of Compliance Programs Effective compliance standards and procedures "High-level personnel" with compliance responsibility No delegation of substantial discretionary authority to individuals whom the organization knew, or should have known, had a "propensity to engage in criminal, civil, and administrative violations" Effectively communicate standards and procedures PPACA Section § 6102 applies to Medicare skilled nursing facilities and Medicaid nursing facilities

Core Elements of Compliance Programs (Continued) Establish monitoring and auditing systems and a system to report violations without fear of retribution Consistently enforcement of standards through disciplinary actions Reasonably respond to the identified offense Periodic reassessment of the organization's compliance program PPACA Section § 6102 applies to Medicare skilled nursing facilities and Medicaid nursing facilities

Compliance Guidance Compliance Program Guidance for Pharmaceutical Manufacturers ( 68 Fed. Reg ; 05/05/2003 ) Compliance Program Guidance for Individual & Small Group Physician Practices ( 65 Fed. Reg ; 10/05/2000 ) Compliance Program Guidance for Nursing Facilities ( 65 Fed. Reg ; 03/16/2000 ) and Supplemental Compliance Program Guidance for Nursing Facilities ( 73 Fed. Reg ; 09/30/2008 ). Compliance Program Guidance for Durable Medical Equipment, Prosthetics, Orthotics, and Supply Industry ( 64 Fed. Reg ; 07/06/1999 ) Compliance Program Guidance for Third-Party Medical Billing Companies ( 63 Fed. Reg ; 12/18/1998 ) Compliance Program Guidance for Clinical Laboratories ( 63 Fed. Reg ; 08/24/1998 ) Compliance Program Guidance for Hospitals ( 63 Fed. Reg. 8987; 02/23/1998 ) and Supplemental Compliance Program Guidance for Hospitals ( 70 Fed. Reg. 4858; 01/31/2005 ).

Seven Elements of Healthcare Compliance Program Each healthcare organization should have the following: 1) Standards and Procedures 2) Oversight (Compliance Officer/Committee) 3) Education and Training 4) Auditing and Monitoring 5) Reporting and Investigation 6) Enforcement and Discipline 7) Response and Prevention

Recommendations To The Healthcare Providers If you don’t have one, get one! Have an effective compliance program in place If you have one, review! Follow the Office of Inspector General Guidance Make sure you have a compliance officers regardless of your size Allocate resources to the compliance functions Educate your Board on compliance issues

Recommendations To The Healthcare Providers (Continued) Educate Employees on How to Report Concerns & Create Effective Communication Methods Train Managers to Receive Reports about Compliance Concerns Respond Quickly and Efficiently to All Complaints Develop and Adhere to Non-Retaliation Policies Be Prepared to Self-Report Conduct Exit Interviews

And, Finally Conduct an Ethical and Legal Workplace