healthcare regulatory environment review

Healthcare Regulatory Environment Review

Marge Scott West Georgia HealthLinda Corley Xtend Healthcare

2 Proprietary and Confidential. © 2009 Xtend Healthcare, LLC. All rights reserved. All registered trademarks are the property of their respective owners

Objectives

Regulatory Challenges FY 2011 – 2012• Current Environment

• Enhanced Enforcement Agenda

Hospital and/or System Wide Responses• Hospital and/or Medical Center Service

• Clinical Research Compliance

• Coverage, Coding and Billing Compliance

• Physician Relationships

• Privacy and Security


The Current Enviroment

New / Tougher Laws• Patient Protection and Affordable Care Act (PPACA)

– Uncertainty• Repeal and replace

• PPACA strengthens fraud and abuse enforcement– Strengthens False Claims Act (FCA)

• Enhances and simplifies enforcement of FCA

• Enhanced protections of whistleblowers

• 60 day reporting requirement of overpayments (credit balances)

– Strengthens Anti-kickback Statute (AKS)• “Intent standard” diminished

• Stark violations now constitute fraudulent acts under FCA


PPACA cont’d

• Anti-fraud provisions comprise several elements:1. Enhanced screening of providers

2. Periodic revalidation of credentials

3. Ongoing monitoring of claims history / payment databases

4. Required reporting and information sharing among Medicare, Medicaid, and CHIP agencies

5. Suspension of payments based on “credible allegation of fraud”

6. Imposition of temporary moratorium

The Current Enviroment


PPACA cont’d

• CMS publication (02/02/2011) of a Final Rule based on PPACA

1. Anti-fraud measures created

2. Enhanced screening requirements

3. Payment suspension

4. Reference to Mandated Compliance Plans

The Current Environment



Clinical research billing

• Medicare, Medicaid, other third party coverage1. Applicable coverage, coding and billing rules

2. Grant provision or contract obligations

3. Consistency across all study related documents

4. Payment of Medicare costs associated with subject illness, injury and/or medical condition


HIPAA – HITECH• Breach notification requirement

• Accounting of disclosures

Emphasis on EHR development requires Compliance• Ensure both regulatory guidelines and HIPAA requirements are

considered for EHR

• “Build” records with audits in mind!• Ensure required data elements meet “revenue integrity”

• Certification requirements for both “records” and

“users”



Healthcare Services (both facility and professional)

1. Recoveries of overpayment• Whether innocent overpayments or fraudulent claims

• Offsetting rising costs in healthcare delivery and billing

2. Increase joint efforts and data sharing• CMS, DHHS, and DOJ

• State and federal agencies

• Commercial payers and government funded payers

3. Focus on new relationships between hospitals and physician practices

• Contracts under scrutiny• Re-visit “med staff directorships,” leasing of space, etc.

Enhanced Enforcement Agenda


Enhanced Enforcement Agenda

1. HEAT Initiative (Healthcare Fraud & Enforcement Action Team)

• New resources and technologies to detect and prevent abuse

• Cabinet level priority

• Data prospecting by CMS

– Proactively identifying target rich environments

– Inpatient vs Outpatient setting

– Drug units

• Data sharing between CMS and DOJ

2. Recovery Audit Contractors (RACs)

• Medicare RACs extended to all 50 states

• Medicaid Integrity Contractors (MICS) in all 50 states


Who are the RACs?

A: Diversified Collection Svr.B: CGIC: Connolly Consulting, Inc.D: HDI - HealthDataInsights, Inc.


Enhanced Enforcement Agenda Cont’d

3. ZPICs - Zone Program Integrity Contractors

-- Expanding initiative

4. National Initiatives as separate reviews

• Medical necessity of implantable devices

• Implantable cardioverter defibrillator

• “Course of care” following evidence-based guidelines

• Reviewing cardiology, dialysis, chemotherapy

• Nursing Homes, Hospice


1. Clinical research billing• Medicare 2000 National Coverage Decision (NCD)

– Increased scrutiny of covered services provided during clinical trials– Treatments stemming from complication / subject injuries– Billings to Medicare versus sponsors

2. HIPAA – HITECH• Substantial increase in monetary penalties collected by Office of

Civil Rights (OCR) for privacy and security violations– “Willful neglect”

• State attorney generals HIPAA enforcement actions• Complainants to share in monetary penalties

Enhanced Enforcement Agenda Cont’d


Hospital and/or Health System Wide Responses

1. Ethics and compliance programs are becoming even more important for assurance of “revenue integrity”

“Your” program should include:• Tightly focused efforts in key compliance risk areas

• Periodic assessment of program “effectiveness”

• Senior leadership and board involvement with quality reports and current issues

• RAC response teams– Multidisciplinary

– Targeted high risk areas

• Focus on prevention versus reaction– Education and training initiatives


2. RAC and/or MIC Interdisciplinary Team(s)• Compliance / audit / recoupment updates

– Sharing information on government audits• e.g., RAC audit

• Best practices in policy and procedure implementation for individual locations

• Ensure separate “types” of services are defined and compliant processes are outlined based on regulations

• Address pro-fee billing policy

• Update HIPAA privacy policy

• Guidelines for Write-Offs and Waivers of Co-Pays and Deductibles

• Are P&Ps being followed to support goal of “culture of compliance” for each risk area identified by the OIG?



3. Consider a “Medical Billing Advisory Group” (new)• Identifying high risk billing and coding issues

• Sharing best practices on auditing, monitoring and training

• Incorporate results into Compliance Program effectiveness evaluation

4. Consider “education” initiative - Leave no staff member untrained!

- And – leave no staff member “un-evaluated” on

knowledge base



Conclusion

Complex healthcare regulatory environment• Continued need of coordination at system level

– Compliance, internal audit, legal, regulatory and risk services / management

– Comprehensive risk profile and compliance work plans

• Continued need for collaboration at hospital/operations level

Heightened importance of outcomes measurements


Healthcare Regulatory Environment Review

Questions


Linda Corley, BS, MBA, CPC

Senior Leader – Compliance & Associate Development

Xtend Healthcare Consulting

Marge Scott, BS, MBA, CHC

Chief Compliance Officer & Chief RAC Officer

West Georgia Health Services, Inc.

healthcare regulatory environment review

Documents

registered trademarks

hipaa requirements

ppaca antifraud measures

abuse enforcement

false claims act fca

regulatory guidelines

injury andor medical

ehr build records