Kusserow on Compliance

 

Richard P. Kusserow was the Department of Health and Human Services Inspector General for over eleven years.  He is the author of nine books related to compliance.  He is the founder and CEO of Strategic Management, a firm that has been providing specialized compliance advisory services since 1992 to 2,000 clients. Richard now contributes content to  Wolters Kluwer to assist the industry in their understanding of compliance from the perspective of a former Inspector General.

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KUSSEROW’S TOP TIPS

Tips on Location and Setting for Investigation Interviews
Tips on Initiating an Investigation Interview
Tips on Interviewing Witnesses
Tips on Making a Hotline a More Effective Communication Tool
Tips on Negotiating a Corporate Integrity Agreement
Winning Strategies in Challenging Demand Letters
Are You Preparing for Compliance with ICD-10?
Are You Prepared to Meet the HIPAA Business Associate Mandates that Go Into Effect this Month?
Tips on Debriefing Individuals Who Register Complaints
HIPAA Enforcement Update and Compliance Tips
Reminder and Tips on Meeting HIPAA Business Associate Deadline
21 Tips for Board Level Briefing Topics
Mobile Devices Continue to Lead in HIPAA Security Violations
Investigation Guidelines and Tips
Investigative Interviews: Conversations with a Purpose
Costly mistakes in negotiating Corporate Integrity Agreements
Advice on selecting an Independent Review Organization (IRO)
Hotline tips and best practices
Outsourcing sanction-screening entirely
Tips on information security from the FTC
Tips for determining sanction-screening costs
Tips on compliance communication effectiveness
Tips and lessons learned from new OCR findings and settlements

KUSSEROW ON COMPLIANCE

General
Compliance Obligations
What Kind of Compliance Training is the Most Effective?
Evidencing Compliance Program Effectiveness
Using Vendors to Supplement the Compliance Program
OIG Lists 2013 Top Management and Performance Challenges
Compliance Records Management Program
Are Accountable Care Organizations Here to Stay?
Time Running Out for SNF Compliance Programs
The Controversy Over the “Two Midnight Rule” Heats Up
Tips on Debriefing Individuals Who Register Complaints
Continuing Controversy with the Two-Midnight Rule
Evidencing and Benchmarking Compliance Program Effectiveness
Develop a Defense Strategy to Government Data Mining
Evidencing and Benchmarking Compliance Program Effectiveness (2)
What is the True Figure for Medicare Fraud?
Regulatory Due Diligence is Critical in Mergers and Acquisitions
OCR Audit Update and Compliance Tips
DOJ Criminal Division Assistant Attorney General on Compliance
Effective Compliance Training
CMS rule changes to audit and inspection authority
OIG Advisory Opinion 15-01, advertising and providing baby care items in connection with services
Annual report on health care fraud and abuse program
OIG recommendations for Medicare fraud prevention
CMS changes five star quality rating for nursing homes
New OIG guidance on the roles and relationships for compliance, internal audit, legal, human resources, and quality assurance
OIG issues advisory opinion regarding use of preferred hospital network as part of Medigap policies
OIG on swing beds at critical access hospitals
OIG issues early alert—federal funds might be used illegally to cover Marketplace operational costs
Payments made to qualified health plan users under the ACA were ineffectively controlled by CMS
Congress asks GAO to review Medicare Fraud Prevention System
OIG work planning driven by CMS program mandates
OIG warns Medicare Part D fraud and drug diversion is growing
OIG June update highlights
OIG congressional testimony on Medicare Part D fraud
GAO enrolled fictitious applicants through the Marketplace
6.6 million taxpayers penalized for not having health insurance
CMS proposes modifying rules on meaningful use requirements
OIG reports most ACA CO-OPs not meeting goals
CMS needs to improve written instructions on prevention of improper Medicare payments
Once again, UCLA cited for PHI security breaches
ICD-10 final countdown: even CMS not sure how its systems will work
CMS makes errors on federal marketplace contract costs
OIG calls for more proactive oversight of HIPAA
Free shuttle to medical facilities considered in OIG Advisory Opinion
OIG baseline analysis of the top 25 lab tests
OIG reports on improper chiropractic payments
OIG 2016 Work Plan highlights investigative priorities and accomplishments
OIG continues to find that Medicare cost reports are not being properly reconciled
OIG report reviews ACA implementation
OIG reports that CMS failure poses federal funding financial risks
OIG modifies patient assistance program Advisory Opinion
DOJ “incident to” rule enforcement effort defeated in jury trial
Protecting the expanding Medicaid program from fraud, waste, and abuse
Most civil fraud recoveries in 2015 were from health care costs
OIG Advisory Opinion okays hospital billing of radiology
OIG issues favorable opinion related to patient assistance charitable foundation
CMS unable to ensure tax credits given only to enrollees who paid their premium
HealthCare.gov failures result of CMS and HHS missteps
OIG Advisory Opinion approves preferred hospital network in Medigap policies
OIG finds inadequate security management practices in Utah
OIG requests 172 more staffers, $68M for Medicare and Medicaid fraud investigations

Investigations
What Is an Investigation?
Decisions to Be Made Before Initiating Investigations
Predicating an Internal Investigation
General Rules for Conducting an Internal Investigation
Tips on Location and Setting for Investigation Interviews
Tips on Initiating an Investigation Interview
Are You Prepared to Properly Conduct Internal Investigations?
Tips on Interviewing Witnesses
OIG Views on Compliance Officer Internal Investigations
Internal Investigations—Be Prepared
OIG Reports Investigative Accomplishments
Court Rules Internal Investigations are Privileged
Investigation Guidelines and Tips
Investigative Interviews: Conversations with a Purpose
OIG reports investigative results for first half of 2015
OIG 2016 Work Plan highlights investigative priorities and accomplishments
OIG reports decline in criminal actions and investigative receivables

Hotlines
Outsourcing Your Hotline
When and How Should a Hotline Vendor be Re-evaluated?
Evaluating the Effectiveness of Your Hotline
Tips on Making a Hotline a More Effective Communication Tool
Promoting Hotline Anonymity
Essential Hotline-Related Policies and Procedures
How to Evaluate and Select a Hotline Vendor
Hotline tips and best practices
OIG Hotline complaints
Ensuring hotline effectiveness

Outsourcing
Outsourcing Your Hotline
Outsourcing Sanction Screening
Outsourcing Your Compliance Program
When and How Should a Hotline Vendor be Re-evaluated?
Can the Entire Sanction-Screening Process be Outsourced?
How to Properly Select an Independent Review Organization
Using Vendors to Supplement the Compliance Program
How to Evaluate and Select a Hotline Vendor
Outsourcing the HIPAA Privacy Officer
Co-Sourcing Series: Compliance in-sourcing, out-sourcing, and co-sourcing
Outsourcing sanction-screening entirely

Sanction Screening
Outsourcing Sanction Screening
Biggest Mistakes with Sanction Screening
GSA Sanction Screening Security Problems
What is the Purpose of the GSA Debarment Database?
Special Advisory Bulletin on the Effect of Exclusion in Federal Health Care Programs
The OIG on Screening Against the GSA EPLS
New Problems With GSA Debarment System
A Dozen Reasons to Not Like the GSA Debarment List
Medicaid Sanction Screening
Tips to Mitigate the GSA Sanction Screening Burden
Medicare Exclusion Database
Health Care Providers Should Screen Unpaid Volunteers
OIG Upgrades Online Searching of the List of Excluded Entities Database
OIG Proposes Amendments to Exclusion Regulations
Overview Relating to Mandates for GSA Sanction Screening
Outsourcing sanction-screening entirely
Tips for determining sanction-screening costs

Compliance Officers
Outsourcing Your Compliance Program
OIG Views on Compliance Officer Internal Investigations
Using Designated Compliance Officers
Hiring Experts to Cover Compliance Officer Vacancies
Experts Answer Questions About Using an Interim Compliance Officer (ICO)
Using Experts to Fill Compliance Officer Gaps
When Does It Make Sense to Use an Interim Compliance Officer?
Compliance Officers and Internal Auditors: Allies or Competitors?
Co-Sourcing Series: Compliance in-sourcing, out-sourcing, and co-sourcing
Common co-sourced functions used by compliance officers
Co-sourcing benefits to compliance officers
Tips on compliance communication effectiveness
Credit balances going to the top of the high risk list
Can small organizations use a part-time expert to run their compliance program?
Tips for measuring compliance program effectiveness

Risks
Offering Group Purchasing Organization Equity Interests is a Fraud Risk
How Kickbacks Result in Civil False Claims Fraud Actions
EMTALA Compliance High Risk Area
Billing, Auditing, and Monitoring Effectively—Measure to Manage Risk!

Oversight
Briefing the Board Compliance Oversight Committee
Hospitals’ Failing Grades–Ongoing Monitoring of Compliance Standards
21 Tips for Board Level Briefing Topics

Policies and Procedures
Compliance Policies and Procedures
Developing and Structuring Compliance Policies and Procedures
Mobile Devices Continue to Lead in HIPAA Security Violations
Department of Justice on Compliance Programs
OCR is off to the races with $5.4 million in penalties for HIPAA violations

Interviews
Tips on Location and Setting for Investigation Interviews
Tips on Initiating an Investigation Interview
Investigative Interviews: Conversations with a Purpose
Exit interviews, another important compliance communication channel

Sarbanes-Oxley
Sarbanes-Oxley’s Continuing Impact on Health Care Organizations

Claims Appeals
Former Medicare Appellate Judge Offers Tips for Managing Claims Appeals
Tips on Medicare Claims Appeals
First Level Medicare Claims Appeals Update
Office of Hearing Appeals Announces Huge Backlogs and Delays on Claims Appeals
Congress Calls for CMS to Fix the Medicare RAC Program
OMHA Medicare Appeals Update
Winning Strategies in Challenging Demand Letters
Recovery Audit Program Update
U.S. Court of Appeals invalidated a portion of the new RAC contract

Corporate Integrity Agreements (CIAs)
Tips on Negotiating a Corporate Integrity Agreement
Costly mistakes in negotiating Corporate Integrity Agreements
Advice on selecting an Independent Review Organization (IRO)
OIG calls for more compliance expertise in reviewing CIAs

ENFORCEMENT NEWS

Physician Arrangements/Stark Law
Ongoing Monitoring and Auditing of Physician Arrangements
Physician Arrangements Remain the Number One Enforcement Priority
The Stark Law Remains an Enforcement Priority
New Stark Enforcement Sends Shockwaves through Hospitals
$12 Million Visiting Physician Practice Fraud Scheme Indictment
Reviewing Physician Arrangements is Critical
OIG Fraud Alert—Laboratory Relationships with Physicians
OIG new fraud alert: physician compensation arrangements
Decade long saga of the Tuomey Case comes to a close
Lessons learned from the Tuomey case
Physicians personally face increased enforcement risks for corrupt arrangements
CMS moves to ease Stark rules for providers and for CMS
Overlap between physician-owned hospitals and distributers could result in violations of the Stark Laws and Anti-kickback Statute

False Claims
DOJ Reports Recoveries of $3.8 Billion from False Claim Act Cases in 2013
How Kickbacks Result in Civil False Claims Fraud Actions
South Carolina Hospital Found Guilty of Submitting More than $39 Million in False Claims
Medicare Payments Made on Behalf of Deceased Beneficiaries
Six Individuals in Florida Indicted in $63 Million Fraud
Update on Health Care Fraud by Armenian Organized Crime
Another Doctor Sentenced in $77 Million Russian Clinic Medicare Fraud Case
Indictments Unsealed in a $190 Million Medicare Fraud Case
Latest Health Care Solutions Network Sentencing
Increased Regulatory and Enforcement of Medicare Advantage Plans
Decade long saga of the Tuomey Case comes to a close
Lessons learned from the Tuomey case
Lessons for providers on the 60-day repayment ruling
Credit balances going to the top of the high risk list
DOJ settles with 21st Century Oncology for almost $20M
Whistleblowers receive $98M in $784.6M FCA settlement

Kickbacks
How Kickbacks Result in Civil False Claims Fraud Actions
More Recruiter Kickback Cases
Continued Crackdown in Miami on Home Health Recruiter Kickbacks
Medicare Nursing Home Resident Hospitalization Rates Merit Additional Monitoring
Hospital President Convicted of $158 Million Medicare Fraud
OIG issues Advisory Opinion on hospital discounts
OIG Advisory Opinion finds arrangement is “low-risk” under Anti-Kickback statute
Overlap between physician-owned hospitals and distributers could result in violations of the Stark Laws and Anti-kickback Statute
OIG warns blocking EHR may be a kickback

Settlements
Johnson & Johnson Settles with DOJ for $2.2 Billion
New Qui Tam Settlement–Sound Physicians, Tacoma, Washington
Walgreens Agrees to the Largest DEA Settlement in History
55 More Hospitals Settle with DOJ as Part of its National Kyphoplasty Initiative
Home Health Agency to Pay $150 Million in DOJ Settlement
Recent Fraud Sentences and Settlements
New Fraud Actions, Settlements for 2014
Extendicare Health DOJ Settlement of $38 Million and Five-Year Quality of Care CIA with the OIG
CMS Round 2 process for inpatient claims settlements
OIG reports investigative results for first half of 2015

Enforcement Actions
Recent Fraud Sentences and Settlements
Holiday Season is Also a Busy Time for Health Care Enforcement
Enforcement Action Update for the Week Leading Up to Thanksgiving
Highlights of December Enforcement Actions, Part 1
Highlights of December Enforcement Actions, Part 2
Final Enforcement Highlights for 2013
DOJ Reports Recoveries of $3.8 Billion from False Claim Act Cases in 2013
DOJ/HHS Report $4.3 Billion in Recoveries from Health Care Enforcement in 2013
DOJ Collects $8 Billion in Civil and Criminal Cases in 2013
New Fraud Actions, Settlements for 2014
Recent Enforcement Actions Against Physicians
Recent Enforcement Actions Against Hospitals
Fraud is Expanding Faster than Those Charged with its Enforcement
Highlights of April Medicare Enforcement
Highlights of April Medicaid Cases
CMS Efforts Have Led to $19 Billion in Fraud Recoveries
OCR to Resume HIPAA Audits
Dental Fraud and Abuse
CMS Failed to Prevent Millions of Dollars in Services to Unlawful Aliens in the Medicare Advantage Program
DOJ Reports Major “Take Down” by Medicare Fraud Strike Force
Hospice Fraud
Doctor Indicted for Role in $158 Million Medicare Fraud Scheme
DOJ Intervenes against Health Management Association Hospitals
OIG Found $6.7 Billion in Improper Medicare E&M Payments
DOJ Reports Over 700 Whistleblower Cases in 2014
OIG Special Assistant United States Attorney Program
OIG June update highlights
Growing use of the responsible corporate officer doctrine increases importance of effective compliance programs

Home Health
Home Health is Among the Most Vulnerable Programs for Fraud
More Home Health Fraud Cases
CMS Moves to Extend Moratoria on Enrollment for Home Health and Ambulance Suppliers
Former Veterans Affairs Psychiatrist Guilty of Home Health Fraud
Update on Home Health Agency Fraud
Home Services Program Fraud Crackdown
Feds Continue Targeting Home Health Fraud
$14 Million Home Health Agency Fraud
Increased Challenges for Home Health Agencies
OMIG Reports Identifying Half a Billion Dollars in Erroneous Home Health Payments
Home Health Agency to Pay $150 Million in DOJ Settlement
OIG and CMS Set Sights on Home Services Agencies
$74 Million Home Health Fraud Case in Miami
CMS Moratoria Extending for New Home Health Agencies and Ambulance Services
New guidance concerning HHA face-to-face encounters
Enrollment moratoria for new ambulance suppliers and home health agencies in several states
OIG reports on background checking by home health agencies

Ambulance
OIG Issues Report on Medicare Ambulance Transports
Multi-Million Dollar Ambulance Fraud
CMS Moves to Extend Moratoria on Enrollment for Home Health and Ambulance Suppliers
Crackdown on Ambulance Fraud Continues
Another Ambulance Service Owner Convicted for Fraud
CMS Moratoria Extending for New Home Health Agencies and Ambulance Services
Update on Ambulance Service Compliance Issues
Enrollment moratoria for new ambulance suppliers and home health agencies in several states

Medical Devices
Questionable Medicare Billing for Diabetes Test Strips
DME Fraud Remains High Enforcement Priority
Former Los Angeles-Area Pastor Sentenced for Role in $11 Million DME Fraud Scheme
OIG Reports on Spinal Devices Supplied by Physician-Owned Distributors (PODs)
Medical Equipment Supply Company Owner Indicted and Three Others Plead Guilty for Roles in $20 Million Medicare Fraud Scheme
Boston Scientific and Guidant to Pay $30 Million for Sale of Defective Heart Devices

Pharmacies/Prescription Drugs
OIG Congressional Hearing on Prescriptive Drug Fraud and Abuse
Department of Justice Once Again Takes Action on Improper Distribution of Prescription Drugs
CMS Improperly Paid Millions of Dollars for Prescription Drugs Provided to Prisoners
Pharmacy Fraud
Arrests in New York Members of Pharmacies Burglary Ring
America’s Other Drug Problem
Wyeth Pharmaceuticals to Pay Nearly $491 Million for Unapproved Off-Label Uses of a Drug
CMS Proposed Payment and Policy Updates for Managed Care and Drug Plans
OIG reports on FDA generic drugs oversight and inspection
OIG warns Medicare Part D fraud and drug diversion is growing
OIG congressional testimony on Medicare Part D fraud
OIG found Medicare continues to overpay for selected drugs
Medicaid paid millions more for generic drugs than necessary

Community Mental Health Centers (CMHCs)
Focus on Community Mental Health Center (CMHC) Fraud
Mental Health Ranks High on Fraud Scale

Civil Money Penalties (CMPs)
OIG Moves to Expand Civil Monetary Penalty Authorities
OIG reports investigative results for first half of 2015

FEATURES

GSA Debarment List
GSA Sanction Screening Security Problems
What is the Purpose of the GSA Debarment Database?
The OIG on Screening Against the GSA EPLS
New Problems With GSA Debarment System
A Dozen Reasons to Not Like the GSA Debarment List
Tips to Mitigate the GSA Sanction Screening Burden

Exclusions Database
Special Advisory Bulletin on the Effect of Exclusion in Federal Health Care Programs
Medicare Exclusion Database
OIG Upgrades Online Searching of the List of Excluded Entities Database
OIG Proposes Amendments to Exclusion Regulations
OIG updates the LEIE
Update on the OIG’s transition to the new LEIE filing system
New program exclusion guidance issued by the OIG
More on the new OIG guidance on exclusions

ALJ Backlog
Office of Hearing Appeals Announces Huge Backlogs and Delays on Claims Appeals
ALJ Hearings for Medicare Claims Appeals is Broken; New Appeals Suspended for Two Years
AHA Lambasts CMS for Two Year Backlog on Claims Appeals
Congress Calls for CMS to Fix the Medicare RAC Program
OMHA Medicare Appeals Update
American Hospital Association Files Lawsuit Over Delay in ALJ Hearings
New Pilot Programs to Address ALJ Appeals Backlog
Medicare Appeals Backlog Update—New Suit Filed by Beneficiaries

Tuomey
Lessons Learned from the Tuomey Case
Update on the Toumey Healthcare System Case
The Tuomey Healthcare Saga Continues
Latest in the Saga of the Tuomey Case
Decade long saga of the Tuomey Case comes to a close
Lessons learned from the Tuomey case
Tuomey saga punctuated with DOJ settlement

WellCare
Former Executives of WellCare Found Guilty
The WellCare Investigation Saga is Coming to a Close

Co-Sourcing
Co-Sourcing Series: Compliance in-sourcing, out-sourcing, and co-sourcing
Common co-sourced functions used by compliance officers
Co-sourcing benefits to compliance officers

GOVERNMENT DOCUMENTS

GAO Report on Data Analytics for Oversight and Law Enforcement
OIG Work Plan has its Sight on CMS Contracting and Contractors
OIG Sent a New Proposed “Safe Harbor” Rule to OMB
HHS OIG’s Spring Semiannual Report to Congress
Medicare Advantage and Part D Benefit Programs Proposed Rule Change (CMS-4159-P)
2015 President’s Budget Moves to Increase Anti-Fraud Funding
OIG Updates its Self Disclosure Protocol
CMS Proposes Increasing Rewards for Whistleblowers
OIG Online Self-Disclosure Protocol
Failing Grade to HIPAA Security Rule Oversight and Enforcement
DOJ Report on 2013 Medicare Fraud Strike Force Precautions
OIG Reports on CMS, EHR Practices; MACs; OCR Security Rule
OIG Sanctions Update
OIG Faults the CMS System for Sharing Information about Terminated Providers
OIG Finds Problems With Provider Enumeration and Enrollment Data
OIG Reports Planned Reduction in Resources
GAO Report Reveals Doctors Self-Referring Patients for Financial Gain
OIG Report on Provider Overpayment Recoveries
OIG Critical of CMS in Failing to Recover Billions of Dollars in Misspent Funds
GAO Issues a Report on Federal Suspensions and Debarments
Senate Aging Committee Reports CMS Failing With Its Contractors
House Hearing on Medicare Fraud and Abuse
OIG Finds Questionable Lab Billings
Favorable OIG Advisory Opinion to Pharmaceutical Direct-to-Patient Product Sales Program
CMS Proposes Rule Changes for OPPS and ASCs
HRSA Issues Interpretive Rule Clarification for 340B(e) Orphan Drug Exclusion
Medicare Trust Fund Estimated to Survive through 2030
HHS Provides Further Clarification for Certification of EHR
OIG Reports Many States are Cheating the Federal Government by Inflating Federal Share of Medicaid
OIG Proposes to Add New Anti-Kickback “Safe Harbors”
Pharmaceutical Manufacturer Co-Payment Coupons May Violate the Anti-Kickback Statute
OIG Calls for Re-Examination of Critical Access Hospital Payment System
HHS OIG Releases Work Plan for FY 2015
13 Highlighted Items in the 2015 OIG Work Plan Relating to Hospitals
Summary of Top 10 Management & Performance Challenges Facing HHS
CMS Announced New Rules to Protect Against Fraud and Abuse
OIG Reports $5B Return as Result of Its Efforts
OIG Defends its Hospital Compliance Reviews
CMS Proposed Payment and Policy Updates for Managed Care and Drug Plans
CMS rule changes to audit and inspection authority
OIG Advisory Opinion 15-01, advertising and providing baby care items in connection with services
Annual report on health care fraud and abuse program
OIG recommendations for Medicare fraud prevention
CMS changes five star quality rating for nursing homes
New OIG guidance on the roles and relationships for compliance, internal audit, legal, human resources, and quality assurance
OIG issues advisory opinion regarding use of preferred hospital network as part of Medigap policies
OIG on swing beds at critical access hospitals
OIG issues early alert—federal funds might be used illegally to cover Marketplace operational costs
OIG reports on background checking by home health agencies
OIG reports on FDA generic drugs oversight and inspection
HHS OIG posts its mid-year Work Plan update
OIG new fraud alert: physician compensation arrangements
Payments made to qualified health plan users under the ACA were ineffectively controlled by CMS
Congress asks GAO to review Medicare Fraud Prevention System
OIG work planning driven by CMS program mandates
GAO enrolled fictitious applicants through the Marketplace
OIG reports most ACA CO-OPs not meeting goals
CMS needs to improve written instructions on prevention of improper Medicare payments
HHS OIG July 2015 update summary
CMS makes errors on federal marketplace contract costs
OIG calls for more proactive oversight of HIPAA
OIG baseline analysis of the top 25 lab tests

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