Federal Health Care Laws
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Transcript Federal Health Care Laws
COMPLIANCE ISSUES FACING GROUP
PRACTICES
Growing and Operating a Large Medical Practice
Broad and Cassel
Hyatt Regency Orlando
International Airport
March 3, 2006
GABRIEL L. IMPERATO, ESQ.
Broad & Cassel
Fort Lauderdale, FL
1
OVERVIEW
1)
2)
3)
4)
5)
6)
RECENT TRENDS IN GOVERNMENT
ENFORCEMENT
PRIVATE PAYOR HEALTH CARE FRAUD
THE ANTI-KICKBACK STATUTE
THE STARK LAW
THE FALSE CLAIMS ACT
OFFICE OF INSPECTOR GENERAL WORK
PLAN
2
TRENDS IN GOVERNMENT
ENFORCEMENT
Health Care Fraud Enforcement Continues As a Priority
and Includes Anything Whistleblowers May Target
Medicare Reform Act-Expansion of Prescription Drug
Benefit – New Fraud Opportunities
Corporate Liability and Compliance
Quality of Care
Stark Law and Anti-Kickback Violations
OIG Work Plan 2006
3
HOT TOPICS
Physician Recruitment
Medical Directorships
Joint Ventures
Pharma and Medical Device Marketing
Clinical Research
4
PHYSICIAN RECRUITMENT
Community need (vs. hospital need)
Physician relocating practice to hospital service
area
Benefits geared to reasonable financial security
of physician in startup phase
Payout period limited to 3 years
No benefits to existing group practice beyond
actual incremental additional costs of adding
new physician
No relationship to anticipated referrals
OK to require maintenance of hospital privileges
5
MEDICAL DIRECTORSHIPS
Actual, necessary, non-duplicative
services
Fair market value payments
Contemporaneous time and effort
documentation
No relationship to referrals
6
JOINT VENTURES
Issue: Excessive reward to referral sources?
Any relationship of investment opportunity to referral
volume
Minimal investment by referral sources
Tracking/pressure regarding referrals
Extraordinary returns on investment
Required divestments/non-transferability of
investment interests
“Shell” structures: contractual joint ventures
7
MARKETING OF PHARMACEUTICALS
AND MEDICAL DEVICES
Discounts and remuneration to purchasers
Educational grants
Research grants
“Switching” or conversion payments
Formularies and formulary support
Relations with formulary committee members
Formulary placement payments
Relationships with physicians
Consulting and advisory payments
Business courtesies and gifts
Education/research funding
8
CLINICAL RESEARCH
NIH Guidance on Financial Conflicts of Interest
Any relationship between outcome and compensation
Researcher’s proprietary interest in studied product
Equity interest in the sponsor
Other significant compensation by sponsor
Grants for unnecessary or duplicative research
Cost mischarging
9
Clinical Research Grants
Commercial Sources
Pharma and medical device
Consultant Arrangements with Clinical Trial Sponsors
(Pharma CPG)
Recruitment of clinical trial subjects
Integrity of reporting of clinical trial information
Medical treatment of clinical trial subjects
Federal Grants
NIH and other
Clinical Investigations time allocation
Billing for services covered under a grant
Recent CPG
10
Hospital Specific Billing Issues
Discharge/Transfers
Inpatient DRG Coding
Suspect Pairings
Pneumonia
Septicimia
Post Acute DRGs (29 existing DRGs)
Bill as transfer, not discharge
OIG highlights in its semi-annual report ($116
million Medicare overpayment in 2 year period)
11
Hospital Specific Billing Issues
Outpatient PPS
Pass-through costs
Outpatient Cardiac Rehab
Incident to/direct supervision by Physician
Diagnostic Testing in ERs
Contemporaneous interpretations
Medically necessary?
12
Hospital Billing/Medical Necessity
Issues
Coronary Artery Stents
Medically necessary
Multiple procedures
70% now drug eluting stents ($ 4,859 extra
payment on OPPS)
13
Hospital and Physicians – Medical
Necessity Conundrum
Physicians decide what is medically necessary
Staff Physicians not employed by hospital
Independent Peer Review function
Overutilization? Patient Care/Safety
United Memorial Hospital/Corporate Liability
Redding Hospital/Physician and Corporate
Liability
14
Physician Billing Issues
E&M coding (perennial target - $ 23 billion
in 2001)
Consultations
Use of -25 Modifier (E&M service
unrelated to procedure code on same day)
Place of Service coding errors
15
Physician Billing Issues
Medical Necessity of Diagnostic Tests
Radiation Therapy Management Services
One billable unit for every five sessions
Services and Suppliers “Incident to”
Training and billing Reviews for physician
practices
Essential in OIG’s view
16
PHARMACEUTICAL FRAUD
Medicaid Rebates – Best Price Violations
Price Manipulation (“AWP”/”ASP”)
Promotion of Off Label Use
Relationships with Health Care Professionals
and Inducements to Prescribe
Marketing Schemes
Pharmacy Benefit Managers and Switching
Arrangements and Contract Kickbacks
Shorting Prescriptions and Drugs Returned to
Stock
Secondary Market and Internet Purchases
17
Quality of Care
Hospital/Physician Services
Cardiac Catheterization Procedures
Hospital/Medical Staff Responsibility
Quality of Care in Nursing Homes
Services Not Provided
“Deficient” Services vs. “Worthless” Services
Physician Services
18
CORPORATE LIABILITY,
COMPLIANCE AND GOVERNANCE
HIPPA 96” and Corporate Scandals
The New Era of Corporate Responsibility
Sarbanes-Oxley Act of 2002
United States Sentencing Guideline
Amendments of 2004
Department of Justice Principles of Federal
Prosecution of Business Organizations
19
SARBANES-OXLEY AND THE SENTINEL
EFFECT ON HEALTH CARE ORGANIZATIONS
Public Companies – Governance and Integrity of
Reporting Financial Information
Private Companies – Fiduciary Obligations of Board of
Directors and Shareholder Derivative Liability
Not-for-Profit Organizations – Fiduciary Obligations and
Attorney General Oversight
Caremark Decision – All Organizations
20
SENTENCING GUIDELINE AMENDMENTS
RAISE THE STAKES FOR BUSINESS
ORGANIZATIONS
Codification of Principles of the Caremark Decision
Oversight and Responsibility of the Board of Directors
and High Level Personnel of the Organization
Board Knowledge About the Content and Operation of
the Compliance Program to Prevent and Detect
Violations of the Law
Board Exercises Reasonable Oversight with Respect to
Implementation and Effectiveness of the Compliance
Program
Risk Assessment as an Essential Component of Design
Implementation of an Effective Compliance Program
Assessment of Likely Compliance Risks Given an
Organization’s Business Activities
21
UNITED STATES SENTENCING GUIDELINE AMENDMENTS AND
DEPARTMENT OF JUSTICE PRINCIPLES OF FEDERAL PROSECUTION OF
BUSINESS ORGANIZATIONS
“COOPERATION” OR “UNCONDITIONAL SURRENDER”
Voluntary Disclosure and Self-Reporting as Quasi Mandatory
Function of Cooperation
Cooperation in Investigating Business Organizations Own
Wrongdoing
Effects Charging Decision Against Business Organization
Effects Scope of Liability for Business Organization
Effects Sentence under Sentencing Guidelines
Business Organization’s Cannot Run the Risk of Failing to
Have an Effective Compliance and Governance Program
Failure to Detect and Prevent Wrongful Conduct will Result in
Consequences for Any Business Organization in Current
Compliance Environment
22
Corporate Integrity Agreements
A part of global criminal and/or civil settlement
May represent OIG’s opinion on the
organization’s compliance programs
7 significant elements of an effective compliance
program, including:
Specific training language
Focused audits/reviews
Independence of Compliance Officer
Annual Reporting Requirements Under CIA
23
Independence of the
Compliance Officer
Dual responsibility of compliance officers
are increasingly suspect to the OIG at
large organizations
Sufficient commitment of resources
Reporting to Board of Directors/Trustees
CCO Subordinate to General Counsel or
CFO Not Favored by OIG
24
OIG Expectations:
Compliance Training
Broad based compliance program training
Extensive and specific training for risk
areas
Document training
Efforts made to train physicians
Technology training
Essential for effective compliance
programs
25
Private Payor Fraud
What
is Private Payor Insurance
Fraud?
Fraud against those who pay for
private heath insurance coverage
26
Federal Statutes Prohibiting Private
Payor Insurance Fraud
Mail Fraud
Wire Fraud
Fraud against health care benefit plans
Conspiracy to commit fraud through false
claims and false statements
Fraud under the RICO statute
27
Federal Prosecutions involving Fraud
Against Private Persons
Examples
US v. Posner, D.C., et. Al (S.D. Fla.)
Mail fraud; 18 U.S.C. § 1341; Wire fraud; 18 U.S.C. §1343;
and Conspiracy; 18 U.S.C. § 371 – for submission of claims to
private payors for services not rendered, not rendered as
claimed and for medically unnecessary services
US v. Individual Chiropractor
Health care fraud; 18 U.S.C. § 1347; Conspiracy; 18 U.S.C. §
371 – for claims for services in accordance with a standard
treatment protocol lasting approximately three months
regardless of the patient injuries or the medical necessity of
the treatment protocol, and for submission of claims for
medical, chiropractic and therapeutic services which were not
performed during the treatment protocol and/or never occurred
28
Private Payor Attempts to Limit Fraud and
Abuse through State Legislation
Examples:
Florida legislation regulating activities under
the personal injury protection program –
limiting solicitation of patients; imposition of
Medical Director responsibilities on personal
injury medical clinics
Licensure and registration of clinics and
denial of payment for unlicensed or
unregistered clinics by private health plans
29
Examples of Private Payor Positions
in Civil Litigation
Violations of federal or state false claims
statutes
Violations of federal or state Anti-Kickback and
self-referral laws
Violations of state law governing insurance and
provider relationships
Submission of claims which are allegedly
medically unnecessary and/or unreasonable
30
Private Payor Affirmative Litigation Against
Providers in State and Federal Courts
Examples:
State Farm Mutual Automobile Insurance Company v. Universal Medical
Center of South Florida, Inc. (Dade County, Court of Appeal) – Denial of
payment because physical therapy performed by medical assistants (not
licensed physical therapists) provided under physician supervision is
prohibited under State law.
State Farm Mutual Automobile Insurance Company v. Comprehensive
Medical Group, Inc., et al (N.D. Illinois) – Complaint by insurance company
against multiple providers for false and fraudulent claims for worthless and
unnecessary diagnostic tests rendered to victims of automobile accidents on
an a nation-wide scale.
Medically unnecessary diagnostic tests of no clinic value
Misleading diagnostic findings
False claims for multiple procedure codes
Diagnostic studies rendered to maximize profit without regard to medical
necessity
Spinal ultra sounds; somotosensory evoke potential; dermatome evoke
potentials; and nerve conduction velocity studies, having no clinical
value in confirming or excluding the existence of nerve root injury or
location of neurological dysfunction or inflammation
Purpose of performing the test is merely for financial gain
31
REVIEW OF PAYMENT & REFERRAL
RELATIONSHIPS UNDER
STATE AND FEDERAL LAW
32
I. THE ANTI-KICKBACK STATUTE
42 USC § 1320a-7b(b)(2)
It is unlawful to knowingly and willfully offer or pay any remuneration
(including any kickback, bribe, or rebate) directly or indirectly, overtly
or covertly, in cash or in kind to any person to induce such person-(A) to refer an individual to a person for the furnishing or
arranging for the furnishing of any item or service for which payment
may be made in whole or in part under a Federal health care
program, or
(B) to purchase, lease, order, or arrange for or recommend
purchasing, leasing, or ordering any good, facility, service, or item
for which payment may be made in whole or in part under a Federal
health care program.
33
The Anti-Kickback Statute
What It All Means? - Prohibits anyone from
purposefully offering, soliciting, or
receiving anything of value to generate
referrals for items or services payable by
any Federal health care program.
42 States and D.C. have enacted antikickback statutes
34
Purpose of the Law
Prevent the corruption of medical decisionmaking
Prevent the overutilization of items or
services
Prevent unfair competition
35
Elements
Remuneration
Offered, Paid, Solicited, or Received
Knowingly & Willfully
To Induce or In Exchange for Federal
Program Referrals
36
Remuneration
Anything of value
“In-cash or in-kind”
Paid directly or indirectly
Examples: cash, free goods or services,
discounts, below market rent, relief of
financial obligations
37
Offered, Paid, Solicited, or Received
Different Perspectives – Payors and
Payees
“It Takes Two To Tango”
Old Focus: Payors Subject to Prosecution
New Focus: Payees (usually doctors)
38
To Induce Federal Program Referrals
Any Federal Health Care program
A nexus between payments and referrals
Covers any act that is intended to
influence and cause referrals to a Federal
Health Care program
One purpose test
39
Knowingly & Willfully
The Anti-Kickback law requires that the individual have a particular
“state of mind”, acting with knowledge and purpose when committing
the offense
This “Knowingly & Willfully” requirement has been interpreted
differently by the various Circuit Courts:
9th Circuit: Must have knowledge of the Anti-Kickback statute and
have specific intent to violate the statute
8th Circuit: Mere knowledge that the conduct was “wrongful”
satisfies the “Knowingly & Willfully” standard
11th Circuit: Must show that one acted with an intent to “disobey
or disregard” the law
40
Fines and Penalties
The Government may elect to proceed:
Criminally:
Felony, Imprisonment up to 5 Years & a fine up to $25,000, or both
Mandatory exclusion from participating in Federal Health Care programs
Brought by the DOJ
Civilly:
Violation is based on express or implied certification of compliance with violations
of the Anti-Kickback and Starks statutes
Penalties are same as under False Claims Act (more later)
Controversial, yet expanding use of the FCA
Administratively:
Monetary penalty of $ 50,000 per violation & assessment of up to three times the
remuneration involved
Discretionary exclusion from participating in Federal Health Care programs
Brought by the OIG
41
Exceptions and Safe Harbors
Many harmless business arrangements
may be subject to the Statute
Approximately 24 Exceptions (“SafeHarbors”) have been created by the OIG
Compliance is Voluntary
Must meet all conditions to qualify for Safe
Harbor protection
Is substantial compliance enough?
42
Statutory Exceptions
The 5 exceptions that have been enacted
by Congress:
1)Discounts and other price reductions
2)Payments to employees
3)An amount paid by a vendor of goods or
services to a group purchasing agent
4)Waiver of Part B co-payments by Federally
qualified health centers
5)“Shared Risk” exception
43
Regulatory Safe Harbors
Investments in large entities
Investments in small entities
Investments in small entities in
underserved areas
Investments in group practices
Investments in ambulatory surgical centers
(ASCs)
44
Additional Safe Harbors
Space and Rental Equipment
Personal Services and
management contracts
Employees
Discounts
Managed Care
Managed Care
“shared risk” arrangements
Practitioner recruiting in
underserved areas
Ambulance restocking
Sale of practice
Referral services
Warranties
Group purchasing
organizations
Routine waiver of co-payments
and deductibles
Subsidies for obstetrical
malpractice insurance in
underserved areas
Cooperative Hospital Services
Organizations
Specialty referral
arrangements between
providers
45
Guidance on the Anti-Kickback Statute
Advisory Opinions from the OIG
A party may request advice on the law, concerning 1)
remuneration within the meaning of the law, 2)
whether they are meeting one of the law’s exceptions
or safe harbors, or whether their arrangement
warrants the imposition of a sanction
Recent Advisory Opinions on Gainsharing
arrangements
Fraud Alerts and Special Advisory Bulletins
Preamble to the Safe Harbor Regulations
Compliance Program Guidance's
www.oig.hhs.gov
46
The Stark Law
Section 1877 of the Social Security Act, 42
U.S.C 1395nn
The law is complicated and consists of the
original statute (Stark I) and the amended
provisions (Stark II)
Most Stark II regulations went into effect in
2002, but some are still pending
47
The Stark Law
A Prohibition on Physician Self-Referrals
If a physician (or immediate family member)
has a direct or indirect financial relationship
(ownership or compensation) with an entity
that provides designated health services
(“DHS”), the physician cannot refer the patient
to the entity for DHS and the entity cannot
submit a claim for the DHS, unless the
financial relationship fits in an exception
48
Penalties
Nonpayment of claims
Civil Money Penalties of $ 15,000 for each
service rendered plus an Assessment of
three times the amount claimed
Penalty of up to $100,000 for
“Circumvention Scheme”
Don’t Forget FCA Liability
49
Difference Between Anti-Kickback
Statute and The Stark Law
Physician Referrals only
No “Knowingly and Willfully Standard” –
Strict Liability
Involves Designated Health Services
(DHS)
50
Types of Designated Health Care
Service (DHS)
Clinical laboratory
Physical therapy
Occupational therapy
Radiology and Imaging Services (MRI, CAT scan, ultrasound)
Radiation therapy & supplies
Durable medical equipment and supplies
Parenteral and enteral nutrients, equipment and supplied
Prosthetics, orthotics, and prosthetic devices and supplies
Home health services
Outpatient prescription drugs
Inpatient and outpatient hospital services
51
What is a Financial Relationship
Nearly any type of investment or compensation
agreement between the referring physician and the DHS
entity will qualify as a financial arrangement under the
Stark law
Examples:
Stock Ownership
Partnership Interest
Rental Contract
Personal Service Contract
Salary
Compensation agreements can be Direct or Indirect
Exceptions for certain indirect compensation arrangements
52
Exceptions
Compliance Is Mandatory
Types of Exceptions:
In-office ancillary services
Personal Physician Services by Member of Group Practice
Pre-Paid Health Plan
Certain Publicly Traded Securities
Rural provider (investment interests)
Hospital Ownership (must be in the “whole” hospital)
Rental of Office Space and Equipment
Bona Fide Employment
Personal Services Arrangement
Physician Recruitment
Fair Market Value Payment by Physicians
53
Additional Exceptions
Added in January 2002
Fair Market Value
compensation arrangements
Academic medical center
arrangements
Implants provided in an ASC
(Implants are DHS, but are not
included in the bundled
Medicare ASC payment)
EPO and other dialysis-related
drugs furnished in or by an
ESRD facility
Preventing screening tests,
immunizations, and vaccines
Eyeglasses and contact lenses
following cataract surgery
Non-monetary compensation
up to $300
Medical staff incidental
benefits provided by a hospital
Risk sharing arrangements
Compliance training
Indirect compensation
arrangements
54
The False Claims Act
31 U.S.C. § 3729, the False Claims Act (“FCA”) sets forth
seven bases for liability. The most common ones are:
1.
2.
3.
4.
Knowingly presenting, or causing to be presented, to the
Government a false or fraudulent claim for payment
Knowingly making, using, or causing to be made or used, a
false record or statement to get a false or fraudulent claim
paid
Conspiring to defraud the Government by getting a false or
fraudulent claim allowed or paid
Knowingly making, using, or causing to be made or used, a
false record or statement to conceal, avoid, or decrease an
obligation to pay or transmit money or property to the
Government
55
Elements of an FCA Offense
The Defendant must:
Submit a claim (or cause a claim to be
submitted)
To the Government
That is false or fraudulent
Knowing of its falsity
Seeking payment from the federal treasury
Damages (Maybe)
56
Knowing & Knowingly
No proof or specific intent to defraud is
required
The Government need only show Person:
Had “actual knowledge of the information”; or
Person acted in “deliberate ignorance” of the
truth or falsity of the information; or
Person acted in “reckless disregard” of the
truth or falsity of the information
57
Penalties
1.
2.
Civil penalty of no less than $5,500 and
no more than $ 11,000 per false claim
Three times the amount of damages
which the Government sustained
58
DEPARTMENT OF JUSTICE
INVESTIGATIVE GUIDELINES
Were false claims submitted by a provider with
knowledge of their falsity?
Was there actual or constructive notice of the rule or policy on
which a potential case would be based?
Was the rule or policy clear?
Does the size of the false claim support inference of knowledge
or inference of mistake?
What plans did the provider make to adhere to the rules?
Are there any past remedial efforts?
Did the provider receive guidance by program agents on the
issue?
Have there been previous audits to the provider of same or
similar billing errors?
59
Qui Tam Actions & Government Intervention
A private person (“Relator”) may bring a
False Claim Act actions under the qui tam
provisions of the FCA – The Whistleblower
Government may intervene in a suit
brought by Relator
The relationship between Relator and
Government
60
FCA Statistics
If the government intervenes and obtains recovery, the
Relator receives between 15% and 25% of the proceeds
Since 1986, of all of the qui tam actions filed, the
average yearly intervention rate has been about 25%
(approximately 300-400 cases)
About $1.5 billion of the $1.7 billion in health care FCA
recoveries in FY’ 03 were from whistleblowers
Recoveries Have Increased (higher penalties and
publicity)
Whistleblower protection is provided to those that take
lawful actions in furtherance of the qui tam suit, including
investigation, initiation, testimony for, or assistance in the
action
61
Role of the OIG in FCA Cases
May assist in the Investigation
Settles as client agency on behalf of HHS
Permissive exclusion authority
May waive exclusion authority in exchange for
Corporate Integrity Agreement
- Monitoring and Annual Reports
- Successor Liability
62
Types of FCA Cases
Unbundling (billing single service as if one service)
Services not rendered
Billing for items or services that are not covered
Upcoding
Duplicate billing
Submitting false or inflated cost reports
Quality of Care (“standard of care claims” or “worthless claims”)
Research Grant and Clinical Trial Fraud
Actions under the Food, Drug & Cosmetic Act
misbranding & adulteration of drugs and promotion of off label use
False Claims Act cases based on violations of the Stark Law
and/or the Anti-Kickback Statute (“Tainted Claims”)
63
OFFICE OF INSPECTOR GENERAL
WORK PLAN
2006
64
OIG Work Plan
Articulates areas of high compliance risk
Priorities for enforcement activity
Identify Federal Health Program vulnerabilities
Road map for compliance program effectiveness and
auditing and monitoring agenda for health care
organizations
Work plan assists in identification and focus for
compliance efforts for health care organizations.
65
Medicare Hospitals – Areas of Focus for
OIG Work Plan 2006
Adjustments for Graduate Medical Education Payments
Payments for Observation Services versus Inpatient Admissions for Dialysis Services
Medical Education Payments for Dental and Podiatry Residents
Nursing and Allied Health Education Payments
Inpatient Prospective Payment System Wage Indices
Inpatient Rehabilitation Facilities Payments
Inpatient Hospital Payments for New Technologies
Inpatient Psychiatric Hospitals
Inpatient Rehabilitation Payments – Late Assessments
Long Term Care Hospital Payments
Critical Access Hospitals
Organ Acquisition Costs
Rebates Paid to Hospitals
Coronary Artery Stents
Outpatient Outlier and Other Charge-Related Issues
Outpatient Department Payments
Unbundling of Hospital Outpatient Services
“Inpatient Only” Services Performed in an Outpatient Setting
Diagnosis-Related Group Coding
Hospital Reporting of Restraint-Related Deaths
66
Medicare Hospitals – Area of Focus
Added to OIG Work Plan 2006
Adjustments for Graduate Medical Education Payments
Payments for Observation Services versus Inpatient Admissions for
Dialysis Services
Inpatient Hospital Payments for New Technologies
Inpatient Psychiatric Hospitals
Outpatient Department Payments
Unbundling of Hospital Outpatient Services
“Inpatient Only” Services Performed in an Outpatient Setting
67
Medicare Hospitals – Areas of Focus
Continued from OIG Work Plan 2005
Medical Education Payments for Dental and Podiatry Residents
Nursing and Allied Health Education Payments
Inpatient Prospective Payment System Wage Indices
Inpatient Rehabilitation Facilities Payments
Long Term Care Hospital Payments
Critical Access Hospitals
Organ Acquisition Costs
Rebates Paid to Hospitals
Coronary Artery Stents
Outpatient Outlier and Other Charge-Related Issues
Diagnosis-Related Group Coding
Hospital Reporting of Restraint-Related Deaths
68
Deleted From OIG Work Plan 2005 and Not
Included in OIG Work Plan 2006
Quality of Improvement Organization Mediation of Beneficiary Complaints
Graduate Medical Education Voluntary Supervision in Non-hospital Settings
Postacute Care Transfers
Inpatient Outlier and Other Charge-Related Issues
Consecutive Inpatient Stays
Level of Care in Long-Term Care Hospitals
Outpatient Cardiac Rehabilitation Services
Lifetime Reserve Days
69
NEW FOCUS AREA FOR HOSPITALS
IN 2006 WORK PLAN
Only seven (7) focus areas in OIG Work Plan 2006 are areas not previously
identified in prior work plans. The most important areas of focus, from a
liability perspective, are as follows:
Payments for observation services versus inpatient admissions for
dialysis services
Payment for interrupted stays and outlier payments at inpatient
psychiatric hospitals
Payments for hospital outpatient departments for multiple procedures,
repeat procedures and global services
Unbundling of hospital outpatient procedures
The most important recurring areas of focus in 2006 OIG Work Plan are as
follows:
Outlier payments to hospital outpatient departments
Hospital reporting of restraint related deaths
Medicaid diagnosis related group payment for hospital services within
three days of admission.
70
RISK AREAS FOR PHYSICIANS
NEW FOCUS AREAS IN OIG WORK PLAN 2006
1.
2.
Duplicate physical therapy claims
Payment to physicians for initial preventative physical examinations pursuant to
coverage under the Medicare Modernization Act
Recurring Focus Areas
1.
2.
3.
4.
5.
6.
7.
8.
9.
Propriety of contractual relationships between physicians and billing companies
Payments to physicians employed at VA hospitals
Physician hospice care plan oversight
Excluded physicians ordering or performing services
In office pathology services
Cardiography professional and technical component billing
Authorization, medical necessity and physician certification for physical and
occupational therapy services
Medical necessity of physician office mental health services
Medical necessity of wound care services and claims by physicians.
71
OTHER AREAS OF
PHYSICIAN CONCERN
1.
Medical necessity for coronary artery stents
2.
Medical necessity of rehabilitation and infusion therapy services in
nursing home
3.
Medical necessity and excessive billing of imaging and laboratory
services in nursing homes
4.
Medical necessity and receipt of DME
5.
Reimbursement for Medicare drug benefit
6.
Focus on physician services in Independent Diagnostic Testing Facilities
(“IDTF’s”) regarding appropriate supervision and licensure of personnel
performing tests
7.
Medical necessity of CORF services
8.
Inappropriate payments and utilization of covered preventative care
services
9.
Physician prescribing of drugs, such as Oxycontin
72
Office of Inspector General
Office of Investigations (“OI”)
OI Conducts Investigations of Fraud and Misconduct and Health Care
Fraud
Identifies Systematic Weaknesses in Vulnerable Program Areas and
Recommends Management, Regulatory and Legislative Corrective Action
Provides Investigative Assistance in Criminal and Civil False Claims, Civil
Money Penalty and Exclusion Cases
Responds to Thousands of Complaints of Health Care Fraud from
Various Sources, including “Whistleblowers”
Provider Self-Disclosure Program
False Claims and Anti-Kickback Violations
73
Office of Inspector General
Office of Legal Counsel (“OCIG”)
Resolution of Civil False Claims Act cases and
negotiation of Corporate Integrity Agreements (“CIA”)
Providers compliance with Corporate Integrity
Agreements
Industry Guidance: Advisory Opinions and Fraud Alerts
Development of regulations, including safe harbors to the
Anti-Kickback Statute
Enforcement of the Civil Money Penalty and Exclusion
Statutes
Enforcement of the Patient Anti-Dumping Statute
74
HOSPICE
75
Hospice Providers
Hospice providers meet quality of care
standards
Provider oversight activities and quality of
care
Evaluate arrangements between Hospice and
nursing homes
76
Excluded Providers
Evaluating the extent to which Medicare is billed
for Part B services ordered by providers
excluded from the Medicare program
Part of physician section, but effects Medicare
Part B Services
Home Health
DME
Outpatient radiology
Laboratories
77
DRG Coding
Analysis
of “aberrant” coding patterns
78
Home Health
79
Outlier Payments
Long term high intensity cases where episode of
care costs exceed threshold amount.
Evaluate the frequency of outliers
Analysis
Payment is based on CMI and historical average
number of visits for a given diagnosis
Rural areas tend to have higher number of visits
per episode than urban
80
Enhanced Payment
Evaluate payment to HHA for therapy services
Number and duration of therapy services
Analysis
Following certain orthopedic procedures patients are
required to go home with therapy services rather than be
directly admitted to rehabilitation hospital
Places HHAs between rock and hard place
Accurate coding of diagnoses for patients being treated
by HHA
Completion of OASIS forms
81
Other HHA Topics
Survey certifications regarding quality of
care
Performed by the State
Follow-up on deficiencies in the nature
of “cyclical non-compliance”
82
Skilled Nursing Facilities
83
Rehab and Infusion Therapy
Analysis of whether rehab and infusion therapy services
were:
Medically necessary
Adequately supported in documentation
Actually provided
Analysis
Analyze MDs assessment data
Diagnosis coding
Facility
Professional
Professional billings
84
Imaging and Laboratory Services
Evaluate the medical necessity and excessive
billing for imaging and laboratory services
provided to nursing home residents
Evaluate a sample of services and examine
utilization patterns
Data Analysis
Diagnosis coding on claims
MDs data
Quality of Care
85
Other Topics
Consolidated billing
Payments for Day of Discharge
Consecutive Inpatient Stays
Deficiency Trends
Quality of Care
Enforcement Action Against Noncompliant
Nursing Homes
Compliance with Complaint Investigations
Immediate jeopardy
Actual harm
86
Medical Equipment &
Supplies
87
DME for Home Health
Medical necessity of durable medical equipment and
supplies
Analysis
OASIS data
Post orthopedic surgery cases receiving therapy?
Relationship between HHA and DME Company
88
DME Other Topics
Medical Necessity
Therapeutic Footware
Pricing of equipment and supplies
Home Glucose Testing Supplies
Test strips
Lancets
Analysis
Utilization of test strips
Based on type of diabetes
Diagnosis coding
– Insulin dependent
– Non-insulin dependent
89
Other Topics
Laboratory services during inpatient stays
Part B radiology services provided to inpatients
Separately billable lab services under ESRD
Lab proficiency testing
Quality of care in dialysis facilities
Ambulance services
Ground
Hospital inpatients
90
THE END
91