1. society
2. welfare
3. healthcare
4. hospital

Faculty Disclosures:
Billing and Coding in Long Term Care:
Miscellaneous Topics
Dr. Gelman has disclosed that he has no
relevant financial relationship(s).
May 19, 2010
presented by
Alva S. Baker, MD, CMD
An AMDA Webinar Series
presented by
LEONARD M. GELMAN, MD, CMD
ALVA S. BAKER, MD, CMD
CHARLES CRECELIUS, MD, PHD, CMD
Dr. B
D
Baker
k h
has di
disclosed
l
d th
thatt h
he h
has no
relevant financial relationship(s).
Dr. Crecelius has disclosed that he has no
relevant financial relationship(s).
Learning Objectives
• Discuss various topics related to correct coding
and billing, including, but not limited to, NPP
services, incident to services, gang visits, and
hospice care
MEDICARE CLAIMS
PROCESSING
MANUAL
• Discuss correct coding and billing for these
services as they relate to fraud and abuse
control initiatives in the current health care
reform environment
CMS Manuals
CMS Manuals
100
– cms.hhs.gov
Introduction
100-01 Medicare General Information, Eligibility and Entitlement
Manual
100-02 Medicare Benefit Policy Manual
100-03 Medicare National Coverage
g Determinations ((NCD)) Manual
– Look for Regulations and Guidance,
Internet Only Manuals
100-04 Medicare Claims Processing Manual
100-05 Medicare Secondary Payer Manual
100-06 Medicare Financial Management Manual
100-07 State Operations Manual
100-08 Medicare Program Integrity Manual
100-09 Medicare Contractor Beneficiary and Provider Communications
Manual
1
Medicare Claims Processing Manual Pub.100
Pub.100--04
Chapter 1 - General Billing Requirements
Chapter 2 - Admission and Registration Requirements
Chapter 3 - Inpatient Part A Hospital
Chapter 4 - Part B Hospital (Including Inpatient Hospital Part B and OPPS)
Chapter 5 - Part B Outpatient Rehabilitation and CORF Services
Chapter 6 - SNF Inpatient Part A Billing
Chapter 7 - SNF Part B (Including Inpatient Part B and Outpatient Fee Schedule)
Medicare Claims Processing
Manual
Manual – Chapter 12
–https://www2.cms.gov/manuals/downlo
ads/clm104c12.pdf (retrieved 05/18/10)
Chapter
p 8 - Outpatient
p
ESRD Hospital,
p
Independent
p
Facility,
y and Physician/Supplier
y
pp
Claims
Chapter 9 - Rural Health Clinics and Federal Qualified Health Centers
Chapter 10 - Home Health Agency Billing
Chapter 11 - Hospice
Chapter 12 - Physician/Practitioner Billing
Chapter 13 - Radiology Services
Chapter 14 - Ambulatory Surgical Centers
Chapter 15 - Ambulance
Chapter 16 - Laboratory Services from Independent Labs, Physicians, and Providers
Chapter 17 - Drugs and Biologicals
Medicare Claims Processing Manual,
Pub.100--04,
Pub.100
• 30.6.13 - Nursing Facility Services
Billing and Coding in Long Term Care:
Miscellaneous Topics
Start of Today’s Topics
A. Visits to Perform the Initial
Comprehensive Assessment and Annual
Assessments
B. Visits to Comply With Federal
Regulations (42 CFR 483.40 (c) (1)) in the
SNF and NF
C. Visits by Qualified Nonphysician
Practitioners
D. Medically Complex Care
30.6.13 C Visits by Qualified Nonphysician
30.6.13 C Visits by Qualified Nonphysician
Practitioners
Practitioners
•
State Regulations, State Scope of Practice
– “All E/M visits shall be within the State scope of
practice and licensure requirements where the
visit is performed and all the requirements for
physician collaboration and physician supervision
shall be met when performed and reported by
qualified NPPs.”
– “General physician supervision and employer
billing requirements shall be met for PA services
in addition to the PA meeting the State scope of
practice and licensure requirements where the
E/M visit is performed.”
•
Federally Mandated Visits
– SNF (31)
– “Following
g the initial visit by
y the p
physician,
y
, the
physician may delegate alternate federally
mandated physician visits to a qualified NPP who
meets collaboration and physician supervision
requirements and is licensed as such by the
State and performing within the scope of practice
in that State.”
2
30.6.13 C Visits by Qualified Nonphysician
MLN MATTERS NUMBER: SE1010
Practitioners
• The long-term care regulations at Section 483.40
require that residents of SNFs receive initial and
periodic personal visits. These regulations insure
that at least a minimal degree
g of ppersonal contact
between a physician or a qualified NPP and a
resident is maintained, both at the point of
admission to the facility and periodically during the
course of the resident's stay.
•
Federally Mandated Visits
– NF (32)
– Per the regulations at 42 CFR 483.40 (f), a
qualified NPP, who meets the collaboration and
physician supervision requirements, the State
scope of practice and licensure requirements,
and who is not employed by the NF, may at the
option of the State, perform the initial visit in a
NF, and may perform any other federally
mandated physician visit in a NF in addition to
performing other medically necessary E/M visits.
30.6.13 C Visits by Qualified Nonphysician
Order to
Admit
Admission
Treatment
Orders
Initial
Comprehen
sive Visit
Other
Required
Visits
NP & CNS employed by facility
N
N
N
Y
NP & CNS not a facility
employee
N
N
N
Y
PA regardless of employer
N
N
N
Y
NP, CNS & PA employed by
facility
N
N
N
N
NP, CNS & PA not a facility
employee
Y
Y
Y
Y
Practitioners
• “Questions pertaining to writing orders
or certification and recertification
issues in the SNF and NF settings
shall be addressed to the appropriate
State Survey and Certification Agency
departments for clarification.”
Other Medically
Necessary Visits
Other
Medically
Necessary
Orders
Certification/
Recertification
SNF
NP & CNS employed by
facility
Y
Y
N
NP & CNS not a facility
employee
Y
Y
Y
PA regardless of employer
Y
Y
N
NP, CNS & PA employed by
facility
Y
Y
Y
NP, CNS & PA not a facility
employee
Y
Y
Y
NF
SNF
NF
Billing and Coding in Long Term Care:
Miscellaneous Topics
Change in Topic
3
Medicare Claims Processing Manual,
Pub.100--04,
Pub.100
• 30.6.13 - Nursing Facility Services
Slide 20
Regulations for subacute care allow:
a. Weekly visits for physicians
b. Monthly visits for physicians
c. Weekly visits for NPP if not employed
by a NF
d. Payment for two visits in one day, if
medically necessary
e. None of the above
A. Visits to Perform the Initial
Comprehensive Assessment and Annual
Assessments
B. Visits to Comply With Federal
Regulations (42 CFR 483.40 (c) (1)) in the
SNF and NF
C. Visits by Qualified Nonphysician
Practitioners
D. Medically Complex Care
*
30.6.13 D Medically Complex Care
30.6.13 D Medically Complex Care
D. Medically Complex Care
D. Medically Complex Care
“Payment
y
is made for E/M visits to p
patients in a
SNF who are receiving services for
medically complex care upon discharge from
an acute care facility when the visits are
reasonable and medically necessary and
documented in the medical record.”
“Physicians and qualified NPPs shall report initial
nursing facility care codes for their first visit
with the patient.”
“The p
principal
p p
physician
y
of record must append
pp
the modifier
“-AI” Principal Physician of Record, to the initial nursing
facility care code when billed to identify the physician who
oversees the patient’s care from other physicians who may
be furnishing specialty care.”
Physicians and qualified NPPs shall report E/M
visits using the Subsequent Nursing Facility
Care, per day (codes 99307 - 99310) for
follow-up visits
Medicare Claims Processing Manual,
Pub.100--04,
Pub.100
• 30.6.13 - Nursing Facility Services
Billing and Coding in Long Term Care:
Miscellaneous Topics
E. Incident to Services
F. Use of the Prolonged
g Services Codes and
Other Time-Related Services
G. Gang Visits
Change in Topic
H. Split/Shared E/M Visit
I. SNF/NF Discharge Day Management
Service
4
60.1 -60.3 - Services of Nonphysician Personnel
Furnished Incident to Physician’s Services
Slide 25
“Incident to” rules allow:
a. Payment to both a NPP and Physician for
split services (same patient/same day)
b Payment in a nursing home as long as
b.
Place of Service Code 11 (office) is used
c. NPP to bill for a new problem
d. NPP to bill under the physician fee
schedule, even if the physician is not on
site
e. The physician to bill with physician UPIN for
services performed by a NPP.
*
“the service can be billed under the
Physicians UPIN/PIN, and payment will
be made at the appropriate physician fee
schedule payment
payment.”
*
30.6.13 E Incident To Services in the Nursing
Home
– Where a physician establishes an office in a
SNF/NF, the “incident to” services and
requirements are confined to this discrete
part of the facility designated as his/her
office.
– “Incident to” E/M visits, provided in a facility
setting, are not payable under the Physician
Fee Schedule for Medicare Part B.
Slide 29
The maximum number of NH visits that a
physician can perform in one day is:
a. 10
b 20
b.
c. 30
d. 40
e. Not defined
Billing and Coding in Long Term Care:
Miscellaneous Topics
Change in Topic
Medicare Claims Processing Manual,
Pub.100--04,
Pub.100
• 30.6.13 - Nursing Facility Services
E. Incident to Services
F. Use of the Prolonged Services Codes and
Other Time-Related Services
G. Gang Visits
H. Split/Shared E/M Visit
I. SNF/NF Discharge Day Management
Service
5
30.6.13 G Gang Visits
– “Claims for an unreasonable number of
daily E/M visits by the same physician to
multiple patients at a facility within a 24hour period may result in medical review
to determine medical necessity for the
visits.”
Billing and Coding in Long Term Care:
Miscellaneous Topics
Change in Topic
– Not quantified
Medicare Claims Processing Manual,
Pub.100--04,
Pub.100
• 30.6.13 - Nursing Facility Services
30.6.13 H Split/Shared Visits
•
Definition
–
a medically necessary encounter with a patient where the
physician and a qualified NPP each personally perform a
substantive portion of an E/M visit face-to-face with the
same patient on the same date of service.
–
The physician and the qualified NPP must be in the same
group practice or be employed by the same employer
–
Can be used for hospital inpatient, hospital outpatient,
hospital observation, emergency department, hospital
discharge, office and non facility clinic visits, and prolonged
visits associated with these E/M visit codes
E. Incident to Services
F. Use of the Prolonged Services Codes and
Other Time-Related Services
G. Gang Visits
H. Split/Shared E/M Visit
•
Nursing Facility
–
I. SNF/NF Discharge Day Management
Service
•
A split/shared E/M visit can not be reported in the SNF/NF
setting.
Also does not apply to critical care services or procedures
Slide 36
Concerning a discharge from a nursing home,
all of the following are true except:
a. Need a Face-to face encounter
b Need to be seen on day of discharge
b.
c. Can bill for discharge upon death only if
death personally pronounced by the
provider
d. Can cover activities over a period of time
e. Billing date is date of actual visit, even if
discharge is a different date
Billing and Coding in Long Term Care:
Miscellaneous Topics
Change in Topic
*
6
Medicare Claims Processing Manual,
Pub.100--04,
Pub.100
• 30.6.13 - Nursing Facility Services
30.6.13 I SNF/NF Discharge Day Management
– Requires a face-to-face visit
E. Incident to Services
F. Use of the Prolonged Services Codes and
Other Time-Related Services
G. Gang Visits
H. Split/Shared E/M Visit
I. SNF/NF Discharge Day
Management Service
– Reported for the date of the actual
y the p
physician
y
or q
qualified
visit by
NPP even if the patient is discharged
from the facility on a different
calendar date.
– 99315-99316
30.6.13 I SNF/NF Discharge Day Management
– Death
– “may be reported using CPT code
p
g on the
99315 or 99316,, depending
code requirement, for a patient who
has expired, but only if the physician
or qualified NPP personally
performed the death
pronouncement.”
Billing and Coding in Long Term Care:
Miscellaneous Topics
Change in Topic
Slide 42
MULTI--SITE SAME DAY VISITS
MULTI
Medicare pays the same physician on the
same date for the following combination
of services:
a Office visit and initial NH visit
a.
b. Hospital admission and NH visit
c. Hospital discharge and NH discharge
d. Hospital discharge and initial NH visit
e. Hospital visit and NH visit
7
MULTI--SITE SAME DAY
MULTI
Office/Outpatient/Emergency Department Visit
w/Nursing Facility Admission
MULTI--SITE SAME DAY
MULTI
Nursing Facility Visit
w/
Hospital Visit or Admission
Same MD, Same date
• Medicare does not pay for the office or ED visit
• M
Medicare
di
will
ill pay only
l IInitial
iti l N
Nursing
i F
Facility
ilit C
Care
code
•
Bundle E/M visits on the same date provided in sites other
than the nursing facility into the initial nursing facility care
code
• 30.6.7 - Payment for Office or Other Outpatient
Evaluation and Management (E/M) Visits
MULTI--SITE SAME DAY
MULTI
Hospital Discharge Management
w/
Nursing Facility Admission
Same MD, Same date
• Medicare
M di
d
does nott pay ffor th
the NH visit
i it
• Medicare will pay only Initial Hospital Care
code
• 30.6.9.1 - Payment for Initial Hospital
Care Services
Visits to Patients in Swing
Beds
• If the inpatient care is being billed by the hospital
as inpatient hospital care:
– hospital care codes apply.
Same MD,, Same date
•
Medicare does pay for the Hospital Discharge visit
(99238, 99239)
•
Medicare will also pay Initial Nursing Facility Care code
• If the inpatient care is being billed by the hospital
as nursing facility care:
– nursing facility codes apply.
30.6.9 D- Payment for Inpatient Hospital Visits - General
• 30.6.9.2 - Subsequent Hospital Visit and
Hospital Discharge Management
Physicians in Group Practice
30.6.5
Billing and Coding in Long Term Care:
Miscellaneous Topics
•Same Group - Same Specialty
• Bill and be paid as though they were single MD
One
e E&M
& code pe
per day pe
per p
problem
ob e
• O
• Can combine same day visits and submit appropriate
code
Change in Topic
• Unrelated problems: can submit different bills
•Same group – Different Specialty
• Bill and be paid without regard to membership in
group
8
Medicare Claims Processing Manual
Pub.100--04
Pub.100
Chapter 1 - General Billing Requirements
Chapter 2 - Admission and Registration Requirements
Chapter 3 - Inpatient Part A Hospital
Chapter 4 - Part B Hospital (Including Inpatient Hospital Part B and OPPS)
Billing and Coding in Long Term Care:
Miscellaneous Topics
Chapter 5 - Part B Outpatient Rehabilitation and CORF Services
Chapter 6 - SNF Inpatient Part A Billing
Chapter 7 - SNF Part B (Including Inpatient Part B and Outpatient Fee Schedule)
Chapter
p 8 - Outpatient
p
ESRD Hospital,
p
Independent
p
Facility,
y and Physician/Supplier
y
pp
Claims
Chapter 9 - Rural Health Clinics and Federal Qualified Health Centers
Chapter 10 - Home Health Agency Billing
Chapter 11 - Hospice
Change in Topic
Chapter 12 - Physician/Practitioner Billing
Chapter 13 - Radiology Services
Chapter 14 - Ambulatory Surgical Centers
Chapter 15 - Ambulance
Chapter 16 - Laboratory Services from Independent Labs, Physicians, and Providers
Chapter 17 - Drugs and Biologicals
Medicare Claims Processing
Manual
Medicare Claims Processing
Manual
Pub.100--04
Pub.100
Pub.100--04
Pub.100
Chapter 11 – HOSPICE
Chapter 11 – HOSPICE
• 40 - Billing and Payment for Hospice Services
Provided by a Physician
• 40 - Billing and Payment for Hospice Services
Provided by a Physician
– 40.1 - Types of Physician Services
– 40.1 - Types of Physician Services
• 40.1.1 - Administrative Activities
• 40.1.2 - Patient Care Services
• 40.1.3 - Attending Physician Services
• 40.1.1 - Administrative Activities
• 40.1.2 - Patient Care Services
• 40.1.3 - Attending Physician Services
• 50 - Billing and Payment for Services
Unrelated to Terminal Illness
• 50 - Billing and Payment for Services
Unrelated to Terminal Illness
Medicare Claims Processing Manual
Medicare Claims Processing Manual
Pub.100--04
Pub.100
Pub.100--04
Pub.100
Chapter 11 – HOSPICE
– 40.1 - Types of Physician Services
• 40.1.1 - Administrative Activities
• Payment for physicians’
physicians administrative and general supervisory
activities is included in the hospice payment rates.
• These activities include participating in the establishment, review
and updating of plans of care, supervising care and services and
establishing governing policies.
• These activities are generally performed by the physician serving
as the medical director (of the Hospice) and the physician member
of the interdisciplinary group (IDG).
• Nurse practitioners may not serve as or replace the medical
director or physician member of the IDG.
Chapter 11 – HOSPICE
– 40.1 - Types of Physician Services
• 40.1.2 - Patient Care Services
• Payment (to Hospices) for physicians or nurse practitioner serving
as the attending physician, who provide direct patient care
services and who are hospice employees or under arrangement
with the hospice, is made in the following manner:
• Hospices establish a charge and bills the FI (MAC) for these
services.
9
Medicare Claims Processing Manual
Medicare Claims Processing Manual
Pub.100--04
Pub.100
Pub.100--04
Pub.100
Chapter 11 – HOSPICE
– 40.1 - Types of Physician Services
• 40.1.3 - Attending Physician Services
• an “attending physician” means an individual who:
Chapter 11 – HOSPICE
– 40.1 - Types of Physician Services
• 40.1.3 - Attending Physician Services
•
– Is a doctor of medicine or osteopathy or
– A nurse practitioner ; and
– Is identified by the individual, at the time he/she elects hospice
coverage, as having the most significant role in the
determination and delivery of their medical care.
Medicare Claims Processing Manual
Medicare Claims Processing Manual
Pub.100--04
Pub.100
Pub.100--04
Pub.100
Chapter 11 – HOSPICE
Chapter 11 – HOSPICE
– 40.1 - Types of Physician Services
• 40.1.3 - Attending Physician Services
•
I order
In
d to
t bill M
Medicare
di
as an “attending
“ tt di physician:”
h i i ”
1. Not employed nor receives compensation by Hospice
2. Professional services only (not technical)
3. Can be in addition to the services of hospiceemployed physicians
4. The professional services of a non-hospice affiliated
attending physician for the treatment and
management of a hospice patient’s terminal illness
are not considered “hospice services.”
In order to bill Medicare as an “attending
g physician:”
y
5. Services are reasonable and necessary for the
treatment and management of a hospice patient’s
terminal illness
6. Services not furnished under a payment arrangement
with the hospice
7. Must be coordinated with any direct care services
provided by hospice physicians.
8. These services are coded with the GV modifier:
“Attending physician not employed or paid under
agreement by the patient’s hospice provider”
Medicare Claims Processing
Manual
•
– 40.1 - Types of Physician Services
• 40.1.3 - Attending Physician Services
g physician:”
p y
Can NOT bill Medicare as an “attending
– When services related to a hospice patient’s terminal
condition are furnished under a payment arrangement
with the hospice by the designated attending
physician, the physician must look to the hospice for
payment.
– In this situation the physicians’ services are hospice
services and are billed by the hospice to its FI (MAC).
Medicare Claims Processing
Manual
Pub.100--04
Pub.100
Pub.100--04
Pub.100
Chapter 11 – HOSPICE
Chapter 11 – HOSPICE
• 40 - Billing and Payment for Hospice Services
Provided by a Physician
– 40.1 - Types of Physician Services
• 40.1.1 - Administrative Activities
• 40.1.2 - Patient Care Services
• 40.1.3 - Attending Physician Services
• 50 - Billing and Payment for Services
Unrelated to Terminal Illness
• 50 - Billing and Payment for Services
Unrelated to Terminal Illness
– Any covered Medicare services not related to the
treatment of the terminal condition for which hospice
care was elected, and which are furnished during a
hospice election period, may be billed by the
rendering provider to the carrier for non-hospice
Medicare payment.
– These services are coded with the GW modifier:
“service not related to the hospice patient’s terminal
condition”
10
Hospice -Summary
• Care not related to terminal illness
Billing and Coding in Long Term Care:
Miscellaneous Topics
• Bill Medicare – modifier GW
• Care related to terminal illness
• MD not associated with hospice
Change in Topic
• Bill Medicare – modifier GV
• MD associated/employed with hospice
• Bill Hospice / Contract
Care Plan Oversight
99374--5(HH) 99377
99374
99377--8(HOSPICE)
99379--80(NH)
99379
• Medicare does not pay separately for
CPO in Nursing Home
Billing and Coding in Long Term Care:
Miscellaneous Topics
• “Bundled” into NH visits
• Suggestion : document work done, add
into next progress note
Change in Topic
a potpourri
•Not delineated in Manual
Place of Service
NF Codes
Employment and Medicare Billing
– “A physician who is employed by the SNF/NF may
perform the E/M visits and bill independently to
Medicare Part B for payment.
– An NPP who is employed by the SNF or NF may
perform and bill Medicare Part B directly for those
services
i
where
h
it iis permitted.
itt d
– The employer of the PA shall always report the
visits performed by the PA.
– A physician, NP or CNS has the option to bill
Medicare directly or to reassign payment for
his/her professional service to the facility.”
– 30.6.13 - Nursing Facility Services
Facility
SNF
POS 31
A patient for whom the facility is receiving payment
under Medicare Part A (Medicare Stay, Part A Stay)
n
Non-Facility
Non
Facility
NF
POS 32
n
Do not have Part A SNF benefits
n
Patients who are in a Nursing Facility
n
In a non-covered SNF stay
nPOS
nPOS
54 (Intermediate Care Facility/Mentally Retarded)
56 (Psychiatric Residential Treatment Center)
31-32 Fee differential lost in 2005
Still need to code appropriately
11
PER DAY SERVICE
– “The Nursing Facility Services codes
represent a “per day” service.”
– “Carriers shall not pay for more than one
E/M visit performed by the physician or
qualified NPP for the same patient on the
same date of service. “
Slide 68
All Evaluation and Management codes
require which one of the following:
a. A physical exam
b A medical
b.
di l hi
history
t
c. Medical decision-making
d. A face-to-face encounter
e. C and D
– 30.6.13 - Nursing Facility Services
Face to Face Encounter
vs. Physical Exam
• All E&M codes require a face to
face contact (Including NF Discharges)
• Physical exam not required for all
E&M codes
• 2 of 3 (Hx, Exam, Medical decision making)
for subsequent NF visits
Assuming Care from
Another Provider
• Need to use appropriate E&M code
• Usually
y 99309 level
• Need to document appropriately
• Can not use 99304-6 codes unless
newly admitted into facility
• Still need face to face contact
Use of Templates for
Visits
• Acceptable
• Caveat: must perform all items
checked or delineated in chart
record
• Suggestion: have nurses
document briefly extent of your
visit
Slide 72
Medicare pays the physician for which one
of the following in the nursing home?
a. Care plan oversight
b Inpatient
b.
I
ti t consultations
lt ti
c. Telephone calls
d. Specialist care
e. Interdisciplinary team meetings
12
Interdisciplinary Team Meetings (old)
Medical Team Conferences (new)
Telephone Calls
• 99361-99362 deleted
• Old codes: 99371-99373 -deleted
• 99366: MTC w/ face to face
• New Codes: 99441-99443
• 99367: MTC w/o face to face w/MD
• Medicare does not pay separately for
telephone calls
• 99368: MTC w/o face to face w/ NPP
•
Medicare does not pay separately for MTC meetings in NH
•
“Bundled” into NH visits
•
Suggestion : document meeting, add into next progress note
• “Bundled” into NH visits
• Suggestion : document calls, add into next
progress note
•Not delineated in Manual
•Not delineated in Manual
•
Subacute Care
• Medicare does not recognize “Subacute
Care” per se
• “All
All medically necessary visits for the
diagnosis or treatment of illness or injury or
to improve the functioning of a malformed
body member are covered under Medicare
Part B,” if properly documented
• 30.6.13 D Medically Complex Care
Pressure Ulcers
• AHRQ Guidelines: evaluate weekly
• Evaluations may be medically
necessary especially if types of
necessary,
treatments are changing
• Can not get paid for dressing changes
only
• Can get paid for debridement
Preservice (24hrs)/postservice (7 days)
Medical Director
Covering of Patient Visits
• Regulatory issues – need to have visits
performed in timely manner
• Emergency care
• Liability issues – knowledge of patient,
malpractice vs.. administrative?
• Payment issues – Medical Director not
Attending or “Consultant”
• Administrative function covered under
contract?
80.3 - Unusual Travel (CPT Code 99082)
• In general, travel has been incorporated
in the MPFSDB individual fees and is
thus not separately payable.
• Carriers must pay separately for
unusual travel (CPT code 99082) only
when the physician submits
documentation to demonstrate that the
travel was very unusual.
13
210 - Outpatient Mental Health
Treatment Limitation
• Expenses a beneficiary incurs in connection
with the treatment of mental, psychoneurotic,
and personality disorders- payment limited to
62.5 percent of the Medicare approved
amount for those services
210 - Outpatient Mental Health
Treatment Limitation
•
•The term “mental, psychoneurotic, and personality
disorders” is defined as the specific psychiatric
diagnoses described in the ICD-9, under the code
range 290-319
•
• Effective January 1, 2010, through January
1, 2014, the limitation will be phased out
Disorders Subject to the Limitation
Services Not Subject to the Limitation
•1. Diagnosis of Alzheimer’s Disease or Related
Disorder
•2. Brief Office Visits for Monitoring or Changing
Drug Prescription
•3. Diagnostic Services
The Law
Billing and Coding in Long Term Care:
Miscellaneous Topics
Fraud and Abuse
Changes
• Anti-Kickback Statute – amended
– relax the ‘intent to violate’ proscription
– excludes from its definition any remuneration
that promotes access to care and poses a low
risk of harm to patients and federal healthcare
programs
• False Claims Act Qui Tam Public
Disclosure Bar
– the original source (whistleblower) no longer
has to have direct knowledge
• The Patient Protection and Affordable
Care Act of 2010, as amended by the
Health Care and Education Reconciliation
Act of 2010 (the Healthcare Reform Law)
Law),
contains more than 32 sections related to
healthcare fraud and abuse and program
integrity and makes significant
amendments to existing criminal, civil, and
administrative anti-fraud statutes.
Changes
• Overpayments and False Claims Act
Liability
– identified overpayments must be reported and
returned (repaid) within 60 days to the
applicable government contractor
contractor,
intermediary, or carrier
– overpayment obligation should be viewed in
context with
• increased government audits under the Recovery
Audit Contractor (RAC) program
• the new self-disclosure protocol for Stark Law
physician self-referral violations
14
Changes
• Stark Law Self-Disclosure Protocol
– the Healthcare Reform Law creates a
statutory disclosure protocol for violations of
the physician self-referral prohibitions, known
as the Stark Law
– a violation results in an overpayment liability
to the government under a strict liability
standard without regard to intent
– the CMS protocol for self-disclosure will be
developed in 2010
Changes
• Healthcare Fraud Criminal Statute
– the U.S. Sentencing Guidelines are also
amended with respect to individuals convicted
of healthcare offenses related to any federal
healthcare program
– the offense level for such individuals is
increased anywhere from 20 to 50 percent
where the loss involves more than a million
• See attached handout from Morgan, Lewis
& Bockius LLP
Changes
• Healthcare Fraud Criminal Statute
– the Healthcare Reform Law amends the intent
requirement contained in the healthcare fraud
criminal statute
• now
now, provides that proof of actual knowledge of the
healthcare fraud statute or specific intent to violate
the statute is not required
• definition of healthcare offense is also amended to
include violations of the AKS, the Food Drug and
Cosmetic Act, and certain ERISA provisions
Summary
• Discussed various topics related to correct
coding and billing, including NPP services,
incident to services, gang visits, hospice care
and a variety of others
• Discussed correct coding and billing for these
services as they relate to fraud and abuse
control initiatives in the current health care
reform environment
Slide 90
Billing and Coding in Long Term Care:
Miscellaneous Topics
Some Final Thoughts
The CPT codes are made by
a. CMS
b. AMDA
c. Medicare Carriers
d. AMA
e. An act of Congress
f. An act of God
15
EXERCISE 6
• You are asked by staff to sit in on a care plan
meeting about a 82 year old patient who is
not present with a recent CVA who is not
progressing well in physical rehabilitation.
Slide 93
Which of the following are required to bill a
99306?
a. Physical
b History
b.
Hi t
c. Medical decision making
d. Face to face service time
e. all of the above
EXERCISE 13
• Telephone call by nursing to assess patient
with chronic atrial fibrillation with an
abnormal Prothrombin time of INR 3.8, no
bleeding noted, no other symptoms noted
Slide 92
Which of the following is NOT required to bill
99305?
a. Moderate to high medical decision
making
b. Comprehensive exam
c. Complete history
d. New MDS
e. Face to face encounter
Slide 94
Which criterion does not fulfill a requirement
in order to bill 99316
a. Less than 30 minutes service time
b Final
b.
Fi l exam
c. Instructions for continuing care
d. Preparation of discharge records
e. Prescriptions
Slide 96
Which of the following are required to bill a
99310?
a. Physical
b History
b.
Hi t
c. Medical decision making
d. a and b and c
e. none of the above
16
Slide 97
What elevates medical decision making
from a moderate to a high level?
a. acute uncomplicated illness
b. 3 or more self-limited or minor
problems
c. Prescription meds
d. 4 or more stable chronic problems
e. Acute threat to life
EXERCISE 21
• 92 year old woman with history of dementia,
ASCVD, and DM who was a DNR and was
found by the nursing staff without pulse or
respirations at the time you were in the
nursing
i h
home.
*
EXERCISE 29
• Family of a 91 year old patient admitted to the
facility one week ago with progression of
dementia requests a meeting to review
patients status and medications.
EXERCISE 33
• A patient who was seen on Monday
for a discharge on Friday, develops
pneumonia on Thursday, you call in
treatment and have the discharge
cancelled.
17
Healthcare Reform Law: Healthcare Fraud and Abuse and
Program Integrity Provisions
March 31, 2010
The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education
Reconciliation Act of 2010 (the Healthcare Reform Law), contains more than 32 sections related to
healthcare fraud and abuse and program integrity and makes significant amendments to existing
criminal, civil, and administrative anti-fraud statutes. The new program integrity provisions impose
substantial requirements that will compel updates and enhancements to business operations, commercial
transactions, and compliance policies in every sector of the health industry. These provisions establish
fundamental expectations for regulatory compliance, disclosure, transparency, and quality of care and
are matched by extraordinary enforcement provisions that could greatly increase potential legal
exposure. Healthcare entities should reinforce their broad and sustained commitment to compliance to
successfully implement these provisions.
This alert presents a brief summary of the major fraud and abuse provisions in the Healthcare Reform
Law as well as an overview of the program integrity provisions. Morgan Lewis has also prepared a
detailed chart1 outlining the fraud and abuse and program integrity provisions in the Healthcare Reform
Law, many of which we note became effective on the date of enactment, March 23, 2010, and will
require prompt compliance attention.
These provisions will also significantly impact government audit, investigation, and litigation resources
and the structure for intra-agency cooperation. To address the impact on key program integrity and law
enforcement agencies, the Healthcare Reform Law provides for the HIPAA Fraud and Abuse Control
Program and the Medicare Integrity Program to receive total funding of $100 million for FY 2011
through 2020 under the March 23, 2010 legislation and an additional $250 million for FY 2011 through
2016 under the Reconciliation legislation, for a total of $350 million.
Morgan Lewis will continue to monitor and report on developments in healthcare fraud and abuse and
program integrity matters.
I.
FRAUD AND ABUSE PROVISIONS
A.
Anti-Kickback Statute. The fraud and abuse amendments that may have the greatest impact on
the healthcare industry in a direct and daily fashion are the amendments to the federal Anti-Kickback
1
This chart is also available at http://www.morganlewis.com/pubs/FraudAbusePrgmIntegrityProvisions.pdf.
For AMDA webinar, this chart is appended to this document.
1
Statute (AKS). Healthcare arrangements and transactions directly and indirectly related to federal
healthcare programs are regulated by the criminal and administrative provisions of the AKS. Violations
of the AKS have resulted in significant False Claims Act liability for many healthcare entities. The
amendments to the AKS will impact fraud and abuse counseling and liability evaluations in criminal and
civil government investigations and judicial proceedings.
Under the Healthcare Reform Law, the AKS is amended to relax the specific intent requirement
judicially recognized in U.S. v. Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995). The
amendment provides that an AKS violation may be established without showing that an individual knew
of the statute’s proscriptions and intended to violate the statute. This new standard will impact
transaction and arrangements counseling and could potentially create significant criminal and civil fraud
exposure for transactions and arrangements where there is no intent to violate the statute.
The AKS is further amended to explicitly provide that a violation of the statute constitutes a false or
fraudulent claim under the False Claims Act. This amendment may have its most significant impact on
downstream liability scenarios involving manufacturers and other entities that do not themselves submit
claims to the government under the “caused the submission of a false claim” liability provisions of the
False Claims Act.
Interestingly, in Section 6402 of the Healthcare Reform Law, the definition of remuneration, the
touchstone for the general application of the statute, is amended for the beneficiary inducement
provisions under the civil monetary provisions of the AKS’s Section 1320a-7a, to exclude from the
definition, among other things, any remuneration that promotes access to care and poses a low risk of
harm to patients and federal healthcare programs. The beneficiary inducement statute does not apply
directly to manufacturers but does apply to providers, practitioners, suppliers, health plans and other
healthcare services entities. This definitional change is potentially significant as many health industry
activities may come within this broad exclusion and will require thoughtful assessment in fraud and
abuse transaction counseling.
B.
False Claims Act Qui Tam Public Disclosure Bar. The Healthcare Reform Law makes a
significant change to the jurisdictional bar that has historically served as a strong protector of health and
other industries from parasitic and opportunistic qui tam suits that do not advance the public interest in
the context of Department of Justice declined whistleblower qui tams. The False Claims Act previously
contained a “public disclosure” jurisdictional element that required dismissal of a qui tam suit pursued
by the private citizen (relator) where the allegations had been publicly disclosed in a criminal, civil, or
administrative proceeding; a congressional, administrative, or GAO report, hearing, audit, or
investigation; or in the news media. The scope of this bar had been judicially extended to include state
proceedings and this expansion was affirmed by the U.S. Supreme Court in Graham County Soil &
Water Conservation District v. U.S. ex rel. Wilson (No. 08-304), issued March 30, 2010, after the
enactment of the Healthcare Reform Law.
The False Claims Act is now amended to provide that the public disclosure bar is not jurisdictional and
does not require dismissal if the government opposes dismissal. Public disclosure is also now limited to
federal criminal, civil, and administrative proceedings in which the government or its agent is a party;
and federal reports, hearings, audits, or investigations. State proceedings and private litigation (for
example, employment, shareholder suits) are not qualifying public disclosures. Importantly, news media
reports, and by logical extension social media, remain a qualified public disclosure.
Where there has been a public disclosure, the relator may only proceed with the action if he or she is the
original source of the information. Prior to the amendments contained in the Healthcare Reform Law, to
2
qualify as an original source, the relator had to have direct and independent knowledge of the
allegations.
The original source exception is now amended to eliminate the direct knowledge requirement and
provides that to qualify as an original source (1) the relator must provide the information to the
government prior to the public disclosure, and (2) the information must be independent of and materially
add to the publicly disclosed allegations.
Unlike the 2009 False Claims Act amendments, which contained express retroactivity provisions, the
2010 public disclosure amendments contain no retroactivity provision. Courts generally have found that
False Claims Act amendments, including the 2009 amendments, are not retroactive. In Graham County,
the majority opinion, authored by Justice Stevens, noted that because the 2010 False Claims Act
amendments contain no retroactivity provisions, the public disclosure amendments are not retroactive.
This means that 2010 False Claims Act amendments do not apply to cases pending on or before March
23, 2010.
While the public disclosure bar remains an important check on abusive qui tam suits, the amendments
add significant litigation complexity and cost to declined qui tam actions and ensure that the Department
of Justice has a prominent role in determining a relator’s status to proceed with the declined qui tam
action. To avoid abusive suits that do not advance the public interest, it will be critical that DOJ develop
fair and balanced objective criteria to assess its now mandatory role in declined qui tams that involve
pubic disclosure issues. It will be necessary for qui tam defense counsel to assess public disclosure
issues well in advance of the government’s intervention decision to positively impact both DOJ’s and
the trial court’s consideration of this important legal defense.
C.
Overpayments and False Claims Act Liability. Section 6402 of the Healthcare Reform Law
provides that identified overpayments must be reported and returned (repaid) within 60 days to the
applicable government contractor, intermediary, or carrier. The retention of any overpayment after the
60-day period constitutes an “obligation” under the False Claims Act. Under the 2009 amendments to
the False Claims Act, the definition of “obligation” was expanded to expressly include “retention of
overpayments.”
The concept of “identified” overpayments in the Healthcare Reform Law is not defined. There are a host
of duplicative and confusing statutory concepts between Section 6402 and the current version of the
False Claims Act that it will be necessary to work through in providing compliance guidance. What is
clear, however, is that the government’s position will be that any delay in processing a known
overpayment creates the potential for False Claims Act liability—a potential that has always existed in
healthcare fraud enforcement and has been the basis for numerous False Claims Act settlements over the
last 20 years.
Healthcare providers, suppliers, and health plans should ensure compliance with the new overpayment
provision by putting in place robust auditing and refund processing structures. The overpayment
obligation should be viewed in context with increased government audits under the Recovery Audit
Contractor (RAC) program for federal healthcare programs, as well as with the new self-disclosure
protocol for Stark Law physician self-referral violations, which should provide an opportunity for
reasonable overpayment settlements under the identified criteria.
D.
Stark Law Self-Disclosure Protocol. The Healthcare Reform Law creates a statutory disclosure
protocol for violations of the physician self-referral prohibitions, known as the Stark Law. Under the
Stark Law, a violation results in an overpayment liability to the government under a strict liability
3
standard without regard to intent. 42 U.S.C. § 1395nn(g)(2) and 42 C.F.R. § 411.353(d). Because the
Stark Law imposes extraordinary financial liability for technical violations, there was an industry need
for a fair and principled process to disclose and resolve Stark Law violations with CMS. Significantly,
the new protocol will provide for agency discretion to resolve Stark violations and authorizes HHS to
reduce the amount due and owing for all violations under the Stark Law, considering such factors as the
nature and extent of the improper practice, timeliness of the disclosure, cooperation, and other factors in
the agency’s discretion. The Stark self-disclosure process will be critical to both the healthcare
community and HHS in reasonably and fairly managing the expected discovery of technical Stark
violations from enhanced compliance reviews.
The CMS protocol for self-disclosure will be developed in the next six months. Healthcare providers and
suppliers need to assess disclosure efforts in context with the new overpayment provision in Section
6402, which is effective now. There will continue to be a significant potential for False Claims Act
exposure for Stark Law violations through qui tam whistleblower suits.
E.
Expanded Recovery Audit Contractor Activities (RAC). RAC audits of providers will
increase and also expand to the Medicare Part D and Medicare Advantage healthcare programs. RAC
auditors are compensated, in part, through a bounty process that includes a percentage of any amounts
recovered through the audit. Healthcare providers and health plans will need to resource both internal
audit activities as well as responses to RAC requests. Because RACs operate on behalf of the
government, and may make program integrity and fraud referrals to law enforcement, it is necessary to
structure audit responses to RACs with the same degree of diligence as a direct government request,
including documenting interactions with RAC representatives.
F.
Healthcare Fraud Criminal Statute. The Healthcare Reform Law amends the intent
requirement contained in the healthcare fraud criminal statute, 18 U.S.C. § 1347. That statute now
provides that proof of actual knowledge of the healthcare fraud statute or specific intent to violate the
statute is not required. The definition of healthcare offense, 18 U.S.C. § 24(a), is also amended to
include violations of the AKS, the Food Drug and Cosmetic Act, and certain ERISA provisions.
The U.S. Sentencing Guidelines are also amended with respect to individuals convicted of healthcare
offenses related to any federal healthcare program. The offense level for such individuals is increased
anywhere from 20 to 50 percent where the loss involves more than a million. In a highly regulated
industry, with a myriad of complex regulations, these provisions effectively increase exposure for a
broad array of business and regulatory activities where there is no specific intent to violate the
provisions of the statute.
II.
PROGRAM INTEGRITY PROVISIONS
The Healthcare Reform Law contains a host of program integrity provisions that will impact business
operations and require enhanced procedures and policies in all health industry sectors. Some of these
provisions, if violated, may comprise a basis for overpayment or fraud liability. These provisions
include new employee and vendor screening requirements, new financial disclosure requirements, the
requirement of face-to-face physician and patient encounters for DME and home health services, and
new price reporting requirements in the 340B program. Of special note in the program integrity
provisions is the requirement that Medicare and Medicaid providers and suppliers, effective January 1,
2011, include their national provider identifier on all program applications and claims.
If you have any questions or would like more information on any of the issues discussed in this
LawFlash, please contact the authors of this LawFlash, Kathleen McDermott (202.739.5458;
4
[email protected]) and Meredith S. Auten (215.963.5860; [email protected]),
or any of the following key members of our cross-practice Healthcare Reform Law resource team:
FDA & Healthcare Practice
Joyce A. Cowan
Washington, D.C.
Kathleen M. Sanzo
Washington, D.C.
202.739.5373
202.739.5209
[email protected]
[email protected]
Employee Benefits & Executive Compensation Practice
Andy R. Anderson
Chicago
312.324.1177
Steven D. Spencer
Philadelphia
215.963.5714
[email protected]
[email protected]
Antitrust Practice
Thomas J. Lang
Scott A. Stempel
[email protected]
[email protected]
Washington, D.C.
Washington, D.C.
202.739.5609
202.739.5211
Business & Finance Practice –
Mergers & Acquisitions, Securities, Emerging Business & Technology
Marlee S. Myers
Pittsburgh
412.560.3310 [email protected]
Scott D. Karchmer
San Francisco
415.442.1091 [email protected]
Randall B. Sunberg
Princeton
609.919.6606 [email protected]
Business & Finance Practice –
Insurance Regulation
David L. Harbaugh
Philadelphia
215.963.5751
[email protected]
Labor & Employment Practice
Joseph J. Costello
Philadelphia
John F. Ring
Washington, D.C.
215.963.5295
202.739.5096
[email protected]
[email protected]
Life Sciences Practice
Stephen Paul Mahinka
202.739.5205
[email protected]
213.612.7375
215.963.4824
215.963.5892
215.963.5103
[email protected]
[email protected]
[email protected]
[email protected]
Washington, D.C.
Litigation Practice –
Commercial & Products Liability
Kathleen M. Waters
Los Angeles
John P. Lavelle, Jr.
Philadelphia
Coleen M. Meehan
Philadelphia
Brian W. Shaffer
Philadelphia
Litigation Practice –
Corporate Investigations & White Collar Practice
Lisa C. Dykstra
Philadelphia
215.963.5699
Jack C. Dodds
Philadelphia
215.963.4942
Eric W. Sitarchuk
Philadelphia
215.963.5840
[email protected]
[email protected]
[email protected]
Tax Controversy & Consulting Practice
Gary B. Wilcox
Washington, D.C.
Barton W. Bassett
Palo Alto
[email protected]
[email protected]
202.739.5509
650.843.7567
Washington Government Relations & Public Policy Practice
Fred F. Fielding
Washington, D.C.
202.739.5560 [email protected]
5
About Morgan, Lewis & Bockius LLP
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please visit us online at www.morganlewis.com.
This LawFlash is provided as a general informational service to clients and friends of Morgan, Lewis & Bockius LLP. It should not be construed as, and does not constitute, legal advice on any
specific matter, nor does this message create an attorney-client relationship. These materials may be considered Attorney Advertising in some states.
Please note that the prior results discussed in the material do not guarantee similar outcomes.
© 2010 Morgan, Lewis & Bockius LLP. All Rights Reserved.
6
Fraud and Abuse and Program Integrity Provisions
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
EFFECTIVE
DATE
FRAUD AND ABUSE
1
Overpayments
Sec. 6402 (42
U.S.C. § 1301 et.
seq.)
 Overpayments must be reported and returned within 60
days of identity or the date a corresponding cost report is
due, which ever is later. Repayments may be made to
the carrier, contractor, or intermediary.
March 23, 2010
 Any overpayment retained after the 60-day deadline is
considered an obligation for purposes of the False
Claims Act.
 2009 False Claims Act amendments provided an
expanded definition of obligation. 31 U.S.C. 3729(b)(3).
2
Medicare SelfReferral
Disclosure
Protocol
Sec. 6409

Establishes a self-referral disclosure protocol (SRDP)
for healthcare providers and suppliers to disclose an
actual or potential violation of the Federal Physician
Self-Referral Law (Stark Law).

Authorizes HHS discretion to reduce the amount due
and owing for all violations under the Stark Law to an
amount less than that specified in the statute. In
establishing the amount due, the following factors may
be considered:
 Nature and extent of the improper or illegal practice
 Timeliness of such self-disclosure
SRDP
procedures to be
established no
more than six
months from the
date of
enactment,
March 23, 2010
Procedures to
be established in
consultation with
the OIG.
 Cooperation in providing additional information
related to the disclosure
 Such other factors as the Secretary considers
appropriate
3
4
Medicare/
Medicaid AntiKickback
Statute (AKS)
Amendments.
Sec. 6402 (42
U.S.C. § 1320a7b)
 A claim that includes items or services resulting from a
violation of the AKS constitutes a false or fraudulent
claim for purposes of the False Claims Act.
AKS CMP
Remuneration
Definition
Amended
Sec. 6402 (42
U.S.C. § 1320a-
Relevant to the beneficiary inducement provisions,
remuneration does not include:
March 23, 2010
 A person need not have actual knowledge of the AKS
nor specific intent to commit an AKS violation.

Any remuneration which promotes access to care and
poses a low risk of harm to patients and federal
healthcare programs.

Offer or transfer by a retailer of coupons, rebates, or
March 23, 2010
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
7a(i)(6))
5
6
7
EFFECTIVE
DATE
other rewards if certain conditions are met.

Offer or transfer of items or services for free or less than
fair market value by a person to an individual in financial
need if certain conditions are met.

After January 1, 2011, the waiver by a PDP sponsor MA
organization of any copayment for an enrollee’s first fill
of a covered part D generic drug.
Expansion of
Recovery Audit
Contractor
(RAC) Program
Sec. 6411 (42
U.S.C. §
1396a(a)(42))
Mandates the expansion of the RAC program into Medicaid
by requiring states to contract by December 31, 2010 with
one or more RACs to identify underpayments and
overpayments and recoup overpayments for Medicaid
services.
Sec. 6411 (42
U.S.C. §
1395ddd(h))
Mandates the expansion of the RAC program to Medicare
Parts C and D by requiring HHS Secretary to contract with
RACs to, among other things, ensure that each Part C MA
plan and each Part D prescription drug plan has an antifraud plan in effect and to review the effectiveness of such
anti-fraud plan.
Sec. 6411
Requires CMS to submit an annual report to Congress
regarding the effectiveness of the RAC program under
Medicare and Medicaid.
Medicaid State
Plans –
Additional
Requirements
Sec. 6501 (42
U.S.C. §
1396a(a)(39))
Mandatory Medicaid termination if an individual or entity is
terminated by Medicare or another Medicaid program.
Sec. 6502 (42
U.S.C. §
1396a(a))
Mandatory Medicaid exclusion of individuals or entities that
own, control, or manage an entity that (1) has unpaid
overpayments determined to be delinquent; (2) is
suspended, excluded, or terminated from participation; or (3)
is affiliated with a suspended, excluded, or terminated
individual or entity.
Sec. 6503 (42
U.S.C. §
1396a(a))
Mandatory registration by agents, clearinghouses, or other
alternate payees that submit claims on behalf of healthcare
providers with the state and the HHS Secretary.
Sec. 6505 (42
U.S.C. §
1396b(a))
Bars Medicaid payments for items or services to any
financial institution or entity located outside the United
States.
False Claims
Act-Public
 Public disclosure no longer an issue of jurisdiction but
amendments do subject declined qui tam actions to
2
March 23, 2010
January 1, 2011,
unless state
legislation is
required.
March 23, 2010
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
Disclosure Bar
to Qui Tam
Actions
Sec. 10104(j) (31
U.S.C. §
3730(e)(4))
EFFECTIVE
DATE
dismissal if allegations are publicly disclosed and relator
is not original source.
 DOJ may oppose dismissal of action where allegations
are publicly disclosed and relator is not original source.
 Limits public disclosures to federal criminal, civil, or
administrative hearings in which the government is a
party and to federal reports, hearings, audits or
investigations. State proceedings and private litigation are
not qualifying disclosures.
 News media reports remain a qualifying disclosure to bar
qui tam suits
 Expands definition of “original source” to include (i) an
individual who discloses to the government the
information on which the claims are based prior to the
public disclosure and (ii) an individual who provides
independent knowledge that adds materially to the
publicly disclosed information to the government before
filing an action.
8
Healthcare
Fraud Offense
Sec. 10606
(18 U.S.C. §
1347; 18 U.S.C. §
24(a))
 Amends 18 U.S.C. § 1347 criminal healthcare fraud
statute to reduce intent required to establish a healthcare
fraud offense violation. Knowing and willful standard does
not require proof of actual knowledge of healthcare fraud
statute or specific intent to violate the statute. Similar
amendment to anti-kickback statute. Sec. 6402 (42
U.S.C. § 1320a-7b).
 Changes definition of healthcare fraud offense in 18
U.S.C. § 24(a) to include violations of the anti-kickback
statute, FDCA and certain ERISA provisions.
9
CMS Civil
Monetary
Penalties (CMP)
Sec. 6402, Sec.
6408 (42 U.S.C.
§ 1320a-7a(a))
Expands CMS liability for the following activities:
 Ordering or prescribing a medical or other item or
service during a period in which the person was
excluded from a federal healthcare program, if the
person knows or should have know that a claim for
such medical or other item or service will be made.
 Knowingly making or causing to be made any false
statement, omission, or misrepresentation of a
material fact in any federal healthcare program
application, bid or contract (Penalty: $50,000 penalty
and 3 times total amount claimed).
 Knowing retention of an overpayment and not
reporting and returning such overpayment.
 Knowingly making, using, or causing to be made or
3
March 23, 2010
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
EFFECTIVE
DATE
used, a false record or statement material to a false or
fraudulent claim for payment for items and services
furnished under a federal healthcare program
(Penalty: $50,000, for each false record or statement).
 Failing to grant timely access, upon reasonable
request, to the HHS Inspector General for audits,
investigations, evaluations, or other statutory functions
of the HHS Inspector General (Penalty: $15,000 per
day).
10
Beneficiary
Fraud
Sec. 6402 (42
U.S.C. § 1301 et.
seq.)
Imposes appropriate administrative penalties on those
beneficiaries who knowingly participate in a federal
healthcare fraud offense or a conspiracy to commit a federal
healthcare fraud offense.
March 23, 2010
11
Expanded HHSOIG Subpoena
Authority
Sec. 6402 (42
U.S.C. § 1320a7(f))
Extends HHS testimonial subpoena authority to program
exclusion investigations and authorizes HHS Secretary to
delegate such subpoena authority to the HHS Inspector
General.
March 23, 2010
12
Obstruction of
Program Audits
Sec. 6408 (42
U.S.C. § 1320a7(b)(2))
Authorizes permissive exclusion for obstructing an
investigation or audit. Prior provision applied only to
obstructing criminal investigations.
January 1, 2010
13
Evidentiary
Privilege of
Inter-Agency
Correspondence
Related to Any
Investigation
Sec. 6607 (29
U.S.C. § 1134(d))
Secretary of Labor may promulgate a regulation that
provides an evidentiary privilege for, and provides for the
confidentiality of communications between or among, certain
federal and state agencies (including State AG, DOJ,
DHHS). Any privilege that is established must apply to
communications related to any investigation, audit,
examination, or inquiry conducted or coordinated by any of
the agencies.
Corresponding
regulations must
be promulgated
before privilege
becomes
effective.
14
Data Sharing
Sec. 6403 (42
U.S.C. § 1320a7e; 42 U.S.C. §
1396r-2)
 Mandates a national healthcare fraud and abuse data
collection program for the reporting of certain final
adverse actions and to furnish the information collected
to the National Practitioner Data Bank.
First day after
the final day of
the transition
period.
 Mandates states have in effect a system for reporting
information with respect to formal licensing proceedings
or final adverse actions.
 Mandates termination of the Healthcare Integrity and
Protection Data Bank and mandates transfer of all data
collected therein to the National Practitioner Data Bank.
4
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
EFFECTIVE
DATE
Transition period is from date of enactment to the later of
one year after enactment or the effective date of
regulations related to this requirement.
 Authorizes the Department of Veteran Affairs to have
access to the National Practitioner Data Bank.
Sec. 6402 (42
U.S.C. § 1301 et.
seq.)
 Mandates the Integrated Data Repository of the Centers
March 23, 2010
for Medicare & Medicaid Services include claims and
payment data from a variety of programs, including
Medicare, Medicaid, Veterans Affairs, and the Indian
Health Service, so that data from such programs can be
matched with data in the HHS system for the purpose of
identifying potential Medicare and Medicaid fraud, waste
and abuse.
 Mandates access by the HHS Inspector General and the
Attorney General to claims and payment databases for
purposes of conducting law enforcement and oversight
activities.
15
Sec. 6402 (42
U.S.C. §
1396b(i))
Prohibits federal matching payments to states for medical
assistance to those individuals for whom the state does not
report enrollee encounter data to Medicaid Management
Information Systems (MMIS) in a timely manner.
March 23, 2010
Sec. 6504 (42
U.S.C. §
1396b(r)(1)(F)
and 42 U.S.C. §
1396b(m)(2)(A)
(xi))
 Mandates states submit expanded data elements under
Applies to data
submitted, and
contract years
beginning, on or
after January 1,
2010.
Uniform Fraud
and Abuse
Referral Format
Sec. 6603 (42
U.S.C. § 300gg93)
Mandates HHS request that the National Association of
Insurance Commissioners develop:
MMIS as necessary for program integrity, program
oversight, and administration.
 Mandates state contracts with Medicaid managed care
organizations provide for the provision of patient
encounter data to the state.
March 23, 2010
 A model uniform report form for private health insurance
issuer seeking to refer suspected fraud and abuse to
responsible state agencies for investigation; and
 Recommendations for uniform reporting standards for
such referrals.
16
17
U.S. Sentencing
Guidelines
(USSG)
Sec. 10606
(Federal
Sentencing
Guidelines)
Transparency
Amends Federal Sentencing Guidelines to provide an
increase of between two and four levels for federal
healthcare offenses involving $1 million or more.
March 23, 2010
There are significant transparency requirements for applicable manufacturers of
5
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
Requirements
for Health
Industry Sectors
EFFECTIVE
DATE
covered devices, drugs, biologics and medical supplies, pharmacy benefit
managers, hospitals, physicians, and skilled nursing facilities.
These transparency requirements are contained in Morgan Lewis’s March 29,
2010 LawFlash, “Healthcare Reform Law Delivers New Transparency
Requirement to the Health Industry” (available online at
http://www.morganlewis.com/pubs/WashGRPP_FDATransparencyRequirements_LF_29mar10.pdf).
Sec. 6001 (Physician and Hospital Disclosures on Physician Ownership
and Investment)
Sec. 6002 (Manufacturer and Group Purchasing Organization Reporting
of Physician Ownership and Investment)
Sec. 6003 (Physician Disclosure Requirements for In-Office Ancillary
Services)
Sec. 6004 (Manufacturer and Distributor Reporting on Prescription Drug
Samples)
Sec. 6005 (Pharmacy Benefit Manager Transparency Requirements)
Sec. 6101 (Nursing Facility and Skilled Nursing Facility Disclosure of
Ownership and Additional Information)
Sec. 6104 (Nursing Facility Staffing Information)
18
19
Suspension of
Payments
Pending
Investigation
Sec. 6402 (42
U.S.C. § 1395y;
42 U.S.C. §
1396b(i)(2))
Fraud and
Abuse
Enforcement
Funding
Sec. 6402 and
Reconciliation
Sec. 1303 (42
U.S.C. §
1395i(k))
Medicare and Medicaid payments may be suspended
pending investigation of a credible allegation of fraud, unless
HHS determines there is good cause not to suspend
payments.
March 23, 2010
The Healthcare Reform Law appropriates to the Health Care
Fraud and Abuse Control Account an additional $100 million
for FY 2011 through 2020 and the Reconciliation Law
appropriates $250 million for FY 2011 through 2016 to cover
the costs of the administration and operation of the
healthcare fraud and abuse control program and the
Medicare Integrity Program.
March 23, 2010
PROGRAM INTEGRITY
20
Provider
Screening and
Other
Enrollment
Requirements
Under Medicare,
Medicaid and

Mandates establishment, for new Medicare, Medicaid
and CHIP providers, of screening procedures, which
must include licensure checks and may include criminal
background checks, fingerprinting, database inquiries
and site visits

Screening must occur within one year of enactment for
6
March 23, 2010,
unless otherwise
noted.
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
Children’s
Health
Insurance
Program (CHIP)
Sec. 6401 (42
U.S.C. §
1395cc(j); 42
U.S.C. §
1396a(a))
21
22
23
OIG Authority to
Obtain
Information
from Providers
and Suppliers
Sec. 6402 (42
U.S.C. § 1301 et.
seq.)
National
Provider
Identifier
Sec. 6402 (42
U.S.C. § 1301 et.
seq.)
Physician
EFFECTIVE
DATE
new providers and suppliers and within two years of
enactment for current providers and suppliers.

Mandates establishment of procedures to provide for a
period (greater than 30 days and up to one year) of
enhanced oversight (e.g., prepayment review and
payment caps) for new providers and suppliers

New providers and suppliers must disclose current or
past affiliations with any provider or supplier with
uncollected debt, suspended payments or exclusion
from a federal healthcare program, or revoked billing
privileges. HHS may deny enrollment if such affiliations
pose undue risk of fraud, waste, or abuse.

HHS may satisfy past due obligations of a provider or
supplier by adjusting payments to providers or suppliers
with the same tax identification number as the provider
or supplier with the past due obligation.

HHS may impose a moratorium on enrollment of new
providers or suppliers if necessary to combat fraud,
waste, or abuse and provided that there would be no
adverse impact on beneficiaries.

Establishment of a compliance program with core
elements determined by HHS, in consultation with HHS
OIG, is a condition of enrollment.

CMS must establish a process for making available to
each state agency responsible for administering a state
Medicaid plan or a CHIP plan the name, national
provider identifier, and other identifying information for
any Medicare or CHIP provider or supplier who is
terminated from participation within 30 days of
termination.
HHS Inspector General may obtain information from any
individual (including beneficiaries) or provider, supplier,
grant recipient, contractor, manufacturer, distributor, or other
entity, for purposes of protecting the integrity of Medicare
and Medicaid, including supporting documentation
necessary to validate Medicare and Medicaid payments.
March 23, 2010
All Medicare and Medicaid providers and suppliers must
include their national provider identifiers on all program
applications and claims.
January 1, 2011
Section 6001 places new restrictions on the Stark Law‘s whole-hospital
7
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
Ownership
Sec. 6001 (42
U.S.C. § 1395nn)
EFFECTIVE
DATE
exception, as well as requiring additional transparency. Among other things,
Section 6001:
 Prohibits physician-owned hospitals that do not have a provider agreement
from participating in Medicare. Physician-owned hospitals with a provider
agreement could participate under prescribed conditions.
 Requires hospitals to submit annual reports to HHS containing a detailed
description of each physician owner or investor (and any other owners or
investors) of the hospital and the nature and extent of all ownership and
investment interests. HHS will publish such information on the CMS website.
 Requires hospitals to implement procedures requiring physician owners and
investors to disclose to patients referred to the hospital the physician’s
ownership or investment interest.
 Requires hospitals to disclose the fact that the hospital is partially owned or
invested in by physicians on the hospital’s public website and in any public
advertising by the hospital.
24
DME and Home
Health Services
Sec. 6405 (42
U.S.C. §
1395m(a)(11)(B))
Limits ordering of DME or home health services for
Medicare beneficiaries to Medicare enrolled physicians or
eligible professionals.
Authorizes HHS to extend these requirements to other
Medicare items and services.
Sec. 6406 (42
U.S.C. §
1395u(h) , 42
U.S.C. 1395cc,
42 U.S.C. §
1320a-7(b)(11))
Authorizes HHS to revoke enrollment, for not more than one
year for each act, of a Medicare physician, supplier, or
provider who fails to maintain and provide access to
documentation relating to written orders or requests for
payment for DME, certifications for home health services or
referrals for other items and services.
Applies to
orders,
certifications,
and referrals
made on or after
January 1, 2010.
Sec. 6407 (42
U.S.C. §
1395f(a)(2)(c); 42
U.S.C. §
1395m(a)(11)(B))
 Requires physician or other permitted professional to
have a face-to-face encounter with a patient prior to
issuing a certification for home health services or written
order for DME.
 Applies to
home health
certification,
after January
1, 2010.
 Applies to Medicare and Medicaid.
 Permits HHS to apply this requirement to other Medicare
items and services based upon a finding that doing so
would reduce the risk of fraud, waste, or abuse.
25
Applies to
written orders
and certifications
made on or after
July 1, 2010.
Surety Bonds
Sec. 6402 (42
U.S.C.
1395m(a)(16)(B);
42 U.S.C.
§1395x(o)(7)(C);
Surety bonds for DME and home health agencies must be
commensurate with volume of billing.
8
 Applies to
written orders
for DME
upon
enactment.
March 23, 2010
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
EFFECTIVE
DATE
42 U.S.C. 1395y)
26
27
28
Application of
Fraud and
Abuse Laws to
Private
Exchange
Insurers
Sec. 1313 (31
U.S.C. § 3729 et
seq.)
See also Sec.
10104 (striking §
1313(a)(6)(B))
 Requires HHS to provide for the efficient and non-
Medicare
Advantage (MA)
or Part D Plan
Sec. 6408 (42
U.S.C. § 1395w27(g)(2)(A); 42
U.S.C. § 1395w27(g)(1))
 Establishes penalties for Medicare Advantage and
Multiple
Employer
Welfare
Arrangements
(MEWAs) under
ERISA
Sec. 6601 (29
U.S.C. § 1149)
Provides criminal penalties for any person, in connection
with a MEWA, that knowingly makes a false statement or
false representation of fact in connection with the marketing
or sale of the MEWA in regard to the:
January 1, 2014
discriminatory administration of Exchange activities and
implement any measure or procedure appropriate to
reduce fraud and abuse.
 Subjects payments made by, through, or in connection
with an Exchange to the False Claims Act if those
payments include any federal funds.
January 1, 2010
Medicare Part D plans that misrepresent or falsify
information of up to the amount claimed by the plan or
plan sponsor in connection with the misrepresentation or
falsified information.
 Authorizes sanctions and penalties for MA and Part D
plans that enroll individuals in a plan without their
consent; transfer an individual from one plan to another to
generate commissions or fees; fail to comply with
marketing restrictions related to approval of marketing
materials and prohibited marketing activities; or employ or
contract with an individual or entity who engages in
conduct for which intermediate sanctions may be
imposed.
March 23, 2010
 Financial condition of the MEWA;
 Benefits provided by the MEWA;
 Regulatory status of the MEWA under any federal or state
law governing collective bargaining, labor management
relations, or internal union affairs; or
 Regulatory status of the MEWA regarding exemption from
state regulatory authority under ERISA.
Sec. 6604 (29
U.S.C. § 1150)
Authorizes Secretary of Labor, for the purpose of identifying,
preventing, or prosecuting fraud and abuse, to adopt
regulations that would prevent MEWAs from claiming federal
preemption as a defense under state law and would subject
MEWAs to the laws of the states in which the MEWA
9
Corresponding
regulations must
be promulgated
before
preemption
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
29
EFFECTIVE
DATE
operates.
change
becomes
effective.
Sec. 6605 (29
U.S.C. § 1151)
Allows Secretary of Labor to issue a “cease and desist”
order if it appears that the alleged conduct of a MEWA (i) is
fraudulent, (ii) creates an immediate danger to the public
safety or welfare, or (iii) is causing or can be reasonably
expected to cause significant, imminent, and irreparable
public injury. Authorizes the seizure of MEWA assets if it
appears that the MEWA is in a financially hazardous
condition.
March 23, 2010
Sec. 6606 (29
U.S.C. § 1021(g))
Mandates MEWAs register with the Secretary and make
annual reports regarding their operations.
March 23, 2010
Section 340B
Program
Integrity
Measures
Sec. 7102 (42
U.S.C. § 256b(d);
42 U.S.C.
256b(a))
 Requires manufacturers to submit quarterly reports of
March 23, 2010
340B ceiling prices and the components used to calculate
them to the Secretary.
 Requires the Secretary to provide certain improvements
in 340B compliance by manufacturers in order to prevent
overcharges and other violations of the 340B discounted
pricing requirements.
 Establishes civil monetary penalties not to exceed
$5,000 for each instance of overcharging a covered
entity.
 Requires the Secretary to provide certain improvements
in 340B compliance by covered entities in order to
prevent diversion and violations of the duplicate discount
provision and other 340B requirements.
 Requires the Secretary to promulgate regulations, within
180 days of the effective date, to establish and implement
an administrative process for the resolution of (i) claims
by covered entities that they have been overcharged for
drugs purchased under 340B and (ii) claims by
manufacturers after an audit has been conducted.
30
Medicare and
Medicaid
Integrity
Programs
Sec. 6402 (42
U.S.C. §
1395ddd; 42
U.S.C. § 1396u6(c)(2))
 Entities contracting with the Medicare Integrity Program
and Medicaid Integrity Program must agree to provide
performance statistics to HHS and HHS Inspector
General.
 HHS must conduct evaluations of contracting entities
every three years and must submit an annual report to
Congress.
10
March 23, 2010
PROVISION
SUMMARY OF REQUIREMENT
(Section of Healthcare
Reform Law and
Related Laws)
31
32
Time Period to
Submit
Medicare Claims
Sec. 6404 (42
U.S.C. §
1395f(a)(1); 42
U.S.C. § 1395u
(b)(3)(B); 42
U.S.C. §
1395n(a))
Medicaid
Coding
Sec. 6507 (42
U.S.C. §
1396b(r))
 Reduces the period of submission of Medicare claims
EFFECTIVE
DATE
January 1, 2010
from three calendar years following the year in which
services were furnished to one calendar year after the
date of service.
 Applies to services furnished on or after January 1, 2010.
For services furnished before January 1, 2010, a bill or
request for payment must be filed not later than
December 31, 2010.
Mandates states use compatible methodologies of the
National Correct Coding Initiative for Medicaid claims.
11
Effective for
claims filed on or
after October 1,
2010.