STARK BASIC TRAINING - The American Health Lawyers Association

STARK BASIC TRAINING
Health Care Compliance Association and
American Health Lawyers Association
Fraud & Compliance Forum
September 30 – October 2, 2012
Run for your
life!!
Joan P. Dailey. Esq.
HHS Office of the General Counsel
200 Independence Ave. S.W.
Washington, D.C. 20201
Telephone: 202-619-2794
Email: joan.dailey@hhs.gov
Robert A. Wade, Esq.
Partner
Krieg DeVault LLP
4101 Edison Lakes Parkway, Suite 100
Mishawaka, IN 46545
Telephone: 574-485-2002
Email: bwade@kdlegal.com 1
OVERVIEW
• Statutory and Regulatory Background
• How to Analyze a Stark Issue
• The Universal 3-Question Analysis
• Key Elements of the Prohibition
• Details on Key Exceptions
• A Few Caveats
2
1

STATUTORY &
REGULATORY
BACKGROUND
(The 30,000 foot view)
3
THE PROBLEM:
FINANCIAL INCENTIVES TIED
TO REFERRALS
• Overutilization
• Increased program costs
• Corruption of medical decision-making
• Systemic corruption
4
2

THE SOLUTION:
MULTIPLE STATUTES
• Anti-Kickback Statute (AKS)
• Stark Statute
• Prohibition against inducements to
beneficiaries
• State laws
5
THE PROHIBITION
If a physician (or immediate family member)
has a direct or indirect financial relationship
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 to CMS for such
DHS, unless the financial relationship fits in
an exception.
6
3

SANCTIONS
• 1877(g)(1): Denial of claims
• Intent is irrelevant
• Recoupment
• Obligation to make refund to CMS
• New compromise authority (§6409 ACA)
• 1877(g)(2): Refunds to beneficiary
• Coinsurances
• Deductible
• Often an overlooked obligation
7
SANCTIONS
• CMPs for knowing violations only
• $15,000/DHS; $100,000 for circumvention
schemes
• Referring physicians can be liable
• Potential False Claims Act liability
• Requires intent to defraud
8
4

WHAT’S NOT PROHIBITED
• Physicians can make some ancillary services
available to patients
• Physicians can own DHS entities if they
don’t refer to them
• Generally, physicians can get fair market
value compensation for their services
9
THE MANY REGS…
• Phase I: 66 FR 856 (2001)
• Phase II: 69 FR 16054 (2004)
• Phase III: 72 FR 51012 (2007)
• EHR Exception: 71 FR 45140 (2006)
• FY 2009 IPPS: 73 FR at 48688 (2008)
• CY 2010 PFS: 74 FR at 61932 (2009)
• ACA Changes (FR 11/24/10, 11/29/10,
11/30/11)
See handout for more… 10
5

HOW TO ANALYZE
A STARK ISSUE
(Get out your crayons and eyeglasses)
11
BREAK IT DOWN
• First, Draw a Diagram!
• Ask Yourself Three Questions
• Five Key Concepts
• Read the Statute, Reg Text & Preambles
• Remember a Few Caveats
12
6

THREE QUESTIONS
1. Is there a referral from a physician for a
designated health service? If so…
2. Does the physician (or an immediate family
member) have a financial relationship with the
entity providing the DHS service? If so…
3. Does the financial relationship fit in an
exception?
If not, there’s a violation
13
KEY CONCEPTS
• Physician referrals
• Designated health services (DHS)
• Entity
• Financial relationships
• Exceptions
14
7

WHAT IS A
“REFERRAL”?
(You had to ask…)
15
WHAT IS A “REFERRAL”?
• A request, order, plan of care, etc. –
• For a DHS
• For a service that includes a DHS
• For consultation with another physician
•Includes DHS ordered by consulting
physician!
• Written, oral, electronic
16
8

IMPUTED REFERRALS
• Consulting physician’s referrals for DHS
imputed to physician requesting consult
• Referrals made by nonphysicians that are
deemed to be made by the physician
• Facts and circumstances test
• Degree of control or influence exerted by
physician on the nonphysician
17
WHAT IS A REFERRAL
“TO AN ENTITY”?
• Anything “reasonably intended” to result in
patient receiving service from the entity
• Need not be in writing or absolute
• Directing/steering referrals
• “Innocent entity exception” (411.353(e))
• For indirect and oral referrals
• Protects DHS entities that do not know identity
of referring physician
18
9

WHAT IS NOT A
“REFERRAL”?
(Brace yourself for the irony…)
19
WHAT’S NOT A REFERRAL
• Personally performed services
• “The work of your own two hands”
• Excludes “incident to” services
• Excludes corresponding TC of hospital
service
20
10

WHAT’S NOT A REFERRAL
• Requests made by pathologists, radiologists,
and radiation oncologists
• Pursuant to a consultation
• For their own services (see defn)
• Furnished by them or under their
supervision (or by/under supervision of
physician in same group and of same
specialty)
21
“REFERRING PHYSICIAN”
• A “physician” who makes a referral
• 1861(r) definition of physician applies
• Does not include physician extenders or
other nonphysicians
• But see discussion of imputed referrals
22
11

TIPS:
• Can have multiple referring physicians for
the same DHS
• Do a separate 3-Question Analysis for each
physician’s referrals
23
• 1877(h)(5)
• 411.351 Definitions
RESOURCES
• “Physician”
• “Referral”
• “Referring Physician”
• Phase I Preamble (2001), pp. 871-75
• Phase II Preamble (2004), pp. 16063-66
• Phase III Preamble (2007), pp. 51019-21
24
12

DESIGNATED
HEALTH SERVICES
(Not everything about Stark is
complicated ….)
25
DHS
• Clinical laboratory*
• Physical therapy*
• Occupational therapy*
• Speech-language pathology*
• Radiology and other imaging services*
• Radiation therapy services and supplies*
* Defined by CPT/HCPCS code
26
13

• DMEPOS
DHS
• Parenteral and enteral nutrients, equipment,
and supplies
• Prosthetics, orthotics, and prosthetic devices
and supplies
• Home health services
• Outpatient prescription drugs
• Inpatient and outpatient hospital services
• except lithotripsy!
27
GENERAL RULES
• Code List is determinative
• DHS bundled into a composite rate payment
is not DHS
• Exception: If the service package itself is listed
in the statute as a DHS (e.g., inpatient hospital
services)
• DHS paid as stand-alone service is DHS
• New Exception (eff. 1/1/08): radiology and
drugs furnished in an ASC that qualify as
“covered ancillary services” per 416.164(b).
28
14

RESOURCES
• 1877(h)(6); 411.351
• Phase I (pp. 922-42)
• Phase II (pp. 16099-16106)
• Nuclear medicine, 70 FR at 70283 (11/21/05)
• CY08 OPPS Final Rule, 72 FR 66851
(11/27/07)
• Revising defns of DHS, outpatient Rxn drugs,
radiology
• PFS CPT/HCPCS Code List Updates
29
ENTITY
(So many entities, so little time…)
30
15

• Old Rule
ENTITY
• Person or entity to whom payment is made
• New Rule (effective 10/1/09)
• Person who presents claim to Medicare, AND
• Person who has “performed services billed as
DHS”
31
ENTITY
• No regulatory definition of what it means to
“perform” services billed as DHS
• See preamble commentary …
• Does physician “do the medical work” for the
service and could she bill for it?
• Entity does not “perform” DHS if it only:
• Leases or sells space/equipment
• Furnishes supplies
• Provides management or billing services; or
• Provides personnel
32
16

ENTITY
• Multiple DHS entities can receive a referral
• Must do separate Stark analysis for referrals to
each DHS entity
• Expanded definition effectively prohibits
physician ownership of entities that perform
DHS “under arrangements” with a hospital
33
RESOURCES
• 411.351 definition
• Phase I (p.943)
• Phase II (pp. 16106-07)
• Phase III (pp. 51014-15)
• CY09 IPPS (73 FR 48721-33) for current law
34
17

Financial
Relationships
(Follow the money .…)
35
FINANCIAL RELATIONSHIP
• Ownership/Investment
• Compensation
• Direct or Indirect
• Statute is implicated even if relationship
is not about the provision of DHS!
36
18

DIRECT
DOCTOR
DHS ENTITY
(No intervening entities)
37
INDIRECT
DOCTOR COMPANY DHS ENTITY
(One or more intervening entities)
38
19

INDIRECT OWNERSHIP
• All links in chain are ownership
• If the links are a mix of ownership and
compensation, it may be an indirect
compensation arrangement.
• DHS entity knows or should know that the
physician has some ownership interest in it.
• No affirmative obligation to inquire
• Duty of reasonable inquiry
39
INDIRECT COMPENSATION
ARRANGEMENTS (ICAs)
• Definition (411.354(c))
• Unbroken chain of 3+ persons/entities;
• Aggregate compensation to physician varies
with or takes into account referrals or other
business for DHS entity; and
• DHS entity knows or should know nature of
physician’s compensation
• Stark not applicable to ICAs that fail to meet
definition
40
20

ICA EXCEPTION
• Compensation must be FMV not taking into
account referrals or other business generated
• Does not look to aggregate compensation
• Apply special compensation rules at
411.354(d)(2),(3) regarding per unit comp
• Other requirements (e.g., in writing)
41
SPECIAL RULES ON
COMPENSATION
• Unit-based comp does not TIA “v/v of referrals” if
per unit payment is FMV and does not vary during
the term in a manner that TIA referrals of DHS.
• Example of varying: $10/item for first 100 items;
$8/item thereafter
• Unit-based comp does not TIA “OBG btw the
parties” if FMV and does not vary during the term
in manner that TIA referrals or OBG, including
private pay business
42
21

THE METHOD BEHIND
THE MADNESS
• ICA definition includes potentially abusive
relationships
• Focus is on aggregate comp
• Per unit comp rules not applied at definition stage
• Captures both fixed and variable comp that reflects
referrals
• Knowledge standard solves liability problem for
nonabusive remote relationships
43
THE METHOD BEHIND
THE MADNESS
• ICA exception immunizes ICAs that are not
actually abusive.
• Focus is on individual, unaggregated payments;
per unit comp rules apply
• Exception will not immunize fixed (flat fee)
compensation that is not FMV
44
22

“STAND IN THE SHOES”
Physician
Owners
(aka, when an unbroken
chain of 3 is a direct comp
arrangement)
DHS ENTITY
Physician
Group
45
“STAND IN THE SHOES”
• Current Rule (since 10/1/08):
• Physician SITS of his physician organization
(PO) if he has an ownership/investment interest
in the PO
• Non-owners and titular owners may elect to
SITS
• Old Rule: All physicians SITS of their PO
• Really Old Rule: Nobody SITS at all
46
23

THE “NEW” DIRECT
COMPENSATION
Group
Physician
Owners
47
INDIRECT
BUT -- No change if intervening entity
owned by physician is not a PO:
DOCTOR COMPANY DHS ENTITY
48
24

RESOURCES
• 1877(a)(2), (h)(1)
• 411.354
• Phase I (pp. 864-870)
• Phase II (pp. 16057-63)
• Phase III (pp. 51026-31)
• CY09 IPPS (pp. 48690-700)
49
EXCEPTIONS
(The devil is in the details ….)
50
25

EXCEPTIONS
• “Close enough” doesn’t work
• Three categories
• Ownership only
• Ownership and compensation
(“service based”)
• Compensation only
51
OWNERSHIP EXCEPTIONS
• Rural providers
• “Whole” hospitals
• Puerto Rico hospitals
• Mutual funds and public securities
52
26

“SERVICE-BASED”
EXCEPTIONS
• Physician Services
• In-Office Ancillary Services
• Supervision, location & billing requirements
• Academic Medical Centers (AMCs)
• Prepaid plans (managed care services)
• Intra-family rural referrals
• Others
53
• Many exceptions
COMPENSATION
EXCEPTIONS
• Fair market value is key
• Multiple exceptions may apply
• In general, provider can choose which of
several potentially applicable exceptions to
satisfy (the “any exception will do” rule)
54
27

FAIR MARKET VALUE
• Value in arm’s length transaction, result of
bona fide bargaining between parties not in
a position to refer to one another
• Special rules for rental property
• Value for general commercial purposes, not
taking into account intended use
• Not adjusted to reflect proximity to physician
lessor
• See definition at §411.351.
55
FAIR MARKET VALUE
• Documentation
• Use of appraisals prudent, but not mandated
• Any appropriate commercially reasonable
methodology
• Ultimately, a facts and circumstances test
• Nature of transaction
• Location
• Other factors
56
28

FMV RESOURCES
• Phase I (pp. 944-45)
• Phase II (p. 16107)
• Phase III (pp. 51015-16)
• Not advisory opinions!
57
COMPENSATION
EXCEPTIONS
• Rentals of space & equipment
• Personal services arrangements, employment
• Employment
• Non-monetary compensation (within limits)
• Medical staff incidental benefits
• Recruitment and retention
• Indirect compensation arrangements
• Fair market value
• Electronic health records donations
• More
58
29

In-Office Ancillary
Services Exception
(A wide, well-worn path out of the
Stark woods….)
59
OVERVIEW
• For provision of DHS when truly ancillary to
office practice of medicine
• Definition of “group practice” is key
• Fully integrated, not a loose confederation of
physicians designed to profit from DHS
referrals
• Financial incentives to make DHS referrals are
attenuated
60
30

GROUP PRACTICE CRITERIA
• Group practice means a single group of two
or more physicians legally organized as a
partnership, professional corporation,
faculty practice plan or similar association
where
• Each physician member provides substantially
the full range of services that physician routinely
provides (including medical care, consultation,
diagnosis or treatment)
• Professional services provided through joint use
of shared office space, facilities, equipment and
personnel
61
GROUP PRACTICE CRITERIA
• Substantially all (75%+) of each physician
member’s patient care services are --
• Provided through group
• Document through time cards, personal schedules, etc.;
• Must meet within 12 months of formation or 12 months
of new physician relocating (25 miles+) to join group.
• Billed under group’s billing number
• All income is treated as receipts of group
• Overhead expenses and income from
practice are distributed in accordance with
previously determined methods
62
31

Member of Group Practice v.
Physician in Group Practice
• Independent Contractors are “Physicians in
Group Practice” but not “Members of Group
Practice”
• Issues:
• Range of Care—Members only
• 75% Test—Members only
• Productivity Bonuses and Profit-Share—All,
including Independent Contractors
63
GROUP PRACTICE CRITERIA
• No physician in group may directly or
indirectly receive compensation based on
volume or value of referrals by physician.
• Exception: Group physicians may be paid
share of overall profits or productivity bonus
(for personally performed or “incident to”
services) if not directly related to DHS
referrals.
64
32

GROUP PRACTICE CRITERIA
• Share of profits will not be directly related to
volume or value of referrals if one of the
following conditions is met:
• Profits divided per capita (i.e., equal share per
physician in group);
• DHS revenues are distributed in the same manner
as non-DHS revenues from any federal health care
program or private payor; or
• DHS revenues for group practice is less than 5% of
group practices’ total revenue and those revenues
allocated to each physician in the group is 5% or
less of each physician’s total compensation from the
group
65
GROUP PRACTICE CRITERIA
Permitted:
Patient
$
GROUP PRACTICE
DHS $ Pooled
%of $
%of $
%of $
DR.
DR.
DR.
Distribution of Profit from DHS
Should Reflect Pooling
66
33

GROUP PRACTICE CRITERIA
Group Practice
Pt.
Pt.
Pt.
Pt.
Pt.
Pt.
Pt.
Pt.
Pt.
Dr.
Dr.
2
Dr.
Can Pool Profits from DHS Into Components If Each Component
Has at Least 5 Physicians
3
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
Dr.
67
GROUP PRACTICE CRITERIA
Not Permitted:
PATIENT
PATIENT
PATIENT
$
$
$
GROUP PRACTICE
$
$
$
DR.
DR.
DR.
$ Passes Through
Group Practice Cannot Be Used To Pay
Physician Directly for DHS Ordered
68
34

69
IN-OFFICE ANCILLARY
SERVICES EXCEPTION
Must answer 3
questions:
Who?
How?
Where?
70
35

IOAS EXCEPTION
Who May Provide Services?
• Referring physician;
• Physician who is member of same group practice
as referring physician;
• Individuals who are directly supervised by
physician or another physician in same group
practice; and
• Physicians in the group practice such as
employees and independent contractors of group
practice
71
IOAS EXCEPTION
Where Are Services Provided?
Same building
or
Centralized building
72
36

IOAS EXCEPTION
Where Are Services Provided?
• “Same Building” where referring physician
(or others in group) furnish services
unrelated to the furnishing of DHS
• Building must have a single street address
assigned by the U.S. Postal Service, not
including interior loading docks, mobile
vehicles, vans or trailers
• Must meet one of three tests
73
IOAS EXCEPTION
Same Building Tests
• 1) Office is open to the group’s patients for medical services at least 35
hours per week and a member of the group provides physician services
(including non-DHS services) to patients at least 30 hours per week
• 2) Referring physician’s group owns or rents an office that is normally
open to patients for medical services at least 8 hours per week and
referring physician provides physician services (include non-DHS
services) to patients at this office at least 6 hours per week
• 3) Referring physician’s group owns or rents an office that is normally
open to patients for medical services at least 8 hours per week, either
referring physician orders DHS services while seeing the patient on the
premises or a member of referring physician’s group practice is on
premises when DHS is performed and referring physician or member
of group practices at site at least 6 hours per week
74
37

IOAS EXCEPTION
Where Are Services Provided?
A Centralized Building, which means
all or part of a building that is owned
or leased on a full-time basis by a
group practice including a mobile
vehicle, van or trailer where some or
all of the group practices DHS is
provided
75
IOAS EXCEPTION
Not Covered by Exception
Given to Patient in
Physician’s Office But
Intended To Be Used at
home or outside
Physician’s Office
76
38

IOAS EXCEPTION
How Are Services Billed?
• By physician performing or supervising services
• By group practice of which such physician is
member, employee or independent contractor
under billing number assigned to group practice;
or
• By entity that is wholly owned by such physician or
such group practice
77
IOAS EXCEPTION
DME
• How is equipment used by patient?
• Durable medical equipment (“DME”), like
canes, crutches, walkers, blood glucose monitors,
can be subject to in-office ancillary exception if:
• the DME is required by the patient to depart from the
physician’s office, or is a blood glucose monitor
• it is furnished in the same building as the patientphysician
encounter; and
• the DME is furnished personally by the physician, a
physician in the same group practice, or an employee of
the same group practice
78
39

IOAS EXCEPTION
Notification Requirements
• Applies only to MRI, CT and PET
• CMS has not extended to any other radiology
services under PPACA specific authority
• Notice of 5 other suppliers of service
• Physician groups need not identify hospital
competitors
• Applies to services furnished on or after
January 1, 2011
79
Recruitment Exception
(It’s so nice to be wanted so
badly…)
80
40

RECRUITMENT
• Payments made to induce physician to
relocate to “geographic area served by
hospital” (zip code test)
• Not conditioned on referrals
• Compensation not determined based on v/v
actual or anticipated referrals or OBG
• Recruit allowed to establish privileges at and
refer to other entities
81
RECRUITMENT
• Relocation of medical practice
• Moving at least 25 miles into geographic area
• Deriving >75% of revenues from new patients
compared to previous 3 years
• Relocation requirement waived for
• Residents, physicians practicing

RECRUITMENT
Additional criteria for physician recruitment
into group practice:
• Except for actual costs incurred by group,
remuneration is passed directly to recruit
• Income guarantee: costs allocated to recruit do not
exceed actual additional incremental costs for that
physician
• Group can’t unreasonably restrict recruit’s ability to
practice in the hospital’s geographic area
83
Personal Service
Arrangements
Exception
(When impersonal service just
won’t do…)
84
42

PSA EXCEPTION
• Arrangement is set out in writing, signed by
parties and specifies services covered by
arrangement
• Arrangement covers all services to be provided
by physician to entity
• References all other arrangements; or
• References master list of contracts that is
maintained with historical record of all
arrangements
• Term for at least one year
85
PSA EXCEPTION
• Services are reasonable and necessary
• Compensation to be paid over term of
arrangement is set in advance, does not
exceed FMV, and is not determined in
manner which takes into account volume or
value of referrals between parties
86
43

PSA EXCEPTION
• Hold over month-to-month following a term
of at least one year, assuming all other
provisions of the exception are met,
continuing on a month-to-month basis for
up to 6 months as long as the terms during
the hold over period are fair market value
will meet the personal service arrangement
exception
87
Rental Exceptions
(When lease is more…)
88
44

RENTAL EXCEPTIONS
• Lease is in writing, signed, and specifies
premises and equipment to be leased
• Space and equipment rented does not
exceed that which is reasonable and
necessary and is used exclusively by lessee
when being leased by lessee
• Term of lease is for at least one year
• Commercially reasonable
89
RENTAL EXCEPTIONS
• Rental charges are set in advance, fair
market value, and not determined in a
manner that takes into account volume or
value of referrals or other business generated
between parties
• No “per click” if physician/owner is source of
referral
• No charges on percentage of revenue
• Remember special FMV definition
90
45

RENTAL EXCEPTIONS
• Hold over month-to-month following a term
of at least one year, assuming all other
provisions of the exception are met,
continuing on a month-to-month basis for
up to 6 months as long as the terms during
the hold over period are fair market value
will meet the rental of office space and
equipment exceptions
91
Employment
Exception
(Becoming more and more
popular…)
92
46

EMPLOYMENT EXCEPTION
• Employment is for identifiable services
• Compensation is:
• Fair market value;
• Not determined in manner which takes into
account volume or value of referrals; and
• Commercially reasonable even if no referrals
were made to employer
93
EMPLOYMENT EXCEPTION
• Productivity bonuses can be paid if based on
services performed personally by the
physician (i.e., worked RVUs)
94
47

EMPLOYMENT EXCEPTION
Required Referrals (411.354(d)(4))
Employer can require employee to refer to a
particular provider, practitioner or supplier if:
• Referral requirement is in writing, signed
• Compensation is set in advance & FMV
• Referral requirement not applicable if:
• Patient expresses a contrary preference
• Provider not covered by patient’s insurance
• Not in the patient’s best medical interest …
95
EMPLOYMENT EXCEPTION
Required Referrals
• The required referrals must relate solely to the
physician’s services covered by the scope of the
employment and be reasonably necessary for
the legitimate business purposes of the
arrangement
Good:
Primary Care –
Inpatient
Bad:
Medical Director –
Inpatient
96
48

Non-Monetary
Compensation Exception
(Because sometimes a physician
needs a gift basket…)
97
NON-MONETARY
COMPENSATION EXCEPTION
• Compensation, not including cash or cash
equivalents (i.e., gift certificates), up to an
aggregate of $373 per year per physician as
long as:
• Benefit is not determined based upon volume or
value of referrals
• Benefit is not solicited by physician or anyone
affiliated with their practice
• Maximum cannot be aggregated to make a
larger gift to a group
98
49

NON-MONETARY
COMPENSATION EXCEPTION
• The current $373 limit is updated annually.
• For updates, see
www.cms.hhs.gov/PhysicianSelfReferral/
99
NON-MONETARY
COMPENSATION EXCEPTION
• If a hospital inadvertently exceeds the annual limit,
the hospital will still be deemed to be in
compliance if (i) the value of the excess is no more
than 50% of the limit, and (ii) the physician returns
the excess by the end of the calendar year or within
180 consecutive calendar days, whichever is earlier
• NOTE: Can only be used once every 3 years
• Hospitals can hold 1 formal medical staff event per
year without including the cost in this exception
100
50

NON-MONETARY
COMPENSATION EXCEPTION
• For example:
• Cannot give $1,000 oil painting to 5 physician
group and allocate $200 to each physician
101
NON-MONETARY
COMPENSATION EXCEPTION
• Preamble, on Page 16112 of Phase II, stated
that “[the Medical Staff Incidental Benefits
Exception] was not intended to cover the
provision of tangential, off-site benefits,
such as restaurant dinners or theater tickets,
which must comply with the exception for
non-monetary compensation
up to $300.” (emphasis added)
102
51

Medical Staff
Incidental Benefits
(Because doctors can’t make
rounds without lab coats and
donuts …)
103
MEDICAL STAFF INCIDENTAL
BENEFITS EXCEPTION
• Items or services used on the hospital's
campus may be given to members of its
medical staff if:
• Provided to all members in the same specialty
without regard to volume or value of referrals
• Provided only during periods when the medical
staff members are making rounds or involved in
other services that benefit the hospital and its
patients
104
52

MEDICAL STAFF INCIDENTAL
BENEFITS EXCEPTION
• The item or service is reasonably related to
the delivery of medical services at the
hospital
• Each item or service is less than $31 per
benefit (updated annually)
Free For
Physicians
105
MEDICAL STAFF INCIDENTAL
BENEFITS EXCEPTION
• Protects internet access, pagers, or two-way
radios, used away from the campus only to
access hospital medical records/info or to
access patients or personnel who are on the
hospital campus
• Protects identification of the
medical staff on a hospital
website or in hospital
advertising
106
53

WHAT IF NO EXCEPTION
APPLIES?
• Consider exceptions for temporary
noncompliance (§411.353(f), (g))
• Disclose to CMS
• Voluntary Refund to CMS payment contractor
• Stark Self-Referral Disclosure Protocol – permits
compromise
Provider Bankruptcy
Prevention Hotline:
1-800-CMS-SRDP
• Disclose to OIG or AUSA
107
SUMMARY
(Yes, Virginia, there IS light at the
end of the tunnel…)
108
54

TIPS
• Always draw a diagram
• Always ask the 3 Questions
• Always reread the applicable definitions and
preambles of all the various rules
• Never rely on your memory!
• Two heads are better than one
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A FEW CAVEATS
• Analyze relationships under the law that
existed at the relevant time
• Revisions can make the difference between
compliance and noncompliance
• E.g., ACA change to IOAS exception; SITS
& entity definition reg changes
• Stark compliant relationships can still
violate AKS
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