This document provides a summary of a publication from the American Health Lawyers Association called "Hospitals & Health Systems Rx". It discusses several topics related to implementing the Affordable Care Act including:
- Community Health Needs Assessments that are required for non-profit hospitals to conduct in order to maintain their tax-exempt status.
- Questions and answers about the goals of CHNAs, how they encourage collaboration, and the key elements of conducting a CHNA and developing an implementation strategy.
- Resources created by the CDC like the CHI Navigator website to provide tools and best practices to help hospitals, health departments, and communities work together on community health improvement initiatives.
2. Hospitals & Health Systems Rx
2
Implementing the Affordable Care
Act—Community Health Needs
Assessments
Martha Somerville*
Somerville Consulting
Baltimore, MD
Gene W. Matthews
The Network for Public Health Law—
Southeastern Region
North Carolina Institute for Public Health
UNC Gillings School of Global Public Health
Chapel Hill, NC
Denise Koo
U.S. Public Health Service
Office of the Associate Director for Policy
Centers for Disease Control and Prevention
Atlanta, GA
David A. Weil, Editor
Quorum Health Resources
Brentwood, TN
This article is brought to you by the Public Health System
Affinity Group of the Hospitals and Health Systems Practice
Group.
T
his article includes three sets of questions and answers
regarding community health needs assessment (CHNA)
requirements for charitable 501(c)(3) hospitals. Each set
is authored by a member of the panel of the September 18,
2015 webinar entitled “Part IV: Implementing the ACA—
Community Health Needs Assessments.” This webinar is one
of six in a series presented in collaboration by the AHLA
Public Interest Committee and Public Health System Affinity
Group and the Centers for Disease Control and Prevention
(CDC) through its Public Health Law Program. The webinar
was moderated by Matthew Penn, Director, Public Health
Law Program, CDC, Atlanta, GA.
Martha Somerville’s Questions and Answers
1. Why does the Affordable Care Act (ACA) require tax-exempt hospitals
to conduct CHNAs?
A nonprofit hospital’s qualification for Section 501(c)(3) tax
exemption depends on its provision of community benefits.
These include unreimbursed health care services and other
hospital activities that improve the health of the commu-
nity as a whole. The CHNA requirement1
of the ACA is
intended to ensure that the community benefits that a tax-
exempt hospital provides are responsive to the specifically
identified priority health needs of its community. CHNA
process requirements promulgated by the U.S. Depart-
ment of Treasury and the Internal Revenue Service (IRS)
(Final Rule)2
establish an inclusive, collaborative assessment
framework emphasizing a hospital’s duty to seek out and
take into consideration the input and expertise supplied by
community stakeholders and governmental public health.
Requirements for CHNA documentation (CHNA report),
an Implementation Strategy, and IRS reporting requirements
ensure transparency and hold hospitals accountable for
conducting compliant CHNA processes that inform hospi-
tals’ community benefit planning and decision making as to
what community benefits they will provide.
2. How do federal CHNA requirements encourage a cross-sector,
collaborative approach to community health improvement?
The Final Rule encourages hospitals to seek out and consider
input from a broad range of community stakeholders (e.g.,
CBOs, employers, schools, providers, insurers) and specifi-
cally requires hospitals to “solicit and take into account” the
input of underserved, low-income, and minority populations
and governmental public health. In addition, provisions
permitting collaborating hospital facilities to incorporate
(under appropriate circumstances) substantially identical
portions of each other’s CHNA reports3
encourage collabo-
ration, facilitate strategic use of resources among collabo-
rating institutions, and can reduce CHNA costs. Moreover,
in appropriate circumstances (including each hospital
adopting identical community definitions), the CHNA and
subsequent implementation strategies may be conducted,
developed, and documented jointly by reducing CHNA
costs. Moreover, when individual hospital facilities’ commu-
nity definitions are identical, CHNA and implementation
strategies may be conducted, developed, and documented
jointly.4
The Final Rule thus sets the stage for community
health improvement partnerships harnessing broad-based
perspectives and expertise within the community, and creates
opportunities to leverage resources and reduce duplication
with respect to both the CHNA and the implementation of
community health improvement (CHI) initiatives.5
3. What are the essential elements of a federally compliant CHNA and
Implementation Strategy?
a. Define the Community the Hospital Facility
Serves
The Final Rule affords a hospital the flexibility
to define its community in consideration of all
the relevant facts and circumstances, including its
geographic service area, the target populations
3. 3
it serves, and its principal functions. However,
it may not exclude medically underserved,
low-income, or minority populations residing
in its service area who, by application of the
method the hospital uses to define its community,
otherwise should be included.6
This flexibility
encourages community definitions that focus
community benefits on areas of greatest need.7
b. Assess the Community’s Health Needs
The IRS expressly recognizes that a community’s
health needs are not limited to clinical care needs;
they include the requisites for health maintenance
and improvement, such as “the need to address
financial and other barriers to accessing care, to
prevent illness, to ensure adequate nutrition, or
to address social, behavioral, and environmental
factors that influence health in the community.”8
A hospital must identify its community’s signifi-
cant health needs, prioritize those needs, and
identify resources that may be available to
meet them.9
A hospital’s determination of what
identified needs are “significant” should be based
on consideration of all the relevant facts and
circumstances in the community; a hospital may
use any criteria (e.g., the burden, scope, severity,
or urgency of the need, or its importance to the
community) to prioritize the community’s signifi-
cant needs. Although a hospital may use any
criteria to prioritize significant community health
needs, it still must consider community input in
determining both the significance and priority of
community needs.10
c. Solicit and Take Into Account Community
and Expert Input
The requirement that hospitals take into account
input from persons “representing the broad
interests of the community” is central to the
inclusive, collaborative assessment model that
the ACA envisions and the Final Rule prescribes.
To minimally satisfy this requirement, a hospital
must solicit and take into account: the input of
medically underserved, low-income, or minority
populations in the community; written comments
the hospital has received on its previous CHNA
and Implementation Strategy; and the input
of one or more state, local, tribal, or regional
governmental public health department, or a
State Office of Rural Health with relevant knowl-
edge, information, or expertise.11
By mandating
the involvement of governmental public health
in a hospital’s CHNA process, the Final Rule
encourages hospital-health department collabo-
ration both in conducting CHNA and in subse-
quent efforts to address the identified health
needs of their communities. Such collaboration
can facilitate the alignment of hospitals’ commu-
nity benefit activities with public health goals and
health improvement strategies.
d. Document and Adopt the CHNA
The Final Rule requires hospital documenta-
tion of CHNA to include a specification of the
hospital’s community definition, a description
of the processes and methods employed in the
assessment, a prioritized description of signifi-
cant community health needs identified and the
process and criteria used to determine signifi-
cance and priority; and a description of resources
potentially available to meet the community’s
significant needs identified. It must also include
an evaluation of hospital initiatives undertaken
since its last CHNA to meet the significant
health needs identified by a previous CHNA.12
A
hospital’s CHNA report must be adopted by “an
authorized body of the hospital facility,” defined
as the governing body of the 501(c)(3) hospital
organization operating the hospital facility, or
a committee or other party it authorizes to do
so, to the extent that that delegation is consis-
tent with state law.13
These requirements hold a
501(c)(3) hospital organization (e.g., a hospital
system) accountable and ensure CHNA transpar-
ency at the facility level.
e. Make the CHNA Report “Widely Available
to the Public”
A hospital must post its CHNA report on its website and
make paper copies available for public inspection upon
request. These obligations continue until the hospital
makes its second subsequent CHNA report widely avail-
able to the public.14
f. Implementation Strategy
A hospital’s implementation strategy articulates
its commitment to provide specified community
benefits during its three subsequent tax years. For
each significant community health need identified
in the CHNA report, the implementation strategy
must include either a description of how the
hospital intends to address the need (specifying
resources to be committed and intended collabo-
rations) or an explanation of why an identified
significant need will not be addressed. An autho-
rized body of the hospital facility must adopt the
4. Hospitals Health Systems Rx
4
CHNA report, which must be made public either
through posting on the hospital website (and
reporting the site’s URL on the hospital’s annual
return to the IRS (Form 990, Schedule H), or by
attaching a copy of the implementation strategy
to its annual return.15
Gene Matthews’ Questions and Answers
1. Do you see a direction in which the CHNA guidance is evolving as
revealed in the more recent IRS and Treasury Department regulations
and issuances?
The more recent IRS and Treasury Department regulations
and issuances are clearly making the CHNA and Implemen-
tation Strategy requirements a continual, iterative process
rather than simply a once-every-three-years event. The
federal agency comments in the Final Rule clearly intend
to establish a continual feedback loop on CHNA reports.16
For example, the 2014 Instructions for Schedule H (Form
990) require in each year that the hospital explain how the
facility “is addressing the significant needs identified in its
most recent CHNA and any such needs that are not being
addressed together with the reasons why such needs are not
being addressed.”17
2. What factors helped North Carolina be able to develop this state-wide
collaboration between hospitals and health departments to focus the
next cycle of CHNA on a common implementation strategy theme of
healthy weight?
Initially a joint initiative was launched in 2007 by the
leadership of the North Carolina Hospital Association and
the North Carolina Division of Public Health focusing on
common issues. Over time it became known as the North
Carolina Community Health Improvement Collaborative
(NC-CHIC). It expanded to include local health department
(LHD) leaders, academic institutions, and community part-
ners. It also increasingly focused on CHNA implementation
for nonprofit hospitals.
For more than a decade, North Carolina has had by statute,
a mandatory LHD accreditation program that requires all
LHDs to periodically conduct community health assess-
ments. By the time the ACA requirements started to go into
effect in 2012 for nonprofit hospitals to conduct CHNAs,
any hospital in North Carolina could readily obtain a
community health assessment for a county electronically
from the state health department website. This asset helped
jump-start collaborations among hospitals and LHDs
focusing on joint health assessments.
As the NC-CHIC efforts matured, it has been able to build
a consensus to provide leadership and resources for local
hospital and LHD collaborations to include other commu-
nity partners in common implementation strategies directed
toward a state-wide healthy weight campaign.
3. What are the most common challenges facing hospitals, LHDs, and
community partners as this CHNA process moves forward?
First, CHNAs can improve their geographical alignment to
accurately reflect the area that the hospital serves and to
include the medically underserved populations within that
jurisdiction.
Second, the Implementation Strategies need to eliminate the
current skewing of priority needs that focus too much on
clinical care. More attention has to be focused on upstream
health determinants of healthy behaviors, social and
economic factors, and the physical environment.
Third, efforts must continue to align hospital community
benefits expenditures with the priority needs identified
through this CHNA process.
Denise Koo’s Questions and Answers
1. What led to the CDC developing the CHI Navigator (www.cdc.gov/
CHInav)?
After the passage of the ACA, with its Section 9007
regarding CHNA for Charitable Hospitals, the IRS contacted
CDC to request technical assistance. CDC staff first worked
with the IRS to help shape the initial guidance and Final
Rule, but quickly realized that resources and tools were
vitally important to aid in translating the regulation into
implementation work that could truly impact the health of
the community. Thus, the CDC created this set of tools to
help with the collaborative process for CHI. The CHI Navi-
gator (www.cdc.gov/CHInav) is a unifying framework and
source of tools and resources that can be used by hospitals,
health systems, public health agencies, community organiza-
tions, and other stakeholders interested in improving the
health of their communities.
2. What is unique about the CHI Navigator and how does it differ from
other similar resources?
The CHI Navigator is unique in the following ways:
a. Infographic
The CHI Navigator’s signature infographic
provides an evocative visual tool that facilitates
dialogue about what affects health, where to
focus efforts, with whom to collaborate, and how
to have the greatest impact on health. This info-
graphic has been downloaded over 3,500 times
(over 150 times/week!) since the site went live in
May 2015, in addition to being an exceedingly
popular handout at meetings.
5. 5
b. Collaborative Stories with Quantified
Bottom-Line Outcomes
The CHI Navigator provides succinct, focused
examples of health systems partnering with
others outside of the health care field, yet hitting
bottom lines important to the health care system
such as decreased admissions or readmissions,
decreased emergency room visits, and increased
per-patient per-month cost savings. These stories
show how important these collaborative partner-
ships are for surviving in the new value-based
health care system.
c. Tools
There are a great many lists of tools out there,
but many of them are just that—lists, and very
long ones at that. Our tools section “curates” the
tools. We carefully reviewed hundreds of tools
looking for ones that helped both to conceptu-
alize and operationalize some key concepts (such
as with templates or checklists). Also, the tools
are presented to the user in a community health
improvement process framework, and provide
some sense of what the tool offers and exactly
where in the tool to go (not just the general URL
for the tool, but what section or page).
d. Database of Interventions
This one-of-a-kind search engine pulls together
evidence-based interventions from multiple
sources. Many people do not know that indi-
vidual-source databases exist, much less how to
find or comb through them for focused inter-
ventions that target their desired risk factor. We
have done the work of identifying these sources,
reviewing interventions from them, to make it
easier for users to find interventions that work
and which they can consider with their partners.
We have tagged these interventions with certain
filters to facilitate users identifying interventions
of particular interest to them.
3. How can hospitals and health systems best capitalize on this
resource?
Health systems can use the CHI Navigator’s examples,
framework, and tools to strengthen their partnerships with
public health and other partners and to conduct needs
assessments and to develop community health improve-
ment plans collaboratively. They can use the CHI Navigator
database to identify evidence-based interventions for inclu-
sion in a population management plan or community health
implementation strategies, and move their partnership from
planning to action, and in the end, to improved community
health and well-being.
*The authors are Martha Somerville, JD, MPH, Principal,
Somerville Consulting, Baltimore, MD; Gene Matthews, JD,
Director, Southeastern Region of The Network for Public
Health Law, and Senior Fellow, North Carolina Institute
for Public Health, University of North Carolina Gillings
School of Global Public Health, Chapel Hill, NC; and
Denise Koo, MD, MPH, Captain, U.S. Public Health Service,
Senior Advisor for Health Systems, Office of the Associate
Director for Policy, Centers for Disease Control and Preven-
tion, Atlanta, GA. The webinar was moderated by Matthew
Penn, Director, Public Health Law Program, CDC, Atlanta,
GA. This article was edited by David Weil, JD, MBA, Chair,
Public Health System Affinity Group, and Vice President,
Quorum Legal Services, Community Health Systems Profes-
sional Services Corporation, Brentwood, TN.
1 I.R.C. § 501(r)(3)(A).
2 Additional Requirements for Charitable Hospitals; CHNAs for Chari-
table Hospitals; Requirement of a Section 4959 Excise Tax Return and
Time for Filing the Return, 79 Fed. Reg. 78954-79016 (Dec. 31, 2014)
(codified at 26 C.F.R. pts. 1, 53, 602).
3 26 C.F.R. §§ 1.501(r)-3(b)(6)(iv) and 1.501(r)-3(c).
4 26 C.F.R. §§ 1.501(r)-3(b)(6)(v) and 1.501(r)-3(c)(4).
5 See, e.g., CHI Navigator: Engage the Community—Key Concepts: “Di-
verse community stakeholders are engaged as ongoing partners; people
who represent the broad interests of the communities served, particularly
vulnerable/underserved populations, are involved in all stages of the CHI
process.” Available at www.cdc.gov/chinav/tools/engage.html.
6 26 C.F.R. § 1.501(r)-3(b)(3).
7 See, e.g., CHI Navigator: Assess the Community—Key Concepts: “A
broad definition of the community is established that allows for measur-
able opportunities to address population-health issues, while being
focused enough to address health disparities.” Available at www.cdc.gov/
chinav/tools/assess.html.
8 26 C.F.R. § 1.501(r)-3(b)(4).
9 See CHI Navigator, Assess Needs and Resources—Key Concepts. Avail-
able at www.cdc.gov/chinav/tools/assess.html.
10 26 C.F.R. §§ 1.501(r)-3(b)(4) and 1.501(r)-3(b)(5)(i).
11 26 C.F.R. § 1.501(r)-3(b)(5).
12 26 C.F.R. § 1.501(r)-3(b)(6).
13 26 C.F.R. § 1.501(r)-1(b)(4)(i).
14 26 C.F.R. §§ 1.501(r)-3(b)(7), 1.501(r)-1(b)(29).
15 26 C.F.R. §§ 1.501(r)-3(c), 501.1(r)-3(a)(2), and 1.6033–2(a)(2)(ii)(I)(2).
16 See agency response to comment submitted during recent rulemaking at
79 Fed. Reg. 78965 (Dec. 31, 2014).
17 IRS Schedule H (Form 990) 2014, Part V, Section B, Line 11.
6. Hospitals Health Systems Rx
6
New Stark Exception for Timeshare
Arrangements
Keith D. Price
Denise Bloch
Sandberg Phoenix von Gontard PC
St. Louis, MO
This article is brought to you by the Real Estate Affinity
Group of the Hospitals and Health Systems Practice Group.
On November 16, 2015, the Centers for Medicare
Medicaid Services (CMS) published the new timeshare
exception to the Stark Law.1
This exception was created in
part to improve access to needed care, especially in rural
and underserved areas, by allowing physicians to utilize
space and equipment on a part-time or periodic basis.
CMS acknowledged that before this exception was created,
patients in rural or underserved areas were left without
services because the needed services could not support
compliant full-time lease arrangements with physicians,
particularly specialists, and/or that many physicians were not
otherwise interested in entering into traditional office space
leases. CMS noted that the new exception is “intended to
promote access to needed services and provide parties with
an option for structuring arrangements in the way that best
suits the needs of the parties and the community in which
the timeshare arrangement is located.”2
Prior to implementation of the timeshare exception, hospitals
and physicians had to structure timeshare arrangements for
office space or equipment to fall within the requirements of
the respective space and equipment lease exceptions set forth
in 42 C.F.R. § 411.357(a) and (b). Now hospitals and physi-
cians also may look to the new timeshare exception found at
42 C.F.R. § 411.357(y). Unlike the existing space and equip-
ment lease exceptions, the timeshare exception is not limited
to a minimum term of one year, the exclusive use require-
ment, or the requirement that the arrangement not exceed
that which is reasonable and necessary for the legitimate
business purpose of the arrangement. The new timeshare
exception still requires that compensation under the arrange-
ment be consistent with fair market value (FMV). In addi-
tion, the timeshare exception contains a new requirement
that the premises, equipment, personnel, items, supplies, and
services covered by the arrangement be used predominantly
for the provision of evaluation and management (E/M)
services to patients.
The exception applies only to arrangements between a
physician or the physician organization in whose shoes
the physician stands, and a hospital, or between a physi-
cian and a physician organization of which the physician is
not an owner, employee, or contractor. The exception does
not protect arrangements between a physician and other
providers of designated health services (DHS) such as labo-
ratories or independent diagnostic testing facilities (IDTFs).
Although a significant goal of the exception is to provide
needed health care services in rural and underserved areas,
CMS did not restrict application of the exception to those
areas. CMS stated “[w]e did not propose to limit the excep-
tion to timeshare arrangements in rural or underserved areas,
and are not including such a limitation in the exception at
§411.357(y) finalized here.”3
Section 411.357(y) requires that all of the following elements
be met:
• The arrangement is set out in writing, is signed by the
parties, and specifies the premises, equipment, personnel,
items, supplies, and services covered by the arrangement;
• The arrangement is between a physician (or the physician
organization in whose shoes the physician stands under
Section 411.354(c)) and either: (1) a hospital, or (2) a
physician organization of which the physician is not an
owner, employee, or contractor;
• The premises, equipment, personnel, items, supplies, and
services covered by the arrangement are used predomi-
nantly for the provision of E/M services to patients and
must be used on identical schedules;
• The equipment covered by the arrangement is: (1) located
in the same building as the suite in which E/M services are
furnished; (2) not used to furnish DHS other than those
incidental to the E/M services furnished contemporane-
ously with the E/M visit; (3) not inclusive of advanced
imaging equipment, radiation therapy, or clinical or
pathological laboratory equipment (other than equip-
ment used to perform Clinical Laboratory Improvement
Amendments (CLIA-)-waived laboratory tests;
• The arrangement is not conditioned on the referral of
patients by the party receiving permission to use the prem-
ises, equipment, personnel, items, supplies, and services
covered by the arrangement and the party granting said
permission;
• The compensation over the term of the arrangement is set
in advance, is consistent with FMV, and is not determined:
(1) in a matter that takes into account, directly or indi-
rectly, the volume or value of referrals or other business
generated between the parties; or (2) using a formula
based on: a percentage of revenue, a per-unit-of-service
fees that are not time based;
• The arrangement is commercially reasonable even in the
absence of referrals between the parties;
• The arrangement does not violate the Anti-Kickback
Statute (AKS) (Section 1128B(b) of the Social Security
Act) or any federal or state law or regulation governing
billing or claims submission; and
7. 7
• The arrangement does not convey a possessory leasehold
interest in the space subject of the arrangement.
As initially proposed, the timeshare exception would have
restricted a hospital from being the licensee4
in the timeshare
arrangement. Commenters requested that CMS modify
the exception to allow timeshare arrangements in which
a physician is the licensor and a hospital or physician is
the licensee. CMS agreed it did not pose a significant risk
of program or patient abuse to permit timeshare arrange-
ments in which a hospital or physician organization is the
licensee. However, CMS declined to expand the exception to
other types of DHS entities, such as IDTFs or laboratories,
to address the issue of potential barriers to accessing health
care. CMS specifically noted that the final exception only
covers timeshare arrangements under which the DHS entity
is a hospital or physician organization. Timeshare arrange-
ments between physicians and non-DHS entities, such as
real estate subsidiaries or management service organizations,
should be analyzed under rules regarding indirect compensa-
tion arrangements set forth at 42 C.F.R. § 411.354(c). When
an indirect compensation arrangement “exists as a result
of chain or financial relationships that runs [a] hospital or
physician organization—affiliate—physician, the arrange-
ment must satisfy the requirements of the exception at
§411.357(p).”5
Practical Considerations
For the practitioner who previously relied on the rental of
office space and rental of equipment exceptions to avoid
Stark violations, there are several new elements in the time-
share exception that merit attention.
Defining “Hospital”
First, the definition of hospital must be assessed. On initial
review, the exception would not seem to apply if a physi-
cian seeks to share space in a clinic or ambulatory surgery
center (ASC). Hospital is defined at 42 C.F.R. § 411.351 as
a “hospital” under Section 1861(e) of the Social Security
Act (Act), as “psychiatric hospital” under Section 1861(f)
of the Act, or as a “critical access hospital” (CAH) under
Section 1861(mm)(1) of the Act, and “refers to any separate
legally organized operating entity plus any subsidiary, related
entity or other entities that perform services for the hospi-
tal’s patients and for which the hospital bills.”6
However, a
hospital does not include entities that perform services for
hospital patients “under arrangements” with the hospital—
i.e., a situation in which the hospital has contracted with
a third party to provide a service to the hospital or its
patients.7
The definition of hospital under Section 1861(e) of the Act
would not include a clinic or ASC, as the definition requires
inpatient care and requires 24-hour nursing service. Further-
more, the definition of a psychiatric hospital under Section
1861(f) of the Act would not include a clinic or ASC as the
definition provides that the institution must be “primarily
engaged in providing . . . psychiatric services for the diag-
nosis and treatment of mentally ill persons” and also includes
the requirement of 24-hour nursing services. Likewise, the
definition of a CAH hospital under Section 1861 (mm)(1) of
the Act, which cross-references to Section 1820(e) of the Act,
would not include a clinic or ASC as the definition requires
certification by participating states that the facility is desig-
nated as a CAH by the state in which it is located. However,
the final phrase of the definition expands the definition of
hospital to include subsidiaries and related entities that
perform services for the hospital’s patients, for which the
hospital bills.8
Consequently, as long as they are not billing
“under arrangement” with other entities, clinics and ASCs that
are subsidiaries or related to larger hospital systems should be
able to take advantage of this new exception.
Understanding What Constitutes “Predominant” Use for the Provision of
E/M Services
The next element to consider is how to interpret the require-
ment that the space, etc., be used predominantly to provide
E/M services to patients. CMS declined a request to more
specifically define predominantly. One commenter requested
that CMS finalize a bright-line standard to include a precise
percentage for the minimum amount of E/M services
furnished under the timeshare arrangement. CMS stated,
however, that an attempt to define the standard further could
inadvertently narrow the exception. CMS noted that parties
could make this determination through “any reasonable,
objective, and verifiable means, which, depending on the
circumstances, may include affecting the volume of patients
seen, the number of patient encounters, the types of CPT
codes billed, or the amount of time spent using the timeshare
premises, equipment, personnel, items, supplies, and services.”9
Conspicuously, CMS took this opportunity to emphasize that
use of the space solely or primarily to furnish DHS to patients
would not be protected by the timeshare exception.10
E/M Services
The biggest difference between the new timeshare excep-
tion and the rental of office space and the rental of equip-
ment exceptions is the requirement that the space be used
to provide E/M (evaluation and management) services. As
discussed above, the new exception requires that the prem-
ises, equipment, personnel, items, supplies, and services be
used predominantly to furnish E/M services to patients of
the party using the space, equipment, etc. The exception
as modified and finalized also provides that the equipment
covered by the arrangement, if any; (1) is located in the same
building as the office suite where the physician performs E/M
services; and (2) is used only to furnish DHS that is inci-
dental to the physician’s E/M services and is furnished at the
time of such E/M services.
8. Hospitals Health Systems Rx
8
E/M services are defined by the McGraw-Hill Concise
Dictionary of Modern Medicine (2002) as any diagnostic and
therapeutic procedure that may be performed by a health care
provider at a specific location, including a history of present
illness, general multi-system examination, and past, family,
and/or social history. In November 2014, CMS published its
Evaluation and Management Services Guide (Guide) to assist
Medicare fee-for-service (FFS) providers in understanding
documentation guidelines for substantiating various levels of
E/M services. Other publications provide additional assistance
for understanding what is needed to demonstrate that E/M
services were provided. These publications include the “1995
Documentation Guidelines for Evaluation and Management
Services” and the “1997 Documentation Guidelines for Evalu-
ation and Management Services.”
Multiple rules and guidelines pertain to coding and billing
for E/M services as substantiation that such services were
provided. While these rules are outside the scope of this
article, it is important that parties to a timeshare arrange-
ment understand that failure to follow the coding and billing
rules for E/M services could potentially result in a challenge
to the E/M element of the timeshare exception.
Use of Equipment Incidental to, and Contemporaneously with,
E/M Services
The practitioner needs to confirm that the equipment
covered by the arrangement is located in the same building
as the suite in which the E/M services will be furnished and
that the equipment will not be used to furnish DHS other
than what is incidental to the E/M services furnished at the
time of the patient’s E/M visit. CMS specifically declined
requests from commenters that the exception allow use of
equipment other than at the time of the E/M visit. While
recognizing circumstances in which DHS might be benefi-
cial at a time when no E/M services need to be furnished
(such as a test ordered by a cardiologist to be performed at
the next visit), CMS declined to expand the exception. The
purpose of the exception is to improve access to care and
outcomes for patients rather than to facilitate provision of
a full array of DHS in supplemental medical practice sites.11
Advanced imaging equipment, radiation therapy equipment,
and clinical or pathology laboratory equipment, other than
equipment used to perform CLIA-waived laboratory tests,
are not covered by the exception. Again, CMS considered
but discounted requests to include this equipment in the
exception, citing again the goal of improving access to care
and outcomes for patients.12
CMS did not believe that including radiation therapy equip-
ment in the exception would improve access to care because
such equipment generally is not portable and already would
be available in the community. Additionally, CMS was not
convinced that excluding advanced imaging equipment
from the exception would hamper access to care or delay
a patient’s diagnosis because parties could still avail them-
selves of the existing exceptions for rental of office space at
Section 411.357(a) and the rental of equipment at Section
411.357(b), both of which contain different safeguards
against program and patient abuse.
Compensation
The final element meriting analysis is the amount of
compensation under the arrangement. Rather than allowing
compensation based on a percentage of revenue or per-unit-
of-service fees (which CMS interprets as presenting a risk
of program or patient abuse),13
CMS allowed compensation
formulas based on other forms of compensation, such as
those utilizing flat-fee or time-based formulas. Time-based
formulas could include payment that is set at a predeter-
mined amount for certain segments of time, such as for each
hour, half day, or full day.
CMS found that certain formulas presented a risk of
program or patient abuse due to potential incentives for over
utilization of services and for patient steering, and noted
that a per-patient compensation formula could incentivize
a party giving permission (grantor) to use the space and
equipment to refer patients to the party using the space and
equipment (grantee), because the grantor would then receive
payment each time the premises, equipment, personnel,
items, supplies, or services was used. Likewise, a compensa-
tion formula using services as a unit of measure, for instance
services tied to CPT codes, could incentivize the grantor to
refer sicker patients or patients with a likely need for DHS to
the grantee because the grantor would then receive payment
for each service furnished. Consequently, CMS indicated it
will allow time-based formulas under which a usage fee is
paid regardless of the number of patients referred by the
grantor or the number of services furnished. CMS declined
to prescribe a minimum amount of time unit to be used with
the time-based formula.
Conclusion
Following consideration of extensive comments, CMS modi-
fied and finalized the proposed timeshare exception with the
express goal of improving access to care and outcomes for
patients. While many elements are the same or similar to
those of the rental of office space and rental of equipment
exceptions, several are new. First, the timeshare exception
limits the parties who may take advantage of the excep-
tion. The arrangement must be between a physician (or the
physician organization in whose shoes the physician stands
under Section 411.354(c)) and either: (1) a hospital, or (2)
a physician organization of which the physician is not an
owner, employee, or contractor. In addition, the arrange-
ment may not convey a possessory leasehold interest in the
9. 9
office space that is the subject of the arrangement, and the
exception expressly notes the arrangement may not violate
the Anti-Kickback Statute or other federal or state laws or
regulations governing billing or claims submission. Most
notably, the timeshare exception incorporates the concept of
E/M services. The new exception mandates that the premises,
equipment, personnel, items, supplies, and services covered
by the arrangement be used predominantly to furnish E/M
services to patients of the grantee and the equipment covered
by the arrangement, if any, (1) is located in the same building
as the office suite where the physician performs E/M services;
and (2) is used only to furnish DHS that is incidental to the
physician’s E/M services and is furnished at the time of such
E/M service. Time will tell if the new exception improves
access to care.
1 80 Fed Reg 70885 – 71386 (Nov. 16, 2015).
2 80 Fed. Reg. 71327.
3 80 Fed. Reg. 71328.
4 The words “licensor” and “licensee” were used throughout the proposed
exception and commentary. CMS did not include these words in the final
exception, recognizing that the words could create unnecessary confusion
and potentially exclude otherwise qualifying non-abusive arrangements.
80 Fed. Reg. 71326.
5 80 Fed. Reg. 71330.
6 42 C.F.R. § 411.351 (emphasis added).
7 Id.
8 42 C.F.R. § 411.357.
9 80 Fed. Reg. 71330.
10 Id.
11 Id.
12 Id.
13 Compensation based on per-unit-of-service fees is prohibited only to
the extent that such fees reflect services furnished to patients referred by
the party granting permission to use its premises, equipment, personnel,
items, supplies, or services to the party receiving such permission. 80 Fed.
Reg. 71331.
Mary Beth E. Fortugno, Chair
Bass Berry Sims PLC
Nashville, TN
(615) 742-7739
mfortugno@bassberry.com
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Membership
HORNE LLP
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Strategic Planning and Special Projects
Chiesa Shahinian Giantomasi PC
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Educational Programs
Breazeale Sachse Wilson LLP
Baton Rouge, LA
(225) 381-8011
emily.grey@bswllp.com
Marta J. Hoffman, Vice Chair –
Publications
Plunkett Cooney PC
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Hospitals and Health Systems
Practice Group Leadership
10. Hospitals Health Systems Rx
10
Physician Compensation Arrangements
Under the Microscope
Arthur J. Fried*
Epstein Becker Green
New York, NY
Andrea M. Ferrari, Editor
HealthCare Appraisers Inc.
Delray Beach, FL
This article is brought to you by the Fair Market Value
Affinity Group of the Hospitals and Health Systems Practice
Group.
O
n June 9, 2015 the Office of Inspector General (OIG)
of the U.S. Department of Health and Human Services
issued a simple, straight-forward, one-page Fraud Alert
entitled “Physician Compensation Arrangements May Result
in Significant Liability.” The Fraud Alert reported OIG’s
recent settlements with 12 individual physicians who had
entered into questionable medical directorship and office
staff leasing arrangements. These settlements, stemming from
alleged violations of the Anti-Kickback Statute, highlight
that improper remuneration may occur when payments:
(1) take into account the volume or value of referrals; (2) do
not reflect fair market value (FMV); (3) are for services that
are not actually provided; and/or (4) relieve physicians of a
financial burden.
While these cases are notable in that they represent recov-
eries against individual physicians, they have been eclipsed
by a rapid succession of record-setting settlements and court
rulings against hospitals and health systems—each involving
questionable physician compensation and each initiated by
qui tam whistleblowers. Many of the settlements are remark-
able not only for the magnitude of the defendant’s payout,
but also for the nature of the allegations that gave rise to
them, and the details of their path to resolution. In many
cases, compensation to employed physicians, who had previ-
ously not often been the subject of enforcement actions, was
an issue, and questions regarding potentially non-FMV and/
or otherwise questionable compensation were pivotal. This
article discusses some of the most recent developments in the
arena of enforcement actions involving physician compen-
sation to help shed light on the various reasons that, in the
words of OIG, “Physician Compensation Arrangements May
Result in Significant Liability.”
11. 11
Qui Tam Relators Turn to Employed Physicians
United States ex rel. Reilly v. North Broward Hospital District,
No. 10-60590 (S.D. Fla.)
In his qui tam complaint, which ultimately settled for $69.5
million, a physician-relator contended that employed physi-
cians were compensated at levels that were above FMV, not
commercially reasonable, and influenced by the volume and
value of inpatient and outpatient designated health services
(DHS) referrals. The complaint alleged that substantial losses
were generated by the employed physicians if the profits
from their referrals were not considered. The qui tam relator
alleged that internal proformas included ancillary revenues,
reflecting that the hiring and compensation of these physi-
cians was based in part on the value of their anticipated
referrals. The complaint also alleged that the hospital
tracked the inpatient and outpatient contribution margins
from referrals of the subject physicians, and inappropriately
pressured the physicians to make internal referrals. The
complaint alleged that the losses were not explained by the
level of charity care provided by the employed physicians;
the compensation levels were not commensurate with the
physicians’ personal productivity; and that, for some of
the employed physicians, the compensation to collections
ratio (which exceeded one) substantially exceeded the 90th
percentile values reported in a published survey.
United States ex rel. Payne v. Adventist Health System/Sunbelt, Inc.,
No. 12-856 (W.D.N.C)
United States ex rel. Dorsey v. Adventist Health System Sunbelt
Healthcare Corp., No. 13-217 (W.D.N.C)
In two related qui tam complaints that were collectively
settled for $118.75 million, the relators contended that
employed physicians and mid-level practitioners were
compensated, for a period in excess of ten years, at levels
that were above FMV, not commercially reasonable, and
influenced by the volume and value of inpatient and outpa-
tient referrals of DHS to their hospital employers. Like
the Broward qui tam complaint, these complaints alleged
that the excessive nature of the compensation and lack
of commercial reasonableness were demonstrated by the
consistent and substantial losses that were generated by the
employed physicians if the profits from their referrals for
inpatient and ancillary services were not considered. The
plaintiffs alleged that underlying the excessive compensation
paid to its employed physicians was Adventist’s strategy to
purchase physician practices and employ physicians in order
to control their referrals and keep them from working for
competitors. Supporting these claims were allegations that
inpatient and ancillary contribution margins from the refer-
rals were internally and surreptitiously tracked, and were
used for calculating physician bonuses.
The complaints further alleged that Adventist: (1) paid “hefty
annual salaries” for part-time or non-productive work;
(2) paid excessive bonuses based on inflated work relative
value unit (wRVU) values; and (3) ignored provisions of
the employment agreements that were intended to mitigate
losses. The complaints alleged that Adventist inappropriately
paid a physician’s personal car loan and provided private
office staff, equipment, and supplies without charge. Finally,
the complaints alleged that Adventist tolerated various and
persistent instances of known over-billing and upcoding by
employed as well as contracted physicians.
United States ex rel Barker v. Columbus Regional System,
No. 4:12-cv-108 (M.D. Ga.)
United States ex rel Barker v. Columbus Regional System,
No. 4:14-cv-304 (M.D. Ga.)
In these actions, which ended when defendant hospital
agreed to pay up to $35 million to the federal govern-
ment, the whistleblower alleged that over a ten-year period,
oncologists were paid lucrative stipends for duplicative
medical director services and other compensation that was
above FMV, was based on work provided by other physi-
cians and mid-level practitioners, and/or based on upcoded
billings. The complaint noted that third-party valuation
opinions had been obtained, but the opinions were based on
the incorrect assumption that payments were made only for
personally performed services. Subsequent valuation opin-
ions concluded that the total wRVU production could not be
solely attributed to physicians’ personally performed services
and instead took into account services provided by another
physician and mid-level providers and therefore exceeded
FMV for the physicians’ services.
United States ex rel. Parikh, v. Citizens Medical Center,
No. 6:10-cv-64 (S.D. Tex.)
In this qui tam action, which settled for $21.75 million, rela-
tors alleged that physician compensation arrangements were
disguised incentives for patient referrals. The whistleblower
alleged in the civil complaint that the cardiologists’ compen-
sation tripled when the cardiologists became employed by
the hospital, despite practice losses of $400,000 and $1
million in successive years shortly thereafter. The complaint
also alleged that the physicians received rich fringe benefits
that included malpractice coverage, health and dental insur-
ance, dictation services, paid advertising, and below-FMV
office space. The complaint further alleged that, prior to
these compensation arrangements, the physicians trans-
ferred Medicare and Medicaid patients to other hospitals.
The court denied a motion to dismiss the whistleblowers
claims regarding the cardiologists’ compensation, despite the
contention that the cardiologists were earning a salary that
was below the median for their specialty.
12. Hospitals Health Systems Rx
12
Also surviving the motion to dismiss were allegations that
emergency department physicians had been paid 50% of a
chest pain center’s revenue as a bonus to induce referrals,
and that gastroenterologists were paid $1,000 per day for
“medical directorship” duties that did not involve additional
work or responsibilities, were duplicative of payments for
professional services, and were assigned based on volume of
referrals.
United States ex rel. Phillip S. Schaengold v. Memorial Health, Inc.,
No. 4:11-cv-58 (S.D. Ga.)
The whistleblower and the United States alleged that the
defendant hospital acquired a physician practice for compen-
sation in excess of FMV, and that the acquisition resulted
in a projected financial loss of approximately $670,000 per
year over a five-year period. The complaints alleged that the
purpose of the transaction was to obtain referrals from the
physicians who owned the practice. Relator alleged that the
physicians’ compensation from Memorial Health was not
justified by business factors such as strategic importance,
quality outcomes, clinical skills, professional accomplishments,
business development skills, or recruitment difficulties. The
whistleblower alleged that incentive payments to employed
physicians were based on the value and volume of referrals
in the prior year, and on intentionally inflated collections
data. The whistleblower alleged that he was instructed by the
chairman of the board of Memorial Health not to take any
action regarding the improper payments, and was terminated
from his position at the hospital as a result of raising concerns
about the compensation arrangements. While the parties have
announced an agreement in principle to resolve the qui tam
complaint, the terms of the resolution have not, as of yet, been
made public. During the entire timeframe of the arrangements
in question, the hospital and its parent were under a Certifica-
tion of Compliance Agreement with the OIG, which included
requirements to report overpayments, probable violations of
criminal, civil, or administrative law, and certain information
regarding internal and external reviews implicating the Stark
and Anti-Kickback laws.
United States ex rel. Drakeford v. Tuomey Healthcare System, Inc.,
No. 3:05-cv-02858 (MBS) (D.S.C.)
After a $237 million judgment and years of procedural
wrangling, this qui tam case was finally settled for $72.4
million, with consideration for the discount being the
requirement that the hospital be divested at nominal
additional consideration.1
According to the decision of
the Fourth Circuit in this case, beginning around 2000,
physicians in several specialty groups who had previously
performed outpatient surgeries at the hospital began doing
so in their own offices, or at ambulatory surgery centers,
causing substantial revenue loss to the hospital. To allegedly
avoid this reduction in surgical case volume, 19 specialists
were given contracts as part-time employees. Each of the ten-
year contracts included essentially the same terms—physi-
cians: (1) were required to perform outpatient procedures
exclusively at the hospital; (2) could not own an interest in
a local ambulatory surgery center, with minor exceptions;
(3) annual base salary was based on prior year’s collections;
and (4) were eligible for a productivity bonus of 80% of the
amount of their collection, plus an incentive bonus up to 7%
of the productivity bonus. The hospital agreed to absorb the
cost of professional liability insurance, employment taxes,
and billing and collection costs, and offered the physicians
participation in the hospital’s health insurance plan. Finally,
the contracts included a non-compete clause, prohibiting
the performance of outpatient surgical procedures within
a 30-mile radius for two years after termination of the
contract. After consulting with numerous counsel and valu-
ation experts who provided negative opinions, the hospital
received favorable counsel and entered into the agreements.
13. 13
United States ex rel. Baklid-Kunz v. Halifax Hospital Medical Center,
No. 09-cv-1002 (M.D. Fla.)
This $85 million qui tam settlement resulted from a
complaint alleging that physicians in various specialties
largely employed by a staffing entity associated with Halifax
Hospital Medical Center were compensated with incen-
tive payments that were not based on personally performed
services. Oncologists were allegedly compensated from
a pool of 15% of the operating margin of the medical
oncology program; psychiatrists 100% of gross collections
after base compensation and collection costs; and neurolo-
gists 100% of collections after base compensation and staff
costs. The total compensation paid to two of the neurologists
was alleged to far exceed the 90th percentile. The produc-
tivity justification for these compensation levels was alleged
to be based on improper billing and coding.
United States ex rel. Schubert v. All Children’s Health System Inc.,
No. 8:11-cv-01687 (M.D. Fla.)
This qui tam action, settled for $7 million, alleged that
arrangements with pediatricians making Medicaid refer-
rals violated the Stark and Anti-Kickback Statutes through
compensation arrangements that resulted in operating losses
for the hospital’s pediatric practice. This case is notable,
in addition to the finding that Medicaid referrals can form
the basis for Stark and False Claims Act violations, for the
finding, citing Tuomey, that fixed compensation to employed
physicians can violate Stark if inflated above FMV to take
into account expected referrals. Relator alleged that almost
one-third of newly hired physicians were paid in excess of
the 75th percentile.
Common Themes
Some common themes that arise in these cases include the
following:
• Perpetual and persistent losses from employed physicians
may be a factor in a whistleblower’s claims of non-FMV,
non-commercially reasonable compensation;
• Evidence that profits from referrals for inpatient and
ancillary services were considered in setting compensation
or assessing whether to move forward with a transaction
is a red flag;
• Inflated RVU values or other inaccurate information
will undermine the reliability of an opinion of FMV or
commercial reasonableness;
• Compensation for services that are not needed or not
performed is generally not FMV and not commercially
reasonable;
• Payment of costs that would normally be borne by a
physician is an FMV and commercial reasonableness
pitfall; and
• Third-party FMV analyses have no value if based on
skewed information provided by the hospital.
Lessons from the Terms of Recent Settlements
Provisions in the Corporate Integrity Agreements (CIAs)
required by OIG continue to evolve. Notable about recent
CIAs are now-standard provisions that:
• Require all owners, officers, directors, commissioners,
employees, members of the medical staff, contractors, and
subcontractors be provided with an institution’s Anti-
Kickback Statute and Stark policies and Code of Conduct,
and be trained on the requirements of those policies, as
well as of the CIA, Compliance Program, and Code of
Conduct;
• Require each member of the governing body to personally
sign a quarterly resolution summarizing its review of compli-
ance with the CIA and federal compliance requirements;
• Suggest, albeit not require, that the Board engage an
independent advisor or third-party resources to assess its
oversight of the compliance program;
• Require implementation of an intense regimen of
processes for entering into, tracking, monitoring, and
reviewing each arrangement that implicates the Stark and
Anti-Kickback Statute requirements, i.e. financial arrange-
ments with a potential referral source; and
• Require engagement of an Independent Review Organi-
zation with legal expertise to test compliance with these
aspects of the CIA by:
14. Hospitals Health Systems Rx
14
–– Periodically reviewing systems and procedures for
entering into arrangements with referral sources, and
identifying weaknesses; and
–– Reviewing a significant proportion of such transactions
for compliance with such systems, including application
of a sound FMV methodology, support by a valid and
documented business rationale, appropriate tracking
and monitoring, and appropriate application of an
internal review and approval processes.
Takeaways
Each of the cases discussed above has an interesting history
and context that contains many potential lessons. In the
authors’ opinion, the most significant of them include:
Practice Losses Merit Scrutiny
There are many legitimate reasons why a hospital or other
health care provider may initiate or continue a service despite
projected losses. In a situation where a particular department
or practice will be losing money, the business justification
should be rigorously documented, particularly if the projected
losses are substantial and perpetual. Documentation may
include the business reasons for the losses, as well as objec-
tive benchmark data that support the compensation paid and
that indicate that the losses are not outside the norm, even if
significant. Throughout the marketplace, physician practices
of various specialties incur losses for various reasons.
High-Compensation Amounts Attract Scrutiny
Although high-compensation amounts may be FMV and
commercially reasonable under some circumstances, they
almost always are at higher risk of attracting scrutiny. When
high compensation is warranted, the supporting detail
showing why it is warranted should be appropriately docu-
mented. The detail may include unusual or unique aspects
of the services for which the compensation is being paid, of
the party who will perform the services, or of the market in
which the services will be provided.
Policy and Procedure Can Be a Blessing or a Curse
The only thing worse than not having a policy or procedure
is having one and not following it. Rigorous compensa-
tion parameters and review requirements can be helpful for
ensuring regulatory compliance, but can become evidence
of improper conduct if they are not followed in any partic-
ular case.
*AHLA would like to thank Andrea Ferrari, JD, MPH,
HealthCare Appraisers Inc., Delray Beach, FL, for editing
this article.
1 The extensive procedural history of the Tuomey case has been well docu-
mented, as have the numerous holdings in the case, including that facility
fees can be the result of a “referral” under Stark, and will not be repeated
here.
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15. 15
Practice Group Mid-Year Luncheon
Monday, February 8, 2016 | 12:30-1:45 pm
Physicians and Hospitals Law Institute
February 8-10, 2016 • Hilton Austin • Austin, TX
Respond to an Active Shooter
Sponsored by the Health Care Liability and Litigation, Hospitals and Health Systems, and In-House Counsel Practice
Groups and the Enterprise Risk Management Task Force.
Active shooters can attack our workplaces, schools, shopping malls, museums, and military installations. Although
many of the perpetrators have a history of negative—sometimes violent—behavior, there is still no single,
accurate, one-size-fits-all profile of an active shooter. Active shooters frequently target some of our nation’s most
vulnerable open-access settings, such as the 2011 attempted assassination of Representative Gabrielle Giffords
during a public appearance at an Arizona shopping center, and the 2007 shooting on the campus of
Virginia Polytechnic Institute and State University.
This presentation will address:
• The protection of our nation’s critical infrastructure from active shooters and other threats is a shared
responsibility between the U.S. Department of Homeland Security and the public- and private-sector partners
who own and operate facilities.
• Given today’s ever-changing threat environment, preparing for active shooter scenarios and training employees
to cope with such incidents should be a key component of any organization’s incident response planning.
Faculty
• Ron McPherson, South Texas Protective Security Advisor, U.S. Department of Homeland Security, Austin, TX
To register for the luncheon only, please call our Member Satisfaction Center at
(202) 833-1100, prompt #2.
Physicians and Hospitals Law Institute
February 8-10, 2016 • Hilton Austin • Austin, TX
Register
16. Hospitals Health Systems Rx
Can We Publish Your Article?
The Hospitals and Health Systems Practice Group is looking for authors to draft member
briefings, executive summaries, and newsletter articles of interest to attorneys working with
hospitals and health systems. What have you worked on recently? Would your colleagues find it interesting?
Contact Vice Chair of Publications Marta Hoffman at mhoffman@plunkettcooney.com for more information about
how we can convert your recent work into an informative publication for your colleagues.
Ideas for Educational Programs
The Hospitals and Health Systems Practice Group (HHS PG) is looking for great topics for educational programs
such as webinars, roundtable discussions, and tutorials. Do you have a topic that you would like to see covered?
Are you working on something that would be of interest to your peers working with hospitals and health systems?
If so, contact Vice Chair of Educational Programs Emily Black Grey at emily.grey@bswllp.com for more information
about getting a topic covered in an HHS PG program.
American Health Lawyers Association
1620 Eye Street, NW, 6th Floor • Washington, DC 20006-4010
(202) 833-1100 • Fax (202) 833-1105 • www.healthlawyers.org