Health Law Advisory Bulletin
OIG Issues Final Supplemental Hospital Compliance
Guidance
By Lisa
Rediger Hayward
[February 2005]
As a part of its ongoing effort to promote effective
compliance programs, the Office of Inspector General (OIG) of the
Department of Health and Human Services recently published Supplemental
Compliance Program Guidance for Hospitals (the “Guidance”).
The Guidance will be of interest to hospital administrators, board
members, compliance personnel and others in their efforts to understand
the OIG’s enforcement priorities.
The Guidance supplements, rather than replaces, the OIG’s
1998 compliance guidance for the hospital industry.1
The new publication focuses on measuring and improving effectiveness
of existing compliance efforts and identifies specific risk areas
for hospitals. Although the Guidance reiterates the OIG’s
longstanding position on a number of regulatory issues, it also
provides valuable instruction to hospitals by offering often detailed
insight into the treatment of new legal developments and industry
practices that have arisen in the more than six years since the
original guidance was issued. For those hospitals with existing
compliance programs, the Guidance may serve as a “benchmark”
against which to measure ongoing efforts and as a roadmap for updating
or refining their compliance plans.
Hospital Compliance Program Effectiveness
In the OIG’s view, the touchstone of an effective compliance
program is an organizational culture that values, and even rewards,
the prevention, detection, and resolution of problems. In view of
recent changes to sentencing guidelines, it notes that successful
compliance programs generally include:
- Commitment of the hospital’s governance and management
at the highest levels
- Structures and processes that create effective internal controls
- Regular self-assessment and enhancement of the existing program
Hospital leadership should endeavor to develop a culture “that
values compliance from the top down and fosters compliance from
the bottom up.” Moreover, hospitals are advised to ensure
that compensation structures and other policies “do not create
undue pressure to pursue profit over compliance.” The culture
of the organization should foster clear, open communication without
fear of retribution.
The OIG goes on to outline what it perceives to be the organizational
structure needed to ensure program effectiveness. The compliance
officer should be a member of senior management with direct access
to the board of directors, senior management and legal counsel.
Training and education should include “[any] other individual
that functions on behalf of the hospital[.]” Scheduled and
unscheduled billing audits should be conducted and response teams
should be created to address all detected deficiencies. Finally,
disciplinary standards should be enforced, including the annual
(or more frequent) check of employees, contractors and medical staff
members against applicable exclusion lists. Hospitals are encouraged
to review and assess all elements of their compliance plans at least
annually.
Not all organizations are either willing or able to follow all
of the OIG’s suggestions. In our opinion, it is more important
to develop a structure that works for your organization than to
slavishly follow the Guidance.
Self-Reporting
The Guidance states: “Where the compliance officer, compliance
committee, or a member of senior management discovers credible evidence
of misconduct from any source and, after a reasonable inquiry, believes
that the misconduct may violate criminal, civil or administrative
law, the hospital should promptly report the existence of misconduct
to the appropriate federal and state authorities within a reasonable
period, but not more than 60 days, after determining that there
is credible evidence of a violation.” The Guidance also states
that “some violations may be so serious that they warrant
immediate notification to governmental authorities prior to, or
simultaneous with, commencing an internal investigation.”
The OIG believes a provider should immediately report misconduct
that “is a clear violation of administrative, civil, or criminal
laws.” The OIG notes that voluntary reporting will demonstrate
the hospital’s “good faith and willingness to work with
governmental authorities to correct and remedy the problem.”
In addition, reporting such conduct will be considered “a
mitigating factor by the OIG in determining administrative sanctions
(e.g., penalties, assessments, and exclusion), if the reporting
hospital becomes the subject of an OIG investigation.”
Self-disclosure requires consideration of a number of legal and
practical risks, particularly if a hospital is considering making
a disclosure prior to an internal investigation. While self- disclosure
may be an appropriate option, hospitals should carefully consider
what is appropriate to disclose, to whom to disclose and the timing
of such disclosure. Counsel can often assist with this process.
Risk Areas
The Guidance identifies a number of risk areas that are particularly
relevant to the hospital industry. Risk areas discussed in the Guidance
include:
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Submission of Accurate Claims and Information |
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Outpatient Procedure Coding
Hospital Outpatient Prospective Payment System (OPPS) coding
errors may lead to overpayments and subject a hospital to
liability for the submission of false claims. The Guidance
recommends that hospitals pay close attention to coder training
and qualifications. Hospitals are urged to review their outpatient
documentation practices to ensure that claims are based on
complete medical records that support the level of service
claimed. It is worthwhile to review the specific areas of
billing and coding mentioned in the Guidance because these
areas obviously have caught the attention of regulators. Specific
problems identified in the Guidance include:
- Billing on an outpatient basis for inpatient-only
procedures
- Submitting claims for medically unnecessary services by
failing to follow the fiscal intermediary’s local
medical review policies
- Submitting duplicate claims or otherwise not following
the National Correct Coding Initiative guidelines
- Submitting incorrect claims for ancillary services because
of outdated Charge Description Masters
- Circumventing the multiple procedure discounting rules
- Failing to follow the Centers for Medicare and Medicaid
Services (CMS) instructions regarding the selection of proper
evaluation and management codes
- Improperly billing for observation services
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Admissions and Discharges
Risk areas with respect to the admission and discharge processes
include:
- Failure to follow the "same-day rule"
- Abuse of partial hospitalization payment
- Same-day discharges and readmissions
- Violation of Medicare’s post-acute care transfer
policy
- Churning of patients by long-term care hospitals
co-located in acute care hospitals
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Supplemental Payment Considerations
Many hospitals receive add-on payments to their PPS payments.
Examples of specific associated risks that the OIG says hospitals
should address include:
- Improper reporting of the costs of pass-through
items
- Abuse of DRG outlier payments
- Improper claims for incorrectly designated provider-based
entities
- Improper claims for clinical trials
- Improper claims for organ acquisition costs
- Improper claims for cardiac rehabilitation services
- Failure to follow Medicare rules regarding payment for
costs related to educational activities
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Use of Information Technology
OPPS requires heightened attention to detailed and accurate
billing, coding, and record keeping. Hospital billing computer
programs have the potential to omit or mischaracterize certain
data, thus creating problematic claims. Such problems can
be particularly difficult because an error in the system can
be replicated hundreds of times before it is detected. |
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| B. |
The “Stark Law” and the Anti-Kickback
Statute |
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The Physician Self-Referral Law (“Stark”)
The Stark law prohibits hospitals from submitting claims
for designated health services provided to Medicare patients
referred from a physician with whom the hospital has a prohibited
financial relationship. According to the Guidance, the Stark
law should be viewed as a “threshold statute”
from a compliance perspective. Hospitals face “significant
financial exposure unless their financial relationships with
referring physicians fit squarely in statutory or regulatory
exceptions to the Stark law.” The OIG recommends that
hospitals pay particular attention to the following areas:
- Physician contracts and the contracting and leasing process
- Policies and procedures to address the reporting requirement
under the Stark law
- Appropriate processes for making and documenting reasonable,
consistent and objective determinations of fair market value
- The total value of non-monetary compensation provided
annually to each referring physician
- The provision and value of medical staff incidental benefits
and professional courtesy
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The Federal Anti-Kickback Statute
The federal anti-kickback statute prohibits payments made
purposefully to induce or reward referrals of federal health
care program business. The Guidance acknowledges that liability
under the anti-kickback statute ultimately turns on a party’s
intent and reiterates the OIG’s long-held position that
neither a legitimate business purpose nor fair market value
payment will legitimize an arrangement if one purpose
for the transaction is to induce federal health care program
business. Notably, the OIG continues to ignore the fact that
courts in some jurisdictions (e.g. the Ninth Circuit, which
covers most of the western states and Arizona) have interpreted
the statute to require a more stringent intent standard than
that articulated by the government. This may signal the OIG's
willingness to use a lower intent standard as the basis for
investigation and prosecution.
In reviewing arrangements or practices under the anti-kickback
statute, the OIG recommends that hospitals ask the following
questions about any potentially problematic arrangements:
- Does the arrangement have a potential to interfere with,
or skew clinical decision-making?
- Does the arrangement have a potential to increase costs
to federal health care programs, or beneficiaries?
- Does the arrangement have a potential to increase the
risk of over utilization or inappropriate utilization?
- Does the arrangement raise patient safety or quality
of care concerns?
Positive responses to these questions can help identify those
arrangements that pose the greatest risk of prosecution. |
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Joint Ventures
The Guidance reiterates the OIG’s long-standing concern
about joint venture arrangements between those in a position
to refer federal health care program business and those providing
items or services reimbursable by such programs. The OIG explains
that its chief concern in the context of joint ventures is
that remuneration from a joint venture might be a disguised
payment for past or future referrals to the venture or to
one or more of its participants. In analyzing current or future
joint ventures, hospitals should examine the following factors:
- Manner in which joint venture participants are selected
and retained
- Manner in which the joint venture is structured
- Manner in which investments are financed and profits
are distributed
The OIG points out that contractual joint ventures “pose
the same kinds of risks as equity joint ventures and should
be analyzed similarly.” Factors to consider when evaluating
a contractual joint venture include:
- Whether the hospital is expanding into a new line of
business created predominately to serve the hospital’s
existing patient base
- Whether a would-be competitor of the new line of business
is providing all or most of the key services
- Whether the hospital assumes little or no bona fide business
risk
The OIG also cautions that “safe harbor protection
may not be available for contractual joint ventures.”
According to the OIG, if a hospital is planning to participate
in a joint venture, a hospital should consider (i) barring
physicians employed by the hospital or its affiliates from
referring to the joint venture; (ii) taking steps to ensure
that medical staff and other affiliated physicians are not
encouraged in any manner to refer to the joint venture; (iii)
notifying physicians annually in writing of the preceding
policy; (iv) refraining from tracking in any manner the volume
of referrals attributable to particular referrals sources;
(v) ensuring that no physician compensation is tied in any
manner to the volume or value of referrals to, or other business
generated for, the venture; (vi) disclosing all financial
interests to patients; and (vii) requiring that other participants
in the joint venture adopt similar steps. |
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Compensation Arrangements with Physicians
Medical director agreements, personal or management services
agreements, space or equipment leases, and agreements for
the provision of billing, nursing, or other staff services
all create compensation arrangements. Many of these arrangements
are legal, but the Guidance urges hospitals to structure these
arrangements with an eye toward compliance.
The general rule is that any remuneration between hospitals
and physicians should be at fair market value for actual and
for necessary items or services based upon an arm’s-length
transaction. Arrangements under which hospitals provide physicians
with items or services for free or less than fair market value,
relieve physicians of financial obligations they would otherwise
incur, or arrangements that inflate compensation paid to physicians
for items or services pose significant legal risk to both
the hospital and the physician.
The OIG is particularly concerned about arrangements with
physicians that:
- Do not achieve legitimate business purposes
- Exceed the needs of the hospital
- Exceed fair market value or do not have a documented
basis for the fair market valuation
- Take into account referrals or business generated between
the parties
- Are not documented in writing
- Do not document physician services provided
- Are not monitored by the hospital
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Relationships with Other Health Care Entities
Hospitals should review relationships with home health agencies,
skilled nursing facilities, durable medical equipment companies,
laboratories, pharmaceutical companies, and other hospital
and managed care organizations using the principles identified
above in the general discussion of the federal anti-kickback
statute the specific discussions of joint ventures and compensation
arrangements with physicians. |
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Physician Recruitment
When assessing the degree of risk associated with recruitment
arrangements, hospitals should examine the following factors,
among others:
- Size and value of the recruitment benefit: Is the
benefit extended reasonably necessary to attract a qualified
physician to the particular community?
- Duration of payout: Are total benefit payout periods
longer than three years? Periods extending longer than three
years should trigger heightened scrutiny.
- The practice of the recruited physician: Is the
physician a new physician (or a physician relocating from
a great distance) with few or no patients or an established
practitioner with a ready stream of referrals?
- The need for recruitment: Is the recruited physician’s
specialty necessary to provide adequate access to medically
necessary care for patients in the community? An assessment
of community need based wholly or partially on the competitive
interests of the recruiting hospital or existing physician
practices would subject the recruitment payments to heightened
scrutiny.
- Joint recruitment: Is the arrangement a joint
recruitment arrangement (i.e. recruitment by a hospital
in conjunction with other providers such as physicians or
medical groups, in which the hospital makes payments directly
or indirectly to the other entity)? According the OIG, joint
recruitment arrangements present a high degree of fraud
and abuse risk and have been the subject of recent government
investigations and prosecutions. Suspect arrangements include
those in which costs such as overhead and build-out costs
for the benefit of the referral source are shifted from
the referral source to the recruited physician and then
paid by the hospital.
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Discounts
The Guidance acknowledges that public policy favors open
and legitimate price competition in health care. Thus, the
anti-kickback statute contains an exception for discounts
offered to customers if the discounts are properly disclosed
and accurately reported. However, to qualify for the exception,
the discount must be in the form of a reduction in the price
of the good or service based on an arm’s-length transaction.
Moreover, the regulation provides that the discount must be
given at the time of sale or, in certain cases, set at the
time of sale, even if finally determined subsequent to the
time of sale (e.g., a rebate).
Discounts should not be a means of “swapping”
government reimbursement for some other benefit. The Guidance
states that a hospital may violate this principle by extending
an unreasonably low price Part A services that it pays for
out of its own pocket in exchange for referring hospital patients
for services that are billable by the supplier directly under
Part B, such as ambulance services. Suspect arrangements include
below-cost arrangements or arrangements at prices lower than
the prices offered by the supplier to other customers with
similar volumes of business, but without federal health care
program referrals. |
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Medical Staff Credentialing
Conditioning privileges on a particular number of referrals
or requiring the performance of a particular number of procedures,
beyond volumes necessary to ensure clinical proficiency, raises
risks. However, a credentialing policy that categorically
refuses privileges to physicians with significant conflicts
of interest should not implicate the anti-kickback statute
in most situations. |
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Malpractice Insurance Subsidies
The Guidance reiterates the OIG’s view that hospital
subsidies of malpractice insurance premiums for potential
referral sources may be suspect under the anti-kickback statute
because the payments may be used to influence referrals. The
OIG recommends that hospitals review their malpractice insurance
subsidy arrangements in light of the following factors:
- Whether the subsidy is being provided on an interim basis
for a fixed period in areas experiencing severe access or
affordability problems;
- Whether the subsidy is being offered only to current active
medical staff (or physicians new to the locality or in practice
less than a year, i.e., physicians with no or few established
patients);
- Whether the criteria for receiving a subsidy is unrelated
to the volume or value of referrals or other business generated
by the subsidized physician or his practice;
- Whether physicians receiving subsidies are paying at
least as much as they currently pay for malpractice insurance;
- Whether physicians are required to perform services or
relinquish rights, which have a value equal to the fair
market value of the insurance assistance; and
- Whether the insurance is available regardless of the
location at which the physician provides services, including,
but not limited to, other hospitals.
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| C. |
Gainsharing” Arrangements
The Guidance identifies risks under the Civil Monetary Penalty
(CMP) law of “gainsharing” arrangements. The CMP
law prohibits a hospital from knowingly making a payment to
a physician to induce her to reduce or limit items or services
furnished to Medicare or Medicaid beneficiaries under the
physician’s direct care. While there is no fixed definition
of a “gainsharing” arrangement, the OIG notes
that the term typically refers to an arrangement in which
a hospital gives physicians a percentage share of any reduction
in the hospital’s costs for patient care attributable
in part to the physicians’ efforts.
The OIG acknowledges that some gainsharing arrangements may
serve legitimate purposes, but cautions that they must be
analyzed in light of the CMP and anti-kickback prohibitions.2
Consequently, the OIG recommends that gainsharing arrangements
should be structured to fit within the personal services safe
harbor. That recommendation is of limited value, however,
because the safe harbor requires that aggregate compensation
be set in advance, and gainsharing arrangements typically
will involve a percentage payment. |
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EMTALA
The OIG urges hospitals to clearly understand their EMTALA
obligations and implementing policies and training (particularly
of on-call physicians and all individuals working in emergency
departments) that accurately reflect those legal responsibilities. |
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Substandard Care
The OIG has the authority to exclude providers from participating
in federal health care programs if the provider fails to meet
professionally recognized standards of care. Hospitals are
urged to continually measure their performance against comprehensive
standards and ensure compliance with all of the Medicare hospital
conditions of participation. |
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Relationships with Federal Health Care
Beneficiaries
Under the CMP law, civil monetary penalties may be imposed
on hospitals that offer remuneration to Medicare or Medicaid
beneficiaries where the hospital knows or should know the
offer is likely to influence the beneficiary to order or receive
items or services from a particular provider. Simply put,
hospitals cannot offer valuable items or services to attract
Medicare and Medicaid patients. Examples discussed in the
Guidance include: gifts over nominal amounts, cost-sharing
waivers (some of which may be acceptable), and free transportation
over nominal value. |
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HIPAA Privacy and Security Rules
The Guidance reinforces the need to comply with the law,
but recognizes that some flexibility exists in tailoring a
hospital's security plans and procedures in light of the particular
hospital’s organization and capabilities. |
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Discounts to Uninsured Patients
The OIG reminds hospitals that no OIG authority prohibits
or restricts hospitals from offering discounts to uninsured
patients who are unable to pay their hospital bills. The Guidance
notes, however, that discounts offered to underinsured
patients potentially “raise a more significant concern
under the anti-kickback statute, and hospitals should exercise
care to ensure that such discounts are not tied directly or
indirectly to the furnishing of items or services payable
by a federal health care program.” |
Conclusion
In today’s environment it is important for hospitals to establish
and maintain effective compliance programs. An ineffective compliance
program not only wastes resources, but it may do more harm than
good. An effective compliance program, on the other hand, not only
demonstrates a hospital’s good faith effort to comply with
applicable statutes, regulations, and other federal health care
program requirements, it may significantly reduce the risk of unlawful
conduct and corresponding sanctions. Hospitals should view the OIG’s
Guidance as a useful resource in their efforts to develop and maintain
effective compliance programs.
FOOTNOTES
1
The entire text of the both the original guidance and the supplemental
guidance can be found at http://oig.hhs.gov//fraud/complianceguidance.html.
2
The OIG recently issued an advisory opinion that analyzes
a gainsharing program and lists features of that program that the
OIG found to be favorable and negative. OIG Advisory Opinion 05-01
can be found at http://oig.hhs.gov//fraud/advisoryopinions/opinions.html.
For more information, please contact:
Susan
L. Fine, Seattle, (206) 628-7684, SusanFine@dwt.com
Robert
G. Homchick, Seattle, (206) 628-7676, RobertHomchick@dwt.com
Edwin
D. Rauzi, Seattle, (206) 628-7761, EdRauzi@dwt.com
Gerry
Hinkley, San Francisco, (415) 276-6530, GerryHinkley@dwt.com
Ingrid
Brydolf, Portland, (503) 276-5804, IngridBrydolf@dwt.com
John
P. Krave, Los Angeles, (213) 633-6873, JohnKrave@dwt.com
This Advisory is a publication of the Health Law Department of Davis
Wright Tremaine LLP. Our purpose in publishing this Advisory is
to inform our clients and friends of recent developments in health
law. It is not intended, nor should it be used, as a substitute
for specific legal advice as legal counsel may only be given in
response to inquiries regarding particular situations.
Copyright © 2005, Davis Wright Tremaine
LLP.
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