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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:
| A. |
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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4. |
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
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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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a. |
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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