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Question
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Response
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Will you please do a similar webinar for manufacturers?
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Since we generally do not represent many manufacturers,
we do not have a separate webinar planned. However, if
you have a specific question you would like addressed,
please let us know and we will do our best to answer it.
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Could you share specific examples of fallouts violating
the new Stark and AKS rules?
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Unfortunately, without additional information, this
question is a little difficult to answer. If you are
requesting specific information regarding exceptions and
safe harbors to the new rules, please see our firm’s
alerts on this topic:
OIG
finalizes new and modified anti-kickback safe harbors
CMS
Finalizes new and modified Stark Law regulations
Challenges
and opportunities in structuring group practice
compensation under the revised self-referral and
anti-kickback regulations
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I am a clinical geneticist and clinical cytogeneticist.
If I see a patient in my office for a genetics condition
and feel they need a genetic test that is offered in my
lab, can I sign out that lab report as an employee of
that lab?
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Unfortunately, we do not have enough facts to provide an
answer. However, some issues that would need to be
looked at include, who is authorized person for signing
lab reports in the specific state and state specific
requirements for responsibilities of supervising
physicians. Whether Stark is implicated would likely be
dictated on whether the “referral” for the test could be
imputed to the physician. AKS considerations would be
broader.
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Is there a minimum number of draws a day that is used to
justify an In office phlebotomist or is that simply a
business decision?
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That would be a business decision, assuming that the
state does not have a prohibition on providing such
services.
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If a referral lab has a collection station in an office,
and part of the agreement between them is that they (the
lab) will accept the office's sliding scale of payment
that the office has set up for their
patients, is there any
risk in this practice?
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We would need more facts about the arrangement to
provide firm guidance. However, it would be important to
ensure that having a collection station is not
prohibited and that the payments scales are not related
to the volume or value of the referrals or business
generated. Additionally, review of any lease arrangement
for that collection station space would need to be
reviewed to ensure compliance with AKS. If the sliding
scale relates somehow to financial inability to pay, the
patient’s financial situation should be well documented
to justify any reduction. Routine discounts are not
acceptable.
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Is the in-office collector allowed to manually upload
the laboratory results to the office's EMR, since they
are results from the laboratory testing, but it is
transmitting it into the office's EMR?
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We do not recommend that a specimen collector do any
tasks other than those directly related to specimen
collection and packaging, so we would advise that the
specimen collector not do any type of data entry or
clerical work.
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Does the lab need to require the recipient to pay for
any part of the interface to their EMR? Or can the
laboratory pay for the full amount?
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As of January 1, 2014, the applicable Stark exception
and antikickback
safe harbor
for EHR
donation no
longer permits pathology or laboratory providers to make
EHR
donations to referral sources. If not included as part
of an EHR donation, the provision of a
dedicated interface should be analyzed separately.
Provision of
an interface used solely for the transmittal of
requisitions, orders,
and/or the delivery of laboratory or pathology reports
between
the laboratory and the referral source is comparable to
the provision
of computer terminals and fax machines. As long as the
interface does not
have an independent utility for the referral source,
it is generally considered acceptable.
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Are you saying that we cannot provide an EHR interface
or on-site collectors for our outreach program?
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As of January 1, 2014, the applicable Stark exception
and antikickback
safe harbor
for EHR
donation no
longer permits pathology or laboratory providers to make
EHR
donations to referral sources. If not included as part
of an EHR donation, the provision of a
dedicated interface should be analyzed separately.
Provision of
an interface used solely for the transmittal of
requisitions, orders,
and/or the delivery of laboratory or pathology reports
between
the laboratory and the referral source is comparable to
the provision
of computer terminals and fax machines. As long as the
interface does not
have an independent utility for the referral source,
it is generally considered acceptable.
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Does patient billing for waiver of co-pay apply to
radiology services
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Providers should collect (and make multiple attempts to
collect) all cost-sharing amounts from patients. Routine
waivers of cost-sharing amounts are not permitted, and
any waiver should be clearly documented.
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Where can we find further guidance on the OIG standards
regarding Covid billing enforcement?
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Additional guidance can be
found by clicking on the following link:
https://oig.hhs.gov/coronavirus/index.asp
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Is a pain management practice subject to self-referral
issues if the pain management practice owns its own
clinical lab that runs and bills its own urine drug
screens?
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It depends on a variety of factors, including whether
the Pain Management clinic submits any claims for
services to Medicare, Medicaid, or any other
governmental payors. If it does not, the clinic likely
would not be subject to federal self-referral
prohibitions, but there may still be state equivalents
of the federal rules and commercial payors might
incorporate the federal rules into their contract or
adopt such rules in policies and procedures. If the Pain
Management Clinic is subject to federal and/or state
self-referrals prohibitions, the lab may by permissible
if it is wholly owned by the Pain Management clinic.
However, EKRA would still likely apply unless the clinic
is a cash-only practice.
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Are labs who give outpatient physicians their lab order
form considered a violation of AKS? The physician
sometimes can be limited on what can be ordered based on
the limitation of the lab order menu.
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Without additional context, this question could have a
few different angles. However, lab order forms/portals
should provide all available test options for every
physician. For any panels, there should be an indication
on the form that each test ordered can also be ordered
without ordering the entire panel.
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Have any labs been sanctioned for paying sales
commissions in violation of EKRA?
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Yes. Two of the enforcement actions have been against
substance abuse facilities who offered or received
inducements in exchange for referrals of lab tests. A
third enforcement action in September 2020 involved
three defendants (2 owners and operators of a lab, and
one marketing) who were charged with AKS and EKRA
kickback schemes.
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Are you aware of any national labs how they are managing
EKRA and compensating sales reps?
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Many labs are converting their sales staff to W2
employees and changing the compensation/bonus
structures. However, we are aware that some labs are
still taking a wait and see approach in the hopes that
clarifying guidance is issued.
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You mentioned the importance of not having excessive
medical director compensation structures. When designing
medical director contracts for the laboratory, where is
the best resource in establishing fair medical director
compensation agreements?
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MGMA or SullivanCotter are good resources for this
information.
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Are laboratories out of compliance when accepting gifts
(i.e. meals for staff) from company sales reps which
products we use and have a contract with them?
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All healthcare providers who are subject to AKS are
prohibited from receiving or soliciting remuneration
(including gifts) in exchange for referrals for items or
services reimbursable under Medicare, Medicaid or any
other government program unless the remuneration fits
within a safe harbor or exception to AKS and Stark.
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Would the devices given to labs to run Covid testing for
free from commercial vendors considered a violation of
the AKS? Can the labs who are running these devices be
penalized?
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We would need more information to properly analyze this.
Generally speaking, the provision of any free equipment
or supplies must be carefully analyzed under Stark and
AKS to determine if the arrangement is acceptable.
However, if it is allowed during COVID, then that
enforcement discretion would likely end upon the end of
the public health emergency and the labs should have a
plan in place to deal with that transition to a non-PHE
compliant arrangement.
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When renewing a contract for POCT glucose testing
supplies is it a Stark Law issue if the vendor offers
free meters during the contract duration, "free
connectivity" (pays a different connectivity vendor for
# meters in contract)?
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It is difficult to analyze without reviewing the terms,
but there would not be any Stark issues if a physician
is not involved in the relationship; there may be AKS
consideration and state law considerations.
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Could you please clarify that Stark and AKS are observed
when using cups for urine collection for drug screening
testing? There are some cups with drug screening
capabilities used at point of care.
Are we out of compliance when using these cups at POCT?
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Generally speaking, POCT cups with test strips
integrated into them can raise concerns under both Stark
and AKS because they are not typically utilized solely
for the collection, transport, processing, or storage of
specimens and instead have independent utility. Any
arrangement involving the provision of testing supplies
must be carefully analyzed.
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How are health fair lab screen test like glucose or
cholesterol evaluated under Stark law?
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The specifics of the screening, ordering and other
considerations would need to be evaluated to determine
if they fit with an exception to Stark (Assuming a
physician is involved in the health fairs and/or related
tests).
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What type of "Innovated Arrangements” examples are now
viewed as acceptable for coordination of care or
value-based care.
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Innovative Arrangements are permitted if they facilitate
a value-based purpose for health care delivery and
payment. Value-based purpose means coordinating or
managing care of a target patient population; improving
quality of care for a target patient population;
appropriately reducing costs to, or growth in
expenditures of, payors without reducing the quality of
care for a target patient population; or transitioning
from health care delivery and payment mechanisms based
on the volume of items/services provided to mechanisms
based on quality of care and control of costs of care
for a target population. There are now exceptions that
are intended to protect arrangements that satisfy
specified requirements based on the characteristics of
the arrangement and the level of financial risk among
the parties.
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How can a physician-owned facility refer patients for
surgical procedures and lab work? Is a discloser saying
the physician has financial interest and receives bonus
to the highest admission rate allowable?
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We would need additional information regarding these
referrals to assess. Also, state law considerations
regarding notice about financial interests would need to
be evaluated. Generally, physicians can receive bonuses
based upon their personal services under both Stark and
AKS if the arrangements fully comply with all the
elements of the relevant exception and safe harbor.
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