March 2018 Takeaways
Tear out this page and keep for reference, or share with a colleague. Visit hcca‑ info.org for more information.
False Claims Act 2017 report card:
$2.4 billion recovered
by Joan W. Feldman (page 23)
» Don’t assume that a whistleblower complaint
cannot be brought against your organization.
» Address compliance concerns promptly, so they
don’t fester and result in a qui tam action.
» The government will continue to rely on individuals
to bring cases to their attention, motivated by
sharing in a federal monetary recovery.
» Providing medically unnecessary services to
patients is typically not an isolated event.
» The government is likely to increase the use of
tools that identify outliers.
Impact of state False Claims Acts
by Denise Atwood (page 29)
» Compliance professionals should become familiar
with the legislation that establishes liability to the
states for Medicaid false claims.
» If a state FCA meets the requirements set forth
by the federal government, it may qualify for a
Medicaid incentive under section 1909 of the
Social Security Act.
» The federal Office of the Inspector General has a
role in reviewing state false claims laws.
» If your state has an FCA, know how that impacts
your organization’s compliance efforts.
» If your organization does business in more than
one state, determine which states have state FCAs.
Stacked physician compensation:
Keys to compliance
by Bartt B. Warner and
Thomas A. Warrington, Jr. (page 35)
» Compensation paid to physicians is under
constant scrutiny as the number of healthcare
settlements continues to rise both in number and in
» Compensation paid to a physician must be
commercially reasonable, consistent with fair
market value (FMV), and not in violation of other
laws and regulations designed to prevent fraud
» Stacked compensation refers to taking
the individual components of a physician
compensation arrangement and adding them up to
derive total compensation.
» If each individual component is consistent with
FMV, that does not automatically mean the total
stacked compensation is as well.
» By thinking through each component of a
physician’s agreement and asking the appropriate
questions, hospitals and health systems can
reduce the risk of enforcement actions for their
Navigating Medicare Secondary Payer
compliance and False Claims Act liability
by Gary W. Herschman, Melissa L. Jampol,
and Tristan A. Potter-Strait (page 42)
» The Supreme Court’s recent decision in Escobar
expands the potential for Medicare Secondary
Payer Act (MSP) enforcement through the False
» The MSP impacts healthcare providers, insurers,
employers, beneficiaries, and other parties.
» Medicare requires timely reimbursement of
» Non-compliance with MSP requirements can result
in double damages.
» Providers need appropriate internal controls
to monitor potential overpayments in a timely
manner to avoid potential exposure under the MSP
How to open oncology clinical trials:
by Alaina Underberg and Christina Head
» Regulatory tasks in healthcare, especially in clinical
research, are a necessary but laborious job that
encompasses all aspects of daily operations.
» Good Clinical Practice (GCP) is a universal set of
principles that are recommended and essential in
the field of research.
» The IRB and the research site are responsible
for ensuring patient’s rights are protected when
conducting human research.
» To be in accordance with FDA regulations, it is of
utmost importance to maintain regulatory integrity
by ensuring clinical trial requirements are met.
» It is important to have a structured process
throughout all phases of opening and maintaining
oncology clinical trials.
Physician supervision of assistants:
What must be countersigned?
by Rose T. Dunn (page 56)
» When researching the regulations, do not assume
that all regulations relevant to physician assistants
will be in a single regulatory source.
» When creating a policy, be certain to research
federal, state, and accrediting agencies.
» The agreement between a supervising physician
and the physician assistant should include the
oversight details and be consistent with the
medical staff rules and regulations.
» Clarity can be enhanced with definitions for the
terms used. This is especially true when using the
» Specialty societies can assist you with
identifying relevant regulations that may apply to
Safety is the law:
Occupational safety compliance
by Dale Sanders and Tom Ealey (page 62)
» Safety management and compliance are multi-faceted, and all facets are important.
» The enforcing agency (state or federal) can
examine the entire safety culture and operation.
» Policies based on legal requirements must be
written for ease of communications and training.
» Employees have a right to be whistleblowers,
without fear of retaliation.
» There are significant negative consequences from
safety failures for both employee and employer.
Building a security program:
It’s not just IT
by Eric Hummel (page 68)
» Executive leadership must be invested in the
» Create a security program led by a compliance
officer who has been trained in cybersecurity.
» Build the governance structure first.
» Propose a realistic budget.
» The security program consists of a set of
projects led by domain leaders (HR, Facilities, IT,
Administration, Clinical, etc.).
Regulatory compliance: Physician needs
assessments are an integral step
by Tynan O. Kugler (page 72)
» Physician needs assessments (PNAs) are evolving
to play an expanding and dynamic role with
respect to fair market value (FMV) and commercial
reasonableness (CR) opinions.
» As the healthcare industry shifts from volume to
value, a historical approach to PNAs based solely
on physician-to-population metrics may no longer
» Modern PNAs should consider market specifics
relative to healthcare transformation because
communities are transitioning at various speeds.
» PNA findings are important to consider in
determining whether a particular transaction is
» Justification for a hospital’s recruitment
or physician affiliation strategy is a
research-intensive, yet critically important,
exercise to support regulatory compliance.