Meet Lew Morris

Compliance
TODAY
February 2013
a publication of the health care compliance association
www.hcca-info.org
Meet Lew Morris
Senior Counsel with Adelman,
Sheff and Smith in Annapolis, Maryland;
former Chief Counsel to the Inspector
General, Department of Health
and Human Services
See page 18
25
35
39
43
OIG 2013
Work Plan
sheds light on
new compliance
projects: Part 2
New Medicare
provider enrollment
regulations: What
compliance officers
need to know
Compliance
challenges: Lessons
from Oregon’s
Coordinated Care
Organizations
New developments
in the Department
of Justice’s
national ICD
investigation
Nathaniel Lacktman
Idalie Cabrera and Al Monte
Aurae Beidler
Bradley M. Smyer
This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call HCCA at 888-580-8373 with reprint requests.
Feature
by Bradley M. Smyer
New developments in the
Department of Justice’s
national ICD investigation
»» The DOJ is investigating implantable cardioverter defibrillator (ICD) claims under the False Claims Act.
»» The DOJ released a “resolution model” for assessing and settling disputed cases.
»» Total damages are assessed based on the type of claim and a facility-specific multiplier.
»» Hospitals should use this investigation as an opportunity to demonstrate their compliance strengths.
»» A number of important, unanswered questions still remain about the investigation.
Dallas office of DLA Piper LLP.
T
Smyer
he Department of Justice (DOJ)
recently released a “resolution model”
for hospitals involved in its national
investigation of implantable cardioverter
defibrillator (ICD) procedures performed
outside of Medicare’s coverage policy. The
DOJ has been investigating hospitals’ Medicare claims involving ICD
implantation since at least 2010. The
DOJ has notified hundreds of hospitals that it is investigating their
ICD claims under the False Claims
Act (FCA) based on standards established in CMS’s National Coverage
Determination (NCD) 20.4. The DOJ’s
resolution model presents medical review
and documentation guidelines and a framework within which the DOJ proposes to settle
claims subject to its investigation.
Although the DOJ’s much anticipated
resolution model provides some answers
for hospitals that have received investigative demands, notices, or other requests
from the DOJ, it also raises (or at least leaves
unanswered) a number of important questions. Hospitals that are subject to the
investigation must consider the immediate
practical issues presented by the DOJ’s resolution model and develop a reasonable approach
to the DOJ’s suggested settlement framework.
All providers should carefully consider the
long-term and far-reaching implications of the
DOJ’s current approach and strengthen their
own policies and processes.
A quick look at the DOJ’s ICD resolution model
The DOJ’s resolution model classifies ICD
cases into six “categories” and proposes medical record documentation requirements and
potential damages for each category. Category I
involves claims for which reimbursement
is allowed under indications Number 1 or
Number 2 of NCD 20.4, or claims that involved
a clinical trial or for which no Medicare
payment was made. Category II represents
potential non-compliance with the NCD that
the DOJ will not enforce as part of its investigation. Cases in Category II include a number
of “technical” or “timing” violations, including ICDs implanted between 30 and 40 days
after an acute MI or between 67 and 90 days
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Bradley M. Smyer ([email protected]) is an Associate in the
43
Feature
after a revascularization. NCD 20.4 contains
stricter standards. Category II is notable
because it represents cases for which the DOJ
will not seek enforcement, even if those cases
are not otherwise consistent with the government’s interpretation of NCD 20.4. Categories
III through VI represent claims for which the
DOJ will seek damages (see table 1).
charges. The DOJ has suggested that it will
be necessary to assign the correct diagnosisrelated group (DRG) code in order to calculate
this difference. Outlier payments may also
need to be recalculated.
The DOJ will then endeavor to increase
these single damages calculations by a multiplier to arrive at a total damages amount for
Table 1: Categories under the DOJ’s Resolution Model
DAMAGES
Compliance Today February 2013
Category
Description of cases within category
I.
Covered by the NCD and/or excluded from this investigation:
Covered under NCD 20.4 Indication #1
Covered under NCD 20.4 Indication #2
Covered under a Clinical Trial
No Medicare payment
II.
DOJ No Enforcement Categories (Buckets):
No MI (Proper code or no payment change)
Pacemaker
CRT-D
Replacement
Technical violation (Late-stage implants)
Syncope
Bridge to Transplant
NCD 20.4 Indication #3 (Familial/Inherited conditions)
III.
Single
Damages x Multiplier
NA
NA
NA
NA
NA
NA
NA
NA
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
DOJ Category — With Enforcement:
Previously Qualified
Yes
Yes
IV.
Coding Error (without repeating patterns):
No MI (Coding error with payment difference)
No ICD (Coding error)
No CABG/PTCA (Coding error)
Yes
Yes
Yes
Yes
Yes
Yes
V.
Not Covered By NCD or DOJ Categories
Yes
Yes
VI.
Not Medically Indicated
Yes
Yes
Single damages and multipliers
The resolution model suggests higher total
damage amounts for cases in the higher categories. The single damages amount under
each category is the difference between what
the facility was paid on each claim and what
the facility should have been paid on each
claim without the ICD code(s) and related
44 www.hcca-info.org 888-580-8373
each category. The multiplier will presumably
be greater at each successive category, but the
DOJ may consider many factors in proposing
multipliers, including (but not limited to) patient
harm, patterns, compliance efforts and effectiveness, ICD registry submissions, and knowledge
evidence. The multipliers will be determined
through discussions with each facility.
Feature
For hospitals that have received demands or
notices from the DOJ, the resolution model
presents some practical challenges. The DOJ’s
resolution model contemplates that hospitals
will have the burden of reviewing, analyzing,
and classifying inpatient ICD claims. Such
a review can be costly. Practically speaking,
however, hospitals should view the resolution
model as an opportunity to obtain a favorable
result through effective advocacy. For example,
the government’s proposed multipliers at each
level will be developed for each facility based
on a number of factors, including compliance efforts and effectiveness. It is important
to engage in an active dialogue with the DOJ
about your efforts and positions, and seek legal
counsel when appropriate.
Practical tips for hospitals:
·· Engage in active dialogue with the DOJ
·· Highlight your strengths
·· Reassess your compliance program
·· Seek a comprehensive release of liability
Even for hospitals that are not currently
under ICD investigation, the DOJ’s investigation
and resolution model present an opportunity
to assess vulnerabilities and improve processes. Hospitals that are not currently under
investigation may review claims and consider
the need for voluntary refunds or other preventative and remedial measures. Hospitals
can also develop ICD policies, procedures,
and documentation guidelines and educate
all physicians who perform cardio implants.
Contact us
email
helpteam @ hcca-info.org
phone888-580-8373
fax952-988-0146
mailHCCA
6500 Barrie Road, Suite 250
Minneapolis, MN 55435
Hospitals can also develop system-wide monitoring, dissemination, and education policies
based on NCDs and applicable Local Coverage
Determinations.
Unanswered questions
Although the DOJ’s resolution model presents
a framework within which the DOJ proposes
to settle claims subject to its ICD investigation,
it still leaves unanswered a number of fundamental questions about the legal basis for the
investigation and the practical realities of any
proposed settlement. For example, will DOJ
settlements trigger the HHS-OIG to ask for
Corporate Integrity Agreements? How does
the DOJ justify using a resolution model that
includes some claims that may be barred by
the statute of limitations? If a hospital lacks the
scienter for violation of the FCA (which appears
likely, based on vague NCD standards), how
does the DOJ justify the use of multipliers in
the resolution model?
A few years into the DOJ’s investigation,
hospitals still have limited information about
the basis of the investigation and what settlements under the resolution model may look
like. In addressing these concerns, hospitals
should seek the advice of qualified counsel
and consultants to address the best resolution
and approach, to deal with the many nuances
and complexities involved in this matter, and
to contend with the high risks involved in FCA
investigations. All providers, however, can take
immediate steps to enhance their ICD policies
and procedures.
To learn how to place an
advertisment in Compliance Today,
contact Margaret Dragon:
email
phone
margaret.dragon @ hcca-info.org
781-593-4924
Compliance
TODAY
February 2013
A PUBLICATION OF THE HEALTH CARE COMPLIANCE ASSOCIATION
WWW.HCCA-INFO.ORG
Meet Lew Morris
Senior Counsel with Adelman,
Sheff and Smith in Annapolis, Maryland;
former Chief Counsel to the Inspector
General, Department of Health
and Human Services
See page 18
25
35
39
43
OIG 2013
Work Plan
sheds light on
new compliance
projects: Part 2
New Medicare
provider enrollment
regulations: What
compliance officers
need to know
Compliance
challenges: Lessons
from Oregon’s
Coordinated Care
Organizations
New developments
in the Department
of Justice’s
national ICD
investigation
Nathaniel Lacktman
Idalie Cabrera and Al Monte
Aurae Beidler
Bradley M. Smyer
888-580-8373 www.hcca-info.org Compliance Today February 2013
What this means for providers today and tomorrow
45