CMS-10328.Crosswalk Document

Revisions Crosswalk (CMS-10328)
Issue
#
1.

2.

Page #
1

1

Section
I.
Introduction,
1st paragraph

I.
Introduction,
2nd paragraph

Action to be
Changes to the Application
performed
Add new 1st paragraph Add:

Reason for the Change
Revised to clarify statutory
language

“The Affordable Care Act (ACA), enacted on March
23, 2010, provides for the establishment of a voluntary
self-disclosure protocol, under which providers of
services and suppliers may self-disclose actual or
potential violations of the physician self-referral
statute (section 1877 of the Social Security Act). The
physician self-referral statute prohibits a physician
from making referrals for certain designated health
services (DHS) payable by Medicare to an entity with
which he or she (or an immediate family member) has
a financial relationship (ownership, investment, or
compensation), unless an exception applies; prohibits
the entity from presenting or causing to be presented
claims to Medicare (or billing another individual,
entity, or third-party payer) for those referred services;
and establishes a number of specific exceptions and
grants the Secretary of Health and Human Services
(HHS) the authority to create regulatory exceptions for
financial relationships that do not pose a risk of
program or patient abuse.”
Delete first sentence

Delete:

Removed repetitive sentence

“The Affordable Care Act (ACA) was enacted on
March 23, 2010.”

Page 1 of 8

Issue
#
3.

Page #
1

Section
I.
Introduction,
2nd paragraph

Action to be
performed
Replace

Changes to the Application

Reason for the Change

Replace:

Clarified to reflect that reductions
will only be made when CMS
determines that an actual violation
has occurred

1) “an actual or potential” with “a”
to the following sentence:

4.

1

I.
Introduction,
2nd paragraph

Revise sentence

“In establishing the amount by which an overpayment
resulting from a violation(s) may be reduced, the
Secretary may consider: the nature and extent of the
improper or illegal practice; the timeliness of such
disclosure; the cooperation in providing additional
information related to the disclosure; and such other
factors as the Secretary considers appropriate.”
Add :

Revised to clarify statutory
language

“related to physician referrals” to the following
sentence:

“Section 6409(a)(3) of the ACA explicitly states that
the SRDP is separate from the advisory opinion
process related to physician referrals set forth in 42
C.F.R. §§ 411.370 through 411.389.”
5.

2

II. The
SRDP, 1st
paragraph

Revise sentence

Add:

Revised to clarify language

“acceptance of” to the following sentence:
“The fact that a disclosing party is already subject to
Government inquiry (including investigations, audits
or routine oversight activities) will not automatically
preclude acceptance of a disclosure.”

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Issue
#
6.

7.

8.

Page #
2

2

2

9.

2

10.

3

Section
II. The
SRDP, 1st
paragraph

II. The
SRDP, 2nd
paragraph

Action to be
performed
Replace

Changes to the Application

Reason for the Change
Editorial Change

Replace “in” with “during” in the following sentence:

Revise sentence

“A disclosing party that attempts to circumvent an
ongoing inquiry or fails to fully cooperate during the
self-disclosure process will be removed from the
SRDP.”
Add:

Editorial change

“above and” to the following sentence:

II. The
SRDP, 2nd
paragraph

Delete last sentence

“As stated above and in section 6409(a)(3) of the
ACA, the SRDP is separate from the CMS physician
self-referral advisory opinion process.”
Delete:

II. The
SRDP, 3rd
paragraph
III.
Cooperation
with OIG and
the
Department
of Justice
(DOJ), 2nd
paragraph

Replace word

“As provided in the physician self-referral law, no
payment may be made for designated health services
that are provided in violation of the physician selfreferral law.”
Replace:

Editorial change

Replace word

“the protocol” with “SRDP”
Replace:

Editorial change

Editorial change

“refer” with “disclose” in the following sentence:
“Accordingly, the disclosing party’s initial decision of
where to disclose a matter involving non-compliance
with section 1877 of the Social Security Act should be
made carefully.”

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Issue
#
11.

12.

13.

14.

Page #
3

4

4

4

Section

Action to be
performed
Correct zip code

IV. A.
Instructions
Regarding
the Voluntary
Disclosure
Submission,
IV. B (1)(d)
Replace words
Required
Information
Related to the
Matter
Disclosed

IV. B (1)(f)
Replace
Required
Information
Related to the
Matter
Disclosed

IV. B (1)(g)
Delete word
Required
Information
Related to the
Matter
Disclosed

Changes to the Application

Reason for the Change

Replace:

Number correction

“21224” with “21244” in the sentence with the CMS
address

Replace:

Editorial change

1) “issue” with “actual or potential violation”; and
2) “abuses” with “instances of non-compliance”
in the following sentence:
“The circumstances under which the disclosed matter
was discovered and the measures taken upon
discovery to address the actual or potential violation
and prevent future instances of noncompliance.”
Replace:

Editorial change

“or through training” with “new training programs” in
the following sentence:
“…….. (e.g., new accounting or internal control
procedures, new training programs, increased internal
audit efforts, increased supervision by higher
management).”
Delete:

Editorial change

“and” after the (,) from the following parenthetical:
(e.g., Securities and Exchange Commission, Internal
Revenue Service)

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Issue
#
15.

Page #
4

Section
IV. B (1)(h)
Required
Information
Related to the
Matter
Disclosed

Action to be
performed
Replace words

Changes to the Application

Reason for the Change

Replace:

Editorial change

1) “entity” with “agency or contractor”; and
2) “or” with “and the”
in the following sentence:
“If the disclosing party has knowledge of a pending
inquiry, identify any such Government agency or
contractor, and the individual representatives involved,
if known.”

16.

17.

4

4

IV. B (1)(h)
Add
Required
Information
Related to the
Matter
Disclosed

Add:

IV. B (1)(h)
Delete word
Required
Information
Related to the
Matter
Disclosed

Delete:

Editorial change

“, if known” to the end of the following sentence:
“If the disclosing party has knowledge of a pending
inquiry, identify any such Government agency or
contractor, and the individual representatives involved,
if known.”
Editorial change

“any” between “inquiry for” and “other matters” in the
following sentence:
“The disclosing party must also disclose whether it is
under investigation or other inquiry for other matters
relating to a Federal health care program, including
any matters it has disclosed to other Government
entities, and provide similar information relating to
those other matters.”

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Issue
#
18.

Page #
5

Section
IV. B(2)
Financial
Analysis

Action to be
performed
Revise sentence

Changes to the Application

Reason for the Change

Change the following sentence from:

Clarified the term “financial
analysis”

“As part of its initial submission, the disclosing party
will be expected to conduct a financial analysis, and
then report its findings to CMS.”
To:

19.

20.

5

5

IV. B(2)
Financial
Analysis

Replace subsection c

IV. B(2)
Financial
Analysis

Make old subsection
c, subsection d and
revise

“As part of its initial disclosure submission, the
disclosing party must conduct a financial analysis
relating to the actual or potential violation(s) of the
physician self-referral law, and report its findings to
CMS.”
Add:

Revised to clarify the information
that should be submitted

“c. Set forth the total amount of remuneration a
physician(s) received as a result of an actual or
potential violation(s) based upon the applicable “look
back” period.”
Create new subsection d and revise the following
sentence from:

Revised to clarify the information
that should be submitted

“Provide a summary of auditing activity undertaken
and a summary of the documents relied upon.”
To:
“d. Provide a summary of any auditing activity
undertaken and a summary of the documents the
disclosing party has relied upon relating to the actual
or potential violation(s) disclosed.”

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Issue
#
21.

Page #
5

Section
IV. C
Certification

Action to be
performed
Replace word

Changes to the Application

Reason for the Change

Replace “any” with “the disclosed” in the following
sentence:

Editorial change

“The disclosing party, or in the case of an entity its
Chief Executive Office, Chief Financial Officer, or
other authorized representative, must submit to CMS,
along with all submissions, a signed certification
stating that, to the best of the individual’s knowledge,
the information provided contains truthful information
and is based on a good faith effort to bring the matter
to CMS’ attention for the purpose of resolving the
disclosed potential liabilities relating to the physician
self-referral law.”
22.

5

V. CMS’
Verification

Delete lower case “s”
from the section title

Delete:

Grammar correction

“s” from “CMS’s Verification”

23.

5

V. CMS’
Verification

Revise sentence

Change the following sentence from:

Editorial change

“There may be documents or other materials, however,
that may be covered by the work product doctrine, but
which CMS believes are critical to resolving the
disclosure.”
To:
“However, there may be documents or other
materials, which CMS believes are critical to resolving
the disclosure, that may be covered by the work
product doctrine.”

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Issue
#
24.

Page #
5

Section
V. CMS’
Verification

Action to be
performed
Replace word

Changes to the Application

Reason for the Change

Replace:

Editorial change

“the need to waive the” with “waiver of” in the
following sentence:

25.

26.

6-7

7

VIII. Factors Replace word
Considered in
Reducing the
Amounts
Owed

PRA
Disclosure
Statement

Replace word

“CMS is prepared to discuss with a disclosing party’s
counsel ways to gain access to the underlying
information without waiver of protections provided by
an appropriately asserted claim of privilege”
Replace:

Editorial change

“has no obligation to” with “is not obligated to” in the
following sentence:
“While CMS may consider these factors in
determining whether reduction in any amounts owed is
appropriate, CMS is not obligated to reduce any
amounts due and owing.”
Replace:
Editorial change
“Maryland” with “MD” in the last sentence with the
CMS address

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