CMS-10328 Self Referral Disclosure

Medicare Self-Referral Disclosure Protocol (CMS-10328)

CMS-10328-Voluntary-Self-Referral-Disclosure-Protocol

Financial Review

OMB: 0938-1106

Document [pdf]
Download: pdf | pdf
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

Form Approved
OMB No. 0938-1106
Expires: XX/XX

CMS VOLUNTARY SELF-REFERRAL DISCLOSURE PROTOCOL
I. INTRODUCTION
The physician self-referral law: (1) prohibits a physician from making referrals for certain designated health services payable by
Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless the requirements
of an applicable exception are satisfied; and (2) prohibits the entity from filing claims with Medicare (or billing another individual,
entity, or third-party payer) for any improperly referred designated health services. A financial relationship may be an ownership
or investment interest in the entity or a compensation arrangement with the entity. The statute establishes a number of specific
exceptions and grants the Secretary of the Department of Health and Human Services (the “Secretary”) the authority to create
regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse.
The Affordable Care Act (ACA), enacted on March 23, 2010, provides for the establishment of a voluntary self-referral disclosure
protocol (SRDP), under which providers of services and suppliers may self-disclose actual or potential violations of the physician
self-referral law, section 1877 of the Social Security Act (the “Act”). Section 6409(b) of the ACA grants the Secretary the authority to
reduce the amount due and owing for all violations of the physician self-referral law. 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 (all citations to the Code of Federal Regulations in this document are citations to Title 42). Thus, a provider of services
or supplier may not disclose an actual or potential violation through the SRDP and request an advisory opinion for conduct
underlying the same arrangement(s) concurrently.
Section 6402 of the ACA establishes a deadline for reporting and returning overpayments by the later of: (1) the date which is
60 days after the date on which the overpayment was identified; or (2) the date any corresponding cost report is due, if applicable.
At the time that the Centers for Medicare & Medicaid Services (CMS) acknowledges receipt of a submission to the SRDP, the
obligation under section 6402 of the ACA to return the disclosed overpayment within 60 days will be suspended until a settlement
agreement is entered, the provider of services or supplier withdraws from the SRDP, or CMS removes the provider of services or
supplier from the SRDP. See § 401.305(b)(2)(ii).

II. THE SRDP
The SRDP is open to all persons (as defined at § 401.303) who may have received an overpayment as a result of an actual or
potential violation of section 1877 of the Act. For purposes of the SRDP, a person submitting a disclosure to the SRDP will
be referred to as a “disclosing party.” 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. The disclosure,
however, must be made in good faith. 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.
The SRDP cannot be used to obtain a CMS determination as to whether an actual or potential violation of the physician selfreferral law occurred. As stated above and in section 6409(a)(3) of the ACA, the SRDP is separate from the CMS physician selfreferral advisory opinion process. The SRDP is intended to facilitate the resolution of only matters that, in the disclosing party’s
reasonable assessment, are actual or potential violations of the physician self-referral law. Thus, a disclosing party should make a
submission to the SRDP with the intention of resolving its overpayment liability exposure for the conduct it identified. In keeping
with these principles, for each disclosed noncompliant financial relationship, the disclosing party must either: (a) state that the
financial relationship was noncompliant, or (b) state that, because it cannot confirm that the financial relationship complied with
the physician self-referral law, it is certifying noncompliance with the law.
CMS will review the circumstances surrounding the matter disclosed to determine an appropriate resolution. In some instances,
Medicare contractors may be responsible for processing any identified overpayment. CMS is not bound by any conclusions made
by the disclosing party under the SRDP and is not obligated to resolve the matter in any particular manner. Nevertheless, CMS
will work closely with a disclosing party that structures its disclosure in accordance with these SRDP instructions to reach an
effective and appropriate resolution. As a condition of disclosing a matter pursuant to the SRDP, the disclosing party agrees that
no appeal rights attach to claims relating to the conduct disclosed if resolved through a settlement agreement. If the disclosing
party withdraws or is removed from the SRDP, the disclosing party may appeal any overpayment demand letter in accordance
with applicable regulations. Furthermore, disclosing parties agree that, if the disclosed matter is not resolved through the SRDP,
the rules at §§ 401.301 through 401.305 and §§ 405.980 through 405.986 shall apply from the date of the initial submission to
the SRDP.

Form CMS-10328 (xx/xx)

1

III. COOPERATION WITH THE INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN
SERVICES (OIG) AND THE DEPARTMENT OF JUSTICE (DOJ)
Participation in the SRDP is limited to actual or potential violations of the physician self-referral law. OIG’s Health Care Fraud
Self- Disclosure Protocol is available for identifying, disclosing, and resolving conduct that raises potential liabilities under
other federal criminal, civil, or administrative laws. See Self-Disclosure Protocol 2021 (hhs.gov) (November 8, 2021). For
example, conduct that raises liability risks under the physician self-referral law may also raise liability risks under OIG’s civil
monetary penalty authorities regarding the Federal anti-kickback statute and should be disclosed through OIG’s Health Care
Fraud Self-Disclosure Protocol. Disclosing parties should not disclose the same conduct under both the SRDP and OIG’s Health
Care Fraud Self-Disclosure Protocol.
Upon review of the disclosing party’s submission(s), CMS will coordinate with OIG and DOJ. CMS may conclude that the disclosed
matter warrants a referral to law enforcement for consideration under its civil and/or criminal authorities. When appropriate,
CMS may use a disclosing party’s submission(s) to prepare a recommendation to OIG and DOJ for resolution of False Claims Act,
civil monetary penalty, or other liability. Accordingly, the disclosing party’s initial decision regarding where to disclose a matter
involving noncompliance with section 1877 of the Act should be made carefully.
Disclosing parties who currently have corporate integrity agreements (CIAs) or integrity agreements (IAs) with OIG should also
comply with any disclosure or reportable event requirements under such agreements. A reportable event that involves solely a
physician self-referral issue should be disclosed to CMS using the instructions set forth in this SRDP with a copy to the disclosing
party’s OIG monitor. Questions about any applicable CIA or IA requirements should be directed to the disclosing party’s OIG
monitor.

IV. INSTRUCTIONS REGARDING THE VOLUNTARY SELF-REFERRAL DISCLOSURE PROTOCOL SUBMISSION
The disclosing party will be expected to make a submission as follows.
(Note that, if multiple entities from a network or system are submitting self-disclosures, each entity that is separately enrolled in
Medicare must submit a separate disclosure.)

A. Required elements of a complete disclosure
1. The nature of the noncompliance being reported to the SRDP determines the required forms and format of the
disclosure. This section explains the required elements of a complete disclosure. (A brief summary of the forms and other
materials that must be submitted to the SRDP can be found in section IV.A.2 below.)
a. For disclosures of noncompliance arising solely from the failure of a physician-owned hospital to disclose physician
ownership on any public website or in any public advertising (see § 411.362(b)(3)(ii)(C)), use the special instructions
available here.
b. For disclosures of noncompliance arising from the failure of a physician practice to qualify as a group practice under
§ 411.352, the self-disclosure must include the following:
i. SRDP Disclosure Form;
ii. Group Practice Information Form (note that the Group Practice Information Form should be used only by physician
practices that are reporting noncompliance with the physician self-referral law arising from the failure to qualify as a
group practice under § 411.352);
iii. Financial Analysis Worksheet; and
iv. Certification.
c. For all remaining types of noncompliance, the self-disclosure must include the following:
i. SRDP Disclosure Form;
ii. Physician Information Form(s) (unless the disclosure qualifies for the special rule for physicians who stand in the shoes
of their physician organization noted in section IV.A.2.c below, the disclosing party must submit a separate Physician
Information Form for each physician included in the disclosure);
iii. Financial Analysis Worksheet; and
iv. Certification.
In addition to all the required information, the disclosing party may submit an optional cover letter, including information that the
party believes may be relevant to CMS’ evaluation of the disclosure.

Form CMS-10328 (xx/xx)

2

Note on the proper use of the Group Practice Information Form and the Physician Information Form(s): The Group Practice
Information Form should be completed only by physician practices that are reporting noncompliance with the physician selfreferral law arising from the failure to qualify as a group practice under § 411.352. For all other reasons for noncompliance, the
noncompliance must be reported using the Physician Information Form(s) (except noncompliance arising solely from the failure
of a physician-owned hospital to satisfy the requirement at § 411.362(b)(3)(ii)(C)). In most circumstances, the disclosing party
will use either the Group Practice Information Form or the Physician Information Form(s), but not both. The following examples
illustrate the required elements of a complete submission to the SRDP for different types of reported noncompliance:
• A hospital had several compensation arrangements with physicians and physician organizations that did not satisfy
the requirements of any applicable exception: the disclosure must include the SRDP Disclosure Form, Physician Information
Form(s), the Financial Analysis Worksheet, and a certification in accordance with section IV.A.2.e below.
• A physician practice intended to rely on the in-office ancillary services exception at § 411.355(b) to permit referrals
by physicians in the practice, but it could not make use of the exception because it did not qualify as a group practice
under § 411.352: the disclosure must include the SRDP Disclosure Form, the Group Practice Information Form, the Financial
Analysis Worksheet, and a certification in accordance with section IV.A.2.e below.
• If the physician practice is also disclosing noncompliance related to a financial relationship with a physician or
immediate family member of a physician who is not a physician in the group, then the practice should also include a
Physician Information Form related to that individual only.
•

•

A physician practice that qualified as a group practice under § 411.352 billed Medicare for certain services that did
not fully comply with the in-office ancillary services exception: the disclosure must include the SRDP Disclosure Form,
Physician Information Form(s), the Financial Analysis Worksheet, and a certification in accordance with section IV.A.2.e below.
A physician made referrals to a home health agency that was owned by the physician’s spouse and the ownership or
investment interest did not satisfy the requirements of any applicable exception: the disclosure must include the SRDP
Disclosure Form, Physician Information Form(s), the Financial Analysis Worksheet, and a certification in accordance with section
IV.A.2.e below.

2. Description of required elements of a disclosure:
a. SRDP Disclosure Form: The SRDP Disclosure Form provides information about the disclosing party, including information
regarding the disclosing party’s history of abuse, pervasiveness of noncompliance, and steps to prevent future
noncompliance. The SRDP Disclosure Form is attached to this document.
b. Group Practice Information Form: The Group Practice Information Form includes questions that are specific to physician
practices that failed to qualify as a group practice under § 411.352. As such, the Group Practice Information Form should be
completed only by physician practices that are reporting noncompliance with the physician self-referral law arising from
the failure to qualify as a group practice under § 411.352. If the noncompliance being reported by the physician practice
arose solely from the failure of the practice to qualify as a group practice under § 411.352, then the physician practice need
not complete Physician Information Forms for any physician in the practice who made prohibited referrals to the practice.
The Group Practice Information Form is available on our website here. Note that, if a physician practice consists of two or
more physicians and does not qualify as a group practice under § 411.352, the practice may not rely on the exception for
physician services at § 411.355(a) or the exception for in-office ancillary services exception at § 411.355(b).
c. Physician Information Forms: For all forms of reported noncompliance other than the failure of a physician practice
to qualify as a group practice under § 411.352 or the failure of a physician-owned hospital to satisfy the requirement at
§ 411.362(b)(3)(ii)(C), the disclosing party must report noncompliance using the Physician Information Forms. Except
as noted immediately below, for each physician included in the disclosure, the disclosing party must submit a separate
Physician Information Form providing details of the noncompliant financial relationship(s) between the physician and the
disclosing party. The Physician Information Form is available on our website here.
Special rule for physicians who stand in the shoes of their physician organization: If a disclosing party is disclosing
multiple compensation arrangements with physicians that violate section 1877 of the Social Security Act due solely to the
fact that, pursuant to § 411.354(c), the physicians are deemed to stand in the shoes of the same physician organization
that is a party to the noncompliant arrangement(s) with the entity, then the disclosing party may submit a single Physician
Information Form that details the noncompliant compensation arrangement(s) with the physician organization along with
a separate listing of each physician who is deemed to have the same noncompliant compensation arrangement(s) with
the entity as the physician organization and the period(s) of noncompliance for each physician. The listing of physicians
should include: (1) the names and NPIs of each physician who stood in the shoes of the physician organization during
the lookback period; (2) the period(s) of noncompliance for each physician relative to each noncompliant compensation
arrangement disclosed; and (3) any other relevant information that is unique to one of the physicians who stands in the
shoes of the physician organization, such as an explanation that the physician became an owner of or left the physician
organization on a certain date, resulting in a change in his or her status as standing in the shoes of the physician
organization. See also the SRDP FAQs on the Physician Self-Referral Law page on the CMS website.
Form CMS-10328 (xx/xx)

3

d. Financial Analysis Worksheet: The Financial Analysis Worksheet quantifies the overpayment for each physician included
in the disclosure who made referrals in violation of section 1877 of the Act. Disclosing parties only report overpayments in
Medicare Parts A and B through the SRDP. CMS does not directly pay providers and suppliers for services furnished under
Medicare Parts C or D or Medicaid. Therefore, the SRDP is not the appropriate administrative remedy for overpayments
arising from services furnished pursuant to prohibited referrals if the services are paid for under Medicare Parts C or D or
Medicaid. The financial analysis is limited to the 6-year look back period at § 401.305(f ). The Financial Analysis Worksheet
must be submitted in Microsoft Excel®-compatible format. The Financial Analysis Worksheet is attached to this document.
e. Certification: The initial disclosure and any related supplemental submission must include a certification signed by the
disclosing party’s Chief Executive Officer, Chief Financial Officer, or other individual who is authorized by the disclosing
party to disclose the matter to CMS and to certify the truthfulness of the information contained in the disclosure. The
signed certification must state 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.

B. Instructions for Submitting the Disclosure
The complete disclosure and all relevant supporting documents must be submitted electronically to [email protected].
When the disclosing party submits a disclosure electronically, CMS will immediately send a response email acknowledging
receipt of the submission. If you have submitted a disclosure that is encrypted or otherwise protected, send a separate email
to [email protected], including the word “ENCRYPTION” in the subject line, which identifies the contact person for the
submission. After reviewing the submission, CMS will send a letter to the disclosing party or its representative either accepting or
rejecting the disclosure. In some cases, CMS may request additional information prior to determining whether to accept or reject
the disclosure.

C. Obligation to Update
If, after the disclosure is made to CMS, the disclosing party files for bankruptcy, undergoes a change of ownership, or changes the
designated representative, the disclosing party must inform CMS of the changes within 30 days. Updates must be submitted by
e-mail to the following address: [email protected]. Include the word “UPDATE” in the subject of the e-mail.

V. VERIFICATION
Following the receipt of a disclosing party’s submission, CMS will begin its verification of the disclosed information. The timeframe
for CMS’ verification effort will depend, in large part, upon the quality and thoroughness of the submissions received. Matters
uncovered during the verification process, which are outside of the scope of the disclosure being verified, may be treated as new
matters outside the SRDP.
To facilitate CMS’ verification process, CMS must have access to all financial statements, notes, disclosures, and other supporting
documents without the assertion of privileges or limitations on the information produced. In the normal course of verification,
CMS will not request production of written communications subject to the attorney-client privilege. However, there may be
documents or other materials, which CMS believes are critical to resolving the disclosure that may be covered by the attorneyclient privilege. CMS will 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.
CMS may request additional information, such as financial statements, income tax returns, and other documents, if needed. If
additional information is requested, a disclosing party will be given at least 30 days to furnish the information.

VI. PAYMENTS
Because of the need to verify the information provided by a disclosing party, CMS will not accept payments of presumed
overpayments determined by the disclosing party prior to the completion of CMS’ review. However, the disclosing party may place
funds in an interest-bearing escrow account to ensure adequate resources have been set aside to repay amounts owed.
While the matter is under CMS review, the disclosing party must refrain from making repayments relating to the disclosed matter
to the Federal health care programs or their contractors without CMS’ prior consent. If CMS consents, the disclosing party will
be required to acknowledge in writing that the acceptance of the payment does not constitute the Government’s agreement as
to the amount of losses suffered by the programs as a result of the disclosed matter, and does not relieve the disclosing party
of any criminal, civil, or civil monetary penalty liability, nor does it offer a defense to any further administrative, civil, or criminal
actions against the disclosing party. We remind disclosing parties that section 1877(g)(2) of the Act requires that any amounts
collected from individuals that were billed in violation of the physician self-referral law must be refunded to the individuals on a
timely basis.

Form CMS-10328 (xx/xx)

4

VII. COOPERATION AND REMOVAL FROM THE SRDP AND TIMELINESS OF DISCLOSURE
The disclosing party’s diligent and good faith cooperation throughout the entire process is essential. Accordingly, CMS expects
to receive documents and information from the disclosing party that relate to the disclosed matter without the need to resort
to compulsory methods. If a disclosing party fails to work in good faith with CMS to resolve the disclosed matter, the lack of
cooperation will be taken into account in CMS’ resolution of the matter. Likewise, the failure to update CMS regarding changes in
ownership, bankruptcy filing, or changes in the designated representative will be taken into account in assessing the disclosing
party’s cooperation. The intentional submission of false or otherwise untruthful information, as well as the intentional omission
of relevant information, will be referred to DOJ, OIG, or other Federal agencies and could, in itself, result in criminal and/or civil
sanctions, as well as exclusion from participation in the Federal health care programs. Furthermore, it is imperative for disclosing
parties to disclose overpayments in a timely fashion once identified. As stated above, section 6402 of the ACA establishes a
deadline for reporting and returning overpayments by the later of: (1) the date which is 60 days after the date on which the
overpayment was identified; or (2) the date any corresponding cost report is due, if applicable.

VIII. FACTORS CONSIDERED IN REDUCING THE AMOUNT OWED
The factors CMS may consider in reducing the amount otherwise owed include, but are not limited to: (1) the nature and extent
of the improper or illegal practice; (2) the timeliness of the self-disclosure; and (3) the cooperation in providing additional
information related to the disclosure. Although 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. CMS will make an individual determination as
to whether a reduction is appropriate based on the facts and circumstances of each disclosed actual or potential violation. The
nature and circumstances concerning a physician self-referral violation can vary given the scope of the physician self-referral law
and the health care industry. Given this variability, CMS evaluates each matter in order to determine the severity of the physician
self-referral law violation and an appropriate resolution for the conduct.

PRA Disclosure Statement: According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless
it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1106. The time required to complete this
information collection is estimated to average 50 hours per response, including the time to review instructions, search existing data resources, gather the
data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions
for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, MD 21244-1850.
**CMS Disclaimer** Please do not send applications, claims, payments, medical records or any documents containing sensitive information to
the PRA Reports Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the
associated OMB control number listed on this form will not be reviewed, forwarded, or retained.
Form CMS-10328 (xx/xx)

5

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

Form Approved
OMB No. 0938-1106
Expires: XX/XX

CMS VOLUNTARY SELF-REFERRAL DISCLOSURE PROTOCOL: CHECKLIST
CHECKLIST OF REQUIRED ITEMS FOR A COMPLETE SUBMISSION:
SRDP Disclosure Form
Physician Information Form(s) (unless the disclosure qualifies for the special rule for physicians who stand in the shoes of
their physician organization noted above at Section IV.A.2.c, the disclosing party must submit one Physician Information
Form for each physician included in the disclosure who made referrals in violation of section 1877 of the Act)
OR
The Group Practice Information Form
Financial Analysis Worksheet, submitted in Microsoft Excel®-compatible format
Certification
The disclosing party may also submit an optional cover letter. All the items listed above (and the optional cover letter, if included)
must be submitted electronically to [email protected].
Obligation to update
Disclosing parties are reminded of the obligation to update the disclosure if the disclosing party files for bankruptcy,
undergoes a change of ownership, or changes its designated representative. The update must be submitted electronically to
[email protected] within 30 days of the change. Include the word “UPDATE” in the subject line of the e-mail.

Form CMS-10328 (xx/xx)

6

Form Approved
OMB No. 0938-1106
Expires: XX/XX

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

SRDP DISCLOSURE FORM: CMS-10328
I. DISCLOSING PARTY
1. Legal Business Name

2. “Doing Business As” name (if applicable)

3. Address

City

4. CMS Certification Number (CCN)

State

5. National Provider Identifier(s) (NPI)

Zip code

6. Tax Identification Number (TIN)

7. Is the disclosing party affiliated with a network or system? Note: If multiple entities from a network or system are submitting self-disclosures, each
entity that is separately enrolled in Medicare must submit a separate disclosure.
Yes
No
If yes, provide the name of the network or system:

II. DESIGNATED REPRESENTATIVE
1. Name

Law firm of designated representative (if applicable)

2. Address

City

3. Phone Number (enter numbers only)

Form CMS-10328 (xx/xx)

State

Zip code

4. Email

1

III. PERVASIVENESS OF NONCOMPLIANCE
For purposes of the SRDP, pervasiveness means how common or frequent the disclosed noncompliance was in comparison with
similar financial relationships between the disclosing party and physicians.
Note: For disclosures of noncompliance arising solely from the failure of a physician practice to qualify as a group practice under
§ 411.352, it is not necessary to complete this section, Pervasiveness of Noncompliance. The Group Practice Information Form
collects all the required information on pervasiveness.
For all remaining forms of noncompliance, determine the type(s) of noncompliance being disclosed (i.e., compensation
arrangement failing to satisfy an applicable exception at § 411.357, ownership or investment interest failing to satisfy an
applicable exception at § 411.356, or the provision of services failing to satisfy an applicable exception at § 411.355), and
report the pervasiveness of the noncompliance relative to the disclosing party’s similar financial relationships (in the case of
compensation arrangements or ownership or investment interests) or similar services furnished (in the case of designated
health services that failed to meet an applicable exception at § 411.355). When reporting more than one type of noncompliance,
the pervasiveness of the noncompliance may be reported by type of noncompliance or in the aggregate. For disclosures of
noncompliant compensation arrangements, do not include arrangements involving nonmonetary compensation or medical
staff incidental benefits in the determination of the pervasiveness of the noncompliance, unless the disclosed noncompliance
resulted from a failure to comply with § 411.357(k) or § 411.357(m). The disclosing party may provide a reasonable estimate of the
pervasiveness of noncompliance. If relying on estimates, please indicate that estimates were used and explain how the estimates
were calculated.
The following examples may be helpful.
• The hospital has numerous compensation arrangements with physicians. We estimate that the noncompliant compensation
arrangements disclosed herein represent less than 3 percent of all financial relationships with physicians.
• Six of the hospital’s 30 call coverage arrangements (20 percent) failed to satisfy the requirements of the exception for personal
service arrangements at § 411.357(d) or fair market value compensation at § 411.357(l). The hospital had no other financial
relationships with referring physicians.
• The hospital has 25 physician owners. Each physician owner had an ownership or investment interest during the entire
lookback period. One of the physician owners was not authorized to perform services at the hospital as required at
§ 411.356(c)(3)(i) for a period of six months during the lookback period.
• In 150 instances during a six-month period, the group practice failed to provide the notice required at § 411.355(b)(7). We
reviewed the medical records and determined that this represents approximately 10 percent of the services subject to the
notice requirement that were furnished by the group practice during the same six-month period.
• The physician practice provided nonmonetary compensation to 50 referring physicians who were not part of the physician
practice during calendar year 2015. The physician practice exceeded the annual limit on nonmonetary compensation with
respect to two physicians. Neither physician returned the excess nonmonetary compensation during the period established at
§ 411.357(k)(3).
Note on the application of the “stand in the shoes” provisions at § 411.354(c): The “stand in the shoes” provisions determine
how arrangements with physician organizations should be counted. If there is a compensation arrangement with a physician
organization, the arrangement is deemed to be an arrangement with all the physicians who stand in the shoes of the physician
organization. For example, assume that a party is disclosing a noncompliant lease arrangement with a physician organization,
and that the organization consists of three owners (mandatorily standing in the shoes of the organization pursuant to
§ 411.352(c)(1)(ii)(B)) and two non-owners who are not permissively standing in the shoes of the organization. For purposes of
the SRDP, this should be counted as three arrangements, because the arrangement with the organization is deemed to be an
arrangement with the physicians standing in the shoes of the organization.
The following example illustrates the application of the “stand in the shoes” provisions:
• During each year of the lookback period, the disclosing entity was a party to approximately 100 compensation arrangements
with referring physicians or their immediate family members, after considering the application of the “stand in the shoes”
rules. During the lookback period, the disclosing entity was a party to approximately 300 compensation arrangements,
after considering the application of the “stand in the shoes” rules, as some arrangements lasted more than one year. These
included compensation arrangements for the rental of office space, call coverage arrangements, medical directorships, and
other personal service arrangements. The disclosed noncompliance relates to a total of eight compensation arrangements
(two directly with individual physicians and one with a six-owner physician organization). The eight arrangements were
noncompliant for a total of 90 out of 576 potential months during the lookback period (8 arrangements x 72 months each in
the lookback period).

Form CMS-10328 (xx/xx)

2

Report the pervasiveness of the noncompliance in the space provided below. The disclosing party may also provide additional details and context to
help CMS evaluate the pervasiveness of the noncompliance.

Attach additional pages if necessary.

Form CMS-10328 (xx/xx)

3

IV. OTHER COMPLIANCE ISSUES AND ACTIVITIES
1. Current government inquiry: Indicate whether the disclosing party has knowledge that the disclosed conduct is under
current inquiry by a Government agency or contractor. If the disclosing party has knowledge of an inquiry, identify the
Government agency or contractor, and the individual representatives involved, if known. 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.
Current government inquiry:

Yes

No

If yes, explain:

Attach additional pages if necessary.

2. History of similar conduct: State whether the disclosing entity has a history of conduct similar to that being disclosed
or any prior criminal, civil or regulatory enforcement action against it.
History of similar conduct:

Yes

No

If yes, explain:

Attach additional pages if necessary.

3. Steps taken to prevent future noncompliance: State whether the disclosing party has taken any steps to prevent
future noncompliance. If yes, briefly summarize what steps, if any, the disclosing party has taken. If no, briefly explain why
the disclosing party believes that additional steps are not necessary.
Steps taken to prevent future noncompliance:

Yes

No

Explain:

Attach additional pages if necessary.
Form CMS-10328 (xx/xx)

4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

Form Approved
OMB No. 0938-1106
Expires: XX/XX

FINANCIAL ANALYSIS WORKSHEET: CMS-10328
I. INSTRUCTIONS FOR THE FINANCIAL ANALYSIS WORKSHEET
A. Financial Analysis
The disclosing party must provide a financial analysis of the potential overpayment based on the 6-year lookback period at
§ 401.305(f ). Disclosing parties only report overpayments in Medicare Parts A and B through the SRDP. CMS does not directly pay
providers and suppliers for services furnished under Medicare Parts C or D or Medicaid. Therefore, the SRDP is not the appropriate
administrative remedy for overpayments arising from services furnished pursuant to prohibited referrals if the services are
paid for under Medicare Parts C or D or Medicaid. (Unless otherwise requested by CMS, disclosing parties are not required to
report the actual amount of remuneration between the parties). The financial analysis worksheet must be submitted in Excel®compatible format; please lock the worksheet for editing before submitting. For each physician included in the disclosure, the
worksheet must include the following:
• Physician’s name
• Physician’s NPI
• Date that the overpayment associated with the physician was identified (see § 401.305(a)(2) for the definition of “identified”)
• Overpayment arising from the physician’s prohibited referrals, itemized by calendar year (i.e., January through December)
• For the yearly itemization of the overpayment, the Worksheet must include 7 columns, each covering an entire calendar
year, even if the 6-year lookback period only falls in a portion of a particular calendar year, and even if the disclosing party
did not receive an overpayment during a particular calendar year.
Example: Assume a party identifies an overpayment on May 14, 2016. The 6-year lookback period for this
overpayment is May 14, 2010 through May 13, 2016. The Worksheet must include columns for the following
calendar years: 2010, 2011, 2012, 2013, 2014, 2015, and 2016. For calendar year 2010 the disclosing party need
only report prohibited referrals from May 14, 2010 through December 31, 2010, and for calendar year 2016 the
disclosing party need only report prohibited referrals from January 1, 2016 through May 13, 2016.
• For disclosures involving multiple physicians with overpayments identified on different dates, use the same table for all
physicians. If necessary, add columns for additional calendar years to account for the 6-year lookback period for each
physician.
Example: Assume a party is disclosing 2 noncompliant arrangements, one identified on December 10, 2016 and
the other on January 15, 2017. The Financial Analysis Worksheet must include columns for calendar years 2010
through 2017.
• If there are no overpayments in a particular year (for example, if the financial relationship was compliant during that year,
if there were no prohibited referrals for that year, or if there was no financial relationship between the parties for that year),
leave the worksheet cell blank.
• There must be a final, total overpayment column for each physician, and the table must also include a row calculating total
overpayment amount for all physicians covered by the disclosure.
B. Methodology
The Excel®-compatible Financial Analysis Worksheet must include a text box describing the methodology used to set forth the
overpayment. The disclosing party must also indicate whether estimates were used, and, if so, how they were calculated.
Example: The following Financial Analysis Worksheet illustrates the required formatting for the Excel®-compatible
work sheet. In this example, assume a disclosure was submitted on April 10, 2016 disclosing noncompliant
arrangements with Drs. A, B, and C. In addition, assume the following:
1. For Dr. A, there was no noncompliant financial relationship between the disclosing party and Dr. A prior to May 1,
2013; the noncompliance was cured in 2015; and the overpayment was identified on February 18, 2016.
2. For Dr. B, the noncompliance began in 2009, prior to the opening of 6-year lookback period; the noncompliance
was not cured until 2016; and the overpayment was identified on March 24, 2016.
3. For Dr. C, there was a noncompliant financial relationship between Dr. C and the disclosing party prior to 2010, but
Dr. C did not make prohibited referrals to the disclosing party until October 2011; the arrangement terminated in
2015, and the overpayment was identified on April 5, 2016.

II. SAMPLE FINANCIAL ANALYSIS WORKSHEET:

Methodology: Actual data was used to determine the overpayment; estimates were not used.
Form CMS-10328 (xx/xx)

1


File Typeapplication/pdf
File TitleCMS Voluntary Self-Referral Disclosure Protocol
SubjectCMS-10328
AuthorCenters for Medicare and Medicaid Services
File Modified2022-08-29
File Created2022-08-25

© 2024 OMB.report | Privacy Policy