Form CMS-10328 CMS-10328_Self-Referral_Disclosure_Protocol_Form

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

Form Approved
OMB No. 0938-1106
(01/2017) pending approval

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 (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; (2) 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 (3) establishes a number of specific exceptions and grants the Secretary of the Department 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.
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 of HHS 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. 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 the provider of
services or supplier electronically submits a disclosure under the SRDP (and receives email confirmation from the Centers for Medicare &
Medicaid Services (CMS) that the disclosure has been received), 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 42 C.F.R. § 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 self- referral law
occurred. 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. 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 42 C.F.R. §§ 401.301 through 401.305 and §§ 405.980 through 405.986 shall apply from the date of the
initial submission to the SRDP.

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 Self- Disclosure Protocol is available for
disclosing conduct that raises potential liabilities under other federal criminal, civil, or administrative laws. See 63 Fed. Reg. 58399 (Oct. 30, 1998);
OIG's Open Letter to Health Care Providers, March 24, 2009. 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 Self-Disclosure Protocol. Disclosing parties should not disclose the same conduct under both the SRDP and OIG's Self-Disclosure
Protocol.

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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 certification of compliance agreements (CCAs) with OIG
should also comply with any disclosure or reportable event requirements under such agreements. Effective September 23, 2010, a
reportable event solely related to 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 CCA requirements should be directed to the
disclosing party's OIG monitor.

IV. INSTRUCTIONS REGARDING THE VOLUNTARY DISCLOSURE PROTOCOL SUBMISSION
The disclosing party will be expected to make a submission as follows.

A. Required elements of a complete disclosure
The disclosing party must submit its disclosure using: (1) the SRDP Disclosure Form, (2) the Physician Information Form(s), and (3) the Financial
Analysis Worksheet (unless the party is a physician-owned hospital disclosing noncompliance resulting solely from the failure to comply with
§ 411.362(b) (3)(C); see section IV.C for more details). The forms, including instructions for completing the forms, are attached to this document as
an appendix. The disclosing party must submit all the information required by all the forms. The following is a brief summary of the forms and
other materials that must be submitted to the SRDP.
1. 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.
2. Physician Information Form(s): 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.
3. 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. Effective March 14, 2016, 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.
4. Certification: The initial disclosure and any related supplemental submission must include a certification signed by the disclosing party
or, in the case of an entity, its 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 selfreferral law.
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.

B. Instructions for submitting the disclosure
The complete disclosure and all relevant supporting documents must be submitted electronically to [email protected]. In addition, a
hard copy of the signed certification only must be sent to: Division of Technical Payment Policy, ATTN: Provider and Supplier Self-Disclosure,
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mailstop C4-25-02, Baltimore, MD 21244-1850. Submissions by facsimile will
not be accepted.
When the disclosing party submits a disclosure electronically, CMS will immediately send a response email acknowledging receipt of 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. Disclosure of noncompliance arising solely from the failure to comply with § 411.362(b)(3)(ii)(C)
Parties disclosing noncompliance arising solely from the failure of a physician-owned hospital to disclose physician ownership on any public
website or in any public advertising must continue to use the special instructions, available at http://www.cms.gov/Medicare/Fraud-andAbuse/PhysicianSelfReferral/Self_Referral_Disclosure_Protocol.html.

D. 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.

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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 attorney-client 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.

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

Form Approved
OMB No. 0938-1106

CMS VOLUNTARY SELF-REFERRAL DISCLOSURE PROTOCOL: CHECKLIST
Checklist of required items for a complete submission:
SRDP Disclosure Form
Physician Information Form(s) (one for each physician included in the disclosure who
made referrals in violation of section 1877 of the Act)
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]. In addition, a hard copy of the certification only must be mailed to Division of
Technical Payment Policy, ATTN: Provider and Supplier Self- Disclosure, Centers for Medicare & Medicaid Services, 7500 Security
Boulevard, Mailstop C4-25-02, Baltimore, MD 21244-1850.
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.

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

Form Approved
OMB No. 0938-1106

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

2. "Doing Business As" name (if applicable)

3. Address

City

State

5. National Provider Identifier(s) (NPI)

4. CMS Certification Number (CCN)

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

2. Address

City

3. Phone Number (enter numbers only)

State

Zip code

4. Email

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.
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 DHS 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).
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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 § 411.354(c)(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.
Note on violations arising from the failure to satisfy the requirements necessary to qualify as a group practice. The exception for
physician services at § 411.355(a) is available only to DHS entities that qualify as group practices. The exception for in-office ancillary services at
§ 411.355(b) is available only to DHS entities that qualify as group practices and to physicians in solo practice. If the disclosed noncompliance
arises from the failure of an entity to satisfy the requirements of § 411.352, the financial relationships between the entity and its physician
owners, employees and contractors should be analyzed under § 411.356 (for ownership or investment interests), § 411.357 (for compensation
arrangements) or both. For example, assume a physician organization has five physician owners and two non-owner physician employees; the
five owners each receive shares of overall profits divided per capita and compensation in the form of salaries; the employees receive
compensation in the form of salaries and productivity bonuses on services furnished incident to their personally performed services; and the
physician owners and employees make referrals to the physician organization for DHS provided in the office. If the physician organization does
not qualify as a group practice, the in-office ancillary services exception is not available. The disclosing party must then determine whether an
applicable exception at § 411.356 or § 411.357 is satisfied for each financial relationship between the entity and a referring physician. In this
example, the physician owners of the physician organization may have both noncompliant ownership interests and noncompliant compensation
arrangements. The physician employees have noncompliant compensation arrangements. For purposes of the SRDP, these financial
relationships should be analyzed and reported as noncompliant ownership interests (i.e., failure to satisfy an exception at § 411.356) and
noncompliant compensation arrangements (i.e., failure to satisfy an exception at § 411.357). Do not analyze and report the financial relationships
as potential violations of § 411.355.
The following examples illustrate the application of the "stand in the shoes" provisions and the failure to qualify as a "group practice" to the
report of pervasiveness:
 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).
 During two calendar years, the physician practice compensated its physicians in a manner that did not comply with § 411.352(g). The
physician practice paid productivity bonuses and profit shares that were determined in a manner that directly related to the volume or
value of physicians' referrals of DHS to the physician practice. Because the physician practice cannot satisfy the requirements for a group
practice, the in-office ancillary services exception is unavailable to it. The compensation arrangements with the physician practice's five
employed physicians failed to satisfy the requirements of the exception at § 411.357(c) (or any other exception). The ownership or
investment interests of the physician practice's three owners do not meet the requirements of any exception at § 411.356. Therefore,
eight of eight financial relationships between the physician practice and its employed physicians and physician owners were
noncompliant for the entirety of the two calendar years.

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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.

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.
Yes

Current government inquiry:

No

If yes, explain:

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:

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 to prevent future noncompliance:
Explain:

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Yes

No

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

Form Approved
OMB No. 0938-1106

PHYSICIAN INFORMATION FORM: CMS-10328
For each physician included in the disclosure, you must submit a separate Physician Information Form providing details of the noncompliant
financial relationship(s) between the physician and the disclosing party. Additional Physician Information Forms are available on the CMS
website.

I. Physician Information:
1. Physician Name

2. Physician NPI

3. Physician Organization, if applicable

Physician Organization TIN

Physician Organization NPI

4. Noncompliant compensation arrangement(s) with the physician (See § 411.357)
Yes
No
4.a. Total number of noncompliant compensation arrangements with the physician during the lookback period

4.b. Are any of the disclosed noncompliant compensation arrangements deemed to be arrangements with the physician because the physician stands in
the shoes of a physician organization under § 411.354(c)(1) or § 411.354(c)(2)?
Yes
No
5. Noncompliant ownership or investment interest of the physician (See § 411.356)
Yes
No
5.a. Direct or indirect ownership or investment
Indirect
Direct
6. Noncompliant designated health services provided pursuant to referrals made by the physician (See § 411.355)
Yes
No

II. Noncompliant compensation arrangement (§ 411.357), noncompliant ownership or investment interest
(§ 411.356), Noncompliant designated health services provided pursuant to referrals made by the physician
(§ 411.355)
Provide the details required below regarding the noncompliant ownership or investment interest, the noncompliant compensation
arrangement, or the prohibited DHS referred by the physician.
Special instructions for disclosures of multiple noncompliant financial relationships with a single physician: In certain circumstances,
there may be more than one reason why DHS referred by a physician violated section 1877 of the Act. For example, the disclosing party may have
had a noncompliant equipment lease arrangement with a physician and a noncompliant call coverage arrangement with the same physician
during the lookback period. If there are multiple reasons why DHS referred by the physician violated section 1877 of the Act, complete a
duplicate of this section for each reason by clicking the box labeled "Click here to add another reason for noncompliance involving the
same physician" at the end of this form.

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A. NARRATIVE EXPLANATION
1. Nature of the compensation arrangement, ownership or investment interest, or noncompliance resulting from the provision of
prohibited services:
 For compensation arrangements:
 Describe the items, space, equipment, and/or services provided under the arrangement. For example, for a medical
directorship arrangement, describe the typical duties and responsibilities of the director and the number of hours per week,
month, or year that the physician performed such services.
 Describe the rate of compensation or the amount of remuneration provided under the arrangement (for example, the
monthly rental charge for a lease of office space, the rate of payment for call coverage, or the cash value of nonmonetary
compensation). If the rate of compensation changed at some point during the disclosed period of noncompliance, explain
when it changed, the amount it was changed to, and why it was changed.
 Provide any additional information that the disclosing party believes is relevant and/or necessary to understanding the nature
of the arrangement.
 For ownership or investment interests:
 Describe the physician's ownership interest in the DHS entity making the disclosure. For disclosures involving physician
ownership of hospitals, state whether the physician's ownership interest is in the entire hospital, as opposed to a distinct part
or department of the hospital. See 42 CFR § 356(c)(3)(iii).
 Provide any additional information that the disclosing party believes is relevant and/or necessary to understanding the nature
of the ownership interest.
 For noncompliance with an applicable services exception:
 Describe the circumstances surrounding the provision of the prohibited services. For example, if you are disclosing a failure to
satisfy the requirements of the in-office ancillary services exception at § 411.355(b), explain who furnished and supervised (if
applicable) the DHS, where the services were furnished, how the services were billed, and the type of services furnished.
 Provide any additional information that the disclosing party believes is relevant.
Nature of noncompliant compensation arrangement, noncompliant ownership or investment interest, or noncompliant DHS furnished pursuant to
referrals made by the physician.

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2. Nature of noncompliance: Explain the nature of the noncompliance.
 Explanation of the noncompliance:
 If you are disclosing the failure to comply with an applicable exception at § 411.356 (exceptions for ownership or investment
interests) or § 411.357 (exceptions for compensation arrangements), explain why the financial relationship failed to comply
with the physician self-referral law. For example, if a lease arrangement was not signed by a physician lessee but otherwise
complied with an applicable exception, the disclosing party could state that "the lease arrangement was not signed by the
physician lessee."
 If you are disclosing the failure to comply with an applicable exception at § 411.355 (excepted services), explain why the DHS
provided did not satisfy the requirements of the applicable exception.
 Describe any potential causes of the incident or practice.
 Provide any additional information that the disclosing party believes is relevant and/or necessary to understanding the nature
of the noncompliance.
NOTE: The disclosing entity must either: (a) certify that the financial relationship was noncompliant (or that the services failed to
satisfy an applicable exception at § 411.355), 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.
Nature of noncompliance narrative

3. Method of cure or termination: Describe how the financial relationship was brought back into compliance or otherwise terminated.
 If the financial relationship was ongoing at the time the disclosing party discovered the noncompliance, explain the steps that
the disclosing entity took to either bring the financial relationship back into compliance or terminate the financial relationship.
For example, if a personal service arrangement was out of compliance because it was not set out in writing, state whether the
parties cured the noncompliance by executing a writing or terminating the arrangement. NOTE: If the parties brought the
arrangement into compliance by executing a signed writing covering the arrangement, CMS may request copies of the
signed writing and other additional information regarding the arrangement.
 If the arrangement was terminated prior to the discovery of the noncompliance, state when the arrangement was terminated
and the circumstances under which it was terminated. For example, a lease arrangement may have terminated prior to the
discovery of the noncompliance because the physician lessee vacated the property.
Method of cure or termination:

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B. RELEVANT DATES
1. Period(s) of noncompliance: Provide the date range(s) of the noncompliance. The party must provide a date range for the entire period of
noncompliance, even if the noncompliance began prior to the 6-year lookback period.

2. Date of discovery: Provide the date that the party determined that it received an overpayment because it failed to comply with the physician selfreferral law. See § 401.305(a)(2).

C. COMPENSATION ARRANGEMENTS ONLY
For compensation arrangements only, complete lines 1 through 6 below. Do not complete lines 1 through 6 for noncompliant ownership or
investment interests or failure to satisfy the requirements of a service exception. The entries for lines 1 through 6 are based on certain common
requirements of a number of exceptions for compensation arrangements. To complete the entries, determine which exception applies to the
disclosed compensation arrangement. For example, for a lease of office space, the exception at § 411.357(a) would be applicable; for a call
coverage arrangement, the exceptions at § 411.357(d) and § 411.357(l) are potentially applicable. After determining the applicable exception,
state whether the requirements in lines 1 through 6 are either satisfied or not satisfied; if the applicable exception does not require this element,
enter N/A. For example, the exception for the rental of office space imposes the requirements in lines 1 through 5 below, but not the requirement
in line 6; thus, a party disclosing a noncompliant arrangement for the rental of office space must answer "yes" or "no" to lines 1 through 5 and "N/
A" to line 6."

1. Satisfies the requirement that compensation is set in advance: State whether the amount of compensation was set in advance, if
required by an applicable exception. (See, e.g., § 411.357(a)(4)).
Yes
No
N/A
2. Satisfies the volume or value of referrals or other business generated requirement: State whether the compensation arrangement
satisfied the volume or value of referrals or other business generated requirement, if applicable. (See, e.g., § 411.357(a)(5)(i)).
Yes
No
N/A
3. Satisfies the fair market value requirement: State whether the compensation arrangement satisfied the relevant fair market value
requirement, if applicable. (See, e.g., § 411.357(a)(4)).
Yes
No
N/A
4. Satisfies the commercial reasonableness requirement: State whether the compensation arrangement satisfied the commercial
reasonableness requirement, if applicable. (See, e.g., § 411.357(a)(6)).
Yes
No
N/A
5. Satisfies the reasonable and necessary requirement: State whether the compensation arrangement satisfied the reasonable and
necessary requirement, if applicable. (See, e.g., § 411.357(a)(3)).
Yes
No
N/A
6. Satisfies the Federal and State law requirement(s): State whether, to the best of the disclosing party's knowledge, the compensation
arrangement satisfied the compliance with Federal and State law requirements, if applicable. (See, e.g., § 411.357(d)(1)(vi)).
Yes

No

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N/A

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

Form Approved
OMB No. 0938-1106

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). (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. 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.
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