TITLE 42--PUBLIC HEALTH
 
                    CHAPTER IV--CENTERS FOR MEDICARE
                          & MEDICAID SERVICES,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 411_EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
--Table of Contents
 
   Subpart J_Financial Relationships Between Physicians and Entities 
                  Furnishing Designated Health Services
 
Sec. 411.361  Reporting requirements.

    (a) Basic rule. Except as provided in paragraph (b) of this 
section, all entities furnishing services for which payment may be made 
under Medicare must submit information to CMS or to the Office of 
Inspector General (OIG) concerning their reportable financial 
relationships (as defined in paragraph (d) of this section), in the 
form, manner, and at the times that CMS or OIG specifies.
    (b) Exception. The requirements of paragraph (a) of this section do 
not apply to entities that furnish 20 or fewer Part A and Part B 
services during a calendar year, or to any Medicare covered services 
furnished outside the United States.
    (c) Required information. The information requested by CMS or OIG 
can include the following:
    (1) The name and unique physician identification number (UPIN) or 
the national provider identifier (NPI) of each physician who has a 
reportable financial relationship with the entity.
    (2) The name and UPIN or NPI of each physician who has an immediate 
family member (as defined at Sec.  411.351) who has a reportable 
financial relationship with the entity.
    (3) The covered services furnished by the entity.
    (4) With respect to each physician identified under paragraphs 
(c)(1) and (c)(2) of this section, the nature of the financial 
relationship (including the extent or value of the ownership or 
investment interest or the compensation arrangement) as evidenced in 
records that the entity knows or should know about in the course of 
prudently conducting business, including, but not limited to, records 
that the entity is already required to retain to comply with the rules 
of the Internal Revenue Service and the Securities and Exchange 
Commission and other rules of the Medicare and Medicaid programs.
    (d) Reportable financial relationships. For purposes of this 
section, a reportable financial relationship is any ownership or 
investment interest, as defined at Sec.  411.354(b) or any compensation 
arrangement, as defined at Sec.  411.354(c), except for ownership or 
investment interests that satisfy the exceptions set forth in Sec.  
411.356(a) or Sec.  411.356(b) regarding publicly-traded securities and 
mutual funds.
    (e) Form and timing of reports. Entities that are subject to the 
requirements of this section must submit the required information, upon 
request, within the time period specified by the request. Entities are 
given at least 30 days from the date of the request to provide the 
information. Entities must retain the information, and documentation 
sufficient to verify the information, for the length of time specified 
by the applicable regulatory requirements for the information, and, 
upon request, must make that information and documentation available to 
CMS or OIG.
    (f) Consequences of failure to report. Any person who is required, 
but fails, to submit information concerning his or her financial 
relationships in accordance with this section is subject to a civil 
money penalty of up to $10,000 for each day following the deadline 
established under paragraph (e) of this section until the information 
is submitted. Assessment of these penalties will comply with the 
applicable provisions of part 1003 of this title.
    (g) Public disclosure. Information furnished to CMS or OIG under 
this section is subject to public disclosure in accordance with the 
provisions of part 401 of this chapter.