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. 411.352  Group practice.

 For purposes of this subpart, a group practice is a physician 
practice that meets the following conditions:
    (a) Single legal entity. The group practice must consist of a 
single legal entity operating primarily for the purpose of being a 
physician group practice in any organizational form recognized by the 
State in which the group practice achieves its legal status, including, 
but not limited to, a partnership, professional corporation, limited 
liability company, foundation, nonprofit corporation, faculty practice 
plan, or similar association. The single legal entity may be organized 
by any party or parties, including, but not limited to, physicians, 
health care facilities, or other persons or entities (including, but 
not limited to, physicians individually incorporated as professional 
corporations). The single legal entity may be organized or owned (in 
whole or in part) by another medical practice, provided that the other 
medical practice is not an operating physician practice (and regardless 
of whether the medical practice meets the conditions for a group 
practice under this section). For purposes of this subpart, a single 
legal entity does not include informal affiliations of physicians 
formed substantially to share profits from referrals, or separate group 
practices under common ownership or control through a physician 
practice management company, hospital, health system, or other entity 
or organization. A group practice that is otherwise a single legal 
entity may itself own subsidiary entities. A group practice operating 
in more than one State will be considered to be a single legal entity 
notwithstanding that it is composed of multiple legal entities, 
provided that--
    (1) The States in which the group practice is operating are 
contiguous (although each State need not be contiguous to every other 
State);
    (2) The legal entities are absolutely identical as to ownership, 
governance, and operation; and
    (3) Organization of the group practice into multiple entities is 
necessary to comply with jurisdictional licensing laws of the States in 
which the group practice operates.
    (b) Physicians. The group practice must have at least two 
physicians who are members of the group (whether employees or direct or 
indirect owners), as defined at Sec.  411.351.
    (c) Range of care. Each physician who is a member of the group, as 
defined at Sec.  411.351, must furnish substantially the full range of 
patient care services that the physician routinely furnishes, including 
medical care, consultation, diagnosis, and treatment, through the joint 
use of shared office space, facilities, equipment, and personnel.
    (d) Services furnished by group practice members. (1) Except as 
otherwise provided in paragraphs (d)(3), (d)(4), (d)(5), and (d)(6) of 
this section, substantially all of the patient care services of the 
physicians who are members of the group (that is, at least
75 percent of the total patient care services of the group practice 
members) must be furnished through the group and billed under a billing 
number assigned to the group, and the amounts received must be treated 
as receipts of the group. Patient care services must be measured by one 
of the following:
    (i) The total time each member spends on patient care services 
documented by any reasonable means (including, but not limited to, time 
cards, appointment schedules, or personal diaries). (For example, if a 
physician practices 40 hours a week and spends 30 hours a week on 
patient care services for a group practice, the physician has spent 75 
percent of his or her time providing patient care services for the 
group.)
    (ii) Any alternative measure that is reasonable, fixed in advance 
of the performance of the services being measured, uniformly applied 
over time, verifiable, and documented.
    (2) The data used to calculate compliance with this substantially 
all test and related supportive documentation must be made available to 
the Secretary upon request.
    (3) The substantially all test set forth in paragraph (d)(1) of 
this section does not apply to any group practice that is located 
solely in a HPSA, as defined at Sec.  411.351.
    (4) For a group practice located outside of a HPSA (as defined at 
Sec.  411.351), any time spent by a group practice member providing 
services in a HPSA should not be used to calculate whether the group 
practice has met the substantially all test, regardless of whether the 
member's time in the HPSA is spent in a group practice, clinic, or 
office setting.
    (5) During the start up period (not to exceed 12 months) that 
begins on the date of the initial formation of a new group practice, a 
group practice must make a reasonable, good faith effort to ensure that 
the group practice complies with the substantially all test requirement 
set forth in paragraph (d)(1) of this section as soon as practicable, 
but no later than 12 months from the date of the initial formation of 
the group practice. This paragraph (d)(5) does not apply when an 
existing group practice admits a new member or reorganizes.
    (6)(i) If the addition to an existing group practice of a new 
member who would be considered to have relocated his or her medical 
practice under Sec.  411.357(e)(2) would result in the existing group 
practice not meeting the substantially all test set forth in paragraph 
(d)(1) of this section, the group practice will have 12 months 
following the addition of the new member to come back into full 
compliance, provided that--
    (A) For the 12-month period the group practice is fully compliant 
with the substantially all test if the new member is not counted as a 
member of the group for purposes of Sec.  411.352; and
    (B) The new member's employment with, or ownership interest in, the 
group practice is documented in writing no later than the beginning of 
his or her new employment, ownership, or investment.
    (ii) This paragraph (d)(6) does not apply when an existing group 
practice reorganizes or admits a new member who is not relocating his 
or her medical practice.
    (e) Distribution of expenses and income. The overhead expenses of, 
and income from, the practice must be distributed according to methods 
that are determined before the receipt of payment for the services 
giving rise to the overhead expense or producing the income. Nothing in 
this section prevents a group practice from adjusting its compensation 
methodology prospectively, subject to restrictions on the distribution 
of revenue from DHS under Sec.  411.352(i).
    (f) Unified business. (1) The group practice must be a unified 
business having at least the following features:
    (i) Centralized decision-making by a body representative of the 
group practice that maintains effective control over the group's assets 
and liabilities (including, but not limited to, budgets, compensation, 
and salaries); and
    (ii) Consolidated billing, accounting, and financial reporting.
    (2) Location and specialty-based compensation practices are 
permitted with respect to revenues derived from services that are not 
DHS and may be permitted with respect to revenues derived from DHS 
under Sec.  411.352(i).
    (g) Volume or value of referrals. No physician who is a member of 
the group practice directly or indirectly receives compensation based 
on the volume or value of his or her referrals, except as provided in 
Sec.  411.352(i).
    (h) Physician-patient encounters. Members of the group must 
personally conduct no less than 75 percent of the physician-patient 
encounters of the group practice.
    (i) Special rule for productivity bonuses and profit shares. (1) A 
physician in the group practice may be paid a share of overall profits 
of the group, provided that the share is not determined in any manner 
that is directly related to the volume or value of referrals of DHS by 
the physician. A physician in the group practice may be paid a 
productivity bonus based on services that he or she has personally 
performed, or services ``incident to'' such personally performed 
services, or both, provided that the bonus is not determined in any 
manner that is directly related to the volume or value of referrals of 
DHS by the physician (except that the bonus may directly relate to the 
volume or value of DHS referrals by the physician if the referrals are 
for services ``incident to'' the physician's personally performed 
services).
    (2) Overall profits means the group's entire profits derived from 
DHS payable by Medicare or Medicaid or the profits derived from DHS 
payable by Medicare or Medicaid of any component of the group practice 
that consists of at least five physicians. Overall profits should be 
divided in a reasonable and verifiable manner that is not directly 
related to the volume or value of the physician's referrals of DHS. The 
share of overall profits will be deemed not to relate directly to the 
volume or value of referrals if one of the following conditions is met:
    (i) The group's profits are divided per capita (for example, per 
member of the group or per physician in the group).
    (ii) Revenues derived from DHS are distributed based on the 
distribution of the group practice's revenues attributed to services 
that are not DHS payable by any Federal health care program or private 
payer.
    (iii) Revenues derived from DHS constitute less than 5 percent of 
the group practice's total revenues, and the allocated portion of those 
revenues to each physician in the group practice constitutes 5 percent 
or less of his or her total compensation from the group.
    (3) A productivity bonus must be calculated in a reasonable and 
verifiable manner that is not directly related to the volume or value 
of the physician's referrals of DHS. A productivity bonus will be 
deemed not to relate directly to the volume or value of referrals of 
DHS if one of the following conditions is met:
    (i) The bonus is based on the physician's total patient encounters 
or relative value units (RVUs). (The methodology for establishing RVUs 
is set forth in Sec.  414.22 of this chapter.)
    (ii) The bonus is based on the allocation of the physician's 
compensation attributable to services that are not DHS payable by any 
Federal health care program or private payer.
    (iii) Revenues derived from DHS are less than 5 percent of the 
group practice's total revenues, and the allocated portion of those 
revenues to each physician in the group practice constitutes 5 percent 
or less of his or her total compensation from the group practice.
    (4) Supporting documentation verifying the method used to calculate 
the profit share or productivity bonus under paragraphs (i)(2) and 
(i)(3) of this section, and the resulting amount of compensation, must 
be made available to the Secretary upon request.