[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR431.55]

[Page 27-29]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 431_STATE ORGANIZATION AND GENERAL ADMINISTRATION--Table of Contents
 
              Subpart B_General Administrative Requirements
 
Sec. 431.55  Waiver of other Medicaid requirements.

    (a) Statutory basis. Section 1915(b) of the Act authorizes the 
Secretary to waive most requirements of section 1902 of the Act to the 
extent he or she finds proposed improvements or specified practices in 
the provision of services under Medicaid to be cost effective, 
efficient, and consistent with the objectives of the Medicaid program. 
Sections 1915 (f) and (h) prescribe how such waivers are to be approved, 
continued, monitored, and terminated. Section 1902(p)(2) of the Act 
conditions FFP in payments to an entity under a section 1915(b)(1) 
waiver on the State's provision for exclusion of certain entities from 
participation.
    (b) General requirements. (1) General requirements for submittal of 
waiver requests, and the procedures that CMS follows for review and 
action on those requests are set forth in Sec. 430.25 of this chapter.
    (2) In applying for a waiver to implement an approvable project 
under paragraph (c), (d), (e), or (f) of this section, a Medicaid agency 
must document in the waiver request and maintain data regarding:
    (i) The cost-effectiveness of the project;
    (ii) The effect of the project on the accessibility and quality of 
services;
    (iii) The anticipated impact of the project on the State's Medicaid 
program and;
    (iv) Assurances that the restrictions on free choice of providers do 
not apply to family planning services.

[[Page 28]]

    (3) No waiver under this section may be granted for a period longer 
than 2 years, unless the agency requests a continuation of the waiver.
    (4) CMS monitors the implementation of waivers granted under this 
section to ensure that requirements for such waivers are being met.
    (i) If monitoring demonstrates that the agency is not in compliance 
with the requirements for a waiver under this section, CMS gives the 
agency notice and opportunity for a hearing.
    (ii) If, after a hearing, CMS finds an agency to be out of 
compliance with the requirements of a waiver, CMS terminates the waiver 
and gives the agency a specified date by which it must demonstrate that 
it meets the applicable requirements of section 1902 of the Act.
    (5) The requirements of section 1902(s) of the Act, with regard to 
adjustments in payments for inpatient hospital services furnished to 
infants who have not attained age 1 and to children who have not 
attained age 6 and who receive these services in disproportionate share 
hospitals, may not be waived under a section 1915(b) waiver.
    (c) Case-management system. (1) Waivers of appropriate requirements 
of section 1902 of the Act may be authorized for a State to implement a 
primary care case-management system or specialty physician services 
system.
    (i) Under a primary care case-management system the agency assures 
that a specific person or persons or agency will be responsible for 
locating, coordinating, and monitoring all primary care or primary care 
and other medical care and rehabilitative services on behalf of a 
recipient. The person or agency must comply with the requirements set 
forth in part 438 of this chapter for primary care case management 
contracts and systems.
    (ii) A specialty physician services system allows States to restrict 
recipients of specialty services to designated providers of such 
services, even in the absence of a primary care case-management system.
    (2) A waiver under this paragraph (c) may not be approved unless the 
State's request assures that the restrictions--
    (i) Do not apply in emergency situations; and
    (ii) Do not substantially impair access to medically necessary 
services of adequate quality.
    (d) Locality as central broker. Waivers of appropriate requirements 
of section 1902 of the Act may be authorized for a State to allow a 
locality to act as a central broker to assist recipients in selecting 
among competing health care plans. States must ensure that access to 
medically necessary services of adequate quality is not substantially 
impaired.
    (1) A locality is any defined jurisdiction, e.g., district, town, 
city, borough, county, parish, or State.
    (2) A locality may use any agency or agent, public or private, 
profit or nonprofit, to act on its behalf in carrying out its central 
broker function.
    (e) Sharing of cost savings. (1) Waivers of appropriate requirements 
of section 1902 of the Act may be authorized for a State to share with 
recipients the cost savings resulting from the recipients' use of more 
cost-effective medical care.
    (2) Sharing is through the provision of additional services, 
including--
    (i) Services furnished by a plan selected by the recipient; and
    (ii) Services expressly offered by the State as an inducement for 
recipients to participate in a primary care case-management system, a 
competing health care plan or other system that furnishes health care 
services in a more cost-effective manner.
    (f) Restriction of freedom of choice--(1) Waiver of appropriate 
requirements of section 1902 of the Act may be authorized for States to 
restrict recipients to obtaining services from (or through) qualified 
providers or practitioners that meet, accept, and comply with the State 
reimbursement, quality and utilization standards specified in the 
State's waiver request.
    (2) An agency may qualify for a waiver under this paragraph (f) only 
if its applicable State standards are consistent with access, quality 
and efficient and economic provision of covered care and services and 
the restrictions it imposes--
    (i) Do not apply to recipients residing at a long-term care facility 
when a restriction is imposed unless the State

[[Page 29]]

arranges for reasonable and adequate recipient transfer.
    (ii) Do not discriminate among classes of providers on grounds 
unrelated to their demonstrated effectiveness and efficiency in 
providing those services; and
    (iii) Do not apply in emergency circumstances.
    (3) Demonstrated effectiveness and efficiency refers to reducing 
costs or slowing the rate of cost increase and maximizing outputs or 
outcomes per unit of cost.
    (4) The agency must make payments to providers furnishing services 
under a freedom of choice waiver under this paragraph (f) in accordance 
with the timely claims payment standards specified in Sec. 447.45 of 
this chapter for health care practitioners participating in the Medicaid 
program.
    (g) [Reserved]
    (h) Waivers approved under section 1915(b)(1) of the Act--(1) Basic 
rules. (i) An agency must submit, as part of it's waiver request, 
assurance that the entities described in paragraph (h)(2) of this 
section will be excluded from participation under an approved waiver.
    (ii) FFP is available in payments to an entity that furnishes 
services under a section 1915(b)(1) waiver only if the agency excludes 
from participation any entity described in paragraph (h)(2) of this 
section.
    (2) Entities that must be excluded. The agency must exclude an 
entity that meets any of the following conditions:
    (i) Could be excluded under section 1128(b)(8) of the Act as being 
controlled by a sanctioned individual.
    (ii) Has a substantial contractual relationship (direct or indirect) 
with an individual convicted of certain crimes, as described in section 
1128(b)(8)(B) of the Act.
    (iii) Employs or contracts directly or indirectly with one of the 
following:
    (A) Any individual or entity that, under section 1128 or section 
1128A of the Act, is precluded from furnishing health care, utilization 
review, medical social services, or administrative services.
    (B) Any entity described in paragraph (h)(2)(i) of this section.
    (3) Definitions. As used in this section, substantial contractual 
relationship means any contractual relationship that provides for one or 
more of the following services:
    (i) The administration, management, or provision of medical 
services.
    (ii) The establishment of policies, or the provision of operational 
support, for the administration, management, or provision of medical 
services.

[56 FR 8847, Mar. 1, 1991, as amended at 59 FR 4599, Feb. 1, 1994; 59 FR 
36084, July 15, 1994; 67 FR 41094, June 14, 2002]