[Title 42 CFR M]
[Code of Federal Regulations (annual edition) - October 1, 2007 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter IV - CENTERS FOR MEDICARE]
[Subchapter A - GENERAL PROVISIONS]
[Part 422 - MEDICARE ADVANTAGE PROGRAM]
[Subpart M - Grievances, Organization Determinations and Appeals]
[From the U.S. Government Printing Office]
42PUBLIC HEALTH32007-10-012007-10-01falseGrievances, Organization Determinations and AppealsMSubpart MPUBLIC HEALTHCENTERS FOR MEDICAREGENERAL PROVISIONSMEDICARE ADVANTAGE PROGRAM
Subpart M_Grievances, Organization Determinations and Appeals
Source: 63 FR 35107, June 26, 1998, unless otherwise noted.
Sec. 422.560 Basis and scope.
(a) Statutory basis. (1) Section 1852(f) of the Act provides that an
MA organization must establish meaningful grievance procedures.
(2) Section 1852(g) of the Act establishes requirements that an MA
organization must meet concerning organization determinations and
appeals.
(3) Section 1869 of the Act specifies the amount in controversy
needed to pursue a hearing and judicial review and authorizes
representatives to act on behalf of individuals that seek appeals. These
provisions are incorporated for MA appeals by section 1852(g)(5) of the
Act and part 405 of this chapter.
(b) Scope. This subpart sets forth--
(1) Requirements for MA organizations with respect to grievance
procedures, organization determinations, and appeal procedures.
(2) The rights of MA enrollees with respect to organization
determinations, and grievance and appeal procedures.
(3) The rules concerning notice of noncoverage of inpatient hospital
care.
(4) The rules that apply when an MA enrollee requests immediate QIO
review of a determination that he or she no longer needs inpatient
hospital care.
(c) Relation to ERISA requirements. Consistent with section
1857(i)(2) of the Act, provisions of this subpart may, to the extent
applicable under regulations adopted by the Secretary of Labor, apply to
claims for benefits under group health plans subject to the Employee
Retirement Income Security Act.
[63 FR 35107, June 26, 1998, as amended at 70 FR 4738, Jan. 28, 2005]
Sec. 422.561 Definitions.
As used in this subpart, unless the context indicates otherwise--
Appeal means any of the procedures that deal with the review of
adverse organization determinations on the health care services the
enrollee believes he or she is entitled to receive, including delay in
providing, arranging for, or approving the health care services (such
that a delay would adversely affect the health of the enrollee), or on
any amounts the enrollee must pay for a service, as defined under Sec.
422.566(b). These procedures include reconsiderations by the MA
organization, and if necessary, an independent review entity, hearings
before ALJs, review by the Medicare Appeals Council (MAC), and judicial
review.
Enrollee means an MA eligible individual who has elected an MA plan
offered by an MA organization.
[[Page 350]]
Grievance means any complaint or dispute, other than one that
constitutes an organization determination, expressing dissatisfaction
with any aspect of an MA organization's or provider's operations,
activities, or behavior, regardless of whether remedial action is
requested.
Physician has the meaning given the term in section 1861(r) of the
Act.
Representative means an individual appointed by an enrollee or other
party, or authorized under State or other applicable law, to act on
behalf of an enrollee or other party involved in the appeal. Unless
otherwise stated in this subpart, the representative will have all of
the rights and responsibilities of an enrollee or party in obtaining an
organization determination or in dealing with any of the levels of the
appeals process, subject to the applicable rules described in part 405
of this chapter.
[63 FR 35067, June 26, 1998, as amended at 65 FR 40328, June 29, 2000;
68 FR 16667, Apr. 4, 2003; 70 FR 4738, Jan. 28, 2005]
Sec. 422.562 General provisions.
(a) Responsibilities of the MA organization. (1) An MA organization,
with respect to each MA plan that it offers, must establish and
maintain--
(i) A grievance procedure as described in Sec. 422.564 for
addressing issues that do not involve organization determinations;
(ii) A procedure for making timely organization determinations;
(iii) Appeal procedures that meet the requirements of this subpart
for issues that involve organization determinations; and
(2) An MA organization must ensure that all enrollees receive
written information about the--
(i) Grievance and appeal procedures that are available to them
through the MA organization; and
(ii) Complaint process available to the enrollee under the QIO
process as set forth under section 1154(a)(14) of the Act.
(3) In accordance with subpart K of this part, if the MA
organization delegates any of its responsibilities under this subpart to
another entity or individual through which the organization provides
health care services, the MA organization is ultimately responsible for
ensuring that the entity or individual satisfies the relevant
requirements of this subpart.
(b) Rights of MA enrollees. In accordance with the provisions of
this subpart, enrollees have the following rights:
(1) The right to have grievances between the enrollee and the MA
organization heard and resolved, as described in Sec. 422.564.
(2) The right to a timely organization determination, as provided
under Sec. 422.566.
(3) The right to request an expedited organization determination, as
provided under Sec. 422.570.
(4) If dissatisfied with any part of an organization determination,
the following appeal rights:
(i) The right to a reconsideration of the adverse organization
determination by the MA organization, as provided under Sec. 422.578.
(ii) The right to request an expedited reconsideration, as provided
under Sec. 422.584.
(iii) If, as a result of a reconsideration, an MA organization
affirms, in whole or in part, its adverse organization determination,
the right to an automatic reconsidered determination made by an
independent, outside entity contracted by CMS, as provided in Sec.
422.592.
(iv) The right to an ALJ hearing if the amount in controversy is
met, as provided in Sec. 422.600.
(v) The right to request MAC review of the ALJ hearing decision, as
provided in Sec. 422.608.
(vi) The right to judicial review of the hearing decision if the
amount in controversy is met, as provided in Sec. 422.612.
(c) Limits on when this subpart applies. (1) If an enrollee receives
immediate QIO review (as provided in Sec. 422.622) of a determination
of noncoverage of inpatient hospital care--
(i) The enrollee is not entitled to review of that issue by the MA
organization; and
(ii) The QIO review decision is subject only to the appeal
procedures set forth in parts 476 and 478 of this chapter.
[[Page 351]]
(2) If an enrollee has no further liability to pay for services that
were furnished by an MA organization, a determination regarding these
services is not subject to appeal.
(d) When other regulations apply. Unless this subpart provides
otherwise, the regulations in part 405 of this chapter (concerning the
administrative review and hearing processes and representation of
parties under titles II and XVIII of the Act), apply under this subpart
to the extent they are appropriate.
[63 FR 35067, June 26, 1998, as amended at 65 FR 40329, June 29, 2000;
70 FR 4738, Jan. 28, 2005; 70 FR 52027, Sept. 1, 2005]
Sec. 422.564 Grievance procedures.
(a) General rule. Each MA organization must provide meaningful
procedures for timely hearing and resolving grievances between enrollees
and the organization or any other entity or individual through which the
organization provides health care services under any MA plan it offers.
(b) Distinguished from appeals. Grievance procedures are separate
and distinct from appeal procedures, which address organization
determinations as defined in Sec. 422.566(b). Upon receiving a
complaint, an MA organization must promptly determine and inform the
enrollee whether the complaint is subject to its grievance procedures or
its appeal procedures.
(c) Distinguished from the quality improvement organization (QIO)
complaint process. Under section 1154(a)(14) of the Act, the QIO must
review beneficiaries' written complaints about the quality of services
they have received under the Medicare program. This process is separate
and distinct from the grievance procedures of the MA organization. For
quality of care issues, an enrollee may file a grievance with the MA
organization; file a written complaint with the QIO, or both. For any
complaint submitted to a QIO, the MA organization must cooperate with
the QIO in resolving the complaint.
(d) Method for filing a grievance. (1) An enrollee may file a
grievance with the MA organization either orally or in writing.
(2) An enrollee must file a grievance no later than 60 days after
the event or incident that precipitates the grievance.
(e) Grievance disposition and notification. (1) The MA organization
must notify the enrollee of its decision as expeditiously as the case
requires, based on the enrollee's health status, but no later than 30
days after the date the organization receives the oral or written
grievance.
(2) The MA organization may extend the 30-day timeframe by up to 14
days if the enrollee requests the extension or if the organization
justifies a need for additional information and documents how the delay
is in the interest of the enrollee. When the MA organization extends the
deadline, it must immediately notify the enrollee in writing of the
reasons for the delay.
(3) The MA organization must inform the enrollee of the disposition
of the grievance in accordance with the following procedures:
(i) All grievances submitted in writing must be responded to in
writing.
(ii) Grievances submitted orally may be responded to either orally
or in writing, unless the enrollee requests a written response.
(iii) All grievances related to quality of care, regardless of how
the grievance is filed, must be responded to in writing. The response
must include a description of the enrollee's right to file a written
complaint with the QIO. For any complaint submitted to a QIO, the MA
organization must cooperate with the QIO in resolving the complaint.
(f) Expedited grievances. An MA organization must respond to an
enrollee's grievance within 24 hours if:
(1) The complaint involves an MA organization's decision to invoke
an extension relating to an organization determination or
reconsideration.
(2) The complaint involves an MA organization's refusal to grant an
enrollee's request for an expedited organization determination under
Sec. 422.570 or reconsideration under Sec. 422.584.
(g) Recordkeeping. The MA organization must have an established
process to track and maintain records on all grievances received both
orally and in writing, including, at a minimum, the date of receipt,
final disposition of the grievance, and the date that the MA
[[Page 352]]
organization notified the enrollee of the disposition.
[68 FR 16667, Apr. 4, 2003, as amended at 70 FR 4738, Jan. 28, 2005]
Sec. 422.566 Organization determinations.
(a) Responsibilities of the MA organization. Each MA organization
must have a procedure for making timely organization determinations (in
accordance with the requirements of this subpart) regarding the benefits
an enrollee is entitled to receive under an MA plan, including basic
benefits as described under Sec. 422.100(c)(1) and mandatory and
optional supplemental benefits as described under Sec. 422.102, and the
amount, if any, that the enrollee is required to pay for a health
service. The MA organization must have a standard procedure for making
determinations, in accordance with Sec. 422.568, and an expedited
procedure for situations in which applying the standard procedure could
seriously jeopardize the enrollee's life, health, or ability to regain
maximum function, in accordance with Sec. Sec. 422.570 and 422.572.
(b) Actions that are organization determinations. An organization
determination is any determination made by an MA organization with
respect to any of the following:
(1) Payment for temporarily out of the area renal dialysis services,
emergency services, post-stabilization care, or urgently needed
services.
(2) Payment for any other health services furnished by a provider
other than the MA organization that the enrollee believes--
(i) Are covered under Medicare; or
(ii) If not covered under Medicare, should have been furnished,
arranged for, or reimbursed by the MA organization.
(3) The MA organization's refusal to provide or pay for services, in
whole or in part, including the type or level of services, that the
enrollee believes should be furnished or arranged for by the MA
organization.
(4) Discontinuation or reduction of a service if the enrollee
believes that continuation of the services is medically necessary.
(5) Failure of the MA organization to approve, furnish, arrange for,
or provide payment for health care services in a timely manner, or to
provide the enrollee with timely notice of an adverse determination,
such that a delay would adversely affect the health of the enrollee.
(c) Who can request an organization determination. (1) Those
individuals or entities who can request an organization determination
are--
(i) The enrollee (including his or her authorized representative);
(ii) Any provider that furnishes, or intends to furnish, services to
the enrollee; or
(iii) The legal representative of a deceased enrollee's estate.
(2) Those who can request an expedited determination are--
(i) An enrollee (including his or her authorized representative); or
(ii) A physician (regardless of whether the physician is affiliated
with the MA organization).
[63 FR 35067, June 26, 1998, as amended at 65 FR 40329, June 29, 2000;
68 FR 50858, Aug. 22, 2003; 70 FR 4739, Jan. 28, 2005]
Sec. 422.568 Standard timeframes and notice requirements for organization determinations.
(a) Timeframe for requests for service. When a party has made a
request for a service, the MA organization must notify the enrollee of
its determination as expeditiously as the enrollee's health condition
requires, but no later than 14 calendar days after the date the
organization receives the request for a standard organization
determination. The MA organization may extend the timeframe by up to 14
calendar days if the enrollee requests the extension or if the
organization justifies a need for additional information and how the
delay is in the interest of the enrollee (for example, the receipt of
additional medical evidence from noncontract providers may change an MA
organization's decision to deny). When the MA organization extends the
timeframe, it must notify the enrollee in writing of the reasons for the
delay, and inform the enrollee of the right to file an expedited
grievance if he or she disagrees with the MA organization's decision to
grant an extension.
(b) Timeframe for requests for payment. The MA organization must
process requests for payment according to the
[[Page 353]]
``prompt payment'' provisions set forth in Sec. 422.520.
(c) Written notice for MA organization denials. If an MA
organization decides to deny service or payment in whole or in part, or
if an enrollee disagrees with an MA organization's decision to
discontinue or reduce the level of care for an ongoing course of
treatment, the organization must give the enrollee written notice of the
determination.
(d) Written notice for MA Organization denials. If an enrollee
requests an MA organization to provide an explanation of a
practitioner's denial of an item or service, in whole or in part, the MA
organization must give the enrollee a written notice.
(e) Form and content of the MA organization notice. The notice of
any denial under paragraph (d) of this section must--
(1) Use approved notice language in a readable and understandable
form;
(2) State the specific reasons for the denial;
(3) Inform the enrollee of his or her right to a reconsideration;
(4)(i) For service denials, describe both the standard and expedited
reconsideration processes, including the enrollee's right to, and
conditions for, obtaining an expedited reconsideration and the rest of
the appeal process; and
(ii) For payment denials, describe the standard reconsideration
process and the rest of the appeal process; and
(5) Comply with any other notice requirements specified by CMS.
(f) Effect of failure to provide timely notice. If the MA
organization fails to provide the enrollee with timely notice of an
organization determination as specified in this section, this failure
itself constitutes an adverse organization determination and may be
appealed.
[65 FR 40329, June 29, 2000, as amended at 70 FR 4739, Jan. 28, 2005; 70
FR 52027, Sept. 1, 2005]
Sec. 422.570 Expediting certain organization determinations.
(a) Request for expedited determination. An enrollee or a physician
(regardless of whether the physician is affiliated with the MA
organization) may request that an MA organization expedite an
organization determination involving the issues described in Sec.
422.566(b)(3) and (b)(4). (This does not include requests for payment of
services already furnished.)
(b) How to make a request. (1) To ask for an expedited
determination, an enrollee or a physician must submit an oral or written
request directly to the MA organization or, if applicable, to the entity
responsible for making the determination, as directed by the MA
organization.
(2) A physician may provide oral or written support for a request
for an expedited determination.
(c) How the MA organization must process requests. The MA
organization must establish and maintain the following procedures for
processing requests for expedited determinations:
(1) Establish an efficient and convenient means for individuals to
submit oral or written requests. The MA organization must document all
oral requests in writing and maintain the documentation in the case
file.
(2) Promptly decide whether to expedite a determination, based on
the following requirements:
(i) For a request made by an enrollee the MA organization must
provide an expedited determination if it determines that applying the
standard timeframe for making a determination could seriously jeopardize
the life or health of the enrollee or the enrollee's ability to regain
maximum function.
(ii) For a request made or supported by a physician, the MA
organization must provide an expedited determination if the physician
indicates that applying the standard timeframe for making a
determination could seriously jeopardize the life or health of the
enrollee or the enrollee's ability to regain maximum function.
(d) Actions following denial. If an MA organization denies a request
for expedited determination, it must take the following actions:
(1) Automatically transfer a request to the standard timeframe and
make the determination within the 14-day timeframe established in Sec.
422.568 for a standard determination. The 14-day period begins with the
day the MA organization receives the request for expedited
determination.
[[Page 354]]
(2) Give the enrollee prompt oral notice of the denial and
subsequently deliver, within 3 calendar days, a written letter that--
(i) Explains that the MA organization will process the request using
the 14-day timeframe for standard determinations;
(ii) Informs the enrollee of the right to file an expedited
grievance if he or she disagrees with the MA organization's decision not
to expedite; and
(iii) Informs the enrollee of the right to resubmit a request for an
expedited determination with any physician's support; and
(iv) Provides instructions about the grievance process and its
timeframes.
(e) Action on accepted request for expedited determination. If an MA
organization grants a request for expedited determination, it must make
the determination and give notice in accordance with Sec. 422.572.
(f) Prohibition of punitive action. An MA organization may not take
or threaten to take any punitive action against a physician acting on
behalf or in support of an enrollee in requesting an expedited
determination.
[63 FR 35107, June 26, 1998, as amended at 65 FR 40329, June 29, 2000;
70 FR 4739, Jan. 28, 2005]
Sec. 422.572 Timeframes and notice requirements for expedited organization determinations.
(a) Timeframe. Except as provided in paragraph (b) of this section,
an MA organization that approves a request for expedited determination
must make its determination and notify the enrollee (and the physician
involved, as appropriate) of its decision, whether adverse or favorable,
as expeditiously as the enrollee's health condition requires, but no
later than 72 hours after receiving the request.
(b) Extensions. The MA organization may extend the 72-hour deadline
by up to 14 calendar days if the enrollee requests the extension or if
the organization justifies a need for additional information and how the
delay is in the interest of the enrollee (for example, the receipt of
additional medical evidence from noncontract providers may change an MA
organization's decision to deny). When the MA organization extends the
deadline, it must notify the enrollee in writing of the reasons for the
delay and inform the enrollee of the right to file an expedited
grievance if he or she disagrees with the MA organization's decision to
grant an extension. The MA organization must notify the enrollee of its
determination as expeditiously as the enrollee's health condition
requires, but no later than upon expiration of the extension.
(c) Confirmation of oral notice. If the MA organization first
notifies an enrollee of an adverse expedited determination orally, it
must mail written confirmation to the enrollee within 3 calendar days of
the oral notification.
(d) How the MA organization must request information from
noncontract providers. If the MA organization must receive medical
information from noncontract providers, the MA organization must request
the necessary information from the noncontract provider within 24 hours
of the initial request for an expedited organization determination.
Noncontract providers must make reasonable and diligent efforts to
expeditiously gather and forward all necessary information to assist the
MA organization in meeting the required timeframe. Regardless of whether
the MA organization must request information from noncontract providers,
the MA organization is responsible for meeting the timeframe and notice
requirements of this section.
(e) Content of the notice of expedited determination. (1) The notice
of any expedited determination must state the specific reasons for the
determination in understandable language.
(2) If the determination is not completely favorable to the
enrollee, the notice must--
(i) Inform the enrollee of his or her right to a reconsideration;
(ii) Describe both the standard and expedited reconsideration
processes, including the enrollee's right to request, and conditions for
obtaining, an expedited reconsideration, and the rest of the appeal
process; and
(iii) Comply with any other requirements specified by CMS.
(f) Effect of failure to provide a timely notice. If the MA
organization fails to provide the enrollee with timely notice
[[Page 355]]
of an expedited organization determination as specified in this section,
this failure itself constitutes an adverse organization determination
and may be appealed.
[63 FR 35107, June 26, 1998, as amended at 65 FR 40329, June 29, 2000;
70 FR 4739, Jan. 28, 2005]
Sec. 422.574 Parties to the organization determination.
The parties to the organization determination are--
(a) The enrollee (including his or her authorized representative);
(b) An assignee of the enrollee (that is, a physician or other
provider who has furnished a service to the enrollee and formally agrees
to waive any right to payment from the enrollee for that service);
(c) The legal representative of a deceased enrollee's estate; or
(d) Any other provider or entity (other than the MA organization)
determined to have an appealable interest in the proceeding.
Sec. 422.576 Effect of an organization determination.
The organization determination is binding on all parties unless it
is reconsidered under Sec. Sec. 422.578 through 422.596 or is reopened
and revised under Sec. 422.616.
Sec. 422.578 Right to a reconsideration.
Any party to an organization determination (including one that has
been reopened and revised as described in Sec. 422.616) may request
that the determination be reconsidered under the procedures described in
Sec. 422.582, which address requests for a standard reconsideration. An
enrollee or physician (acting on behalf of an enrollee) may request an
expedited reconsideration as described in Sec. 422.584.
Sec. 422.580 Reconsideration defined.
A reconsideration consists of a review of an adverse organization
determination, the evidence and findings upon which it was based, and
any other evidence the parties submit or the MA organization or CMS
obtains.
Sec. 422.582 Request for a standard reconsideration.
(a) Method and place for filing a request. A party to an
organization determination must ask for a reconsideration of the
determination by making a written request to the MA organization that
made the organization determination. The MA organization may adopt a
policy for accepting oral requests.
(b) Timeframe for filing a request. Except as provided in paragraph
(c) of this section, a party must file a request for reconsideration
within 60 calendar days from the date of the notice of the organization
determination.
(c) Extending the time for filing a request--(1) General rule. If a
party shows good cause, the MA organization may extend the timeframe for
filing a request for reconsideration.
(2) How to request an extension of timeframe. If the 60-day period
in which to file a request for reconsideration has expired, a party to
the organization determination may file a request for reconsideration
with the MA organization. The request for reconsideration and to extend
the timeframe must--
(i) Be in writing; and
(ii) State why the request for reconsideration was not filed on
time.
(d) Parties to the reconsideration. The parties to the
reconsideration are the parties to the organization determination, as
described in Sec. 422.574, and any other provider or entity (other than
the MA organization) whose rights with respect to the organization
determination may be affected by the reconsideration, as determined by
the entity that conducts the reconsideration.
(e) Withdrawing a request. The party who files a request for
reconsideration may withdraw it by filing a written request for
withdrawal at one of the places listed in paragraph (a) of this section.
[63 FR 35107, June 26, 1998, as amended at 70 FR 4739, Jan. 28, 2005]
Sec. 422.584 Expediting certain reconsiderations.
(a) Who may request an expedited reconsideration. An enrollee or a
physician (regardless of whether he or she is affiliated with the MA
organization) may request that an MA organization
[[Page 356]]
expedite a reconsideration of a determination that involves the issues
described in Sec. 422.566(b)(3) and (b)(4). (This does not include
requests for payment of services already furnished.)
(b) How to make a request. (1) To ask for an expedited
reconsideration, an enrollee or a physician acting on behalf of an
enrollee must submit an oral or written request directly to the MA
organization or, if applicable, to the entity responsible for making the
reconsideration, as directed by the MA organization.
(2) A physician may provide oral or written support for a request
for an expedited reconsideration.
(c) How the MA organization must process requests. The MA
organization must establish and maintain the following procedures for
processing requests for expedited reconsiderations:
(1) Handling of requests. The MA organization must establish an
efficient and convenient means for individuals to submit oral or written
requests, document all oral requests in writing, and maintain the
documentation in the case file.
(2) Prompt decision. Promptly decide on whether to expedite the
reconsideration or follow the timeframe for standard reconsideration
based on the following requirements:
(i) For a request made by an enrollee, the MA organization must
provide an expedited reconsideration if it determines that applying the
standard timeframe for reconsidering a determination could seriously
jeopardize the life or health of the enrollee or the enrollee's ability
to regain maximum function.
(ii) For a request made or supported by a physician, the MA
organization must provide an expedited reconsideration if the physician
indicates that applying the standard timeframe for conducting a
reconsideration could seriously jeopardize the life or health of the
enrollee or the enrollee's ability to regain maximum function.
(d) Actions following denial. If an MA organization denies a request
for expedited reconsideration, it must take the following actions:
(1) Automatically transfer a request to the standard timeframe and
make the determination within the 30-day timeframe established in Sec.
422.590(a). The 30-day period begins the day the MA organization
receives the request for expedited reconsideration.
(2) Give the enrollee prompt oral notice, and subsequently deliver,
within 3 calendar days, a written letter that--
(i) Explains that the MA organization will process the enrollee's
request using the 30-day timeframe for standard reconsiderations;
(ii) Informs the enrollee of the right to file a grievance if he or
she disagrees with the organization's decision not to expedite;
(iii) Informs the enrollee of the right to resubmit a request for an
expedited reconsideration with any physician's support; and
(iv) Provides instructions about the grievance process and its
timeframes.
(e) Action following acceptance of a request. If an MA organization
grants a request for expedited reconsideration, it must conduct the
reconsideration and give notice in accordance with Sec. 422.590.
(f) Prohibition of punitive action. An MA organization may not take
or threaten to take any punitive action against a physician acting on
behalf or in support of an enrollee in requesting an expedited
reconsideration.
[63 FR 35107, June 26, 1998, as amended at 65 FR 40330, June 29, 2000;
70 FR 4739, Jan. 28, 2005]
Sec. 422.586 Opportunity to submit evidence.
The MA organization must provide the parties to the reconsideration
with a reasonable opportunity to present evidence and allegations of
fact or law, related to the issue in dispute, in person as well as in
writing. In the case of an expedited reconsideration, the opportunity to
present evidence is limited by the short timeframe for making a
decision. Therefore, the MA organization must inform the parties of the
conditions for submitting the evidence.
Sec. 422.590 Timeframes and responsibility for reconsiderations.
(a) Standard reconsideration: Request for services. (1) If the MA
organization makes a reconsidered determination that is completely
favorable to the enrollee, the MA organization must issue
[[Page 357]]
the determination (and effectuate it in accordance with Sec.
422.618(a)) as expeditiously as the enrollee's health condition
requires, but no later than 30 calendar days from the date it receives
the request for a standard reconsideration. The MA organization may
extend the timeframe by up to 14 calendar days if the enrollee requests
the extension or if the organization justifies a need for additional
information and how the delay is in the interest of the enrollee (for
example, the receipt of additional medical evidence from noncontract
providers may change an MA organization's decision to deny). When the MA
organization extends the timeframe, it must notify the enrollee in
writing of the reasons for the delay, and inform the enrollee of the
right to file an expedited grievance if he or she disagrees with the MA
organization's decision to grant an extension. For extensions, the MA
organization must issue and effectuate its determination as
expeditiously as the enrollee's health condition requires, but no later
than upon expiration of the extension.
(2) If the MA organization makes a reconsidered determination that
affirms, in whole or in part, its adverse organization determination, it
must prepare a written explanation and send the case file to the
independent entity contracted by CMS as expeditiously as the enrollee's
health condition requires, but no later than 30 calendar days from the
date it receives the request for a standard reconsideration (or no later
than the expiration of an extension described in paragraph (a)(1) of
this section). The organization must make reasonable and diligent
efforts to assist in gathering and forwarding information to the
independent entity.
(b) Standard reconsideration: Request for payment. (1) If the MA
organization makes a reconsidered determination that is completely
favorable to the enrollee, the MA organization must issue its
reconsidered determination to the enrollee (and effectuate it in
accordance with Sec. 422.618(a)) no later than 60 calendar days from
the date it receives the request for a standard reconsideration.
(2) If the MA organization affirms, in whole or in part, its adverse
organization determination, it must prepare a written explanation and
send the case file to the independent entity contracted by CMS no later
than 60 calendar days from the date it receives the request for a
standard reconsideration. The organization must make reasonable and
diligent efforts to assist in gathering and forwarding information to
the independent entity.
(c) Effect of failure to meet timeframe for standard
reconsideration. If the MA organization fails to provide the enrollee
with a reconsidered determination within the timeframes specified in
paragraph (a) or paragraph (b) of this section, this failure constitutes
an affirmation of its adverse organization determination, and the MA
organization must submit the file to the independent entity in the same
manner as described under paragraphs (a)(2) and (b)(2) of this section.
(d) Expedited reconsideration--(1) Timeframe. Except as provided in
paragraph (d)(2) of this section, an MA organization that approves a
request for expedited reconsideration must complete its reconsideration
and give the enrollee (and the physician involved, as appropriate)
notice of its decision as expeditiously as the enrollee's health
condition requires but no later than 72 hours after receiving the
request.
(2) Extensions. The MA organization may extend the 72-hour deadline
by up to 14 calendar days if the enrollee requests the extension or if
the organization justifies a need for additional information and how the
delay is in the interest of the enrollee (for example, the receipt of
additional medical evidence from noncontract providers may change an MA
organization's decision to deny). When the MA organization extends the
timeframe, it must notify the enrollee in writing of the reasons for the
delay, and inform the enrollee of the right to file an expedited
grievance if he or she disagrees with the MA organization's decision to
grant an extension. The MA organization must notify the enrollee of its
determination as expeditiously as the enrollee's health condition
requires but no later than upon expiration of the extension.
(3) Confirmation of oral notice. If the MA organization first
notifies an enrollee of a completely favorable expedited
reconsideration, it must mail
[[Page 358]]
written confirmation to the enrollee within 3 calendar days.
(4) How the MA organization must request information from
noncontract providers. If the MA organization must receive medical
information from noncontract providers, the MA organization must request
the necessary information from the noncontract provider within 24 hours
of the initial request for an expedited reconsideration. Noncontract
providers must make reasonable and diligent efforts to expeditiously
gather and forward all necessary information to assist the MA
organization in meeting the required timeframe. Regardless of whether
the MA organization must request information from noncontract providers,
the MA organization is responsible for meeting the timeframe and notice
requirements.
(5) Affirmation of an adverse expedited organization determination.
If, as a result of its reconsideration, the MA organization affirms, in
whole or in part, its adverse expedited organization determination, the
MA organization must submit a written explanation and the case file to
the independent entity contracted by CMS as expeditiously as the
enrollee's health condition requires, but not later than within 24 hours
of its affirmation. The organization must make reasonable and diligent
efforts to assist in gathering and forwarding information to the
independent entity.
(e) Notification of enrollee. If the MA organization refers the
matter to the independent entity as described under this section, it
must concurrently notify the enrollee of that action.
(f) Failure to meet timeframe for expedited reconsideration. If the
MA organization fails to provide the enrollee with the results of its
reconsideration within the timeframe described in paragraph (d) of this
section, this failure constitutes an adverse reconsidered determination,
and the MA organization must submit the file to the independent entity
within 24 hours of expiration of the timeframe set forth in paragraph
(d) of this section.
(g) Who must reconsider an adverse organization determination. (1) A
person or persons who were not involved in making the organization
determination must conduct the reconsideration.
(2) When the issue is the MA organization's denial of coverage based
on a lack of medical necessity (or any substantively equivalent term
used to describe the concept of medical necessity), the reconsidered
determination must be made by a physician with expertise in the field of
medicine that is appropriate for the services at issue. The physician
making the reconsidered determination need not, in all cases, be of the
same specialty or subspecialty as the treating physician.
[63 FR 35107, June 26, 1998, as amended at 65 FR 40330, June 29, 2000;
70 FR 4739, Jan. 28, 2005]
Sec. 422.592 Reconsideration by an independent entity.
(a) When the MA organization affirms, in whole or in part, its
adverse organization determination, the issues that remain in dispute
must be reviewed and resolved by an independent, outside entity that
contracts with CMS.
(b) The independent outside entity must conduct the review as
expeditiously as the enrollee's health condition requires but must not
exceed the deadlines specified in the contract.
(c) When the independent entity conducts a reconsideration, the
parties to the reconsideration are the same parties listed in Sec.
422.582(d) who qualified during the MA organization's reconsideration,
with the addition of the MA organization.
Sec. 422.594 Notice of reconsidered determination by the independent entity.
(a) Responsibility for the notice. When the independent entity makes
the reconsidered determination, it is responsible for mailing a notice
of its reconsidered determination to the parties and for sending a copy
to CMS.
(b) Content of the notice. The notice must--
(1) State the specific reasons for the entity's decisions in
understandable language;
(2) If the reconsidered determination is adverse (that is, does not
completely reverse the MA organization's adverse organization
determination), inform the parties of their right to an ALJ
[[Page 359]]
hearing if the amount in controversy is $100 or more;
(3) Describe the procedures that a party must follow to obtain an
ALJ hearing; and
(4) Comply with any other requirements specified by CMS.
[63 FR 35107, June 26, 1998, as amended at 65 FR 40330, June 29, 2000]
Sec. 422.596 Effect of a reconsidered determination.
A reconsidered determination is final and binding on all parties
unless a party other than the MA organization files a request for a
hearing under the provisions of Sec. 422.602, or unless the
reconsidered determination is revised under Sec. 422.616.
[65 FR 40331, June 29, 2000]
Sec. 422.600 Right to a hearing.
(a) If the amount remaining in controversy after reconsideration
meets the threshold requirement established annually by the Secretary,
any party to the reconsideration (except the MA organization) who is
dissatisfied with the reconsidered determination has a right to a
hearing before an ALJ.
(b) The amount remaining in controversy, which can include any
combination of Part A and Part B services, is computed in accordance
with part 405 of this chapter.
(c) If the basis for the appeal is the MA organization's refusal to
provide services, CMS uses the projected value of those services to
compute the amount remaining in controversy.
[63 FR 35107, June 26, 1998, as amended at 70 FR 4740, Jan. 28, 2005]
Sec. 422.602 Request for an ALJ hearing.
(a) How and where to file a request. A party must file a written
request for a hearing with the entity specified in the IRE's
reconsideration notice.
(b) When to file a request. Except when an ALJ extends the time
frame as provided in part 405 of this chapter, a party must file a
request for a hearing within 60 days of the date of the notice of a
reconsidered determination. The time and place for a hearing before an
ALJ will be set in accordance with Sec. 405.1020.
(c) Parties to a hearing. The parties to a hearing are the parties
to the reconsideration, the MA organization, and any other person or
entity whose rights with respect to the reconsideration may be affected
by the hearing, as determined by the ALJ.
(d) Insufficient amount in controversy. (1) If a request for a
hearing clearly shows that the amount in controversy is less than that
required under Sec. 422.600, the ALJ dismisses the request.
(2) If, after a hearing is initiated, the ALJ finds that the amount
in controversy is less than the amount required under Sec. 422.600, the
ALJ discontinues the hearing and does not rule on the substantive issues
raised in the appeal.
[63 FR 35107, June 26, 1998, as amended at 70 FR 4740, Jan. 28, 2005]
Sec. 422.608 Medicare Appeals Council (MAC) review.
Any party to the hearing, including the MA organization, who is
dissatisfied with the ALJ hearing decision, may request that the MAC
review the ALJ's decision or dismissal. The regulations under part 405
of this chapter regarding MAC review apply to matters addressed by this
subpart to the extent that they are appropriate.
[70 FR 4740, Jan. 28, 2005]
Sec. 422.612 Judicial review.
(a) Review of ALJ's decision. Any party, including the MA
organization, may request judicial review (upon notifying the other
parties) of an ALJ's decision if--
(1) The Board denied the party's request for review; and
(2) The amount in controversy meets the threshold requirement
established annually by the Secretary.
(b) Review of MAC decision. Any party, including the MA
organization, may request judicial review (upon notifying the other
parties) of the MAC decision if it is the final decision of CMS and the
amount in controversy meets the threshold established in paragraph
(a)(2) of this section.
(c) How to request judicial review. In order to request judicial
review, a
[[Page 360]]
party must file a civil action in a district court of the United States
in accordance with section 205(g) of the Act. See part 405 of this
chapter for a description of the procedures to follow in requesting
judicial review.
[63 FR 35107, June 26, 1998; 63 FR 52614, Oct. 1, 1998, as amended at 65
FR 40331, June 29, 2000; 70 FR 4740, Jan. 28, 2005]
Sec. 422.616 Reopening and revising determinations and decisions.
(a) An organization or reconsidered determination made by an MA
organization, a reconsidered determination made by the independent
entity described in Sec. 422.592, or the decision of an ALJ or the MAC
that is otherwise final and binding may be reopened and revised by the
entity that made the determination or decision, under the rules in part
405 of this chapter.
(b) Reopening may be at the instigation of any party.
(c) The filing of a request for reopening does not relieve the MA
organization of its obligation to make payment or provide services as
specified in Sec. 422.618.
(d) Once an entity issues a revised determination or decision, any
party may file an appeal.
[63 FR 35107, June 26, 1998; 63 FR 52614, Oct. 1, 1998, as amended at 70
FR 4740, Jan. 28, 2005]
Sec. 422.618 How an MA organization must effectuate standard reconsidered determinations or decisions.
(a) Reversals by the MA organization--(1) Requests for service. If,
on reconsideration of a request for service, the MA organization
completely reverses its organization determination, the organization
must authorize or provide the service under dispute as expeditiously as
the enrollee's health condition requires, but no later than 30 calendar
days after the date the MA organization receives the request for
reconsideration (or no later than upon expiration of an extension
described in Sec. 422.590(a)(1)).
(2) Requests for payment. If, on reconsideration of a request for
payment, the MA organization completely reverses its organization
determination, the organization must pay for the service no later than
60 calendar days after the date the MA organization receives the request
for reconsideration.
(b) Reversals by the independent outside entity--(1) Requests for
service. If, on reconsideration of a request for service, the MA
organization's determination is reversed in whole or in part by the
independent outside entity, the MA organization must authorize the
service under dispute within 72 hours from the date it receives notice
reversing the determination, or provide the service under dispute as
expeditiously as the enrollee's health condition requires, but no later
than 14 calendar days from that date. The MA organization must inform
the independent outside entity that the organization has effectuated the
decision.
(2) Requests for payment. If, on reconsideration of a request for
payment, the MA organization's determination is reversed in whole or in
part by the independent outside entity, the MA organization must pay for
the service no later than 30 calendar days from the date it receives
notice reversing the organization determination. The MA organization
must inform the independent outside entity that the organization has
effectuated the decision.
(c) Reversals other than by the MA organization or the independent
outside entity.--(1) General rule. If the independent outside entity's
determination is reversed in whole or in part by the ALJ, or at a higher
level of appeal, the MA organization must pay for, authorize, or provide
the service under dispute as expeditiously as the enrollee's health
condition requires, but no later than 60 calendar days from the date it
receives notice reversing the determination. The MA organization must
inform the independent outside entity that the organization has
effectuated the decision or that it has appealed the decision.
(2) Effectuation exception when the MA organization files an appeal
with the Medicare Appeals Council. If the MA organization requests
Medicare Appeals Council (the Board) review consistent with Sec.
422.608, the MA organization may await the outcome of the review before
it pays for, authorizes, or provides the service under dispute. A MA
organization that files an appeal with the Board must concurrently send
a copy of its
[[Page 361]]
appeal request and any accompanying documents to the enrollee and must
notify the independent outside entity that it has requested an appeal.
[63 FR 35107, June 26, 1998, as amended at 65 FR 40331, June 29, 2000;
68 FR 50858, Aug. 22, 2003]
Sec. 422.619 How an MA organization must effectuate expedited reconsidered determinations.
(a) Reversals by the MA organization. If on reconsideration of an
expedited request for service, the MA organization completely reverses
its organization determination, the MA organization must authorize or
provide the service under dispute as expeditiously as the enrollee's
health condition requires, but no later than 72 hours after the date the
MA organization receives the request for reconsideration (or no later
than upon expiration of an extension described in Sec. 422.590(d)(2)).
(b) Reversals by the independent outside entity. If the MA
organization's determination is reversed in whole or in part by the
independent outside entity, the MA organization must authorize or
provide the service under dispute as expeditiously as the enrollee's
health condition requires but no later than 72 hours from the date it
receives notice reversing the determination. The MA organization must
inform the independent outside entity that the organization has
effectuated the decision.
(c) Reversals other than by the MA organization or the independent
outside entity--(1) General rule. If the independent outside entity's
expedited determination is reversed in whole or in part by the ALJ, or
at a higher level of appeal, the MA organization must authorize or
provide the service under dispute as expeditiously as the enrollee's
health condition requires, but no later than 60 days from the date it
receives notice reversing the determination. The MA organization must
inform the independent outside entity that the organization has
effectuated the decision.
(2) Effectuation exception when the MA organization files an appeal
with the Medicare Appeals Council. If the MA organization requests
Medicare Appeals Council (the Board) review consistent with Sec.
422.608, the MA organization may await the outcome of the review before
it authorizes or provides the service under dispute. A MA organization
that files an appeal with the Board must concurrently send a copy of its
appeal request and any accompanying documents to the enrollee and must
notify the independent outside entity that it has requested an appeal.
[65 FR 40331, June 29, 2000, as amended at 68 FR 50859, Aug. 22, 2003]
Sec. 422.620 Notifying enrollees of hospital discharge appeal rights.
(a) Applicability and scope. (1) For purposes of Sec. 422.620 and
Sec. 422.622, the term hospital is defined as any facility providing
care at the inpatient hospital level, whether that care is short term or
long term, acute or non acute, paid through a prospective payment system
or other reimbursement basis, limited to specialty care or providing a
broader spectrum of services. This definition also includes critical
access hospitals.
(2) For purposes of Sec. 422.620 and Sec. 422.622, a discharge is
a formal release of an enrollee from an inpatient hospital.
(b) Advance written notice of hospital discharge rights. For all
Medicare Advantage enrollees, hospitals must deliver valid, written
notice of an enrollee's rights as a hospital inpatient including
discharge appeal rights. The hospital must use a standardized notice, as
specified by CMS, in accordance with the following procedures:
(1) Timing of notice. The hospital must provide the notice at or
near admission, but no later than 2 calendar days following the
enrollee's admission to the hospital.
(2) Content of the notice. The notice of rights must include the
following information:
(i) The enrollee's rights as a hospital inpatient, including the
right to benefits for inpatient services and for post hospital services
in accordance with 1866(a)(1)(M) of the Act.
(ii) The enrollee's right to request an immediate review, including
a description of the process under Sec. 422.622 and the availability of
other appeals processes if the enrollee fails to meet the deadline for
an immediate review.
(iii) The circumstances under which an enrollee will or will not be
liable for
[[Page 362]]
charges for continued stay in the hospital in accordance with
1866(a)(1)(M) of the Act.
(iv) The enrollee's right to receive additional information in
accordance with section Sec. 422.622(e).
(v) Any other information required by CMS.
(3) When delivery of notice is valid. Delivery of the written notice
of rights described in this section is valid if--
(i) The enrollee (or the enrollee's representative) has signed and
dated the notice to indicate that he or she has received the notice and
can comprehend its contents, except as provided in paragraph (b)(4) of
this section; and
(ii) The notice is delivered in accordance with paragraph (b)(1) of
this section and contains all the elements described in paragraph (b)(2)
of this section.
(4) If an enrollee refuses to sign the notice. The hospital may
annotate its notice to indicate the refusal, and the date of refusal is
considered the date of receipt of the notice.
(c) Follow up notification. (1) The hospital must present a copy of
the signed notice described in paragraph (b)(2) of this section to the
enrollee (or enrollee's representative) prior to discharge. The notice
should be given as far in advance of discharge as possible, but not more
than 2 calendar days before discharge.
(2) Follow up notification is not required if the notice required
under 422.620(b) is delivered within 2 calendar days of discharge.
(d) Physician concurrence required. Before discharging an enrollee
from the inpatient hospital level of care, the MA organization must
obtain concurrence from the physician who is responsible for the
enrollee's inpatient care.
[71 FR 68723, Nov. 27, 2006]
Sec. 422.622 Requesting immediate QIO review of the decision to discharge from the inpatient hospital.
(a) Enrollee's right to an immediate QIO review. An enrollee has a
right to request an immediate review by the QIO when an MA organization
or hospital (acting directly or through its utilization committee), with
physician concurrence determines that inpatient care is no longer
necessary.
(b) Requesting an immediate QIO review. (1) An enrollee who wishes
to exercise the right to an immediate review must submit a request to
the QIO that has an agreement with the hospital as specified in Sec.
476.78 of this chapter. The request must be made no later than the day
of discharge and may be in writing or by telephone.
(2) The enrollee, or his or her representative, upon request by the
QIO, must be available to discuss the case.
(3) The enrollee may, but is not required to, submit written
evidence to be considered by a QIO in making its decision.
(4) An enrollee who makes a timely request for an immediate QIO
review in accordance with paragraph (b)(1) of this section is subject to
the financial liability protections under paragraph (f) of this section,
as applicable.
(5) When an enrollee does not request an immediate QIO review in
accordance with paragraph (b) of this section, he or she may request
expedited reconsideration by the MA organization as described in Sec.
422.584, but the financial liability rules of paragraph (f) of this
section do not apply.
(c) Burden of proof. When an enrollee (or his or her representative,
if applicable) requests an immediate review by a QIO, the burden of
proof rests with the MA organization to demonstrate that discharge is
the correct decision, either on the basis of medical necessity, or based
on other Medicare coverage policies. Consistent with paragraph (e)(2) of
this section, the MA organization should supply any and all information
that a QIO requires to sustain the organization's discharge
determination.
(d) Procedures the QIO must follow. (1) When the QIO receives the
enrollee's request for an immediate review under paragraph (b), the QIO
must notify the MA organization and the hospital that the enrollee has
filed a request for an immediate review.
(2) The QIO determines whether the hospital delivered valid notice
consistent with Sec. 422.620(b)(3).
(3) The QIO examines the medical and other records that pertain to
the services in dispute.
[[Page 363]]
(4) The QIO must solicit the views of the enrollee (or his or her
representative) who requested the immediate QIO review.
(5) The QIO must provide an opportunity for the MA organization to
explain why the discharge is appropriate.
(6) When the enrollee requests an immediate QIO review in accordance
with paragraph (b)(1) of this section, the QIO must make a determination
and notify the enrollee, the hospital, the MA organization, and the
physician of its determination within one calendar day after it receives
all requested pertinent information.
(7) If the QIO does not receive the information needed to sustain an
MA organization's decision to discharge, it may make its determination
based on the evidence at hand, or it may defer a decision until it
receives the necessary information. If this delay results in extended
Medicare coverage of an individual's hospital services, the MA
organization may be held financially liable for these services, as
determined by the QIO.
(8) When the QIO issues its determination, the QIO must notify the
enrollee, the MA organization, the physician, and hospital of its
decision by telephone, followed by a written notice that must include
the following information:
(i) The basis for the determination.
(ii) A detailed rationale for the determination.
(iii) An explanation of the Medicare payment consequences of the
determination and the date an enrollee becomes fully liable for the
services.
(iv) Information about the enrollee's right to a reconsideration of
the QIO's determination as set forth in Sec. 422.626(f), including how
to request a reconsideration and the time period for doing so.
(e) Responsibilities of the MA organization and hospital. (1) When
the QIO notifies an MA organization that an enrollee has requested an
immediate QIO review, the MA organization must, directly or by
delegation, deliver a detailed notice to the enrollee as soon as
possible, but no later than noon of the day after the QIO's
notification. The detailed notice must include the following
information:
(i) A detailed explanation of why services are either no longer
reasonable and necessary or are no longer covered.
(ii) A description of any applicable Medicare coverage rule,
instruction, or other Medicare policy including information about how
the enrollee may obtain a copy of the Medicare policy from the MA
organization.
(iii) Any applicable MA organization policy, contract provision, or
rationale upon which the discharge determination was based.
(iv) Facts specific to the enrollee and relevant to the coverage
determination sufficient to advise the enrollee of the applicability of
the coverage rule or policy to the enrollee's case.
(v) Any other information required by CMS.
(2) Upon notification by the QIO of a request for an immediate
review, the MA organization must supply any and all information,
including a copy of the notices sent to the enrollee, as specified in
Sec. 422.620(b) and (c) and paragraph (e)(1) of this section, that the
QIO needs to decide on the determination. The MA organization must
supply this information as soon as possible, but no later than noon of
the day after the QIO notifies the MA organization that a request for an
expedited determination has been received from the enrollee. The MA
organization must make the information available by phone (with a
written record made of any information not transmitted initially in
writing) and/or in writing, as determined by the QIO.
(3) In response to a request from the MA organization, the hospital
must supply all information that the QIO needs to make its
determination, including a copy of the notices required as specified in
Sec. 422.620(b) and (c) and paragraph (e)(1) of this section. The
hospital must furnish this information as soon as possible, but no later
than by close of business of the day the MA organization notifies the
hospital of the request for information. At the discretion of the QIO,
the hospital must make the information available by phone or in writing
(with a written record of any information not transmitted initially in
writing).
[[Page 364]]
(4) Upon an enrollee's request, the MA organization must provide the
enrollee a copy of, or access to, any documentation sent to the QIO by
the MA organization, including written records of any information
provided by telephone. The MA organization may charge the enrollee a
reasonable amount to cover the costs of duplicating the documentation
for the enrollee and/or delivering the documentation to the enrollee.
The MA organization must accommodate such a request by no later than
close of business of the first day after the day the material is
requested.
(f) Coverage during QIO expedited review. (1) An MA organization is
financially responsible for coverage of services as provided in this
paragraph, regardless of whether it has delegated responsibility for
authorizing coverage or discharge determinations to its providers.
(2) When the MA organization determines that hospital services are
not, or are no longer, covered,
(i) If the MA organization authorized coverage of the inpatient
admission directly or by delegation (or the admission constitutes
emergency or urgently needed care, as described in Sec. 422.2 and Sec.
422.112(c)), the MA organization continues to be financially responsible
for the costs of the hospital stay when an appeal is filed under
paragraph (a)(1) of this section until noon of the day after the QIO
notifies the enrollee of its review determination, except as provided in
paragraph (b)(5) of this section. If coverage of the hospital admission
was never approved by the MA organization or the admission does not
constitute emergency or urgently needed care as described in Sec. 422.2
and Sec. 422.112(c), the MA organization is liable for the hospital
costs only if it is determined on appeal that the hospital stay should
have been covered under the MA plan.
(ii) The hospital may not charge the MA organization (or the
enrollee) if--
(A) It was the hospital (acting on behalf of the enrollee) that
filed the request for immediate QIO review; and
(B) The QIO upholds the non-coverage determination made by the MA
organization.
(3) If the QIO determines that the enrollee still requires inpatient
hospital care, the MA organization must provide the enrollee with a
notice consistent with Sec. 422.620(c) when the hospital or MA
organization once again determines that the enrollee no longer requires
acute inpatient hospital care.
(4) If the hospital determines that inpatient hospital services are
no longer necessary, the hospital may not charge the enrollee for
inpatient services received before noon of the day after the QIO
notifies the enrollee of its review determination.
(g) Effect of an expedited QIO determination. The QIO determination
is binding upon the enrollee, physician, hospital, and MA organization
except in the following circumstances:
(1) Right to request a reconsideration. If the enrollee is still an
inpatient in the hospital and is dissatisfied with the determination, he
or she may request a reconsideration according to the procedures
described in Sec. 422.626(f).
(2) Right to pursue the standard appeal process. If the enrollee is
no longer an inpatient in the hospital and is dissatisfied with this
determination, the enrollee may appeal to an ALJ, the MAC, or a federal
court, as provided for under this subpart.
[71 FR 68723, Nov. 27, 2006]
Sec. 422.624 Notifying enrollees of termination of provider services.
(a) Applicability. (1) For purposes of Sec. Sec. 422.624 and
422.626, the term provider includes home health agencies (HHAs), skilled
nursing facilities (SNFs), and comprehensive outpatient rehabilitation
facilities (CORFs).
(2) Termination of service defined. For purposes of this section and
Sec. 422.626, a termination of service is the discharge of an enrollee
from covered provider services, or discontinuation of covered provider
services, when the enrollee has been authorized by the MA organization,
either directly or by delegation, to receive an ongoing course of
treatment from that provider. Termination includes cessation of coverage
at the end of a course of treatment preauthorized in a discrete
increment, regardless of whether the enrollee agrees that such services
should end.
(b) Advance written notification of termination. Prior to any
termination of service, the provider of the service
[[Page 365]]
must deliver valid written notice to the enrollee of the MA
organization's decision to terminate services. The provider must use a
standardized notice, required by the Secretary, in accordance with the
following procedures--
(1) Timing of notice. The provider must notify the enrollee of the
MA organization's decision to terminate covered services no later than
two days before the proposed end of the services. If the enrollee's
services are expected to be fewer than two days in duration, the
provider should notify the enrollee at the time of admission to the
provider. If, in a non-institutional setting, the span of time between
services exceeds two days, the notice should be given no later than the
next to last time services are furnished.
(2) Content of the notice. The standardized termination notice must
include the following information:
(i) The date that coverage of services ends.
(ii) The date that the enrollee's financial liability for continued
services begins.
(iii) A description of the enrollee's right to a fast-track appeal
under Sec. 422.626, including information about how to contact an
independent review entity (IRE), an enrollee's right (but not
obligation) to submit evidence showing that services should continue,
and the availability of other MA appeal procedures if the enrollee fails
to meet the deadline for a fast-track IRE appeal.
(iv) The enrollee's right to receive detailed information in
accordance with Sec. 422.626 (e)(1) and (2).
(v) Any other information required by the Secretary.
(c) When delivery of notice is valid. Delivery of the termination
notice is not valid unless--
(1) The enrollee (or the enrollee's authorized representative) has
signed and dated the notice to indicate that he or she has received the
notice and can comprehend its contents; and
(2) The notice is delivered in accordance with paragraph (b)(1) of
this section and contains all the elements described in paragraph (b)(2)
of this section.
(d) Financial liability for failure to deliver valid notice. An MA
organization is financially liable for continued services until 2 days
after the enrollee receives valid notice as specified under paragraph
(c) of this section. An enrollee may waive continuation of services if
he or she agrees with being discharged sooner than 2 days after
receiving the notice.
Effective Date Note: At 68 FR 20349, Apr. 4, 2003, Sec. 422.624 was
added. This section contains information collection and recordkeeping
requirements and will not become effective until approval has been given
by the Office of Management and Budget
Sec. 422.626 Fast-track appeals of service terminations to independent review entities (IREs).
(a) Enrollee's right to a fast-track appeal of an MA organization's
termination decision. An enrollee of an MA organization has a right to a
fast-track appeal of an MA organization's decision to terminate provider
services.
(1) An enrollee who desires a fast-track appeal must submit a
request for an appeal to an IRE under contract with CMS, in writing or
by telephone, by noon of the first day after the day of delivery of the
termination notice. If, due to an emergency, the IRE is closed and
unable to accept the enrollee's request for a fast-track appeal, the
enrollee must file a request by noon of the next day that the IRE is
open for business.
(2) When an enrollee fails to make a timely request to an IRE, he or
she may request an expedited reconsideration by the MA organization as
described in Sec. 422.584.
(3) If, after delivery of the termination notice, an enrollee
chooses to leave a provider or discontinue receipt of covered services
on or before the proposed termination date, the enrollee may not later
assert fast-track IRE appeal rights under this section relative to the
services or expect the services to resume, even if the enrollee requests
an appeal before the discontinuation date in the termination notice.
(b) Coverage of provider services. Coverage of provider services
continues until the date and time designated on
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the termination notice, unless the enrollee appeals and the IRE reverses
the MA organization's decision. If the IRE's decision is delayed because
the MA organization did not timely supply necessary information or
records, the MA organization is liable for the costs of any additional
coverage required by the delayed IRE decision. If the IRE finds that the
enrollee did not receive valid notice, coverage of provider services by
the MA organization continues until at least two days after valid notice
has been received. Continuation of coverage is not required if the IRE
determines that coverage could pose a threat to the enrollee's health or
safety.
(c) Burden of proof. When an enrollee appeals an MA organization's
decision to terminate services to an IRE, the burden of proof rests with
the MA organization to demonstrate that termination of coverage is the
correct decision, either on the basis of medical necessity, or based on
other Medicare coverage policies.
(1) To meet this burden, the MA organization must supply any and all
information that an IRE requires to sustain the MA organization's
termination decision, consistent with paragraph (e) of this section.
(2) The enrollee may submit evidence to be considered by an IRE in
making its decision.
(3) The MA organization or an IRE may require an enrollee to
authorize release to the IRE of his or her medical records, to the
extent that the records are necessary for the MA organization to
demonstrate the correctness of its decision or for an IRE to determine
the appeal.
(d) Procedures an IRE must follow. (1) On the date an IRE receives
the enrollee's request for an appeal, the IRE must immediately notify
the MA organization and the provider that the enrollee has filed a
request for a fast-track appeal, and of the MA organization's
responsibility to submit documentation consistent with paragraph (e)(3)
of this section.
(2) When an enrollee requests a fast-track appeal, the IRE must
determine whether the provider delivered a valid notice of the
termination decision, and whether a detailed notice has been provided,
consistent with paragraph (e)(1) of this section.
(3) The IRE must notify CMS about each case in which it determines
that improper notification occurs.
(4) Before making its decision, the IRE must solicit the enrollee's
views regarding the reason(s) for termination of services as specified
in the detailed written notice provided by the MA organization, or
regarding any other reason that the IRE uses as the basis of its review
determination.
(5) An IRE must make a decision on an appeal and notify the
enrollee, the MA organization, and the provider of services, by close of
business of the day after it receives the information necessary to make
the decision. If the IRE does not receive the information needed to
sustain an MA organization's decision to terminate services, it may make
a decision on the case based on the information at hand, or it may defer
its decision until it receives the necessary information. If the IRE
defers its decision, coverage of the services by the MA organization
would continue until the decision is made, consistent with paragraph (b)
of this section, but no additional termination notice would be required.
(e) Responsibilities of the MA organization. (1) When an IRE
notifies an MA organization that an enrollee has requested a fast-track
appeal, the MA organization must send a detailed notice to the enrollee
by close of business of the day of the IRE's notification. The detailed
termination notice must include the following information:
(i) A specific and detailed explanation why services are either no
longer reasonable and necessary or are no longer covered.
(ii) A description of any applicable Medicare coverage rule,
instruction or other Medicare policy including citations, to the
applicable Medicare policy rules, or the information about how the
enrollee may obtain a copy of the Medicare policy from the MA
organization.
(iii) Any applicable MA organization policy, contract provision, or
rationale upon which the termination decision was based.
(iv) Facts specific to the enrollee and relevant to the coverage
determination
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that are sufficient to advise the enrollee of the applicability of the
coverage rule or policy to the enrollee's case.
(v) Any other information required by CMS.
(2) Upon an enrollee's request, the MA organization must provide the
enrollee a copy of, or access to, any documentation sent to the IRE by
the MA organization, including records of any information provided by
telephone. The MA organization may charge the enrollee a reasonable
amount to cover the costs of duplicating the information for the
enrollee and/or delivering the documentation to the enrollee. The MA
organization must accommodate such a request by no later than close of
business of the first day after the day the material is requested.
(3) Upon notification by the IRE of a fast-track appeal, the MA
organization must supply any and all information, including a copy of
the notice sent to the enrollee, that the IRE needs to decide on the
appeal. The MA organization must supply this information as soon as
possible, but no later than by close of business of the day that the IRE
notifies the MA organization that an appeal has been received from the
enrollee. The MA organization must make the information available by
phone (with a written record made of what is transmitted in this manner)
and/or in writing, as determined by the IRE.
(4) An MA organization is financially responsible for coverage of
services as provided in paragraph (b) of this section, regardless of
whether it has delegated responsibility for authorizing coverage or
termination decisions to its providers.
(5) If an IRE reverses an MA organization's termination decision,
the MA organization must provide the enrollee with a new notice
consistent with Sec. 422.624(b).
(f) Reconsiderations of IRE decisions. (1) If the IRE upholds an MA
organization's termination decision in whole or in part, the enrollee
may request, no later than 60 days after notification that the IRE has
upheld the decision that the IRE reconsider its original decision.
(2) The IRE must issue its reconsidered determination as
expeditiously as the enrollee's health condition requires but no later
than within 14 days of receipt of the enrollee's request for a
reconsideration.
(3) If the IRE reaffirms its decision, in whole or in part, the
enrollee may to appeal the IRE's reconsidered determination to an ALJ,
the MAC, or a federal court, as provided for under this subpart.
(4) If on reconsideration the IRE determines that coverage of
provider services should terminate on a given date, the enrollee is
liable for the costs of continued services after that date unless the
IRE's decision is reversed on appeal. If the IRE's decision is reversed
on appeal, the MA organization must reimburse the enrollee, consistent
with the appealed decision, for the costs of any covered services for
which the enrollee has already paid the MA organization or provider.
Effective Date Note: At 68 FR 20349, Apr. 4, 2003, Sec. 422.626 was
added. This section contains information collection and recordkeeping
requirements and will not become effective until approval has been given
by the Office of Management and Budget