SubLM — Health Hippo

Health Hippo: M+C: Subparts LM

Medicare Plus Choice (M+C): Interim Final Rule

Subpart L–Effect of Change of Ownership or Leasing of Facilities During Term of Contract

17. Nomenclature change. Throughout newly designated subpart L,
“HMO or CMP” is revised to read “M+C organization” wherever it
appears.

18. Nomenclature change. Throughout newly designated subpart L,
“HMO’s or CMP’s” are revised to read “M+C organization” and “M+C
organization’s” respectively.

Sec. 422.550 [Amended]

19. In Sec. 422.550, the following changes are made:

a. In paragraph (b), the following sentence is added at the
end: “The M+C organization must also provide updated financial
information and a discussion of the financial and solvency impact
of the change of ownership on the surviving organization.”

b. In paragraphs (c)(2) and (e), “Sec. 417.522” is revised to
read “Sec. 422.552”.

c. In paragraph (d)(2), “subpart L” is revised to read
“subpart K”.

Sec. 422.552 [Amended]

20. In Sec. 422.552, in paragraph (a)(1), the following sentence
is added at the end: “The M+C organization also provides HCFA with
updated financial information and a discussion of the financial and
solvency impact of the change of ownership on the surviving
organization.”

Sec. 422.553 [Amended]

21. In Sec. 422.553, “subpart J” is revised to read “subpart K”.

22. Subparts M through O are added to read as follows:

Subpart M–Grievances, Organization Determinations and Appeals

Sec. 422.560 Basis and scope.
422.561 Definitions.
422.562 General provisions.
422.564 Grievance procedures.
422.566 Organization determinations.
422.568 Standard timeframes and notice requirements for organization determinations.
422.570 Expediting certain organization determinations.
422.572 Timeframes and notice requirements for expedited organization determinations.
422.574 Parties to the organization determination.
422.576 Effect of an organization determination.
422.578 Right to a reconsideration.
422.580 Reconsideration defined.
422.582 Request for a standard reconsideration.
422.584 Expediting certain reconsiderations.
422.586 Opportunity to submit evidence.
422.590 Timeframes and responsibility for reconsiderations.
422.592 Reconsideration by an independent entity.
422.594 Notice of reconsidered determination by the independent entity.
422.596 Effect of a reconsidered determination.
422.600 Right to a hearing.
422.602 Request for an ALJ hearing.
422.608 Departmental Appeals Board review.
422.612 Judicial review.
422.616 Reopening and revising determinations and decisions.
422.618 How an M+C organization must effectuate reconsidered determinations or decisions.
422.620 How M+C organizations must notify enrollees of noncoverage of inpatient hospital care.
422.622 Requesting immediate PRO review of noncoverage of inpatient hospital care.

Subpart N–Medicare Contract Appeals

422.641 Contract determinations.
422.644 Notice of contract determination.
422.646 Effect of contract determination.
422.648 Reconsideration: Applicability.
422.650 Request for reconsideration.
422.652 Opportunity to submit evidence.
422.654 Reconsidered determination.
422.656 Notice of reconsidered determination.
422.658 Effect of reconsidered determination.
422.660 Right to a hearing.
422.662 Request for hearing.
422.664 Postponement of effective date of contract determination when a request for a hearing with respect to a contract determination is filed timely.
422.666 Designation of hearing officer.
422.668 Disqualification of hearing officer.
422.670 Time and place of hearing.
422.672 Appointment of representatives.
422.674 Authority of representatives.
422.676 Conduct of hearing.
422.678 Evidence.
422.680 Witnesses.
422.682 Discovery.
422.684 Prehearing.
422.686 Record of hearing.
422.688 Authority of hearing officer.
422.690 Notice and effect of hearing decision.
422.692 Review by the Administrator.
422.694 Effect of Administrator’s decision.
422.696 Reopening of contract or reconsidered determination or decision of a hearing officer or the Administrator.
422.698 Effect of revised determination.

Subpart O–Intermediate Sanctions

422.750 Kinds of sanctions.
422.752 Basis for imposing sanctions.
422.756 Procedures for imposing sanctions.
422.758 Maximum amount of civil money penalties imposed by HCFA.
422.760 Other applicable provisions. [[Page 35107]]

Subpart M–Grievances, Organization Determinations and
Appeals

Sec. 422.560 Basis and scope.

(a) Statutory basis. (1) Section
1852(f) of the Act provides that an M+C organization must establish
meaningful grievance procedures. (2) Section 1852(g) of the Act
establishes requirements that an M+C organization must meet
concerning organization determinations and appeals.

(b) Scope. This subpart sets forth–
(1) Requirements for M+C organizations with respect to grievance
procedures, organization determinations, and appeal procedures. (2)
The rights of M+C 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 M+C enrollee requests immediate PRO review
of a determination that he or she no longer needs inpatient hospital
care.

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
an enrollee is entitled to receive or any amounts the enrollee
must pay for a service, as defined under Sec. 422.566(b). These
procedures include reconsiderations by the M+C organization, and
if necessary, an independent review entity, hearings before ALJs,
review by the Departmental Appeals Board (DAB), and judicial
review.
Authorized representative means an individual authorized by an
enrollee to act on his or her behalf in obtaining an organization
determination or in dealing with any of the levels of the appeal
process, subject to the rules described in 20 CFR part 404,
subpart R, unless otherwise stated in this subpart.
Enrollee means an M+C eligible individual who has elected an
M+C plan offered by an M+C organization, or his or her authorized
representative.
Grievance means any complaint or dispute other than one
involving an organization determination, as defined in Sec.
422.566(b).
Physician has the meaning given the term in section 1861(r) of
the Act.

Sec. 422.562 General provisions.

(a) Responsibilities of the M+C
organization. (1) An M+C organization, with respect to each
M+C 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; and (iii)
Appeal procedures that meet the requirements of this subpart for
issues that involve organization determinations; and (2) An M+C
organization must ensure that all enrollees receive written
information about the– (i) Grievance and appeal procedures that are
available to them through the M+C organization; and (ii) Complaint
process available to the enrollee under the PRO process as set forth
under section 1154(a)(14) of the Act. (3) In accordance with subpart
K of this part, if the M+C organization delegates any of its
responsibilities under this subpart to another entity or individual
through which the organization provides health care services, the M+C
organization is ultimately responsible for ensuring that the entity
or individual satisfies the relevant requirements of this subpart.

(b) Rights of M+C 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 M+C 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 M+C 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 M+C 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 HCFA, as provided in Sec. 422.592. (iv) The
right to an ALJ hearing if the amount in controversy is $100 or more,
as provided in Sec. 422.600. (v) The right to request DAB 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 $1000 or more, as provided in Sec. 422.612.

(c) Limits on when this subpart applies.
(1) If an enrollee receives immediate PRO 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 M+C organization; and (ii) The PRO review decision is
subject only to the appeal procedures set forth in part 473 of this
chapter. (2) If an enrollee has no further liability to pay for
services that were furnished by an M+C organization, a determination
regarding these services is not subject to appeal.

(d) When other regulations apply.
Unless this subpart provides otherwise, the regulations in 20
CFR, part 404, subparts J and R (covering, respectively, the
administrative review and hearing process and representation of
parties under title II of the Act), apply under this subpart to the
extent they are appropriate.

Sec. 422.564 Grievance procedures.

(a) General rules. (1) Each M+C
organization must provide meaningful procedures for timely hearing
and resolution of grievances between enrollees and the organization
or any other entity or individual through which the organization
provides health care services under any M+C plan it offers. (2)
Grievance procedures must meet any guidelines established by HCFA.

(b) Distinguished from organization
determinations and appeals. Grievance procedures are separate
and distinct from organization determinations and appeal procedures,
which address organization determinations.

(c) Distinguished from the PRO complaint
process. Under section 1154(a)(14) of the Act, the PRO 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 M+C
organization.

Sec. 422.566 Organization determinations.

(a) Responsibilities of the M+C organization. Each M+C
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
M+C 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 M+C
organization must have a [[Page 35108]] 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 Secs. 422.570 and
422.572.

(b) Actions that are organization
determinations. An organization determination is any
determination made by an M+C organization with respect to any of the
following: (1) Payment for emergency services, post-stabilization
care, or urgently needed services. (2) Payment for any other health
services furnished by a provider other than the M+C 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 M+C organization. (3) The M+C organization’s
refusal to provide services that the enrollee believes should be
furnished or arranged for by the M+C organization when the enrollee
has not received the services outside the M+C organization. (4)
Discontinuation of a service, if the enrollee disagrees with the
determination that the service is no longer medically necessary.

(c) Who can request an organization
determination. Any of the parties listed in Sec. 422.574 can
request an organization determination, with the exception that only
the parties listed in Sec. 422.570(a) can request an expedited
determination.

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
M+C 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 M+C
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 M+C
organization’s decision to deny). The M+C 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.

(b) Timeframe for requests for
payment. The M+C organization must process requests for
payment according to the “prompt payment” provisions set forth in
Sec. 422.520.

(c) Written notification for denials.
If an M+C organization decides to deny service or payment in
whole or in part, it must give the enrollee written notice of the
determination.

(d) Content of the notice. The notice
of any denial under paragraph (c) of this section must– (1) State
the specific reasons for the denial in understandable language; (2)
Inform the enrollee of his or her right to a reconsideration; (3)
Describe both the standard and expedited reconsideration processes,
including the enrollee’s right to and conditions for obtaining an
expedited reconsideration for service requests, and the rest of the
appeal process; and (4) Comply with any other requirements specified
by HCFA.

(e) Effect of failure to provide timely
notice. If the M+C 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.

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 M+C organization) may
request that an M+C 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.)

(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 M+C organization
or, if applicable, to the entity responsible for making the
determination, as directed by the M+C organization. (2) A physician
may provide oral or written support for a request for an expedited
determination.

(c) How the M+C organization must process
requests. The M+C 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 M+C 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 M+C 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 M+C 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
M+C 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 M+C
organization receives the request for expedited determination. (2)
Give the enrollee prompt oral notice of the denial and follow up,
within 2 working days, with a written letter that– (i) Explains that
the M+C organization will process the request using the 14-day
timeframe for standard determinations; (ii) Informs the enrollee of
the right to file a grievance if he or she disagrees with the M+C
organization’s decision not to expedite; and (iii) Provides
instructions about the grievance process and its timeframes.

(e) Action on accepted request for expedited
determination. If an M+C 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 M+C 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.

Sec. 422.572 Timeframes and notice requirements for expedited
organization determinations.

(a) Timeframe. Except as provided in
paragraph (b) of this section, an M+C 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 [[Page 35109]] 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 M+C 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 M+C organization’s
decision to deny). The M+C 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 M+C organization first notifies an enrollee of its expedited
determination orally, it must mail written confirmation to the
enrollee within 2 working days of the oral notification.

(d) How information from noncontract
providers affects timeframes for expedited determinations. If
an M+C organization must receive medical information from noncontract
providers, the 72-hour period begins when the organization receives
that information. Noncontract providers must make reasonable and
diligent efforts to expeditiously gather and forward all necessary
information in order to receive timely payment.

(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 HCFA.

(f) Effect of failure to provide a timely
notice. If the M+C organization fails to provide the enrollee
with timely notice of an expedited organization determination as
specified in this section, this failure itself constitutes an adverse
organization determination and may be appealed.

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);

(d) Any other provider or entity (other than the M+C 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 Secs. 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 M+C organization or HCFA
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 filing a written request
with– (1) The M+C organization that made the organization
determination; (2) An SSA office; or (3) In the case of a qualified
railroad retirement beneficiary, an RRB office.

(b) Timeframe for filing a request.
Except as provided in paragraph (c) of this section, a party
must file a request for a reconsideration within 60 calendar days
from the date of the notice of the organization determination. If the
SSA or RRB receives a request, it forwards the request to the M+C
organization for its reconsideration. The timeframe within which the
organization must conduct its review begins when it receives the
request.

(c) Extending the time for filing a
request. (1) General rule. If a party shows good cause, the
M+C 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 a reconsideration has
expired, a party to the organization determination may file a request
for reconsideration with the M+C organization, SSA, or an RRB office.
If SSA or RRB receives a request, it forwards the request to the M+C
organization for its reconsideration. 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 M+C 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.

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 M+C organization) may
request that an M+C organization 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.) A physician that requests an expedited reconsideration must
be acting on behalf of the enrollee as an authorized representative.

(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 M+C organization or, if applicable, to the entity
responsible for making the reconsideration, as directed by the M+C
organization. (2) A physician may provide oral or written support for
a request for an expedited reconsideration.

(c) How the M+C organization must process
requests. The M+C organization must establish and maintain the
[[Page 35110]] following procedures for processing requests for
expedited reconsiderations: (1) Handling of requests. The M+C
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 M+C 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
M+C 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
M+C 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 M+C organization receives the request for
expedited reconsideration. (2) Give the enrollee prompt oral notice,
and follow up, within 2 working days, with a written letter that–
(i) Explains that the M+C 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; and
(iii) Provides instructions about the grievance process and its
timeframes.

(e) Action following acceptance of a
request. If an M+C organization grants a request for expedited
reconsideration, it must conduct the reconsideration and give notice
in accordance with Sec. 422.590(d).

Sec. 422.586 Opportunity to submit evidence.

The M+C 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 M+C
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 M+C organization makes a reconsidered
determination that is completely favorable to the enrollee, the M+C
organization must issue 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
M+C 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 M+C
organization’s decision to deny). For extensions, the M+C
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 M+C
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 HCFA 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 M+C organization makes a reconsidered
determination that is completely favorable to the enrollee, the M+C
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 M+C 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 HCFA 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 M+C 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 M+C 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
M+C 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 M+C 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 M+C organization’s decision to deny). The M+C 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
M+C organization first notifies an enrollee orally of a completely
favorable expedited reconsideration, it must mail written
confirmation to the enrollee within 2 working days. (4) How
information from noncontract providers affects timeframes for
expedited reconsiderations. If the M+C organization must receive
medical information from noncontract providers, the 72-hour period
begins when the [[Page 35111]] organization receives the information.
Noncontract providers must make reasonable and diligent efforts to
expeditiously gather and forward all necessary information in order
to receive timely payment. (5) Affirmation of an adverse expedited
organization determination. If, as a result of its reconsideration,
the M+C organization affirms, in whole or in part, its adverse
expedited organization determination, the M+C organization must
submit a written explanation and the case file to the independent
entity contracted by HCFA 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
M+C 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 M+C 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 M+C 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 M+C organization’s
denial of coverage based on a lack 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.

Sec. 422.592 Reconsideration by an independent entity.

(a) When the M+C 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 HCFA.

(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 M+C organization’s
reconsideration, with the addition of the M+C
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
HCFA.

(b) Content of the notice. The notice
must– (1) State the specific reasons for the entity’s decisions; (2)
If the reconsidered determination is adverse (that is, does not
completely reverse the M+C organization’s adverse organization
determination), inform the parties of their right to an ALJ 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
HCFA.

Sec. 422.596 Effect of a reconsidered determination.

A reconsidered determination is final and binding on all parties
unless a party files a request for a hearing under the provisions of
Sec. 422.602, or unless the reconsidered determination is revised
under Sec. 422.616.

Sec. 422.600 Right to a hearing.

(a) If the amount remaining in controversy is $100 or more, any
party to the reconsideration (except the M+C organization) who is
dissatisfied with the reconsidered determination has a right to a
hearing before an ALJ. The M+C organization does not have the right
to request 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 Sec. 405.740 of this chapter for Part A services and Sec.
405.817 of this chapter for Part B services.

(c) If the basis for the appeal is the M+C organization’s refusal
to provide services, HCFA uses the projected value of those services
to compute the amount remaining in controversy.

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 at one of
the places listed in Sec. 422.582(a) or with the independent, outside
entity. The organizations listed in Sec. 422.582(a) forward the
request to the independent, outside entity, which is responsible for
transferring the case to the appropriate ALJ hearing office.

(b) When to file a request. Except
when an ALJ extends the timeframe as provided in 20 CFR 404.933(c), a
party must file a request for a hearing within 60 days of the date of
the notice of a reconsidered determination.

(c) Parties to a hearing. The parties
to a hearing are the parties to the reconsideration, the M+C
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) When the amount in controversy is less
than $100. (1) If a request for a hearing clearly shows that
the amount in controversy is less than $100, the ALJ dismisses the
request. (2) If, after a hearing is initiated, the ALJ finds that the
amount in controversy is less than $100, he or she discontinues the
hearing and does not rule on the substantive issues raised in the
appeal.

Sec. 422.608 Departmental Appeals Board (DAB) review.

Any party to the hearing, including the M+C organization, who is
dissatisfied with the ALJ hearing decision, may request that the DAB
review the ALJ’s decision or dismissal. Regulations located at 20 CFR
404.967 through 404.984 regarding SSA Appeals Council Review apply to
DAB review for matters addressed by this subpart.

Sec. 422.612 Judicial review.

(a) Review of ALJ’s decision. Any
party, including the M+C organization, may request judicial review
(upon notifying the other parties) of an ALJ’s decision if– (1) The
DAB denied the party’s request for review; and (2) The amount in
controversy is $1,000 or more.

(b) Review of DAB decision. Any
party, including the M+C organization, may request judicial review
(upon notifying the other parties) of the DAB decision if– (1) It is
the final decision of HCFA; and (2) The amount in controversy is
$1,000 or more.

(c) How to request judicial review. A
party must file a civil action in a district court of the United
States in accordance with section 205(g) of the Act (see 20 CFR
422.210 for a description of the procedures to follow in requesting
judicial review).

Sec. 422.616 Reopening and revising determinations and
decisions.

(a) An organization or reconsidered determination made by an M+C
[[Page 35112]] organization, a reconsidered determination made by the
independent entity described in Sec. 422.592, or the decision of an
ALJ or the DAB that is otherwise final and binding may be reopened
and revised by the entity that made the determination or decision,
under the rules in Sec. 405.750 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 M+C
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.

Sec. 422.618 How an M+C organization must effectuate
reconsidered determinations or decisions.

(a) Reversals by the M+C
organization–(1) Requests for service. If, on reconsideration
of a request for service, the M+C 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 M+C 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 M+C organization
completely reverses its organization determination, the organization
must pay for the service no later than 60 calendar days after the
date the M+C organization receives the request for reconsideration.

(b) Reversals other than by the M+C
organization. If the M+C organization’s organization
determination is reversed in whole or in part by the independent
outside entity or at a higher level of appeal, the M+C 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 organization determination. The M+C organization must
also inform the independent, outside entity that the organization has
effectuated the decision.

Sec. 422.620 How M+C organizations must notify enrollees of
noncoverage of inpatient hospital care.

(a) Enrollee’s entitlement. Where an
M+C organization has authorized coverage of the inpatient admission
of an enrollee, either directly or by delegation (or the admission
constitutes emergency or urgently needed care, as described in Secs.
422.2 and 422.112(b)), the enrollee remains entitled to inpatient
hospital care until he or she receives notice of noncoverage of that
care.

(b) Physician concurrence required.
Before the M+C organization gives notice of noncoverage as
described in paragraph (c) of this section, the physician who is
responsible for the enrollee’s hospital care must concur.

(c) Notice to the enrollee. The M+C
organization must give the enrollee written notice that includes the
following: (1) The reason why inpatient hospital care is no longer
needed. (2) The effective date of the enrollee’s liability for
continued inpatient care. (3) The enrollee’s appeal rights. (4)
Comply with any other requirements specified by HCFA.

(d) Physician concurrence when a hospital
determines if care is necessary. If the M+C organization
allows the hospital to determine whether inpatient care is necessary,
the hospital obtains the concurrence of the contracting physician
responsible for the enrollee’s hospital care or of another physician
as authorized by the M+C organization, and notifies the enrollee,
following the procedures set forth in Sec. 412.42(c)(3) of this
chapter.

Sec. 422.622 Requesting immediate PRO review of noncoverage of
inpatient hospital care.

(a) Enrollee’s right to review or
reconsideration. (1) An enrollee who wishes to appeal a
determination by an M+C organization or hospital that inpatient care
is no longer necessary must request immediate PRO review of the
determination in accordance with paragraph (b) of this section. An
enrollee who requests immediate PRO review may remain in the hospital
with no additional financial liability as specified in paragraph (c)
of this section. (2) An enrollee who fails to request immediate PRO
review in accordance with the procedures in paragraph (b) of this
section may request expedited reconsideration by the M+C organization
as described in Sec. 422.584, but the financial liability rules of
paragraph (c) of this section do not apply.

(b) Procedures enrollee must follow.
For the immediate PRO review process, the following rules apply: (1)
The enrollee must submit the request for immediate review– (i) To
the PRO that has an agreement with the hospital under Sec. 466.78 of
this chapter; (ii) In writing or by telephone; and (iii) By noon of
the first working day after he or she receives written notice that
the M+C organization or hospital has determined that the hospital
stay is no longer necessary. (2) On the date it receives the
enrollee’s request, the PRO must notify the M+C organization that the
enrollee has filed a request for immediate review. (3) The M+C
organization must supply any information that the PRO requires to
conduct its review and must make it available, by phone or in
writing, by the close of business of the first full working day
immediately following the day the enrollee submits the request for
review. (4) In response to a request from the M+C organization, the
hospital must submit medical records and other pertinent information
to the PRO by close of business of the first full working day
immediately following the day the organization makes its request. (5)
The PRO must solicit the views of the enrollee who requested the
immediate PRO review. (6) The PRO must make a determination and
notify the enrollee, the hospital, and the M+C organization by close
of business of the first working day after it receives all necessary
information from the hospital, or the organization, or both.

(c) Liability for hospital costs–(1)
When the M+C organization determines that hospital services are not,
or are no longer, covered. (i) Except as provided in paragraph
(c)(1)(ii) of this section, if the M+C organization authorized
coverage of the inpatient admission directly or by delegation (or the
admission constitutes emergency or urgently needed care, as described
in Secs. 422.2 and 422.112(b)), the organization continues to be
financially responsible for the costs of the hospital stay when a
timely appeal is filed under paragraph (a)(1) of this section until
noon of the calendar day following the day the PRO notifies the
enrollee of its review determination. If coverage of the hospital
admission was never approved by the M+C organization (or the
admission does not constitute emergency or urgently needed care, as
described in Secs. 422.2 and 422.112(b)), the M+C organization is
liable for the hospital costs only if it is determined on appeal that
the hospital stay should have been covered under the M+C plan. (ii)
The hospital may not charge the M+C organization (or the enrollee)
if– [[Page 35113]] (A) It was the hospital (acting on behalf of the
enrollee) that filed the request for immediate PRO review; and (B)
The PRO upholds the noncoverage determination made by the M+C
organization. (2) When the hospital determines that hospital services
are no longer required. If the hospital determines that inpatient
hospital services are no longer necessary, and the enrollee could not
reasonably be expected to know that the services would not be
covered, the hospital may not charge the enrollee for inpatient
services received before noon of the calendar day following the day
the PRO notifies the enrollee of its review determination.