[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Rules and Regulations]
[Page 16651-16669]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-14]
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Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 422 and 489
Medicare Program; Improvements to the Medicare+Choice Appeal and
Grievance Procedures; Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
42 CFR Parts 422 and 489
[CMS-4024-FC]
RIN 0938-AK48
Medicare Program; Improvements to the Medicare+Choice Appeal and
Grievance Procedures
AGENCY: The Centers for Medicare & Medicaid Services, HHS.
ACTION: Final rule with comment period.
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SUMMARY: This final rule with comment period responds to comments on
the January 24, 2001, proposed rule regarding improvements to the
Medicare+Choice (M+C) appeal and grievance procedures. It establishes
new notice and appeal procedures for enrollees when an M+C organization
decides to terminate coverage of provider services. The January 24,
2001 proposed rule was published as a required element of an agreement
entered into between the parties in Grijalva v. Shalala, civ. 93-711
(U.S.D.C. Az.), to settle a class action lawsuit.
This rule also specifies a Medicare-participating hospital's
responsibility for issuing discharge or termination notices under both
the original Medicare and M+C programs, amends the Medicare provider
agreement regulations with regard to beneficiary notification
requirements, and amends M+C enrollee grievance procedures.
DATES: Effective date: Except for Sec. Sec. 422.564, 422.620, 422.624,
and 422.626, which are subject to the Paperwork Reduction Act (PRA),
this final rule with comment period is effective May 5, 2003. We will
publish the effective dates of those sections of the rule that are
subject to the PRA in the Federal Register when the sections have been
approved by the Office of Management and Budget.
Comment date: We will consider comments on this final rule if
received at the appropriate address, as provided below, no later than 5
p.m. on June 3, 2003.
ADDRESSES: Mail written comments (one original and three copies) to the
following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-4024-FC, P.O.
Box 8013, Baltimore, MD 21244-8013. To insure that mailed comments are
received in time for us to consider them, please allow for possible
delays in delivering them.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses: Room 443G, Hubert H.
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201,
or Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-8013.
Comments mailed to the above addresses may be delayed and received
too late for us to consider them.
Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code CMS-4024-FC. Comments received timely will be available
for public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 443-G of
the Department's office at 200 Independence Avenue, SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Chris Gayhead, (410) 786-6429 (for
issues concerning improvements to the M+C appeals and grievance
procedures); Rhonda Greene Bruce, (410) 786-7579 (for issues related to
hospital discharge notices).
I. Background
A. Balanced Budget Act of 1997
Section 4001 of the Balanced Budget Act of 1997, (BBA) (Pub. L.
105-33), enacted August 5, 1997, added sections 1851 through 1859 to
the Social Security Act (the Act) to establish a new Part C of the
Medicare program, known as the ``Medicare+Choice (M+C) Program.''
Implementing regulations for the M+C program are set forth in 42 CFR
part 422. Subpart M of part 422 implements sections 1852(f) and (g),
which set forth the procedures M+C organizations must follow with
respect to grievances, organization determinations, and
reconsiderations and other appeals. Under section 1852(f) of the Act,
an M+C organization must provide meaningful procedures for hearing and
resolving grievances between the organization (including any other
entity or individual through which the organization provides health
care services) and enrollees in its M+C plans.
Section 1852(g) of the Act addresses the procedural requirements
concerning coverage determinations (called ``organization
determinations'') and reconsiderations and other appeals of such
determinations. In general, organization determinations involve the
question of whether an enrollee is entitled to receive, or should
continue to receive, a health service, and the amount the enrollee is
expected to pay for the service. An organization determination may also
involve an enrollee's request for reimbursement for services obtained
with or without prior authorization. Only disputes concerning
organization determinations are subject to the reconsideration and
other appeal requirements under section 1852(g) of the Act. All other
disputes are subject to the grievance requirements under section
1852(f) of the Act. For purposes of this final rule, a reconsideration
consists of a review of an adverse organization determination (a
decision that is unfavorable to the M+C enrollee, in whole or in part)
by either the M+C organization or an independent review entity (IRE) or
entities. We use the term ``appeal'' to denote any of the procedures
that deal with the reviews of organization determinations, including
reconsiderations, hearings before administrative law judges (ALJs),
reviews by the Medicare Appeals Council (MAC) and judicial review.
B. Grijalva v. Shalala
Grijalva v. Shalala is a 1993 class action lawsuit brought by
beneficiaries enrolled in Medicare risk-based managed care
organizations. The plaintiffs challenged the adequacy of the managed
care appeals process and claimed that CMS failed to assure that
contracting managed care organizations afforded enrollees rights to
which plaintiffs contended enrollees were entitled when the
organization denied, reduced, or terminated health care coverage.
The Secretary and the plaintiffs reached a settlement agreement in
the case, which the Arizona District Court approved on December 4,
2000. Under the settlement agreement, we agreed to publish a notice of
proposed rulemaking (NPRM) proposing regulations that would establish
new notice and appeal procedures when an M+C organization decides to
terminate coverage of provider services to an enrollee. Providers that
would be affected under the proposed rules published pursuant to the
settlement agreement included skilled nursing facilities (SNFs), home
health agencies (HHAs) and comprehensive outpatient rehabilitation
facilities (CORFs). A key element of the agreement was that CMS would
propose to establish an independent review entity to conduct fast-track
reviews of appeals of decisions to terminate services. Under the
proposed process, M+C enrollees would receive detailed written notices
concerning their service
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terminations and their appeal rights at least four days before a
service termination. The proposed appeal process would be carried out
during those four days. (See our January 24, 2001, proposed rule, 66 FR
7594, for a more detailed description of the settlement agreement.)
The settlement agreement contained a great deal of specificity with
respect to both the notice and appeal procedures to be set forth in the
proposed rule, and the timeframes for publication of proposed and final
rules. However, consistent with Administrative Procedure Act (APA)
standards for notice and comment rulemaking, the agreement explicitly
established that publication of the proposed requirements ``[should]
not be construed as a promise or predetermination regarding the content
of [the] final rule * * * on notice and appeal procedures for M+C
organization decisions to terminate provider services.''
II. Provisions of the Proposed Rule
On January 24, 2001, we published an NPRM (66 FR 7593) that,
consistent with the settlement agreement, proposed regulations that
would establish that an M+C enrollee who is dissatisfied with an M+C
organization's decision to terminate SNF, HHA, or CORF services would
have the right to a fast-track review by an independent entity. As
described below, the proposed rule set forth the notification and
appeals procedures for implementing this new appeal right. The proposed
rule also addressed the notification procedures associated with similar
appeal rights available to Medicare beneficiaries receiving inpatient
hospital services as well as M+C beneficiary grievance procedures.
A. Proposed Notice and Appeal Procedures
We proposed that for any termination of services furnished by one
of the affected types of providers, the enrollee would receive a
standardized notice informing them of the M+C organization's decision
to terminate the services. Under our proposal, the provider would be
charged with the delivery of the notice four calendar days before the
scheduled termination. If the services were expected to be furnished to
an enrollee for a time span of fewer than four calendar days in
duration, the enrollee would be given the notice upon admission. Valid
delivery of the notice required the enrollee to sign the notice to
indicate that he or she had received the notice and could comprehend
it.
We proposed that the termination notice contain the following
information:
A specific and detailed explanation why services were either no
longer medically necessary or were no longer covered (with a
description of any applicable Medicare coverage rule).
Any applicable M+C organization policy, contract provision, or
rationale upon which the termination decision was based.
Specific, relevant information to an extent sufficient to advise
the enrollee of how a Medicare or M+C organization policy applied to
the enrollee's case, as well as the date and time that the
organization's coverage of services would end (and the enrollee's
liability would begin).
A description of the enrollee's fast-track appeal rights, including
how to contact the IRE to initiate an appeal, as well as the
availability of other M+C appeal procedures if the enrollee failed to
meet the deadline for (or decided not to pursue) a fast-track IRE
appeal.
Under our proposal, an enrollee who wanted to appeal a termination
decision to the IRE needed to contact the IRE by noon of the first
calendar day after receiving the termination notice. We specified that
an enrollee who timely sought IRE review would be protected from
liability for the costs of services during the fast-track appeals
process. Coverage of provider services would continue until noon of the
day after an enrollee received notice of an IRE's decision upholding
the M+C organization's determination, or until the time and date
designated on the termination notice, whichever was later.
We proposed that when an enrollee appealed an M+C organization's
decision to terminate provider services, the burden was on the M+C
organization to prove that the termination was the correct decision.
The M+C organization would be required to supply any information that
the IRE required to sustain the termination decision, including a copy
of the termination notice. The M+C organization would be required to
supply this information as soon as possible, but no later than the
close of business of the first day after the day the IRE notified the
M+C organization that the enrollee had requested a review.
Assuming that the IRE received all needed information on a timely
basis, the proposed process would have resulted in a decision by the
close of business on the second full day after the deadline for an
enrollee's appeal request, with the following possible results:
If the IRE decided that services should not be terminated, a new
termination notice would be required, with attendant appeal rights,
before the M+C organization could terminate services.
If the IRE deferred its decision, coverage of the services would
continue until the decision was made but no additional termination
notice would be required.
If the IRE decided to uphold the M+C organization's decision to
discontinue services, coverage of the enrollee's services would end at
noon on the day after the IRE made its decision or as specified in the
termination notice, whichever is later.
In the event that the M+C organization's decision was upheld, the
enrollee would be financially liable for any services provided after
the effective date identified in the notice. The proposed rule outlined
that an enrollee's first recourse after an unfavorable IRE decision
would be to request, within 60 days, that the IRE reconsider its
decision. The IRE would have up to 14 calendar days from the date of
the request for reconsideration to issue its reconsidered
determination, with subsequent appeals possible to an ALJ and the MAC,
consistent with the procedures set forth in the existing M+C
regulations.
B. Hospital Notification Procedures
We also proposed in the January 24, 2001, rule requirements
regarding hospitals' responsibility for issuing discharge notices under
both the original Medicare and the M+C program. Specifically, we
proposed that hospitals be required to provide to all Medicare
beneficiaries (including those enrolled in M+C plans) a notice that
includes the reasons for a discharge and information on their appeal
rights. Under the proposed rule, hospitals would be responsible for
delivering such a notice to each beneficiary the day before the date of
the discharge. We noted that these notices would have to be approved by
the Office of Management and Budget under section 3506(c)(2)(A) of the
Paperwork Reduction Act.
C. Grievance Procedures
The January 2001 rule also proposed to revise the existing
definition of a ``grievance,'' and proposed that an M+C organization be
required to notify the enrollee of its decision as expeditiously as the
case required, but no later than 30 calendar days after the date the
organization received the grievance. In conjunction with this
timeframe, we also proposed that the M+C organization be permitted to
extend the timeframe by
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up to 14 calendar days if the enrollee requested the extension or if
the organization justified a need for additional information and the
delay was in the interest of the enrollee.
Our proposal would require an M+C organization to inform the
enrollee of the disposition of the grievance in writing if the
grievance was submitted in writing. Grievances submitted orally could
under the proposal be responded to either orally or in writing unless a
written response was specifically requested by the M+C enrollee.
We proposed that the M+C organization's written response to a
grievance involving quality of care issues or concerns must describe
the enrollee's right to seek Quality Improvement Organization (QIO)
review. For any complaint involving a QIO, the M+C organization must
cooperate with the QIO in resolving the complaint.
The proposed rule specified that an M+C organization would be
required to expedite a grievance if: (1) The grievance involved an M+C
organization's decision to invoke an extension relating to an
organization determination or reconsideration; (2) the grievance
involved an M+C organization's refusal to grant an enrollee's request
for an expedited organization determination; or (3) applying the
standard timeframe could seriously jeopardize the enrollee's life,
health or ability to regain maximum function. We proposed that the M+C
organization notify the enrollee of its decision on an expedited
grievance within 72 hours of receipt of the enrollee's grievance. The
proposed grievance procedures concluded with the requirement that the
M+C organization have a system to track and maintain records on all
grievances received both orally and in writing, including the final
disposition of the grievance. The tracking system would be required to
maintain, at a minimum, date of receipt, disposition and date the
response was given.
D. Reductions of Service
As part of the Grijalva settlement, we agreed to solicit comments
in the January 2001 rule on how to provide notice and appeal procedures
for decisions by M+C organizations to reduce provider services. We
stated in the January 2001 proposed rule that, based on our review of
this issue, we were considering adopting the position that a written
notice should be required whenever there was a reduction in any
previously authorized ongoing course of treatment. We did not put forth
specific regulatory language to implement this approach, but instead
asked for public comments on the appropriateness of such a requirement
and recommendations on specific regulatory revisions in this regard.
III. Analysis of and Responses to Public Comments
A. Overview of Comments on January 24, 2001 Proposed Rule
We received 33 timely comments from organizations representing
hospitals and other providers, M+C organizations, beneficiary advocacy
groups and others. Commenters representing providers and managed care
organizations uniformly agreed that the new appeals procedures were
unworkable as proposed. They raised a series of objections to the
proposed provisions, with concerns focusing on the following areas:
[sbull] Creation of a fast-track appeals process.
[sbull] Timing of the termination notices.
[sbull] Content and delivery of the notices.
The commenters representing beneficiary groups generally supported the
procedures as proposed and urged CMS to finalize the proposed
provisions. Commenters also expressed concern over the revised
procedures for notifying Medicare beneficiaries of their right to
appeal when discharged from an inpatient hospital. We also received
comments on the proposed grievance procedures and the appropriateness
of establishing notice and appeal procedures for reductions in provider
services. These comments and our responses are discussed below.
B. The Proposed Fast-Track Review Process (Sections 422.624 and
422.626)
1. Need for a New Fast-Track Appeals Process
Comment: Several commenters opposed the creation of a fast-track,
independent appeals process. These commenters argued that the current
expedited appeals process is effective to handle appeals of provider
terminations. They pointed out that the appeals process had changed
considerably since the Grijalva lawsuit was first filed in 1993,
including the implementation of an expedited appeals process for
Medicare managed care enrollees (through an April 30, 1997, final rule
(62 FR 23375)) and the subsequent establishment of the M+C program
appeals procedures (under the BBA and implementing regulations). They
asserted that the new fast-track appeals process would be confusing,
duplicative, burdensome and expensive.
Response: We recognize that many of the problems that led to the
original Grijalva lawsuit have been rectified through subsequent
statutory and regulatory changes, and we believe that the existing
expedited appeals process constitutes an important and effective
beneficiary protection. However, the current expedited appeals process
was designed primarily to address denials of the initiation of a
service. The fast-track appeals process proposed in the January 24,
2001, rule would deal with decisions about the termination of provider
services. Moreover, obtaining an independent review of an M+C
organization's decision to terminate an enrollee's provider services
now takes at least 6 days to complete, under a process where both the
M+C organization and CMS's independent contractor must review an
adverse organization determination about the need for further services.
Our experience has been that decisions involving the termination of
provider services, particularly in nursing homes, have been among the
most contentious, and have often exposed enrollees to potentially
significant financial liability for continuation of services. Under the
fast-track process, an enrollee may appeal directly to an IRE, with
greatly limited, if any, financial liability. This one-step process,
carried out at government expense, can limit appeal processing costs
for both the enrollee and the M+C organization.
We also note that section 1869(b) of the Act, as amended by section
521 of the Medicare Medicaid, and SCHIP Benefits Improvement and
Protection Act (BIPA), has introduced significant new appeal
requirements for beneficiaries under the original Medicare program that
substantially parallel those proposed pursuant to the Grijalva
settlement. BIPA requires the Secretary to establish a new fast-track
appeal process when a provider of services plans to terminate an
individual's services or discharge the individual from the provider.
Currently, this right to an expedited review only exists with respect
to hospital discharges under sections 1154 and 1155 of the Act. Our
decision to implement an independent review process for terminations of
provider services furnished to M+C enrollees is entirely consistent
with, and bolstered by, the Congressional intent and direction
evidenced by the BIPA provisions. (See our November 15, 2002, proposed
rule, at 67 CFR 69312 for further details on the BIPA statute and our
proposed new appeal provisions.) We believe that CMS must assure that
all Medicare beneficiaries are afforded a fair and equitable process to
appeal
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provider terminations whether the beneficiary is enrolled in M+C or
original Medicare.
2. Timing of the Termination Notices
Comment: Many commenters stated that it is clinically improbable
that an M+C organization or provider could accurately predict four days
in advance when a discharge would be appropriate, particularly in the
nursing home setting where discharge decisions are made ``at most 48
hours prior to discharge.'' They argued that requiring delivery of the
termination notices four days in advance would result in unnecessary
appeals being initiated in situations where there could be a subsequent
decision that services should not be terminated. They also believe that
the four-day advance notice would greatly complicate the appeals
decision-making process, since appeals would need to be decided as much
as two days before the actual termination of services. Commenters
suggested a number of alternative requirements for delivery of the
termination notice, including: three days before termination of
services, two days before termination, one day before termination of
services, and ``promptly'' after the M+C organization decides that
termination is appropriate.
Several commenters representing home health providers expressed
concern that providers of such intermittent care in effect would be
required to arrange for their staff to make extra visits solely to
deliver termination notices. Commenters also suggested that if CMS
retained the four-day advance notice requirement, the requirement
should be more flexible, i.e., delivery could be carried out before the
proposed four-day deadline if circumstances permitted.
Response: The primary intent of the proposed four-day advance
notification requirement was to enable the appeals process to be
completed by the time services were scheduled to end, and thus to
protect enrollees from any financial liability during the course of the
appeal process. However, we have become convinced based on our review
of the comments and further research into medical practice patterns
that providing these notices four days in advance of termination is
often not practical, particularly in institutional settings. Therefore,
in this final rule, we are requiring under 422.624(b)(1) that enrollees
receive notices no later than two days in advance of termination of
services. We are also revising the proposed requirements to state
explicitly that if, in a noninstitutional setting, the span of time
between services exceeds two days, the notice may be provided the next
to last time services are furnished.
We recognize that the result of this change would be that in some
situations, enrollees will be exposed to potential liability for
services that are found unnecessary by the independent review entity.
However, we have concluded that it is not possible to construct a
system that in all situations provides a meaningful notice about
termination of services and still builds in complete financial
protection for enrollees during the course of an appeal to an IRE. Note
that we are also revising the appeals process itself (by shortening the
time frame for records to be sent to the IRE, under 422.626(e)(3)) to
ensure that it is completed within three days of the notice of
termination. The effect of these changes is that an enrollee will face
a maximum of one day of financial liability if the IRE rules that the
disputed discharge date is appropriate.
In establishing this policy, we carefully considered how to balance
two conflicting responsibilities--the need to ensure that an M+C
enrollee has an opportunity to a meaningful appeal without undue
financial exposure with the obligation not to impose inappropriate
financial burdens on M+C organizations. Clearly, except in the
inpatient hospital setting, the Medicare statute generally does not
provide financial liability protection for either M+C enrollees or
other Medicare beneficiaries who have chosen to continue to receive
services pending the result of an appeal or claim determination. Absent
a statutory mandate, we do not believe we have the authority to require
M+C organizations to pay for services that are subsequently determined
by an independent review entity not to be medically necessary, or
otherwise covered, for the enrollee in question. (As noted above,
section 521 of BIPA establishes a similar right to a fast track appeal
of a termination of provider services (under section 1869(b)(1)(F) of
the Act), but did not provide for continuation of Medicare coverage
during the pendency of the appeal.)
It is important to note that an enrollee's potential financial
liability for continuing provider services occurs only after valid
delivery of the advance termination notice. That is, consistent with
the requirements outlined at Sec. 422.624(b), a standardized, signed
and dated advance termination notice is required for financial
liability to accrue to the enrollee. Providing this notice as soon as
the termination date is known (rather than waiting until two days in
advance of service termination) will in many cases serve the best
interests of both plan enrollees and the M+C organizations who are
responsible for payment for the services.
Comment: Several commenters responded to our specific request for
comments on what constituted four-day notice and expressed confusion
over whether the deadline for notice delivery would be 3 p.m. or
``close of business.'' Commenters indicated that requiring that the
notices be delivered by 3 p.m. was not appropriate, given for example
that physicians frequently visit nursing homes late in the afternoon or
early in the evening after their office hours are over. Commenters
recommended that CMS clarify that termination notices could be given
until the end of the business day, which would still enable enrollees
to request an appeal by noon of the next day.
Response: We agree with commenters that the deadline for notice
delivery needs to be later than 3 p.m. to allow physicians and other
practitioners enough time to visit nursing homes or other service
settings late in the day. We recognize that practice patterns are
different in these settings than in inpatient hospitals and thus that
it may not be appropriate to apply the same standard across all
provider settings. Thus, rather than establish a more precise time
standard in regulations, the regulations will continue to indicate the
latest day that a notice must be delivered. We intend to issue further
program guidance that will be based on the prevalent practice patterns
for the various service types. This guidance will reflect our general
agreement that delivery of the advance termination notice by ``close of
business'' will provide sufficient time for an enrollee to appeal by
noon of the next day.
Comment: Two commenters raised concern over whether the four-day
advance notice requirement should include weekends and holidays. One
commenter asked that we consider the fact that many of the notices may
be given on a day that would place the fourth day on a Saturday,
Sunday, or holiday. Another commenter stated that since HHA and CORF
services are not usually rendered on weekends or holidays, and M+C
organizations have limited staff available on these days, CMS should
consider using business rather than calendar days, where appropriate.
Response: As noted above, this final rule changes the requirement
for advance notification of termination of services or discharge from
the four day standard in the proposed rule to no later than two
calendar days prior to termination of services or discharge. The new
standard of ``at least'' two days
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affords an M+C organization or provider the option of providing notice
more than two days in advance if the second day before discharge is a
non-business day (for example, for a Monday discharge). We have also
provided that situations involving non-institutional settings, where
the time-span between service delivery exceeds two days, an enrollee
should be notified no later than the next to the last time services are
furnished. We will work with provider and M+C organization
representatives, and with the IRE to develop uniform procedures to deal
with those rare situations where an enrollee needs to be given notice
or discharged on a weekend. At a minimum, we intend to require, through
its contract, that the IRE be able to accept expedited review requests
on any day of the week and notify an M+C organization of that request.
3. Content and Delivery of the Termination Notice
Comment: Commenters raised a series of related concerns about both
the delivery and content of the termination notices. Many commenters
viewed as unnecessarily burdensome the requirement that each enrollee
in a provider setting receive a detailed termination notice, regardless
of whether the enrollee agreed with the termination of services. They
generally believe that in most situations the contents of the required
notice were too extensive and would provide little or no benefit to
most enrollees.
Commenters were divided on the issue of who should be responsible
for distributing the notices. Managed care industry commenters
generally supported the proposed requirement that the providers of
services deliver the notices, although they expressed concern over
their liability in situations where the providers failed to do so.
Commenters representing providers objected to being charged with this
responsibility, particularly in view of the detailed nature of the
notice. They indicated that it would be difficult to obtain all needed
information from M+C organizations and that it was unfair to in effect
shift the responsibilities of M+C organizations to providers. One
commenter argued that a policy whereby providers would be responsible
for giving notices does not comport with the settlement agreement.
Response: We continue to believe that providers clearly are in a
better position than M+C organizations to carry out routine delivery of
service termination notices to their patients. At the same time,
although all enrollees need to be made aware of their appeal rights on
a timely basis, we recognize that only a small proportion are likely to
object to the termination of their services. Thus, it is in the best
interests of all parties that the notice delivery process be as
streamlined and simple to administer as possible.
To that end, we are requiring a two-step notification procedure
under this final rule. We are revising the proposed requirement that
providers deliver a detailed termination notice to M+C enrollees.
Instead, we are requiring under 422.624(b) that providers deliver a
standardized, largely generic, notice to each M+C enrollee whose
services are terminating that will explain the enrollee's appeal
rights. The notice will contain only two enrollee-specific elements--
the enrollee's name and the date services will end. These notices will
contain standardized information on an enrollee's appeal rights and how
to initiate an appeal if necessary. Unless the enrollee wishes to
dispute the termination of services, no further notice will be
required.
The notice will instruct the enrollee to contact the IRE if he or
she believes that the services should continue. If the enrollee
indicates to the IRE that he or she disagrees with the discharge, the
IRE will immediately contact the M+C organization, which will be
required under 422.626(e) to deliver a detailed notice to the
dissatisfied enrollee and to the IRE. The detailed notice must contain
the remaining elements required under the proposed rule, including an
explanation of why services were no longer needed, a description of any
applicable Medicare coverage rule or policy, a statement of any
applicable M+C organization policy or rationale, and facts specific to
the enrollee that establish the applicability of Medicare or M+C
organization policies. We believe that M+C organizations are in the
best position to give detailed notices regarding their specific
policies and the criteria that they applied in deciding to terminate
provider services. Moreover, in view of the fact that M+C organizations
ultimately bear the responsibility for both the service termination/
discharge decision and for paying for services covered under their
plans, we believe that is appropriate that M+C organizations be
responsible for preparing and delivering them under the limited
circumstances when they are needed.
Comment: Commenters were concerned that providers would refuse to
comply with instructions to deliver notices and wanted to know what
incentives were in place to obligate providers to deliver notices.
Response: We believe that the streamlined notification process
should greatly ameliorate this concern. Providers will be obligated to
comply with notice requirements through the amendment of the provider
agreement regulations at Sec. 489.27(b), as well as through their
contractual arrangements with M+C organizations. We recognize that M+C
organizations may also choose to delegate to providers the
responsibility for discharge and termination decisions, and for the
delivery of detailed notices in disputed termination cases. M+C
organizations may choose to offer incentives to providers for
compliance with these responsibilities, or penalties for non-
compliance, through these private contractual arrangements. However,
consistent with 422.502(i), M+C organizations remain ultimately
responsibility for carrying out such delegated requirements.
We also note that section 1819(h) of the Act specifies remedies
that may be used by the Secretary when a SNF is not in substantial
compliance with the requirements for participation in the Medicare
program. These penalties are applied on the basis of surveys conducted
by CMS or by a survey agency. The regulations at Sec. 488.406 include
other penalties for non-compliance such as denials of payment, and
corrective action plans. Also, HHAs are regulated in part by conditions
of participation found at Sec. 484.12, which indicate that HHAs must
operate and furnish services in compliance with all applicable Federal,
State and local laws and regulations.
Comment: Several commenters raised questions about financial
liability in situations where a provider failed to deliver timely
notice. They believe that it would be unfair for M+C organizations to
be liable for services in such situations.
Response: Again, we believe that the prevalence of this sort of
situation will be greatly lessened in light of the direction that we
have taken in this final rule, which places a clear, reasonable
obligation on both providers and M+C organizations with respect to
informing enrollees of their rights. Nevertheless, the nature of the
arrangement between an enrollee and a managed care organization
dictates that the organization is ultimately responsible for payment
for services that are found to be covered under the enrollee's plan.
When an IRE makes a decision on an enrollee's appeal of a service
termination, that decision will determine the extent to which liability
rests on either the M+C organization or the enrollee. Consistent with
[[Page 16657]]
422.624(a)(2), an IRE's review will be available with respect to
termination decisions where an enrollee first was ``authorized, either
directly or by delegation, to receive an ongoing course of treatment
from that provider.'' Thus, the IRE's determination is limited to
whether continuation of an ongoing course of treatment is covered under
an enrollee's plan. The IRE will not be expected to assign liability
between the provider and the M+C organization.
Accomplishing proper advance notification of termination by the
provider requires coordination and information sharing between the
provider and the M+C organization to ensure that the enrollee receives
the correct information at the proper time. We believe that the
interdependence between M+C organizations and SNFs, HHAs, and CORFs
reflects the typical daily reality of health plans and insurers.
Comment: Some commenters suggested that the 4-day advance notice
requirement could result in the overutilization of services. They were
concerned, for example, that an enrollee could be kept in a SNF
unnecessarily even if the individual's condition had improved
sufficiently to permit an unexpectedly early discharge. Commenters also
asked about situations where an IRE determined that services should
continue only one or two additional days. They questioned the need for
additional notices in such situations.
Response: The notice requirement is not intended to impede or
substitute for appropriate medical decision-making practices. Nothing
in these requirements precludes an enrollee from being discharged from
a SNF or HHA when an enrollee and his or her physician are in agreement
that the discharge is medically appropriate. To clarify this point, we
have revised section 422.624(d) to specify that, although an M+C
organization is financially liable for continued services until 2 days
after an enrollee receives a termination notice, the enrollee may waive
the right to continued services if he or she agrees with being
discharged sooner than 2 days after receiving the notice. However, an
enrollee who objects to the service termination would not be liable for
the services until 2 days after receiving the notice.
Similarly, it is not our intent to require M+C organizations to
provide more care than an IRE determines would be appropriate. If an
IRE specifies the number of days that coverage should continue, the
IRE's decision itself takes the place of any further notice. However,
there may be instances where an IRE will defer to an M+C organization
to determine when coverage should end. In those cases, another advance
termination notice must be given to the enrollee within a time frame
consistent with the circumstances involved. Again, we believe that this
concern is lessened or eliminated under the change to a 2-day advance
notice.
Comment: Several commenters were concerned about the length and
complexity of the notice, believing that this would cause delays in its
preparation and create noncompliance with the delivery and appeals
timeframes. Some commenters also argued that preparing these detailed
notices about policies, coverage rules and contract provisions for
every enrollee prior to provider services terminating would be
administratively burdensome.
Response: As discussed above, we agree that it is not necessary to
provide a detailed notice to all enrollees. We have learned through
consumer testing that Medicare beneficiaries prefer to receive relevant
information timed according to when they need to act. Thus, we have
revised the proposed policy from requiring 100 percent distribution of
a detailed notice from providers to all enrollees, to 100 percent
distribution of a largely generic notice that explains when services
will end, where to appeal if the enrollee disagrees, and potential
liability for continued coverage during an appeal. For those enrollees
who choose to appeal, M+C organizations would be required to provide a
detailed notice that: explains why services are no longer covered or
medically necessary, describes any applicable coverage rules, policies,
or contract provisions, and contains facts specific to the enrollee and
relevant to the coverage determination that are sufficient to advise
the enrollee about the enrollee's care. We believe that this two-step
notification process meet the needs of the large majority of enrollees
who need to know when their services will end and what their appeal
rights are, as well as the small minority of enrollees who want more
specific information about why their services are ending. This approach
also ensures that providers and M+C organizations are not faced with
unnecessary administrative costs and burdens. CMS will develop both
notices--the advance termination notice, and the detailed termination
notice, through OMB's PRA process.
Comment: Some commenters viewed our proposal to require providers
to deliver termination notices as evidence that CMS was unfairly
favoring M+C organizations over providers, by allowing M+C
organizations to avoid responsibility for providing notices. Some
commenters believed that making providers responsible for termination
notices simply because they were in the best position to deliver
notices was unprecedented and argued that this violated the
Administrative Procedure Act (APA).
Response: In developing these proposals, as well as in developing
this final rule, we have attempted to arrive at policies that balance
the rights and responsibilities of all the involved parties, including
Medicare beneficiaries, providers, and M+C organizations. We continue
to believe that beneficiaries need to be informed of their appeal
rights and that providers are in the best position to carry out this
function. At the same time, we are very cognizant of the need to
accomplish such notification in the most cost-effective and least
burdensome manner. Thus, as explained above, we have made adjustments
to the proposed provisions to reflect concerns raised by commenters.
This is the essence of notice and comment rulemaking, and thus we
believe that implementing the notification requirement through this
rulemaking process is entirely consistent with the APA. That is, the
preamble to the proposed rule satisfied the requirements of the APA by
describing our proposed policies and explaining the reasoning behind
the proposal that providers deliver the termination notices. This final
rule then reflects our careful consideration of the comments received.
In response to comments on the burden imposed by the proposal on
providers, we have in this final rule lessened that burden.
Comment: Various commenters raised questions regarding whether a
notice needed to be provided in certain scenarios, such as when
services did not meet Medicare coverage criteria, or where a provider
or attending physician disagreed with an M+C organization's decision to
terminate services.
Response: M+C organizations must determine when services should end
on the basis that services are no longer medically necessary, or
otherwise are not covered under Medicare or the M+C plan's coverage
policies. Once an M+C organization determines that provider services
should end, providers must deliver notices to enrollees at least two
days in advance of services terminating. The requirement to provide the
notice is independent of the basis for termination of a course of
treatment. In other words, it applies whether the decision is based on
a medical necessity judgment or the application of a Medicare coverage
rule.
[[Page 16658]]
Similarly, the provider's obligation to give an advance termination
notice to the enrollee exists even if a provider or attending physician
disagrees with the M+C organization that services should terminate. The
M+C organization's decision to end services is not an indication that
the provider necessarily agrees that services should end, but it is
necessary to ensure that the enrollee has the opportunity to appeal the
M+C organization's decision.
Comment: Commenters recommended that CMS permit providers to
request appeals on behalf of enrollees and recommended that an IRE's
decision bind an M+C organization to pay a provider for necessary
services.
Response: Providers have the ability to file appeals on behalf of
enrollees as authorized representatives in accordance with Sec.
422.562(d). We have not created any additional provider appeal rights
in this regulation. The purpose of these regulations is to ensure that
enrollees receive the services that they are entitled to under their
M+C plans, through the implementation of appropriate notice and appeal.
CMS generally does not specify the payment arrangements between M+C
organizations and providers; therefore, an IRE's reversal of an M+C
organization's decision to terminate services is not a ruling on
whether, or the extent to which, an M+C organization is financially
obligated to the provider. Instead, the relevance of an IRE's reversal
is that the M+C organization is obligated to continue services for the
enrollee beyond the services that the M+C organization previously
authorized.
Comment: Some commenters suggested that the requirement for a 4-day
advance notice in situations where an IRE determined that services
should continue only one or two additional days would result in the
overutilization of health care services. They questioned the need for
additional notices in such situations.
Response: It is not our intent to require M+C organizations to
provide more care than an IRE determines would be appropriate. If an
IRE specifies the number of days that coverage should continue, the
IRE's decision itself takes the place of any further notice. However,
there may be instances where an IRE will defer to an M+C organization
to determine when coverage should end. In those cases, another advance
termination notice must be given to the enrollee within a time frame
consistent with the circumstances involved. Again, we believe that this
concern is lessened or eliminated under the change to a two-day advance
notice.
Comment: Commenters expressed concern that an IRE might delay
making a decision if it believed that it needed additional information
from the M+C organization. The commenter proposed that CMS require an
IRE to inform the M+C organization promptly, by fax or e-mail, if an
IRE believed that it needed more information to make a decision, and to
specify the precise information it required to make a decision on the
merits.
Response: Section 422.626(d)(5) specifies that if an M+C
organization fails to provide sufficient information to support its
decision to terminate an enrollee's services, an IRE may defer issuing
a decision until it receives needed information about the case. If an
IRE chooses to do so (rather than simply decide the case in the
enrollee's favor based on the evidence at hand), we agree that an IRE
should make best efforts to promptly notify an M+C organization of the
information the IRE needs, and that the submission of this information
could affect the IRE's decision on the merits. However, M+C
organizations should not expect IREs to routinely follow-up to complete
the record. It is the M+C organization's responsibility to provide all
relevant material necessary to sustain its termination decision by
close of business of the day that the IRE notifies the M+C organization
that an enrollee has requested an appeal. Thus, we will instruct IREs
through their contracts with CMS that in the event that the M+C
organization fails to submit documentation that would sustain the M+C
organization's decision, and the IRE either cannot obtain the prompt
cooperation of the M+C organization, or does not deem it practical to
obtain additional information, the IRE should issue a decision based on
the information available and err on the side of the beneficiary.
Comment: One commenter suggested that CMS should extend the same
provider notice requirements to original Medicare beneficiaries whose
services are being terminated.
Response: As noted above, section 1869(b)(1)(F) of the Act, as
amended by section 521 of BIPA, establishes appeal rights for
beneficiaries under original Medicare that are largely parallel to
those available to M+C enrollees under this final rule. As discussed in
detail in our November 15, 2002, proposed rule concerning those
provisions, we believe that existing Advance Beneficiary Notices (ABNs)
that are now used in Medicare fee-for-service settings are the
appropriate vehicle to trigger the right to an expedited appeal of a
provider termination of services. (See 67 FR 69337.)
Comment: Several commenters are concerned that the standard for
``valid delivery'' of a termination notices is difficult to meet. They
indicated that it would require a clinician to deliver the notice in
order to determine the enrollee's level of consciousness, and ability
to read and comprehend it, which would be expensive and burdensome.
Response: Section 422.624(c) specifies that ``delivery'' of a
notice is valid only if an enrollee has signed and dated the notice to
indicate that he or she both received the notice and can comprehend its
contents. This policy is consistent with other CMS requirements
governing the delivery of similar notices such as those set forth in
CMS program memoranda A-99-52 and A-99-54 for HHA advanced beneficiary
notices under original Medicare. We have no indication that this
standard has proven problematic and believe that it is appropriate to
apply similar protections to enrollees in the M+C program. Note that
this requirement for successful delivery does not permit an enrollee to
extend coverage indefinitely by refusing to sign a notice of
termination. If an enrollee refuses to sign a notice, the provider
would annotate its copy of the notice to indicate the refusal, and the
date of the refusal would be considered the date of receipt of the
notice.
By the time that termination notices are issued, providers will
have already needed to assess an enrollee's ability to accept delivery
of a notice, based on typical admission assessments, care planning
evaluations and discharge planning activities that have taken place
during the course of treatment. In the event a provider believes that
an enrollee is not capable to receive the notice, providers should be
well-acquainted enough with the enrollee's particular situation to make
alternative arrangements, if necessary, to deliver a valid notice. For
example, an incapacitated enrollee is not able to act on his or her
rights and, therefore, could not validly ``receive'' the notice. This
situation could be remedied through the use of an authorized
representative under Federal or State law.
4. Other Comments
Comment: Several commenters objected to the proposed requirement
under Sec. 422.502(i)(3)(iv) that M+C organizations include specific
provisions in their contracts with providers to require providers to
comply with the notice requirements in 422.624. They believe it is
burdensome to reopen
[[Page 16659]]
contracts with providers to incorporate these requirements, citing that
the change in the conditions of participation at Sec. 489.27(b) should
be sufficient to ensure compliance.
Response: We agree that the change in conditions of participation
at Sec. 489.27(b) is sufficient to ensure that providers comply with
the notice requirements at Sec. 422.624. Although we believe that it
would be in the best interests of providers and M+C organizations to
include these notice requirements in their contracts, we do not intend
to require that providers and M+C organizations renegotiate their
contracts solely for the purpose of including a clause regarding notice
delivery requirements. Therefore we have removed proposed Sec.
422.502(i)(3)(iv).
Comment: One commenter wanted to know if M+C organizations could
charge enrollees a reasonable flat fee for the costs of duplicating and
mailing case files to enrollees upon request.
Response: In accordance with the Privacy Act and 45 CFR 5b.13,
``[f]ees may only be charged where an individual requests that a copy
be made of the record to which he is granted access.'' No fee is
permissible unless the copying costs are at least $25. Thus, an M+C
organization may not charge a fixed fee for the costs of duplicating
and mailing case files to enrollees, but may apply the fee schedule
outlined in Sec. 5b.13(b). This would allow an M+C organization to
charge $.10 per page for photocopied records above the $25 threshold,
or the actual cost determined on a case-by-case basis for records not
susceptible to photocopying.
Comment: One commenter noted that the proposed rule was silent on
the type of entity that could serve as an IRE. The commenter (an
organization representing Quality Improvement Organizations)
recommended that QIOs should be designated as IREs since QIOs already
interact on a daily basis with families who question whether the timing
of a provider discharge is appropriate. The commenter indicated that
relying on an entity other than QIOs would be confusing to enrollees.
The commenter recommended that CMS change all references from IRE to
QIO so that CMS would not have to develop and maintain a costly and
unnecessary contractual and regulatory structure that duplicates the
QIO program.
Response: Although we recognize that QIOs have experience with
making similar determinations, we do not believe that it is appropriate
to designate in a final rule that QIOs will carry out the fast-track
reviews. We are still evaluating whether these reviews are more
appropriately accomplished through a single IRE, or multiple entities,
as well as the extent to which these procedures can be linked with
expedited reviews required under the new BIPA provisions. There are
various independent entities, including QIOs, which already have
contractual relationships with CMS to make coverage decisions. As we
attempt to develop improved, more efficient appeals procedures under
both M+C and original Medicare, CMS will determine whether it is
prudent to use these existing contractors to fulfill the requirements
of this regulation, or whether it is necessary to seek bids for this
important work.
Comment: One commenter expressed concern that the proposed rule did
not require that IRE reviewers include clinicians or practicing
physicians. The commenter also believed that a reviewer should have a
background in the specialty or subspecialty relevant to the case.
Response: The regulations at Sec. Sec. 422.624 and 626 are part of
the overall M+C appeals process under subpart M. These fast-track
reviews effectively replace M+C organization's reconsiderations on SNF,
HHA, and CORF termination cases. Thus, similar to the requirement under
Sec. 422.590(g)(2) for reconsideration decisions by M+C organizations,
we intend to require through our contract with the IRE(s) that
decisions involving denial of coverage based on a lack of medical
necessity ``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.''
C. Hospital Discharge Notices (Sec. Sec. 422.620 and 489.27)
Comment: Many commenters strongly opposed the proposed requirements
under 422.620 and 489.27 that hospitals issue a standardized notice of
appeal rights for a second time on the day before discharge to all
Medicare beneficiaries, including those that are enrolled in a Medicare
managed care health plan. They believe that this requirement poses a
significant administrative burden in both delivering and explaining the
form and takes away from time better spent on providing services and
discharge planning. They contend that the notice is unnecessary in
either the managed care or fee-for-service context and indicated that,
in many cases, beneficiaries are confused by the notice. One commenter
stated that after the enactment in 1998 of the requirement under
422.620 that all M+C enrollees receive discharge notices the day before
the end of their hospital stay, the Quality Improvement Organizations
(QIO) received many phone calls from confused beneficiaries not
understanding the notice. The commenters believe that very few
beneficiaries have any interest in disputing their hospital discharges
and thus the cons of this requirement far outweigh any benefits.
Two commenters supported the proposal that hospitals issue notices,
both near admission and the day before discharge, to all Medicare
beneficiaries. They supported CMS's efforts to combine the Important
Message from Medicare (IM) with the Notice of Discharge & Medicare
Appeals Rights (NODMAR), and Hospital Issued Notice of Noncoverage
(HINN). The commenters found the notices largely duplicative and
welcomed the simple one page document. (Please note that since the
publication of the proposed rule, the required notices and the
distribution process have also been the subject of public comment
through the Office of Management and Budget (OMB) approval process
required under section 3506(c)(2)(A) of the Paperwork Reduction Act
(PRA).)
Response: After careful consideration of the public comments on
these requirements, the many comments received on the notices
themselves through the PRA process, and evaluation of CMS data on the
hospital discharge appeals process, we are convinced that changes are
needed in the proposed notice requirements. Consistent with the notice
requirements discussed above for other provider termination situations,
we are revising 422.620 to eliminate the requirement that hospitals
provide a written notice of noncoverage to each M+C enrollee the day
before discharge. Section 489.27 will continue to require that
hospitals furnish the Important Message from Medicare, which explains a
beneficiary's appeal rights to every Medicare inpatient during their
stay, but will not specify that the notice be delivered the day before
discharge.
We continue to strongly believe that all beneficiaries need to be
informed of their Medicare appeal rights when admitted as inpatients to
hospitals, and this will continue to take place in compliance with
section 1866(a)(1)(M) of the Act. However, we have reached the
conclusion that requiring that this notice in effect be delivered
twice, once upon admission and again before discharge, would be an
unnecessarily burdensome requirement on hospitals. We have reviewed
data from the QIOs
[[Page 16660]]
via CMS's Standard Data Processing System covering the period November
1999-March 2001. During this time, there were approximately 11 million
Medicare beneficiaries discharged from hospitals, only about 15,000 of
whom (slightly more than one tenth of 1 percent) chose to appeal the
hospital discharge decision. Tellingly, the proportion of M+C enrollees
that exercised their right to appeal was no different than that for
other beneficiaries, despite the ongoing requirement that all M+C
enrollees receive notice of their discharge and Medicare appeal rights
the day before discharge--a requirement that does not exist for other
Medicare beneficiaries. Thus, we believe this evidence indicates the
efficacy of the current practice under which hospitals issue detailed
notices of noncoverage to beneficiaries under original Medicare only
when they express dissatisfaction with the termination of hospital
services.
Therefore, hospitals will continue to be responsible for issuing
both the Important Message from Medicare to all Medicare inpatients, as
well as for issuing HINNs to inpatients covered under the original
Medicare program when they indicate that they disagree with a
hospital's discharge decision. For enrollees in the M+C program, we are
revising 422.620 to specify that M+C organizations are responsible for
providing a written notice of noncoverage when an enrollee disagrees
with a discharge decision. The notice must be issued no later than the
day before hospital coverage ends and must explain the reason why care
is no longer needed, the enrollee's appeal rights, and the effective
date of time of the enrollee's liability for continued inpatient care.
We believe that it is appropriate to place this responsibility on M+C
organizations, given their financial liability for continued care in
such situations.
We intend to submit updated versions of both the Important Message
from Medicare and the detailed notices of noncoverage to OMB for public
comment through the PRA process. (We anticipate that there will
continue to be two notices of noncoverage--one for patients under
original Medicare and one for patients enrolled in the M+C program.)
Until that process is completed, hospitals and M+C organizations should
continue to use the existing Important Message, HINN, and NODMAR for
accomplishing the notification requirements of this final rule. We
intend to continue our efforts to simplify the messages delivered by
these notices, including limiting each notice to a one-page format.
Comment: One commenter stated that although the proposed rule made
it clear that CMS intends to have hospitals administer the IM to all
Medicare beneficiaries, it was unclear as to when and how often the
notice is to be administered during an inpatient stay. The commenter
acknowledges the value to beneficiaries of administering appeal notices
for inpatient stays, but believes that hospitals should continue to
distribute the IM only at admission, as they have done for years.
Response: We recognize the need for clarity in this regard. The
intent of the proposed rule, in conjunction with the procedures set
forth through the PRA process, was that hospitals generally would issue
the notice twice during an inpatient stay, that is, once at or near the
time of admission and again before discharge. However, that proposal
has been superceded by the requirements of this final rule. As
explained above, hospitals thus should continue their current practice
of issuing the IM at or near admission to all Medicare inpatients, and
issuing a notice of noncoverage before discharge only in situations
where a beneficiary other than an M+C enrollee has indicated
dissatisfaction with his or her scheduled discharge date. M+C
organizations will be responsible for administering notices of
noncoverage to inpatient M+C enrollees when they disagree with an M+C
organization's discharge decision.
Comment: One commenter suggests that CMS increase its educational
and outreach efforts to ensure beneficiaries' understanding of the
notices they receive. The commenter stated that hospitals should not be
relied upon to provide all of the education necessary for a beneficiary
to understand their Medicare rights.
Response: We are committed to ensuring that notices provided to
beneficiaries are clear and understandable, and that beneficiaries with
questions can get prompt, reliable answers. To this end, we now
routinely consumer test major beneficiary notices such as these
hospital notices, as well as subject them to public comment through
OMB's Paperwork Reduction Act process. Beneficiaries with questions can
contact Medicare's toll free number (1-800-MEDICARE) or work with
beneficiary outreach groups sponsored by CMS, such as the State Health
Insurance Assistance Programs (SHIPs).
Comment: Two commenters were strongly opposed to CMS's practice of
submitting standard termination and similar notices, such as the
hospital Important Message, for review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act (PRA). For notices like
these, these commenters believe that this practice makes no sense, and
introduces lengthy and they believe unnecessary delays in the
implementation of legally required notices. The commenters, citing 44
U.S.C. 3501 et seq., contend that these notices do not fall within the
requirements of the PRA for agency actions involving collection of
information. They allege that the delay in implementing standardized
notices caused by CMS's practice delays compliance with legal
requirements, as noted above. Another commenter contends that, while
Congress created the PRA to reduce the amount of paperwork providers
utilize, over the past five years, providers have seen nothing but
increases in the amount of paperwork they must complete. The commenter
further argues that the notices required under the proposed rule add to
the paperwork burden that providers have to comply with instead of
decreasing the burden, as outlined under the PRA.
Response: We do not agree with the commenter's interpretation of
the requirements of section 3506(c)(2)(A) of the Paperwork Reduction
Act (PRA). The PRA applies both to information collection and paperwork
burden, and thus we believe it is required and appropriate to obtain
public comment on notices that are required under Federal regulations.
We intend to work closely with OMB to minimize any delays in the
development and clearance of the revised standardized notices. We note
that in this final rule, we have reduced the paperwork burden that
would have been imposed under the proposed rule, including the
elimination of certain notice requirements absent an objection to, or
decision to appeal, a discharge.
Comment: Several commenters raised concerns about the discharge
decision-making process for hospital inpatients who are enrollees of
M+C plans. They contend that there will inevitably be disagreements
between plans and providers about the timing of patient discharges and
that the proposed rule would exacerbate these disputes by requiring
hospitals to distribute detailed discharge notices to all M+C
enrollees. This in effect requires a hospital to explain an M+C
organization's decision. Another commenter stated that over the past
few years, its member hospitals have encountered numerous instances in
which M+C plans have reduced or denied payment to hospitals for days
during which the plan and the beneficiary's physician have disagreed
[[Page 16661]]
about whether the beneficiary should be discharged.
Response: Clearly, the hospital discharge decision-making process
requires substantial coordination and cooperation between M+C
organizations and hospitals. We recognize that requiring detailed
discharge notices for all M+C inpatients would have potentially
increased the difficulties in this regard without achieving any
demonstrable benefits for enrollees. Thus, we have revised the
requirements in this final rule to make clear that such notices, when
needed, are the responsibility of M+C organizations. However, we
continue to believe that it is inappropriate for CMS to interfere in
the business relationships between M+C organizations and their hospital
providers and that any tension between these parties largely parallels
that in the private health insurance sector.
Comment: One commenter noted that under the original Medicare,
hospitals must provide QIOs copies of all HINNs given to beneficiaries.
In view of the proposal that a detailed discharge notice be given to
each Medicare inpatient, the commenter suggested that we eliminate the
requirement that QIOs receive copies of every discharge notice.
Response: We believe that hospitals should continue to provide QIOs
with copies of all HINNs, and that M+C organization should provide QIOs
with copies of the noncoverage notices that they provide to
dissatisfied beneficiaries. This is consistent with the policy
described above for expedited reviews of other provider terminations,
where M+C organizations will furnish copies of their detailed
termination notices to both the IRE and the enrollee when there is a
dispute over a discharge or service termination.
D. Grievance Procedures (Sec. Sec. 422.561 and 422.564)
Comment: Some commenters argued that the proposed grievance
procedures were overly prescriptive, while others supported
establishing the proposed new standards. One commenter believed that
grievance procedures should be flexible, given our interpretation of
the preemption provision under section 1856(b)(3)(B)(iii), i.e.,
Federal rules do not specifically preempt State grievance requirements
unless they relate to coverage determinations. One commenter stressed
that any grievance requirements we imposed should be consistent with
those applied by accrediting organizations, so that M+C organizations
would not have to change current procedures to a great extent.
Response: In the June 26, 1998, interim final rule to establish the
M+C program (63 FR 35,030), we set forth the general requirement that
an M+C organization must resolve grievances in a timely manner and have
grievance procedures to meet CMS guidelines. In both the interim final
rule and the June 29, 2000, final rule (65 FR 40,170, 40,275), we
indicated that we intended to establish more detailed requirements for
grievance procedures.
We generally agree with the commenters that the regulations should
not be overly prescriptive with respect to grievance procedures. We
note that many States have processes to address complaints that involve
issues other than coverage, and State grievance procedures, unlike
appeal procedures, are not specifically preempted by Federal rules. We
consulted with representatives of the managed care industry,
beneficiary advocacy groups, and QIOs, and examined standards developed
by the National Association of Insurance Commissioners (NAIC). We
learned that M+C organizations already adhere to State requirements
concerning grievances. Also, our experience has shown that enrollees
overwhelmingly pursue appeals rather than grievances, and rarely raise
concerns or problems associated with the existing grievance procedures.
Therefore, as discussed below, we are not including in this final rule
the proposed procedural provisions set forth in Sec. 422.564(d) and
(e), which pertain to the method for filing and the notification and
time frames associated with grievances.
Nevertheless, we believe that a basic uniform grievance structure
should be in place to address those issues that fall outside of the
appeals process. In particular, we believe that grievance provisions
are needed to address complaints involving procedural issues that arise
during the appeals process. Thus Sec. 422.564(d) establishes an
expedited grievance process for the following circumstances: (1) The
grievance involves an M+C organization's decision to invoke an
extension related to an organization determination or reconsideration;
or (2) the grievance involves an M+C organization's refusal to grant an
enrollee's request for an expedited organization determination under
Sec. 422.570 or reconsideration under Sec. 422.584.
We believe that the changes we are setting forth in this final rule
either have a direct effect on the M+C appeals process, or provide
clarification in existing requirements, but allow M+C organizations the
flexibility needed to maintain current procedures that comply with
State requirements.
Comment: Several commenters strongly encouraged CMS to establish
mandatory time frames and notification procedures for resolving
grievances. One commenter suggested that grievance time frames mirror
those for standard and expedited organization determinations. Two
commenters suggested a 30-calendar day time frame to render a grievance
decision, with an opportunity for a 14-calendar day extension for peer
review. Another commenter argued that the grievance procedure must have
a mechanism to resolve a dispute regarding an M+C organization's denial
to grant an expedited review within 24 hours, so that an
inappropriately denied request can proceed quickly in the appeals
process. Finally, one commenter expressed concern about State privacy
requirements, which, in some cases, prevent health plans from providing
specific information on how grievances get resolved.
Response: As noted above, we have not in this final rule adopted
the proposed provisions that prescribed time frames for responding to
grievances generally. We do not believe that establishing Federal
requirements for the manner and timeliness within which grievances must
be disposed is necessary, and as we have noted it could be unduly
burdensome in light of varying State requirements. Furthermore, we have
not received any reports that enrollees have encountered frustration or
problems in getting M+C organizations to respond to enrollees'
grievances timely or communicate in an effective manner. Enrollees will
continue to have regulated formal avenues to pursue complaints
involving all payment, coverage and quality of care issues.
We also agree with the commenter who suggested that grievances
involving expedited appeals needed to be addressed as quickly as
possible. Therefore, as noted above, we are specifying under Sec.
422.564(d) that an M+C organization must notify the enrollee within 24
hours of receiving a grievance about the M+C organization's refusal to
expedite a review, or the M+C organization's decision to invoke an
extension to the organization determination or reconsideration time
frames. This will ensure that any inappropriate procedural actions
under the appeals process are resolved and that the appeal proceeds
without delay. In this situation, any extension would clearly be
inappropriate, since it would constitute a de facto denial of the
[[Page 16662]]
enrollee's request for an expedited review.
Comment: One commenter asked who will determine which route is more
appropriate for the beneficiary in pursuing a remedy to a complaint,
since we acknowledge that the same claim or circumstances that gave
rise to an appeal could have elements of a grievance. This may cause
the beneficiary to be confused as to which route is more appropriate.
Another commenter asserted that M+C organizations should be required to
provide clear, accurate and standardized information concerning
grievance and appeal procedures.
Response: We are adding to Sec. 422.564(b) a requirement that when
an M+C organization receives a complaint, it must promptly determine
and inform the enrollee whether the issue is subject to its grievance
procedures or its appeal procedures. Note that we view ``complaint''
and ``dispute'' as generic terms that cover various expressions of
dissatisfaction or disagreement that may be brought to the attention of
an M+C organization or its providers. Thus, complaints or disputes can
encompass grievable or appealable issues, but in either case would
require resolution in accordance with the organization's internal
procedures.
CMS already requires M+C organizations to provide clear and concise
information to all enrollees regarding appeal and grievance procedures.
M+C organizations include this information annually in their Evidence
of Coverage (EOC). In addition to other information that M+C
organizations wish to convey, CMS also provides standard information
that all EOCs must contain regarding appeals and grievances.
Comment: Various commenters expressed conflicting views on the most
appropriate means for dealing with quality of care issues. Some
commenters believed that a quality of care issue should first be
resolved by the M+C organization and subsequently sent to the QIO.
Other commenters argued that quality of care issues should be referred
immediately to the QIO for resolution, while others maintained that
complaints should be processed by both M+C organizations and QIOs
simultaneously.
Response: As reflected under new Sec. 422.564(c), we decided that
the most flexible approach would be to permit enrollees to file quality
of care complaints with either the M+C organization, the QIO, or both.
We expect M+C organizations and QIOs to coordinate and cooperate with
one another to resolve enrollees' complaints.
Comment: Many commenters suggested that CMS should not include a
definition of ``quality of care'' in the regulations because defining
it would oversimplify the many issues that quality of care might
encompass.
Response: We agree with the commenters that the term ``quality of
care'' does not lend itself to a regulatory definition. Instead, we
will rely on the States and M+C organizations to identify the types of
issues that might fall into the quality of care category.
Comment: A commenter questioned how CMS would enforce record-
keeping requirements for M+C organization grievances.
Response: Section 422.564(e) requires M+C organizations to maintain
records associated with processing grievances. M+C organizations
already should have a system to track and maintain records on all
grievances in light of existing requirements under section
1852(c)(2)(C) and Sec. 422.111(c)(3), whereby M+C organizations must
report aggregate information on the disposition of grievances. Thus,
the record-keeping requirement will be enforced through CMS' existing
procedures to monitor grievance activities, and if appropriate, place
M+C organizations on corrective action plans. We expect M+C
organizations, at a minimum, to keep track of the receipt date and
final disposition of the grievance, and the date that the M+C
organization notified the enrollee of the disposition.
E. Reductions of Services
This final rule does not set forth any new regulations regarding
reductions in services. As part of the Grijalva settlement, we agreed
to solicit comments on whether new notice and appeal procedures were
needed for decisions by M+C organizations to reduce health services.
The issue of what constitutes appropriate notice and appeal procedures
for reductions of service was also raised in the regulations to
implement the M+C program.
In the M+C final rule, we made several changes to Sec. 422.566(b),
which describes actions that constitute organization determinations. We
added language at Sec. 422.566(b)(3) to clarify that an organization's
refusal to pay for or provide services, in whole or in part,
``including the type or level of services'' can constitute an
organization determination if the enrollee believes that services
should be furnished or arranged. We stated in the preamble to the final
rule that we agreed that a reduction in service could be considered an
organization determination that was subject to an appeal. To the extent
that the organization refused to continue to provide all or part of the
services that the enrollee believed should be furnished, the reduction
constituted an appealable issue.
However, the existing M+C regulations do not specify that notices
are routinely required in connection with reductions of services. The
notices are required only if the enrollee disagrees that the services
are no longer medically necessary.
We have reviewed several public comments on these issues, both
after the publication of the M+C interim final rule on June 26, 1998,
and again with respect to the January 24, 2000, proposed rule. Several
commenters both times strongly urged us to consider the administrative
and financial burden associated with notice requirements. They
maintained that it is unnecessary to require notification to enrollees
when services are reduced because the normal progression of a clinical
course of treatment is from increased to decreased services. Some
commenters have argued that providing detailed notices in all reduction
situations would be confusing, burdensome and intrusive upon the
physician/patient relationship.
Based on our review of current and previous comments on this issue,
we believe that the process of changing the notice requirement for
reductions of services is unnecessary, particularly in light of the
requirement that all enrollees receive notice of their appeal rights
before the termination of services in hospital and other provider
settings. We will monitor the new policy on discontinuations of
provider services, and if we find that it is necessary to create
additional procedures for reductions of services, we will initiate the
necessary rulemaking.
IV. Provisions of This Final Rule With Comment Period
A. Summary of Provisions
For the convenience of the reader, listed below are the major
changes to the M+C regulations that are set forth in this final rule
with comment period. This listing is intended solely as a reference aid
rather than as a comprehensive statement of the policies set forth in
the regulation text.
[sbull] New Sec. 422.502(i)(3)(iv) specifies that M+C organization
contracts with providers and other related entities entered into after
(the effective date of this final rule) must contain a provision
specifying that these entities will comply with the applicable notice
and appeal provisions in Sec. Sec. 422.620, 422.624, and 422.626.
[[Page 16663]]
[sbull] In Sec. 422.561, the definition of grievance is revised to
mean any complaint or dispute, other than one that constitutes an
organization determination, expressing dissatisfaction with any aspect
of an M+C organization's or provider's operations, activities, or
behavior, regardless of whether remedial action is requested.
[sbull] In Sec. 422.564, paragraph (c) clarifies that an enrollee
may file a quality of care complaint either with the QIO, the M+C
organization, or both entities. New paragraphs (d) and (e) establish
specific procedures for handling expedited grievances and for record-
keeping with respect to grievances, respectively.
[sbull] Section 422.620 provides that an M+C organization (or a
hospital that has accepted delegation of the authority to make the
discharge decision) must issue a written notice of noncoverage to any
M+C enrollee who disagrees with the M+C organization's decision to
discharge the enrollee. As discussed above, this represents a change
from the proposed provision that hospitals issue such notices for all
discharges of M+C enrollees.
[sbull] Section 422.624 sets forth the requirements for notifying
enrollees when their SNF, HHA, or CORF services are being terminated.
These procedures require that the provider deliver, generally no later
than two days before the termination of services, a standardized
advanced termination notice that informs the enrollee of the date of
discharge and how to file an appeal. As discussed above, the provisions
set forth in this final rule represent a change from the proposed
provisions, which would have required that more detailed notices be
delivered four days in advance of service termination.
[sbull] Section 422.626 establishes an enrollee's right to a fast-
track appeal of an M+C organization's decision to terminate these
provider services, and the requirements and procedures associated with
these fast-track appeals. This section explains the liability rules and
evidence standards during these appeals, and establishes the procedures
to be followed, including the responsibilities of M+C organizations and
the IRE that makes the decisions on the appeals. As discussed above,
this final rule with comment period provides that M+C organizations
must furnish detailed termination notices only to enrollees who timely
request a fast-track appeal but must furnish these notices to the
enrollee and the IRE on the day of the request. This change from the
proposed rule may result in a maximum of one day of potential financial
liability for services for an enrollee whose appeal is unsuccessful.
(Note that under existing M+C appeal procedures, an enrollee's
potential liability in an unsuccessful appeal would be at least 4
days.)
[sbull] Section 489.27 specifies that, as an element of the
provider's agreement to participate in the Medicare program, hospitals
and other providers must furnish beneficiaries with applicable OMB-
approved notices concerning their discharge rights, including the
hospital discharge notice required under section 1866(a)(1)(M) of the
Act and the advance termination notice for M+C enrollees whose SNF,
HHA, or CORF services are being terminated. This final rule with
comment period does not specify that a hospital discharge notice must
be provided the day before a discharge.
B. Decision To Issue a Final Rule With Comment Period
As discussed above, section 1869(b)(1)(F) of the Act, as revised by
section 521 of BIPA, requires that the Secretary establish a process by
which a beneficiary may obtain an independent, expedited determination
if he or she receives a notice from a provider of services that the
provider plans to terminate the services or discharge the individual
from the provider. Currently, this right to an expedited review exists
only with respect to hospital discharges (under sections 1154 and 1155
of the Act). On November 15, 2002, we published a proposed rule setting
forth the procedures needed to implement this statutory directive.
Clearly, the new appeal rights proposed in accordance with section
1869 of the Act in many ways resemble those envisioned by the Grijalva
settlement agreement and now set forth in this final rule. However, for
the most part, the January 24, 2001, proposed rule that preceded this
final rule was developed without the benefit of that statutory
direction. We believe it is prudent and appropriate to consider further
public comments on the requirements set forth here, now that the public
has had an opportunity to review our proposal to implement the BIPA
provisions. For example, we welcome comments on whether, and the extent
to which, the procedures set forth here for M+C enrollees and those
proposed to implement the BIPA expedited determination rights for
original Medicare beneficiaries can or should be integrated or
combined, or at least made uniform. If these additional comments result
in changes to these requirements, we will publish a subsequent final
rule to set forth these changes. (Note that publication of such a final
rule would not delay the implementation of the procedures established
under this final rule, which will begin on January 1, 2004, consistent
with our commitment not to implement significant changes to the M+C
program on a mid-year basis.)
V. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the comments in the preamble to the
document.
VI. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), agencies are
required to provide a 30-day notice in the Federal Register and solicit
public comment when a collection of information requirement is
submitted to the Office of Management and Budget (OMB) for review and
approval. To fairly evaluate whether an information collection should
be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comments on the following issues:
Whether the information collection is necessary and useful to carry
out the proper functions of the agency;
The accuracy of the agency's estimate of the information collection
burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection burden on
the affected public, including automated collection techniques.
Several commenters addressed the burden associated with the
proposed termination notice provisions, and these comments are
discussed in detail above in section III.B.3 of this final rule. As
discussed there, this final rule contains changes to these provisions
based on public comments. Our estimates of the revised information
collection requirements are set forth below, and we welcome further
comments on these issues.
Section 422.564--Grievance Procedures
As discussed in detail in section II.D of this preamble, this final
rule does not include the proposed detailed requirements with respect
to the general grievance procedures to be followed by
[[Page 16664]]
M+C organizations. Instead, we have largely maintained the existing
standard. That is, an M+C 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 M+C organization
notified the enrollee of the disposition. We have specified that an M+C
organization must respond to an enrollee's grievance within 24 hours if
the complaint involves an M+C organization's refusal to grant an
enrollee's request for an expedited organization determination or an
M+C organization's decision to invoke an extension on an appeal
request. M+C organizations must routinely respond to such grievances,
and although the 24-hour time frame represents a new requirement, it
does not affect the information collection burden. (Note that M+C
organizations already document their case files or notify enrollees
when they process requests for expedited reviews under Sec. Sec.
422.570 and 422.584, and invoke extensions to the organization
determination and reconsideration times frames under Sec. Sec.
422.568, 422.572, and 422.590.) Thus, while the new requirement is
subject to the PRA, the burden associated with this requirement is
captured by the requirements in Sec. Sec. 422.568, 422.572 and
422.590, approved under OMB number 0938-0829.
Section 422.620--How M+C Enrollees Must Be Notified of Noncoverage of
Inpatient Hospital Care
When 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 sections 422.2 and 422.113), the M+C organization (or hospital that
has been delegated the authority to make the discharge decision) must
provide a written notice of noncoverage when the beneficiary disagrees
with the discharge decision.
Based on the 2002 CMS Data Compendium, (CMS Publication Number
03437), there are approximately 11.8 million Medicare beneficiaries
discharged from hospitals each year. We extrapolate that approximately
1.8 million of these are M+C discharges. As discussed in section II.C
of this preamble, based on previous inpatient hospital appeals data
from the QIO's Standard Data Processing System, we estimate that about
0.1 to 0.2 percent (1,800 to 3,6000) of M+C enrollees' hospital
discharges will be disputed. We project that it would take M+C
organizations (or hospitals that have been delegated the authority to
make the discharge decision) approximately 30 minutes to prepare and
furnish the notice required in these cases. Thus, the total annual
burden associated with providing notices to M+C enrollees is
approximately 900 to 1800 hours. (Note that issuance of these notices
will not take effect until a separate PRA statement has been
published.)
Section 422.626--Fast-Track Appeals of Service Terminations to the IRE
An enrollee who desires a fast-track appeal must submit a request
for an appeal to the IRE, in writing or by telephone, by noon of the
first calendar day after receipt of the written termination notice. If
the IRE is closed on the day the enrollee requests a fast-track appeal,
the enrollee must file a request by noon of the next day that the IRE
is open for business.
In 1999, the Center for Health Dispute Resolution (CHDR), the
entity with whom CMS now contracts to conduct appeals of M+C
reconsiderations, reviewed approximately 3,000 cases involving services
provided by SNFs, HHAs, and CORFs. (Note that we have no way of knowing
the proportion of these cases that involved service terminations, but
for purposes of this analysis, we will make the assumption that all of
these 3,000 cases involve service terminations.) Based on the General
Accounting Office's 1999 Report to the Special Committee on Aging,
``Greater Oversight Needed to Protect Beneficiary Rights,'' managed
care organizations reverse their original adverse organization
determinations in approximately 75 percent of appealed cases.
Therefore, we believe that the 3,000 cases that went to CHDR likely
represent about 25 percent of all appeals (i.e., ``reconsiderations'')
involving affected providers that are now conducted by M+C
organizations. Thus, we estimate that the number of provider appeals
that would likely be heard by an IRE would be 12,000 cases. This
constitutes approximately 2 percent of the 616,500 M+C enrollees that
we estimate will receive termination notices, which we believe is a
reasonable estimate of the maximum number of enrollees that are likely
to file appeals with the IRE. It is estimated that it will take 12,000
enrollees 15 minutes to file an appeal on an annual basis. The total
annual burden associated with this requirement is 3,000 hours.
The enrollee may submit evidence to be considered by the IRE in
making its decision and may be required by the IRE to authorize access
to his or her medical records in order to pursue the appeal. It is
likely that no more than 10 percent of the 12,000 enrollees who file
appeals will also submit additional evidence. It is estimated that it
will take 1,200 enrollees 60 minutes to submit evidence on an annual
basis. That is, since enrollees may not be functioning at their maximum
capacity, they may need to contact family members, friends, or their
personal physicians who might provide assistance in gathering
additional evidence. The total annual burden associated with this
requirement is 1,200 hours.
Upon notification by the IRE of a fast-track appeal, the M+C
organization must supply any and all information, including a copy of
the notice sent to the enrollee, no later than by close of business of
the following day. It is estimated that it will take M+C organizations
60-90 minutes to gather and prepare a case file to send to the IRE.
Since we have estimated that approximately 12,000 enrollees would
request appeals, the total annual burden associated with this
requirement is 12,000-18,000 hours.
Upon an enrollee's request, the M+C organization must provide a
copy of, or access to, any documentation sent to the IRE no later than
close of business of the first day after the day the material is
requested. We estimate that 20% of the 12,000 enrollees who file an
appeal will request copies of information forwarded to the IRE. It is
estimated that it will take M+C organizations 15 minutes to provide a
copy of all of the information provided to the IRE, to 2,400 enrollees.
The total annual burden associated with this requirement is 600 hours.
If the IRE upholds an M+C organization's termination decision in
whole or in part, the enrollee may appeal by requesting that the IRE
reconsider its decision. It is estimated that 50 percent of the 12,000
appeals will result in the IRE upholding the M+C organization's
termination decision. Of those 6,000 cases, we estimate that 20 percent
of the enrollees will request a reconsideration by the IRE. It is
estimated that it will take 1,200 enrollees 30 minutes to file a
request for reconsideration on an annual basis. The total annual burden
associated with this requirement is 600 hours.
Section 489.27--Beneficiary Notice of Discharge Rights
A hospital that participates in the Medicare program must furnish
each Medicare beneficiary, or an individual acting or his or her
behalf, the notice of discharge rights required under section
[[Page 16665]]
1866(a)(1)(M) of the Act. In addition, providers (as identified at
Sec. 489.2(b)) that participate in the Medicare program must furnish
each Medicare beneficiary, or authorized representative, applicable CMS
notices in advance of the termination of Medicare services, including
the notices required under Sec. 422.624 of this part.
The information collection requirements associated with Sec.
489.27 are currently approved under OMB PRA approval number 0938-0692.
We have submitted a copy of this final rule to OMB for its review
of the information collection requirements in Sec. Sec. 422.564,
422.620, 422.624,and 422.626. The new hours associated with these
collections are summarized in the chart below.
------------------------------------------------------------------------
Estimated Burden
Section No. Entity Hours
------------------------------------------------------------------------
422.620......................... Hospitals.......... 900-1800
422.624......................... SNFs/HHAs/CORFs.... 200,320
422.626 (a) and (c)............. M+C Enrollees..... 4,200
422.626 (e)..................... M+C organizations. 12,600-18,600
422.626 (f)..................... M+C organizations. 600
------------------------------------------------------------------------
These requirements are not effective until they have been approved
by OMB. If you have any comments on any of these information collection
and record keeping requirements, please mail the original and 3 copies
within 30 days of this publication date directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Office of Regulations Development
and Issuances, Room N2-14-26, 7500 Security Boulevard, Baltimore, MD
21244-1850. Attn: Julie Brown, CMS-4024-FC.
And, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10235, New Executive Office Building,
Washington, DC 20503, Attn: Brenda Aguilar, CMS Desk Officer.
VII. Regulatory Impact Statement
A. Introduction
We have examined the impact of this rule under the criteria of
Executive Order 12866 (September 1993, Regulatory Planning and Review),
section 1102(b) of the Social Security Act, the Regulatory Flexibility
Act (RFA), Pub. L. No. 96-354, the Unfunded Mandates Reform Act of
1995, Pub. L. No. 104-4, and Executive Order 13132. Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects, distributive
impacts, and equity). A regulatory impact analysis (RIA) must be
prepared for major rules with economically significant effects ($100
million or more annually). We estimate a burden of not more than $10
million associated with this final rule. Thus, this rule does not meet
the $100 million threshold and is not, therefore, a major rule. In
accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
The RFA requires agencies, in issuing certain rules, to analyze
options for regulatory relief of small businesses. For purposes of the
RFA, small entities include small businesses, nonprofit organizations
and government agencies. Most hospitals, SNFs, and HHAs are small
entities, either by nonprofit status or by having revenues of $25
million or less annually. For purposes of the RFA, all providers
affected by this regulation are considered to be small entities.
Individuals and States are not included in the definition of a small
entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis for a final rule that may have a significant
impact on the operations of a substantial number of small rural
hospitals. This analysis must conform to the provisions of section 603
of the RFA. For purposes of section 1102(b) of the Act, we define a
small rural hospital as a hospital that is located outside of a
Metropolitan Statistical Area and has fewer than 100 beds.
We are not preparing analyses for either the RFA or section 1102(b)
of the Act because we have determined, and we certify, that this rule
would not have a significant economic impact on a substantial number of
small entities or a significant impact on the operations of a
substantial number of small rural hospitals. While it will have an
impact on small entities, the economic impact on any particular entity
will be negligible.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that would include any Federal mandate that may result
in expenditure in any one year by State, local, or tribal governments,
in the aggregate, or by the private sector, of $110 million. This rule
would not have such an effect on State, local, or tribal governments,
or on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that would impose
substantial direct requirement costs on State and local governments,
preempts State law, or otherwise has federalism implications. This rule
does not have a substantial effect on State and local governments.
Although a regulatory impact analysis is not mandatory for this
final rule, we believe it is appropriate to discuss the possible
impacts of the new appeals procedures on beneficiaries, providers, and
M+C organizations, regardless of the monetary threshold of that impact.
Therefore, a discussion of the anticipated impact of this rule is
presented below.
B. Scope of the Proposed Changes
As discussed in detail above, this final rule establishes new
notice and appeal procedures for enrollees when an M+C organization
decides to terminate coverage of services by SNFs, HHAs, and CORFs.
This rule specifies the responsibilities of M+C organizations and
providers in issuing termination notices associated with these new
appeal rights. It also clarifies the responsibilities of hospitals and
M+C organizations for informing Medicare beneficiaries of their right
to appeal a hospital discharge and amends the associated Medicare
provider agreement regulations with regard to beneficiary notification
requirements. Finally, it revises the existing regulations with respect
to M+C grievance procedures. In general, we believe that these changes
would enhance the rights of M+C enrollees and other Medicare
beneficiaries, without imposing any
[[Page 16666]]
significant financial burden on these individuals. The impact of the
final rule on M+C organizations and providers is discussed below.
C. New Notice and Appeal Procedures for Provider Terminations
(Sec. Sec. 422.624 and 422.626)
As explained in detail in the proposed rule, we examined available
appeals data from the Center for Health Dispute Resolution (CHDR), the
organization with whom CMS now contracts to conduct appeals of M+C
reconsiderations to project the likely number of appeals that may be
expected under these new provisions. (Under existing Sec. 422.592, any
case where an M+C organization's reconsideration results in affirming
an adverse organization determination is automatically sent to CHDR for
review.) Based on this analysis, we estimated that the annual number of
possible appeals that will be heard by an IRE under the procedures set
forth in this final rule will be approximately 12,000 cases. We
received no comments on the validity of this estimate and continue to
believe that it is realistic. (See our January 24, 2001, proposed rule
for further details--66 FR 6600-6602.)
Although commenters generally did not object to this volume
estimate, both provider and M+C industry commenters found the
procedures associated with implementing the new expedited appeals very
problematic. Throughout this preamble, we have acknowledged and
responded to the comments concerning the unnecessarily burdensome
nature of these procedures. As discussed in detail above, we have made
several significant changes to the notification procedures that we
believe should ameliorate these concerns. Most notably, this final rule
greatly simplifies the notice that providers furnish to enrollees whose
services are ending and provides that M+C organizations must furnish
detailed termination notices only to enrollees who timely request a
fast-track appeal.
Thus, for approximately 12,000 cases, M+C organizations will be
required under this final rule to make available to the enrollee a copy
of the detailed termination notice, and to the IRE, and to the enrollee
upon request, a copy of any documentation needed to decide on the
appeal. Although we recognize that there is an administrative burden
associated with this requirement, we believe that the existing M+C
reconsideration process would already result in the M+C organization
gathering and reviewing the case file to reach a termination decision.
Moreover, we note that this burden on M+C organizations is largely
offset by the fact that M+C organizations will no longer be responsible
for conduct internal reconsiderations of any cases covered under this
final rule. That is, IREs will conduct reviews not just of the 3,000
cases that now go to CHDR but also of the 9,000 cases that are now
subject to the M+C organization reconsideration process.
Similarly, with respect to providers, the requirements of this
final rule should prove much easier to implement than those in the
proposed rule. The required termination notices will be largely
standardized, requiring only the insertion of the enrollee's name and
discharge date. We estimate that it should take no more than 5 minutes
to deliver such a notice, at a per-notice cost of no more than $7.50
(based on a $30 per hour rate if the notice is delivered by health care
personnel). Based on an estimated 600,000 notices annually, we estimate
the aggregate cost of delivering these notices should be less than $5
million.
Thus, we believe that the new notice and appeal provisions of this
final rule should have minimal financial impact on M+C organizations
and providers. We note that both the advance termination notice and the
detailed termination notice will be developed through OMB's Paperwork
Reduction Act process and thus will be the subject of further
opportunity for public comment.
D. Hospital Discharge Notices (Sec. Sec. 422.620 and 489.27)
Under the proposed rule, hospitals would have been required to
issue a standardized discharge notice to each Medicare beneficiary
twice during an inpatient stay, that is, once at or near the time of
admission and again before discharge. The second notice (a revised
version of the Important Message from Medicare now required under
section 1866(a)(1)(M) of the Act and 489.27) would have included more
detailed information about the reason for the discharge. Comments on
this proposal, many of which focused on the administrative burden
associated with this notice, are discussed in detail above. We
estimated that the additional aggregate burden on hospitals would
exceed $100 million.
Under this final rule, hospitals instead will continue to be
responsible for issuing the Important Message from Medicare to all
Medicare inpatients, as well as for issuing HINNs to inpatients covered
under the original Medicare program when they indicate that they
disagree with a hospital's discharge decision. These requirements are
identical to those currently in effect and thus will entail no
additional burden for hospitals.
All inpatient enrollees in the M+C program will also continue to
receive the Important Message from their hospital during an admission.
In addition, consistent with the notice requirement for other Medicare
beneficiaries, we are revising 422.620 to specify that M+C
organizations are responsible for providing a written notice of
noncoverage when an enrollee disagrees with a discharge decision. The
notice must be issued no later than the day before hospital coverage
ends and must explain the reason why care is no longer needed, the
enrollee's appeal rights, and the effective date of time of the
enrollee's liability for continued inpatient care. Again, we estimate
that the incidence of this notice will be no more than 0.1 to 0.2
percent of all M+C enrollee discharges, or roughly 1800 to 3600
notices, at an estimate aggregate annual cost to M+C organizations of
$15,000-$30,000. Again, all of the required notices for hospital
inpatient discharges will be published through the OMB PRA process.
E. Grievance Procedures (Sec. 422.564)
Grievances essentially include any complaint or dispute, other than
one that constitutes an organization determination, expressing
dissatisfaction with any aspect of an M+C organization's or provider's
operations. As discussed in detail above, the primary new requirements
set forth under this final rule (422.564(d) and (e)) are that an M+C
organization establish specific procedures for handling expedited
grievances and for record-keeping with respect to grievances,
respectively.
Again, we have carefully examined the grievance procedures now in
use by M+C organizations, and in particular the grievance procedures
spelled out in the NAIC's Model Grievance Act, in developing these
procedures. We believe that M+C organizations are in large measure
already in compliance with the grievance procedures set forth here, and
thus these requirements will have no substantial impact on most M+C
organizations.
F. Federalism Summary Impact Statement
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has federalism
implications.
[[Page 16667]]
This rule would not have a substantial effect on State or local
governments.
In accordance with Executive Order 12866, this regulation was
reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare+Choice, Penalties, Privacy,
Provider-sponsored organizations (PSO), Reporting and recordkeeping
requirements.
42 CFR Part 489
Health facilities, Medicare, Reporting and recordkeeping
requirements.
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For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 422--MEDICARE+CHOICE PROGRAM
Part 422 is amended as set forth below:
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1. The authority citation for part 422 continues to read as follows:
Authority: Secs. 1102, 1851 through 1857, 1859, and 1871 of the
Social Security Act (42 U.S.C. 1302, 1395W-21 through 1395w-27, and
1395hh).
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2. In Sec. 422.561, the definition of ``grievance'' is revised to read
as follows:
Sec. 422.561 Definitions.
* * * * *
Grievance means any complaint or dispute, other than one that
constitutes an organization determination, expressing dissatisfaction
with any aspect of an M+C organization's or provider's operations,
activities, or behavior, regardless of whether remedial action is
requested.
* * * * *
3. Section 422.564 is revised to read as follows:
Sec. 422.564 Grievance procedures.
(a) General rule. Each M+C 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
M+C 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 M+C 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 M+C organization. For
quality of care issues, an enrollee may file a grievance with the M+C
organization; file a written complaint with the QIO, or both. For any
complaint submitted to a QIO, the M+C organization must cooperate with
the QIO in resolving the complaint.
(d) Expedited grievances. An M+C organization must respond to an
enrollee's grievance within 24 hours if:
(1) The complaint involves an M+C organization's decision to invoke
an extension relating to an organization determination or
reconsideration.
(2) The complaint involves an M+C organization's refusal to grant
an enrollee's request for an expedited organization determination under
Sec. 422.570 or reconsideration under Sec. 422.584.
(e) Recordkeeping. The M+C 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 M+C
organization notified the enrollee of the disposition.
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4. Section 422.620 is revised to read as follows:
Sec. 422.620 How M+C enrollees must be notified of noncoverage of
inpatient hospital care.
(a) Enrollee's entitlement. (1) 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 Sec. Sec. 422.2 and 422.113),
the M+C organization (or hospital that has been delegated the authority
to make the discharge decision) must provide a written notice of
noncoverage when--
(i) The beneficiary disagrees with the discharge decision; or
(ii) The M+C organization (or the hospital that has been delegated
the authority to make the discharge decision) is not discharging the
individual but no longer intends to continue coverage of the inpatient
stay.
(2) An enrollee is entitled to coverage until at least noon of the
day after such notice is provided. If QIO review is requested under
Sec. 422.622, coverage is extended as provided in that section.
(b) Physician concurrence required. Before notice of noncoverage is
provided, the entity that makes the noncoverage/discharge determination
(that is, the hospital by delegation or the M+C organization) must
obtain the concurrence of the physician who is responsible for the
enrollee's inpatient care.
(c) Notice to the enrollee. The written notice of non-coverage must
be issued no later than the day before hospital coverage ends. The
written notice must include the following elements:
(1) The reason why inpatient hospital care is no longer needed.
(2) The effective date and time of the enrollee's liability for
continued inpatient care.
(3) The enrollee's appeal rights.
(4) Additional information specified by CMS.
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5. New Sec. Sec. 422.624 and 422.626 are added to subpart M to read as
follows:
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 M+C
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 must deliver valid
written notice to the enrollee of the M+C 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
M+C 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
[[Page 16668]]
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 M+C 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 M+C
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.
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 M+C
organization's termination decision. An enrollee of an M+C organization
has a right to a fast-track appeal of an M+C 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 M+C 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 the termination notice,
unless the enrollee appeals and the IRE reverses the M+C organization's
decision. If the IRE's decision is delayed because the M+C organization
did not timely supply necessary information or records, the M+C
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 M+C 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 M+C organization's
decision to terminate services to an IRE, the burden of proof rests
with the M+C 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 M+C organization must supply any and
all information that an IRE requires to sustain the M+C 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 M+C 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 M+C 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 M+C organization and the provider that the enrollee has filed a
request for a fast-track appeal, and of the M+C 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 M+C 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 M+C 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 M+C 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 M+C
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 M+C organization. (1) When an IRE
notifies an M+C organization that an enrollee has requested a fast-
track appeal, the M+C 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 M+C
organization.
[[Page 16669]]
(iii) Any applicable M+C 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 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 M+C organization must provide
the enrollee a copy of, or access to, any documentation sent to the IRE
by the M+C organization, including records of any information provided
by telephone. The M+C 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 M+C
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 M+C
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 M+C 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 M+C organization that an appeal has been received from
the enrollee. The M+C 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 M+C 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 M+C organization's termination decision,
the M+C 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
M+C 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 DAB, 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 M+C 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 M+C organization or provider.
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
Part 489 is amended as set forth below:
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1. The authority citation for part 489 continues to read as follows:
Authority: Secs. 1102, 1819, 1861, 1864(m), 1866, and 1871 of
the Social Security Act (42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m),
1395cc, and 1395hh).
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2. In Sec. 489.20, paragraph (p) is revised to read as follows:
Sec. 489.20 Basic commitments.
The introductory text of Sec. 489.20 is republished without change
and paragraph (p) is revised to read as follows:
The provider agrees to the following:
* * * * *
(p) To comply with Sec. 489.27 of this part concerning
notification of Medicare beneficiaries of their rights associated with
the termination of Medicare services.
* * * * *
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3. Section 489.27 is revised as follows;
Sec. 489.27 Beneficiary notice of discharge rights.
(a) A hospital that participates in the Medicare program must
furnish each Medicare beneficiary, or an individual acting on his or
her behalf, the notice of discharge rights required under section
1866(a)(1)(M) of the Act. The hospital must provide timely notice
during the course of the hospital stay. For purposes of this paragraph,
the course of the hospital stay begins with the provision of a package
of information regarding scheduled preadmission testing and
registration for a planned hospital admission. The hospital must be
able to demonstrate compliance with this requirement.
(b) Notification by other providers. Other providers (as identified
at Sec. 489.2(b)) that participate in the Medicare program must
furnish each Medicare beneficiary, or authorized representative,
applicable CMS notices in advance of the termination of Medicare
services, including the notices required under 42 CFR 422.624. These
notices must be approved by the Office of Management and Budget prior
to implementation under section 3506(c)(2)(A) of the Paperwork
Reduction Act.
Dated: February 10, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
Approved: February 25, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-8204 Filed 4-1-03; 2:28 pm]
BILLING CODE 4120-01-P