Centers for Medicare & Medicaid Services

Department of Health and Human Services,

Attention: CMS--4127--P

P.O. Box 8016

Baltimore, MD 21244--8016.

Re: File Code CMS--4127--P

73 Federal Register 14341 (March 17, 2008)

Submitted electronically: http://www.regulations.gov.

To Whom It May Concern:

Disability Rights Wisconsin submits the following comments to the
above-described proposed rules concerning the application of certain
appeals provisions to the

Medicare prescription drug appeals process. Disability Rights Wisconsin
is the protection and advocacy agency for our state. We also run a
prescription drugs helpline for people with disabilities. Our helpline
works directly with thousands of Medicare Part D beneficiaries each
year. We thank you for the opportunity to comment.

[COMMENTS ON HIGHTLIGHTS AND ORGANIZATION SECTION]{.underline}

We take issue with the statement in the Highlights and Organization
section of this notice "that while we are proposing to make conforming
changes to the language of some of the redesignated sections, we are not
proposing to make any substantive changes to the policies established by
these provisions." (Page 14343.) This is misleading and disingenuous.
While some changes can be appropriately classified as nonconforming,
many more of the general appeals provisions changes, especially those to
the time frames, submission of evidence, ALJ remand criteria, and
participants at a hearing, are definitely substantive.

[COMMENTS ON OTHER GENERAL COMMENTS SECTION]{.underline}

The notice states in this section (page 14346) that CMS is not including
in these regulations enrollment or entitlement appeals, because SSA does
not perform appeals regarding enrollment in or entitlement to Part D. If
that is so, then what entity does perform these appeals, especially,
although not limited to, special enrollment period eligibility appeals,
and where in the regulations IS that addressed? Advocates have had
clients who have experienced a continuous run-around when trying to
challenge an enrollment or entitlement appeal, with their plan,
1-800-Medicare ,and sometimes the regional office and/or SSA all
claiming they are not responsible. A clear statement of where
responsibility lies, and the appeals process to use when the responsible
entities do not do their job or when the beneficiary disagrees with the
decision, is needed to address these problems.

[COMMENTS ON PROVISIONS OF THE PROPOSED REGULATIONS]{.underline}

[General comments concerning timeframes for deciding appeals at the ALJ
and MAC levels]{.underline}

We have three recommendations in regard to timeframes under the proposed
regulations. First, enrollee and advocate experience to date with CMS,
IRE and Part D sponsor's respect for timelines has been dismal, at best.
Clearly, something must be done to improve this situation. A suggestion
would be that any request not responded to within the designated time
frame be deemed approved and the pharmacist be authorized to fill the
prescription.

Second, we ask that CMS specify in the regulations, as is stated on page
14345, that "(a)ll time periods in this proposed rule refer to calendar
days." This is not stated anywhere in the proposed regulations and
experience to date has been that weekends and holidays have been
excluded in timeframe calculations with unfortunate frequency. Including
this statement in the regulations themselves will hopefully provide
greater assurance of compliance.

Third, throughout the regulations, expedited determinations should be
automatic when there has been an expedited decision at a lower level.
The decision whether to expedite has already been made. Another decision
should not have to be made at any subsequent level(s). This would be
crucial even if there were provisions for escalation; without such
provisions, it is essential. This is a practical concern from the
perspective of the enrollee. Doctors who have already provided
statements to the Part D plan to satisfy the requirements for expedited
review, as well as medical statements of the need for the drug in
question, are often reluctant to keep providing the same information at
each level of review. Asking them to re-submit their statement at the
ALJ and the MAC levels of review only adds to their already large Part D
paperwork burden.

[§ 423.1972 Request for an ALJ hearing; § 423.2002(a) Right to an ALJ
hearing]{.underline}

These two provisions of the proposed regulations are inconsistent.
Section 423.1972(b) requires a beneficiary to request an ALJ hearing
within 60 days of the date on the [decision]{.underline} by the
Independent Review Entity (IRE). Section 423.2002(a)(1), however, says a
beneficiary may request within 60 days after [receipt]{.underline} of
the written notice of the IRE's reconsideration. Meanwhile, § 423.2002
itself is internally inconsistent. Subsection (b)(2), which addresses
requests for expedited ALJ hearings, gives an enrollee 60 days from the
date of the IRE notice to request the hearing.

The regulations should be consistent, so as to minimize beneficiary
confusion, and should be consistent with the time frames for appeals
under Parts A and B. The Part D appeals regulations should include the
following elements of the Part A/B appeals regulations: all timeframes
for beneficiary appeals should begin with the date of receipt of the
IRE's decision, with the date of receipt presumed to be five days after
the date of the notice, absent evidence to the contrary. Additionally,
the regulations should include the language of the Part A/B regulations
that provides for an extension of time for requesting an ALJ hearing for
good cause. See 42 C.F.R. § 405.1014 (ALJ); § 405.1102 (MAC).

[§ 423.1980 Reopenings of coverage determinations, redeterminations,
reconsiderations, hearings and reviews]{.underline}

We commend the agency's acknowledgement of the enrollee's right to
request a reopening of an unfavorable decision. Upon requesting a
reopening, however, many enrollees may believe that the deadline to
appeal the unfavorable decision has been extended by their reopening
request. This confusion can be devastating -- if the request to reopen
is denied after the deadline to appeal the unfavorable decision has
passed, or if an unfavorable decision is issued upon reopening, the
enrollee could lose the right to appeal the claim at issue. For this
reason, the regulations should clearly state that a request to reopen
extends an enrollee's timeframe to appeal the unfavorable decision and
the duration of the extension.

[§ 423.1990 Expedited access to judicial review]{.underline}

Providing expedited access to judicial review will benefit many
enrollees. However, the proposed regulations currently lack any
provision for those enrollees who have appealed to an ALJ or the MAC and
have not received a decision in timely manner, but whose claims do not
raise issues that can only be resolved by a federal court. A provision
allowing escalation to the MAC or to federal court, similar to 42 C.F.R.
§ 405.1104 and 42 C.F.R. § 405.1132, respectively, should be
incorporated into the Part D regulations.

[§ 423.2010 When CMS, the IRE, or Part D plan sponsors may participate
in an ALJ hearing;]{.underline}

The Part D statute and current rule do not provide for CMS, the IRE, or
the Part D sponsor to be a party to the hearing. One has to assume that
this is deliberate. The hearing is a non-adversarial forum to allow the
plan member, or his or her representative, to present his arguments and
position. Allowing the ALJ to request CMS, IRE and/or Part D sponsor
participation, or CMS, the IRE and/or the Part D sponsor to request
participation in the hearing process - even though not given party
status - is thus inappropriate and could be a distinction without a
difference. It is also unclear why their participation would be
necessary or valuable. Participation will only serve to add unnecessary
confusion to the hearing, allow the participant to behave as a party
and, even with appropriate advance written notice, which must be made an
absolute requirement, blindside the enrollee.

The experience of advocates to date demonstrates why we are concerned
that participation by these entities at an ALJ hearing gives them a
greater role than they are accorded under the Medicare statute. Plan
sponsors are often represented at ALJ hearings by medical professionals,
such as doctors, nurses or pharmacists. Officially, these medical
professionals are *participating* in the ALJ hearing as representatives
of plan sponsors, and, consequently, no advance notice is given to
beneficiaries that any experts will be present at their hearings.
Nevertheless, ALJs often turn to these professionals for answers to
medical questions that arise during hearings -- including general
questions (i.e., not pertaining to the particular enrollee's case) --
essentially allowing these plan sponsor representatives to submit expert
testimony without any opportunity for the beneficiary to prepare by
bringing his or her own expert to the hearing. By allowing them to
participate in hearings, ALJs are giving them a greater role than that
to which they are entitled, and denying enrollees and their
representatives an opportunity to present opposing testimony.

We urge CMS to deny these entities the right to participate at the
hearing. If CMS insists on permitting plans to participate , then the
regulations should more clearly state that ALJs may not rely on
representatives of CMS, the IRE, or a Part D plan sponsor participating
in the hearing for expert testimony or information. The regulations
should also provide ALJs with the authority to request expert testimony
from outside medical professionals who are not connected in any way with
the plan , with the IRE, or with CMS. Finally, §423.2010(a) should
include a set time frame by which the ALJ may request the participation
of CMS, the IRE, or a plan sponsor, preferably within 5 days of receipt
of the hearing request for a non-expedited appeal.

[§ 423.2016 Timeframes for deciding an appeal before an ALJ]{.underline}

We thank CMS for its decision to extend the 90-day time frame for Part
A/B ALJ decisions to decisions concerning Part D cases. We particularly
support the decision to provide for expedited hearings and to require
decisions to be issued within 10 days. As CMS acknowledges in the
background section, shortened time frames may be critical, particularly
where the plan enrollee has not yet obtained a needed prescription.

Section 423.2016(b) says that the ALJ "[may]{.underline} consider" the
standards for an expedited hearing met if a request for expedited review
was granted at a lower level of review. As stated earlier, we ask CMS to
require the ALJ to grant expedited consideration to an appeal that has
been accorded expedited consideration previously.

[§ 423.2018 Submitting evidence before the ALJ hearing]{.underline}

This section requires that an enrollee submit all written evidence to be
considered at the hearing with 10 days, 2 days if expedited, of
receiving the notice of hearing. These regulations are supposed to, but
do not, mirror the regulations in Part 405, which provide that the time
frames for admission of evidence do not apply to oral testimony given at
a hearing or to evidence submitted by an unrepresented
beneficiary---interpreted to include beneficiary advocates who are often
not contacted by the beneficiary soon enough to enable compliance.
§405.1018. The Medicare A and B rationale is applicable to Medicare D
and the same exception for beneficiaries should apply. There should be
no limitation on the enrollee's ability to submit evidence.

This section also provides that, if an enrollee wishes to have evidence
about changes in his or her condition since the coverage determination
considered in an appeal, the submission of the new evidence will result
in a remand of the case to the Part D sponsor. This proposal is a sure
recipe for disaster and destined to result in further delay.

In the experience of advocates, plan sponsors routinely fail to abide by
relevant appeals rules and regulations, unnecessarily -- and sometimes
dangerously -- lengthening the appeals process for enrollees. For
instance, submitted appeals, including appropriately documented requests
for expedited appeals, are often not responded to in a timely fashion,
ignored, or lost altogether, and plan representatives frequently have no
knowledge of submitted appeals and cannot give callers information on
their status. Remanding a case to a Part D plan sponsor may be
equivalent to sending it into a black hole -- and the enrollee may go
without medically necessary medication as a result. Much of the new
evidence will consist of further deterioration in condition that results
from the denial of the prescribed medication. Enrollees experiencing a
change of or deterioration in condition should not be further penalized
by having to go back to the plan and wait longer for an independent
review.

If a remand is required, the case should be remanded to the IRE, rather
than the Part D plan sponsor.

If remand is required either to the plan or to the IRE, the regulations
should include very strict timelines for responding to an appeal, and,
if the timelines are not met, the case should automatically be sent to
the ALJ.

It is unclear from these proposed regulations whether submitting
evidence of changes in condition in support of a pending appeal and
submitting a request for a new coverage determination, which could be
faster, are mutually exclusive. We ask for clarification of this issue.

[§423.2020 Time and place for a hearing before an ALJ]{.underline}

Although the regulations state that the good cause examples for
requesting a rescheduling listed in §423.2020(g)(3) are not all
inclusive, advocate experience has shown that they are often regarded as
such. We request an explicit statement that the need for more
preparation time by a representative appointed within 10 days, or 2 days
if expedited, of a hearing or a prior commitment to be in court or at
another administrative hearing on the date scheduled for the hearing are
not the only acceptable situations in which good cause can be found.

[§ 423.2022 Notice of Hearing]{.underline}

The regulations provide insufficient time for notification to the
enrollee of the participation of CMS, the IRE, and or the Part D sponsor
for the reason stated above.

[§ 423.2034 When an ALJ may remand a case]{.underline}

We reiterate our concerns about remanding a case. We object to a remand
to the Part D sponsor. We also urge CMS to include in the regulations
specific time frames for deciding a remanded case or for forwarding
missing information to the appropriate hearing officer, including the
ALJ. At a minimum, the Part D plan sponsor and the IRE should be
required to forward missing information within 5 calendar days. The IRE
should issue a remanded decision within the same time frame for standard
and expedited reconsiderations.

[§ 423.2036 Description of an ALJ Hearing]{.underline}

We disagree with the decision not to apply to Part D § 405.1036(f),
which provides for a subpoena at the request of a party. Despite what
CMS indicates, the Part D hearings we have attended are adversarial,
even when the IRE and the Part D plan sponsor are considered only
"participants' and not parties. As we have stated, beneficiaries may
need to bring their own experts to counteract the treatment by the ALJ
of the plan representatives as medical experts.

Even if the hearing is not adversarial, subpoena power may still be
necessary to ensure access to medical records and ensure participation
by the beneficiary's physician at the hearing. Again, as we have stated,
some physicians are reluctant to provide medical records or to
participate in the hearing because of the already burdensome nature of
the Part D coverage and appeals process. Beneficiaries in some
situations may need to request a subpoena to have the testimony and
other evidence they need presented before the ALJ.

[§ 423.2046 Notice of an ALJ decision]{.underline}

Section (a)(3) of the proposed regulation provides that a copy of the
decision will be mailed "to the enrollee." We propose adding that a copy
of the decision will also be mailed to the enrollee's representative, if
one has been appointed. This will allow advocates to better assist
beneficiaries, saving time and potential confusion.

[§ 423.2048 The effect of an ALJ's decision]{.underline}

Chapter 18, Section 130.4 of the CMS Prescription Drug Benefit Manual
requires the IRE to monitor plans' effectuation of any
decisions/determinations that fully or partially reverse an adverse
coverage determination. In our experience, plans often do not promptly
and fully effectuate reversals of adverse determinations. Consequently,
monitoring of plans' compliance with reversals is particularly
important. We propose that this responsibility also be set forth in the
regulations.

[§423.2108 Standard for expedited treatment]{.underline}.

As discussed with ALJ review, we urge that §423.2108(d) provide that the
MAC "must," rather than "may," consider the standard for expedited
review met if a lower level of adjudicator has granted a request for an
expedited appeal.

[§423.2110 MAC reviews on its own motion.]{.underline}

We agree with CMS that limiting requests for MAC review of the IRE and
excluding plans from making such requests is a reasonable approach that
promotes administrative efficiency. We have concerns, however, about the
bases for these requests. As noted in the background statement, the IRE
is the repository of MAC decisions. Such decisions are not available to
enrollees or their representatives. Advocates have seen several
situations where the IRE has discussed particular prior MAC decisions in
its request for MAC review and has made substantive arguments based on
those opinions. This practice denies enrollees the most basic due
process rights since they do not even have access to the documents that
are being used to argue against their coverage claim. Without such
access, an enrollee is unable to determine whether the IRE is accurately
characterizing the holding of the MAC or whether the facts of the cited
cases are comparable to their own. The practice also violates the
privacy rights of the beneficiaries named in the cited cases, since the
IRE memoranda often disclose private medical facts.

We urge CMS to add to the regulation a provision that requires that any
case the IRE cites to the MAC must be provided to the enrollee or the
enrollee's representative in redacted form and that all references to
prior decisions protect the privacy of beneficiaries. If such cases are
not provided to the enrollee, the MAC should be precluded from relying
upon them in its decision.

Advocates also have seen instances where the IRE has participated in ALJ
hearings and cited MAC cases to the ALJ, and not always accurately. We
urge CMS to include the same requirement in the regulations governing
ALJ hearings as well.

This regulation at §423.2110(b)(2)(iv) also requires that an enrollee
submitting comments to the MAC must send the comments to CMS or the IRE.
This requirement is a burden on unrepresented enrollees who are unlikely
to understand their responsibilities. The regulation should instead
provide that the MAC will send copies to CMS or the IRE.

[§423.2112 Content of request for review.]{.underline}

We are concerned that the current requirements for the content of
requests for review are overly rigid for unrepresented enrollees and for
enrollees who are represented by family, friends or other untrained
advocates. We urge instead that, if the information required in
§423.2112(a)(4) is incomplete, the MAC must be required to contact the
enrollee or representative to obtain such missing information and not be
permitted to dismiss the appeal unless reasonable inquiries have failed.
We also are concerned that §423.2112(c) is overly harsh in situations
where a request for review is initially filed for an enrollee by a
representative who is a friend, relative or other lay advocate and the
enrollee subsequently obtains assistance from a trained advocate. To
accommodate such situations, we urge a provision allowing liberal leave
to amend the request for review to add issues as appropriate.

[§423.2114 Dismissal of Request for Review.]{.underline}

CMS is proposing that a request for review may be dismissed if the
enrollee dies while the request for review is pending and the enrollee's
representative, if any, either has no remaining financial interest in
the case or dose not continue the appeal. As written, the provision does
not protect what could be substantial financial interests of the estate
of a deceased beneficiary who had paid for prescription drugs and was
seeking reimbursement for those payments. When a beneficiary dies, the
beneficiary's appointment of a representative, like any power of
attorney, expires. Yet, when a reimbursement is at issue, the estate
still has a claim against the plan sponsor. Thus the regulation should
provide instead that, where a claim is for reimbursement, the proceeding
may be stayed for up to 90 days to provide time for the authorized
representative of the estate to review the matter and determine whether
to continue the appeal. A similar provision should be added to the
provisions covering ALJ hearings.

[Sec 423.2122 What Evidence May be Submitted.]{.underline}

We reiterate our comments in the ALJ section opposing the requirement
that a case must be remanded to the plan if a beneficiary seeks to have
evidence of a change in medical condition considered. This requirement
is particularly onerous at the MAC level where, even with expedited
treatment, a beneficiary can have been without needed medication for a
considerable length of time and the likelihood of a worsening of
condition is increased. Low income beneficiaries unable to cover the
costs of medication while pursuing an appeal are particularly vulnerable
and should not be required to make strategic decisions about whether to
forfeit the right to consideration of all evidence, including evidence
of a worsening medical condition, in order to get review by the MAC.

[COMMENTS ON REGULATORY IMPACT ANALYSIS]{.underline}

In the section entitled *Alternatives Considered* CMS invites comments
on additional or alternative reforms that could improve the appeals
process further. An immediate response to this invitation is to request
that reforms not be limited to the third and fourth levels of appeals
only, but that reforms also address the coverage determination,
redetermination and reconsideration regulations, such as providing for
automatic approval of a coverage request which has not been timely
decided.

Thank you for the opportunity to submit comments on this important
topic. Please feel free to contact us if you have any questions.

Sincerely

Eva Shiffrin

Program Attorney

Disability Rights Wisconsin

131 W. Wilson St., Suite 700

Madison, WI 53704