CMS-10137 30-day comments #2 thru #4

Caporale Ofice:
8170 3 r d Avenue South

Blwm~nglocr.MN 55425

Mailing Address.
P.O. Box 1309
Mnneapol~s.MN 55440-1309

haalthpmtnersmm

OMB Hum11Rtsources and Housing Branch
Anention. Carolyn Lavcqt
Ncw Esccuriuc Office Uuildiy,

Room 10235
Washinbeon, DC 20503

Rc

Part D Scrvice Area Expuion Applical.ion
Medicare Admtage Master Application

Dear Ms.Lovclt.
Anached, please find our comments regarding the proposed applications.

If you have any questions, plcac fccl free to conua mc ar 952-967-5 183.

Attachnients:

Medicare Advanage Master Applics~ionsCornmcnt Documcnt
Psn D SAE Application Commenr Documenc

Medicare Advantage Masfer Application Comments
1 1/07
First: We would like to commend CMS on the automation and sirearnlining of the application process.

Section

Page

Subject

Overall

Comment
1. Will all users have access to [he application module or will there be a
separate process b r rcquestiog se&ity for certain HPMS Users?
2. Will plans have an opportunity to view the application tool on KPMS
and provide comrncnts?
3. Will the application tool have a tracking page so we can see which
I
elements or uploads are missing?
4. There should b t sensitivity added to the yesfno answers in attestation
I
boxes.

10

10.3

Protecting Coi~fidential
Information
Administrafive

Management
Cotnplimce Plan

1.5

15

5. If we upload a document on HPMS on 311 and need lo subnrit a
revised version on 3/9, does that hnctionality exist?
We used to define specific sections of our applications as confidcotial and
proprietary in ihc cdver lener that accornpa&d the application. How will this
designation be made in an online (HPMS) submission?
Number I0 - replact "executive manager" with "chief executive officer"

The instructions shotlld specify that the provisions in application will be
implemented by 0 I/OL/09 unless specifically noted in individual attestations.

1 18

I

1 1.7.3.
1.9.2,3,4

19

20

29

I

( Fiscal Soundness

Provider Contracts &
Agreements
1.10.9
Contracts and
I Administration and
Management Services
1.13.2.A. 19 Enrollmcnl, Disenrollment
and Ejigibility
1.13.2.A.2 1 Same

P

21

I

We have a concern about the word "any" financial concerns. This is too
broad. Need definitive language.
NiA for PFFS. Plans use Terms and Conditions. Please provide allowance in
attestations.
This stakment spccifies Part C. Does Ihat mean the othcr statements apply to
I both Parts C and D? Please spccif>l.

Spelling enor - "disenlbroils"

How is this different than # I , #2 and #4?

I

I

Mcdicarc Advantage Mestcr Application Comnlents
1 1/07
29

1.13.3.2

Working Aged Membership Please add limiting language, example "...to the extent we are aware of other

$0
30
30
31

1.13.4
I .13.4.3
1.14
1.15

Claims
Claims

35

1.20

40

3.1.8.

Access toservices

45
SO

1.2.2
1.5

State Licensure
HSD

Minimum Enrollment
Comrnunicafion between
MA plan and CMS
Medicare Advantage
Certification
- - -

53

I

D.

covcragc.':
Please define prompt.
Please clarify "denial." Denial of what??
Refcrcnccs refcr to same section.
Please clarify date action rnusr be completed. We are assuming before
January In.
Typically, the application is completd by staff no1 authorized lo bind he
organization. WilI CMS separate this piece for ofticers? Will h i s be a
printed documen(? Do oficers need HPMS access?
1s tllis for network plans only? PFFS plans do not have neMtorks hence, no
HSD lables.
Please remove "some type" language is too broad.
PFFS p l a ~ do
s not have a contracted provider netwoxk.
Spelling error "are" should be "area"

M U D Employer Group Application
Page
3

Section

Name
Application Instructions

Comment

HPMS dara is performed by staff not authorized lo bind [he
organization through certifications or attestations. Does CMS have
, rccomendalions for this or do our executives need HPMS access?

NOU- 13-2807
-

13: 19

,

TOTAL P. 04

November 12,2007
Carolyn Lovett
OMB Human Resources and Housing Branch
New Executive Office Building, Room 10235
Washington, DC 20503
Dear Ms. Lovett:
I would like to thank the Centers for Medicare and Medicaid Services (CMS)for this
opportunity to review and submit comments related to the draft of 2009 MA, MA-PD and
PDP Applications. After reviewing CMS' revisions, we request the following
clarifications to assist plans in completing the applications.

Section 3.6.A.8 page 43 of MA-PD application
Section 3.5.A.18 page 42 of PDP application
We suggest that CMS add the following clarification, after the requirement :'Applicant
agrees to provide CMS with the 4 Rx data for all their enrollees as part of the enrollment
transaction. The reports should verify that the Applicant's plan demonstrates the ability
to have 4 Rx data in place for 95% of its prospective dual eligible enrollees." For those
cases in which the enrollee was auto assigned, facilitated, or otherwise a CMS
generafed enrollment., the 4Rx data would be submitted via a change transaction, after
receiving the enrollment transaction from CMS.

HSD table instructions in the 2009 MA Application (starting page 107 of MA
application)
We requests clarification for three of the elements in the HSD tables:
HSD-1, Medicare Provider Breakdown-Nos. 2 & 3 on the table instructions.
The table requires a breakdown of physicians by specialty into physicians
who are 'Direct with MAO' and 'Downstream Arrangement'. We are
requesting clarification as to whether the term 'Direct with MAO' would
include only single. directly contracted providers (i.e.a one-to-one
agreement between the MA0 and physician) or if it would also include a
contract between the MA0 and a physician practice where the providers did
not sign individual agreements, but are signatories to a group agreement.

HSD-2, Medical Group Affiliation, No. 12 on the table instructions. The
instructions state that "For example, if you have a provider with a direct
contract that is affiliated with a 'XYZ' medical group/lPA you must input 'DC'
in column number 3 and the name of 'XYZ' medical group1lPA in column 16".
There is no 'DC' in the Contract Type instructions under No. 3. We request
that CMS clarify if this means '0'for direcf since that is how it is designated
elsewhere on the table.

6705 Rockledge Dnve Suice 900 Bcthesda, MD 20817-1850
301-581-0600

500-843-7421

Carolyn Lovett
November 12,2007
Page 2

HSD-2, Employment Status. No. 13 on the table instructions. The
instructions state to "Indicate whether the provider is an employee of a
medical group/lPA or whether a downstream contract is in place for that
provider. Insert 'E' if the provider is an employee. Insert 'DC' if a
downstream contract is in place for the provider." We are asking for
clarification in the event that this is not a mutually exclusive arrangement.
There may be instances in which an employee of a medical group is still in a
downstream relationship to the MAO. Is this element asking whether the
physician is an employee of or has a downstream contract with their medical
group/lPA? Please clarify how the physician should be listed if they are both
an employee of the medical group1lPA and delegated with the MAO.

Again, thank you for the opportunity to provide input into the 2009 application process.
We appreciate all of the work that CMS put into these documents. And we look forward
to our continued partnership with CMS.
Sincerely,

cheryl A ow ell
Director, Policy and Compliance

NOU-13-2007

13: 16

OtlB/O I R A

202 395 5167

November 12,2007
Kerry Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health & Human Services
Attn: CMS-10137
7500 Security Boulevard
Mail Stop: C4-26-05
Baltimore, MD 21244-1850

Re: Comments on Draft 2009 Part C Medicare Advantage, Draft 2009 Part D, and
the EmployerAJnion-Only Croup Waiver Plan (ECWP)Applications
Dear Mr. Weems:
CVS Caremark is the largest provider of prescriptions and related healthcare services in
the nation. The Company fills or manages more than one billion prescriptions annually.
It operates 6,200 CVSJpharmacy stores; a pharmacy benefit management, mai1 pharmacy
and specialty pharmacy division, Carernark Pharmacy Services; its retail-based health
clinic subsidiary, MinuteClinic; and its online pharmacy, CVS.com. SilverScript
Insurance Company, a national Part D Sponsor, and SilverScript, Inc., a Part D pharmacy
benefit management company (PBM), are both affiliates of Caremark.
SiIverScript Insurance Company (SSIC) is one of only 10 national PDPs servicing the
Part D market. We have united with distribution partners, including health plans and
Medicare Supplement providers, in the sales of our products nationwide. We bring
substantial prescription drug benefit management experience through operating our own
PDP (SSIC) as well as through our affiliate SilverScript, Inc. (SSI), a PBM offering
prescription drug management services to Part D plans. SSI supports over 30 of our
health plan clients, which have a combined membership of 2 million lives in Mediwe
Advantage and PDP programs.
1. Section 28.1 Retail Pharmacv Access
We believe that this is an area where CMS can significantly reduce the administrative
burden on plans and itself by setting up a process to allow subcontractors that establish
and manage the retail pharmacy network on behalf of multiple Part D applicants to
submit one set of access reports on behalf of all their Part D applicant clients. Since most
SilverScript, lnc.
Comments on Draft Part 0 Application

P.11/17

Part D applicants in a given service area that use the same PBM subcontractor also use
the identical pharmacy networks, the identical reports will be generated multiple times
for multiple Part D applicants by the subcontractor. Currently, it takes SiIverScript
approximately 1800 man-hours to prepare access reports for its Part D clients' annual
application process. This time commitment could be significantly reduced if it were not
necessary to run a separate geo-access report for each client that utilizes the Silverscript
network.

In light of this enormous expenditure of resources to submit essentially duplicative
reports, we urge CMS to consider a more streamlined approach to submitting the geoaccess reports on behalf of multiple Part D sponsors. This would greatly reduce the
administrative burden and the time and effort associated with this application requirement
- fiom about 1800 hours annually to less than 100 hours. Specifically, we recommend
that a certification process be established such that a subcontractor may submit its access
report to CMS once on behalf of all its Part D applicant clients. While we understand that
the current access reporting requirements are specific to an applicant's proposed service
area, a subcontractor could submit a national geo-access report or, at least, a geo-access
report covering all the service areas of its various Part D applicants, broken down to the
county level if need be to address local plans. Adopting this approach will satisfy the
CMS concern that retail pharmacy access be reviewed and monitored, but will make the
information reporting and review process much more efficient by eliminating duplicative
reports and redundant administrative work inherent in the current process, and will
accomplish the same outcome at far less cost to all concerned.
Recommendation: Develop a process to allow a subcontractor to submit one set of
retail pharmacy access reports for all Part D sponsor applicants that will use its
retail pharmacy network This report can cover all relevant service areas and be
broken down to the county level where required.
2. Section 3.9 and 3.21 - Coverane Determinations and Paper Claims
We are concerned that the references in Section 3.9 to the time frames for standard
coverage determinations does not address or take into account the standard time frame for
processing paper claims, as stated in Section 3.21. While we understand that Section 3.2 1
can be interpreted to refer only to those paper claims received fiom non-network
pharmacies, and that Chapter 18 of the Part D Manual has been interpreted to require that
beneficiaries be notified of the plan's determination on a paper claim submission within
72-hours, we believe that such an interpretation would be inconsistent with CMS' intent
as stated in the preamble, the realities of paper claims processing, and existing industry
standards. Each of these issues is discussed in seater detail below.

First, limiting the lawage in Section 3.21 of the Application to only those paper claims
submitted by non-network pharmacies is inconsistent with the realities of paper claims
processing. The time and process to make a determination on a paper claim is the same
whether the claim is submitted by a non-network pharmacy or a beneficiary, and requires
a full adjudication of the claim. Unlike POS electronic claims, paper claims are typically
submitted by the beneficiary, either because they paid cash at a network pharmacy for
Silverkript, Inc
Comments on Oraft Part D Application

some reason or because they went to an out-of-network pharmacy. Although it is
possible for non-network pharmacies to submit paper claims directly to us (using a
Universal Claim Form), this is very rare, and most non-network claims are submitted by
the beneficiary. These claims are adjudicated manually by clerical staff using the
identical plan design criteria as the automated process, with no additional discretion or
judgment.
Thus, it is not possible to notify an enrollee whether hidher claim will be paid without
first hlly adjudicating the claim. A full adjudication involves at least the following steps,
each of which must be done manually in the case of a paper claim: processing and sorting
of all inbound mail, handwritten data keyed fiom the claim form, mn a system
adjudication process run for eligibility and drug coverage editing, obtain incomplete data
(such as looking up the N b C number if only the drug name is provided), among several
other tasks that must be completed before a decision can be reached as to whether the
claim will be paid or denied.
In light of the fact that the processing time for a claim depends not on who submitted it,
but whether it is submitted by paper vs, electronically, there is no rational basis for
interpreting the 15/30 day timefiame specified in Section 3.21 of the Application to only
those submitted by a non-network pharmacy. From a plan's perspective, the sender is
irrelevant in terms of the steps and time required to process a paper claim. While we
understand that in the case of beneficiary-submitted claim the beneficiary is out-ofpocket as opposed to the pharmacy, even under the 72-hour turnaround time h e , actual
payment to the beneficiary is only required to be made within 30 days. So the beneficiary
does not receive reimbursement any quicker, whether the plan is required to process the
claim within the 72-hour time frame or 15 to 30-day timefiame. Thus, we read the
reference to non-network pharmacies in Section 3.21 as simply a reflection of CMS'
assumption that this was the most likely circumstance in which paper claims would be
received by a plan. But a paper claim is a paper claim for processing purposes, and the
overall processing time doesn't change based on who sends it in. Indeed, from a health
care industry perspective, it would be quite unprecedented to require that a paper claim
be processed in 72 hours.
Second, the stated purpose and intent behind the 72-hour determination time frame,
namely to protea beneficiaries who had not yet obtained their medications fiom suffering
serious adverse effects, does not apply in the case of paper claims, since the beneficiary
has in every case already obtained the medication. In the preamble, CMS explained the
rationale behind the 72-hour time kame as follows:
nere is too much riskfor an enrollee's health rf&termi~larionsare not made sooner
rhan 14 dzysfiom the d i e the request is received, since an cmollee ofien will not be able
to pry our-of-pcht for uprescribed medication and thus musfforgo necessary therap).
until a defermination is ma&. . . . Clearly, Pmt D enroIIees are likely to suflet
~ignxjhntadverse consequences if medications me nor received quicuy.

SilverScript, Inc.
Comments on Draft Part 0 Application

This rationale simpIy does not apply to paper claims, where the enrollee has always
already obtained the drug, and is simply seeking reimbursement. In providing for the 15
and 30-day turnaround time for paper cIaims from non- network pharmacies, CMS,like
IDOL, recognized that paper claims take considerably more time to process than do PO$
claims, and do not warrant the tighter time fiames required when the beneficiary is
awaiting the medication.
Finally, a 72-hour timefiame for processing paper claims would be unprecedented in the
health care industry, and inconsistent with the paper claims processing times required by
DOL and the FEW program, both of which are viewed as models for Part D. In the
preamble, CMS references with approval the approach to coverage determinations in the
Department of Labor (DOL) claim procedure regulation for ERISA plans under 29 CFR
2560.503-1. In the ERISA claims procedure, however, the DOL clearly distinguished
between claims for urgent care, pre-service and post-service claims. For post-service
claims (i.e. claims where the service has already been received and that are thus not
awaiting plan approval), the regulation states that the time frame is 30 days, with the
option to extend it far up to 15 days . The DOL clearly recognized that expedited time
frames are not warranted once the care or service has already been provided and it is
simply a matter of reimbursement. Beneficiary submitted paper claims clearly fall into
this category.

-

Similarly, paper claims submitted by beneficiaries under various state and government
plans are generally required to be adjudicated within 30 days. Thus, changes in
processes and staffing in order to perform this extremely manual process within a 72
"real time" hours for Part D claims would require an enormous and unprecedented ramp
up in resources at a significant cost to the program, and in a situation where there would
be little practical benefit or impact to the beneficiary - namely, simply knowing payment
status but not receiving payment.
Recommendation :Clarify that the time frames for standard coverage
determinations applies only to requests for drugs that have not yet been dispensed
as well as requests for payment made after and in response to a paper daim
adjudication, and that the time frame for an initial paper claim adjudication is the
15/30-day time frame set forth in Section 3.21, regardless of the party that submits
the paper claim.
3. Section 3.18.B and Ae~endixXI - Data Use Agreement
Part D sponsor applicants and existing Part D sponsors, are required to sign a data use
agreement that limits their use of data (and that of their subcontractors and related
parties) obtained from CMS information systems to those "directly related to the
administration of the Medicare benefits". We are concerned that this would restrict Part
D sponsors not only From improper uses of PHI,such as to support other lines of
business, but also tiom legitimate and entirely proper uses of PHIthat are expressly
permitted by HIPand indeed, in many cases mandated by other laws. For example, if
a Part D sponsor is named in a lawsuit or a government investigation by a govenunent
Silverscript, I nc.
Comments on Draft Part D Application

agency other than CMS,it may be required to maintain information obtained 6om CMS'
systems for these purposes, even though these purposes do not relate to administration of
the Part D benefrt. Similarly, a subcontractor may be required to provide access to this
data to its auditors for financial reporting purposes, even though this is not directly
related to the administration of the Part D benefit. There are many other legitimate uses
and disclosures (e.g. to law enforcement) that do not fall within the very narrow confines
of the data use agreement, and that are permitted under the HIPAA Privacy Rule and that
should similarly be permitted here.
While we understand that CMS intends this agreement to apply only to that information
obtained fiom its information systems, as a practical matter it will be extremely difficult
for Part D sponsors to (i) determine which data is uniquely obtained fiom a CMS
information system, and (ii) isolate this information fiom other information it maintains
about beneficiaries. In light of this, we urge CMS to add language to the data use
agreement making clear that Part Sponsors may use the information as otherwise required
by law and, in the case of Protected Health Information, as otherwise permitted by
HIPAA.
Recommendation : Revise the data use agreement to allow the use and disclosure of
CMS data as otherwise required by law and, for data that also constitutes PBX, to
those uses and disclosures permitted by the BlPAA Privacy Rule and 42 CFR
423.136.

We appreciate the opportunity to provide these comments. If you have any questions or
would like discuss our comments, please do not hesitate to contact me at 202-772-3501.
Sincerely,
Russell C. Ring
Sr. Vice President
Government Affairs

Silverscript, lnc
Comments on Draft Part D Application