The purpose of this training is to provide a high-level overview of the Medicare Part
D applications for any new entities seeking to enter the Part D market for the first time
and as a refresher for existing Part D sponsors applying to expand an existing contract or
offer a new contract.
Part D Applications – Deadline and Submission – The first two slides give an overview
of key dates. CMS posts the Part D application materials in late December or early January
each year to our website and they become available for completion in HPMS in mid-January. They
include instructions, templates, reference materials and the I/T/U addendum. In additional
to the application .pdf document, there are three zip files.
The first zip file labeled, 20XX Resources for HI LTC ITU References or something similar,
includes the: Minimum requirements for adequate access to
Network Home Infusion Pharmacies by State, List of Long Term Care facilities and bed
count, I/T/U Addendum to the pharmacy contracts,
and I/T/U pharmacies to which contracts must be
offered. The second zip file, labeled Templates for
20XX Application or something similar, includes the templates to be completed and uploaded
into HPMS, including contract crosswalks, etc. These materials are also available in
the application section of HPMS. The third zip file, the 20XX Beneficiary Count,
contains information the number of beneficiaries in each zip code and county.
You may only submit your materials via HPMS. Any applications sent to CMS via mail or email,
or means other than through HPMS, will be rejected.
There will be no extension to the mid-February online application deadline that is announced
via HPMS memo. Immediately following the deadline, HPMS will automatically lock down the application
modules and no further application work will be possible.
The automated Part D application for a new contract with CMS is available to entities
that submitted a Notice of Intent to Apply, or N O I A, for a new Part D contract. Depending
on the product and plan type submitted in the N O I A, required elements of the Part
D application will be automatically made available to applicants in HPMS.
That is why the first attestation, described on slide 4, is important. If the product type
indicated for your contract in HPMS is correct, you answer “yes” and proceed. If it is
incorrect. For example, if you wanted to apply for an HMO and the contract is an LPPO, you
should stop and contact CMS immediately. You cannot change the product type you are applying
for after you submit the application.
Slide 5 describes how expansion applications are generated. CMS encourages you to read
the Online User Guide to find answers to your questions. Expansion applications include
existing sponsors that are expanding their service area, adding individual market to
an existing employer-only contract, adding EGWP to their contract for the first time,
or expanding an EGWP service area must enter their pending service area and complete the
EGWP attestation, if applicable.
A description of the application itself begins on slide 6. The Part D application consists
of a series of attestations and document uploads for the sections:
Contracting with first tier, downstream, and related entities,
Compliance program, and Network pharmacy access.
CMS provides the pharmacy network templates and the contract crosswalk documents for download
from the application module in HPMS. Additional reference files are available on the Medicare
Part D Application Guidance Webpage. The address is provided on the slide. Please use the materials
posted for the correct application cycle. Older materials may no longer be applicable
and using them may result in your application being denied.
Things to Note are found on slides 7 and 8. Beginning with the 2022 applications CMS will
not allow applicants to redact pricing terms from their contracts. We must be able to see
and review the pricing terms your organizations have agreed to with your first tier, downstream
and related entities in order to determine whether you have a final and valid contract.
As always with all of the documents you submit, if you consider the contents of your contracts
to be sensitive, you should place the recommended disclaimer, described in the application,
on each page of the documents. This will help to protect them from public disclosure if
CMS later receives a Freedom of Information Act Request.
Otherwise, you should be aware that organizations that are new to the program not be eligible
to receive new contracts for service area expansions the following year, per our regulation.
For example, if you were new to the program in 2022 you will not be eligible to receive
new contracts for service area expansions until 2024. Therefore, CMS urges organizations
to apply for everything they want to and are prepared to offer in the initial application,
rather than waiting until the following year. As has also been the case for several years,
the Part D regulation requires that applicants must themselves be experienced with Part D
or employ a first tier, downstream, or related entity with experience to handle certain key
functions. For details, please consult the application and the regulation for details.
Slides 9 & 10 describe our requirements for the contracting section. Organizations often
have difficulty with this section. We strongly recommend that you carefully complete the
crosswalks and that you make your contracting documents searchable.
This makes our review of your documents easier and decreases the chances that we will mistakenly
believe documents do not contain required elements. Please use the correct templates,
including the model ITU addendum.
Slides 11 and 12 describe licensure and solvency requirements.
You should direct questions to the email address indicated on slide 12.
As indicated on Slide 13, having the correct service area is very important to our evaluation
of your application. You cannot expand the service area of your application after you
submit the application, so please be sure you’ve included all the regions, states,
and/or counties you intend to include before you hit final submit. We use the service area
to determine whether your networks are adequate and whether you meet licensure requirements.
Slides 14 and 15 give a high-level overview of pharmacy network submission requirements.
All applicants must submit retail, home infusion, and long term care pharmacy lists using the
templates in the reference files. If there is an ITU pharmacy in your service area, you
must submit an ITU list and if you intend to offer mail order pharmacy services, you
must submit a list of mail order pharmacies in your network. Access will be determined
based on the individual market service area of your contract if you offer individual market
only or if you offer individual and employer market plans.
For employer only contracts, access is determined based on your employer service area. As always,
if you plan to associated different pharmacy networks with different PBPs under the same
contract, you must submit your most restrictive network based on executed contracts.
Finally, note that applications must meet all our requirements at time of submission.
We conduct a courtesy review first which we complete in mid to late March. If there are
deficiencies, you will receive a deficiency notice and a have a few days to submit curing
materials. Then we conduct a second round of reviews, after which we send conditional
approvals and notices of intent to deny. If you receive a notice of intent to deny, you
have 10 days to cure per the regulation. We then review all curing materials and send
denial or conditional approval notices in late May. If we deny your application, you
may pursue our administrative appeals process while going through the regular Part D bid
process.
An important note for applicants failing to submit a complete application by the deadline
– CMS will not accept applications that do not represent an organization’s good
faith effort to submit a substantially complete application. Organizations should not submit
an application so deficient that CMS can only conclude that it was developed solely as a
placeholder intended to do little more than meet the application deadline. Organizations
taking this course will not be afforded the opportunity to cure their application nor
request an administrative appeal of a CMS decision not to accept the application for
review.
Those applicants meeting all requirements of the Part D application will be issued a
conditional approval. It is important to note that the application review is separate and
distinct from the reviews that occur related to the annual benefit design, the formulary,
and the bid. The conditional approval of your application is not a guarantee that you will
be issued a contract. You will need to separately meet all deadlines and receive approval of
all other required elements to be awarded a contract in September of the year in which
the application was submitted. For example, September 2021 for the 2022 contract year.
Part D application contact information is provided on the final slide.
Thank you for your time and attention. We look forward to working with you throughout
this process.