How to Use the Formulary Review Suite
Did you know that CMS provides review tools that issuers and states can use to
prepare for the QHP Application process? These review tools allow you to check
for errors within your QHP Application that would result in corrections after submission.
Issuers are encouraged to use these tools to identify and
correct data errors prior to submitting application data,
in order to reduce the number of required corrections identified during CMS’ reviews.
States are encouraged to use these tools during their reviews to identify potential
errors in their issuers’ application data that would require issuers to make corrections.
The Formulary Review Suite runs two different non-discrimination reviews
primarily based on data from the Prescription Drug Template.
These two reviews include the Non-Discrimination Formulary Outlier Review,
and the Non-Discrimination Clinical Appropriateness Review.
The Formulary Outlier Review identifies and flags as outliers those plans that have
unusually large numbers of drugs subject to prior authorization and/or step therapy requirements
in 27 United States Pharmacopeia classes compared to other plans in the state.
The Clinical Appropriateness Review analyzes the availability of covered drugs to ensure
that issuers are offering a sufficient type and number of drugs in accordance with clinical
guidelines for certain medical conditions.
The review also checks to see whether certain drugs
used in first-line treatment are available without prior authorization or step therapy.
To use the Formulary Review Suite, you must have a populated Prescription Drug Template.
However, for the tool to work most effectively, you’re highly encouraged
to use a populated Master Review Tool, with data from the Plans & Benefits Template.
While use of the Master Review Tool is not required, it allows the Formulary Review
Suite to remove any drug lists included in the Prescription Drug Template that are not
associated with a plan. With the Master Review Tool data imported,
you will also see your review results at the plan level, not just the formulary or drug list level.
To download the Formulary Review Suite, visit the Review Tools webpage of the
QHP certification website and click on the Automated Review Tools link.
A zip file will be downloaded to your computer. Within this zip file,
you’ll see several of the stand-alone review tools,
including the Formulary Review Suite. There will also be a folder labeled “FRS Reference Files.”
Open this folder to find the Formulary Review Suite instructions.
Read these instructions carefully before using the tool.
Once you read the instructions, open the tool in Excel, and enable macros.
Also read the “Instructions” tab carefully before beginning.
Step 2 asks if you have separate Individual and SHOP Prescription Drug Templates.
If you or your issuer submit data through the System for Electronic Rate & Form Filings, or
SERFF, and have separate templates for individual and Small Business Health Options Program,
or SHOP, market plans, select “yes.” Otherwise, leave the selection as “no.”
If you selected “yes,” be sure to follow the template naming convention described in step 2.
In step 3, select the state being reviewed using the drop-down menu under “State Selection.”
In Step 4, you have the option to import a Master Review Tool
to pull in Plans & Benefits data into the Formulary Review Suite. Again,
it’s highly recommended you use a Master Review Tool when running the Formulary Review Suite.
If you do wish to complete this step, click on the “Import Data from Master Review Tool” button.
In Step 5, indicate whether you wish to run both the Formulary Outlier
Review and the Clinical Appropriateness Review at the same time, or separately.
Then, click the “Run Formulary Review Suite” button.
A series of dialogue boxes will appear, asking questions surrounding the thresholds you want to
use for each review. Read and answer each question carefully. If you need clarification on any of
these questions, please refer to the Instructions document you read before opening the tool.
Note that the Formulary Outlier Review uses data from all issuers in a state to run,
and will not return meaningful review results for a single issuer. However, issuers may still find
it useful to run the tool in order to see which categories and classes are included,
and drug counts for each one. After you complete the threshold
questions, select the folder in which the Prescription Drug Templates can be found.
Running the tool could take several minutes depending on how much data is processing.
The tool will populate several tabs that provide
more detail on the Formulary Review Suite review results.
If there are any data errors, an Errors tab will generate, identifying and describing the error.
On the “Output Description” tab, you will find a more detailed explanation of the two reviews the
tool runs, an overview of the corresponding tabs, and descriptions of additional supplementary tabs.
The “Formulary Outlier Summary” and “Clinical Summary” tabs give summaries of each review.
The top row of each tab will show the review results.
If you see “All lists met,” then the data imported passes both reviews.
If, however, either tab shows that there were plans or lists that did not meet the requirements,
use the corresponding summary and detail tabs to further identify the error,
and where the issuer will need to make corrections in order to pass each review.
The Formulary Review Suite will populate an “Issuer Summary” tab.
If you imported data from the Master Review Tool, you will also see a “Plan Summary” tab.
These tabs will display review results at the issuer and plan level.
If you imported data from the Master Review Tool and any “Not Met” review results were received,
the “Plan Details” tab will appear.
This detail tab will more directly identify the
exact errors a plan receives as well as detailed messaging to help you better understand why a plan
has been identified as deficient and what steps you can take to correct the error.
Issuers should review the errors for necessary corrections, update the
relevant templates, and save and validate them. If any changes are made to the Plans & Benefits
Template, be sure to reimport the new Plans & Benefits Template into the Master Review Tool.
Then, reimport any corrected data into the Formulary Review Suite tool and repeat the
review process until all plans and lists meet the requirements.
Be sure to use the Instructions document you read
before opening the tool for any further clarifications on rerunning the tool.
Now let’s review examples of possible corrections you may receive, and how issuers can resolve them.
During the Formulary Outlier Review, you might receive a correction if a plan has too few drugs
without prior authorization or step therapy in any USP categories and classes under review.
This correction will be outlined in the “Formulary Outlier Summary”
and the “Formulary Outlier Details” tabs.
To address this correction, issuers may modify their Prescription Drug Template
to remove prior authorization and step therapy requirements from the identified list of drugs,
or add drugs, without restriction, to the deficient category or class.
Issuers may also provide a justification; issuers submitting justifications should be sure to:
Submit appropriate justifications and supporting documents for the relevant review;
Use the Combined Prescription Drug Supporting Documentation
and Justification form to respond to corrections;
Provide clinical support and/or evidence to justify a drug list’s design; and
Explain why the correction occurs and how it is not discriminatory.
During the Clinical Appropriateness Review, you might receive a correction if a plan does
not cover enough drugs in any class to treat a specific condition under review.
This correction will be outlined in the “Clinical Summary” and the “Clinical Details” tabs.
Issuers can also use the 'All RXCUIs Submitted' tab to see an overview of RXCUIs included in the
formulary outlier and clinical appropriateness reviews that may or may not be covered on an
issuer's Prescription Drug Template.
For each issuer and drug list, this tab identifies
whether the drug is covered, the tier the drug is on, and the restriction status of each drug.
Note that the RXCUIs shown here are examples, and may not reflect the RXCUIs included in the
formulary outlier and clinical appropriateness reviews for the upcoming plan year.
To address this correction, issuers may choose to cover the missing drug or drugs
in the identified class by modifying their Prescription Drug Template,
or provide a justification with supporting clinical guidelines
identifying the reasons why the correction occurs and how it is not discriminatory.
If issuers choose to submit justifications, they should again make sure to:
Submit appropriate justifications and supporting documents for the relevant review;
Use the Combined Prescription Drug Supporting Documentation
and Justification form to respond to corrections;
Provide clinical support and/or evidence to justify a drug list’s design; and
Cite clinical guidelines to assist with justification submissions.
If you have questions regarding the QHP Application Review Tools,
please contact the Marketplace Service Desk at CMS_FEPS@cms.hhs.gov, or 855-CMS-1515.
For more information about the QHP Certification Process, visit www.qhpcertification.cms.gov.