The document discusses prescription drug benefit mandates under the Affordable Care Act and strategies for designing non-discriminatory health plan formularies. It outlines requirements for covering essential health benefits, including prescription drugs, and prohibitions against denying coverage or setting discriminatory benefits based on health conditions. The document provides an agenda for a meeting on formulary drug reviews, outlining tools to assess formulary compliance with non-discrimination standards.

1. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has
not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated,
distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full
extent of the law.
Prescription Benefit Mandates of the
Affordable Care Act
May 19, 2015
1
Designing Non-
Discrimination
Formulary Drug
Reviews

2. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
• ACA –Patient Protections and the Health Care
Law
• Prescription Drugs- an Essential Health Benefit
• A New Way to Skirt the Denial of Pre-Existing
Conditions Rule
• Health Plan Formulary Reviews
• Conclusion- Future Reviews
• References
Agenda
2

3. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
• Preventive Drugs at No Cost
• Pre-existing Conditions (Non-Denial)
Prescriptions Drugs an Essential Health
Benefit
• Health Plan Shopping Transparency
• Insurance Coverage Non-Cancellation
• Benefit -No Discrimination
ACA Patient Protections
3

4. Essential Health Benefit –Rx Drugs
• Ambulatory Patient
Services;
• Emergency Services;
Hospitalization;
• Maternity and Newborn
Care;
• Preventive services ;
• Pediatric services
• Mental Health and
Substance use Disorder
Services;
• Behavioral Health
Treatment;
• Prescription
Drugs Coverage
4

5. Denial of Coverage-The Latest Trends
5
• Specialty/Mail order
Prescription Drug Access
• Office of Civil Rights Complaints
• Birth Control- All 18 FDA-
Approved Forms Must be
Covered

6. Key Prescription Benefit Related Legislation
6
•
• 45 C.F.R. 156.122, requires health plans cover at least the greater of: (1)
one drug in every USP category and class, or (2) the same number of Rx
drugs in each category and class as the EHB state benchmark plan
formulary.
• 45 C.F.R. part 156.225 prohibits Qualified Health Plan (QHP) issuers from
using marketing practices or benefit designs that will discourage the
enrollment of individuals with significant health needs.
• Regulation 45 CFR 156.125 prohibits insurers from adopting benefit
designs or implementing benefit designs that discriminate based on age,
expected length of life, disability, medical dependency, quality of life, or
other health conditions

7. Health Plan Formulary Reviews
7
• Drug Count Tool
• Formulary Outlier Tool
• Clinical
Appropriateness Tool
• Treatment Protocol
Calculator (New for
this year)

8. Category Class Drug Count Tool
8
Tests for meeting the EHB standards to cover at least
the greater of:
(1) one drug in every USP category and class, or
(2) the same number of prescription drugs in each
USP category and class as the EHB benchmark plan
Identifies categories and classes that do not meet the
EHB Benchmark Count,
Generates the count of chemically distinct drugs that
are submitted on a given drug list for each USP category
and class.

9. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
Drug Count Tool
9

10. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
Non-Discrimination Clinical Appropriateness
Tool
10
• Analyzes the availability of drugs associated
with four conditions (diabetes, rheumatoid
arthritis, bipolar disorder, and schizophrenia)
• Ensures plans are offering a sufficient number
and type of drugs needed to effectively treat
these conditions and are not restricting access
by lack of coverage or inappropriate use of
utilization management techniques

11. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
Clinical Appropriateness Tool
11

12. Non-Discrimination Formulary Outlier Tool
12
Identifies plans that have unusually
high numbers of restricted drugs
subject to utilization management
restrictions in specific categories
and classes when compared to
other plans at the state and national
level.

13. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
Formulary Outlier Tool
13
Pharmacological Therapy Protocol

14. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
• TPC Drug List Tab screenshot
TPC Review Workbook
14

15. OOPC Shell
Program
Plan CS
Calculator
OOPC
Calculator
(TPC Version)
TPC OOPC Calculations
(high level schematic)
Drug CS
Calculator
Formulary
Analysis
Tool
RXFATFile
PB
Template
Data
(formatted)
RX
Template
Data
(formatted)
Non-RX
Scenario
Utilization
Data
TPC
Results (std
variant)
Analyst Outlier
Analysis
Plans with
Issues
Plan, scenario, RX tier utilization, RX
tier cost sharing,
plan cost sharing
OOPC Results
Scenario List,
Plan List
Input
Data
Intermediate
Output
Final
Results
Automated
Process
Manual
Process
Key

16. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
• Data Integrity
• Patient Access to formulary
• Machine Readable Website
• Adverse Tiering/Risk Adjustment
(proposed)
• Preventives/Birth Control (proposed)
Post Certification Analysis Formulary
Reviews
16

17. References
• CMS has posted the
review tools, the EHB Rx
Crosswalk, and a
reformatted RxNorm
database in the following
locations:
– http://www.cms.gov/cciio/
programs-and-
initiatives/health-
insurance-
marketplaces/qhp.html#20
16 QHP Application Tools
17

18. Rx Benefit Discrimination In the News
HHS rewrites Obamacare rules:
Orders free birth control for all
Advocates declare victory after citing
violations
Read more:
http://www.washingtontimes.com/news/2
015/may/11/obama-admin-orders-insurers-
to-provide-birth-contr/#ixzz3ZtVvDA4b
Insurers' Drug Tiering Can Keep
Sickest Patients Away
http://www.medscape.com/viewarticle/83
8896
18
NHeLP and The AIDS Institute
Complaint to HHS Re HIV/AIDS
Discrimination by Florida
Insurers
http://www.healthlaw.org/publications/bro
wse-all-publications/HHS-HIV-Complaint
Consumer group sues Cigna, says
mail-order drug policy
discriminates against people
with HIV
http://www.usnews.com/news/us/articles/
2015/04/28/consumer-group-sues-cigna-
alleges-discrimination

19. CLOSE HOLD – DO NOT SHARE – INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to
receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.
Questions
19