1. Promoting consumer access to affordable Prescription drugs
Katie Keith, JD, MPH
wn.edu

2. Setting the stage Rate of Rx spending is increasing due to:
Chronic conditions
Scientific advancements
Drug pricing
Cost-shifting to consumers
Affects utilization rates, esp. for underserved communities
Can result in higher health care costs

3. Report: Promoting Access to Affordable Prescription Drugs
Report on behalf of NAIC consumer representatives
NAIC’s Model Law 22 revision process
Recommendations informed by:
State approaches, QHP standards, Medicare Part D standards, consumer experience
Disclaimer on drug pricing/costs
Report: p- content/uploads/2016/08/Pro moting-Access-to-Affordable- Prescription-Drugs_Aug pdf

4. Report: Promoting Access to Affordable Prescription Drugs
Topic areas
Improving Access to Comprehensive Rx Coverage
Consumer Affordability of Rx Coverage
Nondiscrimination in Formulary Design
Improving Transparency of Rx Coverage
Meaningful Oversight and Regulation of Rx Benefits
Addressing Emerging Therapies

5. Improving access Pharmacy and therapeutics committees
Have at least 15 members and adopt conflict of interest standards for P&T committees
Exceptions and appeals processes
Extend exceptions process to include cost-sharing/tiering and UM restrictions
Pharmacy network access
Adopt quantitative access standards for retail pharmacies, such as those used by Medicare
Continuity of drug coverage
Cover a one-time, temporary 30-day supply of a nonformulary drug for all enrollees
Addressing health disparities
Minimize cost-sharing or UM for drugs disproportionately used in underserved communities

6. Access: State Spotlights
Betty can request a nonformulary drug that she’d received for at least 6 months prior and receive a determination within 1 business day
Betty can request an exception to her plan’s fail first protocol and receive a determination within 3 business days

7. Consumer affordability
Copays and coinsurance
Prohibit coinsurance for Rx drugs (or require disclosure of actual dollar cost-sharing amount)
Establish maximum levels of cost-sharing per Rx and/or per month
Drug tiering
Limit the total number of permitted drug tiers, define “specialty” tier, adopt standard plans
Drug deductibles
Disclose whether a plan uses a separate drug deductible and how it applies
Value-based insurance design
Adopt evidence-based incentives and allow for exceptions to VBID criteria

8. Affordability: State Spotlights
Betty’s cost-sharing for prescription drugs is capped:
E.g., $150/specialty drug per 30-day supply
E.g., $1,000/year for self-only coverage
E.g., max cost-sharing of no more than 1/12 of the out-of-pocket max

9. Nondiscrimination Comprehensive nondiscrimination protections
Define “discriminatory benefit design” and prohibit specific examples in Rx context (i.e., placing most or all drugs for a specific condition on the highest cost-sharing tier)
Solicit feedback from external stakeholders (advocates, CAPs, AG offices, ombudsmen, etc.)
Adverse tiering
Adopt standard plans with meaningful cost-sharing limits to mitigate adverse tiering
Utilization management
Adopt uniform standards for prior authorization requirements and responsiveness

10. Nondiscrimination: State Spotlights
Prohibited plans from placing all drugs in a given class on a specialty tier
OIR developed a “chronic conditions template” to track coverage of drugs used to treat certain conditions, such as breast cancer and bipolar disorder

11. Improve transparency Access to comprehensive, accurate formularies
Require standardized formulary display requirements so consumers can compare across plans, add more (accurate) information to formularies
Limit mid-year formulary changes
Prohibit mid-year formulary changes that negatively affect enrollee access to drugs (removing a formulary drug, moving a drug to a higher tier, or adopting new UM)
Consumer support tools
Require issuers to submit standardized Rx info in machine- readable formats and develop consumer-tested plan comparison tools based on consumer Rx needs

12. Transparency: State Spotlights
Requires formularies to include cost-sharing amounts or ranges for each drug and UM requirements, among other information
Prohibits many mid-year formulary changes such as removing a drug from a formulary, adding UM, or moving a drug to a higher cost- sharing tier

13. Oversight and Regulation
Tools for monitoring and enforcement
Collect standardized plan-level data on Rx drug benefits and analyze MCAS data
Data collection and analysis
Release more detailed information about Rx-related consumer complaints
Regulation of pharmacy benefit managers
Consider adopting policies related to licensure, information disclosure, accreditation, drug pricing, and fiduciary duties
Collect data about PBM pricing, rebates, and conflicts of interest

14. Oversight: State Spotlights
CSI limited high coinsurance requirements for specialty tier drugs and required insurers to offer at least one plan at the silver level or above to have all copays
OIR established an optional HIV/AIDS benefit design safe harbor with maximum cost- sharing in the form of fixed copays

15. Addressing emerging therapies
Review new therapies within 90 days of FDA approval and make a coverage determination within 180 days of release onto market
Ensure that routine patient costs are approved for clinical trial participants
Encourage value-based pricing and other incentives for risk-sharing with drug manufacturers
Participate in the development of value frameworks to assess the value of new treatments

16. Katie Keith, JD, MPH Katie.Keith@Georgeto wn.edu
Questions?
Katie Keith, JD, MPH
wn.edu