Electronic pharmacy benefit tools like Real Time Benefit Tools (RTBTReal Time Benefit Tools), electronic prior authorization (ePAelectronic prior authorization), and electronic prescribing (eRxelectronic prescribing) reduce administrative burden and speed access, enabling clinicians to allocate more time to direct patient care. Patient eligibility and benefit verification and claim submissions have been streamlined as health care providers and pharmacies have fully integrated pharmacy benefit companies’ “real-time” tools. Pharmacy benefit companies conduct 94% of eligibility and benefit verifications electronically, in real-time. Eligibility is verified during the real-time adjudication process for pharmacy claims, and pharmacy benefit companies lead the way in adjudicating claims at the point of service, with nearly 100% of pharmacy benefit companies (99%) and health plans (96%) processing claims fully electronically. Full adoption of RTBTReal Time Benefit Tools, ePAelectronic prior authorization, and eRxelectronic prescribing offers similar promise. Pharmacy benefit companies, electronic health record providers, and pharmacies are equipped to facilitate RTBTReal Time Benefit Tools, ePAelectronic prior authorization, and eRxelectronic prescribing. To incentivize prescribers to use these services, which support increased medication adherence and reduce medication abandonment, PCMA recommends policymakers take the below actions.

• Expand the use of RTBTReal Time Benefit Tools.
  • Pharmacy benefit companies strongly support the use of RTBTReal Time Benefit Tools to increase transparency by giving prescribers and patients the exact information they need to determine the most appropriate and cost-effective prescription drugs to prescribe and use for each patient. RTBTReal Time Benefit Tools recommendations lead to lower patient out-of-pocket costs, with the largest savings – typically around 40% – occurring for high-cost medications, especially when therapeutically appropriate lower-cost alternatives exist. A recent study revealed RTBTReal Time Benefit Tools recommendations were made for only a small percentage of prescriptions, presenting a key opportunity for improving access to affordable prescription drugs. RTBTReal Time Benefit Tools tools are the most promising vehicle to increase medication adherence and reduce medication abandonment.
• Require the use of electronic prescribing and prior authorization.
  • Seventy-five percent (75%) of pharmacy prior authorizations are fully electronic and use the National Council for Prescription Drug Programs (NCPDPsNational Council for Prescription Drug Programs) SCRIPT electronic standard for prior authorizations. Prior authorization is a critical tool for helping patients access safer and lower cost drugs and reflects the most recent clinical standards. Public policies should focus on establishing and adopting technical standards and resources for everyone to facilitate adoption and uptake of electronic prior authorization. Requiring the use of electronic prior authorization will streamline the process for patients and health care providers. Pharmacy benefit companies stand ready to support our partners in health care to implement ePAelectronic prior authorization and urge other stakeholders to join us.
• Add ePAelectronic prior authorization to Medicare quality measures.
  • In Medicare Part D, eRxelectronic prescribing adoption has not fully actualized for all providers, limiting ePAelectronic prior authorization capabilities. Rulemaking has added the use of eRxelectronic prescribing to Medicare quality measures for physicians. CMS should propose to add ePAelectronic prior authorization to quality measures as well.
• Pave the way for interoperability.
  • For the commercial market, the U.S. Department of Health and Human Services (HHSHealth and Human Services) Office of the National Coordinator for Health Information Technology (ONCOffice of the National Coordinator for Health Information Technology ) should propose and finalize NCPDP SCRIPT 20170701 for prescription drugs, American National Standards Institute (ANSIAmerican National Standards Institute) X12 for medical, and work through issues related to electronic health record (EHRelectronic health record) and eRxelectronic prescribing interoperability to prepare the way for eRxelectronic prescribing and ePAelectronic prior authorization interoperability.

Decisions made about sites of care and drug products selected have cost implications. To enable pharmacy benefit companies to more effectively partner with clinicians to help contain drug costs, PCMA recommends policymakers take the below actions.

• Allow pharmacists to “practice at the top of their license.”
  • Pharmacists are skilled accessible health care providers. Policymakers and regulators should enact legislation enabling pharmacists, where appropriate, to perform diagnostic testing, prescribe indicated medication, and administer vaccines to expand access to care.
• Provide biosimilars education for providers and resources they can share with patients.
  • Reliable sources, including government entities, academia, and clinician groups, can increase health literacy and promote uptake of biosimilars, which will generate savings for patients.
• Provide incentives for using RTBTReal Time Benefit Tools.
  • To support the use of economical treatment options, the Center for Medicare and Medicaid Innovation (CMMICenter for Medicare and Medicaid Innovation) should conduct a demonstration that incentivizes providers who use RTBTReal Time Benefit Tools and choose therapeutically appropriate, lower cost alternatives. CMMICenter for Medicare and Medicaid Innovation could later expand the demo in an alternative payment model to include prescribers eligible to share in any potential plan-level savings if they select lower-cost alternatives at the list price level, such as demonstrating a shift toward generic drugs over brands.
    • To evaluate patient behavior in the demo, CMMICenter for Medicare and Medicaid Innovation should expand its limited “rewards and incentives” (R&I) reach for beneficiaries (R&I is currently only available in one Medicare Advantage model). CMMICenter for Medicare and Medicaid Innovation should then evaluate improvements in medication adherence resulting from the use of lower-cost drugs, as well as improvements in total spend resulting from guiding and incentivizing prescriber choices.
• Sponsor a Senior Savings Model focused on areas of known health inequities.
  • For purposes of reducing risk selection and with the intention of promoting health equity, the next Senior Savings Model demo should take the form of targeted therapeutic class-specific plan offerings focused on at least one disease state in which health inequities are particularly significant, such as asthma, chronic obstructive pulmonary disease (COPD chronic obstructive pulmonary disease), or heart disease. The Senior Savings Model demo should operate in a manner nearly identical to the Medicare Part D Senior Savings Model implemented for insulins in 2021 and 2022 – recognizing the use of manufacturer-side agreements related to the Coverage Gap Discount Program may be less feasible in crowded classes, especially as the Coverage Gap Discount Program transitions into the new, but lower-discounted Manufacturer Discount Program (MDPManufacturer Discount Program) in 2025 (10% and 20% dependent on the benefit phase). MDPManufacturer Discount Program discounts could serve a similar purpose, to reduce cost-sharing for model drugs, as could existing manufacturer rebates paid to Part D plan sponsors. Additionally, CMS currently limits sponsors to offering no more than three Part D plans in a region. To facilitate robust participation, CMMICenter for Medicare and Medicaid Innovation should allow sponsors to offer a fourth Part D plan in a region if at least one of their plans was a Part D Senior Savings plan. 

Pharmacy benefit companies and drug manufacturers negotiate value- and outcomes-based contracts for drugs that have proven clinical value for patients. Data collected to inform these contracts continue to provide physicians and payers with insights that enhance clinical decision-making, improve patient health, and increase competition in the marketplace. Greater adoption of value-based purchasing (VBPvalue-based purchasing) and accelerating patient-focused pharmacy care can improve health outcomes. Providing Medicare Part D Prescription Drug Plans with access to Medicare Parts A and B claims data, expanding safe harbors for VBPvalue-based purchasing contracting, and allowing Medicare Part D and state Medicaid plans greater flexibility to adopt private-sector formulary management techniques will provide a boost to these payment models. To accelerate value-based care, PCMA recommends policymakers take the below actions.

• Give Medicare Part D plans meaningful access to Medicare Part A and B claims data.
  •  Part D plans can utilize medical data in combination with prescription data to improve health outcomes. Legislative changes allowing use of these data for this purpose also would advance indication-based formularies and decrease prescriber burden.
• Permit states the same tools available to employers and Medicare Part D plans to limit coverage of drugs in their Medicaid programs for which there is inadequate evidence of clinical effectiveness or ample competition of therapeutic alternatives.
  • New legislation should provide states flexibility to adopt private-sector formulary management techniques to drive value and lower costs in their Medicaid programs, including:
    1. Allowing states to exclude covered outpatient drugs with insufficient clinical evidence,
    2. Creating a state option to include drugs provided as part of a bundled service in the Medicaid Drug Rebate Program, and
    3. Allowing states to exclude or otherwise restrict coverage of a covered outpatient drug for 180 days after a new drug or new formulation of a drug has been approved by the FDA and entered the market.
• Remove remaining barriers to the uptake of innovative payment and incentive structures that promote pharmaceutical value and ensure flexibility that allows for other innovative contract models.
  • While CMS took a necessary first step with respect to the treatment of VBPvalue-based purchasing arrangements under Medicaid Best Price, there are additional improvements that would foster greater innovation and expansion in the use of VBPvalue-based purchasing for prescription drugs. Regulatory amendments creating a safe harbor for VBPvalue-based purchasing of prescription drugs would enable innovation in design and encourage participation, specifically by:
    1. Creating additional safe harbors for drug related VBPvalue-based purchasing at 42 C.F.R. § 1001.952,
    2. Expanding the “value-based purpose” definition to include “reducing total cost of care of a target patient population” as a value-based purpose at 42 C.F.R. § 1001.952 and 42 C.F.R. § 411.351, and
    3. Expanding the “value-based entity participant” definition to include pharmacy benefit companies and, to the extent that such parties are participating in VBPvalue-based purchasings with pharmacy benefit companies and health plans, drug manufacturers, manufacturers of durable medical equipment, wholesalers, and distributors at 42 C.F.R. § 1001.952 and 42 C.F.R. § 411.351.

In a world where the cost of a drug can exceed an individual’s lifetime earnings, drug manufacturers should be expected to undertake ongoing research to ensure effectiveness and durability of effectiveness, even after their products are approved. Clinicians need accurate, scientifically reliable information on prescription drugs throughout their lifecycles, from pre-approval for timely coverage decisions to post-market surveillance, and research into side effects and long-term efficacy for expedited approvals. These efforts should include rigorous evidence of performance under real-world conditions and capture demographics, including race and ethnicity, which can be used to determine whether a drug functions better or worse than anticipated for specific populations. To help the health care industry realize the promise of real-world evidence, PCMA recommends policymakers take the below actions.

• Require manufacturers to provide comparative effectiveness research (CERcomparative effectiveness research ) studies 
  • as part of their application for new drug approval or new indications.
• Authorize the FDA to assess value at the time of a drug’s approval or authorization (e.g., low additional value, high additional value, innovative and high value).
  • If a drug is deemed by the FDA to be conditional or low additional value, such information should be used by payers as a criterion for negotiating down net prices and/or negotiating outcomes-based contracting.
• Increase funding of efforts focused on producing objective information
  • and research on the evidence of prescription drug value and comparative effectiveness.
• Accelerate efforts to build a robust real-world evidence (RWEreal-world evidence) program
  • and rigorous, science-based criteria for how RWEreal-world evidence can be used to inform payment and coverage decisions (e.g., for use in VBPvalue-based purchasing strategies).
• Enforce and strengthen existing post-market surveillance requirements,
  • particularly for accelerated approvals, and require the FDA to share findings publicly to inform coverage decisions and value-based payment of prescription drugs.
• Require manufacturers to continue research into the long-term efficacy and side effects of drugs under accelerated approval
  • (after they come to market) with specific timelines and reporting requirements.