August 12, 2020
Dr. Jennifer Richards, PharmD, JD, CSP
Product Development Principal
Utilization Review Accreditation Commission
1220 L St NW STE 900
Washington, DC 20005
RE: Draft Revisions to URAC Pharmacy Benefit Manager Accreditation Standards
Dear Dr. Richards:
The National Pharmaceutical Council (NPC) commends the Utilization Review Accreditation Commission (URAC) on the revised Pharmacy Benefit Manager Accreditation Standards. As a health policy research organization committed to the generation of evidence to inform coverage policy, we support URAC’s evidence-based approach to developing measures and standards for utilization management through engagement with key stakeholders.
The advancement in biopharmaceutical innovation is occurring rapidly. Treatments are more personalized, and more evidence is available regarding the efficacy and safety among diverse patient populations. At the same time, rising health care costs and a changing reimbursement environment pose challenges in the coverage decision-making process. Further, as patients become more engaged, communication channels have evolved, and purchasers are increasingly balancing increases in health costs with business costs, there is a need for greater transparency and communication.
Pharmacy benefit accreditation standards help benefit managers make formulary decisions by prioritizing evidence of safety and efficacy of therapeutics while managing the cost of care. Standards provide plans with the parameters to maintain appropriate and continuous care for patients. We are encouraged to see the 2020 revised standards highlight the importance of these key components with the goal of facilitating appropriate patient access.
Our recommendations focus on the following:
- Evidence: Formulary development should be based on up-to-date, best-available evidence. The formulary structure should allow for flexibility given individual patient health characteristics.
- Transparency: Transparency of formulary processes and utilization management protocols is necessary to ensure plan sponsor accountability and empower patients and prescribers to make informed decisions.
- Evaluation: Mechanisms to measure performance and care quality are necessary to ensure that policies and utilization management programs are achieving their intended goals.
We provide specific recommendations by section below:
Pharmacy and Therapeutics Committee (PBM-PT): URAC’s requirements regarding Pharmacy and Therapeutics (P&T) Committee practices recognize that objectivity and diverse perspectives are needed for formulary development. The revisions recognize that mitigating conflicts of interest is essential to maintaining objectivity throughout the P&T committee processes and protocols. Inclusion of multiple scientific and clinical disciplines on the committee ensures formulary design is driven by established scientific evidence and consideration for the needs of vulnerable populations. One of the challenges for P&T committees is ensuring treatment generalizability among plan membership or usual care settings. The body of evidence demonstrating the effectiveness of pharmaceutical therapies includes real-world evidence – observational comparative effectiveness studies that examine the impact of a drug in an uncontrolled health care setting covering typical patient populations. Given the increase in availability of real-world evidence, benefit managers and health plans should regularly review this evidence. Reviewers on a Pharmacy & Therapeutics Committee should have the appropriate training and tools to identify and interpret RWE studies.
1-1 Membership: We are encouraged to see the membership requirements include various clinical specialties, practicing pharmacists and those with expertise in the care of elderly or disabled individuals.
Health plans’ P&T committees include a variety of specialists to enable clear understanding of the specific nuances related to special patient populations. Similar emphasis is needed to understand the specific nuances related to different types of evidence. There is a growing role of real-world evidence (RWE) to improve decision-certainty, assess reimbursement- rather than regulatory-based endpoints, and understand the degree to which results may be generalizable to typical plan membership and provider networks. As recommended by experts in clinical guideline development and evidence-based medicine, best available evidence using high-quality evidence, regardless of study design, is recommended. However, the challenge in recognizing high-quality RWE is an important barrier to broader and more consistent use of RWE. While payers recognize the value of RWE, they highlight organizational barriers to the use of RWE to guide P&T practices. These barriers include the lack of skill in conducting and interpreting RWE, and opportunities to increase organizational capacity to improve those skills. Given these challenges, the use of this type of evidence is limited and varies across payers. [i]
Coverage decisions have the power to impact a patient’s overall quality of life and encompass important elements of care and cost for the patient. One way to ensure patient experience with a disease or condition is considered in the design of pharmaceutical benefits is by incorporating the beneficiary perspective into P&T committees or other similar groups. Outside the United States, health technology assessment (HTA) processes have begun seeking patient and public input to guide resource allocation and coverage decisions. [ii] In the United States, the Department of Defense formulary process presents formulary recommendations to the Beneficiary Advisory Panel, which includes members of the TRICARE beneficiary population, the military’s health plan for active duty and retired uniformed service personnel. Similar input from patients and consumers to guide beneficiary access to medications in the United States, however, is less common. In a review of standard operating procedures for developing medical policy among 17 of the largest commercial health plans, 15 actively seek specialty provider society or network input. Yet, no health plans offered the same opportunity to seek patient or beneficiary input. [iii]
These recommendations for broader inclusion of perspectives on the P&T committee are echoed by other groups, including the Academy of Managed Care Pharmacy (AMCP). [iv]
We recommend including additional perspectives on P&T committees with a focus on patient representation and experts in the understanding and interpretation of real-world evidence.
1-3 Membership Exclusion: We are encouraged to see URAC’s continued commitment to mitigating conflict of interest with this requirement.
We recommend guidance for how plans can facilitate attendance at meetings by product sponsors prior to the voting process. Improved understanding of which evidence is used in decision-making can improve the evidence generated and the ultimate decision-certainty of plans and pharmacy benefit managers.
2-1 Meetings: While some information must remain confidential, the clinical evidence used to inform the decision can be made publicly available.
We recommend expanding this requirement to document the underlying evidence considered to inform the committee’s decision, which allows greater transparency for practicing clinicians, patients and others to understand the clinical rationale behind the formulary decision.
2-2 Responsibilities: We applaud the focus of the P&T committee responsibilities on scientific evidence as the foundation of formulary review and development. However, given the varying evidence available to inform the use of a particular therapy, specific guidance on the information considered during formulary review is necessary and should be incorporated in the standard operating procedures for developing formulary recommendations.
We recommend that URAC include two additional items in the P&T committee responsibilities:
- Policies should include an evidence-based search process to identify best-available evidence (including RWE) to inform formulary development.
- Routinely evaluate the effectiveness of a utilization management program recommended by the committee.
Formulary and Drug Management (PDM-FDM): Health plans and pharmacy benefit managers must acknowledge that what works best for the “average” patient, or member, may not provide the same outcome in each and every patient circumstance and must work to incorporate this heterogeneity of treatment effect into the benefit design. [v] The study design, patient population, outcomes identified, and analytic approaches may differ across studies, creating heterogeneity in treatment response. This flexibility – operationalized as an exceptions or appeals process - is central to ensuring appropriate patient access. [vi] URAC’s requirements to implement clear exceptions processes align with best practices to ensure the needs of unique patient circumstances are considered. [vii] Further, we are encouraged to see the revisions include requirements on communication of these details between the benefit managers, the prescribers and patients to facilitate a seamless process of care for the patient.
1-1 Formulary Development: We recommend that URAC include additional language that requires formulary recommendations to be developed using the full body of available and up-to-date evidence including safety, efficacy of the therapy and patient experiences with the disease. [iv]
1-2 Formulary Review: We applaud URAC’s commitment to continued review of formulary decisions.
We recommend that URAC include additional language requiring periodic evaluation and update of the evidence that informs formulary decisions when new information becomes available. [viii]
1-3 Formulary Exceptions: We applaud the multiple components in URAC’s requirements around formulary exceptions. Individual patient circumstances may require an alternative path to the preferred treatment path outlined in the formulary.
We recommend that URAC include specific requirements for providing information on the exceptions process electronically (i.e., on the benefit manager or plan sponsor’s website) in easily accessible language. [viii]
2-1 Program Implementation: We recommend including guidance that, when utilized, e-prior authorization software is accessible to pharmacists, given their role at the point of service with the patient. [ix]
A pharmacist’s access to a patient’s prescription history at the point of service makes them a critical resource for patients. Pharmacists may be able to streamline the prior authorization process in this position and ensure continuity of care for patients. We recommend that URAC include guidance on the role of the pharmacist in the prior authorization process. [vii]
2-2 Determination Decisions: We are encouraged by URAC’s focus on the clinical evidence and the requirements that decisions are made by health professionals with the appropriate expertise and experience.
Research suggests that if only clinical factors (e.g., blood pressure, cholesterol) are considered in determining treatment “success,” we may overlook patients who are experiencing other more subjective adverse effects, such as nausea or rash, which impact treatment adherence. [I] Further, the same therapy or treatment may be safe and effective for some, but not all patients. Other treatments may be harmful for some, but not all patients. Understanding when treatments have different effects for different patients is critical when developing formulary decision-making for populations of patients.
We recommend that URAC include guidance on how benefit managers or plan sponsors should consider provider judgment of patient benefits or adverse effects in their process for reviewing requests for exceptions. Further work is required on the best approaches to measure this information in an actionable way, but limiting decisions to clinical metrics may adversely impact patients with unique characteristics. [viii]
2-3 Determination Notifications: We recommend that URAC include requirements that benefit managers notify patients and prescribers in writing or electronically of appeals or exceptions determinations.
2-5 Denial Determination Appeals: While certain appeals requests may be addressed by a general practitioner, other more complex patient situations should be addressed by the appropriate specialist. [viii]
We recommend that URAC standards include guidance on “peer-to-peer” discussions of exceptions and appeals requests. Specifically, benefit managers should have a process in place to determine when specialty practitioners are necessary.
2-6 Appeal Decision Notification: The revised standards regarding determination notifications require benefit managers to include instructions for initiated appeals.
We recommend that URAC include requirements regarding the opportunity to request an external appeal in accessible language for patients. [viii]
2-8 Transition Process: We are encouraged to see requirements in place when patients transition between plans to ensure continuity of care.
We recommend that URAC specify this requirement for both internal changes to the formulary and external transitions between plans.
5-4 Drug Utilization Review Overrides: We commend URAC’s commitment to oversight and continued improvement of PBM policies and programs. Any policy enacted should be evaluated to ensure it is achieving its intended goals. Clients should have insight into the results of those evaluations. Purchasers have specifically indicated that benefit managers have a role to play in ensuring and improving consumer adherence through various disease-specific programs. [x]
By having the full spectrum of information, pharmacy benefit managers and clients can make more informed decisions for their members.
We recommend that URAC provide specific guidance for benefit managers to share the results of its evaluations with clients (plan sponsors, employers, purchasers) regarding drug utilization review, utilization management activities, generic dispensing rates, adherence, and drug utilization review overrides.
Network Management (PBM – NM): We are encouraged to see the revised standards around legal and regulatory parameters includes mechanisms of oversight to 1) limit risk to patient health, fraud or abuse, 2) ensure access to medicines is maintained and 3) measure pharmacy satisfaction. We have no further recommendations on the items in this section.
Client Relations (PBM-CR): In addition to patients and prescribers, employers choosing coverage for their employees also benefit from increased transparency regarding benefit design and formulary decisions. A survey of employer health benefit experts demonstrated that to improve the value of prescription drug benefits, benefit managers should disclose the rationale behind their formulary and exclusion list decisions. Nearly half of the employers surveyed indicated that pharmacy benefit managers lacked transparency about formulary development.
3-2 Client Reporting: We commend URAC’s commitment to the documentation and communication of formulary and network management to plan sponsors, employers or purchasers, given the value of this information when selecting coverage for their employees or members.
We recommend that URAC include guidance for benefit managers on the specific statistics they should provide to clients. These might include: number of requests for exceptions, percent of exceptions approved/denied, number of requests for appeals, percent appeals approved/denied, number requests for external appeals, and percent decisions overturned.
Consumer Service and Communication (PBM-CSC): Transparency regarding processes and protocols are necessary to maintain a seamless exchange of relevant information across the stakeholders involved in providing pharmacy benefits to consumers – the benefit manager, the pharmacy, the health plan or employer. When health plans or employers are considering various pharmacy benefit managers for their members, transparency regarding both benefit decisions and underlying evidence for those decisions helps these stakeholders make informed decisions. URAC’s requirements regarding the exchange of information across these groups recognizes the impact of maintaining open lines of communication on continuity of patient care. Research by Dean et al. suggests that while methods to capture how evidence is evaluated by P&T committees are evolving, communicating this information in a clear, consistent transparent manner is necessary. [iii] We are encouraged to see the revised standards support the communication and transparency of the coverage and benefit design details, as well as the factors affecting those formulary decisions.
1-1 Consumer Information: We commend URAC on ensuring consumers have the information they need about their health care coverage and prescription drug benefits in order to make informed health care decisions. In addition to the details on the protocols and processes, patients can benefit from a better understanding of the underlying evidence for these decisions.
We recommend that URAC include in this item guidance on how benefit managers and plan sponsors make available to patients, in writing or electronically, the evidence used in the formulary development process.
1-2 Support Services: We recommend that URAC include specific requirements regarding making this information available online. For example, the website should be in easily accessible language and navigable for patients so they can identify relevant information for health care decision making. [viii]
1-4 Consumer Materials Maintenance: We commend URAC’s requirements that benefit managers continually review and update benefit information for its members.
We recommend that URAC require these updates be 1) done routinely and 2) shared with consumers in a timely manner upon completion to ensure information used by patients is up to date. [iv]
3-2 Non-Telephone Communication: We commend the specific performance metrics URAC has outlined for telephone communications and its clear commitment to data-informed policies. Ongoing research suggests electronic resources, including online websites, patient portals or opt-in text messaging platforms, be comprehensive and in easily accessible language for patients to navigate. [viii]
We recommend that URAC provide more specific guidance or define a “timely” response for electronic communications.
NPC appreciates URAC’s revisions of the accreditation standards and the focus on evidence-based policies, clear channels of communication and continued performance measurement to ensure high quality health care. We appreciate this opportunity to provide input on URAC’s Draft Revisions to the Pharmacy Benefit Manager Accreditation Standards. NPC looks forward to answering any questions and contributing to the URAC Advisory Group as the team moves to finalize and implement these revisions.
Jennifer S. Graff, PharmD
Vice President Comparative Effectiveness Research
National Pharmaceutical Council
Taruja Karmarkar, PhD
2018-20 Health Policy Fellow
National Pharmaceutical Council
[i] Malone DC, Brown M, Hurwitz JT, Peters L and Graff JS. “Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies?” Value Health. 2018; 21(3):326-333.
[ii] Facey KM, Hansen HP Single AN (eds). Patient Involvement in Health Technology Assessment. Copyright 2017.
[iii] Dean BB, Ko KJ, Graff, JS, Localio AR, Wade R, Dubois RW. “Transparency in evidence evaluation and formulary decision-making: from conceptual development to real-world implementation.” P.T. 2013;38(8):465-483.
[iv] Academy of Managed Care Pharmacy Partnership Forum: Principles for Sound Pharmacy and Therapeutics (P&T) Committee Practices: What’s Next? J Manag Care Spec Pharm. 2020; 26(1):48-53.
[v] Malone DC, Hines LE and Graff JS. “The Good, the Bad, and the Different: A Primer on Aspects of Heterogeneity of Treatment Effects.” J Manag Care Pharm. 2014;20(6):555-63.
[vi] Teagarden JR. “Managing Heterogeneity in Prescription Drug Coverage Policies.” J Manag Care Pharm. 2014;20(6):564-65.
[vii] AMCP Partnership Forum: Optimizing Prior Authorization for Appropriate Medication Selection. J Manag Care Spec Pharm. 2020; 26(1):55-62.
[viii] Karmarkar T, Dubois RW and Graff JS. “Stakeholders Agree on When, Not How, Step Therapy Should Be Implemented.” April 2020. Work in Progress.
[ix] Academy of Managed Care Pharmacy Partnership Forum: Principles for Sound Pharmacy and Therapeutics (P&T) Committee Practices: What’s Next? J Manag Care Spec Pharm. 2020; 26(1):48-53.
[x] Purchasers Guide to PBM Quality. National Alliance of Healthcare Purchaser Coalitions. 2019.
[xi] Toward Better Value – Employer Perspectives on What’s Wrong With the Management of Prescription Drug Benefits and How to Fix It. National Pharmaceutical Council, 2017.