AMCP Partnership Forum: Optimizing Prior Authorization for Appropriate Medication Selection

Prior authorization (PA) and step therapy (ST) are utilization management tools that have been in use by managed care organizations for decades. These processes require that health care providers obtain advanced approval to qualify a specific product for coverage from a health plan before it is delivered to the patient. These tools are intended to ensure that patients have access to evidence-based medications while payers remain good stewards of limited health care resources. PA and ST are growing in use to support appropriate use of medications and manage associated costs but may pose challenges related to administrative burden and access to care. In June 2019, the Academy of Managed Care Pharmacy (AMCP) conducted a multistakeholder forum to identify processes for optimizing PA and ST utilization management programs. Health care leaders representing academia, health plans, integrated delivery systems, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations participated in the forum. Participants explored current operations of these programs, evaluated stakeholder perspectives on opportunities to improve these programs, and provided recommendations for next steps. They also reviewed current federal and state legislative and regulatory activities to reform PA and ST processes and offered guidance to support program improvements. The goal of the forum was to gather stakeholder input to inform the development of recommendations to improve efficiencies around PA and ST processes; provide recommendations to address administrative burdens; increase the visibility of the clinical and economic value of PA and ST utilization management programs; collect, review, and disseminate data-driven, real-world experiences of PA programs that support clinical and economic value; collect and disseminate best practices around PA appeals and denial processes; and improve channels of communications between health insurance providers, health care professionals, and patients to minimize care delays and improve clarity of coverage authorization requirements.

P rior authorization (PA) and step therapy (ST) are utilization management tools that are often applied to certain pharmacy and medical benefit services. Although such tools can support safe, appropriate, and cost-effective care, stakeholders have called for review of PA and ST programs to ensure that policies facilitate optimal patient outcomes while reducing costs and ensuring safety without creating unnecessary barriers to care. To address these issues, the Academy of Managed Care Pharmacy (AMCP) convened a forum in Alexandria, Virginia, on June 25-26, 2019.
As a foundation for the forum, a PA and utilization management concepts paper written by the AMCP Professional Practice Committee and PA and utilization management reform principles that were developed by a workgroup convened by AMCP Partnership Forum: Optimizing Prior Authorization for Appropriate Medication Selection SUMMARY Prior authorization (PA) and step therapy (ST) are utilization management tools that have been in use by managed care organizations for decades. These processes require that health care providers obtain advanced approval to qualify a specific product for coverage from a health plan before it is delivered to the patient. These tools are intended to ensure that patients have access to evidence-based medications while payers remain good stewards of limited health care resources. PA and ST are growing in use to support appropriate use of medications and manage associated costs but may pose challenges related to administrative burden and access to care.
In June 2019, the Academy of Managed Care Pharmacy (AMCP) conducted a multistakeholder forum to identify processes for optimizing PA and ST utilization management programs. Health care leaders representing academia, health plans, integrated delivery systems, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations participated in the forum. Participants explored current operations of these programs, evaluated stakeholder perspectives on opportunities to improve these programs, and provided recommendations for next steps. They also reviewed current federal and state legislative and regulatory activities to reform PA and ST processes and offered guidance to support program improvements.
The goal of the forum was to gather stakeholder input to inform the development of recommendations to improve efficiencies around PA and ST processes; provide recommendations to address administrative burdens; increase the visibility of the clinical and economic value of PA and ST utilization management programs; collect, review, and disseminate data-driven, real-world experiences of PA programs that support clinical and economic value; collect and disseminate best practices around PA appeals and denial processes; and improve channels of communications between health insurance providers, health care professionals, and patients to minimize care delays and improve clarity of coverage authorization requirements.
collaboration between prescribers and payers to ensure that patients receive timely access to cost-effective, evidence-based treatment (Table 3). 1 During the forum, participants reviewed the detailed descriptions of each of these concepts and assessed alignment of these concepts with real-world examples of existing PA criteria. 1 They identified several gaps between the concepts for effective PA processes and current practice. Opportunities for improvement emerged around addressing patient, prescriber, and pharmacist burden; transparency for stakeholders; clarity regarding requirements; variability among plan requirements; and reducing the complexity of criteria. Options for expanding the use of electronic PA (ePA) systems were also explored. However, automated decision support typically relies on binary data fields (e.g., yes/no). Organizations seeking to use ePA could structure their criteria to support binary data questions and responses.

■■ Evaluating Current Initiatives to Improve Processes
Participants outlined criteria and identified barriers for recommended approaches to ensure that processes are patientcentered and reduce the administrative burden. The burden on prescribers, pharmacists, and patients is well described and complicated by a lack of consistency across formularies, requirements, and processes among plans, even for the same medication. 13 The forum participants outlined factors that contribute to inconsistency in processes and formularies, including that employers have different priorities and offer different plans to their employees, regulations vary across states and plans by line of business, and organizational priorities and business operations of plans vary.
currently have practices that align with these principles, including that they collaborate with prescribers to develop criteria that are clinically sound and evidence based (unpublished data, Academy of Managed Care Pharmacy, 2019).
Participants reviewed publications, including those from AMCP and the workgroup convened by AMA, that explore how plans and providers can collaborate to reduce administrative burdens and costs associated with PA in its current form. 1,16 Given that there is substantial alignment among organizations regarding factors for consideration, participants acknowledged that there are opportunities for collaboration to develop innovative solutions to improve PA processes and implement best practices.
Participants emphasized the need to focus on the patient's experience while addressing other stakeholder needs. They also recognized the need to return autonomy to the point-ofcare for prescribers who practice evidence-based medicine, while acknowledging that this requires accountability for costeffective care. Resources that remain abreast of the accelerative pace of new evidence generation will be an important tool to support evidence-based decision making.
Participants discussed examples of PA or utilization program elements that some states are considering and offered suggestions for fine-tuning these elements, including the description of PA, the purpose of PA and declarations, disclosure and review of PA requirements, and the appropriate use of PA and ST protocols (Table 1).

AMCP PA and Utilization Management Concepts in Managed
Care Pharmacy. AMCP's Professional Practice Committee has developed 9 concepts for effective PA processes to support

Aspect
Perspectives from Participants General characteristics of medications that may lead to utilization management • Specific safety concerns, including certain drug interactions • Availability of more affordable alternatives • Potential for off-label use • Potential for misuse or abuse • Limited distribution or special handling requirements • Multiple indications across benefits (e.g., medical and cosmetic) Description of PA PA is a process for the provider to obtain approval for medications and/or services to qualify for coverage by the plan. It can be a collaborative process that includes evidence-based criteria.

Purpose of PA
The purpose of PA is to ensure selection of safe, cost-effective, evidence-based treatment that maximizes therapeutic value. Processes should be reasonable, accessible, and timely. Disclosure and review of PA requirements Communications need to be relevant, available in multiple formats, and easily accessible to patients, prescribers, and pharmacists. There is a need to have some materials that are appropriate for patients, and health literacy and readability should be considered when designing these communications. Patient, prescriber, and pharmacist communication should be incorporated throughout the PA process.

Appropriate use of PA and ST protocols
It is important for patients to receive access to cost-effective, evidence-based treatments. Incentives should be aligned in a manner that influences total cost of care. Complying with appropriate PA and ST should not be challenging to operationalize for providers. PA = prior authorization; ST = step therapy. Participants provided insights on how to improve existing recommendations and guidance for the use of potential solutions, including pharmacist-initiated PA, sunset programs, and gold card programs. Several proposed strategies could reduce administrative burdens.

Sequencing Therapy: ST and Clinical Pathways
Participants discussed the similarities of characteristics across ST and clinical pathway programs. They identified challenges associated with sequencing programs, including lack of consistent descriptions across health plans and gaps in communication between health plans, patients, and providers. Processes for exempting patients from ST and the process to initiate an appeal were also cited as challenges.
To improve sequencing programs, participants suggested the development of criteria that would allow prescribers to (a) answer "yes" or "no" to a series of questions and (b) rely more on provider attestations to avoid requirements for submitting detailed patient records (e.g., PDFs), which may not be interoperable with current technology systems. Clinical practice guidelines could be an effective tool for the development of criteria if they are available, current, and sufficiently specific for the disease being treated and could support consistency among plans.
Participants observed that value-based arrangements that place providers at risk for total cost of care support incentives to provide cost-effective care. Accountability for the financial and clinical outcomes of care, combined with robust quality improvement programs, may support increased autonomy for prescribers and could result in a reduction in PA or ST requirements. As the health system continues the trend toward value-based purchasing, PA may increasingly shift to acting as a decision support tool.
Participants also addressed challenges related to the durability of approvals. Ideally, patients are only required to progress through ST requirements once. However, when patients switch employers or insurance plans or have a lapse in therapy, they may be required to document that they have been through ST processes. Because of the effect on patient outcomes and safety, some health plans "grandfather" patients, allowing those who are already responding well to a therapy to continue treatment without interruptions. However, challenges transferring patient data among health plans may affect the ability of payers to provide timely "grandfathering" of existing treatments.
The general perspective of forum participants was that patients established on therapy should have continuity of care and not be required to step through new or additional therapies or criteria to remain on treatment that is effective for them. However, communication across payers to facilitate continuity of care is a recognized challenge. As greater sharing of data occurs in the health care system, stakeholders will need to support increased sharing of patient history information, including medication history, to assist in the review of ST requirements.

PA Denial and Appeal Processes
Stakeholders seek transparency and improved communication throughout PA denial and appeal processes. Effective communication among health plans, health care providers, and patients is necessary to ensure timely completion of PA requests and to minimize care delays.
Participants discussed opportunities to improve the denial and appeal process, including timelines for these processes, the qualifications of the individual who reviews requests, and the need for clear patient-centric communication about reasons for denial. Regulatory requirements exist that define timelines for   Key Themes in Guiding Principles for Utilization Management Reform [12][13][14][15][16][17][18] approvals and denials of requests, exceptions, and appeals. For example, for an initial coverage determination, Medicare Part D requires a response from the reviewer within 72 hours, or 24 hours for expedited reviews. 19 Participants identified an opportunity to improve communication consistency and approval timelines across health plans and lines of business to facilitate timely resolution of PA requests and minimize care delays.
To inform, refine, and improve utilization management programs, several stakeholders have called for health plans to improve transparency by listing metrics on their websites such as PA volume, approval rates, and denial rates. Participants observed that details regarding the reasons for PA denials (e.g., medical necessity not demonstrated, incomplete PA submission, and safety issues) would be needed to provide important context for interpreting statistical data.

Pharmacist-Initiated PA
Participants reviewed the operations of a pharmacist-initiated PA clinic and discussed various aspects of the process (Figure 1). A key benefit is that pharmacists have access to information from the patient's prescription history to supply to the plan to process the PA. Ideally, pharmacists will also have direct access to the patient's electronic health record (EHR) to obtain additional details that may be required, such as diagnosis or laboratory values. Finally, the greater accessibility of pharmacists to patients, particularly on evenings and weekends, was cited as a benefit for patients, who may have questions throughout the process.
A similar solution currently in practice is the use of centralized PA teams. This approach allows the administrative burden to be shifted away from physicians to other health care professionals, such as pharmacists, nurses, and pharmacy technicians, who specialize in performing PA support services. Compared with usual care, pharmacy-led interventions in PA processing significantly improve time to PA approval, time to first fill, and time to pick up. 20 That further examination of pharmacist responsibilities, as well as the potential for improved workflow efficiencies, is necessary for advancing pharmacist-initiated PAs.

Evaluating PA Criteria
Regular review of the metrics associated with approvals and denials for products and services that are subject to PA requirements can help identify therapies that no longer warrant PA. For example, low variation in use or low PA denial rates may suggest that the criteria are no longer clinically relevant. Ideally, health plans will track metrics about rationales for denials and reasons for overturning denials on appeal to make informed decisions about criteria effectiveness. Regular review can help identify services, particularly new and emerging therapies, where PA may be warranted.
Some programs, including sunset and gold card programs, remove PA requirements either entirely or for a subset of prescribers. Although sunset and gold card programs are an option that health plans can implement to reduce provider burden, participants cautioned against the universal removal of PA criteria due to the possibility that this could have an undesirable effect on prescribing behavior. 21 In addition, participants observed that the complexity of the health care system may require the use of PA programs in certain circumstances, such as when there is a reinsurance program (a form of insurance that insurance companies purchase to manage risks of covering patients with high medical costs) or a safety concern.
Sunset Programs. Participants discussed key considerations for establishing PA sunset programs ( Figure 2). 22 High PA approval rates alone were generally not considered sufficient to justify a sunset program, as they may indicate that prescribers are familiar with the requirements of the program. Participants noted that safety is an important reason to continue a PA regardless of approval rates but that the existence of a Risk Evaluation and Mitigation Strategy program for certain prescribing requirements could support removal of redundant PA criteria. They commented that the frequency of appeals should also be considered when developing a sunset program.

Gold Card Programs.
Gold card programs differentiate the application of PA and/or ST based on provider performance on specific measures (e.g., adherence to formulary, evidence-based medical practices), or participation in a value-based agreement with the health insurance provider. 23,24 Such programs minimize administrative burdens for prescribers who meet the program's requirements but may also have an undesirable effect on prescribing behavior. 21

Technology and Real-World HIT Solutions
Participants discussed real-world applications and benefits of electronic PA (ePA) processes compared with fax and telephonic processes. An important advantage of ePA is that it can automate many steps of the process. ePA is more commonly

AMCP Prior Authorization and Utilization Management Concepts in Managed Care Pharmacy
used for drugs covered under the pharmacy benefit compared with those covered under the medical benefit (e.g., certain drugs that are injected or infused in medical settings). Within the medical benefit, ePA is used to address procedures services and devices; it could be more widely used for drugs covered under the medical benefit, including specialty drugs. 25 However, interoperability challenges across different technology systems remain.
Participants considered how ePA could help reduce burdens on patients and providers. Ideally, ePA would automatically connect with the EHR in real time to populate required information so that it does not have to be entered manually by prescribers. Participants also recommended that ideally the e-prescribing systems would be able to perform a real-time benefit check at the point of prescribing, similar to electronic claim adjudication performed in the pharmacy.
The ability of ePA to reduce the burdens on providers and patients was explored. Participants observed that, if PA is required, ePA facilitates a more seamless process for prescribers and patients. Further, they noted that it can reduce the time for approval from days or weeks to a few minutes and reduces the rate of prescriptions that are abandoned by patients. Participants observed that ePA programs that function as decision-support tools are available, but not all providers have access to these programs and not all health plans have the required technology.
Participants supported consistency in the structure of web access to ePA to minimize administrative burdens and discussed the possibility of standardization of user interfaces and processes to improve consistency among programs. The development of industrywide standards was suggested as an approach to implement this solution. Participants recommended collaborating with technology vendors to support standardization and develop incentives to improve use of tools that currently exist.

■■ Legislative Activities and Reform Principles
Several states have legislation that includes patient protections when PA or ST is implemented. Most state-level legislation has provisions for clear exceptions and appeals processes for PA and ST. Common areas of focus include timelines and appeals processes, but there is variability in how these concepts are addressed. For example, state-required time limits for the review of appeals range from 24 to 72 hours. A few laws include specific provisions for patients with advanced metastatic cancer; others are not specific to particular conditions. Legislation currently being considered by states generally reflects guidance from stakeholder principles and statements. Examples of issues that are being addressed in various legislative initiatives include the following: • Clinical criteria must be evidence based, current, consider provider input, and accommodate unique patient populations. • ST protocols should be accessible, include electronic processes for communication, and have flexibility to accommodate individual needs. Patients should not be required to repeat treatment steps. • Interruptions in care should be avoided. • Appeals processes should be clear and readily accessible. • Prescribers have the option to request overrides with appropriate justification.
Federal legislation could address some of the existing loopholes at the state level and provide some consistency for health plans. At the federal level, The Safe Step Act (H.R. 2279), currently under consideration, amends the Employee Retirement Income Security Act of 1974 to require an exceptions process for ST programs. The proposed legislation calls for clear processes for exceptions, lists requirements for granting exceptions, and requires that exceptions be granted within 72 hours (24 hours in urgent situations). However, participants observed that deadlines can result in denials if plans are unable to obtain the information needed to process the PA within the required timeline.

When a new medication is prescribed for a patient, the clinic pharmacist would:
• Check the patient's insurance plan to determine if a PA is required. • The pharmacist, working under a collaborative practice agreement, would either perform a therapeutic interchange or initiate a PA request.
When a PA is needed, the pharmacist accesses the patient's medical record to gather required information. • Appropriate forms are completed (either electronically or manually) and a letter of medical necessity, written by the pharmacist, accompanies each form. The letter of medical necessity covers patient-specific reasons why the prescribed medication is preferred over alternative formulary options. • After the determination by the insurance company is made, this information is communicated to the pharmacist who informs the prescriber and patient. • In the event of a denial, the pharmacist recommends alternative options to the prescriber and/or patient, including another medication, patient-assistance programs, coupons, or vouchers.

FIGURE 1
Description of Pharmacist-Initiated PA in a Centralized Refill Clinic 20 of health information technology solutions by health care entities is needed to enable a more efficient health care system. Finally, legislative and regulatory approaches and collaborative initiatives that address challenges associated with PA and ST will need to be mindful of the needs of all stakeholders while focusing on ensuring that patient care is optimized in an evidence-based, cost-effective manner.
Participants stressed that legislative solutions can be difficult to achieve and alternative approaches may be needed. Reporting requirements for certain plans (e.g., Medicare Part D or Medicare Advantage plans) and collaboration with accrediting bodies were mentioned as examples of alternative strategies that could be used to drive change.
Some participants proposed that AMCP lead a discussion around the creation of model legislative language that considers all stakeholders. They stressed that legislation be written in a manner that is broad enough to be implementable and operational as practice evolves, and participants recommended that accrediting bodies and industry groups be responsible for addressing more detailed aspects of the processes.

■■ Conclusions
Work to improve the current PA and ST processes requires ongoing efforts and collaboration among payers, prescribers, pharmacists, and patient groups to ensure that solutions meet the needs of all stakeholders. Organizations looking to improve PA and ST programs will need to consider how to automate processes, increase transparency, and remove the need for PA where appropriate while also promoting evidencebased prescribing. The importance of maintaining prescriber autonomy coupled with accountability, so that evidence-based and cost-effective treatments are prescribed, was highlighted throughout the forum.
Expanding the use of health information technology tools, such as ePA, is a best practice to reduce the administrative burdens of PA programs. Broader implementation and utilization A PA sunset program includes the regular review of the list of medical services and prescription drugs that are subject to PA requirements to help identify therapies that no longer warrant PA due to, for example, low variation in utilization or low PA denial rates. Regular review can also help identify services, particularly new and emerging therapies, where PA may be warranted due to a lack of evidence on effectiveness or safety concerns. Plans considering implementing a PA sunset program should consider using multiple evaluation criteria and data points and ensure that the metrics are powered appropriately to assess utilization, especially for medications used in small populations or for rare diseases. Criteria for review could include: