Pharmacy Team Engagement in Navigating the Revenue Cycle for High-Cost Medications in Patients With Cancer

HEALTHCARE TEAMS FUNCTIONING IN

today’s evolving healthcare landscape shoulder the responsibility of delivering high-quality care while reducing costs throughout the entire revenue cycle. This cycle encompasses several key steps to appropriately bill patients and third party providers and capture revenue. The major components of the revenue cycle include patient access, clinical documentation, coding, billing processes, denial management, and reimbursement.¹ To optimize the revenue cycle, key stakeholders, including clinicians, financial staff, and institutional leadership, need to be engaged in the process to maximize reimbursement for the health system and minimize patient costs and burden. Pharmacists and pharmacy staff play a pivotal role in cost containment through optimization of medication regimens and engagement in the revenue cycle, particularly for high-cost medications (Figure 1).^1,2 The high-cost medications referred to in this article are those commonly used in the treatment of patients with cancer, such as oral antineoplastics, immunosuppressants, antifungals, and select anticoagulants.

To facilitate the billing process, the medications must be appropriately coded. Every hospital has a charge description master, which includes the general ledger number, product description, billing units, Healthcare Common Procedure Coding Systems (HCPCS) codes, revenue codes, and pricing information.³ With constant updates to CMS’ billing requirements and rapid changes in the drug market of new brand and generic medications, there is a high possibility that HCPCS codes can easily become out- dated or incorrectly associated with a medication. For example, blinatumomab (Blincyto), approved in 2014 for the treatment of Philadelphia chromosome—negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, had different HCPCS codes for 2015 (J7799) and 2016 (J9039)^.4 It is essential for hospital and pharmacy leadership to understand the financial implications of such changes. These leaders should include individuals well-versed in charge coding and actively engaged in the ever-changing drug market and insurance industry.

Growing Drug Costs

In addition to the complexities associated with billing, the problem of sky-rocketing drug prices has garnered much attention in recent years and made budget management more complex. In its annual report on national trends in prescription projections and spending, the American Society of Health-System Pharmacists (ASHP) showed a 6% increase in US prescription sales between 2015 and 2016, totaling $448.2 billion in 2016.⁵ Overall, adalimumab was associated with the highest overall spend in 2016 with $13.6 billion in expenditures; in clinics and nonfederal facilities, in iximab had the highest expenditure with $5.3 billion in spending.⁵

Nonfederal facilities are de ned as licensed hospitals that are not owned by the government, including inpatient treatment and rehabilitation facilities. Nonfederal facilities also include general and specialty acute care institutions. Federal facilities refer to US ships or hospitals that belong to the Public Health Service, the Veterans Health Administration, and other federal branches. Higher drug prices and more prescribing were primarily responsible for the growth in expenditure in nonfederal hospitals and clinics.⁵ Drug expenditures in 2017 are projected to increase 6% to 8% overall and by 3% to 5% in hospitals.⁵ Therefore, health-system pharmacy leaders and clinicians should be actively engaged in the revenue cycle process and develop strategies that emphasize cost containment and ensure optimal medication reimbursement.^2,6,7

Top 5 Opportunities for Pharmacy Team Engagement in Containing Drug Costs and Maximizing Reimbursement in Patients Undergoing Cancer Treatment

Pharmacists caring for patients undergoing cancer treatment are in a unique position to help other providers and patients navigate the convoluted reimbursement structure. Strategies include finding suitable therapeutic alternatives to meet the needs of formulary restrictions or obtaining approval for off-label use of agents. Starting upon admission and continuing post discharge, transitions-of-care pharmacy team members provide continuity of care and enhance medication adherence. Transitions-of-care pharmacy team efforts, starting upon admission and continuing through discharge, can ensure coverage and enhance medication adherence.

Many antineoplastic and supportive care medications are expensive and/or challenging to obtain. Timely acquisition is essential in order to initiate cancer treatment expeditiously. This article reviews key strategies that pharmacy team members can utilize to optimize medication-related revenue cycle compliance, including prior authorizations (PAs), hospital formulary management, patient assistance programs, accessibility of medications, and risk evaluation and mitigation strategies (REMS) programs.

1. Managing inpatients who are taking medications outside of the hospital formulary as outpatients.

Hospital formularies ensure safe, efficacious, and cost-effective medication use in the inpatient setting, especially for high-cost medications.⁶ Medications included on a hospital formulary vary based on an institution’s patient population and contracting options, among other factors. Strategies to appropriately manage admitted patients who continue to take medications as outpatients that are not included on the inpatient hospital formulary include therapeutic interchanges, nonformulary review processes, and using the patients’ own medication(s) during their hospital stay.

A therapeutic interchange is a tool that provides a roadmap to transition patients from an outpatient medication that is not on the hospital formulary to a medication that is included, and this often presents healthcare providers with a medication that has an equivalent dosage as the formulary medication.⁸ For example, if a patient was taking candesartan 8 mg by mouth once daily as an outpatient and losartan was the hospital formulary angiotensin receptor blocker, a therapeutic interchange would direct prescribers to order losartan 50 mg orally once daily. These interchanges are most effective when the electronic health record (EHR) automatically directs prescribers to this alternate choice when the nonformulary drug is ordered. This strategy alerts prescribers that they are attempting to order a non-formulary medication and presents them instantly with alternatives. Some institutions utilize automatic therapeutic interchanges whereby the pharmacist, upon order verification, would automatically make the switch to the appropriate formulary medication. Developing therapeutic interchanges requires appropriate research and evidence supporting the specific interchange so that the healthcare team has information readily available.

For a medication that is not a part of an institution-approved therapeutic interchange, most institutions have a process in place whereby pharmacists are responsible for reviewing non- formulary medications and providing formulary alternatives, when appropriate.⁹ Depending on the specific institutional practice, this may be built into the role of the pharmacist who is verifying orders or a pharmacist with specialized training in the particular therapeutic area may be consulted for reviewing and approving nonformulary medication use, if needed. By having a review process in place, prescribers can become accustomed to discussions with the pharmacist when ordering nonformulary medications to assist with providing formulary alternatives.

When it may not be appropriate to transition a patient to a hospital formulary medication, the hospital may elect to order the medication and dispense it from their inventory. In certain circumstances, if a patient brought the medication with them to the hospital, that may be used during the hospital stay. This may occur if waiting for the hospital to acquire the nonformulary medication poses a safety risk to the patient or if the medication requires a patient-specific distribution channel, such as a REMs program or clinical trial. Ensuring safe use of a medication brought in by a patient requires appropriate practices for ordering and verifying these medications. Many EHRs have an option to allow the prescriber to indicate that a patient’s own medication may be used. This acts as a trigger for the verifying pharmacist to check the product by confirming identity and appropriate dating. When applicable, appropriate barcoding of the patient’s own medication also needs to be accounted for using institution-specific practices.

An example of this in oncology practice is the tyrosine kinase inhibitor, dasatinib. If a hospital did not have this medication on formulary, it would not be clinically appropriate to substitute another agent during the hospital stay. If the patient brought his or her own supply to the hospital, it would be important to not interrupt therapy, to continue the medication using the patient’s supply. Many hospital formularies do not include all oral antineoplastic agents; this becomes an important education point when prescribing oral chemotherapy in the outpatient setting by informing patients that they should be prepared to bring their own supply in the event of hospitalization.

Using a combination of the above strategies will prepare institutions to appropriately manage patients that are taking medications outside of the hospital formulary as they transition to being inpatient.

2. Setting patients up for success by facilitating coverage via outpatient prescription insurance.

Outpatient prescription insurance plans also have a formulary to optimize medication use for their members. Often, medications and criteria for their use differ between the hospital formulary and the outpatient insurance formulary. Additionally, preferred drugs may differ from institutional pharmacies based on contracting or rebates received from a pharmacy bene t manager (PBM). In order to best assist patients in navigating the outpatient prescription formulary, it is first necessary to access and interpret the outpatient formulary and then meet any requirements necessary to access the formulary medication.

One method to determine outpatient prescription coverage is to process a test claim through an outpatient pharmacy. This practice will adjudicate the prescription to make a coverage determination but then immediately cancel the claim to prevent the prescription from processing completely. To use this method, it is important to clarify the intention of the test claim to the outpatient pharmacy—safety and insurance issues can arise if prescribers are attempting to ll the same prescription multiple times. If one does not have access to a test claim process, some outpatient insurance plans will post their formulary information online. It is important to note that updates to these documents are determined by the individual insurance plans and may not correlate in real-time with decision changes.

For the most accurate information, it is best to contact the company via phone. Also, what is listed on the online formulary will not be specific to the patient in terms of any deductible or other patient-specific plan information, so contacting the insurance company directly or having the patient use their online portal to obtain the most accurate patient-specific information about coverage may be necessary. Several test claims of different drugs in a therapeutic class may be needed to help determine the preferred drug with the most affordable cost. It is important to remember that the test claim result is only an estimate specific to that pharmacy as the co-pay may differ at another pharmacy due to various insurance and pharmacy acquisition cost factors.

Once outpatient insurance coverage has been determined, it may be necessary to facilitate PA of the medication. The PA process typically requires the prescriber to review the patient’s medical history and ensure that they meet certain criteria for medication use. PA approval can take place over the phone, even online in some instances, and an immediate determination could be made. Other cases require forms to be submitted via fax or online, and coverage determination may take 24 to 72 hours. Once issued, it is important to note that the standard timeframe for the PA is 1 year, but that it may be a shorter period in other instances and re-authorization must be obtained to ensure continuity of care.

An area of growing complexity, especially when navigating from the inpatient to the outpatient setting, is the realm of biosimilar medications. Although a hospital formulary may include one brand of a biologic, the outpatient PBM formulary may prefer another. An example of this is filgrastim, where a hospital formulary may include filgrastimsndz (Zarxio), while the outpatient plan prefers filgrastim (Neupogen). This is also common with the new follow-on biologic for insulin glargine, Basaglar, which is becoming more common for outpatient formularies even though many hospitals still have Lantus or another basal insulin as their preferred product. Being aware of these different formulary preferences can help patients safely transition from inpatient to outpatient, avoiding interruptions in treatment or duplications in these high-risk medications.

3. Assisting patients to obtain drugs with no coverage or high co-pays.

Patient assistance programs, private grants, and medication replacement programs are a few mechanisms that support patient access to medications.¹⁰ Pharmaceutical manufacturers can provide assistance to obtain insurance approval and help patients get coverage for their medications. The provision of this assistance is often outsourced to a third-party company that oversees the disbursement of funds and/or free medications.

Most insurance plans have strict guidelines outlining which medications are covered within their plan. There are specific clinical scenarios with limited treatment options where a medication may need to be used off label or its FDA approval may be pending. In these situations, obtaining reimbursement from the insurance company can be challenging. Free distribution programs offered by pharmaceutical manufacturers provide an alternative to procuring expensive medications. However, the approval process can take several days to weeks, so starting early can prevent delays in treatment initiation. Submission of specific income documentation and copies of insurance denial is often required, which can be time-consuming to collect.

On an institutional level, many pharmacy departments have hired reimbursement coordinators/specialists, who may be pharmacy technicians or nonhealthcare individuals with a background in finance or health insurance. These individuals focus on PAs, drug replacement, co-pay assistance, and denial management and they work closely with the PBM and insurance companies to find alternatives and investigate co-pays for high-cost medications. They serve as a liaison to the financial offices at the hospital and coordinate with replacement drug programs to recover medications. Upon obtaining the power of attorney from patients, reimbursement coordinators can request co-pay assistance from manufacturers on the patients’ behalf and provide valuable assistance, especially for patients who may be too ill or overwhelmed by the reimbursement process. The addition of pharmacy reimbursement coordinators/specialists has significantly reduced the amount of time pharmacists and other health- care providers spend on getting drugs reimbursed for patients.² These programs often lead to increased outpatient prescription capture rates for institutional pharmacies. One institution increased its outpatient pharmacy’s capture rate from 57% to 73% for the general pediatric service.¹¹

There are exclusions for some programs, such as federal or state Medicare and Medicaid programs, where patients may not be allowed to receive co-pay assistance. This can be particularly di cult for patients who cannot afford high co-pays or for those who must first meet their deductible. Additionally, several private programs offer grants to cover out-of-pocket costs for patients undergoing cancer treatment. Being on funding cycles and considering their high demand, these grant programs are at risk of quickly exhausting their capital. It is important to have a backup plan in place and understand the extent of assistance that a patient may require so an entire treatment is covered.

4. Navigating patient registration for drugs requiring REMS programs.

The FDA Amendments Act of 2007 gave the regulatory body authority to require a REMS from manufacturers to ensure that the benefits of a medication outweigh its risks (Table).^12,15 The drugs selected for REMS programs have been found to have safety risks, such as teratogenic effects; special initiation requirements; or communication mandates to the patient beyond a black box warning.¹³ These programs often require the physician to undergo additional training to gain the privileges to pre- scribe these drugs. Patients also have to complete a survey, undergo education, and sometimes obtain the medication through a designated pharmacy. Medications such as thalidomide, lenalidomide, and pomalidomide, which can cause severe birth defects, require female patients to undergo pregnancy testing and all patients to agree to contraceptive use. While these added steps improve safety, the process significantly slows down drug procurement and complicates their use in the inpatient setting.¹⁴

In scenarios where the medication is distributed directly to the patient, patients must use their own supply during hospitalization. Outpatient pharmacies are required to adapt to the increasingly complex monitoring requirements of specialty medications that have limited distribution and high costs, require close monitoring or specialty handling, need patient or provider education, and are used in a unique patient population. This has resulted in a shift to higher utilization of specialty pharmacies, which are equipped to distribute specialty medications as they maintain adequate training and necessary procedures. PBMs often have preferred pharmacies, and it is time consuming to determine what the preferred pharmacy is for each patient.

5. Timely delivery of medications.

In certain circumstances, it may be urgent to start cancer treatment. However, we often experience delays with obtaining high-cost novel targeted medications. PAs delay drug procurement in addition to identifying the patient’s preferred pharmacy, which is more often a mail order pharmacy (Figure 2) so that these medications need to be directly shipped to the patient. Providers and support staff spend a large amount of time on the phone with insurance representatives to obtain PA and ensure timely drug delivery, and specialty pharmacies work to ensure prompt delivery of medications as soon as approval is obtained. It is important to communicate with the pharmacy when urgent delivery is needed so the drug can be overnighted to the patient, if necessary.

Due to drug shortages or restricted use, some medications undergo limited supply distribution. For example, procarbazine, a drug used in combination treatment for lymphoma in the brain, is not carried by all pharmacies. There also have been instances where a patient’s insurance required a specific specialty pharmacy, but that pharmacy was unable to obtain a supply of the drug. These circumstances take a significant amount of time to manage and ensure patient access to the medication.

It can be logistically challenging, especially for patients from out of town, to have their drugs delivered to a hotel or temporary residence. They often need someone to sign for the package, which requires the caregiver to leave the patient’s bedside to obtain medications. Some medications require special handling, such as refrigeration, which adds complexity. Mail order prescriptions may have lower co-pays for chronic medications. If caregivers know medications will be delayed, they can defer the start of cancer treatment until the entire regimen can start at the same time—unless the patient’s clinical situation prevents this. It is often difficult to predict what other medication needs may arise during a course of chemotherapy; therefore, a local community pharmacy is often necessary for obtaining medications to manage symptoms in a timely fashion. In addition, patients often have to rely on caregivers, friends, and relatives to ensure timely delivery of their medications, which may include personally carrying or mailing the medications to the patient’s temporary location.

Conclusion

With the clinical and financial implications of high-cost medications, and their impact on health system revenue, it is of utmost importance for all key stakeholders to be engaged in the complex revenue cycle. Tackling PBMs’ insurance formularies and the reimbursement process can be dynamic and complex. It is crucial for the pharmacy team to collaborate with other providers, hospital financial team members, PBMs, and hospital leadership and leverage their skill sets to manage costs and optimize reimbursement for the health system. Overall, this collaboration will maximize benefits for both institutions and patients, ultimately ensuring the most optimal use of medications.

AUTHOR INFORMATION

Brandon R. Shank, PharmD, MPH, BCOP, is a clinical pharmacy specialist, Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX.


Phuoc Anh (Anne) Nguyen, PharmD, MS, BCPS, is a clinical pharmacy specialist, Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX.

Emily C. Pherson, PharmD, BCPS, is a clinical pharmacy specialist, Department of Pharmacy, Johns Hopkins Hospital, Baltimore, MD.

ADDRESS FOR CORRESPONDENCE

Brandon R. Shank, PharmD, MPH, BCOP


Clinical Pharmacy Specialist, Division of Pharmacy,

The University of Texas MD Anderson Cancer Center

1515 Holcombe Blvd - Unit 377, Houston, TX 77030.

E-MAIL BShank@mdanderson.org

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