Testing for severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) to identify coronavirus disease-19 (COVID-19) has been one of the most prominent topics discussed since cases began being reported in early 2020. Increasingly, pharmacists are seen as vital team members in controlling the disease. While a lot of progress has been made, there are still significant opportunities where pharmacists can be leveraged to bridge gaps. In this blog post, we review how far we have come and where progress still needs to be made.
In times of great uncertainty, it can be helpful to look to history to guide the decision making of policymakers and public health officials. Although there appear to be many paths out of this immediate pandemic, it is unclear where these paths may lead, and the long-term ramifications to public health and the economy that may be waiting at the ends. Experts and news outlets have frequently compared COVID-19 to the 1918 influenza pandemic and have looked to decisions made by leaders at that time to inform decisions made today.
Consensus has been found on the singular importance that testing for the disease will lead us down a path out of this first wave of the pandemic and may lessen future waves. Widespread testing during public health emergencies are vital to the public health response. During the 1918 flu, tests were not available to detect or isolate the disease. Without the ability to test, leaders had to rely on quarantine and social distancing instead of the ability to provide more individualized recommendations for those afflicted.
Despite efforts to increase the availability of testing during the current pandemic, researchers from Harvard University are now projecting that for the U.S. to safely begin reopening, SARS-COV-2 testing needs to triple. As healthcare professionals are pulled in different directions to respond to the pandemic, many have suggested that pharmacists are an underutilized resource. During the pandemic, pharmacists can be better leveraged to increase the provision of SARS-COV-2 testing.
Initial win in increasing access to testing
In March, several policy think tanks began recognizing the pharmacist’s ability to increase testing capacity and made recommendations to legislators and regulators to lift barriers to pharmacists providing SARS-COV-2 tests and to test for other conditions. The Buckeye Institute, a midwestern think tank, recommended that Ohio “should permit pharmacists to test for the virus once tests become available, and encourage them to test and prescribe treatments for common illnesses like the flu and strep throat.” The John Locke Foundation made similar recommendations for flu and strep throat for North Carolina.
In response to recommendations, and thanks to the strong advocacy work of national organizations such as the American Pharmacists Association (APhA), the National Community Pharmacists Association (NCPA), and the American Society of Health-System Pharmacists (ASHP), the U.S. Department of Health and Human Services (HHS) published a guidance on April 8th. This guidance clarified that pharmacists can order and administer COVID-19 tests that the Federal Drug Administration (FDA) has authorized. Unfortunately, the guidance concluded with the following statement: “This guidance does not speak to or change reimbursement policy whether a licensed pharmacist may obtain reimbursement from a government or private payer for ordering or administering an FDA-authorized test.”
The reimbursement question
The lack of reimbursement for pharmacist-provided patient care services has devalued pharmacy services in the eyes of the public and other healthcare professionals. Continuing to provide these services without a sustainable business model, is more likely to cause pharmacies and critical healthcare access points to close, impacting patients’ ability to seek out care. It is empowering to see this guidance from HHS and the recognition that pharmacists can be better leveraged to provide care during the pandemic, however, without a sustainable business model supporting this policy, it is unlikely that healthcare practices will invest in allowing pharmacists to provide tests, especially when other healthcare providers can bill for administering the same service.
Testing needs to increase in order to lead the country down a path out of this pandemic. However, at the time of publication, this guidance appeared to be nothing more than an encouraging, but unactionable statement. Analysis of recent legislation passed through Congress may be exactly what is needed to make the HHS guidance actionable.
The Families First Coronavirus Response (FFCR) Act was signed into law on March 18th. As identified by analysts, including the Kaiser Family Foundation, this legislation requires health insurers to cover COVID-19 testing and prohibits cost-sharing with patients for said tests. Soon after, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 27th. The CARES Act brought further clarification, that may be particularly pertinent to pharmacists. It is stated that if there is no previous relationship between a health plan and a provider, the “plan or issuer shall reimburse the provider in an amount that equals the cash price for such service.”
As a result of the change in law from the CARES Act and the FFCR Act, one may make the argument that there was already an established reimbursement pathway for pharmacists to provide COVID-19 testing, they just needed further guidance from HHS allowing them to begin testing. With the HHS guidance published on April 8, it is made clear that the guidance “does not speak to or change reimbursement policy whether a licensed pharmacist may obtain reimbursement from a government or private payer for ordering or administering an FDA-authorized test.” If a reimbursement pathway was already outlined in legislation signed into law on March 18 and March 27, this guidance issued on April 8 does not change the law and simply allows pharmacists the ability to test for SARS-COV-2.
Inconsistencies in rules
Despite the HHS guidance and the potential path to reimbursement, questions began to arise about pharmacists ability to provide testing due to inconsistencies in recent rules. Although many expected that the point-of-care serological tests that pharmacists will likely be providing would be allowed without Emergency Use Authorization (EUA), the FDA clarified that these tests can only be performed in high-complexity CLIA laboratories. Without further guidance and changes in rules, this put the breaks on many pharmacists ability to provide these tests.
On April 28th, HHS published an interim rule amending current regulation and allowing Medicare to reimburse pharmacists for providing COVID-19 tests. It is important to note that this rule is only in effect during the COVID-19 public health emergency and pertains to the following tests: COVID-19 tests and tests for “influenza virus and respiratory syncytial virus”. CMS is currently finalizing a full list of tests that will be covered and will publish in the coming days.
Although encouraging, this interim rule has requirements that makes it more complicated for pharmacists to provide and receive reimbursement for these tests. Medicare will only reimburse these tests if the pharmacist is a part of a Medicare enrolled laboratory. In a guidance published by CMS on April 29th, they state, “A pharmacy that acquires a [Clinical Laboratory Improvement Act] CLIA certificate can enroll with Medicare as a clinical diagnostic laboratory to conduct and bill for clinical diagnostic laboratory tests it is authorized to perform under its CLIA certificate.” In order to provide these tests pharmacists either need to submit an initial CLIA application for certificate or request to amend their current certificate. Information for how to apply for a CLIA certificate can be found here.
Gaps in testing pharmacists can fill
Recent reports have shown that minority populations, that may be at higher risk of COVID-19, have decreased access to current pharmacist testing locations. As of April 24th, less than 13 percent of testing locations “are in predominantly black neighborhoods.” As more pharmacists receive CLIA certificates and ramp up testing, they have the potential of making a significant impact, especially for the patient populations which have been shown to have decreased access to testing.
Throughout history, we have seen that expanding the global testing capability is vital to overcoming pandemic diseases. In 1918, these tests were unavailable, resulting in extended quarantines of numerous citizens. In 2020, much of the focus has been on increasing the availability of diagnostic and serological tests. However, we must consider scaling the number of healthcare professionals that are able to administer these tests to the broader public. Pharmacists now have guidance from HHS to provide testing, and can receive reimbursement from Medicare. Other payors, such as State Medicaid Departments and private insurers should consider following CMS’ example. As pharmacists scale up testing sites, they can maximize their impact by providing care where there are gaps for patient populations that need increased access to testing. Through the ability to test for COVID-19, the pharmacist can be more optimally leveraged during the pandemic and get the country closer to the number of tests being provided needed to take us down a path out of the current state of emergency.