Keith Loria

Antiretroviral (ARV) medicines have significantly decreased mortality over the past 30 years, but treatment failure remains a concern, especially for heavily treatment-experienced people living with multidrug resistant HIV.

ViiV Healthcare has publicized positive long-term results from its phase 3 BRIGHTE study of its drug, 

 (fostemsavir), that may seed hope that those treatment failures can be overcome.

The results showed that people living with multidrug resistant HIV-1 who are "heavily treatment experienced" and treated for approximately five years with fostemsavir-based regimens, experienced durable virologic responses and continued clinically meaningful improvements in CD4+ cell count and CD4+/CD8+ ratio, according to 

, vice president head of global early development and research strategy at ViiV Healthcare.

Importantly, BRIGHTE study participants continued to show clinically meaningful improvements in CD4+ cell count and CD4+/CD8+ ratio, which is crucial for immune recovery, according to ViiV.

The study involved 371 people living with multidrug resistant HIV who are heavily treatment-experienced and have few treatment options left due to the significant complexities of resistance, safety, tolerability, contraindications and prior treatment failure.

“All trial participants were required to have a viral load ≥400 copies/mL and ≤2 classes of ARV (antiretroviral) medications remaining at baseline,” said Andrew Clark, global medical lead at ViiV Healthcare. “Trial participants were enrolled in either a randomized or non-randomized cohort.”

Within the randomized cohort, participants had one, but no more than two, fully active and available ARV agent(s) at screening, which could be combined as part of an efficacious background regimen. Randomized participants received either fostemsavir 600mg twice daily or placebo in addition to their current failing regimen for eight days of functional monotherapy. Beyond Day 8, randomized participants received open-label fostemsavir 600mg twice daily plus an optimized background therapy.

Within the nonrandomized cohort, participants had no fully active and licensed antiretroviral agent(s) available at screening, Clark explained. Nonrandomized participants were treated with open label fostemsavir 600mg twice daily plus optimized background therapy from Day 1 onward. The use of an investigational drug as a component of the optimized background therapy was permitted in the nonrandomized cohort.

Overall BRIGHTE study participants had very advanced HIV; 75% had a CD4 count <200 and 86% had a prior history of AIDS.

Lataillade noted that there are people living with multidrug resistant HIV who are often unable to benefit from newer therapies in existing classes due to complex resistance profiles. As a result, they can run out of treatment options.

“In addition, most people living with MDR (multidrug resistant) HIV also have a poor immune system response to HIV despite ART,” he said. “What this data shows is that this specific patient population can take fostemsavir as part of their antiretroviral regimen and still experience a durable and favorable virologic response after a five-year period.”

Importantly, BRIGHTE study participants continued to show clinically meaningful improvements in CD4+ cell count and CD4+/CD8+ ratio, which is crucial for immune recovery.

This article originally appeared on Managed Healthcare Executive.

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ViiV Healthcare reports long-term positive results for its drug, Rukobia (fostemsavir).

Rukobia Works for Some AIDS Patients, According to New Research

Pharmacies have come a long way over the past 3 decades in their use of data analytics, according to Heidi Polek, RPh, a pharmacist and strategic program manager at DrFirst, a provider of innovative technology solutions that works with 67,000 pharmacies nationwide. “We’ve grown from doing our own simple paper-and-pencil calculations to being able to choose from a host of vendors and consultants that offer detailed analytics on things that community pharmacies can have a direct impact on, such as prescription abandonment,” said Polek. “With insights into trends like these, pharmacists can more effectively intervene to improve medication adherence.”

Pharmacy expert Lindsay Dymowski, CEO of Centennial Pharmacy Services in Philadelphia, Pennsylvania, noted that data collection is common in pharmacies, as it is with most health care organizations in the digital age. Pharmacies have always had access to huge volumes of data from various sources, including patient, prescription, insurance, and medication supply chain and pricing data.

“Historically, independent pharmacies haven’t used the data collected to their advantage,” Dymowski said. “Most pharmacy data have been collected by large organizations—PBMs [pharmacy benefit managers], insurance companies, wholesalers, [and so on]—and used to help these organizations make decisions on things like drug pricing and formularies. When pharmacies did look at their data, they mainly looked at prescription volume and reimbursements.”

That is changing, as the COVID-19 pandemic has propelled independent pharmacies into taking a more analytic approach. “Providers collaborated with pharmacists to get patients counseled on disease states and medications to people who were too scared or too sick to visit an office. And when the country needed a resource to quickly administer millions of lifesaving vaccinations, independent community pharmacies were the ones who stepped up,” Dymowski said.

Joe Moose, PharmD, owner of Moose Pharmacy, with 8 locations across North Carolina, said that when he first started working as a pharmacist, computers were just coming into the profession—where they served as nothing more than glorified word processors. Through the years, the pharmacy has evolved to use data to make a greater difference in the lives of customers.

“Over the last 5 years, using data has gone from operations and business-side management to changing patient outcomes,” he said. “We input our data knowing we can mine this information to give the patient a better outcome.”

Through data analytics, pharmacies can identify claims with a high potential for audits and ensure that all requirements are in place to prevent a financial challenge from the payer. They can also analyze postaudit results to identify areas where they were most penalized and put measures in place to avoid penalties in the future. And, Dymowski pointed out, data insights have only served to help prescription and patient documentation as well.

“In robust pharmacy systems in states that allow for electronic record keeping, pharmacists have the ability to receive electronic prescriptions directly from prescribers with patient demographics, clear prescription information, and even notes written by the prescribing team,” she said. “Those prescriptions can then be annotated on the pharmacy level with information such as calculations for ‘days’ supply,’ which helps with pharmacy audits.”

With all prescriptions and prescribing data being kept electronically, pharmacies can easily access information for events such as drug recalls. They also can notify the affected patients quickly.

Aysha Ahmed, PharmD, chief medical director, president, and cofounder of Vasa HealthIV, a mobile infusion therapy company, noted that independent pharmacists utilize medication therapy management. This allows them to see if some patients are regularly picking up their prescribed medications and taking them as they should.

“It also shows if they have multiple disease states and if they are being monitored for drug interactions as well as dose-appropriate alterations,” she said. “This information is sent to insurance companies regularly to ensure that the patient avoids any risk of hospitalization along with providing evidence of much-needed pharmaceutical intervention conducted daily by the pharmacist.”

Some pharmacies participate in collaborative practice agreements, disease state management, or other clinical programs that require care planning. These pharmacies now have the opportunity to develop and manage care plans through a pharmacy management system in most major health systems.

“With this, pharmacies are able to create customized care plans for patients based on their data: their medications, their disease states, and their demographics are controlling what happens with their health,” Dymowski explained. “Care plans can include quantitative information such as test results, labs, vitals, and prescribing data, or more qualitative data such as observations, questionnaires, counseling [or] coaching notes, and other socioeconomic and environmental factors that can impact patient health.”

Care plans also allow pharmacies to set specific goals. This enables them to identify high-risk patients, then set up these patients for success based on targets they can achieve.

“By measuring this outcome and following along with each patient using metrics, pharmacists can identify patients who are at risk of developing a poor prognosis and get to them before any hospital-related events come up,” Ahmed said. “Putting raw pharmacy data into metrics can help pool patients into certain groups that can be targeted early on and followed… to ensure the best possible health outcome.”

With the growth of direct patient care programs offered by community pharmacies, such as chronic care management and medication therapy management, there are numerous opportunities for data analytics to inform care. Many pharmacy information systems have modules that can provide pharmacies with this type of information.

“For example, pharmacists can use insights into adherence patterns to plan interventions with high-risk and vulnerable patients, such as seniors with multiple chronic health conditions, including diabetes, high blood pressure, high cholesterol, and congestive heart failure,” Polek said. “[Findings from] numerous studies have shown how pharmacists can help patients avoid adverse events and hospital readmissions. Now these programs can use data analytics to target interventions for the best results.”

Reimbursement is another key area where pharmacies can benefit from data analytics.

“Pharmacies need to pay particular attention to DIR [direct and indirect remuneration] fee patterns and ensure they take all possible precautions to reduce these clawbacks as much as possible,” Polek explained. “In extreme cases, a pharmacy may choose not to participate with an insurer that has a history of poor reimbursements and high DIR fees. However, with a deep understanding of prescription drug plans and their reimbursement patterns, pharmacists can share coverage and co-pay information to help patients choose a plan that provides the highest level of coverage for their current medications while also fairly reimbursing pharmacies.”

This benefits both patients and pharmacies. Historically, pharmacies have been reimbursed for dispensing medication, which still accounts for the majority of revenue made by independent community pharmacies. But potential exists for reimbursements above and beyond dispensing medication, because the pharmacist is recognized as a holistic health care provider.

“Along with the opportunity for different types of reimbursements, most pharmacy contracts have data-driven goals built in that provide higher reimbursement or some type of alternative or higher payment to pharmacies that achieve greater quality metrics,” Dymowski said. “Pharmacy is no longer about dispensing a prescription; it’s about supporting your patients’ medication regimens and increasing their health outcomes through prescriptions.”

Analytics can improve things for the independent pharmacist in a number of other ways. Data insights can be used across all facets of health care to improve quality of care in the industry, and they can change the way independent pharmacies operate for the better.

For example, data analytics within patient engagement programs can help improve medication adherence and outcomes. “Some patient engagement technology can analyze prescription abandonment trends and send patients pick-up reminders that include tailored information about prescription costs, financial savings, and educational materials, which helps improve adherence,” Polek said.

Dymowski noted that pharmacies can use the information collected to better collaborate with community providers. Additionally, they can use prescribing information to meet specific metrics set out by payers and document via care plans to get different types of reimbursements.

“Pharmacy organizations are increasingly pushing for pharmacists to be given provider status in all 50 states, especially since pharmacies played such a huge role during the vaccine rollout,” she said. “For pharmacists to receive that status, pharmacies need to start incorporating data collection, care planning, and other outcome-related analytics into their daily workflows to prove to the health care community that pharmacists can make positive impacts on patient health.”

Today’s pharmacists are busier than ever as they care for an aging population that takes more and more prescription medications. Thus, with the avalanche of patient data now available to pharmacists, it makes sense to use fast, efficient data analytics tools to do what would otherwise take hundreds of work-hours—find the patients who need help the most.

“More pharmacists are recognizing the importance of data analytics and becoming experts in its use, including working at—or starting—companies that can help community pharmacies benefit from this technology,” Polek said. “I love the idea of pharmacists building tools to benefit other pharmacists and their patients. That is how health care can and should work.”

Data and analytics, therefore, are the future. Payers are structuring contracts on quality metrics, and integrated health systems are collaborating with community pharmacies that are attending to and bettering those metrics. Further, millions of people went to bed last night knowing how many steps they took.

“As the population wearing technology ages, more providers are going to rely on that technology to better care for their patients,” Dymowski said. “Pharmacists need to be prepared to combine their pharmaceutical and clinical expertise with databased care plans that increase patient health and have the data to prove it if they want to be seen and respected as a health care provider.”

Big data and analytics are everywhere—including in independent pharmacy. But is the collected information being used to help with documentation, care planning, and reimbursement?

How Has the Evolution of Data Changed Independent Pharmacy?

CAR-T therapies are a new and promising treatment for cancer. The global market for CAR-T therapies is projected to increase from $2.9 billion in 2020 to $11.8 billion by 2025, according to MarketsandMarkets.

But some major obstacles loom ahead, cost being one of them. A single CAR-T treatment can run into the hundreds of thousands of dollars. Although CAR-T therapy is a relative rarity now and therefore not a huge burden on payers, as the number of patients receiving it increases, so will the cost and payer scrutiny. The enthusiasm about the promise of CAR-T is also tempered somewhat by the risk of cytokine release syndrome, an adverse effect that can be life threatening.

CAR-T therapies involve genetically engineering a patient’s own T cells so they recognize and kill tumor cells.

Approved by the FDA in 2017, Kymriah (tisagenlecleucel) was the first CAR-T therapy to get the agency’s OK. Yescarta (axicabtagene ciloleucel) was next, approved a few months later as a treatment for large B-cell lymphoma in adults after at least two other kinds of treatment failed.

In 2021, the agency approved Abecma (idecabtagene vicleucel), the first CAR-T for multiple myeloma. And in February 2022, the FDA approved a second CAR-T therapy for multiple myeloma, Carvykti (ciltacabtagene autoleucel).

Sankalp Sethi, the cell and gene therapy practice lead at ZS Associates, has helped more than 25 oncology manufacturers commercialize cancer innovations and notes that this approval marks a strong gain in efficacy outcome.

“Nearly all patients (98%) in the study of Carvykti achieved a clinical response, and 78% achieved a stringent complete response,” he says. “Time is needed to determine how the product impacts overall survival, though many say that these results represent a new gold standard in CAR-T efficacy.”

Abhinav Deol, M.D., a hematologist-oncologist at Karmanos Cancer Institute in Detroit, says the recent spate of CART-T approvals is notable. In addition to Carvykti, the FDA approved Yescarta as a treatment for a broader group of patients with large B-cell lymphoma, Kymriah as a treatment for relapsed or refractory follicular lymphoma and Breyanzi (lisocabtagene maraleucel) as a treatment of patients with large B-cell lymphoma.

Deol also points to the ongoing trials evaluating allogeneic CAR-T cells, which would be available “off the shelf,” replacing the complicated process that involves using the patient’s own T cells. “Additionally,” he says, “there are ongoing studies looking at rapid manufacturing of autologous CAR-T cell product, thereby shortening the time it takes to have the product ready for infusion.”

Deol explains that CAR-T therapy provides another option for an increasing number of patients with cancers that have come back despite multiple rounds of other types of treatment.

“Long-term data in diffuse large B-cell lymphoma in the third-line setting shows that about 30% to 40% of patients can have sustained remission after CAR-T cell therapy,” Deol says. “Heavily treated (patients with multiple myeloma) can have disease control for over a year after one infusion of CAR-T cell therapy.”

For many patients, CAR-T represents their best potential option at a key moment of treatment eligibility. However, availability has been limited.

“These advancements mean these products can be more safely administered, more patients will be able to receive them and patients will be able to receive them earlier,” Sethi says.

“Remember, when CAR-Ts first came out, only a select number of centers of excellence were certified to administer. Given the complex nature of the products as well as the serious potential (adverse) effects, there was a need for providers to build more experience with the products before allowing for wider distribution.”

Progress has been made in overcoming some of the chief barriers to access to CAR-T, says Sethi, which include traveling distance for patients, management of adverse effects and financial viability of the administering centers.

“We are now reaching a stage where access is much more widespread — at this time, 70% of the U.S. population lives within 50 miles of a center that administers a CD19 CAR-T,” he says. “Geographic access to these products will no longer be a major barrier for most patients.”

Additionally, providers have become more comfortable handling the adverse events that come with CAR-T, he says. This means that for the right patients, outpatient administration is possible. Patients can stay with their families and caregivers while being monitored, improving their quality of life.

A recent study by ZS Associates also found that around 90% of CAR-T providers today are profitable overall with CAR-T administration.

“When first approved, CAR-Ts negatively impacted treatment centers’ finances, as reimbursement rates and mechanisms were still being sorted out,” Sethi says. “But we are now seeing that these centers have been able to become profitable through better management of (adverse) effects, applying markups and manufacturer discounts, and where applicable, receiving hospital-specific Medicare reimbursement adjustments. As a result, we expect more providers to be able to scale their capacity over time and offer CAR-Ts to more patients in the future.”

The supply chain and manufacturing challenges of CAR-T are center stage in discussion today.

Maria Whitman, global head of the pharmaceutical and biotech practice at ZS Associates, notes that Carvykti launched with a more limited number of certified centers (32) and limited manufacturing slots. This means that although patients and providers are eager for these products, the benefit is limited to a very small proportion of patients deemed eligible.

“Looking forward, it is also a source of budding innovation in support of patients,” she says. “Limited capacity and commercial availability are not only a challenge for meeting demand, but for scaling accessibility.”

For instance, Novartis recently unveiled T-Charge, a next-generation CAR-T platform that is expected to develop the cancer-finding T cells in the patient’s body instead of in a cell culture, reducing manufacturing time.

Gracell Biotechnologies Inc.’s proprietary FasTCAR platform is currently being evaluated in trials in China, and the company claims it has “next-day manufacturing” capabilities.

“Manufacturing turnaround times have long been a barrier to broader accessibility of CAR-T, and these developments are a strong sign that we are moving toward a future where patients are no longer waiting weeks to receive product,” Whitman says.

The high cost of CAR-T is another obstacle. CMS announced in 2019 that Medicare would cover CAR-T, but some provider groups have expressed discontent with what they say are low rates.

“One important thing to note is the cost for these advanced therapies can lead to sticker shock,” says Deol. “But the cumulative cost of other cancer therapies over a period of time is very high too, and CAR-T therapy is generally a one-time cost.”

More of these treatments have been approved, but supply chain issues and cost remain obstacles.

Looking at the CAR-T Therapy Landscape

Pediatric patients in need of infusion therapy face the same access barriers as their adult counterparts. But they also deal with the added challenges of finding sites of care and infusion providers that are accustomed to caring for children.

Robert Dracker, MD, MHA, MBA, CPI, medical director of Summerwood Pediatrics & Infusacare Medical Services in Liverpool, New York, spoke on these issues at the 2022 National Infusion Center Association (NICA) Annual Conference, held June 17 and 18, 2022, in New Orleans, Louisiana.

Dracker discussed considerations and developmentally appropriate interventions to promote high-quality, patient-centered pediatric infusion care. Dracker started with a question: “What is infusion medicine?” There is no standard definition, he said, so he crafted his own, drawing on his decades of experience in the field. Dracker defined this growing sector as, “the health care specialty involved with the clinical science and practice of administering parenteral fluids, medications, biologic, and cellular therapies to adults and children.”

Dracker also touched on the unique needs of children who will be receiving intravenous (IV) or parenteral medications. Compared with an emergency department visit or for a hospitalized child, outpatient infusion therapy is semielective and scheduled, allowing time to prepare the child for the therapy.

“This is a very difficult thing to do for a child in general,” he said. “A [provider] should explain the need for the therapy and obtain an informed consent in some cases, particularly with regards to some of the newer biologic therapies for diagnoses like eczema and psoriasis.”

He compared general therapy considerations with important concerns specific to dealing with pediatric patients, reminding health care professionals that children are not just tiny adults. Things to know and factor into the care include the age of the child and any developmental issues, how ill the child is (acute vs chronic), who is with the child at the visit, any preexisting conditions that could complicate the therapeutic intervention, and the child’s understanding of the treatment and informed consent.

Dracker spoke about the importance of establishing a relationship between a provider and the infusion site team; there must be open communication between both to address issues such as special needs of a particular patient, who will be monitoring the response and follow up labs, and how to partner medically with regards to new emerging therapies.

Dracker also noted that treating a child may raise the anxiety of the medical team, so a collaborative approach is helpful, especially at the start of the therapy. He stressed that an open, interactive relationship between the provider's practice and the therapy site is critical for care.

“There should obviously be communication between both regarding currently available and emerging therapies, the needs for prior authorization, follow-up lab work required, and the fact that the infusion center staff will commonly see the patient during treatment more often than the dermatologist, which means that the response to treatment, or lack thereof, should also be conveyed back to the referring office,” he said.

Providers can take steps to prepare children for treatment in this environment by familiarizing the child with the environment, explaining each step of the process, and surrounding them with love, affection, and even “bribes” such as cartoons, books, and snacks.

In general, parents are fairly motivated to ensure that their child receives their therapy on a scheduled basis. It is important to provide a reminder to parents for an upcoming appointment with regards to date and time. Dracker also urged infusion providers to make an attempt to accommodate a child’s needs, especially related to school and activities.

Dracker also touched on vascular access issues in pediatric patients, the importance of being honest with children, and steps the FDA is taking to ensure access to safe and effective medical products for children.

At the conclusion of his talk, Dracker shared his hope that attendees could walk away with the understanding that children have special needs when it comes to infusion therapy treatments and that in many ways, these providers are treating a whole family—an experience that can be positive or negative depending upon the efforts made and the accommodations provided.

1. Dracker R. Not just tiny adults: considerations for a pediatric population. Presented at: 2022 National Infusion Center Association Annual Conference; June 17-18, 2022; New Orleans, LA.

An expert offers considerations and developmentally appropriate interventions to promote high-quality, patient-centered pediatric infusion care.

Optimizing Outcomes for Pediatric Infusion Therapy

A new study finds that fully vaccinated people in the U.S.with HIV have a significantly higher risk of COVID-19 breakthrough infections than people without HIV.

The study, published in early June in the 

 examined a cohort of 113 994 patients, and found that while the risk of breakthrough infection was low overall with just 3.8 percent, it was 28 percent higher in those with HIV.

“The higher rate and risk of infection in people with HIV observed in this study suggests comprehensive inclusion of this population in recommendations for additional primary doses in immunocompromised groups,” revealed study author Sally B. Coburn, Ph.D., M.P.H., department of epidemiology for Johns Hopkins Bloomberg School of Public Health.

Researchers in the study compared the risk of breakthrough infection by HIV status using Cox proportional hazard models to better estimate unadjusted hazard ratios (HRs) and adjusted hazard ratios (aHRs).

“We adjusted for cohort as a surrogate for sociodemographic and regional differences in COVID-19 transmission rates, vaccine rollout, COVID-19 testing protocols, and access to care,” the study authors said. “An interaction term with calendar period was included due to nonproportional hazards by history of COVID-19 and improved model fit.”

From there, CD4 count and suppressed viral load were assessed as risk factors for breakthrough infection.

The findings showed that COVID-19 vaccination, especially with a booster dose, was effective against infection with SARS-CoV-2 strains circulating through December 31, 2021 but people with HIV had an increased risk of breakthrough infections compared with those without.

While the CDC currently recommends those with untreated or advanced HIV receive an additional dose 28 days or more after the second mRNA dose and a booster three months or more for mRNA or two months or more for those initially vaccinated with Ad26.COV2.S dose, the authors argue that all people with HIV would benefit from being included in this recommendation.

The risk of breakthrough was higher in people living with HIV regardless of CD4 count or HIV viral suppression, according to the findings reported by Coburn and her colleagues.

“A first booster dose is now recommended for those aged 12 years and older, and a second booster is recommended for those aged 50 years and older and certain immunocompromised groups; our findings suggest these booster doses may be even more important for all people with HIV to prevent breakthrough infections,” the authors wrote, noting further research is required to study this potential association.

“Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations,” the study concluded. “Increased risk of breakthrough infections in PWH merits continued monitoring as the pandemic persists, immunity to primary vaccine series wanes, boosters are widely recommended, and new variants emerge.”

The risk of breakthrough was higher in people living with HIV regardless of CD4 count or HIV viral suppression, according to findings reported by researchers at Johns Hopkins.

Patients With HIV More Susceptible to Breakthrough COVID Cases

The COVID-19 pandemic has highlighted the unique role pharmacies can play in promoting 

public health in their communities. With health care trends constantly evolving, there is no better time for community pharmacies to build a point-of-care (POC) testing practice. Although most independent pharmacies are offering COVID-19 and influenza vaccines, so much more can 

be done to bring in new customers and increase revenue.

Paige Clark, vice president of pharmacy programs and policy at Prescriptive Health, who spent the past 11 years at Oregon State University College of Pharmacy, is passionate about pharmacists expanding their scope of practice and is a champion of POC testing for 

independent pharmacies. “Given the role they play in their community, [and] the convenience that having these services done at their local independent pharmacy provides [to patients], pharmacists should definitely look to these services,” she said. “Momentum is with 

us now in the community pharmacy settings again from a public health standpoint. We clearly haven’t seen anything like this pandemic before and it has just massively extrapolated the 

visibility and the functionality that our retail pharmacies play in the overall 

Beth Bryan, PharmD, pharmacist and owner of Surgoinsville Pharmacy in Surgoinsville, Tennessee, noted that the pandemic has instigated practice changes for all medical offices. “Medical practices across the nation implemented new protocols, from temperature checks 

and mask protocols to COVID-19 testing and vaccinations,” she said. “So there couldn’t be a better time for pharmacies to consider implementing [POC] testing in their practice.”

Community pharmacies are among the most accessible health care destinations in the country. According to the CDC, more than 90% of the population lives within 5 miles of a community 

pharmacy and an estimated 77% of community pharmacies operate in populations of less than 50,000.

To get started in POC testing, there needs to be an assessment of the pharmacy 

practice to see which tests would make the most sense for the pharmacy and 

the population that it serves, Bryan explained. “Then, I would recommend a training program for the start  to learn about testing procedures and allow for certification for the staff  performing 

the tests,” she said. “As soon as the pharmacy decides which test(s) they want to provide, they need to apply for a CLIA [Clinical Laboratory Improvement Amendment] waiver. Additional 

tests can be added later if the pharmacy decides to do more or grow their testing program.”

Independent pharmacists can get their CLIA Certificate of Waiver by submitting the application (Form CMS-116) to the appropriate state agency.

Lisa Faast, PharmD, CEO of DiversifyRx, noted that every state is different; pharmacists 

cannot necessarily rely on what they have heard from someone else in the business.

“The next step is to ensure that you have the appropriate Provider Transaction Access Number [PTAN] for billing CMS [Centers for Medicare & Medicaid Services] for these tests as a clinical 

laboratory,” said Jason Ausili, PharmD, chief clinical o. cer, FDS. “This is different from the typical mass immunizer or pharmacy PTANs that pharmacies are accustomed to,” he added. 

Finally, pharmacies will want to ensure they have a seamless medical billing platform 

in place that allows them to submit the appropriate codes for reimbursement to the medical plan.

The most popular POC services that pharmacies provide are for influenza, streptococcus, and now COVID-19 testing. These tests are a good fit for pharmacies; they are attractive to 

patients because of the quick turnaround and easy access. Because POC tests are relatively inexpensive, they are very affordable for patients and often cheaper than a co-pay for urgent 

There are hundreds of tests that pharmacies can provide under the CLIA waiver. Bryan asserted that pharmacies should quickly add strep and urinary tract infection (UTI) testing because they 

would appeal to patients needing a fast diagnosis and treatment option.

“Another good option to consider is [hemoglobin] A1C testing, especially if the pharmacy offers any diabetes services such as counseling, education classes, or diabetes prevention programs,” Bryan said. “A pharmacy can also consider cholesterol screening to add to its disease management programs such as MTM, hypertension management, and risk-assessment programs.”

Community pharmacies, Ausili noted, are ideally suited to administer CLIA waived 

tests that screen for infectious diseases as well as those that aid in chronic disease monitoring. Under the public health emergency (PHE), pharmacists are authorized to order and administer 

COVID-19 tests and influenza or respiratory syncytial virus tests if done in conjunction with a COVID-19 test.

Several states have adopted legislation during the PHE that gives pharmacists this privilege moving forward. In addition to screening for infectious diseases and monitoring chronic 

diseases, community pharmacies have a key role in “test and treat” programs for conditions like group A strep and influenza.

“Patients who are experiencing the symptoms of strep and flu typically turn up at urgent care, emergency [departments], or do not seek care at all,” said Ausili. “This often leads to the patient 

receiving a much higher level of care than needed, or the increased risk of community spread.”

Community pharmacies o.er a convenient, effective alternative that takes pressure overburdened primary care and emergency care channels. Kentucky, for example, has a statewide protocol 

supporting pharmacy-driven “test and treat” programs and has improved access to quality care for residents.

Some pharmacists are hesitant about POC tests because they do not know whether 

their patients want it or will pay for it, according to Faast. “They have this uncertainty that they will go out and buy this test and they don’t know whether they are throwing money away 

or whether their patients are interested in paying for the tests,” Faast said.

Still, she recommends pharmacists start with POC tests for cholesterol panels, hepatitis, HIV, A1C, UTI, and INR, and believes most will find success. “The ultimate benefit is for the patient—the more that they can get a clear path on how to feel better is good for all,” she 

For pharmacies, the bottom-line benefit is increasing profitability and lessening reliance on pharmacy benefit managers (PBMs). “Obviously, everybody associates pharmacists with their drugs, but I think the more that we can start to associate pharmacists with more clinical-

based activities, I think the better off it’s going to be for the community and the profession,” said Faast.

POC testing is predicted to exceed immunizations as a driver of revenue for community pharmacies, according to research from Deloitte. Although research has shown tremendous growth in the number of pharmacies becoming CLIA-waived facilities, highlighting 

a 45% increase between 2015 and 2020, so far, very few pharmacies have taken 

The ROI is an important consideration for pharmacists as they add POC testing. Clark explained that pharmacists start in the cash lane and crack open the Medicaid lane for reimbursement, 

which then opens the door for the commercial lanes. Pharmacies will 

need a medical billing solution that seamlessly integrates with their normal 

workflow to bill and get reimbursed for these tests.

“A billing solution that does not deviate from pharmacy workflow will 

provide a more effcient billing experience for community pharmacies while 

enabling them to get paid as a provider for services versus a dispenser of services,” he said. 

“Because these claims go directly to the medical benefit and not the PBM, pharmacies will maximize reimbursement and administration fees by being recognized as a provider.”

Medical billing is a possibility with POC testing but not required for pharmacies to offer testing to their patients, according to Bryan. “Most testing options are completely affordable to patients and billing isn’t a huge concern for the general public,” she said. “There is the option for the patient to file a paper form or use their flex spending cards to cover the costs. To bill medically, 

the pharmacy will be required to individually contract with the insurance providers, as well as implement an electronic platform for processing claims.”

For independent pharmacists to get the most out of their POC testing, they need to let people in their community know they are offering these services. Faast recommended utilizing social media and Facebook Live to connect to individuals and get more eyes on websites advertising 

the new testing. “Educating in an entertaining, personal, authentic way will drive more traffic,” she said.

Independent pharmacies can turn this opportunity into a revenue strem