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Pharmacogenomics in the Community Pharmacy

It's no secret that pharmacies are going to have to diversify their revenue streams and continue to expand on non-dispensing revenue in order to survive. This can take many forms, including boosting front-end sales, adding new services like MTM and chronic care management, and more recently pharmacogenomics.


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With pharmacogenomics being so new, it can be hard to even know how to get started, where it fits in with your existing business model, and where to learn more on the subject.


In the spirit of PharmCompliance, this article won't be discussing the clinical details of pharmacogenomics, but rather how to operationalize and build your genomics business.


OK let's get started!


Where do I learn the clinical side of pharmacogenomics?


Thankfully, pharmacy schools and professional organizations have stepped in and started offering a lot of education in this area. Most people probably got little to no education in genomics in school (I only remember them droning on about VKORC1), so if you decide to get in the business you'll need to get up to speed.


Here are a few to get you started in your search:


University of Florida

University of Colorado-Denver

NACDS

ASHP

Mayo Clinic

Shenandoah University

RxGenomics

ACCP


I'm not advocating one over the other, so do your homework.


OK that's about all I'll say on the clinical side. Now on to how to make it happen, and more importantly, how to grow your business with the service.


Do I need a lab or expensive equipment for this?


Absolutely not. Patients will typically have a genomics test ordered by their provider, and will then go to a commercial lab to have it done. Both Quest Diagnostics and LabCorp are in this business. They then send the results back to the provider's office, just like they would any other test.


Should everyone get tested?


It's not really cost-effective to test everyone, because there are going to be many patients on just a few meds that have not had any genes identified that affect response. Because of this, you're going to need an efficient way to screen patients that might benefit from the service.


There are actually genomics software platforms that integrate with your pharmacy dispensing system to help you risk-stratify and determine who will benefit the most from the service. Examples include Rxight and MedTek21.


How can I make money doing this?


Now for the million-dollar question (OK it's probably not that much). The bad news is, most insurance companies are not currently going to pay for the service.


HOWEVER


That isn't a reason not to launch the business. After all, if you can get patients who are willing to pay cash to have it done, is that not better than dealing with billing?


Here is how you can do it, in a few broad categories:

  1. Work with a provider's office

  2. Contracting directly with a facility or company

  3. Hiring a provider or provider service

Now let's break each of these down:


1. Working with a provider's office


Billing for Chronic Care Management (CCM)


Regardless, with providers being the ones to order the test, you'll need to develop a good relationship with a provider. However, this relationship can go deeper to allow pharmacists to actually bill for their services under the provider. This is done using specific CPT codes for Chronic Care Management. You can take a look at the guide here.


CPT Code 99490, for example, requires this:


"Chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements:

  • Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient

  • Chronic conditions place the patient at significant risk of death, acute exacerbation/ decompensation, or functional decline

  • Comprehensive care plan established, implemented, revised, or monitored Assumes 15 minutes of work by the billing practitioner per month."

"Clinical staff time" could encompass numerous things, including pharmacogenomics; while there are service elements to meet in order to bill under these CPT codes (see page 11 of the guide), that's required for basically all services, including disease-state management, so this is no different. You just need to learn what's required and do it, but it can be done.


PROS:

  • Billing Medicare allows a patient to participate with either no out-of-pocket or only their copay

  • Working with the doctor's office will give you a good patient base

  • Because CCM can encompass more than genomics, you can incorporate MTM and disease-state management into the model to fill out your appointments for the day

  • Can be done with no out of pocket costs to the provider

CONS:

  • You'll need a lot of enrolled patients for this service to significantly add to your bottom line; reimbursement from CMS is around $40 per 20 minute visit (you can search for reimbursement by CPT code here)

  • CCM only allows Medicare patients to receive the service, meaning you miss commercial patients

  • The patient will still have to pay for the lab; only the pharmacist's time is covered under this CPT code

Offering it as a cash-only service at the provider's office


To capture the non-Medicare patients, why not offer genomics at a cash rate too? Again, working with the provider, you both can create a 'packaged deal' that includes the lab test, the pharmacist review, and then final physician review of the pharmacist recommendations.


If we look at the same 20-minute review from a pharmacist, the physician's order and final acceptance/rejection of recommendations, and lab test, you could still offer it to patients for a price many patients would pay and make money doing it.


Don't believe me? Here's a paper I found describing pharmacists that did just that.


PROS:

  • Cash only means no hassle about billing or getting paid, and no complicated contracts to sign with insurance companies

  • Allows you to expand past the Medicare population to people

  • Probably the easiest way to get the business started

CONS:

  • Many patients still won't pay (or be able to pay) cash for the service

2. Contracting directly with a facility or company


Long term care facilities


Many of you reading this are probably already in the long-term care business, considering it's a staple of many community pharmacies. If you are, you know that consultant pharmacists are required to do monthly reviews of patient charts anyway; why not distinguish your service by adding pharmacogenomics?


You would likely be the only one in town doing it, and if you can demonstrate cost-savings or improved quality to the facility through either national data or case studies it could help you land the contract over the next guy. That alone could be worth a lot of money, regardless of what you make providing the pharmacogenomics services to the facility.


If you look at Medicare's Quality Measures, for example, for nursing homes, you'll see a lot of quality scores related to medications. Many of these could be affected by genomics; for example, if a patient is not responsive to clopidogrel they would be more likely to be admitted to the hospital. Making a strong case statement to the facility, with examples such as these, could help you land the contract. For that matter, making a case like that could help you land a deal under any of these models.


PROS:

  • Even one contract with an LTC could provide you an entire new line of business

  • Billing is usually simple, with the charges paid by the LTC and the LTC billing the patient's insurance plan or covering the cost as part of their monthly expenses

CONS:

  • If you're not in the long term care business, or don't have existing relationships with LTCs, it could be harder to get your foot in the door

  • Some states (like Florida) require an additional license to be a consultant at a nursing home, and it might require additional education to feel comfortable doing it

  • LTCs have a lot of additional regulation, and consultant pharmacists are responsible for helping with the regulatory side of medication use, so it could be a steep learning curve, depending on your experience in the area

Large employers


With large employers, they likely already have contracts in place for healthcare, but that doesn't mean their current provider would offer genomics services. If not, many employers could be contractually allowed to go elsewhere for the service, and again if you can create a strong case for why they should do it you stand a good chance of getting the business.


For companies, the biggest case is going to be in ROI; it's not that they don't care about employees, but cost is at the forefront of any company's mind when it comes to providing healthcare.


PROS

  • Lots of potential patients with one contract

  • Good potential to stack revenue; for example, becoming one of their preferred pharmacies and delivering employee medications when you go out for site visits could drastically increase dispensing volumes

CONS

  • Most large employers have existing contracts for health services that could make it difficult for them to do business with you

  • Compared to small businesses, harder to get your foot in the door and more internal bureaucracy means contracting will take longer


Small businesses


Small businesses, while worth less individually than the large employers, could be much easier to get, especially if you created packaged deals for them that included all of their employee's pharmacy services (dispensing, MTM, etc). This is also a good way to stack revenue. If they only have a few employees, perhaps you could go on-site just one half-day per month, and bring them their prescriptions. You might even consider having a catalog of OTC's and front-end items they can order in advance. All of this combined could drastically increase the revenue of each visit and make it a good model overall. Alternatively, you could ask them to come in or provide the service through telepharmacy.


PROS

  • Small businesses can move quickly and are easier to get in front of

  • Stacking revenue streams can increase the profitability of the model

  • Enrolling multiple small business can add up to significant revenue

CONS

  • You'll need to enroll quite a few businesses to see real profit (it's probably best to develop a standard contract for the service that you then offer to each potential client)

  • With more limited budgets than larger companies, they might not be able to afford to offer the service (it will be very important to make a strong case for ROI to small businesses).

  • They might also have contract terms with other healthcare providers limiting their ability to do business with you

3. Hiring a provider


No, you're not going to have to commit to over a hundred thousand per year to get a provider.


Start small and find a provider interested in working for you a few hours per week and wanting to get into genomics. Paired with a genomics platform to screen your patients, you can then build a cash-only model with them. If they are interested in building the business, perhaps they can own equity in that portion of the business or receive a percentage of Net Revenue.


How could this work? Let's say you set aside a small room somewhere in your pharmacy building for them (or even use telemedicine), screen patients throughout the work day using a genomics platform, and then call (or have a technician call, like is often done with MTM) to enroll them, and then the provider evaluates them and orders the test. You then review it and make recommendations.


The big problem, that I'm sure many of you are thinking, is - how this would work with the patient's existing primary care provider?


To all you naysayers out there about this method, pharmacies are using this exact model now for travel medicine (other than the details about who is hiring who, but that is irrelevant to patient care).


Yes, it's true that the provider you hire shouldn't be changing their chronic medications, but they can:

  • Order the test

  • Review your recommendations

  • Be included in the final report that goes to the patient and their primary care provider

That way, just like we now notify offices of vaccines, travel medicine, MTM, etc., you could notify the patient's primary provider office of the genomics consult as well as both the pharmacist and provider recommendations, all on a pretty report that makes it easy for them to discuss changes with their patient.


Combine that with some local doctor detailing that describes the service, and you might end up with referrals from physician offices on top of the patients you currently have in the pharmacy.


PROS

  • Finding a provider also interested in building a business could allow you to generate a lot more revenue than you could alone

  • Having the provider removes barriers to implementation (i.e. the patient wants the test, but their PCP refuses to order it, doesn't know how, or doesn't know what they would do with it)

  • Having the provider on staff could further distinguish you from your competitors

CONS

  • You'll need either some start-up capital or you'll need to give up equity in the genomics portion of your business (a very small downside, if you ask me)

  • You need to be careful not to step on the toes of all the other docs in town seeing your patients. Communication is critical with this model!

The bottom line


It will likely take a combination of these strategies to be successful, but genomics is truly one of those areas that could transform the future of community pharmacy, and we need it considering the bleak outlook of dispensing revenue.


By stacking genomics with other services (MTM, Chronic Care Management, and even dispensing and front-end revenue by bringing in more foot traffic to the pharmacy and delivering), you can start creating new revenue streams to keep you going in the future and break free from the PBMs.


Keywords: pharmacogenomics, PGx, genomics, personalized medicine, Medtek21, Rxight, non-dispensing revenue