State, Federal Legislation Impacting the Future of Specialty Pharmacies

Pharmacy Times interviewed Tracy Russell, senior director, State Government Affairs at CoverMyMeds, on her presentation at Asembia Summit 2022 titled Legislation Affecting the Future of Specialty Pharmacies: From the State to Federal Level.

Question: What federal legislation in particular may be impacting the future of specialty pharmacies and the patient care they deliver?

Tracy Russell: There are several federal initiatives in play right now, and these are focused in 3 areas: lowering drug cost, access to care, and access to data. I will say that it would be great if we could pass federal legislation because the states will continue to move and they'll do 50 different ways of doing things, and so looking to the federal legislature to make this more universal is great.

Looking in those 3 areas, and lowering cost, the Build Back Better Act currently includes provisions that are designed to lower cost, and if it was advanced, as it is today, it would redesign Medicare Part D and establish inflation penalties, caps on insulins, co-pays, and it would eliminate the so-called rebate rule. It's not yet been approved and could change and there potentially may be an update at the time that we present at Asembia—so stay tuned.

There's also a proposal for Medicare Part D, which defines the negotiated price, or the lowest price the pharmacy could receive as reimbursement for a drug under its contract with the plans, and those 2 are working in lowering the drug cost arena and the access to care section of bills. There's an effort to expand access by improving reimbursement models, and it's been proposed with the Equitable Community Access to Pharmacist Services Act, that’s HR 7213, and that would add pharmacists as Medicare providers for some of the services that would be reimbursed at 85% of the scheduled fee, and it would help to continue some of those services that pharmacists were allowed to do during the pandemic and make those in law.

In addition to making better use of technology, the Office of the National Coordinator, or ONC, is expected to issue a rule this year that would mandate electronic prior authorization for Medicare Advantage services. That's a similar mandate to what was implemented in 2022 for medications, and that will help create better access to care.

Also access to data, making sure that the use of technology to access the patient specific data reduces the administrative burden for providers across the care team. Now, the Centers for Medicaid and Medicare Services, or CMS, included a beneficiary real-time benefit requirements for Part D plans that will take effect in January of 2023. This requirement would allow enrollees to view patients’ specific real-time formulary benefit cost information at the point of prescribing, which is prospectively. When this is implemented, it paves the way for the patients to navigate the affordability and benefit challenges by providing necessary action and patient-specific information, and the patient and the provider can discuss whether or not the patient can afford that medication before they leave the office. This prioritizes the interoperability aspect and can enable data flow and the data fluidity that's necessary to empower those care teams to help the patient solve the challenges through the medication access journey.

Question: How about legislation on the state level that may be impacting the future of specialty pharmacies?

Tracy Russell: Yeah, as I said before, the states are active. If they're not going to get things overriding with Federal, they continue to move, and what we're seeing at the state level, in addition to scope and reimbursement issues, is white bagging. That particularly impacts specialty pharmacies at the state level because it's when a provider is required to order the therapy from a specialty pharmacy that's typically outside of their own health system. This kind of further complicates the cost transparency for patients. There have been 11 states that have debated proposals to either prohibit pharmacy benefit managers from mandating clinical administrative drugs to be dispensed by a specific pharmacy or prohibiting the steering to a specific pharmacy.

The prohibition to steering is a part of the white bagging challenge, and that's mostly been the concern of independent pharmacies for quite some time as they compete with the larger chains and because they tend to have their own mail order units. But for specialty pharmacies, it translates to the opportunity to help more patients access their needed medication and strengthen the pharmacist-patient relationship, and they're not opposed to the white bagging process, they're just opposed to the mandate from the plans that the patient has to have a specific way of delivering, because, really, it needs to be the patient's choice and whatever is best for the patient.

Then there's also, as I mentioned, the scope of practice and reimbursement issues. Those challenges together prevent specialty pharmacies from being able to provide a wider range of services. So better integration between pharmacy and medical services can empower the specialty pharmacists to deliver the patient care at the highest levels they need and be able to operate at the highest level of their licensure. So we see a lot of states that are working with collaborative practice arrangements that are making it better for the whole health care team to work.

Question: How about legislation on the state level that may be impacting the future of specialty pharmacies?

Tracy Russell: Well, as the pharmacist role expands on the care team, especially pharmacy, and especially pharmacists, they should be ahead of the movement. They've been working in collaborative practice arrangements with physicians and nurses for some time, and as I mentioned, the states are really looking to make those pathways easier. Patients have shown that they are increasingly reliant on their specialty pharmacies for the services that that are not just the clinical services, but wanting more information like information about their condition, their side effect management, and the training on the medication that's administered because many of these have to be self-administered. These services are helping the patients not only learn more about the medication, but to find affordability options, and that can have a measurable impact on the patient's medication adherence, whether or not they can afford it.

It's going to be essential that the industry make the use of technology a priority. Assessing patient specific information prospectively throughout the care is important to get the patients to therapy more quickly and to improve their adherence. Biologics [and] cell and gene therapies entering the market can also further complicate because the patient's journey gets more complicated and will increase the need for pharmacists to have that data within their systems because these are very expensive medications, and the specialty pharmacy will be working more and more with those patients to make sure that they can access the care.