State and federal legislation impacting the future of specialty pharmacies

State and federal legislation impacting the future of specialty pharmacies

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

Request: What federal legislation in particular could impact the future of specialty pharmacies and the patient care they provide?

Tracy Russell: There are several federal initiatives at play right now, and these are focused on 3 areas: reducing drug costs, access to care and access to data. I’ll say it would be great if we could pass federal legislation because states will keep moving and doing 50 different ways of doing things, so looking to the federal legislator to make it more universal is great.

Looking into these 3 areas and reducing costs, the Build Back Better Act currently includes provisions designed to reduce costs and, if advanced, as it is today, would redesign Medicare Part D and establish inflation penalties, insulin limits, co-pays, and would eliminate the so-called discount rule. It hasn’t been approved yet and it may change and there could potentially be an update by the time we present to Asembia, so stay tuned.

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

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

Access to data too, ensuring that the use of technology to access patient-specific data reduces the administrative burden for providers across the care team. Now, the Centers for Medicaid and Medicare Services, or CMS, included the beneficiary’s real-time benefit requirements for Part D plans that go into effect in January 2023. This requirement would allow enrollees to view the specific cost of the benefit Real-time form of patient information when prescribing, which is in perspective. When this is implemented, it paves the way for patients to address the challenges of accessibility and benefits by providing necessary action and patient-specific information, and the patient and provider can discuss whether or not the patient can afford that drug sooner. to leave the office. This prioritizes the interoperability aspect and can enable the data flow and data fluidity needed to enable those care teams to help the patient solve challenges across the drug access path.

Request: How about state-level legislation that could impact the future of specialty pharmacies?

Tracy Russell: Yes, as I said earlier, states are active. If they don’t take precedence over things with the Federal, they will continue to move and what we’re seeing at the state level, beyond reach and reimbursement issues, is white bagging. This has a particular impact on state-level specialty pharmacies because it is when a provider is required to order therapy from a specialty pharmacy that is typically outside their healthcare system. This type of further complicates the transparency of costs for patients. There were 11 states that discussed proposals to ban pharmacy benefit managers from enforcing the delivery of clinical administrative drugs from a specific pharmacy or to ban switching to a specific pharmacy.

The ban on swerving is part of the white bagging challenge, and this has mainly been the concern of independent pharmacies for some time as they compete with the larger chains and because they tend to have their own mail order units. But for specialized pharmacies, it translates into the opportunity to help more patients access the necessary medications and strengthen the pharmacist-patient relationship, and they are not opposed to the white bagging process, they are only opposed to the mandate of the plans that the patient must have. a specific way of delivering, because, in reality, it has to be the patient’s choice and whatever is best for the patient.

Then there is also, as I said, the scope of the practice and the issues relating to refunds. These challenges together prevent specialty pharmacies from being able to provide a wider range of services. So better integration between pharmacy and medical services can enable specialist pharmacists to provide patient care at the highest levels they need and be able to operate at the highest level of their license. So we see a lot of states that are working with collaborative practice agreements that are improving the work of the entire healthcare team.

Request: How about state-level legislation that could impact the future of specialty pharmacies?

Tracy Russell: Well, as the role of the pharmacist expands in the care team, especially the pharmacy, and especially pharmacists, they should be ahead of the move. They have been working in collaborative practice arrangements with doctors and nurses for some time, and as I said, the states are really trying to make these paths easier. Patients have been shown to increasingly rely on their specialty pharmacies for services that are not just clinical services but want more information such as information about their condition, managing side effects and training on medications given because many of them must be self-administered. These services are helping patients not only learn more about the drug, but also find affordable options, and this can have a measurable impact on a patient’s drug adherence, whether they can afford it or not.

It will be essential for industry to prioritize the use of technology. Evaluating patient-specific information prospectively during care is important to bring patients to therapy faster and to improve their adherence. biological [and] cell and gene therapies entering the market can also complicate further as the patient journey becomes more complicated and the need for pharmacists to have that data within their systems will increase because these are very expensive drugs and the specialty pharmacy will work increasingly with those patients to make sure they can access treatment.


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