Mike Agostino

	The modernization of Medicare, Medicaid and every other government health program has caused the national health care market to change.  

	As consolidation and integration of health care occurs in rural areas, it does so to the detriment of patients, whose futures will be impacted by the choices that lead to fewer options for care.

	A challenge by way of example is labeled as “vertical integration." Vertical integration can take the consumer out of consumerism. In other words, it is now more common than ever before that when a health benefit is offered, there is a high likelihood that if you have a mail order benefit, or a specialty benefit, that these services will be provided by the manager of your pharmacy benefit.

	This may not sound like a big deal but it could mean the difference between picking up your medication order at your local pharmacy versus having it delivered by an out-of-state pharmacy.

	This is particularly troublesome for patients in need of the life-saving and life-sustaining specialty medications used to treat those with chronic illnesses and rare diseases. Therefore, the main point to convey here is the paramount importance of making sure that the management of a specialty medication benefit for patients must be thoroughly vetted, from start to finish.

	Specialty pharmacy is like the quarterback for care, seamlessly coordinating what happens with the patient, doctors, drugs, and pharmacy to beat a staunch opponent: diseases that are chronic, rare, progressive, debilitating, or fatal if left untreated or undertreated. 

	Navigating the world of treatment for a chronic or life-threatening disease can be complex and frightening. After receiving a terrible diagnosis, patients shouldn’t have the added burden of feeling that they are fighting the disease alone, or the worry of bankrupting their family to cover the costs of therapy.

	There is an emerging and growing complexity that the public may not realize. There are well more than 155 medications available in the United States that treat these types of conditions, which are called limited distribution medications.

	Simply, that means that not every specialty pharmacy has access to every drug; rather it's predicated on the arrangement with manufacturers, who decide which pharmacies can dispense their medications.This is a whole different side of healthcare that is growing and it is based on the deep experience and expertise that a specialty pharmacy may hold in a given field of care, including proper delivery and management based on protocol for each unique medication and/or condition.

	Specialty pharmacy serves as the backbone for patients when they need it the most, providing the patient-centric treatment and essential support needed for patients battling tough diseases. According to the Drug Channels Institute and other sources, specialty pharmacy drugs will represent 44% of US drug expenditures by the year 2020, but yet will be used by approximately 2% of the US population.

	Specialty pharmacists do more than dispense prescriptions; they are subject matter experts with levels of accreditation and certifications within certain conditions and disease states, which allows specialty practitioners the know-how to properly manage a patient on a specific medication for specialized condition.

	Work with specialty pharmacy is important to ensure continuity-of-care, without disruption of service, so patients remain healthy and satisfied with treatments and suffer no consequences associated with increased costs. The alternative to such a high standard, high-touch level of care is the threat of completely unnecessary hospitalizations. 

	Illnesses treated by specialty drugs include cancer, hepatitis C, infectious diseases, infertility, Crohn’s disease, rheumatoid arthritis, psoriasis, HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, human growth hormone deficiencies, hemophilia, and other bleeding disorders. Specialty pharmacy helps patients with these challenging disease states to stay on their drugs, despite sometimes painful and debilitating side effects.

	The primary goal for specialty pharmacy is to ensure patients receive the right drug, at the right time, in the right dosage, and at the right intervals. Under no circumstances should a patient receive a medication that is “automatically” filled from a specialty pharmacy; instead it is quite the opposite.

	As the number of health care options for patients continues to erode across the country, we must be mindful of the effect on patient outcomes—especially those with debilitating diseases that require an additional level of “white glove” care, from premature newborns struggling just to survive, to seniors nearing the end of a long, productive life.

	Americans with serious health conditions should not face barriers to the care that they, their physicians, and their pharmacists determine is best for them. We are committed to working with all stakeholders and policymakers to ensure that these cost-effective and life-saving medications are carefully, effectively and efficiently furnished to those who need them. 

Mike Agostino is the Vice President of Pharmacy Innovation and Business Development for Hy-Vee, and serves on the Board of Directors for the National Association of Specialty Pharmacy (NASP). The Association will convene its fourth annual meeting from Sept. 26 to Sept. 28 in Washington, D.C. 

Articles

Specialty pharmacy is like the quarterback for care, seamlessly coordinating what happens with the patient, doctors, drugs, and pharmacy. 

NASP: Specialty Medication Benefits Must be Thoroughly Vetted

Current political debates, including the ongoing presidential race, have highlighted specialty pharmacy in a less than favorable manner. When stories in national publications focus on the “Pharma Bro” and question relationships between pharmaceutical manufacturers and specialty pharmacies, we are bound to receive negative attention.

Other challenges we face include those that directly impact our operations and could have consequences for patient care. For example, within Medicare Part D plans, fees attached to a prescription claim were introduced by CMS in 2014. These fees are intended to effectively lower premiums for beneficiaries, however, as attorney Christine Clements noted, the language CMS used “blurred the lines between (Direct and Indirect Remuneration) and negotiated prices.”

Currently, there seems to be no end in sight toward its negative impact on remaining profit within the setting of traditional discounts offered off of published Average Wholesale Price or published Wholesale Acquisition Cost. Patients are receiving inadequate notification when network changes are made.

Medicare changes are made before we can even assess the impact to all stakeholders. The list can, and does, go on. If I were to sum up the state of the specialty pharmacy industry in 1 word, that word would be “headwind.”

The challenges we are currently facing could have dire consequences, and it is because of these challenges that we must participate in advocating for our industry. As a profession, we need to invest our time to gather together, speak up, and interact with our government officials at all levels. The time is now.

In November 2013, our pharmacy was faced with what seemed to be an insurmountable amount of Medicare audits (specifically related to transplant). This was not only the case for us, but also for other pharmacies that focus on servicing the transplant community. That is when it became clear that I needed to implement a change.

At the time, there was no unified group that represented the practice of specialty pharmacy to our government officials. We decided that the first step was getting our voice heard in Washington, DC. We hired our own lobbyists, The Federal Group, with 1 primary goal: Get in front of the most influential government officials so we can articulate the value of servicing patients who take specialty medications.

Our chief concern at the time was the need to change the policy of durable medical equipment audit expectations for specialty pharmacies. The ability of pharmacies to get paid is dependent on hospital systems sending specific documentation to validate the medical necessity of medications. Frustratingly, this documentation is in the hands of the hospital systems and not within the reach of the specialty pharmacy.

“Amber Pharmacy knew that the concerns it had with a Medicare contractor couldn’t go unanswered. They worked with The Federal Group to communicate their concerns to CMS, Capitol Hill and the contractor itself,” said Patrick Cooney, president of The Federal Group. “The outcome was a reprieve from burdensome audits for an entire year. But to address the concern more permanently, they realized a change needed to be made to the law to protect access to their essential services. Working with our firm, they have crafted policy reforms and secured congressional supporters with the goal of changing the law.”

As a voice for our industry, we are a voice for our patients. We have the ability and responsibility to speak up, not only for ourselves, but also for the individuals who trust us with their care. On December 23, 2014, something happened that brought that responsibility into sharp, painful focus.

I received a call from 1 of our patients with cancer who had been on a limited distribution medication with an associated risk evaluation and mitigation strategy program. The patient had a letter in her hand, dated just a few days earlier, stating she must use a new preferred specialty pharmacy effective January 1, 2015.

As a specialty pharmacy practitioner, you are familiar with the panic that set in.

“How will I take care of this person?”

Unfortunately, the patient (who did not need any form of worry or anxiety), was transferred to a pharmacy that was less than accommodating and she suffered as a result. Her medication was delivered several weeks past its due date.

Working with The Federal Group has taught us how to get face time with senators and representatives to educate them about the value specialty pharmacy provides for all stakeholders, particularly patients, and how our industry can help manage an ever-growing portion of health care expenditure. We are able to use that knowledge to get the right message to the right people.

Founded in 2012, the National Association of Specialty Pharmacy (NASP) has quickly become instrumental for our industry in terms of education and advocacy. With such a diverse group of board members, ranging from pharmaceutical manufacturers and health plans to specialty pharmacies and group purchasing organizations, one might expect NASP meetings to get contentious.

However, I have found that all egos are checked at the door and our time together is a true collaboration that focuses on elevating our industry.

“Specialty pharmacy has a wonderful story to tell, but lawmakers in Washington and the states are just beginning to understand the value of the products and services the industry provides to its patients every day,” said Paul Kelly, Principal at The Federal Group. “There is no substitute for focused engagement by the industry with Congress, HHS and other policymakers — and NASP and other specialty groups – are starting to take important steps in that direction.”

In the last year, momentum at NASP has been picking up and membership has begun to grow. With that growth, we were able to form our own Government Affairs Committee, and for the first time, our industry is speaking with one voice.

“Advocacy starts with education,” said Jayson Slotnik, partner at Health Policy Strategies. “Since the beginning of 2015, NASP has met with CMS several times to explain the many services that specialty pharmacies provide and how these services improve patient outcomes and reduce overall drug spend. NASP is confident that, through our partnership with CMS, we can help improve access to specialty drugs and preserve the ability of our pharmacies to remain independent and patient-focused.”

Whether you are a stakeholder, specialty pharmacy practitioner, clinician, nurse, student, or someone who simply wants to learn more about our industry, I encourage you to engage with NASP. Advocacy can be as simple as staying up-to-date on the issues and speaking up when needed, and NASP can help you do just that.

As previously mentioned, the first step of advocacy is education. Because of our passion for what we do, we sometimes get ahead of ourselves or forget our audience. Sometimes it helps to get back to the basics. We reached a significant milestone recently when thought leaders within NASP issued definitions of both “specialty pharmacy” and “specialty medication.”

These definitions are a valuable resource when engaging with policy makers and other industry stakeholders. It gives us the opportunity to define ourselves, rather than be defined by others, and truly spells out all of the value that we provide to our patients.

Not a day goes by when I am not asked to explain what a specialty pharmacy is; so having this leave-behind adopted by NASP is a great tool. Will the definitions ever change?

As new medications are introduced, new or refreshed clinical protocols become available, value-based outcomes begin to merge more into fair market value, and as even more agreement of comparable efficacy and performance become more mainstream, my answer is YES.

There are 2 things we learned quickly from our time in Washington, DC:

1. Government officials do, in fact, want to hear from their constituents. We can help our legislators by providing the information they need to make informed decisions.

2. Patience is paramount. Our efforts to improve the CMS audit process have been 2 years in the making.

“It is important that we meet with federal legislators and represent the specialty pharmacy industry on behalf of NASP and our patients,” said Aaron Wiese, president of Amber Pharmacy and Hy-Vee Pharmacy Solutions. “Our practice of pharmacy is complex and dynamic. Specialty pharmacy patients are the sickest of the sick. Access and affordability of specialty medications are critical. Our patients have unique needs, as well as safety and care issues, and we must be a voice for them on the legislative and regulatory side.”

The key to winning the hearts and minds of legislators is approaching legislative issues the same way you approach your work every day: patients first. Demonstrate that your primary goal is having a positive impact on your patients’ well-being rather than your own bottom line.

Other ways to catch attention include proposing solutions that do not require money and suggesting policy changes rather than new legislation. New legislation is a laborious, time-consuming process, while policy changes can be quicker and an equally effective means of achieving your goals.

Today, we have an ever-growing group of industry professionals who donate their time to the Government Affairs Committee within NASP. We have planned an annual visit to Capitol Hill to help maintain awareness of our industry with focus on the issues that may impact accessibility to specialized services to patients in need.

We are building relationships with significant potential for long-term impact. Most importantly, we have demonstrated that advocacy is not just a buzzword. Both of the issues that I described at the beginning of this article — excessive audits and patient notifications – are now in draft format and are being presented by our local representative to implement policy change.

If such big accomplishments can be made by a few individuals, imagine the impact we can have by coming together as an industry.

Stay involved. As a health care professional, make sure you understand how our scale of economy is being impacted. Do you really understand how the recent CMS publication on average manufacturer price (AMP)-based reimbursement impacts services that you render to patients?

Are you up to speed regarding state fee-for-service Medicaid programs transitioning over to managed care? What are your next steps?

Stay true to our profession. Specialized services within pharmacy need innovation, demand curiosity, and require that we push away complacency. We will always need thought leaders who are not afraid to try something that is better than what we have today. Stay true to yourself.

Ask yourself if you have the same level of passion you did when you first started your career. If the answer is no, there are no hard feelings, follow your heart. If the answer is yes, however, continue to fuel your passion by teaching others around you who support you, as well as those who help create the policies that impact you.

For more information on this topic, I encourage you to attend the panel, “The Practice of Specialty Pharmacy and Our Government Representatives” at the upcoming Armada Specialty Pharmacy Summit, on May 3, 2016. Armada, the largest US conference for specialty pharmacy, is an opportunity to learn about relevant industry topics, network with peers, and gain real insight into key issues. SPT

, Vice President, Pharmacy Innovation and Business Development Hy-Vee, Inc

Ongoing challenges in specialty pharmacy could have dire consequences, which require industry stakeholders to get involved so legislators make informed decisions. 