B. Douglas Hoey, RPh, MBA, Chief Executive Officer, National Community Pharmacists Association

Meaningful federal compounding legislation has been developed.

A whirlwind year-long legislative process to enact compounding reform recently concluded with Congress’ passage of a compounding and prescription drug supply chain integrity bill known as The Drug Quality and Security Act (H.R. 3204). It is milestone legislation worth reflecting on both for its own merits as well as for the lessons it holds for the future of community pharmacy.

Pharmacists, like the rest of the nation, were appalled by the tragic 2012 meningitis outbreak originating from the New England Compounding Center (NECC) that has been attributed to more than 60 deaths and the sickening of hundreds more. In the tragedy’s aftermath, Congress held hearings and rightfully demanded action.

National Community Pharmacists Association (NCPA) members and staff participated in dozens of calls and meetings with lawmakers and their staffs throughout 2013 to educate them on pharmacy compounding. Despite these extensive efforts, deeply flawed legislation, S. 959, was on the cusp of passage.

That bill, probably inadvertently, went well beyond what was needed to prevent another NECC tragedy. For example, it would have trumped state boards of pharmacy and given the FDA broad new authority over independent community pharmacists and what they compound in response to a physician’s request. It also would have required pharmacists to notify the FDA any time they compound a drug in shortage. At the same time, the bill would have exempted entire classes of compounding conducted in hospital systems and their affiliates from the new requirements. These serious shortcomings in S. 959 reflected how powerful interests were actively lobbying Congress to pass legislative provisions that would increase their profits at the expense of small business community pharmacists’ ability to compound medications for their patients.

NCPA members spoke out about these and other problems to their elected officials in a vigorous grassroots exercise of their First Amendment rights. The resulting legislative delay bought time for lawmakers, NCPA staff, and others to forge a compromise in H.R. 3204 that is monumentally better for community pharmacists and their patients. The compromise legislation takes reasonable steps to protect patients without saddling independent community pharmacists with the onerous provisions referenced above.

The same involvement by community pharmacists that was a key to the enactment of H.R. 3204 can also help facilitate reform in 3 other areas that form the bulk of NCPA’s legislative priorities.

First, in the wake of dramatic generic drug price spikes, NCPA is seeking reforms to ensure timely reimbursement updates that account for the costs paid by community pharmacies. In the age of instant communication, there is no reason for health plans or their pharmacy benefit managers to wait weeks, or even months, to update payment benchmarks. NCPA will continue working with pharmacists in support of state and federal legislation addressing this and other issues related to maximum allowable cost practices.

NCPA’s second goal is to expand independent community pharmacies’ ability to participate in “preferred networks” in the Medicare Part D Prescription Drug Benefit and other programs. Since the first preferred Part D plan was rolled out 3 years ago, NCPA has consistently and aggressively been expressing its concerns to government authorities. Medicare officials have heard these concerns, and earlier this year said they strongly believe that allowing any pharmacy that can meet the plan’s terms and conditions to participate in the sponsor’s preferred network is the best way to encourage price competition and lower costs. We encourage community pharmacists to support our continuing work with Congress and Medicare officials on this vital issue.

Third, NCPA is working to increase recognition of the expanding role of the pharmacist in health care—sometimes referred to as “provider status.” As a doctor told me recently, we don’t have a physician shortage problem in this country; we have a pharmacist underutilization problem! We couldn’t agree more.

To start, every pharmacist should urge his or her US senators and representatives to cosponsor the Medication Therapy Management Empowerment act (S. 557/H.R. 1024) to expand Medicare coverage of medication therapy management services that will enhance health outcomes and lower costs. In addition, pharmacists should support efforts in their home states to replicate a new law increasing pharmacists’ roles as providers in California as a first step in expanding the pharmacist’s scope of work. These step-by-step victories will further acceptance of pharmacist-administered services and help build the case for eventually amending the Social Security Act to recognize pharmacists as health care providers, a goal NCPA shares with other leading pharmacy organizations.

Developing meaningful and workable federal compounding legislation over the past year was a significant accomplishment for independent community pharmacists. That experience also provides a road map for addressing the additional 3 NCPA legislative priorities on behalf of community pharmacists—and ultimately helps them to better serve patients.

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Meaningful federal compounding legislation has been developed. 

The New Compounding Law and Community Pharmacy's Future

Recently introduced bills seek to expand counseling sessions with pharmacists for patients.

As the Centers for Medicare & Medicaid Services (CMS) administrator, Mark McClellan oversaw the implementation of the Medicare Part D prescription drug program. He understood the importance of pharmacists to the program’s success and how vital medication therapy management (MTM) could be to those efforts. In a 2005 speech regarding the launch of Part D and the law that created it, McClellan made several statements that equally apply to 2013 efforts to expand to MTM:

“To get the most value from the drug benefit, we also want to reward and support the extensive knowledge and real world experience of community pharmacists for assisting in coordinating and managing drug therapies. A key part of achieving this goal is the law’s requirement that every Medicare drug plan have a program to ensure that prescription drugs are used appropriately, to improve outcomes and reduce adverse drug interactions. Pharmacists play a critical role in managing patients’ medication needs, helping patients deal with chronic illnesses, and achieving better health outcomes by improving medication use and reducing the risk of adverse events such as drug interactions. Under the law, plans must implement a program of medication therapy management for certain high-risk beneficiaries, in particular, patients with high spending who take multiple drugs for multiple chronic diseases. Based on the initial results of a variety of medication therapy management programs, we are confident that medication therapy management programs, like other care-coordination programs, will have increasing prominence in Medicare.”

In March of this year, Representative Cathy McMorris Rodgers (R-WA) introduced H.R. 1024, the Medication Therapy Management Empowerment Act of 2013; and soon after Senator Kay Hagan (D-NC) introduced S. 557, the Medication Therapy Management Empowerment Act. The need for this legislation is demonstrated by adherence facts published by NEHI, formerly known as the New England Health Institute. They found America’s health care system wastes up to $290 billion a year on the improper use of medications and approximately 2 billion cases of poor medication adherence are preventable. As a result, NEHI concluded that over $100 billion a year in excess hospitalizations occur. Furthermore, as an indicator of what proper adherence can mean, they found the average health care spending for a low-adherence diabetic patient is $16,499, while a high-adherence patient cost is $8886.

MTM is a great vehicle to reduce costs and improve adherence. The program involves pharmacists working with seniors to review and monitor their medication plan to maximize its effectiveness. Both of the aforementioned bills expand the number of Part D beneficiaries who are eligible for one-on-one counseling sessions with a licensed pharmacist to anyone with a chronic medical condition, such as diabetes or hypertension. This is a departure from the current system that is limited to patients suffering from specific multiple chronic conditions.

The National Community Pharmacists Association (NCPA) is pleased to support beneficiary eligibility pool expanding, common-sense, cost-effective federal legislation that recognizes the growing contributions of pharmacists to patient care. NCPA recently joined others in sending official endorsement letters for H.R. 1024 and S. 557, and certainly encourage Congress to act quickly on both bills.

NCPA’s support for MTM is long-standing. Seven years ago, NCPA created a company called Mirixa to work with independent community pharmacies and health plans in providing MTM services to Medicare beneficiaries and private patients. Those efforts have helped plans and payers lower overall health care costs and enhance the quality of care. The evidence of the effectiveness of MTM can be seen in a Minnesota study, which found a 12:1 return on investment for MTM. In North Carolina, Kerr Drug reports that MTM programs there helping seniors produced a 13:1 return.

The benefits of MTM expansion are readily apparent, and any vehicle in furtherance of that goal should be embraced. So tell your Congressman and your patients to support H.R. 1025 and S. 557.

B. Douglas Hoey is the chief executive officer of the National Community Pharmacists Association. He has spent more than 20 years working in and representing community pharmacies.

MTM Legislation Introduced in the US Senate and House of Representatives

Independent community pharmacists are well positioned to aid patients with specialty medications.

I strongly believe independent community pharmacists are best suited to help patients optimize the use of specialty drugs or biologics that treat diseases—from cancer to arthritis&mdash;with such drugs as Humira, Enbrel, Remicade, Avastin, and Rituxan. You might ask what justifies such a declaration.

Specialty medications are enormous investments for the health plan that pays for them and for the patient who takes them. These medications often require special storage, special administration, special handling, and special counseling to ensure adherence to these pharmaceuticals and manage their sometimes very potent side effects. Who better than a community pharmacist to serve these special patient and payer needs?

However, for years, financially aggressive pharmacy benefit managers (PBMs) have exploited their ability to dictate the definition of what is considered a specialty drug to create another profitable revenue stream and send these high-touch medications to a mailbox!

PBMs that own mail order pharmacies have utilized their managed prescription formularies to liberally label one product after another as a specialty drug. Once that designation is made, the PBM can dictate that patients acquire the specialty drug exclusively through the mail order pharmacy it owns. With the consolidation and acquisitions occurring in that industry, such profiteering will likely only grow worse.

Looking at the trend line for specialty drugs, the stakes become clear. Around the middle of this decade, specialty drugs will account for 40 to 45 percent of pharmaceutical manufacturer sales and will comprise 7 of the top 10 best-selling drugs. If the current rate of mandatory mail order requirements for specialty drugs continues or accelerates under the current PBM business model, PBM profits will grow even more. But it will be unpopular with patients and I predict it will prove costly for employers, taxpayers, and other health plan sponsors.

At the National Community Pharmacists Association (NCPA), we are working on this mostly at the state level where each respective legislature has been or soon will be tasked with creating a more concrete definition of specialty drugs that creates an environment that is financially feasible for broad participation and not easily exploited by PBMs.

Recently, we have worked with our allies in several states to create specialty drug definitions that allow independent community pharmacies to compete. We are also focused like a laser on the state legislatures, and tweaks to existing legislation and/or the introduction of new legislation that will become possible. Working with our allies, NCPA has created a preliminary draft for a model definition.

At the federal level, NCPA is raising awareness about the current specialty drug dynamic and pushing for a more uniform national standard in Congress. In addition, a federal judge upheld the specialty drug claim brought by NCPA and the National Association of Chain Drug Stores (NACDS) in a pending lawsuit challenging the ESI-Medco merger.

So, an obvious question is how to best prepare for the growth of specialty drugs and services to your patients. First, examine the medical needs of patients in your community to determine if you can fill a current void for specialty drugs. Second, if necessary, sharpen your knowledge about the disease state in which you are specializing. Third, consider how you are currently and how you will collect data about the services you are offering specialty patients. Fourth, utilize or develop a medication adherence program. NCPA offers the Simplify My Meds program free to all members (

). Fifth, come up with a marketing plan for health plan sponsors and patients so they are aware of the specialty drugs and accompanying services your pharmacy will be offering.

Independent community pharmacies should provide more and more niche services in order to remain competitive and enhance their viability. If incorporated properly, specialty drugs can become part of that equation and eventually their market size will dictate they become much more than a niche. Moreover, utilizing community pharmacists to help maximize the benefits of specialty drugs can be a win for patients, a win for health plan sponsors, and a win for pharmacists. Let’s not let PBMs decide who controls this terrain.

The Wave of the Future is Here-- Specialty Drugs

Independent community pharmacists are well positioned to aid patients with specialty medications. 

Recently, we have worked with our allies in several states to create specialty drug definitions that allow independent community pharmacies to compete. We are also focused like a laser on early 2013 when many state legislatures will be back in session, and tweaks to existing legislation and/or the introduction of new legislation will become possible. Working with our allies, NCPA has created a preliminary draft for a model definition.

At the federal level, NCPA is raising awareness about the current specialty drug dynamic and pushing for a more uniform national standard in Congress. In addition, NCPA is pursuing the specialty drug claim that was upheld in the recent legal complaint by the National Association of Chain Drug Stores (NACDS) and NCPA against the ESI-Medco merger.

So, an obvious question is how to best prepare for the growth of specialty drugs and services to your patients. First, examine the medical needs of patients in your community to determine if you can fill a current void for specialty drugs. Second, if necessary, sharpen your knowledge about the disease state in which you are specializing. Third, consider how you are currently and how you will collect data about the services you are offering specialty patients. Fourth, utilize or develop a medication adherence program. NCPA offers the Simplify My Meds program free to all members (www.simplifymymeds.com). Fifth, come up with a marketing plan for health plan sponsors and patients so they are aware of the specialty drugs and accompanying services your pharmacy will be offering.

Independent community pharmacies should provide more and more niche services in order to remain competitive and enhance their viability. If incorporated properly, specialty drugs can become part of that equation and eventually their market size will dictate they become much more than a niche. Moreover, utilizing community pharmacists to help maximize the benefits of specialty drugs can be a win for patients, a win for health plan sponsors, and a win for pharmacists.

Let’s not let PBMs decide who controls this terrain.