The New Compounding Law and Community Pharmacy's Future

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.