If and when they gain status as providers, pharmacists will become subject to more complex regulation. Laws such as the Anti-Kickback Statute and federal False Claims Act could create new liability for pharmacists as providers seeking fee-for-service reimbursement . False Claims Act violations incur penalties of between $5,500 and $11,500 per violation, not including treble damages.
Pharmacies with large customer bases could expose themselves to unparalleled liability. The Medicare Benefits Policy Manual also delineates specific classes of providers for purposes of reimbursement, each with its own set of conditions and requirements for billing. Provider status for pharmacists would likely receive a similar set of regulations and conditions of participation with new requirements for compliance and accreditation.
Providers have been operating under these regulatory constraints for decades, but pharmacists will face a host of new challenges in conforming to new rules. Pharmacies will need to strengthen their compliance programs and craft careful policies to limit exposure to liability under federal and state statutes and regulations, likely posing a heftier burden on small and independent pharmacies. More regulatory burdens could lead to even greater consolidation of pharmacies and pharmacists over time, reflecting similar changes that have occurred with other providers in the wake of the ACA.
Movement towards Provider Status
The Pharmacy and Medically Underserved Areas Act (H.R. 592) was introduced by Rep. Brett Guthrie (R-KY) of Kentucky and would grant provider status to pharmacists practicing in medically underserved areas or health professional shortage areas; this would make them eligible for reimbursement for certain Medicare services in the same manner as physicians, although at a slightly reduced rate. The bill has garnered bipartisan support in both houses of Congress, but it has been languishing in the House Subcommittee on Health since January. This is the second time this bill has been introduced to Congress with broad bipartisan support, but little movement on the issue has taken place.
Acknowledging Changing Roles
In recent years, new rules have allowed Medicare billing for chronic care management and transitional care management, highlighting an understanding that these services are beneficial in a patient-centered care regime as well as the likelihood that practitioners already provide this type of care without the ability to bill for it. In much the same way, elevation of pharmacists to provider status would acknowledge that pharmacist services have expanded to include new roles traditionally held by other providers, albeit without the financial remuneration afforded by Medicare. Pharmacists have been required to counsel patients about their medications for years without reimbursement. Inclusion of pharmacist as providers is well overdue. Rather than intrude on the duties of other providers, pharmacists can supplement care, as well as fill in gaps of provider coverage in underserved areas. Comprehensive, efficient and coordinated patient care requires a reexamination of assumptions about how health care is provided in a modern context, and that analysis begins with recognizing how non-physician providers such as pharmacists already perform the necessary services. As our payment system moves to value and quality based reimbursement, pharmacists can provide tremendously important services. Allowing them to bill for these services is the next step in the evolution of our payment system.
I thank my pharmacist for looking out for me by assessing the interactions of the medications I take and spending countless hours to obtain pre-authorization for those medications. I even get my flu shot and other immunizations from my pharmacist. I think it is time that these valuable professionals are recognized and compensated in addition to payment for the medication. Pharmacists’ expertise should be put to use.
Lisa English Hinkle
McBrayer, McGinnis, Leslie & Kirkland, PLLC
 42 U.S.C. §1320a-7b, 31 U.S.C. §§3729-3733