While the passage of the Patient Protection and Affordable Care Act (“ACA”) ushered in a new era of access to health care, it only served to exacerbate a growing crisis in the provision of health care – lack of providers. As of April 2015, the Health Resources and Services Administration lists the population of the United States that lives within a health professional shortage area (“HPSA”) for primary care as 103,847,716, with 1,023,989 of those living in Kentucky. This shortage calls for a reimagining of ways that non-physician providers can fill the care gap, and the debate surrounding the provider status of pharmacists with regard to federal health care programs is evidence of a changing mindset.
Pharmacists currently lack provider status under federal law, although many states, including Kentucky, give provider status to pharmacists in some form or another in the context of state health and Medicaid programs. Provider status would allow pharmacists to bill federal (and possibly also state or private) health programs for basic patient care services that many already provide, such as immunization, medication coordination, medication therapy management, chronic disease management and preventative care. Many of these services are provided through interdisciplinary teams working under collaborative practice agreements. In Kentucky, these agreements recently received a significant expansion with the passage of HB 377, creating plans for cooperative management of a patient’s medication-related health care between multiple doctors and pharmacists.
Arguments for and against Provider Status
Pharmacists and the American Pharmacists Association (“APhA”) in particular, argue that lack of provider status creates barriers that prevent the optimal use of pharmacists’ services in modern payment models such as accountable care organizations (“ACOs”). Pharmacists have a particularly close relationship with patients, with an unprecedented ability to provide cost savings through generic substitutions, chronic condition management and patient education. ACOs and other similar organizations often refuse inclusion of pharmacists precisely because of their inability to receive reimbursement for certain Medicare services. The APhA argues that the more than 1.5 million preventable medication-related adverse events – generating up to $290 billion annually in unnecessary expenditures – can be mitigated by the inclusion of pharmacists more directly in patient care. It is difficult to imagine a scheme of truly comprehensive, patient-centered care without the inclusion of those dispensing and managing patient medications.
The Advancing Pharmacy Practice in Kentucky Coalition is advocating similar measures, namely the achievement of non-physician provider status so that pharmacists may paid under Medicare Part B. Kentucky already confers provider status on pharmacists, although it does not reimburse for patient care.
This push for provider status creates friction within already strained relationships with the physician community as the American Medical Association has opposed many measures that expand the scope of pharmacist duties. For instance, in 2012, the AMA House of Delegates adopted a policy opposing any legislation that gives pharmacists authority to prescribe without supervision by a doctor. This came in response to a proposal by the FDA to allow certain drugs to be sold over the counter at the discretion of the pharmacist. In 2013, the House of Delegates adopted a policy “stating that a pharmacist who makes inappropriate queries on a physician’s rationale behind a prescription, diagnosis or treatment plan is interfering with the practice of medicine.” The reasoning behind the AMA’s position is that physicians are best suited to provide prescription care of the patient as a whole, with a higher degree of knowledge and training in disease management.
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 that 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 is a Member of McBrayer, McGinnis, Leslie & Kirkland, PLLC. Ms. Hinkle concentrates her practice area in health care law and is located in the firm’s Lexington office. This article is intended as a summary of newly enacted federal law and does not constitute legal advice.