Antitrust and the future of nursing: federal competition policy and the scope of practice.

Author:Gilman, Daniel J.
Position:Continuation of II. Discussion B. The Nursing Advocacies through Conclusion, with footnotes, p. 175-208
  1. APRN Regulations

    FTC staff comments on a 2012 Louisiana bill are illustrative of the competitive concerns associated with APRN supervision requirements. (145) Louisiana law requires that an APRN must practice under a formal written collaborative practice agreement if he or she is to work to the full extent of APRN scope of practice, including performing "acts of medical diagnosis and prescription" as otherwise permitted under Louisiana law. (146) Physicians are not similarly required to collaborate with APRNs or other health care professionals. (147) The bill in question would have removed the collaborative practice requirement for certain APRNs practicing in medically underserved areas or treating medically underserved populations. (148)

    The underlying empirical basis for the staffs analysis was straightforward. First, staff noted both federal and state findings of primary care provider and service shortages throughout much of the state: "Recent reports indicate that more than half of Louisiana's population lives in a federally-designated Health Professional Shortage Area (HPSA). All 64 Louisiana Parishes contain HPSAs, and 53 entire Parishes comprise primary care shortage areas." (149) Such shortages were--and are--expected to persist (150) and were linked to significant problems in health care access and delivery in Louisiana. (151) Healthcare reform promised in some regards to exacerbate the shortages as more Louisiana consumers gain health insurance and seek access to primary health care services. (152) Second, staff rioted that APRNs might help to alleviate such shortages. (153) APRNs--observed to be the fastest growing segment of the primary care professional workforce in the United States (154) already were providing primary care services throughout Louisiana, and in many other states, they were doing so without regulatory requirements of direct supervision or formal collaborative practice agreements. (155) APRNs make up a greater share of the primary care workforce in less densely populated, less urban, and lower income areas, as well as in HPSAs. (156) Also, APRNs are more likely than primary care physicians to practice in underserved areas and to care for large numbers of minority patients, Medicaid beneficiaries, and uninsured patients. (157) In Louisiana there were approximately 3,500 licensed APRNs, and most of the state's designated HPSAs contained practicing APRNs. (158) Hence, the potential benefits associated with the bill appeared amplified in markets that, from a health care access perspective, are most disadvantaged. Correspondingly, competitive concerns about the costs of undue regulations might be greater in markets or areas where health care needs are greatest.

    Third, staff noted that the statutory requirement of a formal, written collaborative practice agreement could impede the ability of APRNs to help fill this gap (or meet this demand). (159) There were at least ad hoc reports that some APRNs were paying very high fees to enter into and maintain collaborative practice agreements and that some practicing APRNs found it difficult to secure a replacement agreement and continue their treatment of patients when a collaborating physician retired, moved, or died. (160)

    The competition analysis was simpler still. An existing undersupply --likely due, at least in part, to regulatory barriers to entry appeared substantial. (161) Reducing some of those barriers--in particular, the statutory requirement of a collaborative practice agreement for APRNs serving medically underserved areas or treating underserved patient populations--could "improve access and consumer choice for primary care services, especially for rural and other underserved populations." (162) In brief, reducing such barriers could increase the supply of service providers and lower average costs of production, at least for some basic primary care services. At the margin, in underserved areas, the effect could be the provision of services not otherwise available. Hence, "[g]iven the potential benefits of eliminating unwarranted impediments to APRN practice, [FTC staff] recommend[ed] that the Louisiana legislature seek to ensure that statutory limits on APRNs are no stricter than patient protection requires." (163)

    Moreover, staff suggested that the bill could facilitate innovation in health care delivery. (164) In fact, collaboration between APRNs and MDs is common. (165) Even in states that do not require any formal collaborative or supervisory arrangement, APRNs frequently consult with or refer patients to physicians, and many APRNs are employed by physician practices or institutional providers that privately implement various collaboration and oversight arrangements. (166) Such collaboration may be highly varied, a locus of considerable innovation, and, often, uncontroversial. (167) But statutory requirements may constrain, rather than implement, enable, or enhance such practices. For example, in tying collaboration to specific formal agreements between individual APRNs and individual physicians (168) or restricting the number of APRNs with whom a physician may collaborate (or supervise), (169) the state may constrain the ability of an institutional provider to experiment with flexible oversight and collaboration arrangements or to accommodate staffing changes across central and satellite facilities in real time (or its administrative facsimile). (170) Similarly, by restricting the permissible physical distance between APRNs and supervising doctors, the State of Florida restricts the ability of providers to develop new models of networked or telemedicine-facilitated collaboration. (171) Diverse public and private experiments with the roles that APRNs might play in primary care delivery suggest quality of care benefits associated with the use of APRNs as primary care providers. (172) They suggest, in turn, not just particular roles that APRNs might fill in delivering safe, high-quality primary care services but a further policy question of whether this type of institutional innovation ought to be constrained by any particular supervision regulations.

    Evidence that the collaborative practice agreements were necessary to protect patients (or even helpful in that regard) appeared to be non-existent. No record of patient harms associated with expired or defective collaborative practice agreements in Louisiana was in evidence. (173) More telling was a sort of natural experiment across the United States. As the IOM observed, APRNs had long provided diverse primary care services and had done so, in many jurisdictions, without anything analogous to Louisiana's "collaborative practice" requirement. Yet "the contention that APRNs are less able than physicians to deliver care that is safe, effective, and efficient is not supported by the decades of research that has examined this question." (174) To the contrary, a large body of empirical research strongly suggests that APRNs are safe and effective providers of diverse primary care services. (175) Note, further, that one of the defining criteria for independent practice--and an ongoing source of contention--is independent prescribing of legend drugs. (176) Studies that examine APRN prescribing suggest comparable outcomes for APRN- and MD-provided care. (177) We are not aware of countervailing empirical evidence suggesting special patient harms or risks associated with APRN prescribing. (178)

    No other countervailing policy benefits appeared to be at issue, and no substantial implementation costs were associated with the bill. Yet the bill did not escape committee. Given the impact of provider shortages across much of Louisiana, we prefer to find that result baffling. Of course, none of this is to suggest that APRNs should not consult, collaborate with, or refer patients to physicians. None of this suggests that a consumer might not prefer an MD practitioner as a primary care service provider or the locus of a "medical home." (179) None of this suggests that APRNs and primary care physicians ought to share a single, uniform scope of practice. The question, rather, is whether there are adequate grounds--or even any substantial grounds --on which to circumscribe APRN scope of practice in the way that the legislature did and thus to impose substantial health care access costs on the public.

  2. Retail Clinic Regulations

    Reification of supervisory arrangements also has been a point of concern with the regulation of "retail" or "limited service" clinics (RCs). RCs--which tend to be staffed by APRNs--are health care clinics located in retail settings (such as pharmacies and supermarkets) that offer consumers a convenient way to obtain basic medical care at transparent and competitive prices. (180) RCs tend to offer a limited subset of the primary care services available at primary care centers, ambulatory care clinics, and urgent care centers. (181) Evidence indicates that RC care, although limited, tends to be high quality. (182)

    States have, in various ways, made room for RCs in their clinic or facilities regulations, and FTC staff members have not found competition concerns where proposed RC rules "mirror basic consumer protection standards that are imposed on competing providers of basic health care services." (183) Heightened restrictions on care delivered under a particular business model have, however, raised concerns both as they may discriminate against an innovative model of delivery and as they may work as de facto scope of practice restrictions on those professionals employed under the model. For example, an Illinois bill stipulated that RCs appoint a physician director and that "[a] physician may be a medical director of no more than 2 facilities" (184)--potentially a costly and unnecessary limitation on the organization and operation of retail clinics. Moreover, FTC staff were concerned that the two-clinic limit could be read to impose special supervisory...

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