As the retail clinic industry has worked to establish its niche in the broader health care infrastructure, an important step along the way has been the successful navigation of legislative and regulatory challenges to the clinics’ viability and ability to provide accessible, affordable, quality health services.  These challenges have come in myriad form, mostly in the last two years as the industry and public awareness have grown. 

Generally, though, regulatory or legislative opposition to the convenient care industry, as we at the Convenient Care Association (CCA) like to call it, can be classified as belonging to one of three categories: 1) challenges relating to the operation of the clinics themselves, 2) challenges pertaining to the providers who practice in the clinics, and 3) challenges which may attempt to restrict the clinics based on an indirect argument.  Each carries its own particular concerns and nuances.  To date, in its young life so far, the convenient care industry has been successful in clearing these obstacles.  But undoubtedly challenges will continue to arise, and it is helpful to understand previous opposition in order to prepare for those challenges.

Clinic Operation Challenges
 Legislation and regulation proposed to regulate the operation of convenient care clinics will often take the form of suggested mandates for licensing and permitting, requirements that the clinics have entrances separate and apart from that of the retail host, and criteria around space, physical layout, and clinic amenities such as restrooms.  The differentiating factor of these particular challenges is that they relate to the clinic facility.
 An early question about convenient care clinic operation was posed in Massachusetts, and was successfully resolved in January 2008.  The original regulatory proposal in Massachusetts would have been very burdensome to the clinics, and included restrictions on clinic layout and advertising.  Members of the CCA worked closely with representatives of the Massachusetts Office of Health and Human Services’ Public Health Council to reach a consensus.  The opinion of the Federal Trade Commission was also sought, which issued a statement cautioning against any action taken with respect to the clinics that could be construed as hindering consumer choice.  In 2009, the first clinics opened in Massachusetts and all indications are that they have been well received by the public, especially given the primary care provider shortage.

Another significant challenge in 2008 arose with the introduction in Illinois of the proposed Retail Health Clinic Facility Permit Act.  Introduced as House Bill 5372, the bill sought to impose numerous restrictions on how convenient care clinics could function in the state of Illinois, including a lengthy permitting and licensing process.  Again, the involvement of the Federal Trade Commission was influential.  Their opinion issued about the Illinois bill reiterated the necessity to recognize consumer choice and not unwarrantedly restrict the development of alternatives in health care.

In 2009, a similar bill was introduced in Indiana, as Senate Bill 216.  Among other provisions, this bill would apply a licensing requirement to convenient care clinics, require that all clinics be accredited by The Joint Commission, and mandate that individual clinics maintain separate entrances.  Members of the CCA who have locations in Indiana worked directly with legislators to achieve a favorable outcome.  Given the current economic climate and widespread inaccessibility across the health care system, many of the legislators tasked with considering this bill were hesitant to take steps that would effectively cut off a valuable access point to Indianans.  Concerns about patient safety and the quality of care at the clinics were heard from representatives of some medical organizations, but could not be substantiated, as convenient care clinics have a strong track record of providing high-quality care.  In fact, two member companies of the CCA are currently accredited through The Joint Commission.  All members of the CCA are required to maintain some version of formal accreditation or certification, and the CCA maintains a relationship with Jefferson Medical College to administer a certification process devised specifically for its members.

Provider Challenges

Challenges to the clinicians who provide care in convenient care clinics usually are directed at scope of practice.  Specifically, proposals may attempt to limit providers’ practice authority by enhancing collaborative practice requirements, including such elements of practice as the percentage of time a collaborating physician must be on site, the percentage of charts a collaborating physician must review, the number of providers a collaborating physician may enter into an agreement with at any given time, and the maximum distance from the clinic location that the collaborating physician may maintain.  If adopted, these limitations would impede the affordability and efficiency that are tenets of the convenient care industry.

The CCA was involved in addressing a proposal to further constrain nurse practitioner practice in Tennessee in 2008.  The suggested rule changes included a mileage limitation, chart review provisions, practice ratio, and other criteria detrimental to the nurse practitioner scope of practice. 

Critical to the success of the CCA’s interests in this matter was a meeting among members of the CCA, the Tennessee Medical Association, the Tennessee Nurses Association, and the Tennessee Academy of Physician Assistants, at which the CCA was able to outline the important role that convenient care clinics play in improving access to basic health care services in a community.  Through these outreach efforts, the original proponents of the regulatory changes were assuaged and that no further limitations were warranted.

This year controversy has arisen between nursing and physician groups in certain states over nurse practitioner practice.  However, in many states there have been bills introduced that would actually broaden the scope of either nurse practitioner or physician assistant practice.  Depending on the state and the proposed reach of the bill, these legislative efforts have variable chances of passing into law.  The CCA and its members have focused heavily on Texas.  Texas historically has imposed strict limitations on how a nurse practitioner may practice.  However, the Texas Medical Association and the CCA worked to draft a bill that would ease some of those practice restrictions, to ensure greater access to care.

Indirect Challenges
 By far the most potent indirect challenge the convenient care industry has faced has come in the form of proposals to prohibit the practice of health care where tobacco products, and sometimes also alcohol, are sold.  Challenges of this nature arose in 2008 in Tennessee, Rhode Island, and Illinois, and in 2009 in Rhode Island, Massachusetts, and Washington State.  The public health reasoning behind these efforts is that it is incongruous to promote good health where there is simultaneous access to unhealthy consumer goods.  The CCA, representing its members, has countered that it actually makes more sense to expose users of tobacco or alcohol to information about how to improve their health at the very source of the unhealthy behavior.  That proximity may encourage greater uptake of health information, which could not occur if users of those products simply went elsewhere to make their purchases.

These bills have met with limited success in the state legislatures in which they have been so far introduced.  In Illinois, the proposed ban on tobacco and alcohol sales in stores with clinics was contained in the same bill mentioned above, HB 5372, and also garnered a mention in the Federal Trade Commission’s opinion on that bill.  The Federal Trade Commission concluded that, “the rationale for not allowing a clinic in a retail store that also sells tobacco or alcohol us unclear,” particularly as the language arbitrarily applied to Convenient Care clinics and not any other type of health care provider.  However, it is reasonable to anticipate that tobacco bans with a broad scope will become more prevalent in local and state jurisdictions in the coming years, in which case convenient care clinics may by default fall under those regulations.

Other Policy Involvement
 The convenient care industry is on the radar of state policymakers.  Previously, members of the CCA have presented about their clinic efforts to the National Conference of State Legislatures (NCSL), and NCSL has published a briefing document about the industry.  Earlier in 2009, the CCA was invited to present to the National Conference of Insurance Legislators (NCOIL) about the cost-effectiveness of the convenient care clinic model and the growing acceptance of the clinics by the payer community.  In 2008, the Health and Human Services Task Force of the American Legislative Exchange Council (ALEC) approved a model resolution in support of the convenient care industry.

The industry has so far been largely uninvolved in federal policy, though the CCA and its members hope to spearhead greater recognition of convenient care within the overall rubric of national health care reform.  If significantly more Americans become insured, which the President has identified as a priority, there will be a need for rapid expansion in the number of delivery sites, as the current network of ambulatory care services is already under strain and would be unable to grow to meet the increased demand.  Convenient care clinics are also able to contribute to preventive care, and offer numerous vaccines and health screening services.

In this time of heightened concern about the risk of a global pandemic, convenient care clinics also offer a front line of defense because of their unique degree of access to the public and comprehensive use of electronic health records, enhancing the ease with which data can be recorded and trends can be identified and subsequently communicated to public health officials.  Convenient care clinics are currently demonstrating their value by providing access to consumers concerned about the H1N1 (swine flu) outbreak, as well as performing diagnostic screenings and prescribing anti-viral medications as clinically appropriate.

Conclusion
 The CCA, on behalf of, with, and through its members, monitors and takes steps to address legislation and regulation that is detrimental to the interests of the industry.  To date, challenges to the convenient care industry have been largely mitigated, as the companies operating the clinics have demonstrated their consistent commitment to accessibility, affordability, and high clinical quality.  Despite its early successes and highly visible growth, the convenient care industry is still nascent and is likely to continue to face opposition.  But with consistent support from consumers, growing adoption by payers, increasing awareness among policymakers, and emerging relationships with many members of the traditional medical community, convenient care is poised to grow into an important facet of U.S. health care.
 
For more information contact the author or the CCA (www.ccaclinics.org).
Caroline Ridgway is a program and policy associate at the Convenient Care Association .  You can contact her at caroline@ccaclinics.org or (267)765-2354.

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He has lived in the world of corporate travel management and now the world of healthcare.  Oddly enough, the corporate travel world seems to know a lot more about Hal Rosenbluth than the healthcare world.  But that may be about to change.