State Legislative Conference

Spread of For-profit Medicine May Pose Patient Safety Threat

December 03, 2014 08:19 pm Michael Laff New Orleans –

Patient care services being offered by nonphysician health care professionals or in nontraditional settings in a number of states have sparked concern in the medical community that they may not be subject to appropriate state oversight.

North Carolina AFP EVP Greg Griggs discusses the growth of retail clinics in his state and how they continue to expand their range of services despite early promises to the contrary. Griggs spoke during the 2014 AAFP State Legislative Conference in New Orleans.

During the Academy's 2014 State Legislative Conference, AAFP chapter representatives from North Carolina, Michigan and Colorado addressed this issue, telling chapter leaders and staff who attended the meeting about their efforts to educate both the public and state officials about the spread of these services and the potential patient safety hazards they pose.

Tracking the "Retailization" of Health Care

North Carolina AFP EVP Greg Griggs, M.P.A., C.A.E., addressed the rapid rise of retail clinics in his state and the changes these clinics have instigated in recent years. The state's first Minute Clinic opened in the Raleigh area in 2005. At the time, company representatives specified that the range of services the clinic would provide would be narrowly focused on allergies, sinus conditions, strep throat and vaccinations. CVS Corporation (now CVS Health) bought the company in 2006.

In subsequent meetings with the North Carolina AFP, the North Carolina Medical Society and others, Minute Clinic representatives told the groups that the clinics would be staffed by nurse practitioners and physician assistants and that a physician located no farther than one hour away would serve as medical director for the clinics. The chapter later learned, however, that the organization's first medical director was licensed to practice in North Carolina but actually lived in Las Vegas.

"That was the first hint that they were not telling us the whole truth," Griggs said.

Story highlights
  • During the 2014 AAFP State Legislative Conference, state chapter leaders addressed various patient safety issues, including retail pharmacies in North Carolina that are providing patient care services with no physician on-site.
  • In addition, pharmacists in Michigan are offering patients rapid diagnostic testing without physician supervision and then prescribing medication based on the results.
  • In Colorado, free-standing emergency clinics are able to operate without having to follow the same rules as ERs that are affiliated with a hospital.

Other concerns soon began to crop up, according to Griggs. For example, the clinics had said they would send patients' electronic health records to their primary care physicians, but in the rare cases when the records were sent to a physician, that transmission was by fax, he said.

This lack of care coordination is specifically addressed in the AAFP's policy on retail clinics, which cautions that care delivered in this setting can lead to the continued fragmentation of care "unless it is coordinated with the patient's primary care physician's office."

By 2009, CVS' Minute Clinic operations had expanded from 15 to 30 clinics, and the sites started offering services such as sports physicals and chronic disease monitoring. Eventually, Minute Clinic applied to become a Medicaid provider, but state officials turned the request down.

The geographic areas in which the clinics chose to locate also generated some consternation among members of the North Carolina medical community, Griggs said. Rather than open sites across the state or in areas with reduced access to care, the company now operates 58 clinics primarily in urban areas in which incomes are higher, including five sites in the prosperous Research Triangle area.

"This is a business model, not a health care model," Griggs observed. "I don't think the 'retailization' in health care will go away. There's too much opportunity."

Retail clinics are appealing, Griggs noted, because they offer patients the convenience of obtaining medical services where and when they want on short notice. "We have to change the way we deliver care and go to the medical home model," he concluded. "We have to think of our patients as customers and not just patients. That's what CVS is doing."

The Pharmacist Will See You Now

In another development involving retail drug stores, pharmacists in some states now are administering patient screening tests, making diagnoses and providing treatment -- all with virtually no physician supervision.

A nine-month pilot project that funded health screenings by pharmacists was recently completed in Michigan, Minnesota and Nebraska. Known as rapid diagnostic testing, or RDT, the service is offered by pharmacists.

The pilot is being supported by the University of Nebraska Medical Center College of Pharmacy and Michigan's Ferris State University. The Michigan Pharmacy Association offers a 20-hour certification course in rapid diagnostic testing to train pharmacists on the procedure.

Debra McGuire, Michigan AFP chapter executive, discusses how pharmacists in Michigan are offering rapid diagnostic testing to patients with limited involvement from physicians.

RDT by pharmacists has already proven to be a contentious issue among family physicians in Michigan. During the 2014 AAFP Congress of Delegates, the Michigan AFP introduced a resolution that called for greater exchange of information among the states about the problem and development of a strategy to mitigate its spread.

After considerable debate, the measure was referred to the AAFP Board of Directors, which will closely scrutinize and decide how to act on the issue.

Debra McGuire, CEO of the Michigan AFP, told attendees at the state legislative meeting that a report on the initiative's outcomes is expected by the end of 2014, but she decried the fact that it was developed and implemented without input from family physicians.

In pharmacies where the testing was available, physician supervision was minimal, with a single physician being responsible for 27 pharmacies that were participating in Michigan. During the pilot phase, testing focused on strep throat and influenza. During the next phase, however, testing will be offered for HIV, hepatitis C infection, Helicobacter pylori infection and mononucleosis. During the pilot phase, each test was provided at no charge but will cost patients $25 going forward.

Ultimately, "It's just a matter of time before they start expanding services not just for acute care but for chronic conditions," McGuire said.

"(Those implementing the pilot) are saying that they can solve the problems that we have because of the shortage of primary care doctors," said McGuire. But the actual end result will be further exacerbation of the problem of fragmented care, she noted, because use of the tests leads to misdiagnosis, duplication of care and lack of continuity.

And although McGuire said she has opened up conversations with state public health officials about those adverse consequences, generating documentation about negative health outcomes has proven difficult because of privacy rules instituted by the Health Insurance Portability and Accountability Act.

Free-standing Emergency Clinics Proliferate in Colorado

Meanwhile, the Colorado AFP has been dealing with a different regulatory issue: a loophole in Colorado law that allows independent, free-standing emergency departments to operate according to rules different from those to which hospital-based ERs must adhere. The chapter has tracked the expansion of these free-standing facilities and met with state officials in an attempt to introduce greater regulation of their operations.

Colorado law permits the existence of the independent facilities primarily to improve access in the state's rural corners and make emergency services available at numerous ski resorts. Operating as for-profit institutions, they are defined as community clinics but are not affiliated with a hospital and so are not required to comply with the same regulations as hospital-affiliated ERs, such as accepting all patients or stabilizing patients before they are transferred to another health institution.

Medicare and Medicaid do not recognize the clinics and will not reimburse for their services. The state is home to a high population of military veterans but they cannot receive treatment at the free-standing facilities.

"They tout themselves as being able to do everything an emergency room facility can do, but there are many things they can't do, like blood transfusions," said Jeff Thormodsgaard, a lobbyist with Mendez Consulting who advises the Colorado AFP. And now, the for-profit clinics are expanding their reach into areas that don't have limited access.

Aside from the questions about care, patients could face much higher costs because the clinics do not negotiate rates with insurance companies and do not wish to, Thormodsgaard said.

"A set of stitches that could have cost $50 from a family physician or a regulated ER costs $3,000, and insurance will only pay 40 percent," he said.

A large coalition of medical associations in Colorado have banded together to support draft legislation that would have introduced tighter control over the free-standing clinics. To date, however, state legislators have rejected strict regulation of the sites, saying such measures represent an unfair restraint of trade.

Given the high stakes -- both for patient care and for overall costs to the health care system -- it's an issue that will continue to command the chapter's attention, said Thormodsgaard.