Each Patient Counts: Massachusetts Medical Society Weblog

Boston Ban on Cigarettes in Pharmacies Takes Effect

The Boston Globe's website noted today that CVS and other pharmacies have begun to comply with a new city regulation banning the sale of tobacco products in pharmacies. The regulation took effect today.

It's of interest to us, because of legislation the MMS proposed last week that would ban tobacco sales in any health care facility.

Wall Street Journal: Retail Clinics ‘Not Unlike the Dot Com Bubble’

This begins to validate our position that the breathless advocates of retail clinics have oversold their benefits, particularly with regard to saving costs. If we're looking to save costs, we have to look elsewhere. Saving a dollar or two treating a sore throat isn't going to get the job done.

Read the Wall Street Journal item.

Minute Clinics: A Final Word, For Now

It’s time for us to close the loop on this chapter of MinuteClinics.

Careful readers of the MMS’ materials over the last seven months know that we had many concerns over how CVS planned to roll out these facilities. We stated clearly that if CVS wanted to call them clinics, they should act like clinics, no matter how limited their services.

I remain unconvinced that these clinics will save money, which is the hope of good people like Rick Lord at AIM. I remain skeptical that they will augment our fragile primary care system.  I am actually worried they will further undermine it. I remain skeptical of many more things, more than I have space to list.

Perhaps this is an idea that can be tried, at least for a few years, now that the state has imposed some reasonable rules for their operations. I wish the DPH and the Public Health Council would have gone farther in its rule-making, but nothing in life is perfect.

The real story here is that our often-criticized regulatory system worked. When these clinics surfaced last spring, CVS asked for a virtually regulation-free blessing from the state. With CVS’ political and economic firepower, it would not have been a surprise if they got what they asked for.

But they didn’t. A large number of responsible individuals and groups with direct knowledge of the Massachusetts health care environment stepped forward and raised many legitimate questions that slowed what seemed like a runaway train. We made strong, reasonable arguments that the application should not be fast-tracked. Then we argued that some basic, fair regulations had to be in place. The MMS is proud of our commitment to the public health, patient safety and access to quality care. And we are proud of our role in facilitating oversight of limited service clinics. DPH Commissioner John Auerbach did a great job managing the issues, and the Public Health Council did its job, as well.

The DPH will be watching what happens over the next few years, and so will we.

Bruce Auerbach, MD
President-Elect
Massachusetts Medical Society

Public Health Council postpones vote on limited service clinics

After nearly 90 minutes of discussion on a wide range of issues, the state Public Health Council today tabled a vote on new proposed regulations governing "limited service clinics" in drug stores and other retail establishments. The Council will now vote at its January meeting at the earliest, after amendments have been added to the regulations and selected proposed regulations have been revised.

The 13-members of the newly re-constituted Public Health Council engaged in vigorous discussion about topics that focused on quality of care and public health and safety. The public health expertise and experience of the panel greatly contributed to the quality of the debate.

Among the specific issues raising questions were the capabilities and training of on-site staff to adequately address the differences between adult care and pediatric care; the conflict engendered by the sale of tobacco products in a healthcare environment; the location of toilet facilities and waiting room areas, away from the normal retail consumer traffic; the availability of back-up and follow-up care and interpreter services if needed by the patient; how referrals to additional care would be addressed; and how the Public Health Council and Department of Public Health would handle violations of regulations. 

"The focus of today's discussion," said Bruce Auerbach, M.D., President-Elect of the Massachusetts Medical Society, "clearly demonstrated the Council's deep concerns about limited service clinics in the areas of quality of care, ensuring the public’s health through sanitation and infection control, potential conflicts of interest and patient safety. The Council is to be commended for its thoughtful approach to public health policy." 

Dr. Auerbach said that the Council pinpointed some of the same issues that have been raised by physicians, hospitals, and community health centers regarding limited service clinics. 

The revised regulations presented today to the Council followed two public hearings and a public comment period in which some 50 individuals and organizations offered testimony and comment. 

DPH Commissioner John Auerbach chaired the meeting of the council and presided over the discussion. The Commissioner identified ten specific areas for further amendments to be developed prior to next month’s vote on a revised set of proposed regulations. The identified areas were:

1. Potential conflicts of interest in siting clinics in pharmacies.
2. Requirements for a more distinct waiting area to address infection control and patient privacy.
3. Whether clinics should be prohibited in stores selling tobacco or whether a disclosure posting on health impacts would suffice.
4. Services involving disrobing were prohibited but this may need further definition.
5. Adequate credentialing of practitioners and supervising physicians must be guaranteed to ensure competence of those serving pediatric and adult populations.
6. Location of toilet and janitor facilities must be more specific.
7. Hand sanitizers may be mandated, ( The new version mandates handwashing facilities specific to examination rooms.)
8. The role of the Public Health Council in reviewing complaints and license actions will be revisited.
9. The issue of referrals of patients with needs beyond those the clinic may meet and the question of payment when services may be duplicated will be addressed.
10. Systems of quality evaluation may be mandated. 

Walk-In Clinics Tie for Last Place in Canadian Satisfaction Survey

A new study in Annals of Family Medicine suggests that patients may not necessarily be satisfied with the care they would get at walk-in clinics.

The study, conducted on Ontario, Canada, measured the satisfaction levels of patients who received care at their family physician, their physician’s after-hours clinic, emergency departments, telephone advisory services, and walk-in clinics. Here are the results, on a scale of 1 to 7:

Family physician: 6.1
After-hours clinic: 5.6
Emergency department: 5.3
Telephone health advisory service: 4.8
Walk-in clinic: 4.7
More than 1 service: 4.7

It’s interesting that the much-maligned emergency department did better than walk-in clinics. The after-hours clinics in the study are staffed by physician practices on weekends and evenings, possibly the equivalent of urgent-care hours provided by many practices in the U.S.

This study was also cited in boston.com’s White Coat Notes.

Health, Safety Should Rule Clinics

By Bruce Auerbach, MD

The debate over retail health clinics in the Commonwealth is a healthy one. From the outset, when MinuteClinics filed its application to set up shop in Weymouth, to last month, when the Department of Public Health correctly recognized that the best way to evaluate this new approach to healthcare was to set new requirements for "limited service clinics" and hold public hearings on them, the pros and cons of retail clinics have been considered. This is transparency in healthcare at its best.

Proponents claim that these clinics are a key part of healthcare reform and will improve access, be convenient and affordable, and provide for continuity of care. Yet there is not sufficient evidence to support these claims.

The company's initial application was rife with requests for exemptions from state regulations on such critical issues as space requirements, infection control, and handicapped accessibility. These areas are critical to public health and safety. The regulations now under review appear to be nothing more than a conversion of this waiver application into new draft regulations to allow such clinics.

In healthcare, convenience and affordability are not always compatible with public health and patient safety. Many physicians are concerned that retail clinics, as proposed, have few provisions for sanitation and hygiene, storage and disposal of medical waste, and accommodation for the handicapped.

Further, continuity of care is not assured through such clinics. The fragmentation of care, especially for children and those who may have multiple chronic conditions, needs to be thought through carefully.

Staffing patterns are another concern. How many nurses will a supervising physician oversee? With CVS recently announcing its intention to open as many as 60 to 80 such clinics in the first year, what will be the guidelines for physician supervision of nurse practitioners? How many clinics and what geographical areas will a physician be responsible for?

And then there is the the inherent conflict of interest, where patients can obtain medications and prescription drugs from the same profit-making organization engaged in diagnosing and prescribing - something tacitly prohibited for physicians and hospitals. Prescription errors have increased in Massachusetts, and the Food and Drug Administration has reported that it has received 2 1/2 times more reports of serious health problems linked to medications in 2005 than it did in 1998.

As an emergency physician, I believe that the argument that such clinics will improve the capacity of the state's healthcare system by diverting patients from emergency departments is a hollow one. Emergency departments always focus on genuine emergencies. Any crowding that exists is not related to patients with minor ailments, but rather inadequate inpatient resources to efficiently transfer patients from the emergency department for more extensive services.

Will these clinics lower healthcare costs? While the cost per visit at such a clinic is less than other venues, there is not sufficient data to support the assertion that they are either a replacement for a more expensive visit at a different site of service, or whether the problem was so minor that the costs would have been incurred at all.

The Department of Public Health and its newly reconstituted Public Health Council are wise to proceed cautiously, through a public process, in developing regulations. Limited service clinics can perhaps play a role in enabling access for a small array of minor problems. But many physicians believe their role must be specifically stated and monitored, their integration and collaboration with the existing healthcare delivery system assured, and their participation in facilitating enrollment into our universal healthcare process mandated.

Good health policy dictates that medical clinics be established with health and safety as the top priorities and not because they demonstrate a good "business model." This is not a competitive or "turf" issue for physicians. Above all else, it's an issue of public health and safety. We must put more value on the practice of medicine and patient safety than to driving traffic into stores and selling prescriptions.

Bruce Auerbach, MD
MMS President-Elect

This op-ed appeared in the Boston Globe on Sept. 18, 2007.

Asking the Right Questions: State Releases Draft Rules for Minute Clinics

The state Public Health Council yesterday released a complex proposal to regulate the operation of "limited services clinics." CVS hopes to open the first of these clinics in Massachusetts under its MInute Clinics brand.

We are still looking carefully at the proposal, and it's too early to share our specific comments. The hearing is Sept. 5. However it's fair to say that we will continue to study them through the lens of whether they address the quality, health and safety, and continuity of care issues we raised earlier.

To our eyes, the Public Health Council is asking the right kinds of questions. The Globe's article today covered the issues pretty well. Like the council's members, we're keenly interested in how the clinics will maintain quality of care, and how they will integrate with the rest of the health care system, as imperfect as the system is. They could provide something valuable. We would like to see the clinics improve the delivery of care in the system, not aggravate the dysfunctional aspects that we all quite familiar with.

Frank Fortin
Communications Director

MMS Comments on Minute Clinics at Board of Medicine

Bruce A. Auerbach, M.D., president-elect of the Massachusetts Medical Society, delivered these remarks today (July 25) at a public meeting of the Board of Registration in Medicine on the application of Minute Clinics to open a limited health clinic at a CVS store in Weymouth:

The Medical Society and the physicians of Massachusetts welcome innovations in health care. We need innovations in our health care. We all know that much in our current health care delivery system is dysfunctional. Therefore, the only intellectually honest position to take – especially in a state which is committed to making care accessible to everyone – is to support innovation. But those innovations must ensure safety, improve the quality of care, and deliver care efficiently and in a coordinated manner.

My brief comments today will focus on only two areas – the supervision of the care delivered and the continuity of care after a patient encounter at one of these facilities.

First, on the supervision of care:

The business model of the Minute Clinic is to have nurse practitioners deliver all, or almost all, of the care. Certainly, for the limited scope of conditions that these clinics are designed to accept, this is not inappropriate, on its face. Nurse practitioners have adequate training to treat many of the conditions outlined in the original application to DPH. I have great respect for and value the skills of nurse practitioners. In fact, they are used extensively in the delivery system in which I practice.

Training is not our issue – collaboration and supervision is. The original application by Minute Clinics outlined – and I stress “outlined” – an arrangement that does not appear to ensure the integrated high-quality care for which we strive. 

In what most consider the ideal model, the one that ensures quality, safety and continuity, the nurse practitioner has constant, ready access to their supervising physician. The patient also knows with which physician their nurse practitioner has a supervising relationship and to whom they can turn for issues beyond the scope of the nurse practitioner.

In other words, there is a physician-patient relationship and accountability. In many cases, these providers are in practice in close physical proximity to each other, again supporting the collaborative, consistent relationship and the consultative, supervisory role. This type of model supports quality, safe practice.

Patients do not present with a diagnosis, similar to the list of “accepted” problems for the retail clinic. They present with complaints. Every patient who presents with a sore throat does not have Streptococcus pharyngitis. Every patient presenting with red eye does not have simple conjunctivitis. Having the ready, consistent access to a physician colleague helps ensure that the sore throat that is a peritonsillar abscess and the red eye that is a herpes lesion are not missed. My 25 years of experience working alongside physician assistants and nurse practitioners has provided me with more than anecdotal examples of similar cases.

The Minute Clinic model does not attempt to mirror this ideal model nor does it appear to even meet the standards that this Board has supported in other instances when physicians who are not always on site are called upon to supervise care by nurse practitioners. The current standards not only create a mandate for a consistent supervisory relationship with the nurse practitioner, but support the link between the patient and the supervising physician.

This does not appear to be the case with the Minute Clinic model, where the physician seems to be responsible for only a sampling audit of the nurse practitioner’s activity. There does not appear to be any attempt to establish a relationship with the patient or be available for consultation. We believe the relationship intended by the Board’s standards is the one that is in the best interest of safe, high quality patient care. It should not be altered. 

Second, some comments on how these clinics should relate to the rest of our health care system.

One of the historic scourges of our health care delivery system has been its fragmented nature. Thankfully, we are starting to make some headway in reversing this direction. Chapter 58 promises to bring us even closer to our objective of providing care along an effective, efficient continuum to every resident of our Commonwealth.

One example is the concept of the Advanced Medical Home, proposed by the American College of Physicians. It’s an excellent step in the right direction. It includes a large role for nurse practitioners in settings like this – but in close association with the physician’s practice. A number of pilot programs for the Advanced Medical Home could be implemented in the Commonwealth within the next year.

Some questions that might be posed are:

• Who will be responsible if the patient worsens after their Minute Clinic visit?
• How will the entity assuming any follow-up care, scheduled or otherwise, be made aware of the evaluation and treatment rendered by the clinic.
• Will records at the, now closed, retail-based clinic be available for those providing after hours follow-up care?
• How will follow-up or more extensive care be facilitated if the patient does not have a primary care physician?

This is just a small sampling of the types of issues that concern provider groups with the proposed model. To reiterate, these are all issues with the potential to impede our progress towards the most integrated, comprehensive, coordinated, safe and high quality health care system we can devise. 

Without significant changes in its plans for physician supervision and connecting to the larger health care community the Minute Clinic model would be a step backwards, in the wrong direction -- towards more fragmentation, and away from collaboration and continuity of care. This model would undo much of the progress that the Board, our hospitals, and our physicians have made to ensure that care is not only effective, but efficient, coordinated and patient-centered.

Mini-Clinics: Not So Fast!

CVS has announced plans to open 20 to 30 "mini clinics" throughout the state.

At first glance, these “mini-clinics” may seem like a good idea: convenience, extended hours, multiple locations, no long lines in emergency departments, no long waits for appointments with primary care physicians.

Not so fast.

Concern #1: Safety. We’re worried that medical care will be delivered without the knowledge of the patient's primary care physician and without the knowledge or availability of a patient's medical history. This raises the risk of medical error. Elderly persons with multiple chronic conditions, on multiple prescriptions, are even more challenging.

Concern #2: They could kill our fragile primary care system. Our primary care network is already in crisis. Allowing mini-clinics to skim the easy, less complex patients might be the death knell of primary care, and our community health centers, too. Who would pick up the slack if that happens? Our emergency departments, of course, which are already over capacity. In other words, these clinics could replace what already exists -- with something worse.

Concern #3: Conflict of interest. It’s an inherent ethical conflict when a pharmacy is located at the same site as a primary care clinic, owned by the same company. There’s good reason why most doctors can’t dispense drugs in their own offices; the same reasoning applies to mini clinics like these.

We don’t think the Department of Public Health should allow mini-clinics to cut corners on good standards that serve the public well. If such organizations want to establish clinics, they should be subject to the same rules and regulations that govern other, designated sites for medical clinics.

Kenneth Peelle, MD
MMS President