Public Health and Health Planning Council Releases Ambulatory Care Services ReportNovember 30, 2013 |
The New York State Public Health and Health Planning Council (the “Council”) recently released a draft report on ambulatory care services, including most notably a discussion of retail clinics, urgent care centers, and freestanding emergency departments. The report was reviewed at a full meeting of the Council on December 12th, and is slated to be further discussed at meetings on January 7th and February 12th. The report recommends changes to the legislative and regulatory levels of ambulatory care services, indicating that the complete reform proposed in the report may take some time to fully implement if it is approved by the Council. The proposed changes would create Retail Clinics, eliminate Upgraded Diagnostic and Treatment Centers, set forth new requirements for Urgent Care Clinics and Free-Standing Emergency Departments (“FEDs”), and address other services, including radiation therapy and advanced diagnostic imaging.
Retail Clinics are generally small offices that are located in pharmacies, supermarkets, and “big-box” stores like Costco or Sam’s Club, and have become fairly common in some states. They are easily accessible and offer basic health care services for minor ailments, and may also include wellness screenings. A limited number of retail clinics already exist in New York, but are considered physician offices and as such are not regulated by the Department of Health. The report recommends changing that by providing detailed recommendations for statutory and regulatory changes that would more carefully regulate Retail Clinics and place them under DOH oversight. For example, the clinics would be referred to as “Limited Service Clinics” to denote the limited nature of the services provided and would be classified under Article 28 of the Public Health Law. The scope of services provided at these Limited Service Clinics would be limited to services that can be provided based on a medical history and limited physical examinations, as well as vaccinations for adults (children would be prohibited from receiving vaccinations at Limited Service Clinics to promote interaction with their pediatricians). They would also be required to receive accreditation from a designated third party and accept Medicaid. They would not be allowed to perform venipuncture, but at the December 12th meeting there was discussion of allowing Limited Service Clinics to perform CLIA-approved testing. Limited Service Clinics would not require a Certificate of Need in order to be established. Additionally, in the report, the Council reiterated that it would suggest an exception to the corporate practice of medicine prohibition to allow Limited Service Clinics to be run by corporate entities, a right that is currently reserved only in very limited circumstances in New York.
Urgent Care centers are already common throughout New York, though the Council expressed concern about the breadth of services provided between different Urgent Care centers. As it currently stands, doctor’s offices or Article 28 facilities that refer to themselves as “Urgent Care” facilities may be open a range of different times and provide varying treatment and diagnostic services, which the Council worries has led to significant consumer confusion in the use of Urgent Care facilities. While the Council has not specifically called for the imposition of either licensure or Article 28 certification, it has recommended licensure within the class of the clinic and third party accreditation, including an Office Based Surgery accreditation if any procedure that requires more than minimal sedation is to be performed. The Council is also considering requiring Urgent Care centers be open at least 12 hours on weekdays and 8 hours on weekends, accept unscheduled walk-in visits, and provide a significantly higher level of services than Limited Service Clinics. Urgent Care clinics would also require signage that indicates the scope of services provided by the Urgent Care center and prohibit the use of the term “emergency” in the center’s name so as to help avoid consumer confusion.
FEDs provide the highest level of care of the three ambulatory service centers discussed thus far. They provide the full scope of emergency services one would expect in a hospital setting, and may even have an inpatient bed or two for patients that need overnight observation. Most notably, the Council recommended that FED development be limited to hospital-owned FEDs. There had been discussion earlier in the process of allowing Urgent Care centers to “upgrade” to FEDs, but such a step was not included in the draft report. All aspects of the FED must be part of the hospital that operates it, such as the medical staff, nursing staff, governing body, and medical records being all part of the controlling hospital’s “single organized” staff and system. FEDs would not be required to be available 24/7 as they are currently, though they would continue to need a CON to operate and would need to be accredited by a third party. There was significant debate at the December 12th meeting regarding the benefits of permitting FEDs to operate less than 24/7, and it seems possible that recommendation may change before the report is finalized.
The report addressed other issues in addition to the three levels of ambulatory service centers discussed above. The report proposed eliminating Upgraded Diagnostic and Treatment Centers, which the Council acknowledged has never been as effective as planned (there are currently none operating in New York) and may now be obsolete in light of the new proposals for Urgent Care centers and Limited Service Clinics. The report also addressed “Advanced Diagnostic Imaging,” which it classified as MRI, CT, and PET scans, and which the Council stated may be prone to over-utilization. Consequently, the Council proposed enacting regulations that would allow for it to collect and analyze data on the use of Advanced Diagnostic Imaging so that three years from the start of collecting the data it can evaluate if a Certificate of Need is necessary for such services.
Finally, the Council, upon the advice of the Office Based Surgery (“OBS”) Advisory Group, proposed amending PHL 230-d, which regulates OBS. The amendment would broaden the premise of the law, loosen the requirements in some areas (such as expanding the scope of providers who can provide OBS and limiting recovery time requirements) while expanding it in others (including sharing information with the appropriate regulatory authorities).
Indeed, the Council’s report proposes some significant changes to the ambulatory services landscape, and is already having an effect on those services. For example, a large health system recently announced that it would halt previous plans to build a FED until the Council’s report was finalized and action was taken regarding FEDs. The January 7th and February 12th Public Health and Health Planning meetings should shed more light on this evolving landscape.