On April 1st, the Department of Health and Social Services (“DHSS”), through the Office of Health Facilities Licensing and Certification, published proposed regulations governing accreditation standards and safety and sanitation standards that, if implemented, would apply to all medical offices, dentist offices and podiatry offices where certain invasive procedures are performed. Physicians, dentists, and podiatrists who perform even minor medical procedures in their offices while utilizing “any level of anesthesia” should carefully review the regulations, as the Delaware health care community will undoubtedly be surprised by the proposed new requirements that may soon apply to these practices.
Anyone interested in these regulations may submit comments and concerns to the DHSS in writing on or before April 30th. We feel there is a great deal to be concerned about.
The regulations were drafted as a result of House Bill 47 and House Bill 144, which require the DHSS to establish standards with respect to safety and sanitary conditions and to establish standards for a facility accreditation program, respectively. While these bills provide a framework for the DHSS’s regulations, the agency’s proposed regulations seem to go further than the General Assembly intended. The regulations would apply to “medical facilities” that perform “invasive medical procedures” utilizing “any level of anesthesia.” (Any facility already licensed pursuant to Title 16 such as ASCs, freestanding emergency centers, or freestanding birthing centers are exempt). A “medical facility” explicitly includes the office of a physician, dentist, podiatrist, group practice or clinic. “Invasive medical procedures” are defined broadly, including any procedure structurally altering the human body by the incision or destruction of tissues. “Any level of anesthesia” shall include local anesthesia, nitrous oxide inhalation, minimal or moderate intravenous, intramuscular or rectal sedation, deep sedation, general anesthesia, or major conduction blockade.
These regulations have potentially far-reaching applicability in the Delaware medical community. Even health care practices that perform such procedures on an infrequent or limited basis, will be bound by these regulations. Any health care practice meeting these definitions would be required to be accredited by an outside accrediting agency within six months of the effective date of the regulations. The regulations propose standards with respect to safety and sanitary conditions and they attempt to define the accreditation process for such facilities. However, to our knowledge no accrediting agency or company has yet been approved. The cost and timing of the accreditation process remains unknown. However, anyone who has been through an accreditation process will certainly appreciate the unlikelihood of completing that process within the timeframe provided.
Beyond the challenges of accreditation, the regulations prompt unanswered questions, and may produce potentially troubling application of the law. One significant concern is that the proposed regulations would make physician/dentist/podiatrist quality of care a basis for discipline. In other words, as currently written, these proposed regulations would give the DHSS the right to impose discipline for quality of care concerns that are unrelated to the types of environmental concerns, such as environmental safety and sanitary concerns, that prompted the General Assembly to enact these laws. For example, the proposed regulations define certain predicate events (“adverse events”) that impose a duty to self-report to the DHSS. Some of these “adverse events” are clearly aimed at physician/dentist/podiatrist behavior, as opposed to safety and sanitary conditions. Facilities subject to these regulations would have to report any suspected abuse, neglect, or mistreatment, the admission of the patient to another facility due to complications, and serious cardiovascular events.
What kind of discipline would the DHSS be able to impose? Under the proposed regulations, the DHSS would have authority to impose any order it “deems necessary to protect the public health,” including the authority to close a facility, even prior to a hearing. This is the most troubling aspect of the proposed regulations. It may seem unimaginable that the DHSS would unilaterally close an entire health care practice, but as currently written, these proposed regulations allow that to happen. Patients of a medical practice need to be seen for a variety of services, including evaluation and management. Concerns related to the performance of minimally invasive procedures should not be a basis for shuttering an entire practice.
Now is the time to act. It is imperative for Delaware health care providers to review the regulations and consider how they may affect their practices if finalized. If no one voices concern, these regulations are likely to be finalized. Again, comments must be submitted to DHSS by Tuesday, April 30. Feel free to contact us to share your concerns.
The regulations may be viewed in their entirety at: http://regulations.delaware.gov/register/april2013/proposed/16%20DE%20Reg%201033%2004-01-13.htm