The Centers for Medicare and Medicaid Services (CMS) issued its final rule revising the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) on May 16, 2012, in response to the President's Executive Order instructing federal agencies to streamline the regulatory framework for hospitals. These regulatory reform initiatives are anticipated to achieve $940 million in savings per year. Although the expressed intent of the proposed rule, issued on October 24, 2011, was to simplify and clarify certain CoPs for the hospital industry, the final rule appears to have made what amounts to substantive changes that drew the immediate ire of the hospital industry.
In one of the most striking changes, CMS requires that a member or members of the hospital's medical staff be included in a hospital's governing body as a means of assuring communication and coordination between a single governing body and its medical staffs. This appears to be in response to several comments, as described in the preamble to the regulations, which request more medical staff membership representation on the governing body of hospitals and a need for greater communication. In addition to this new requirement, the preamble to the regulations muddied the water with regard to a provision that the hospital industry believed was settled, reinterpreting an existing medical staff provision to prohibit a health system from having a single and integrated medical staff serving more than one hospital.
Interestingly, CMS could have chosen to issue interim final regulations, allowing for at least some additional commentary with regard to such substantive changes, but they did not, opening the agency up, it seems, to some very threatening language from the American Hospital Association (AHA) regarding CMS's alleged violation of the Administrative Procedures Act (APA). To that end, AHA submitted a strongly worded letter protesting both substantive changes in the final rule, indicating that they substantially changed the current practice in many hospitals around the country and, in some cases, could not be implemented due to existing state laws. Issuing such substantive changes in final form without the benefit of notice and comment would form the basis for an action under the APA.
Prompted by concerns raised by the AHA and other stakeholders, CMS issued a notice on June 15, 2012, to the State Survey Agency Directors referencing the "numerous questions and concerns raised by various stakeholders" relating to the requirement to include a medical staff member on the hospital's governing body. Recognizing that the requirement could give rise to questions under federal, state and local laws, CMS wrote in its notice, "Given the complexity of the issues that have been raised, we are carefully reviewing comments and will reconsider this requirement in future rulemaking." In addition, the agency said CMS-approved hospital accreditation programs are not expected to revise standards or survey processes related to the requirement "until we have addressed the issue completely."
The final rule impacts several CoPs and makes changes including:
- Changing requirements relating to restraint-related deaths;
- Broadening the concept of a "medical staff," allowing hospitals the flexibility to include other practitioners as eligible candidates (drawing a significant letter-writing campaign in proposed form from the anesthesia community);
- Allowing podiatrists to assume new leadership roles within the hospital, if so chosen;
- Allowing hospitals to have a single nurse care plan;
- Changing the self-administration policies as they apply to patients;
- Eliminating the special training requirements for nonphysician personnel to administer blood transfusions and intravenous medications;
- Making changes relating to orders by other practitioners;
- Allowing for drugs and biologicals to be prepared and administered on the orders of practitioners (other than a doctor) in accordance with hospital policy and state law;
- Making changes regarding proper use of standing and verbal orders;
- Eliminating the obsolete requirements for a hospital to maintain an infection log;
- Eliminating the requirement to have a separate outpatient services director;
- Simplifying organ transplantation verification requirements; and
- Eliminating the requirement that CAHs must furnish diagnostic and therapeutic services, lab and other services directly by CAH staff.
The final regulations should be reviewed by hospitals to ensure their continued compliance with the CoPs and to determine whether some existing processes can be modified to accomplish the intended goal of eliminating overly burdensome regulations.
In their verve to save hospitals time and money, however, CMS has created some controversial changes that have yet to be removed, but at least will not be implemented until a more thorough review and analysis can be conducted.