QUESTION: Are there new Medicare Conditions of Participation (“COPs”) for hospitals and critical access hospitals (“CAHs”)?
ANSWER: Yes. As background, on March 4, 2020, CMS issued guidance stating that hospitals should inform certain individuals and entities regarding persons who have COVID-19. This week, as alluded to in Your Government at Work, CMS issued an interim final rule (“IFC”) which requires hospitals and CAHs to report data regarding COVID-19 in a standardized format. The new COPs are at §§ 482.42(e) for hospitals and 485.640(d) for CAHs, and the purpose is to track the incidence and impact of COVID-19 to help public health officials detect outbreaks.
The IFC emphasizes that the new COPs “do not relieve a hospital or a CAH, respectively, of its obligation to continue to comply with §§ 482.42(a)(3) or 485.640(a)(3), each of which requires a facility to address any infection prevention and control issues identified by public health authorities.”
The new COPs will become effective once the IFC is published in the Federal Register.
QUESTION: The five medical staffs in our system are thinking about unifying. Are there any particular steps we need to follow and any changes we need to make to our bylaws?
ANSWER: In May 2014, CMS revised the Medicare Conditions of Participation to allow a multi-hospital system to have a unified and integrated Medical Staff. There are several steps that must be taken in the integration process. First, the system must ensure that there is nothing in the state hospital licensing statutes or regulations that would prohibit the medical staffs of separately licensed hospitals from integrating into a single staff.
Second, the Board (and there must be a single Board) must document in writing its decision to use a unified medical staff model. This decision would be conditioned on acceptance by the hospitals’ medical staffs to opt-in to an integrated medical staff model.
Third, the medical staff of each of the hospitals must take a separate vote to opt in or opt out of the unified medical staff. The vote at each hospital must be governed by the respective medical staff bylaws in effect at the time. Only voting members of the medical staff who hold privileges to practice on site at the hospital may participate in the vote.
Fourth, the unified medical staff will also want to adopt new medical staff bylaws and related policies. The new bylaws should take into account the unique circumstances of each hospital, including any significant differences in the patient populations and the clinical services that are offered at each hospital.
Importantly, the new bylaws must also include a process by which the voting members of the medical staff who exercise clinical privileges at the hospital may vote to opt out of the unified medical staff in the future.
QUESTION: Are two Critical Access Hospitals (“CAHs”) allowed to unify their medical staffs?
ANSWER: No. Moreover, as CMS made clear in analyzing the comments it received to the proposed regulations related to unified QAPI and infection control programs in the final version published on September 30, 2019, there are other limits: “One commenter requested that CMS include ‘affiliate’ and CAHs in the unified and integrated QAPI and infection control requirements.” CMS responded:
A CAH must be separately evaluated for its compliance with the CAH CoPs (found at 42 CFR part 485, subpart F), which would not include the requirements included in this section of the rule since these are hospital CoPs. It would not be possible to evaluate the CAH’s compliance as part of an evaluation of a hospital’s compliance. However, this does not preclude a multi-hospital system’s single governing body from also serving as the CAH’s governing body, so long as the governing body clearly identifies the policies and decisions that are applicable to the CAH. 84 Fed. Reg. at 51742.
However, CMS stated that it encourages CAHs to “work with other hospitals or CAHs in their network (if available) for pharmaceutical support” (among other resources) in dealing with the revised antibiotic stewardship requirements. 84 Fed. Reg. at 51783.
The regulations pertaining to CAHs are just a small part of the entire set of regulations.
Join Charlie Chulack and Joshua Hodges for a special audio conference entitled:
“Patients Over Paperwork”?
The New CMS Rules and Their Impact on Your Patients and Policies
October 29, 2019
1:00 to 2:30 pm (ET)
They will discuss the key points in these new regulations, particularly those that affect Medical Staff Rules & Regulations and policies, and revisions you should think about now.
And stay tuned for another special audio conference coming in 2020 on Medical Staff basics for Critical Access Hospitals.
QUESTION: What are the responsibilities of our hospital’s Board of Directors (“Board”) with regard to oversight responsibilities of the Medical Staff?
ANSWER: Although it is important to check your state laws and standards set forth by your accrediting organization, a good starting point would be to refer to the Medicare Conditions of Participation (“Medicare CoPs”) pertaining to the Board’s responsibilities, including its oversight responsibilities of the medical staff. For instance, the Medicare CoPs place the ultimate responsibility for quality of care provided at a hospital and monitoring the care provided to patients on the Board. Among others, the Medicare CoPs require the Board to define criteria for and appointing members to the medical staff, grant clinical privileges, ensure the existence and approval of medical staff bylaws, and approve various services in the hospital. Ultimately, the Board holds the responsibility for the quality of patient care in the hospital. The Board and medical staff engage to provide effective credentialing, privileging, and peer review and quality management processes.
Although responsibilities provided by the Medicare CoPs are extensive, do not forget to consult your applicable state laws as well as the standards of your accrediting organization, which may dictate further oversight responsibilities of the Board.
QUESTION: A patient is asking the hospital staff to allow him to use medical marijuana that he obtained in compliance with state law. Should we let him?
ANSWER: This is a tough question especially in light of the recent, increased, legal acceptance on a state level of both medical and recreational marijuana. The patient in the question is claiming that he obtained the medical marijuana in compliance with state law. In such a situation, you should ask yourself a number of questions. First, does your state law protect facilities or staff that permit medical marijuana use? For example, Maine law states that hospitals and staff members will not be liable for facilitating the use of medical marijuana by certified, admitted patients, as long as the marijuana is not smoked or vaped. Second, does your state law require a hospital to accommodate a patient’s use of medical marijuana? Minnesota has a law on the books that says, in part, “no [health care] facility shall unreasonably limit a patient’s access to or use of medical cannabis to the extent that use is authorized by the patient.”
Even if the answer to these first two questions is “yes,” you have to ask yourself if you are willing to accept the legal risk under federal law. Marijuana is a Schedule 1 controlled substance under the federal Controlled Substance Act. Regardless of state laws to the contrary, it is still a violation of federal law to manufacture, possess or prescribe marijuana for either medical or recreational purposes. The Medicare Conditions of Participation (“COPs”) for hospitals state “drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.” The COPs do not anticipate that Schedule 1 controlled substances will be stored or distributed in hospitals. The applicable regulations and the Interpretive Guidelines to the COPs only refer to Schedule 2-5 substances.
Some hospitals have accepted the risk and permit patients to bring their own medical marijuana into the hospital for administration. At least one of those hospitals has put the following safeguards in place:
- Hospital staff (such as nurses and pharmacists) are not permitted to assist with dispensing or administering medical marijuana. The drug must be self-administered.
- The hospital is required to verify that the patient is registered with the state’s medical marijuana program.
- The hospital must provide a safe for the storage of medical marijuana in the patient’s room. Hospital employees do not access the safe or handle the medical marijuana at any time.
- The medical marijuana must be in liquid or capsule form, and must have been provided by an in-state dispensary.
That being said, such safeguards do not protect you from CMS disapproval or sanctions. Although it is a fascinating topic with numerous legal issues to consider, the fact is that marijuana continues to be a Schedule 1 drug under federal law. Consequently, there is risk that CMS could take action based on the COPs.
QUESTION: Our hospital policies allow almost anyone to order outpatient services, regardless of whether they are a member of the Medical Staff or not. Is this a problem?
ANSWER: This poses compliance issues under the Medicare Conditions of Participation (“CoPs”). The CoPs only allow outpatient services to be ordered by practitioners who meet certain conditions. The ordering practitioner must be (1) responsible for the patient, (2) licensed in the state where he or she provides care to the patient, (3) acting within his or her scope of practice under state law, and (4) authorized by state law and policies adopted by the Medical Staff (with approval from the governing body) to order the applicable outpatient services.
Your Medical Staff policies can reflect a determination as to whether practitioners who are not on your Medical Staff are permitted to order outpatient services. However, these policies must address how you will verify that the referring/ordering practitioner meets the requirements in the CoPs. You will need to keep documentation to show that you have complied with the CoPs (e.g., documents showing that you checked the ordering practitioner’s license).
If you permit allied health professionals not affiliated with your hospital to order outpatient services, you may have to do a significant amount of work. Be sure to check their scope of practice to make sure they are permitted to order the service in question. In addition, be sure to follow the laws of your own state!
You may decide that certain orders should be permitted only by individuals with specific hospital privileges. The Interpretive Guidelines give the example of requiring practitioners to have hospital privileges before they can place an order for outpatient chemotherapy services. If you do this, be sure to delineate these terms clearly in your policies.