BEFORE THE DEPARTMENT OF PUBLIC
HEALTH AND HUMAN SERVICES OF THE
STATE OF MONTANA
In the matter of the adoption of New Rules I through IX, the amendment of ARM 37.106.1130 and 37.106.1845, and the repeal of ARM 37.106.1001 pertaining to licensing requirements for outpatient facilities for primary care
NOTICE OF ADOPTION, AMENDMENT, AND REPEAL
TO: All Concerned Persons
1. On November 26, 2010, the Department of Public Health and Human Services published MAR Notice No. 37-526 pertaining to the public hearing on the proposed adoption, amendment, and repeal of the above-stated rules at page 2690 of the 2010 Montana Administrative Register, Issue Number 22.
2. The department has adopted New Rules I (37.106.1002), II (37.106.1004), III (37.106.1006), IV (37.106.1008), V (37.106.1010), VII (37.106.1014), VIII (37.106.1016), and IX (37.106.1018) as proposed.
3. The department has amended ARM 37.106.1130 and 37.106.1845, and has repealed ARM 37.106.1001 as proposed.
4. The department has adopted the following rule as proposed with the following changes from the original proposal. Matter to be added is underlined. Matter to be deleted is interlined.
NEW RULE VI (37.106.1012) MINIMUM STANDARDS FOR OUTPATIENT CENTERS FOR PRIMARY CARE: BIRTH CENTERS (1) through (1)(b) remain as proposed.
(c) establish a coordinated transfer of care through a mutually established agreement to the nearest hospital or critical access hospital that provides obstetrical and surgical services as required by the patient's acuity or the outpatient birth center 24 hour length of stay limitation.
(d) A transfer of care agreement must show that a physician who has admitting privileges at the hospital or critical access hospital that provides obstetrical and surgical services has agreed to admit and treat patients of the birthing center should the need arise. In transferring patients, the birth center shall:
(i) and (ii) remain as proposed.
AUTH: 50-5-103, 53-6-106, MCA
IMP: 50-5-103, 50-5-106, MCA
5. The department has thoroughly considered the comments and testimony received. A summary of the comments received and the department's responses are as follows:
COMMENT #1: One comment was received from the Montana Nurses Association in conjunction with the Council on Advanced Practice. These two groups were very concerned that the language as written would cause all nurse managed centers and private nurse practitioner run clinics to be under the direct supervision of a licensed physician or have to contract with a physician to provide these services.
RESPONSE #1: The department does not agree. Title 37, MCA is the chapter under which the Department of Labor and Industry provides for occupational/professional licensing. The Department of Public Health and Human Services considers advanced practice registered nurses (APRNs) and any other practitioners licensed under Title 37, MCA as exempt from health care facility licensure. In other words, if a practitioner is already licensed to practice medicine they may open a private practice or clinic without having to license as a health care facility. Any licensed practitioner can sign up and bill Medicare/Medicaid for professional services rendered.
If a licensed healthcare practitioner additionally wants to bill for a facility fee (such as for a birthing center) a health care facility license must be acquired; hence the rule for licensing "outpatient facilities for primary care". The health care facility standards are only applicable to those healthcare professionals who would seek and qualify for a healthcare facility license, in addition to their professional credentials.
COMMENT #2: One comment was received indicating support of the proposed rule.
RESPONSE #2: The department thanks the commenter.
COMMENT #3: One comment was received with regard to naming a medical director and specifying their qualifications. Additionally, this commenter indicated that the rule should include a provision requiring that the center have insurance for professional staff. The commenter further requested the following language be inserted into the rule:
(1) the medical director is a qualified physician who has current obstetrical
experience and is capable of performing cesarean sections
(2) an affiliation with their local hospital so that emergent cases can be transferred with ease
(3) the medical director has privileges at that hospital and covers these emergent cases when they present OR has an arranged coverage process in place
(4) Insurance coverage for all providers including the medical director
(5) Only certified midwives with Montana licensure are on staff at the outpatient birth center.
RESPONSE #3: The department has considered the suggested language and will not insert the language into the rule. It is not appropriate for the department to limit the duties of licensed health care professionals who are practicing within the scope of their license. It is not necessary to require the medical director to have current obstetrical experience. The rule requires the medical director to either be a medical doctor (MD) or a doctor of osteopathy (DO). Cesarean sections are not performed in outpatient centers for primary care. Therefore, requiring a medical director to be an obstetrician or surgeon would be unnecessary and burdensome for licensure of a facility. Additionally, this requirement would severely limit the number of qualified physicians who could serve as medical director, causing undue hardships for those seeking licensure as an outpatient center for primary care.
In response to the comment on transferring cases and admitting privileges, these issues are addressed in ARM 37.106.1012(1)(c) and (1)(d) respectively. The medical director does not have to have admitting privileges, but the birth center must arrange for a coordinated transfer. The department disagrees with the suggestion that insurance coverage be required for all providers. This is beyond the scope of the rules. No statute or current health care administrative rule requires insurance for any health care facility. The department disagrees with the commenter's last suggestion regarding certified midwives with Montana licensure on staff at the outpatient birth center. There are a variety of duties for licensed personnel in health care facilities. The department does not have jurisdiction to limit a nurse or any other licensed health care professional operating within the scope of their practice.
COMMENT #4: It was suggested that the department modify its proposed rule to specify that the hospital to which a birth center will transfer patients be equipped to handle obstetric and surgical emergencies. If a birth center transfers a mother and/or baby to a hospital without such capacity, the need for emergency interventions will only be further delayed until a transfer to a facility with treatment capacity can be arranged. Emergencies involving delivery services usually have a very brief window of opportunity for successful intervention. A birth center should not expect transfer to a hospital without surgical and/or obstetric services to be an adequate protection of the mother and/or the baby.
RESPONSE #4: The department agrees, but believes this is addressed in 37.106.1012(1)(c) which requires coordination of transfer of care. In licensing birth centers, the department would not approve a proposed transfer of care agreement if the designated receiving hospital or critical access hospital (CAH) was unable to provide obstetric and surgical services. However, the department has revised the rule to clarify which hospitals and CAHs are eligible for transfer agreements.
COMMENT #5: One commenter suggested that the department require a birth center to perform newborn screening services, including screening for hearing impairment as is required of other health facilities.
RESPONSE #5: The department believes it is unnecessary to amend the proposed rules to include a requirement that a birth center perform newborn screening services, including screening for hearing impairment. These functions are performed as part of the practitioner's scope of practice under Title 37, MCA. This rule package deals exclusively with the standards necessary to obtain a facility license. It is not intended to describe duties required under an individual's licensed scope of practice. Reiterating infant screening requirements in this rule serves no purpose.
COMMENT #6: One commenter recommended that the department require a birth center to report typical financial and utilization data on an annual basis similar to that collected from other health facilities.
RESPONSE #6: The department has the ability to require any health care facility to report financial and utilization data as required by 50-5-106, MCA. It is not necessary to include this requirement in administrative rule.
/s/ John Koch /s/ Anna Whiting Sorrell
Rule Reviewer Anna Whiting Sorrell, Director
Public Health and Human Services
Certified to the Secretary of State April 4, 2011