In this subtitle the following words have the meanings indicated.
“Ambulatory surgical facility” means any center, service, office facility, or other entity that:
Operates exclusively for the purpose of providing surgical services to patients requiring a period of postoperative observation but not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following admission; and
Seeks reimbursement from payors as an ambulatory surgery center.
“Ambulatory surgical facility” does not include:
The office of one or more health care practitioners seeking only professional reimbursement for the provisions of medical services, unless:
The office operates under contract or other agreement with a payor as an ambulatory surgical facility regardless of whether it is paid a technical or facility fee; or
The office is designated to receive ambulatory surgical referrals in accordance with utilization review or other policies adopted by a payor;
Any facility or service owned or operated by a hospital and regulated under Subtitle 2 of this title;
The office of a health care practitioner with not more than one operating room if:
The office does not receive a technical or facility fee; and
The operating room is used exclusively by the health care practitioner for patients of the health care practitioner;
The office of a group of health care practitioners with not more than one operating room if:
The office does not receive a technical or facility fee; and
The operating room is used exclusively by members of the group practice for patients of the group practice; or
An office owned or operated by one or more dentists licensed under the Health Occupations Article.
“Freestanding ambulatory care facility” means:
An ambulatory surgical facility;
A freestanding endoscopy facility;
A freestanding facility utilizing major medical equipment;
A kidney dialysis center; or
A freestanding birthing center.
“Freestanding birthing center” means a facility that provides nurse midwife services under Title 8, Subtitle 6 of the Health Occupations Article.
“Freestanding birthing center” does not include:
A hospital regulated under Subtitle 2 of this title; or
The private residence of the mother.
“Freestanding endoscopy facility” means a facility:
For the testing, diagnosis, or treatment of a medical disorder in conjunction with the use of microscopic, endoscopic, or laparoscopic equipment that is inserted in a naturally occurring orifice of the body; and
That seeks reimbursement as a freestanding endoscopy facility from payors or Medicare.
“Freestanding endoscopy facility” does not include:
The office of one or more health care practitioners unless:
The office operates under a contract or other agreement with a payor as a freestanding endoscopy facility regardless of whether it is paid a technical or facility fee; or
The office is designated to receive endoscopic referrals in accordance with utilization review or other policies adopted by a payor; or
Any facility or service operated by a hospital and regulated under Subtitle 2 of this title.
“Freestanding facility operating major medical equipment” means a facility using major medical equipment.
“Freestanding facility operating major medical equipment” does not include any facility or service owned or operated by a hospital and regulated under Subtitle 2 of this title.
“Health care practitioner” means a person who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide medical services in the ordinary course of business or practice of a profession.
“Kidney dialysis center” means a facility that provides hemodialysis or chronic peritoneal dialysis.
“Kidney dialysis center” does not include any facility or service owned or operated by a hospital and regulated under Subtitle 2 of this title.
“License” means a license issued by the Secretary under this subtitle.
“Major medical equipment” means:
Cardiac catheterization equipment;
A computer tomography (CT) scanner;
A lithotripter;
Radiation therapy equipment, including a linear accelerator; or
A magnetic resonance imager (MRI).
“Nonsterile procedure room” means a room:
In which minor surgical procedures are performed, including endoscopy and endoscopic procedures requiring deep sedation;
That can only be accessed from a semi–restricted corridor or an unrestricted corridor;
That is not used for open surgical procedures that:
Enter the thorax, abdomen, pelvis, cranium, or spine; or
Routinely require induction of deep sedation or general anesthesia for the entirety of the surgical procedure; and
In which deep sedation or general anesthesia may be induced if:
Warranted by the clinical situation; and
The room is equipped to safely conduct the required level of anesthesia.
“Payor” means:
A health insurer, nonprofit health service plan, or health maintenance organization that holds a certificate of authority to offer health insurance policies or contracts in the State in accordance with this article or the Insurance Article;
A third party administrator or any other entity under contract with a Maryland business to administer health benefits; or
A self–insured group.
“Sterile operating room” means a room in a surgical suite that meets the requirements of a restricted area and is designated and equipped for performing surgical operations or other invasive procedures that may require an aseptic field.
“Surgical services” has the meaning incorporated in the Centers for Medicare and Medicaid Services State Operations Manual – Guidance for Surveyors: Ambulatory Surgical Centers.
A freestanding ambulatory care facility may not operate in the State unless the Secretary has granted the facility a license.
The Secretary shall issue a license to an applicant that meets the requirements of this subtitle and all applicable regulations adopted by the Secretary.
A license issued under this subtitle is not transferable.
After consultation with representatives of payors, health care practitioners, and freestanding ambulatory care facilities, the Secretary shall by regulation establish:
Procedures to implement the provisions of this subtitle; and
Standards to ensure quality of care and patient safety that shall include:
Procedures for credentialing and practitioner performance evaluation;
Qualifications of health care practitioners and support personnel;
Procedures to be followed in the event of an emergency, including a requirement that in the event of an emergency the patient be transported to the nearest appropriate emergency care facility;
Procedures for quality control of any biomedical equipment;
Procedures for postoperative recovery;
Procedures for discharge;
Procedures for ensuring that an anesthesia practitioner is not precluded from providing the highest level of anesthesia support that may be required to safely treat patients undergoing procedures in a freestanding ambulatory surgical facility performed in a nonsterile procedure room or a sterile operating room;
The use of ultrasound imaging in a freestanding birthing center;
Minimum perinatal care standards for a freestanding birthing center that meet or exceed the Maryland Perinatal System Standards that a freestanding birthing center shall meet as a condition of licensure; and
Any other procedures that the Secretary considers necessary for quality of care and patient safety.
The procedures for practitioner performance evaluation required under paragraph (1)(ii)1 of this subsection shall include a review of care provided to patients at the freestanding ambulatory care facility by members of the medical staff.
The review of care shall:
Be undertaken for cases chosen at random and for cases with unexpected adverse outcomes;
Be based on objective review standards;
Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and
Except as provided in paragraph (4) of this subsection, be conducted by at least two members of the medical staff who:
As appropriate, are of the same specialty as the member of the medical staff under review; and
Have been trained in the freestanding ambulatory care facility’s policies and procedures regarding practitioner performance evaluation.
A review of the care provided by a member of the medical staff who is a solo practitioner shall be conducted by an external reviewer.
A freestanding ambulatory care facility shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process.
If appropriate certification by Medicare is available, obtaining the certification shall be a condition of licensure for:
An ambulatory surgical facility; and
A kidney dialysis center.
Each freestanding ambulatory care facility shall provide assurances satisfactory to the Secretary that the freestanding ambulatory care facility does not discriminate against patients, including discrimination based on ability to pay for nonelective procedures.
The Secretary may delegate to the Kidney Disease Commission the Secretary’s authority under § 19–3B–07 of this subtitle to inspect kidney dialysis centers.
Except as provided in paragraph (2) of this subsection, the Department shall survey freestanding ambulatory care facilities in accordance with federal regulations.
The Department shall survey each freestanding birthing center at least once per calendar year.
If a newborn is delivered in a freestanding birthing center following a high–risk pregnancy, the freestanding birthing center shall:
Complete a postpartum infant and maternal referral form and submit the form to the local health department for the county in which the birthing parent resides;
Provide to the birthing parent resources and information specific to the circumstances of the birthing parent, including information regarding the risks, signs, preventive measures, and treatment needs for postpartum complications, including cardiovascular conditions, chronic disease, substance misuse, and mental health conditions; and
Call the birthing parent at least 24, but not later than 48, hours after discharging the parent to evaluate the parent’s status and, as necessary, provide information about postpartum complications.
On or before October 1 each year, each local health department shall submit to the Department a report that includes the number and type of referrals made based on the referral forms submitted to the local health department in accordance with subsection (a)(1) of this section.
An applicant for a license shall submit an application to the Secretary.
The application shall:
Be on a form and accompanied by any supporting information that the Secretary requires, including documentation that the Maryland Health Care Commission has determined that the freestanding ambulatory care facility either received a certificate of need or is exempt from certificate of need requirements; and
Be signed and verified by the applicant.
A license does not entitle the licensee to an exemption from other provisions of law relating to:
The review and approval of hospital rates and charges by the Health Services Cost Review Commission; or
The review and approval of new services or facilities by the Maryland Health Care Commission.
The Secretary, by regulation, may encourage the joint acquisition, purchase, or operation of major medical equipment by two or more health care practitioners, despite the fact that such joint acquisition, purchase, or operation may limit free economic competition.
The Secretary may investigate complaints concerning the conformance of a freestanding ambulatory care facility to the requirements of this subtitle or to the regulations adopted under this subtitle.
If the complaint concerns health care practitioner performance or standards of medical practice, the complaint shall be referred to the board that licenses, certifies, or otherwise authorizes the health care practitioner under the Health Occupations Article to provide medical services.
The Secretary may deny a license to any applicant, or suspend, restrict, or revoke a license if the applicant has been convicted of:
A felony that relates to Medicaid; or
A crime involving moral turpitude.
The Secretary may deny a license to any applicant or may restrict, suspend, or revoke any license if the applicant does not meet the requirements of this subtitle or any regulation that the Secretary adopts under this subtitle.
Before denying, suspending, restricting, or revoking a license or a provisional license under this section, the Secretary shall provide the applicant an opportunity for a hearing.
The Secretary shall send a hearing notice to any applicant by certified mail, return receipt requested, at least 30 days before the hearing.
A person who violates any provision of this subtitle or any regulation adopted under this subtitle is guilty of a misdemeanor and on conviction is subject to a penalty not exceeding $1,000 or imprisonment not exceeding 1 year or both. Each day a violation is continued after the first conviction is a separate offense.
In addition to the provisions of subsection (a) of this section, the Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this subtitle or any regulations adopted under this subtitle.
The Secretary shall adopt regulations to provide standards for the imposition of an administrative penalty under paragraph (1) of this subsection.