# COMAR Title 10 — Maryland Department of Health

## Subtitle 30 — Maryland Commission on Kidney Disease

### Chapter 01 — General Regulations

**Authority:** Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland

**Administrative History:** Effective date: July 1, 1972

**Administrative History:** Regulations .01 — .09 repealed and new regulations .01 — .09 adopted effective July 19, 1982 (9:14 Md. R. 1431)

**Administrative History:** Regulations .04, .05, and .07L amended effective August 1, 1983 (10:15 Md. R. 1350)

**Administrative History:** Regulation .07B amended effective February 27, 1984 (11:4 Md. R. 314); August 20, 1987 (14:16 Md. R. 1775); November 16, 1987 (14:23 Md. R. 2414)

**Administrative History:** Regulation .07B and Q amended as an emergency provision effective January 1, 1987 (14:6 Md. R. 711, 14:9 Md. R. 1077); emergency status expired August 20, 1987 (Emergency provisions are temporary and not printed in COMAR)

**Administrative History:** Regulation .07Q amended effective July 2, 1984 (11:13 Md. R. 1777); August 20, 1987 (14:16 Md. R. 1775)

**Administrative History:** Regulation .07Q amended as an emergency provision effective July 2, 1984 (11:15 Md. R. 1327); adopted permanently effective December 19, 1984 (11:23 Md. R. 1992)

**Administrative History:** Regulation .07R adopted effective August 1, 1983 (10:15 Md. R. 1350)

**Administrative History:** Regulation .07S adopted as an emergency provision effective September 14, 1983 (10:20 Md. R. 1781); emergency status expired January 31, 1984 (Emergency provisions are temporary and not printed in COMAR)

**Administrative History:** Regulation .10 adopted effective December 20, 1982 (9:25 Md. R. 2484)

**Administrative History:** Regulations .11 and .13 adopted effective August 1, 1983 (10:15 Md. R. 1350)

**Administrative History:** Regulation .11 amended effective November 3, 1986 (13:22 Md. R. 2399)

**Administrative History:** Regulation .12 adopted effective June 4, 1984 (11:11 Md. R. 962)

**Administrative History:** Chapter revised effective October 31, 1988 (15:22 Md. R. 2556)

**Administrative History:** Regulation .04A amended effective April 15, 1991 (18:7 Md. R. 773); May 20, 1996 (23:10 Md. R. 732)

**Administrative History:** Regulation .04C adopted effective May 20, 1996 (23:10 Md. R. 732)

**Administrative History:** Regulation .05 amended effective December 19, 1994 (21:25 Md. R. 2105)

**Administrative History:** Regulation .06F amended effective December 19, 1994 (21:25 Md. R. 2105)

**Administrative History:** Regulation .07 repealed and new Regulation .07 adopted effective December 19, 1994 (21:25 Md. R. 2105)

**Administrative History:** Regulation .07A and M amended effective April 15, 1991 (18:7 Md. R. 773)

**Administrative History:** Regulation .11C amended effective December 19, 1994 (21:25 Md. R. 2105)

**Administrative History:** Regulation .14 amended effective December 19, 1994 (21:25 Md. R. 2105)

**Administrative History:** Regulation .15 adopted as an emergency provision effective July 1, 1992 (19:13 Md. R. 1200); emergency status expired November 8, 1992 (Emergency provisions are temporary and not printed in COMAR)

**Administrative History:** Regulation .15 adopted effective May 9, 1994 (21:9 Md. R. 751)

**Administrative History:** Regulation .15 repealed and new Regulation .15 adopted effective October 24, 1994 (21:21 Md. R. 1814)

**Administrative History:** Regulation .15F repealed effective August 23, 1999 (26:17 Md. R. 1323)

**Administrative History:** Regulation .16 adopted effective December 19, 1994 (21:25 Md. R. 2105)

**Administrative History:** Regulations .01 — .16 repealed and new Regulations .01 — .11 adopted effective December 22, 2003 (30:25 Md. R. 1846)

**Administrative History:** Regulation .02B amended effective April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .02-1 adopted effective April 5, 2010 (37:7 Md. R. 571)

**Administrative History:** Regulation .03G adopted effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .08B amended effective April 5, 2010 (37:7 Md. R. 571)

**Administrative History:** Regulation .10A amended effective April 5, 2010 (37:7 Md. R. 571)

**Administrative History:** Regulation .11C adopted effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Chapter revised effective August 18, 2025 (52:16 Md. R. 846)

#### Regulation .01 Purpose.

*COMAR 10.30.01.01*

In recognition of its continuing responsibility to its citizens to aid in reduction of the personal financial hardships associated with end-stage kidney disease, the State continues its commitment of resources to the Kidney Disease Program of Maryland. This subtitle is designed so that Maryland may provide help and support for its citizens whose needs are partially or wholly unmet by present federal or private support, or both, for end stage kidney disease.

#### Regulation .02 Definitions.

*COMAR 10.30.01.02*

A. In this subtitle, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Abusive and dangerous patient” means a patient who is physically or verbally threatening to the patient's person, facility staff, or other patients.

  (2) “Acute dialysis” means dialysis employed in the treatment of temporary kidney failure, with the expectation that dialysis may be necessary for 4 weeks or less because recovery of kidney function is anticipated.

  (3) “Administrator” means an individual appointed by the governing body who is responsible for the facility's daily operations and the duties set forth in COMAR 10.30.02.03F.

  (4) “Certified nursing assistant—dialysis technician” means an individual licensed by the Maryland Board of Nursing to perform nursing tasks delegated by a licensed nurse in the dialysis facility.

  (5) “Certified patient” means a patient who is certified by the Commission on Kidney Disease and is eligible for benefits from the Kidney Disease Program.

  (6) “Chief executive officer” means an individual who meets the requirements set forth in 42 CFR §494.180, which is incorporated by reference;

  (7) “Chronic dialysis” means dialysis employed to compensate for the severe and irreversible loss of kidney function and is a permanent treatment modality unless replaced by kidney transplantation.

  (8) “Chronic peritoneal dialysis” means dialysis performed repetitively by exchanging large volumes of solution within the peritoneal cavity.

  (9) “Commission” means the Commission on Kidney Disease.

  (10) “Department” means the Maryland Department of Health.

  (11) Dialysis.

    (a) “Dialysis” means the process of filtering waste products and excess fluid from the blood of a patient with severely compromised kidney function.

    (b) “Dialysis” includes the terms hemodialysis and peritoneal dialysis.

  (12) “Governing body” means an identifiable individual or individuals who are designated in writing with full legal authority and responsibility for the governance and operation of the facility.

  (13) “Home dialysis” means chronic hemodialysis or chronic peritoneal dialysis performed regularly in the home by the patient and an assistant, if necessary.

  (14) “Home training dialysis” means:

    (a) Chronic peritoneal dialysis, including continuous ambulatory peritoneal dialysis and continuous cycling peritoneal dialysis; or

    (b) Instructional chronic hemodialysis.

  (15) “In-center hemodialysis” means a hemodialysis treatment that:

    (a) Lasts 3 to 5 hours;

    (b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and

    (c) Is provided in a kidney dialysis facility.

  (16) “In-center nocturnal hemodialysis” means a hemodialysis treatment that:

    (a) Lasts 6 to 9 hours;

    (b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and

    (c) Is provided in a kidney dialysis facility.

  (17) “Monitoring individual” means an individual who is a direct patient care provider.

  (18) “Nurse manager” means an individual who is responsible for nursing services and provides oversight and direction to all direct care staff that provide dialysis and nursing care in a kidney dialysis facility.

#### Regulation .02-1 Incorporation by Reference.

*COMAR 10.30.01.02-1*

A. In this chapter, the following documents are incorporated by reference.

B. Documents Incorporated.

  (1) 42 CFR §§494.1 — 494.110, as amended; and

  (2) 42 CFR §§494.130 — 494.180, as amended.

#### Regulation .03 Categories of Dialysis.

*COMAR 10.30.01.03*

A. The categories of dialysis listed in §§BF of this regulation are recognized on the basis of differing facility requirements.

B. Acute Dialysis. Acute dialysis is not reimbursable under the Kidney Disease Program and nothing in this subtitle is meant to refer to acute dialysis.

C. Chronic Dialysis.

  (1) Chronic dialysis may be provided in the dialysis facilities defined and described in this subtitle.

  (2) Chronic dialysis may be preceded by adequate studies to confirm that the kidney failure is irreversible.

D. Home Dialysis. A period of training in an approved home dialysis training facility is required before a patient can safely undergo dialysis treatments in the home.

E. Home Training Dialysis.

  (1) Home training dialysis is usually conducted in a center with simultaneous dialysis and instruction provided to the patient that includes the technique of performing the type of dialysis selected.

  (2) The period required for this training differs depending on the individual circumstances, and requires the expertise and equipment necessary for providing adequate home training.

  (3) A responsible third party may be included in the training.

F. Chronic Peritoneal Dialysis.

  (1) This process can substitute for kidney function that has been permanently lost and represents a permanent treatment unless replaced by either hemodialysis or kidney transplantation.

  (2) Long-term care of end-stage kidney disease by chronic peritoneal dialysis may be carried out either in a dialysis facility or in the home.

G. Nocturnal Hemodialysis. Nocturnal hemodialysis may be provided in the dialysis facilities defined and described in this subtitle.

#### Regulation .04 Classifications of Facilities.

*COMAR 10.30.01.04*

A. Kidney Transplant Center.

  (1) A kidney transplant center shall be a physically discrete unit or division within a hospital approved by the Joint Commission on Accreditation of Healthcare Organizations having the staff and facilities capable of evaluating potential candidates for kidney transplantation.

  (2) Transplantation Service. The transplantation division may be administratively and physically separate from the dialysis division, but shall work in close cooperation with an associated dialysis program.

B. Freestanding Dialysis Facility. The freestanding dialysis facility's functions include:

  (1) A dialysis facility capable of providing chronic staff-assisted dialysis which may be performed in a freestanding dialysis facility or in an end-stage kidney disease certified hospital-based unit;

  (2) Referrals provided for operative, X-ray, and laboratory services under arrangement;

  (3) Affiliation with a certified dialysis facility for backup purposes; and

  (4) Affiliation with a certified transplant center.

C. Home Dialysis Programs. A home dialysis program's functions include a dialysis facility specifically designed and staffed to train patients and patients' helpers to perform dialysis at home.

#### Regulation .05 Patient Standards.

*COMAR 10.30.01.05*

A. General Considerations.

  (1) Patients who are accepted for dialysis and kidney transplantation:

    (a) Shall be accepted on medical grounds alone;

    (b) May not be accepted based on age, race, sex, social background, national origin, religion, or financial resources; and

    (c) Are the responsibility of the dialysis or transplant centers, or both, but shall conform to the medical guidelines established in §B of this regulation.

  (2) The Kidney Disease Program is financially responsible only for residents of the State who are certified as eligible for participation in the Kidney Disease Program.

  (3) Maryland residents treated in dialysis facilities or transplant centers outside the State are not eligible for reimbursement unless the treatment has been preauthorized by the Commission.

  (4) The Commission may authorize a treatment for documented reasons of continuity of care, or geographical proximity of the patient's residence to the dialysis facility or transplant center, or both.

  (5) Except as provided in §C of this regulation, if a patient is accepted by a facility for dialysis, transplantation, or both, the patient is the responsibility of that facility and the facility's staff until that responsibility is terminated by mutual agreement between the facility and patient.

  (6) The Commission shall review each facility's policy regarding discharge of patients from the facility's program.

  (7) Any separation that is not mutually accepted shall be documented in writing by the facility and reviewed by the Commission to determine whether there has been a violation of laws or regulations of the State.

B. Medical Guidelines. A patient may be accepted for treatment if the patient meets any of the following criteria:

  (1) Has end-stage kidney disease requiring kidney replacement therapy to sustain life;

  (2) A patient who grants informed consent and who has had a thorough medical, psychosocial evaluation indicating a reasonable expectation of benefiting from either chronic dialysis or transplantation;

  (3) Has chronic end-stage kidney disease and is a qualified resident of this State, except when documented medical reasons contraindicate dialysis; or

  (4) Has rejected a transplanted kidney making the patient immediately eligible for consideration for readmission into a chronic dialysis program if the patient is a medically suitable candidate.

C. Abusive and Dangerous Patients.

  (1) A facility shall:

    (a) Develop policies for the management of abusive and dangerous patients;

    (b) Maintain these policies in the policy and procedures manual in the dialysis facility; and

    (c) Inform the patient in writing of the facility's policy for the management of abusive and dangerous patients.

  (2) A separation or discharge may be implemented by the facility only after the patient has been given written notice by the facility and has had a reasonable opportunity to terminate the abusive and dangerous behavior, however:

    (a) A patient who commits violence in a facility may be discharged; and

    (b) The Commission shall require documentation of the violence to support a discharge.

  (3) The Commission shall review each facility's policy for the management of abusive and dangerous patients and the facility's method of implementation of this policy during the Commission's survey.

D. Complaints.

  (1) The Commission shall investigate complaints received from patients, providers, anonymous persons, and other interested parties including family members.

  (2) The Commission shall consider all complaints submitted to the Commission office for further investigation.

#### Regulation .06 Reimbursement Principles.

*COMAR 10.30.01.06*

A certified facility and recipient shall comply with COMAR 10.20.01 and with the requirements of this chapter to be eligible for reimbursement.

#### Regulation .07 Procedures for Certification of Facilities.

*COMAR 10.30.01.07*

A. Providers or consumers of medical care contemplating development of a transplant center or a dialysis facility shall notify the Commission within 30 days of applying for licensure or certification with the Office of Health Care Quality of the Department.

B. The Department or the Commission, or both, shall:

  (1) Review the facility application;

  (2) Survey for compliance with this subtitle; and

  (3) Certify the facility’s existing Office of Health Care Quality license.

C. The Commission, through the Department, shall certify the dialysis facilities and transplant centers once the standards have been met as set forth in this subtitle.

D. Certified patients are eligible for reimbursement of medical care only after a dialysis facility or transplant center has received Kidney Disease Program certification.

E. Programs denied certification on the basis of a failure to meet the Commission's standards may file an appeal with the Commission for a specific interpretation of the standards applicable in that individual case.

#### Regulation .08 Affiliation Guidelines.

*COMAR 10.30.01.08*

A. To assure quality and continuity of patient care, formal affiliation agreements shall be negotiated as required in the standards and guidelines of the Commission. The affiliation agreement shall be constructed so no entity benefits financially.

B. Affiliation agreements shall include, but not necessarily be limited to, the:

  (1) Means by which patients may be transferred between the affiliated institutions for the purpose of providing dialysis, transplantation services, or other medical care;

  (2) Conditions under which dialysis facilities, hospitals, and transplant centers agree to provide medical backup facility to assure optimal patient care;

  (3) Mechanisms for assuring quality of care including provisions for consultative help and review of patient progress;

  (4) Provisions of or referral to a certified home dialysis training program with specific mechanisms for ensuring adequate supervision and assistance for patients on home dialysis; and

  (5) Specific provisions by hospitals to end-stage kidney disease patients for dialysis services as well as adequate:

    (a) Laboratory services;

    (b) Social services; and

    (c) Dietetic services;

C. The dialysis facility shall review and revise the affiliation agreements periodically and if a change in ownership or other details of operation changes during the period while the affiliation agreement is in force.

#### Regulation .09 Residency Requirements.

*COMAR 10.30.01.09*

To be eligible for the Kidney Disease Program, an individual shall be one of the following:

A. A citizen of the United States residing in Maryland; or

B. An alien lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law, including an alien who is lawfully present in the United States pursuant to 8 U.S.C. §1101 et seq. and who is residing in Maryland.

#### Regulation .10 Certification and Revocation.

*COMAR 10.30.01.10*

A. Certification.

  (1) The Commission, through the Department, shall certify a facility or center to perform dialysis upon determination that the facility or center meets the standards adopted by the Commission, including:

    (a) 42 CFR §§494.1 — 494.110, as amended; and

    (b) 42 CFR §§494.130 — 494.180, as amended.

  (2) The certification of the facility or center shall continue in effect unless suspended or revoked by the Secretary as recommended by the Commission.

B. Revocation of Certification or Suspension of Payments.

  (1) The Secretary shall delegate to the Commission the performance of periodic surveys of dialysis facilities or transplant centers.

  (2) The Commission shall immediately report to the Secretary if patient safety and welfare are compromised at the facility. However, this reporting does not preclude the Commission from taking immediate independent corrective action.

  (3) The Commission may, by vote of the majority of the members in attendance, recommend to the Secretary to revoke or suspend payments to a dialysis facility or transplant center not in compliance with this subtitle.

  (4) Reimbursements may not be made during the term of the suspension or revocation.

C. The Secretary may revoke the certification of a dialysis facility or transplant center to participate in the Kidney Disease Program at any time for failure to comply with this subtitle.

D. The Commission may review any revocation or proposed revocation of certification and make an independent recommendation to the Secretary.

E. In accordance with the Maryland Administrative Procedure Act, a person aggrieved by a decision of the Secretary is entitled to a hearing in accordance with COMAR 10.01.03.

#### Regulation .11 Miscellaneous Items.

*COMAR 10.30.01.11*

A. A serious occurrence which threatens the safety and health of the patients shall be reported immediately by a facility to the Commission, local health department, and the Office of Health Care Quality of the Department.

B. In the event of a natural disaster or other imminent threat to the safety or health of a group of dialysis patients, the Secretary may immediately authorize, with timely notification of all involved professional personnel and patients, the:

  (1) Relocation of an existing dialysis facility or center; and

  (2) Transfer of dialysis patients in accordance with medical needs.

C. Emergency Management.

  (1) A kidney dialysis facility shall have an emergency plan.

  (2) An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address:

    (a) The safe management of individuals who are receiving services at the kidney dialysis facility when an emergency occurs;

    (b) Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis services to the individuals served by the kidney dialysis facility;

    (c) Staff coverage, organization, and assignment of responsibilities; and

    (d) The continuity of operations, including procedures to secure access to essential goods, equipment, and dialysis services.

  (3) This regulation does not prohibit a kidney dialysis facility from applying for and receiving reimbursement:

    (a) Under any applicable insurance policy; or

    (b) From any State or federal funds that may be available due to a declared State or federal emergency.

  (4) A kidney dialysis facility is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the kidney dialysis center under this regulation.

  (5) For purposes of coordinating local emergency planning efforts, a kidney dialysis facility shall provide access to the emergency plan developed under this regulation to local organizations for emergency management.

  (6) A dialysis provider shall provide to the Commission a 24/7 live operational contact phone number.

  (7) Information Regarding the Status of Generators. A kidney dialysis facility shall have:

    (a) An on-site generator;

    (b) The capacity to hook up a generator; or

    (c) A contract with a company who will provide a generator in the event of an emergency, if there is no on-site generator.

  (8) If the center has no plan to use the services of a generator, the center shall provide to the Commission a copy of the center's emergency plan that will demonstrate that all measures possible are in place to avoid disruption of dialysis services to patients.