# COMAR Title 10 — Maryland Department of Health

## Subtitle 09 — Medical Care Programs

### Chapter 22 — Free-Standing Dialysis Facility Services

**Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland

**Administrative History:** Effective date: December 2, 1985 (12:24 Md. R. 2348)

**Administrative History:** Regulation .01B amended effective February 17, 2014 (41:3 Md. R. 201)

**Administrative History:** Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)

**Administrative History:** Regulation .03B amended effective February 17, 2014 (41:3 Md. R. 201)

**Administrative History:** Regulation .04B amended effective February 17, 2014 (41:3 Md. R. 201)

**Administrative History:** Regulation .05 amended effective February 17, 2014 (41:3 Md. R. 201)

**Administrative History:** Regulation .07 amended effective February 17, 2014 (41:3 Md. R. 201)

**Administrative History:** Regulation .07G amended effective July 4, 2016 (43:13 Md. R. 712)

**Administrative History:** Regulation .07J amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)

**Administrative History:** Regulation .07J amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)

**Administrative History:** Regulation .09C adopted effective January 24, 2011 (38:2 Md. R. 84)

**Administrative History:** Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84)

**Administrative History:** Chapter revised effective March 26, 2018 (45:6 Md. R. 319)

#### Regulation .01 Definitions.

*COMAR 10.09.22.01*

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

B. Terms Defined.

  (1) “CMS” means Centers for Medicare and Medicaid Services.

  (2) “Continuous ambulatory peritoneal dialysis (CAPD)” means a dialysis treatment method performed manually during the day by patient in which the patient’s peritoneal membrane is used as a dialyzer.

  (3) “Continuous cycling peritoneal dialysis (CCPD)” means a dialysis treatment method performed automatically during the night with a peritoneal dialysis cycler in which the patient’s peritoneal membrane is used as a dialyzer.

  (4) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq.

  (5) “Dialysis” means a treatment method in which waste products are removed from the body by diffusion from one fluid compartment to another across a semi-permeable membrane.

  (6) “Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Board of Dietetic Practice to practice dietetics in Maryland.

  (7) “Free-standing dialysis facility” means a dialysis unit capable of providing staff-assisted dialysis, which is not located in an acute hospital setting.

  (8) “Hemodialysis” means a dialysis treatment method in which blood passes through an artificial kidney machine and the waste products diffuse across a manmade membrane into a bath solution known as dialysate after which the cleansed blood is returned to the patient’s body.

  (9) “Home dialysis” means hemodialysis or peritoneal dialysis performed regularly in the home with the assistance of a family member or the patient’s caregiver.

  (10) "Home dialysis training” means instructions on how to perform dialysis services in a home setting.

  (11) “Licensed practical nurse (LPN)” means an individual licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.

  (12) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons.

  (13) “Medically necessary” means that the service or benefit is:

    (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

    (b) Consistent with currently accepted standards of good medical practice;

    (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

    (d) Not primarily for the convenience of the consumer, family or provider.

  (14) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq.

  (15) “Nurse practitioner” means an individual who is licensed and certified to practice as a nurse practitioner as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.

  (16) “Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.

  (17) “Patient care policies” means written policies and protocols describing patient care practices and procedures established by a group of professional personnel (including one or more physicians affiliated with the free-standing dialysis facility) and approved in writing by the facility's medical director.

  (18) “Peritoneal dialysis” means a dialysis treatment method in which waste products pass from the patient’s body through the peritoneal membrane into the peritoneal cavity where the bath solution (dialysate) is introduced and removed periodically.

  (19) “Physician” means an individual who is authorized under the Maryland Medical Practice Act to practice medicine in this State as stated in Health-General Article §1-101, Annotated Code of Maryland.

  (20) “Physician assistant” means an individual who is licensed to practice medicine with physician supervision as stated in Health Occupations Article, §§15-301(d) and (e) and 15-302, Annotated Code of Maryland.

  (21) “Plan of care” means a written plan for evaluation, treatment, and follow-up of each participant documented in the participant’s medical record that should include, at a minimum, the following information:

    (a) Patient identification data;

    (b) Date of service;

    (c) Reason for visit;

    (d) Medical history;

    (e) Plan for treatment;

    (f) Results of all laboratory tests ordered and performed; and

    (g) Interpretation of all diagnostic radiology procedures ordered and performed.

  (22) “Program” means the Maryland Medical Assistance Program.

  (23) “Registered nurse (RN)” means an individual licensed to practice registered nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland.

  (24) “Social worker” means a person who is licensed as a social worker in accordance with COMAR 10.42.01.05.

#### Regulation .02 License Requirements.

*COMAR 10.09.22.02*

A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.

B. A physician providing services in a free-standing dialysis facility shall be licensed and legally authorized to practice medicine in the state in which the service is provided.

C. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02, or other applicable standards established by the state in which the service is provided.

D. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:

  (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or COMAR 10.10.06, as applicable; or

  (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.

#### Regulation .03 Conditions for Participation.

*COMAR 10.09.22.03*

A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.

B. Specific requirements for participation in the Program as a free-standing dialysis facility include all of the following:

  (1) Be approved by Medicare to furnish dialysis service to kidney disease patients and maintain documentation of certification by the Division of Survey and Certification of CMS.

  (2) Verify the licenses and credentials of all professionals employed by, or under contract with, the free-standing dialysis facility to provide services.

  (3) Meet the requirements of COMAR 10.30.01.05C, for a dialysis facility, home dialysis unit, or self-care dialysis facility, or all of the above.

  (4) Have clearly defined, written, patient care policies.

  (5) Maintain adequate documentation of each participant visit, as part of the plan of care, which, at a minimum, shall include:

    (a) Date of service;

    (b) Participant’s reason for visit;

    (c) A brief description of service provided;

    (d) A legible signature and printed or typed name of professional providing care, with the appropriate title.

  (6) Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01.

  (7) Maintain adequate administrative and medical records which are defined as having documentation sufficient in quantity, scope, and detail to confirm that the free-standing dialysis facility services are provided in accordance with this regulation.

  (8) Not employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Medical Assistance participants.

  (9) Be approved by the Medical Assistance Program in the state in which the service is provided.

#### Regulation .04 Covered Services.

*COMAR 10.09.22.04*

A. The Program covers medically necessary services described in §B of this regulation, rendered to participants in a free-standing dialysis facility, when these services are:

  (1) Performed by a physician or by one of the following:

    (a) A physician assistant;

    (b) A nurse practitioner;

    (c) An RN;

    (d) An LPN;

    (e) A social worker; or

    (f) A dietitian-nutritionist;

  (2) Provided by a non-physician listed in §A(1) of this regulation, when the following conditions are met:

    (a) The individual performing the service is in the employ of, or under contract with, the free-standing dialysis facility;

    (b) The individual performing the service is under a physician's direct supervision or written direction;

    (c) The individual performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of the physician's services; and

    (d) The services are provided according to the free-standing dialysis facility physician's written plan of care;

  (3) Curative or rehabilitative services, when clearly related to the participant’s individual needs;

  (4) Adequately described in the participant’s medical record and consistent with the physician’s written plan of care.

B. Covered services include:

  (1) Dialysis services furnished on an outpatient basis and provided by a free-standing dialysis facility, to include hemodialysis, peritoneal dialysis, CAPD, CCPD, and home dialysis training; and

  (2) Laboratory tests, supplies, and prescription drugs as related to dialysis services.

#### Regulation .05 Limitations.

*COMAR 10.09.22.05*

The Program does not cover the following:

A. Services not specified in Regulation .04 of this chapter;

B. Services not medically necessary;

C. Investigational and experimental drugs and procedures;

D. Drugs and supplies which are acquired at no cost;

E. Injections and visits solely for the administration of injections, unless both the participant’s inability to take oral medications and medical necessity for the injections are documented in the participant’s medical record;

F. Travel expenses;

G. Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service;

H. Laboratory or X-ray services performed by another facility;

I. Completion of forms and reports;

J. Broken or missed appointments; and

K. Professional services rendered by mail or telephone.

#### Regulation .06 Payment Procedures.

*COMAR 10.09.22.06*

A. Reimbursement Principles.

  (1) Reimbursement by the Program is for services described in Regulation .04B of this chapter provided at a free-standing dialysis facility which has been approved for Medicare by the Division of Survey and Certification of CMS.

  (2) Reimbursement shall be consistent with the rates established by the Program for those services which are approved by Medicare.

  (3) Physician services are not reimbursed under this regulation. Reimbursement for physician services are in accordance with COMAR 10.09.02.07.

B. The provider shall submit a request for payment on the form designated by the Department.

C. The Program reserves the right to return to the provider, any invoice that is not properly completed.

D. A provider shall bill the program the established Medicaid rate for dialysis services.

E. Payments on Medicare claims are authorized if:

  (1) The provider accepts Medicare assignment;

  (2) Medicare makes direct payment to the provider;

  (3) Medicare has determined that the services are medically necessary;

  (4) Services are covered by the program; and

  (5) Initial billing is made directly to Medicare according to Medicare guidelines.

F. The Department will make supplemental payment on Medicare claims subject to the following provisions:

  (1) Deductible and coinsurance are to be paid in full; and

  (2) Services not covered by Medicare are payable according to §D of this regulation.

G. The provider may not bill the Program for:

  (1) Completion of forms and reports;

  (2) Broken or missed appointments;

  (3) Professional services rendered by mail or telephone; or

  (4) Home visits unless satisfactorily documented as an emergency.

H. The Program will make no direct payment to a participant.

I. The Program will make no separate direct payment to any person employed by or under contract to any free-standing dialysis facility for services covered under this regulation.

J. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.

#### Regulation .07 Recovery and Reimbursement.

*COMAR 10.09.22.07*

A. If the participant has insurance or if any other person is obligated either legally or contractually to pay for, or to reimburse for, any service covered by this chapter, the provider shall seek payment from that source. If payment is made by both the Program and by the insurace or other source, the provider shall refund the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less.

B. The provider shall reimburse the Department for any overpayment.

#### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions.

*COMAR 10.09.22.08*

A. If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with all applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:

  (1) Recovery of overpayments as specified in Regulation .07 of this chapter;

  (2) Withholding part or all of the payment by the Program;

  (3) Suspension from the Program;

  (4) Permanent removal from the Program;

  (5) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed.

B. If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action.

C. The Department shall give to the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department shall:

  (1) Establish the:

    (a) Effective date of the proposed action; and

    (b) Reasons for the proposed action; and

  (2) Advise the provider of the right to appeal.

#### Regulation .09 Appeal Procedures.

*COMAR 10.09.22.09*

Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09.

#### Regulation .10 Interpretive Regulation.

*COMAR 10.09.22.10*

Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services which are provided without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations.