Maryland Register
Issue Date:  January 5, 2018
Volume 45• Issue 1 • Pages 19—20
Title 10
10.09.22 Free-Standing Dialysis Facility Services
Authority: Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland
Notice of Proposed Action
The Secretary of Health proposes to amend Regulations .01 and .03—.05, repeal existing Regulation .06, amend and recodify existing Regulations .07—.09 to be Regulations .06—.08, and recodify existing Regulations .10 and .11 to be Regulations .09 and .10 under COMAR 10.09.22 Free-Standing Dialysis Facility Services.
Statement of Purpose
The purpose of this action is to:
(1) Clarify conditions for participation and covered services; and
(2) Update specific terms and definitions.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele Phinney, Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to, or fax to 410-767-6483. Comments will be accepted through February 5, 2018. A public hearing has not been scheduled.
.01 Definitions.
   A. [The] In this chapter, the following terms have the meanings indicated.
   B. Terms Defined.
       (1)—(5) (text unchanged)
       (6) “Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Board of Dietetic Practice to practice dietetics in Maryland.
        [(6)] (7)—[(7)] (8) (text unchanged)
        [(8)] (9) “Home dialysis” means hemodialysis or peritoneal dialysis performed regularly in the home [and assisted by] with the assistance of a family member or the patient’s caregiver.
        [(9)] (10) (text unchanged)
        (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.
        [(10)] (12)—[(12)] (14) (text unchanged)
        (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.
        [(13)] (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[, by signature,] in writing by the facility’s medical director.
        [(14)] (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 [(abdominal)] 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.
        [(15)] (21) “Plan of care” means a written plan for evaluation, treatment, and follow-up of each [patient established] participant documented in the [individual’s] participant’s medical record that should include, at a minimum, the following information:
          (a)—(d) (text unchanged)
          (e) Plan [of] for treatment;
          (f)—(g) (text unchanged)
        [(16)] (22) (text unchanged)
        [(17) “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits.]
        (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
.03 Conditions for Participation.
   A. (text unchanged)
   B. Specific requirements for participation in the Program as a free-standing dialysis facility include all of the following:
       (1)—(2) (text unchanged)
       (3) Meet the requirements of COMAR [and D], for a dialysis facility, home dialysis unit, or self-care dialysis facility, or all of the above.
       (4) (text unchanged)
       (5) Maintain adequate documentation of each [recipient] participant visit, as part of the plan of care[. The documentation], which, at a minimum, shall include:
          (a) (text unchanged)
          (b) [Recipient’s] Participant’s reason for visit;
          (c)—(d) (text unchanged) 
      (6) Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01 [and].
      (7) (text unchanged)
      (8) Not employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Medical Assistance [recipients] participants[, unless prior approval has been received by the Department].
       (9) (text unchanged)
       [(10) Provide for in-house program evaluation and clinical record review which assess use of services for appropriateness in meeting recipients’ needs.]
.04 Covered Services.
   A. The Program covers medically necessary services described in §B of this regulation, rendered to [recipients] participants in a free-standing dialysis facility, when these services are:
       (1) Performed by a physician or by one of the following:
          (a) [Certified registered physician’s] A physician assistant;
          (b) [Licensed certified] A nurse practitioner;
          (c) [Licensed registered nurse] An RN;
          (d) [Licensed practical nurse] An LPN;
          (e) A [licensed] social worker; or
          (f) A [dietician who is in compliance with Medicare requirements (42 CFR §405.2102(r)(2)) when employed by a free-standing dialysis facility] 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 [to] with, the free-standing dialysis facility;
          (b)—(d) (text unchanged)
      (3) [Diagnostic, curative, palliative,] Curative or rehabilitative services, when clearly related to the [recipient’s] participant’s individual needs;
      (4) Adequately described in the [recipient’s] participant’s medical record and consistent with the physician’s written plan of care.
   B. Covered services include:
      (1) (text unchanged)
      (2) Laboratory tests, supplies, and prescription drugs as related to dialysis services.
.05 Limitations.
   The Program does not cover the following:
   A.—C. (text unchanged)    
   D. [Services denied by Medicare as not medically necessary.] 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.
[.07] .06 Payment Procedures.
   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 [Maryland Medical Assistance] Program for those services which are approved by Medicare.
      [(2)] (3) (text unchanged)
   B.—G. (text unchanged)
   H. The Program will make no direct payment to a [recipient] participant.
   I.—J. (text unchanged)
[.08] .07 Recovery and Reimbursement.
   A. If the [recipient] 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. (text unchanged)
[.09] .08 Cause for Suspension or Removal and Imposition of Sanctions.
   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 [.08] .07 of this chapter;
      (2)—(5) (text unchanged)
   B.—C. (text unchanged)
Secretary of Health