PROPOSAL
Maryland Register
Issue Date: June 24, 2016
Volume 43 • Issue 13 • Pages 728—732
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Notice of Proposed Action
[16-153-P]
The Secretary of Health and Mental Hygiene proposes to:
(1) Amend Regulation .03 under COMAR 10.07.02 Comprehensive Care Facilities and Extended Care Facilities;
(2) Amend Regulations .05 and .06 under COMAR 10.07.03 Health Care Staff Agencies;
(3) Amend Regulation .03 under COMAR 10.07.04 Related Institutions — Residential Treatment Centers for Emotionally Disturbed Children and Adolescents;
(4) Amend Regulation .05 under COMAR 10.07.08 Freestanding Medical Facilities;
(5) Amend Regulation .04 under COMAR 10.07.10 Home Health Agencies;
(6) Amend Regulation .07 and under COMAR 10.07.14 Assisted Living Programs;
(7) Amend Regulation .02 and repeal Regulation .03 under COMAR 10.07.15 Application for Hospitals and Related Institutions;
(8) Amend Regulation .04 under COMAR 10.07.21 Hospice Care Programs;
(9) Amend Regulations .03, .04, and .06 under COMAR 10.10.03 Medical Laboratories — Licenses;
(10) Amend Regulations .01 and.02 and repeal Regulation .03 under COMAR 10.10.04 Medical Laboratories;
(11) Amend Regulation .04 under COMAR 10.10.12 Medical Laboratories — Public Health HIV Testing Programs;
(12) Amend Regulation .04 under COMAR10.12.04 Day Care for the Elderly and Adults with a Medical Disability;
(13) Amend Regulation .05 and repeal Regulation .06 under COMAR 10.23.01 Advance Directive Registry;
(14) Amend Regulation .01 under COMAR 10.51.02 Responsibilities, Accreditations, and Audits; and
(15) Amend Regulations .02 and .03 and repeal Regulation .04 under COMAR 10.51.03 Licenses.
Statement of Purpose
The purpose of this action is to eliminate or reduce the licensing fees for the regulated industries listed in the Notice of Proposed Action.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. The reduction and elimination of the various fees proposed will accrue cost savings to various health care providers who are required to obtain initial and renewal licenses from the Department of Health and Mental Hygiene.
Specifically, the following provider types will receive annual fee decreases as listed below.
• Comprehensive care facilities $690,600
• Health care staffing agencies $86,550
• Residential treatment centers for emotionally disturbed children and adolescents $20
• Freestanding medical facilities $1,000
• Home health agencies $19,600
• Assisted living facilities $357,980
• Intermediate care facility for individuals with intellectual disabilities $6,654
• Hospice care program $2,700
• Clinical laboratories $506,655
• Public health HIV testing $900
• Day care for elderly adults with medical disabilities $72,036
• Forensic laboratories $5,480
|
|
Revenue (R+/R-) |
|
|
II. Types of Economic Impact. |
Expenditure
(E+/E-) |
Magnitude |
|
|
|
|
|
|
|
A. On issuing agency: |
(R-) |
$1,750,175 |
|
B. On other State agencies: |
NONE |
|
|
C. On local governments: |
NONE |
|
|
|
|
|
Benefit (+)
Cost (-) |
Magnitude |
|
|
|
|
|
|
|
D. On regulated industries or trade groups: |
(+) |
$1,750,175 |
|
E. On other industries or trade groups: |
NONE |
|
|
F. Direct and indirect effects on public: |
NONE |
|
|
III. Assumptions. (Identified by Impact Letter and Number from Section II.) |
|
A. and D. This estimate is based on elimination and reductions of fees collected for the 12 provider categories encompassed by the cited COMAR regulations in the previous fiscal year (2015), and assumes the same number and type of applicant when the regulations become effective. This includes a decrease in annual fee collections of $357,980 from the proposed 75 percent reduction in fees for assisted living facilities, as well as a $1,000 annual decrease in fee collections from the proposed 33 percent reduction in fees for freestanding medical facilities. All other fees associated with provider types contemplated in this proposal will be eliminated. All fees collected are deposited into the General Fund. |
Economic Impact on Small Businesses
The proposed action has a meaningful economic impact on small business. An analysis of this economic impact follows.
Assisted living facility operators will see a 75 percent decrease in initial and renewal license costs. As a large proportion of assisted living providers in Maryland are small businesses, this will result in a significant positive economic impact to the owners.
Operators of freestanding medical facilities will see a reduction of $1,000 for 3-year license renewals. The Department notes that the three freestanding medical facilities in Maryland are associated with larger medical institutions and would not be considered small businesses.
The elimination of all fees set forth in the remaining COMAR regulations listed in this proposal will have a significant positive impact on small businesses. Small business owners constitute varying percentages of the operators of facilities in the industries affected by the fee eliminations, and represent hundreds of individual businesses in the State of Maryland.
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, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through July 25, 2016. A public hearing has not been scheduled.
Subtitle 07 HOSPITALS
10.07.02 Comprehensive Care Facilities and Extended Care Facilities
Authority: Health-General Article, §§19-308, 19-308.1, 19-323, and 19-1401 et seq.; Public Safety Article, §14-110.1; Annotated Code of Maryland
.03 Licensing Procedure.
A. Application for License.
(1) (text unchanged)
[(2) A nonrefundable 2-year license fee shall accompany the application based on the following payment schedule:
(a) 1—50 beds: $3,000;
(b) 51—99 beds: $5,000;
(c) 100+ beds: $7,000; and
(d) Transitional care units: $600.]
[(3)] (2)—[(6)] (5) (text unchanged)
[(7) A facility that is a transitional care unit with fewer than 50 beds and that is affiliated with a licensed Maryland hospital shall pay the 2-year license fee for a transitional care unit.]
[(8)] (6)—[(9)] (7) (text unchanged)
B. Restrictions of License.
(1)—(3) (text unchanged)
(4) Renewal of License.
(a) (text unchanged)
(b) The renewal application shall be[:
(i) Submitted] submitted on forms provided by the Secretary[; and
(ii) Accompanied by a nonrefundable 2-year license renewal fee based on the payment schedule in §A(2) of this regulation].
[(5) A facility that is a transitional care unit with fewer than 50 beds and affiliated with a licensed Maryland hospital shall pay the 2-year license renewal fee for a transitional care unit.]
[(6)] (5)—[(7)] (6) (text unchanged)
10.07.03 Health Care Staff Agencies
Authority: Health-General Article, Title 19, Subtitle 20, Annotated Code of Maryland
.05 Licensing Procedure.
A. Application for Licensure.
(1)—(2) (text unchanged)
(3) Along with the application, the applicant shall submit a[:
(a) Nonrefundable 1-year license fee of $100 made payable to the Department; and
(b) Copy] copy of the agency’s policies and procedures as specified in Regulation .08 of this chapter.
B.—C. (text unchanged)
D. License Renewal.
(1) (text unchanged)
(2) Before a license expires, the agency may renew its license for an additional term, if the agency:
(a) Otherwise is entitled to be licensed; and
[(b) Pays to the Office the $100 license renewal fee; and]
[(c)] (b) (text unchanged)
(3) (text unchanged)
E.—G. (text unchanged)
.06 Changes to Licensure Information.
A. (text unchanged)
B. Any change in agency ownership, name, or address requires the issuance of a new license [and a fee of $150]. If the sale, transfer, assignment, or lease of an agency causes a change in the person or persons who control or operate the agency, the agency shall be considered a “new agency” and the new owner shall comply with all regulations of this chapter when applying for a new license.
C. (text unchanged)
10.07.04 Related Institutions — Residential Treatment Centers for Emotionally Disturbed Children and Adolescents
Authority: Health-General Article, §19-308, Annotated Code of Maryland
.03 Licensing Procedure.
A. Application. Applicants shall conform to the following:
(1)—(2) (text unchanged)
(3) [Each application shall be accompanied by a fee of $10]. All licenses issued shall expire 1 year from the date of issuance unless revoked. [Fees will not be refunded.]
(4) (text unchanged)
(5) Renewal. Application for the renewal of the license shall be made each year at least 30 days before expiration of issued license, submitted on forms provided by the Secretary[, and accompanied by the $10 license renewal fee. by the $10 license renewal fee].
B.—F. (text unchanged)
10.07.08 Freestanding Medical Facilities
Authority: Health-General Article, §2-104 and Subtitle 19-3A, Annotated Code of Maryland
.05 Renewal of License.
A.—B. (text unchanged)
C. The application fee for license renewal shall be accompanied by a nonrefundable 3-year license renewal fee of [$3,000] $2,000.
10.07.10 Home Health Agencies
Authority: Health-General Article, §19-404, Annotated Code of Maryland
.04 General Licensure Provisions.
A. (text unchanged)
B. Application for License. An agency desiring to conduct, operate, or maintain a home health agency in the State shall file an application with the Secretary, on a form provided by the Secretary. [A nonrefundable licensing fee of $350 shall accompany the application for licensure.]
C. Renewal of License. An agency shall file an application for renewal of the license at least 60 days before expiration of the issued license[, submitted] and submit it on forms provided by the Secretary [and accompanied by a nonrefundable license renewal fee of $350].
D.—G. (text unchanged)
10.07.14 Assisted Living Programs
Authority: Health-General Article, Title 19, Subtitle 18, Annotated Code of Maryland
.07 Licensing Procedure.
A. Application for License.
(1)—(2) (text unchanged)
(3) Fees. The annual license fee schedule for assisted living programs is as follows:
(a) 1—4 beds: [$200] $50 annually;
(b) 5—15 beds: [$300] $75 annually;
(c) 16—49 beds: [$450] $125 annually;
(d) 50—99 beds: [$650] $165 annually;
(e) 100—149 beds: [$1,000] $250 annually; and
(f) 150 plus beds: [$1,500] $375 annually.
(4)—(5) (text unchanged)
B.—D. (text unchanged)
10.07.15 [License Fee Schedule] Application for Hospitals and Related Institutions
Authority: Health-General Article, §§19-320 and 19-323, Annotated Code of Maryland
.02 Application [and Fee] Requirements.
A. Any person desiring to open a related institution or to continue the operation of a related institution shall[:
A. File] file an application with the Secretary, on a form provided by the Secretary.
B. Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency and names of their board members shall be submitted.
C. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee’s.
D. The names of persons holding 2 percent or more of the stock or assets shall be disclosed.
[B. Submit to the Department the fee as prescribed under Regulation .03.]
10.07.21 Hospice Care Programs
Authority: Health-General Article, §19-903, Annotated Code of Maryland
.04 Application Procedure.
A. (text unchanged)
B. [To apply for an initial license or renewal of a license, an applicant shall:
(1) Submit an application to the Secretary on a form provided by the Secretary; and
(2) Pay to the Secretary an application fee of $300.] The applicant shall submit an application for an initial license or renewal of a license on a form provided by the Secretary.
C.—E. (text unchanged)
Subtitle 10 LABORATORIES
10.10.03 Medical Laboratories — Licenses
Authority: Environment Article, §6-303; Health-General Article, §§2-104(b), 17-202, 17-205—17-210, 17-212, 17-502, 17-503, 17-505, 17-508, and 17-510; Annotated Code of Maryland
.03 Permits.
A.—B. (text unchanged)
C. Regulatory Requirements. A person operating a medical laboratory under a permit shall:
(1) Obtain, complete, and submit permit applications [and fees] as prescribed in this chapter and COMAR 10.10.04;
(2)—(5) (text unchanged)
.04 Letter of Exception and Permit—Administrative Procedures.
A. (text unchanged)
B. Application—Evaluation and Billing.
(1) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if[:
(a) An] an application is complete[; and].
[(b) A] (2) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the laboratory is eligible for a:
[(i)] (a)—[(iii)] (c) (text unchanged)
[(2) After reviewing and evaluating an application, the OHCQ shall bill a laboratory and the laboratory shall immediately pay the applicable remaining balance of the licensing fee.]
C.—D. (text unchanged)
E. Amending a Permit. Except as prescribed in §D of this regulation, a licensee holding an unexpired permit who wishes to amend it shall:
(1) Submit a written request for amendment to the Secretary; and
[(2) Remit to the OHCQ a $50 relicensing fee; and]
[(3)] (2) (text unchanged)
F.—G. (text unchanged)
.06 Letter of Exception—Limited Testing for Rare Diseases; Standards and Requirements.
A. Application Requirements and Testing Approval. A person required to obtain a license to operate a laboratory that chooses to operate under a letter of exception—limited testing for rare diseases shall:
(1) Submit:
(a)—(b) (text unchanged)
(c) Documentation of the rare disease testing offered or performed, including but not limited to:
(i)—(v) (text unchanged)
(vi) Additional information necessary for determining eligibility and compliance with this subtitle; and
[(d) The licensing fee stated in COMAR 10.10.04.02B, unless the fee is waived as set forth in COMAR 10.10.04.01E; and]
(2) (text unchanged)
B.—E. (text unchanged)
10.10.04 Medical Laboratories [— Fees]
Authority: Health-General Article, §§17-202, 17-204, 17-205, 17-207, 17-209, 17-502, 17-503, and 17-506, Annotated Code of Maryland
.01 General.
A.—D. (text unchanged)
E. Fee Waiver. The Secretary may waive all licensing fees for a:
(1) Municipal or county health department; or
(2) Governmental agency that receives funding to operate from the State[; or
(3) Laboratory operating under a letter of exception—limited testing for rare diseases, if the laboratory is operated as:
(a) A not-for-profit entity; or
(b) Part of an accredited educational institution].
.02 Licensing — Letter of Exception [and Permit].
A. Letter of Exception. [Except as set forth in §C(4) of this regulation, a] A person applying for a letter of exception for a POL or POCL shall submit [a licensing fee of $100 with] an initial application and biennially after that with each renewal application.
B. Letter of Exception — Limited Testing for Rare Diseases. A person applying for a letter of exception-limited testing for rare diseases for a laboratory shall submit [a licensing fee of $100 with] an initial application and biennially after that with each renewal application.
[C. Permit — General.
(1) A person applying for a permit to operate a laboratory shall submit with each initial application a partial licensing fee of:
(a) $50 when the application covers three or fewer disciplines; and
(b) $200 when the application covers more than three disciplines.
(2) After evaluating the application for a permit, the OHCQ shall bill the person making application for the unpaid portion of a licensing fee by mailing an invoice listing the required fee as set forth in §C(3) of this regulation.
(3) A person obtaining or renewing a permit shall pay initially, and biennially after that, a licensing fee of $200 for each discipline in which the laboratory offers to perform or performs tests.
(4) A person who qualifies for a letter of exception as set forth in COMAR 10.10.03.02 and performs one or more tests that require obtaining or renewing a permit shall pay initially, and biennially after that, a licensing fee of $200 as set forth in §C(3) of this regulation for each discipline in which the laboratory offers to perform or performs nonexcepted tests.
(5) A person issued a permit under §C(4) of this regulation is not required to pay the partial licensing fees set forth in §C(1) of this regulation.
D. Permit — Cholesterol Testing.
(1) A person applying for a cholesterol testing permit to perform cholesterol testing at a temporary or mobile laboratory shall submit an initial licensing fee of:
(a) $250 if there will be fewer than 21 testing events during the license year and they will be held at fewer than six testing sites;
(b) $350 if there will be 21 to 40 testing events during the license year or they will be held at six to 11 testing sites; and
(c) $450 if there will be more than 40 testing events during the license year or they will be held at 12 or more testing sites.
(2) A cholesterol testing permit holder shall pay an additional licensing fee equal to the difference between the initially submitted licensing fee and the higher licensing fee, as set forth under §D(1) of this regulation, when the cholesterol testing permit holder conducts more testing events or uses more testing sites than authorized in a given permit period.]
10.10.12 Medical Laboratories — Public Health HIV Testing Programs
Authority: Health-General Article, §§17-202, 17-204—17-210, Annotated Code of Maryland
.04 Public Health Testing License for Rapid HIV Antibody Testing and HCV Testing.
A.—D. (text unchanged)
E. To obtain, maintain, or renew a public health testing license, a person shall:
(1)—(2) (text unchanged)
(3) Submit to the Department:
(a) (text unchanged)
(b) The location of all testing sites; and
(c) (text unchanged)
[(d) A $50 licensing fee for each initial license or license renewal, remitted as a check made payable to the Department of Health and Mental Hygiene; and]
(4) (text unchanged)
F.—G. (text unchanged)
Subtitle 12 ADULT HEALTH
10.12.04 Day Care for the Elderly and Adults with a Medical Disability
Authority: Health-General Article, §§2-104, 14-206, and 14-304; State Government Article, §10-226; Annotated Code of Maryland
.04 Licensing Procedure.
A. Letter of Interest.
(1)—(3) (text unchanged)
(4) Upon approval of the letter of interest, an application for licensure shall be submitted on the form developed by the Department [along with a licensure fee calculated under the provisions of §A(5) of this regulation].
[(5) License fee for initials and renewals.
(a) The 2-year license fee, based upon total licensed capacity of the center, shall be computed at a rate of $200, plus $12 times the licensed capacity of the center.
(b) The nonrefundable fee shall be payable by certified check or money order to the Department.]
B. (text unchanged)
C. Issuance of License. When the Department determines that the center has submitted a complete application, [including the required fee,] and that the center is in compliance with this chapter, the Department shall issue a license to operate the center.
D.—E. (text unchanged)
Subtitle 23 ADVANCE DIRECTIVE REGISTRY
10.23.01 Advance Directive Registry
Authority: Health-General Article, §§5-620—5-626, Annotated Code of Maryland
.05 Amendment or Revocation of a Registered Advance Directive.
A. (text unchanged)
B. The Department shall amend the file of a registrant on receipt of:
(1) An application for amendment on a form provided by the Department; and
[(2) The required fee, as set forth in Regulation .06 of this chapter; and]
[(3)] (2) (text unchanged)
C.—D. (text unchanged)
Subtitle 51 FORENSIC LABORATORIES
10.51.02 Responsibilities, Accreditations, and Audits
Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland
.01 Responsibilities of the Department.
A.—C. (text unchanged)
D. Administration and Information Management. The Department shall:
(1)—(3) (text unchanged)
[(4) Set and collect fees as set forth in COMAR 10.51.03.04;] and
[(5)] (4) (text unchanged)
E. (text unchanged)
10.51.03 Licenses [and Fees]
Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland
.02 License — Requirements.
A. Requirements. A person operating a forensic laboratory that performs one or more forensic analyses shall:
(1) Obtain, complete, and submit permit applications [and fees] as prescribed in this subtitle;
(2)—(3) (text unchanged)
B. (text unchanged)
.03 License — Administrative Procedures.
A. Application — Filing.
(1)—(2) (text unchanged)
[(3) A person shall submit with the application the nonrefundable application fee set forth in COMAR 10.51.03.04.]
B. Application — Evaluation and Billing.
[(1)] The Department shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the:
[(a)] (1)—[(b)] (2) (text unchanged)
[(2) After reviewing and evaluating an application, the Department shall bill a forensic laboratory, and the forensic laboratory shall immediately pay the applicable licensing fee.]
C. Application — Denial of License. If the Department determines that a forensic laboratory is not in compliance with the requirements of this subtitle and therefore cannot be issued a license, the Department shall provide to the forensic laboratory:
(1) (text unchanged)
(2) The opportunity to:
(a) Amend and resubmit the application [upon payment of a new application fee]; or
(b) (text unchanged)
D.—H. (text unchanged)
VAN T. MITCHELL
Secretary of Health and Mental Hygiene
