Chapter 04. Certification Requirements
Regulation .01 Scope.LinkCopy Citation
This chapter sets forth additional requirements that a program shall meet to be certified to offer a particular level of treatment. The program shall meet the requirements of COMAR 10.47.01 and this chapter.
Regulation .02 Definitions.LinkCopy Citation
A.
In this chapter, terms have the meanings stated in COMAR 10.47.01.02.
B.
In addition to terms referenced under §A of this regulation, in this chapter the following terms have the meanings indicated.
C.
Terms Defined.
(1)
“Deficiency” means a failure to meet a regulation or its intent.
(2)
“Plan of correction” means the program's proposed response to findings of noncompliance identified by the Office of Health Care Quality or the Administration.
(3)
“Sale” means the transfer of a majority interest of ownership.
Regulation .03 Certification Required.LinkCopy Citation
A.
All programs and prevention programs shall be certified by the Department before program services and prevention program services may be provided in the State.
B.
The following are exempt from certification under this chapter:
(1)
A health professional licensed under the Health Occupations Article who is treating patients within the scope of the professional's practice and who does not advertise the practice as an alcohol abuse or drug abuse program;
(2)
Alcoholics Anonymous, Narcotics Anonymous, transitional housing programs, or other similar organizations, if the organization holds meetings or provides support services to help individuals who show the effects of drug abuse or alcohol abuse;
(3)
An employees' assistance program of a business entity; and
(4)
A hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland, accredited by the Joint Commission on Accreditation of Health Care Organizations with a separately accredited alcohol and drug abuse program.
C.
All programs offering drug and alcohol treatment, care, and rehabilitation are required to be certified except as in §A of this regulation.
D.
Each level of service offered by a program requires a certification.
E.
A separate certification is required for each physical site regardless of the service.
F.
A certification is valid only for the program to which it is issued and is not subject to voluntary or involuntary sale, assignment, or transfer.
G.
Upon sale, transfer, assignment, lease, or relocation, the program shall obtain a new certification.
Regulation .04 Type and Duration of Certification.LinkCopy Citation
A.
Initial Certification.
(1)
After receipt of the completed written or electronic application provided by the Administration and after inspection by the Office of Health Care Quality, if there are no deficiencies, the Administration shall grant an initial certification.
(2)
The initial certification is valid for a period in the discretion of the Administration, not to exceed 6 months.
B.
Provisional Certification.
(1)
After a program has been in operation for 4 months, after inspection by the Office of Health Care Quality, and, if there are deficiencies which are not life threatening, the Administration, with the program's consent, may grant a provisional certification to permit the program to correct its deficiencies as set forth in its plan of correction.
(2)
If upon review of a written or electronic renewal application provided by the Administration, the Office of Health Care Quality finds deficiencies which are not life threatening, the Administration may grant a provisional certification to permit the program to correct the deficiencies as set forth in the plan of correction.
(3)
A provisional certification is valid for a period in the discretion of the Administration, not to exceed 6 months, and may be issued once.
C.
General Certification.
(1)
After a program has been in operation for 4 months, after inspection by the Office of Health Care Quality, if there are no deficiencies, the Administration shall grant the program a general certification.
(2)
A general certification is valid for 2 years from date of issue.
D.
Surrender of Certification. A program shall surrender its certificate to the Administration on:
(1)
Revocation of the program's certification by the Administration;
(2)
Sale of the program;
(3)
Transfer of the program;
(4)
Assignment of the program;
(5)
Lease of the program;
(6)
Relocation of the program; or
(7)
Voluntary decision to close the program.
Regulation .05 Application Process and Evaluation.LinkCopy Citation
A.
Application. An applicant for certification of a program or renewal of certification shall submit to the Office of Health Care Quality:
(1)
A completed application on a written or electronic form approved by the Administration;
(2)
Documentation of:
(a)
The program service plan;
(b)
Satisfactory fire, safety, and health inspection reports; and
(c)
Compliance with COMAR 10.47.01 and the applicable specific program requirements under COMAR 10.47.02;
(3)
A request for a variance or a waiver of a regulation; and
(4)
An application fee of $700 with initial application and at recertification, if the program provides opioid maintenance therapy as described in COMAR 10.47.02.11.
B.
Incomplete Application or Information.
(1)
After reviewing the application, if the Office of Health Care Quality or the Administration finds it needs more information, the Office of Health Care Quality or the Administration shall request the information in writing.
(2)
The application shall remain open for 6 months after the information is requested. If the program does not provide the requested information, the Office of Health Care Quality shall close the application.
C.
Initial Site Visit and Written Report.
(1)
On receipt of a completed application under this regulation and the required documentation, the Office of Health Care Quality shall conduct a site visit and issue a written report. If deficiencies are found, the Office of Health Care Quality shall require the program to submit a written plan of correction within 15 working days.
(2)
Deficiencies in a New Program. If a new program with deficiencies:
(a)
Fails to submit a plan of correction, the Office of Health Care Quality shall considered the application withdrawn; or
(b)
Submits a plan of correction that the Office of Health Care Quality believes:
(i)
Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program initial certification; or
(ii)
Does not correct the deficiencies, the Office of Health Care Quality may issue a denial or permit the program to submit an additional plan of correction.
(3)
Deficiencies in a Program Being Renewed. If a renewal program with deficiencies:
(a)
Fails to submit a plan of correction, the Office of Health Care Quality may recommend disciplinary action; or
(b)
Submits a plan of correction which the Office of Health Care Quality believes:
(i)
Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program general certification;
(ii)
Does not immediately correct the deficiencies but which brings the program into compliance within 4 months, the Office of Health Care Quality may recommend a provisional certification; or
(iii)
Cannot bring the program into compliance within 4 months, the Office of Health Care Quality may recommend disciplinary action, or request another plan of correction.
(4)
No Deficiencies. If no deficiencies are found, the Office of Health Care Quality shall:
(a)
For new applicants, recommend an initial certification; and
(b)
For renewal applicants, recommend general certification.
D.
Site Visit and Written Report After Issuing Initial or Provisional Certificate.
(1)
Within 4 months after the issuance of an initial certification or provisional certification, the Office of Health Care Quality shall conduct a site visit and submit a written report.
(2)
Deficiencies in a Program with Initial Certification. If deficiencies are found, the Office of Health Care Quality shall require the program to submit a plan of correction within 15 days. If the program:
(a)
Fails to submit a plan of correction, the Office of Health Care Quality may recommend disciplinary action; or
(b)
Submits a plan of correction which the Office of Health Care Quality believes:
(i)
Corrects the deficiencies, the Office of Health Care Quality shall recommend the Administration grant the program general certification;
(ii)
Does not immediately correct the deficiencies but which brings the program into compliance within 4 months, the Office of Health Care Quality may recommend a provisional certification; or
(iii)
Cannot bring the program into compliance within 4 months, the Office of Health Care Quality may recommend disciplinary action, or request another plan of correction.
(3)
Deficiencies in a Program with Provisional Certification. The Office of Health Care Quality shall:
(a)
For good cause, permit the program to submit a plan of correction within 15 days and follow §C(1) of this regulation; or
(b)
Recommend disciplinary action.
(4)
No Deficiencies. If no deficiencies are found, the Office of Health Care Quality shall recommend a general certification.
E.
In considering a renewal application, the Administration may accept accreditation of the program by an accreditation organization approved in accordance with Health-General Article, §19-2302(a) and (b), Annotated Code of Maryland, in lieu of the site visit and written report by the Office of Health Care Quality that is otherwise required by this regulation.
Regulation .06 Waiver and Variances.LinkCopy Citation
A.
Upon written request by the program, the Director shall issue a written decision which may:
(1)
Grant a variance or waiver from a regulation if the:
(a)
Variance or waiver would not endanger the life or safety of a patient in a program; or
(b)
Intent of the regulation to which a variance or waiver is sought meets the alternative proposed by the program; or
(2)
Deny the variance or waiver.
B.
The Director may grant a variance or waiver that:
(1)
Remains in effect for as long as the program continues to comply with the conditions under which the variance or waiver is granted; or
(2)
Is time limited.
C.
The program is responsible for maintaining a copy of the decision in its certification file.
Regulation .07 Investigation or Inspection by the Administration or Office of Health Care Quality.LinkCopy Citation
A.
A program shall be open at all reasonable times for announced and unannounced inspections or investigations by the Administration or its designees.
B.
A program shall be open at all reasonable times for announced and unannounced inspections or investigations by the Office of Health Care Quality.
Regulation .08 Denial, Probation, Intermediate Sanctions, Suspension, or Revocation.LinkCopy Citation
A.
If an applicant or program fails to comply with the applicable State and federal laws, rules, or regulations, the Director may:
(1)
Deny approval to the applicant; or
(2)
Take disciplinary action, such as:
(a)
Placing the program on probation;
(b)
Suspending or revoking the certification of the program; or
(c)
Imposing intermediate sanctions on the program.
B.
For purposes of §A of this regulation, intermediate sanctions include:
(1)
A directed plan of correction, if the program is directed to take a specific action by a certain date;
(2)
A mandatory staffing pattern that is stricter than that required under the appropriate level of care required under COMAR 10.47.02, if the Administration defines for the program the level of individual supervision;
(3)
Mandatory training, if the Administration identifies deficient areas in which training is needed;
(4)
Patient relocation, if the Administration reserves the right to relocate a patient to another program in order to protect the health and safety of the patient;
(5)
Expansion ban, if the Administration retains the authority to prohibit the program from obtaining additional sites, admitting individuals, or providing additional services at the site;
(6)
Imposition of an intensive monitoring protocol by the Administration; or
(7)
Imposition of a temporary site monitor, if the Administration maintains an ongoing physical presence for the purpose of providing assistance and evaluating the extent of the program's corrective actions.
C.
If the Director proposes to deny approval to an applicant or to take disciplinary action against a program, the Director shall give written notice to the governing body or the health officer and the administrator of the program.
D.
In the written notice under §C of this regulation, the Director shall include:
(1)
The statutory and regulatory authority upon which the proposed action is based;
(2)
The facts supporting the alleged violation of law; and
(3)
The applicant's or program's right to a hearing before final action under §F of this regulation.
E.
Summary Suspension.
(1)
Under the State Government Article, §10-226(c)(2), Annotated Code of Maryland, and if appropriate, after a predeprivation hearing, the Director may summarily order the suspension of a certification if the Administration finds that the public health, safety, or welfare imperatively requires emergency action.
(2)
The Director shall notify the program in writing of the suspension, findings, and reasons that support the findings, and, if appropriate, the opportunity for a predeprivation hearing. The notice shall include:
(a)
The proposed order for summary suspension which includes:
(i)
The statutory and regulatory authority upon which the order is based;
(ii)
The facts supporting the alleged violations of law;
(iii)
The facts supporting the belief that there is an imminent danger to the health, safety, and welfare of individuals; and
(iv)
The program's right to appeal the summary suspension, if executed by the Director; and
(b)
A show cause notice providing an opportunity for the program to show cause as to why an order under §C(1) of this regulation should not be issued.
(3)
The Director may suspend an approval without prior notice and the opportunity to be heard if:
(a)
The Director determines that the health, welfare, and safety of the public imperatively requires immediate suspension;
(b)
Notice of an opportunity to be heard before the action is not feasible; and
(c)
The Administration provides the program with a post-deprivation hearing opportunity within 15 working days of the suspension.
(4)
The Administration shall:
(a)
Notify the individuals being served by the program and, if appropriate, their families or proponents, regarding the summary suspension; and
(b)
Assist the individuals in finding alternative services if the approval is summarily suspended.
F.
Procedures for Hearings.
(1)
If the Director proposes to deny an approval or take disciplinary action against a program, the Director shall give the program written notice according to §D of this regulation.
(2)
Within 10 working days of receipt of the notice, the governing body or health officer may file a written request for a hearing with the Office of Administrative Hearings and send copies of the request to the:
(a)
Director; and
(b)
Administrative prosecutor.
(3)
If the governing body or the health officer does not file a request for a hearing within 10 working days of receipt of the notification, the:
(a)
Program waives its right to request a hearing; and
(b)
Director may implement the proposed action.
(4)
If a timely request for a hearing has been received, the Office of Administrative Hearings shall:
(a)
Notify the Director, the governing body or health officer, and administrative prosecutor of the date, time, and location of the hearing; and
(b)
In accordance with COMAR 28.02.01, hold a hearing and, unless the final decision is delegated to the Office of Administrative Hearings, render a proposed decision to the Director.
(5)
After giving the parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Director shall issue a final decision and send notice to the governing body or the health officer.
(6)
A program may appeal any final decision from a contested case by following the provisions of Health-General Article, §2-207, Annotated Code of Maryland, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.
(7)
In addition to disposing of a case by a hearing, the Director may dispose of a contested case by:
(a)
Stipulation;
(b)
Settlement;
(c)
Consent order;
(d)
Default;
(e)
Withdrawal;
(f)
Summary disposition; or
(g)
Dismissal.
Chapter annotations
Authority: Health-General Article, §§7.5-205, 8-401 — 8-405, and 19-308, Annotated Code of Maryland
History: Effective date: June 10, 2002 (29:11 Md. R. 882)
History: Chapter recodified from COMAR 10.47.03 to 10.47.04 as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); recodified permanently effective May 5, 2008 (35:9 Md. R. 898)
History: Regulation .01 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)
History: Regulation .03 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)
History: Regulation .04A, B amended effective March 13, 2017 (44:5 Md. R. 292)
History: Regulation .04D adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898)
History: Regulation .05A amended effective March 13, 2017 (44:5 Md. R. 292)
History: Regulation .05A, B amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)
History: Regulation .05E adopted effective November 24, 2014 (41:23 Md. R. 1374)
History: Regulation .07 recodified to be Regulation .08 and new Regulation .07 adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); adopted permanently effective May 5, 2008 (35:9 Md. R. 898)
History: Regulation .08 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 894); amended permanently effective May 5, 2008 (35:9 Md. R. 898)