In this subtitle, “Commission” means the Maryland Health Care Commission.
The General Assembly finds that the health care regulatory system in this State is a highly complex structure that needs to be constantly reevaluated and modified in order to better reflect and be more responsive to the ever changing health care environment and the needs of the citizens of this State.
The purpose of this subtitle is to establish a streamlined health care regulatory system in this State in a manner such that a single State health policy can be better articulated, coordinated, and implemented in order to better serve the citizens of this State.
There is a Maryland Health Care Commission.
The Commission is an independent commission that functions in the Department.
The purpose of the Commission is to:
Develop health care cost containment strategies to help provide access to appropriate quality health care services for all Marylanders, after consulting with the Health Services Cost Review Commission;
Promote the development of a health regulatory system that provides, for all Marylanders, financial and geographic access to quality health care services at a reasonable cost by:
Advocating policies and systems to promote the efficient delivery of and improved access to health care services; and
Enhancing the strengths of the current health care service delivery and regulatory system;
Facilitate the public disclosure of medical claims data for the development of public policy;
Establish and develop a medical care database on health care services rendered by health care practitioners;
Encourage the development of clinical resource management systems to permit the comparison of costs between various treatment settings and the availability of information to consumers, providers, and purchasers of health care services;
In accordance with Title 15, Subtitle 12 of the Insurance Article, develop a uniform set of effective benefits to be included in the Comprehensive Standard Health Benefit Plan;
Analyze the medical care database and provide, in aggregate form, an annual report on the variations in costs associated with health care practitioners;
Ensure utilization of the medical care database as a primary means to compile data and information and annually report on trends and variances regarding fees for service, cost of care, regional and national comparisons, and indications of malpractice situations;
Establish standards for the operation and licensing of medical care electronic claims clearinghouses in Maryland;
Reduce the costs of claims submission and the administration of claims for health care practitioners and payors;
Determine the cost of mandated health insurance services in the State in accordance with Title 15, Subtitle 15 of the Insurance Article;
Promote the availability of information to consumers on charges by practitioners and reimbursements from payors;
Oversee and administer the Maryland Trauma Physician Services Fund in conjunction with the Health Services Cost Review Commission; and
Establish policies and standards to protect the confidentiality of patient and health care practitioner information related to legally protected health care as defined in § 4–301 of this article.
The Commission shall coordinate the exercise of its functions with the Department and the Health Services Cost Review Commission to ensure an integrated, effective health care policy for the State.
The Commission shall consist of 15 members appointed by the Governor with the advice and consent of the Senate.
Of the 15 members:
Eight shall be individuals who do not have any connection with the management or policy of a health care provider or payor; and
Of the remaining seven members:
Two shall be physicians;
Two shall be payors, as defined in § 19–132 of this subtitle;
One shall be an administrator of a hospital, as defined in § 19–301 of this title;
One shall be a nursing home administrator in the State; and
One shall be a nonphysician health care practitioner.
The term of a member is 4 years.
The terms of members are staggered as required by the terms provided for members of the Commission on October 1, 1999.
At the end of a term, a member continues to serve until a successor is appointed and qualifies.
A member who is appointed after a term has begun serves only for the rest of the term and until a successor is appointed and qualifies.
The Governor may remove a member for neglect of duty, incompetence, or misconduct.
A member may not serve more than two consecutive terms.
When appointing members to the Commission, the Governor shall:
Assure that:
At least four members are residents of different counties with a population of 300,000 or more; and
At least three members are residents of different counties with a population of less than 300,000, of which at least:
One shall be a resident of the Eastern Shore;
One shall be a resident of Allegany County, Garrett County, Washington County, Carroll County, or Frederick County; and
One shall be a resident of Southern Maryland; and
To the extent practicable, assure geographic balance and promote racial, ethnic, and gender diversity in the Commission’s membership.
The Governor shall appoint the chairman of the Commission.
The chairman may appoint a vice chairman for the Commission.
With the approval of the Governor, the Commission shall appoint an executive director who shall be the chief administrative officer of the Commission.
The executive director, the deputy directors, and the principal section chiefs serve at the pleasure of the Commission.
The executive director, the deputy directors, and the principal section chiefs shall be executive service or management service employees.
The Commission, in consultation with the Secretary, shall determine the appropriate job classification and, subject to the State budget, the compensation for the executive director, the deputy directors, and the principal section chiefs.
Under the direction of the Commission, the executive director shall perform any duty or function that the Commission requires.
A majority of the full authorized membership of the Commission is a quorum.
The decision of the Commission shall be by a majority of the quorum present and voting.
The Commission shall meet at least six times each year, at the times and places that it determines.
Each member of the Commission is entitled to:
Compensation in accordance with the State budget; and
Reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget.
The Commission may employ a staff in accordance with the State budget.
The Commission, in consultation with the Secretary, may set the compensation of a Commission employee in a position that:
Is unique to the Commission;
Requires specific skills or experience to perform the duties of the position; and
Does not require the employee to perform functions that are comparable to functions performed in other units of the Executive Branch of State government.
The Secretary of Budget and Management, in consultation with the Secretary, shall determine the positions for which the Commission may set compensation under paragraph (2) of this subsection.
In addition to the duties set forth elsewhere in this subtitle, the Commission:
Shall adopt regulations specifying the Comprehensive Standard Health Benefit Plan to apply under Title 15, Subtitle 12 of the Insurance Article; and
On or before March 1, 2008, in consultation with the Department, shall propose regulations to:
Specify the components of wellness benefits, offered under Title 15, Subtitle 12 of the Insurance Article, that include incentives or differential cost–sharing for employees based on their participation in wellness activities; and
Require small employers receiving a subsidy of small employer health benefit plan premium contributions under Title 15, Subtitle 12A of the Insurance Article to agree to purchase a wellness benefit.
In carrying out its duties under this section, the Commission shall comply with the provisions of § 15–1207 and Title 15, Subtitle 12A of the Insurance Article.
In addition to the duties set forth elsewhere in this subtitle, the Commission shall maintain on its website an application that a small business may use to compare premiums of health benefit plans offered by health insurance carriers under Title 15, Subtitle 12 of the Insurance Article.
The application required under this section shall provide information on:
Premiums for health benefit plans sold under Title 15, Subtitle 12 of the Insurance Article, categorized by age bands; and
Premiums for health benefit plans sold under Title 15, Subtitle 12 of the Insurance Article that include riders typically purchased by small employers in the State.
The Commission shall update the information required under this section at least quarterly.
In this section the following words have the meanings indicated.
‘‘Health care service” has the meaning stated in § 15–10A–01 of the Insurance Article.
“Payor” means:
An insurer or nonprofit health service plan that provides hospital, medical, or surgical benefits to individuals or groups on an expense–incurred basis under health insurance policies or contracts that are issued or delivered in the State;
A health maintenance organization that provides hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State; or
A pharmacy benefits manager that is registered with the Maryland Insurance Commissioner.
“Provider” has the meaning stated in § 19–7A–01 of this title.
“Step therapy or fail–first protocol” has the meaning stated in § 15–142 of the Insurance Article.
In addition to the duties stated elsewhere in this subtitle, the Commission shall work with payors and providers to attain benchmarks for:
Standardizing and automating the process required by payors for preauthorizing health care services; and
Overriding a payor’s step therapy or fail–first protocol.
The benchmarks described in subsection (b) of this section shall include:
On or before October 1, 2012 (“Phase 1”), establishment of online access for providers to each payor’s:
List of health care services that require preauthorization; and
Key criteria for making a determination on a preauthorization request;
On or before March 1, 2013 (“Phase 2”), establishment by each payor of an online process for:
Accepting electronically a preauthorization request from a provider; and
Assigning to a preauthorization request a unique electronic identification number that a provider may use to track the request during the preauthorization process, whether or not the request is tracked electronically, through a call center, or by fax;
On or before July 1, 2013 (“Phase 3”), establishment by each payor of an online preauthorization system to approve:
In real time, electronic preauthorization requests for pharmaceutical services:
For which no additional information is needed by the payor to process the preauthorization request; and
That meet the payor’s criteria for approval;
Within 1 business day after receiving all pertinent information on requests not approved in real time, electronic preauthorization requests for pharmaceutical services that:
Are not urgent; and
Do not meet the standards for real–time approval under item (i) of this item; and
Within 2 business days after receiving all pertinent information, electronic preauthorization requests for health care services, except pharmaceutical services, that are not urgent;
On or before July 1, 2015, establishment, by each payor that requires a step therapy or fail–first protocol, of a process for a provider to override the step therapy or fail–first protocol of the payor; and
On or before July 1, 2015, utilization by providers of:
The online preauthorization system established by payors; or
If a national transaction standard has been established and adopted by the health care industry, as determined by the Commission, the provider’s practice management, electronic health record, or e–prescribing system.
The benchmarks described in subsections (b) and (c) of this section do not apply to preauthorizations of health care services requested by providers employed by a group model health maintenance organization as defined in § 19–713.6 of this title.
The online preauthorization system described in subsection (c)(3) of this section shall:
Provide real–time notice to providers about preauthorization requests approved in real time; and
Provide notice to providers, within the time frames specified in subsection (c)(3)(ii) and (iii) of this section and in a manner that is able to be tracked by providers, about preauthorization requests not approved in real time.
The Commission shall establish by regulation a process through which a payor or provider may be waived from attaining the benchmarks described in subsections (b) and (c) of this section for extenuating circumstances.
For a provider, the extenuating circumstances may include:
The lack of broadband Internet access;
Low patient volume; or
Not making medical referrals or prescribing pharmaceuticals.
For a payor, the extenuating circumstances may include:
Low premium volume; or
For a group model health maintenance organization, as defined in § 19–713.6 of this title, preauthorizations of health care services requested by providers not employed by the group model health maintenance organization.
On or before October 1, 2012, the Commission shall reconvene the multistakeholder workgroup whose collaboration resulted in the 2011 report “Recommendations for Implementing Electronic Prior Authorizations”.
The workgroup shall:
Review the progress to date in attaining the benchmarks described in subsections (b) and (c) of this section; and
Make recommendations to the Commission for adjustments to the benchmark dates.
If necessary to attain the benchmarks, the Commission may adopt regulations to:
Adjust the Phase 2 or Phase 3 benchmark dates;
Require payors and providers to comply with the benchmarks; and
Establish penalties for noncompliance.
In this section the following words have the meanings indicated.
“Carrier” includes insurers, nonprofit health service plans, health maintenance organizations, third–party administrators, and pharmacy benefits managers.
“Health care provider” includes hospitals, physicians, nurse practitioners, pharmacists, and other persons entitled to reimbursement under § 15–701(a) of the Insurance Article.
“Workgroup” means the Health Care Provider–Carrier Workgroup.
The Commission shall establish a Health Care Provider–Carrier Workgroup.
The purpose of the Workgroup is to provide a mechanism for health care providers and carriers to resolve disputes on issues over which no State agency has statutory or regulatory authority.
The Workgroup shall be composed of representatives of:
Professional organizations or associations of health care providers who bill and receive reimbursement for health care services from carriers;
Carriers or organizations or trade associations representing carriers that reimburse health care providers for health care services provided under health benefit plans; and
Subject to subsection (e)(1)(iii) of this section, consumer organizations.
The Commission shall invite the following to appoint members to the Workgroup:
Professional organizations or associations of health care providers;
Carriers or organizations or trade associations representing carriers; and
When appropriate to the issue under discussion, consumer organizations.
Membership in the Workgroup may change depending on the issues before the Workgroup.
The size of the Workgroup shall be at the discretion of the Commission but large enough to represent the appropriate range of stakeholders.
Workgroup members may not receive compensation or reimbursement for serving on the Workgroup.
The Workgroup shall meet at least quarterly.
Commission staff shall facilitate Workgroup meetings and provide research and other support to the Workgroup.
At least annually, Commission staff shall solicit issues for consideration by the Workgroup.
Issues shall be solicited from:
Members of the General Assembly;
Professional organizations or associations of health care providers and carriers or organizations or trade associations representing carriers;
State agencies, including the Department, health occupations boards, the Maryland Insurance Administration, and the Commission; and
Consumer organizations.
After soliciting issues under subsection (i) of this section, Commission staff shall select the issues to be considered by the Workgroup.
Commission staff shall:
Research each issue before the issue is considered by the Workgroup;
Use the results of the research to inform Workgroup meetings;
Facilitate Workgroup meetings in a way that promotes resolution of disputes on issues and is satisfactory to the members of the Workgroup; and
On or before January 1, 2016, and each year thereafter, submit a report to the Commission and, in accordance with § 2–1257 of the State Government Article, the Senate Finance Committee and the House Health and Government Operations Committee regarding the issues considered by the Workgroup during the preceding year and the outcome of the Workgroup’s consideration of each issue.
In this section, “primary care” means health care provided in the following fields’ outpatient settings:
Family medicine;
General pediatrics;
Primary care internal medicine;
Primary care obstetrics and gynecology;
Primary care nurse practitioner services; and
Primary care midwifery.
On or before December 1 each year, beginning in 2024, the Commission shall provide a report to the Governor and, in accordance with § 2–1257 of the State Government Article, the General Assembly that includes:
An analysis of primary care investment over the immediately preceding year, including data stratified by zip code and county, in relation to total health care spending over the previous year;
Ways to improve the quality of and access to primary care services, with special attention to increasing health care equity, reducing health care disparities, and avoiding increased costs to patients and the health care system; and
Any findings and recommendations of the Commission.
The Commission shall form a workgroup to develop the report required under subsection (b) of this section, including by interpreting the results of the required analysis and making the recommendations.
The workgroup required under this subsection shall include representatives of:
The Maryland Primary Care Program;
The Health Services Cost Review Commission;
The Maryland Insurance Administration;
The Health Care Financing Division of the Maryland Department of Health;
The primary care community, including from the Maryland Academy of Family Physicians, the Maryland Chapter of the American Academy of Pediatrics, the Maryland Section of the American College of Obstetricians and Gynecologists, the Maryland Nurses Association, the Maryland Affiliate – American College of Nurse Midwives, the Maryland Community Health System, and the MidAtlantic Association of Community Health Centers;
Payors of primary care services, including carriers and managed care organizations;
Health services researchers with expertise in primary care; and
Other interested stakeholders.
In this section the following words have the meanings indicated.
“Carrier” has the meaning stated in § 15–1301 of the Insurance Article.
“Health care provider” has the meaning stated in § 19–108.3 of this subtitle.
On or before July 1, 2026, a carrier shall establish and maintain an online process that:
Links directly to all e–prescribing systems and electronic health record systems that use the National Council for Prescription Drug Programs SCRIPT standard and the National Council for Prescription Drug Programs Real Time Benefit Standard;
Can accept electronic prior authorization requests from a health care provider;
Can approve electronic prior authorization requests:
For which no additional information is needed by the carrier to process the prior authorization request;
For which no clinical review is required; and
That meet the carrier’s criteria for approval; and
Links directly to real–time patient out–of–pocket costs, including copayment, deductible, and coinsurance costs, and more affordable medication alternatives made available by the carrier.
A carrier may not:
Impose a fee or charge on a person for accessing the online process required under paragraph (1) of this subsection; or
Access, without health care provider consent, health care provider data via the online process other than for the insured or enrollee.
On or before July 1, 2025, a carrier shall:
On request of a health care provider, provide contact information for each third–party vendor or other entity that the carrier will use to meet the requirements of subsection (b) of this section; and
Post the contact information required to be provided under item (1) of this subsection on its website.
On or before July 1, 2026, each health care provider shall ensure that each e–prescribing system or electronic health record system owned or contracted for by the health care provider to maintain a health record of an insured or enrollee has the ability to access, at the point of prescribing:
The electronic prior authorization process established by a carrier under subsection (b) of this section; and
The real–time patient out–of–pocket cost information and available medication alternatives required under subsection (b) of this section.
The Commission shall establish by regulation a process through which a health care provider may request and receive a waiver of compliance from the requirements of this subsection.
On or before July 1, 2026, each carrier, or a pharmacy benefits manager on behalf of the carrier, shall:
Provide real–time patient–specific benefit information to insureds and enrollees and contracted health care providers, including any out–of–pocket costs and more affordable medication alternatives or prior authorization requirements; and
Ensure that the information provided under item (i) of this paragraph is accurate.
Each carrier, or a pharmacy benefits manager on behalf of the carrier, shall make available the information required to be provided under paragraph (1) of this subsection to the health care provider at the point of prescribing in an accessible and understandable format, such as through the health care provider’s e–prescribing system or electronic health record system that the carrier, pharmacy benefits manager, or designated subcontractor has adopted that uses the National Council for Prescription Drug Programs SCRIPT standard and the National Council for Prescription Drug Programs Real Time Benefit Standard from which the health care provider makes the request.
On or before December 1 every 4 years, beginning in 2026, the Commission shall submit a report to the Governor and, in accordance with § 2–1257 of the State Government Article, the General Assembly that includes:
Advances or developments in the area of telehealth, including:
Evolving modalities of telehealth delivery; and
Changes in the costs of delivering telehealth services; and
Any findings or recommendations of the Commission.
In addition to the powers set forth elsewhere in this subtitle, the Commission may:
Adopt rules and regulations to carry out the provisions of this subtitle;
Create committees from among its members;
Appoint advisory committees, which shall include consumers and may include representatives of interested public or private organizations, to make recommendations to the Commission on community–based services, long–term care, acute patient services, ambulatory surgical services, specialized health care services, residential treatment centers for emotionally disturbed children and adolescents, mental health and alcohol and drug abuse services, and any other topic or issue that the Commission considers necessary;
Apply for and accept any funds, property, or services from any person or government agency;
Subject to subsection (d) of this section, award any funds received from any person or government agency;
Make agreements with a grantor or payor or with a grantee or payee of funds, property, or services, including an agreement to make any study, plan, demonstration, or project;
Publish and give out any information that relates to the financial aspects of health care and is considered desirable in the public interest; and
Subject to the limitations of this subtitle, exercise any other power that is reasonably necessary to carry out the purposes of this subtitle, including adopting regulations that set reasonable deadlines for filing of information or reports required under this subtitle and impose reasonable penalties for failure to file information or reports as required.
In addition to the duties set forth elsewhere in this subtitle, the Commission shall:
Adopt rules and regulations that relate to its meetings, minutes, and transactions;
Keep minutes of each meeting;
Prepare annually a budget proposal that includes the estimated income of the Commission and proposed expenses for its administration and operation;
Beginning December 1, 2000, and each December 1 thereafter, submit to the Governor, the Secretary, and, subject to § 2–1257 of the State Government Article, the General Assembly an annual report on the operations and activities of the Commission during the preceding fiscal year, including:
A copy of each summary, compilation, and supplementary report required by this subtitle; and
Any other fact, suggestion, or policy recommendation that the Commission considers necessary;
Except for confidential or privileged medical or patient information, make:
Each report filed and each summary, compilation, and report required under this subtitle available for public inspection at the office of the Commission during regular business hours; and
Each summary, compilation, and report available to any other State agency on request; and
In collaboration with the Office of Health Care Quality, develop a process to receive the following information and publish it on the Commission’s Maryland Quality Reporting website for each applicable facility:
The date of the Office’s most recent inspection; and
Any associated ratings or other quality metrics calculated.
The Commission may contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the Commission.
Unless permission is granted specifically by the Commission, a third party hired by the Commission may not release, publish, or otherwise use any information to which the third party has access under its contract.
In awarding funds under subsection (a)(5) of this section, the Commission shall:
Use a competitive process that affords interested persons an opportunity to submit a proposal for funding; and
Evaluate proposals for funding using a panel that consists of internal and external evaluators.
The Commission shall:
Provide on its website information that is easily accessible to the general public about funds to be awarded under subsection (a)(5) of this section and how to submit a proposal; and
Submit, in accordance with § 2–1257 of the State Government Article, an annual report to the General Assembly listing all funds awarded under subsection (a)(5) of this section.
Except as expressly provided in this subtitle, the power of the Secretary over plans, proposals, and projects of units in the Department does not include the power to disapprove or modify any regulation, decision, or determination that the Commission makes under authority specifically delegated by law to the Commission.
The power of the Secretary to transfer, by rule, regulation, or written directive, any staff, functions, or funds of units in the Department does not apply to any staff, function, or funds of the Commission.
The Secretary may assess an administrative charge, consistent with the indirect cost charge assessed to federal grants, to fund services provided to the Commission by the Executive Branch.
The power of the Secretary over the procurement procedure for units in the Department does not apply to the procurement procedure for the Commission.
Subject to the provisions of paragraph (1) of this subsection, any procurement for services to be performed or for supplies to be delivered to the Commission is subject to the purposes and requirements of the State Finance and Procurement Article.
In this section the following words have the meanings indicated.
“Fund” means the Maryland Health Care Commission Fund.
“Health benefit plan” has the meaning stated in § 15–1201 of the Insurance Article.
“Health care practitioner” means any individual who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide health care services.
“Nursing home” means a related institution that is classified as a nursing home.
“Payor” means:
A health insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in the State in accordance with this article or the Insurance Article; or
A health maintenance organization that holds a certificate of authority in the State.
Subject to the provisions of subsection (d) of this section, the Commission shall assess a fee on:
All hospitals;
All nursing homes;
All payors; and
All health care practitioners.
The total fees assessed by the Commission may not exceed $20,000,000.
The fees assessed by the Commission shall be used exclusively to cover the actual documented direct costs of fulfilling the statutory and regulatory duties of the Commission in accordance with the provisions of this subtitle.
The costs of the Commission include the administrative costs incurred by the Department on behalf of the Commission.
The amount to be paid by the Commission to the Department for administrative costs, not to exceed 30.5% of the salaries of the Commission, shall be based on indirect costs or services benefiting the Commission, less overhead costs paid directly by the Commission.
The Commission shall pay all funds collected from the fees assessed in accordance with this section into the Fund.
The fees assessed may be expended only for purposes authorized by the provisions of this subtitle.
The amount in paragraph (1) of this subsection limits only the total fees the Commission may assess in a fiscal year.
In determining assessments of the total fees, the Commission shall:
Use a methodology that accounts for the portion of the Commission’s workload attributable to each industry assessed; and
Recalculate workload distribution every 4 years.
The fees assessed in accordance with this section on health care practitioners shall be:
Included in the licensing fee paid to the health care practitioner’s licensing board; and
Transferred by the health care practitioner’s licensing board to the Commission on a quarterly basis.
The Commission may adopt regulations that waive the fee assessed under this section for a specific class of health care practitioners.
Subject to subparagraph (ii) of this paragraph, the Commission shall adopt regulations to permit a waiver of the fee assessment requirements for certain health care practitioners.
In adopting regulations to permit a waiver of the fee assessment requirements for certain health care practitioners, the Commission shall:
Consider the hourly wages of the health care practitioners; and
Give preference to exempting health care practitioners with an average hourly wage substantially below that of other health care practitioners.
There is a Maryland Health Care Commission Fund.
The Fund is a special continuing, nonlapsing fund that is not subject to § 7–302 of the State Finance and Procurement Article.
The Treasurer shall separately hold, and the Comptroller shall account for, the Fund.
The Fund shall be invested and reinvested in the same manner as other State funds.
Any investment earnings shall be retained to the credit of the Fund.
The Fund shall be subject to an audit by the Office of Legislative Audits as provided for in § 2–1220 of the State Government Article.
This section may not be construed to prohibit the Fund from receiving funds from any other source.
The Fund shall be used only to provide funding for the Commission and for the purposes authorized under this subtitle.
The Commission shall:
Assess fees on payors in a manner that apportions the total amount of the fees to be assessed on payors under subsection (d)(1) of this section among each payor based on the ratio of each payor’s total premiums written in the State for health benefit plans to the total written premiums of all payors written in the State; and
On or before June 30 of each year, assess each payor a fee in accordance with item (i) of this item;
Assess fees for each hospital equal to the sum of:
The amount equal to one–half of the total fees to be assessed on hospitals under subsection (d)(1) of this section times the ratio of admissions of the hospital to total admissions of all hospitals; and
The amount equal to one–half of the total fees to be assessed on hospitals under subsection (d)(1) of this section times the ratio of gross operating revenue of each hospital to total gross operating revenues of all hospitals;
Establish minimum and maximum assessments; and
On or before June 30 of each year, assess each hospital a fee in accordance with item (i) of this item; and
Assess fees for each nursing home equal to the sum of:
The amount equal to one–half of the total fees to be assessed on nursing homes under subsection (d)(1) of this section times the ratio of admissions of the nursing home to total admissions of all nursing homes; and
The amount equal to one–half of the total fees to be assessed on nursing homes under subsection (d)(1) of this section times the ratio of gross operating revenue of each nursing home to total gross operating revenues of all nursing homes;
Establish minimum and maximum assessments; and
On or before June 30 of each year, assess each nursing home a fee in accordance with item (i) of this item.
On or before September 1 of each year, each payor, hospital, and nursing home assessed under this section shall make payment to the Commission.
The Commission shall make provisions for partial payments.
Any bill not paid within 30 days of the payment due date may be subject to an interest penalty to be determined and collected by the Commission.
In this section the following words have the meanings indicated.
“Center” means a Patient Safety Center designated by the Commission.
“Fund” means the Maryland Patient Safety Center Fund.
On or before December 31, 2025, the Commission shall designate a Center for the State.
The Center designated under paragraph (1) of this subsection shall continue to act as the State–designated Center for the duration of the designation period, as determined by the Commission, if the Center continuously meets the standards and requirements established by the Commission.
The designated Center shall:
Develop, coordinate, and implement patient safety initiatives across the State;
Be a model for patient safety innovation and implementation in the State;
Convene health care providers, patients, and families to:
Improve the quality of health care and reduce preventable and avoidable harm; and
Provide safe and equitable health care for State citizens; and
Share information relating to best practices among providers and patients in the State.
There is a Patient Safety Center Fund.
The purpose of the Fund is to subsidize a portion of the costs of the Center so that the Center may perform the duties described under subsection (c) of this section.
The Commission shall administer the Fund.
The Fund is a special, nonlapsing fund that is not subject to § 7–302 of the State Finance and Procurement Article.
The State Treasurer shall hold the Fund separately, and the Comptroller shall account for the Fund.
The Fund consists of:
Money appropriated in the State budget to the Fund;
Interest earnings; and
Any other money from any other source accepted for the benefit of the Fund.
The Fund may be used only to subsidize a portion of the costs of the Center so that the Center may perform the duties described under subsection (c) of this section.
The State Treasurer shall invest the money of the Fund in the same manner as other State money may be invested.
Any interest earnings of the Fund shall be credited to the Fund.
For fiscal years 2023 through 2025, the Governor shall include in the annual budget bill an appropriation of $1,000,000 for the Fund.
For fiscal year 2027 and each fiscal year thereafter, the Governor shall include in the annual budget bill an appropriation of $1,000,000 for the Fund.
The Commission may provide an annual grant from the Fund to the Center in the amount appropriated under paragraph (1) of this subsection, plus any interest and other income distributed to the Fund.
Expenditures from the Fund may be made only in accordance with the State budget.
Money expended from the Fund for the Center is supplemental to, and is not intended to take the place of, funding that otherwise would be appropriated for the Center.
On or before October 1 each year, the Commission, in conjunction with the Center, shall report to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, on:
The Center’s statewide activities related to the development, coordination, and implementation of patient safety initiatives; and
How the Center’s statewide initiatives align with State–designated priorities.
In this Part II of this subtitle the following words have the meanings indicated.
“Acquisition” means:
A transfer of stock or assets that results in a change of the person that controls a health care facility; or
The transfer of more than 25% of stock or ownership interest in a health care facility.
“Ambulatory surgical facility” means any center, service, office, facility, or office of one or more health care practitioners or a group practice that:
Has three or more operating rooms;
Operates primarily for the purpose of providing surgical services to patients who do not require overnight hospitalization; and
Seeks reimbursement from payors as an ambulatory surgical facility.
“Certificate of need” means a certification of public need issued by the Commission under this Part II of this subtitle for a health care project.
“Health care facility” means:
A hospital, as defined in § 19–301 of this title;
A limited service hospital, as defined in § 19–301 of this title;
A related institution, as defined in § 19–301 of this title;
An ambulatory surgical facility;
An inpatient facility that is organized primarily to help in the rehabilitation of disabled individuals, through an integrated program of medical and other services provided under competent professional supervision;
A home health agency, as defined in § 19–401 of this title;
A hospice, as defined in § 19–901 of this title;
A freestanding medical facility, as defined in § 19–3A–01 of this title; and
Any other health institution, service, or program for which this Part II of this subtitle requires a certificate of need.
“Health care facility” does not include:
A hospital or related institution that is operated, or is listed and certified, by the First Church of Christ Scientist, Boston, Massachusetts;
For the purpose of providing an exception to the requirement for a certificate of need under § 19–120 of this subtitle, a facility to provide comprehensive care constructed by a provider of continuing care, as defined in § 10–401 of the Human Services Article, if:
Except as provided under § 19–123 of this subtitle, the facility is for the exclusive use of the provider’s subscribers who have executed continuing care agreements, including continuing care at home agreements, and paid entrance fees that are at least equal to the lowest entrance fee charged for an independent living unit, an assisted living unit, or a continuing care at home agreement before entering the continuing care community, regardless of the level of care needed by the subscribers at the time of admission;
The facility is located on the campus of the continuing care community; and
The number of comprehensive care nursing beds in the community does not exceed:
24 percent of the number of independent living units in a community having less than 300 independent living units; or
20 percent of the number of independent living units in a community having 300 or more independent living units;
For the purpose of providing an exception to the requirement for a certificate of need under § 19–120 of this subtitle, a facility to provide comprehensive care that:
Is owned and operated by the Maryland Department of Veterans and Military Families; and
Restricts admissions to individuals who meet the residency requirements established by the Maryland Department of Veterans and Military Families and are:
Veterans who were discharged or released from the uniformed services under honorable conditions;
Former members of a reserve component, as defined in § 9–901 of the State Government Article; or
Nonveteran spouses of eligible veterans;
Except for a facility to provide kidney transplant services or programs, a kidney disease treatment facility, as defined by rule or regulation of the United States Department of Health and Human Services;
Except for kidney transplant services or programs, the kidney disease treatment stations and services provided by or on behalf of a hospital or related institution; or
The office of one or more individuals licensed to practice dentistry under Title 4 of the Health Occupations Article, for the purposes of practicing dentistry.
“Health care practitioner” means any individual who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide health care services.
“Health service area” means an area of this State that the Governor designates as appropriate for planning and developing of health services.
“Local health planning agency” means the health department of a jurisdiction or a body designated by the local health department to perform health planning functions.
“State health plan” means the State health plan for facilities and services.
In addition to the duties set forth elsewhere in this subtitle, in this Part II of this subtitle, the Commission shall:
Act as the State agency to represent the State under Title VI of the federal Public Health Service Act; and
Periodically participate in or perform analyses and studies that relate to:
Adequacy of services and financial resources to meet the needs of the population;
Distribution of health care resources;
Allocation of health care resources;
Costs of health care in relationship to available financial resources; or
Any other appropriate matter.
In addition to the duties set forth elsewhere in this Part II of this subtitle, the Governor shall direct, as necessary, a State officer or agency to cooperate in carrying out the functions of the Commission.
This State recognizes the federal act and any amendment to the federal act that does not require State legislation to be effective. However, if the federal act is repealed or expires, this Part II of this subtitle remains in effect.
The Secretary shall provide for a study of systems capacity in health services.
The study shall:
Determine for all health delivery facilities and settings where capacity should be increased or decreased to better meet the needs of the population;
Examine and describe the implementation methods and tools by which capacity should be altered to better meet the needs; and
Assess the impact of those methods and tools on the communities and health care delivery system.
In addition to information that an applicant for a certificate of need must provide, the Commission may request, collect, and report any statistical or other information that:
Is needed by the Commission to perform its duties described in this Part II of this subtitle; and
Is described in regulations of the Commission.
If a health care facility fails to provide information as required in this subsection, the Commission may:
Impose a penalty of not more than $100 per day for each day the violation continues after consideration of the willfulness and seriousness of the withholding, as well as any past history of withholding of information;
Issue an administrative order that requires the applicant to provide the information; or
Apply to the circuit court in the county in which the facility is located for legal relief considered appropriate by the Commission.
The Commission may send to the Department or a local health planning agency any statistical or other information the Commission is authorized to collect under paragraph (1) of this subsection.
In accordance with criteria that the Commission sets, the Governor shall designate health service areas in this State.
After a 1-year period, the Governor may review or revise the boundaries of a health service area or increase the number of health service areas, on the Governor’s initiative, at the request of the Commission, at the request of a local government, or at the request of a local health planning agency. Revisions to boundaries of health service areas shall be done in accordance with the criteria established by the Commission and with the approval of the legislature.
Within 45 days of receipt of the State health plan or a change in the State health plan, the plan becomes effective unless the Governor notifies the Commission of the Governor’s intent to modify or revise the State health plan adopted by the Commission.
On or before October 1 each year, the Commission shall adopt a State health plan.
The plan shall:
Be consistent with the Maryland All Payer Model Contract;
Include methodologies, standards, and criteria for certificate of need review; and
Prioritize conversion of acute capacity to alternative uses where appropriate.
Annually or on petition by any person, the Commission shall:
Assess each State health plan chapter;
Determine the chapter or chapters of the State health plan that should be reviewed and revised;
Establish, at a public meeting, the priority order and timeline of the State health plan chapter review and revision; and
Publish any changes in the State health plan that the Commission considers necessary, subject to the review and approval granted to the Governor under this subtitle.
The Commission shall adopt rules and regulations that ensure broad public input, public hearings, and consideration of local health plans in development of the State health plan.
The Commission shall develop standards and policies consistent with the State health plan that relate to the certificate of need program.
The standards:
Shall address the availability, accessibility, cost, and quality of health care; and
Are to be reviewed and revised periodically to reflect new developments in health planning, delivery, and technology.
In adopting standards regarding cost, efficiency, cost–effectiveness, or financial feasibility, the Commission shall take into account the relevant methodologies of the Health Services Cost Review Commission.
Annually, the Secretary shall make recommendations to the Commission on the plan. The Secretary may review and comment on State specifications to be used in the development of the State health plan.
All State agencies and departments, directly or indirectly involved with or responsible for any aspect of regulating, funding, or planning for the health care industry or persons involved in it, shall carry out their responsibilities in a manner consistent with the State health plan and available fiscal resources.
In carrying out their responsibilities under this Part II of this subtitle for hospitals, the Commission and the Secretary shall recognize, but may not apply, develop, or duplicate standards or requirements related to quality which have been adopted and enforced by national or State licensing or accrediting authorities.
The Commission shall transfer to the Maryland Department of Health health planning functions and necessary staff resources for licensed entities in the State health plan that are not required to obtain a certificate of need or an exemption from the certificate of need program.
The Commission shall develop and adopt an institution-specific plan to guide possible capacity reduction.
The institution-specific plan shall address:
Accurate bed count data for licensed beds and staffed and operated beds;
Cost data associated with all hospital beds and associated services on a hospital-specific basis;
Migration patterns and current and future projected population data;
Accessibility and availability of beds;
Quality of care;
Current health care needs, as well as growth trends for such needs, for the area served by each hospital;
Hospitals in high growth areas; and
Utilization.
In the development of the institution-specific plan the Commission shall give priority to the conversion of acute capacity to alternative uses where appropriate.
The Commission shall use the institution-specific plan in reviewing certificate of need applications for conversion, expansion, consolidation, or introduction of hospital services in conjunction with the State health plan.
If there is a conflict between the State health plan and any rule or regulation adopted by the Commission in accordance with Title 10, Subtitle 1 of the State Government Article to implement an institution-specific plan that is developed for identifying any excess capacity in beds and services, the provisions of whichever plan that is most recently adopted shall control.
Immediately upon adoption of the institution-specific plan the Commission shall begin the process of incorporating the institution-specific plan into the State health plan and shall complete the incorporation within 12 months.
A State health plan developed or adopted after the incorporation of the institution-specific plan into the State health plan shall include the criteria in subsection (b) of this section in addition to the criteria in § 19-118 of this subtitle.
In this section the following words have the meanings indicated.
“Consolidation” and “merger” include increases and decreases in bed capacity or services among the components of an organization that:
Operates more than one health care facility; or
Operates one or more health care facilities and holds an outstanding certificate of need to construct a health care facility.
“Health care service” means any clinically related patient service.
“Health care service” includes a medical service.
“Hospital capital threshold” means the lesser of:
25% of the hospital’s gross regulated charges for the immediately preceding year; or
$50,000,000.
“Limited service hospital” means a health care facility that:
Is licensed as a hospital on or after January 1, 1999;
Changes the type or scope of health care services offered by eliminating the facility’s capability to admit or retain patients for overnight hospitalization;
Retains an emergency or urgent care center; and
Complies with the regulations adopted by the Secretary under § 19–307.1 of this title.
“Medical service” means:
Any of the following categories of health care services:
Medicine, surgery, gynecology, addictions;
Obstetrics;
Pediatrics;
Psychiatry;
Rehabilitation;
Chronic care;
Comprehensive care;
Extended care;
Intermediate care; or
Residential treatment; or
Any subcategory of the rehabilitation, psychiatry, comprehensive care, or intermediate care categories of health care services for which need is projected in the State health plan.
The Commission may set an application fee for a certificate of need for health care facilities not assessed a user fee under this subtitle.
The Commission shall adopt rules and regulations for applying for and issuing certificates of need.
The Commission may adopt, after October 1, 1983, new thresholds or methods for determining the circumstances or minimum cost requirements under which a certificate of need application must be filed.
A person shall have a certificate of need issued by the Commission before the person develops, operates, or participates in any of the health care projects for which a certificate of need is required under this section.
A certificate of need issued before January 13, 1987, may not be rendered wholly or partially invalid solely because certain conditions have been imposed, if an appeal concerning the certificate of need, challenging the power of the Commission to impose certain conditions on a certificate of need, has not been noted by an aggrieved party before January 13, 1987.
Except as provided in subsections (g)(2)(iii) and (p) of this section, a certificate of need is required before a new health care facility is built, developed, or established.
A certificate of need is required before an existing or previously approved, but unbuilt, health care facility is moved to another site.
This subsection does not apply if:
The Commission adopts limits for relocations and the proposed relocation does not exceed those limits;
The relocation is the result of a partial or complete replacement of an existing hospital or related institution, as defined in § 19–301 of this title, and the relocation is to another part of the site or immediately adjacent to the site of the existing hospital or related institution;
Subject to the provisions of subsections (i) and (j) of this section, the relocation is of an existing health care facility owned or controlled by a merged asset system and is to:
A site within the primary service area of the health care facility to be relocated if:
The proposed relocation is not across county boundaries; and
At least 45 days prior to the proposed relocation, notice is filed with the Commission;
A site outside the primary service area of the health care facility to be relocated but within the primary service area of the merged asset system if:
At least 45 days prior to the proposed relocation, notice is filed with the Commission; and
The Commission in its sole discretion, and in accordance with the criteria adopted by regulation, finds that the relocation is in the public interest, is not inconsistent with the State health plan, and will result in the more efficient and effective delivery of health care services; or
For a limited service hospital, a site within the immediate area as defined in regulation by the Commission; or
The relocation involves moving a portion of a complement of comprehensive care beds previously approved by the Commission after January 1, 1995, for use in a proposed new related institution, as defined in § 19–301 of this title, but unbuilt on October 1, 1998, if:
The comprehensive care beds that were originally approved by the Commission in a prior certificate of need review were approved for use in a proposed new related institution to be located in a municipal corporation within Carroll County in which a related institution is not located;
The comprehensive care beds being relocated will be used to establish an additional new related institution that is located in another municipal corporation within Carroll County in which a related institution is not located;
The comprehensive care beds not being relocated are intended to be used to establish a related institution on the original site; and
Both the previously approved comprehensive care beds for use on the original site and the relocated comprehensive care beds for use on the new site will be used as components of single buildings on each site that also offer independent or assisted living residential units.
Notwithstanding any other provision of this subtitle, a certificate of need is not required for a relocation described under paragraph (2)(iv) of this subsection.
A certificate of need is required before the bed capacity of a health care facility is changed.
This subsection does not apply to any increase or decrease in bed capacity if:
For a health care facility that is not a hospital, during a 2–year period the increase or decrease would not exceed the lesser of 10 percent of the total bed capacity or 10 beds;
The increase or decrease would change the bed capacity for an existing medical service; and
The change would not increase total bed capacity;
The change is maintained for at least a 1–year period; and
At least 45 days prior to the change, the hospital provides written notice to the Commission describing the change and providing an updated inventory of the hospital’s licensed bed complement;
At least 45 days before increasing or decreasing bed capacity, written notice of intent to change bed capacity is filed with the Commission;
The Commission in its sole discretion finds that the proposed change:
Is pursuant to the consolidation or merger of two or more health care facilities, conversion of a health care facility or part of a facility to a nonhealth–related use, or a change in bed capacity at an intermediate care facility that offers medically managed residential substance use disorder treatment services and has a current license issued by the Secretary;
Is not inconsistent with the State health plan or the institution–specific plan developed by the Commission;
Will result in the delivery of more efficient and effective health care services; and
Is in the public interest; and
Within 45 days of receiving notice, the Commission notifies the health care facility of its finding;
The increase or decrease in bed capacity is the result of the annual licensed bed recalculation provided under § 19–307.2 of this title; or
The increase or decrease in bed capacity will occur in an existing general hospice program that has a current license issued by the Secretary; and
At least 45 days before increasing or decreasing bed capacity, written notice of the intent to change bed capacity is filed with the Commission.
Except as provided in paragraph (2) of this subsection, for a hospital located in a county with three or more hospitals, a certificate of need is not required before the bed capacity is increased or decreased if the change:
Occurs on or after July 1, 2000;
Is between hospitals in a merged asset system located within the same health service area;
Does not involve comprehensive or extended care beds; and
Does not occur earlier than 45 days after a notice of intent to reallocate bed capacity is filed with the Commission.
A hospital may not create a new health care service through the relocation of beds from one county to another county pursuant to this subsection.
A certificate of need is required before the type or scope of any health care service is changed if the health care service:
Is offered:
By a health care facility;
In space that is leased from a health care facility; or
In space that is on land leased from a health care facility; or
Results in a change in operating room capacity in a hospital, a freestanding medical facility, or an ambulatory surgical facility.
This subsection does not apply if:
The Commission adopts limits for changes in health care services and the proposed change would not exceed those limits;
The proposed change and the annual operating revenue that would result from the addition is entirely associated with the use of medical equipment;
The proposed change would establish, increase, or decrease a health care service and the change would not result in the:
Establishment of a new medical service or elimination of an existing medical service;
Establishment of a cardiac surgery, organ transplant surgery, or burn or neonatal intensive health care service;
Except as provided in § 19–120.1 of this subtitle, establishment of percutaneous coronary intervention services;
Establishment of a home health program, hospice program, or freestanding ambulatory surgical center or facility; or
Expansion of a comprehensive care, extended care, intermediate care, residential treatment, psychiatry, or rehabilitation medical service, except for an expansion related to an increase in total bed capacity in accordance with subsection (h)(2)(i) of this section; or
At least 45 days before increasing or decreasing the volume of one or more health care services, written notice of intent to change the volume of health care services is filed with the Commission;
The Commission in its sole discretion finds that the proposed change:
Is pursuant to:
The consolidation or merger of two or more health care facilities;
II. The conversion of a health care facility or part of a facility to a nonhealth–related use;
III. The conversion of a hospital to a limited service hospital; or
IV. The conversion of a licensed general hospital to a freestanding medical facility in accordance with subsection (o)(3) of this section;
Is not inconsistent with the State health plan or the institution–specific plan developed and adopted by the Commission;
Will result in the delivery of more efficient and effective health care services; and
Is in the public interest; and
Within 45 days of receiving notice under item 1 of this item, the Commission notifies the health care facility of its finding.
Notwithstanding the provisions of paragraph (2) of this subsection, a certificate of need is required:
Before an additional home health agency, branch office, or home health care service is established by an existing health care agency or facility;
Before an existing home health agency or health care facility establishes a home health agency or home health care service at a location in the service area not included under a previous certificate of need or license;
Before a transfer of ownership of any branch office of a home health agency or home health care service of an existing health care facility that separates the ownership of the branch office from the home health agency or home health care service of an existing health care facility which established the branch office; or
Before the expansion of a home health service or program by a health care facility that:
Established the home health service or program without a certificate of need between January 1, 1984, and July 1, 1984; and
During a 1–year period, the annual operating revenue of the home health service or program would be greater than $333,000 after an annual adjustment for inflation, based on an appropriate index specified by the Commission.
A certificate of need is required before any of the following capital expenditures are made by or on behalf of a hospital:
Any expenditure that, under generally accepted accounting principles, is not properly chargeable as an operating or maintenance expense, if:
The expenditure is made as part of an acquisition, improvement, or expansion, and, after adjustment for inflation as provided in the regulations of the Commission, the total expenditure, including the cost of each study, survey, design, plan, working drawing, specification, and other essential activity, is more than the hospital capital threshold;
The expenditure is made as part of a replacement of any plant and equipment of the hospital and is more than the hospital capital threshold after adjustment for inflation as provided in the regulations of the Commission;
The expenditure results in a substantial change in the bed capacity of the hospital; or
The expenditure results in the establishment of a new medical service in a hospital that would require a certificate of need under subsection (i) of this section; or
Any expenditure that is made to lease or, by comparable arrangement, obtain any plant or equipment for the hospital, if:
The expenditure is made as part of an acquisition, improvement, or expansion, and the total expenditure, including the cost of each study, survey, design, plan, working drawing, specification, and other essential activity, is more than the hospital capital threshold;
The expenditure is made as part of a replacement of any plant and equipment and is more than the hospital capital threshold after adjustment for inflation as provided in the regulations of the Commission;
The expenditure results in a substantial change in the bed capacity of the hospital; or
The expenditure results in the establishment of a new medical service in a hospital that would require a certificate of need under subsection (i) of this section.
A certificate of need is required before any of the following capital expenditures are made by or on behalf of a health care facility other than a hospital:
Any expenditure that, under generally accepted accounting principles, is not properly chargeable as an operating or maintenance expense, if:
The expenditure results in a substantial change in the bed capacity of the health care facility other than a hospital; or
The expenditure results in the establishment of a new medical service in a health care facility other than a hospital that would require a certificate of need under subsection (i) of this section; or
Any expenditure that is made to lease or, by comparable arrangement, obtain any plant or equipment for the health care facility other than a hospital, if:
The expenditure results in a substantial change in the bed capacity of the health care facility other than a hospital; or
The expenditure results in the establishment of a new medical service in a health care facility other than a hospital that would require a certificate of need under subsection (i) of this section.
A certificate of need is required before any equipment or plant is donated to a health care facility, if a certificate of need would be required under paragraph (1) or (2) of this subsection for an expenditure by the health care facility to acquire the equipment or plant directly.
A certificate of need is required before any equipment or plant is transferred to a health care facility at less than fair market value if a certificate of need would be required under paragraph (1) or (2) of this subsection for the transfer at fair market value.
A certificate of need is required before a person acquires a health care facility if a certificate of need would be required under paragraph (1) or (2) of this subsection for the acquisition by or on behalf of the health care facility.
This subsection does not apply to:
Site acquisition;
An acquisition of a health care facility if:
At least 30 days before making the contractual arrangement to acquire the facility, written notice of the intent to make the arrangement is filed with the Commission and the Commission does not find, within 30 days after the Commission receives notice, that the health services or bed capacity of the facility will be changed, provided that, for a merger with or acquisition of an existing general hospice, the purchaser of the general hospice may only acquire the authority to provide home–based hospice services in jurisdictions in which the seller of the general hospice is licensed to provide home–based hospice services; and
For an acquisition of a nursing home, the acquisition has been approved in accordance with § 19–120.2 of this subtitle;
Acquisition of business or office equipment that is not directly related to patient care;
Capital expenditures to the extent that they are directly related to the acquisition and installation of major medical equipment;
A capital expenditure made as part of a consolidation or merger of two or more health care facilities, or conversion of a health care facility or part of a facility to a nonhealth–related use if:
At least 45 days before an expenditure is made, written notice of intent is filed with the Commission;
Within 45 days of receiving notice, the Commission in its sole discretion finds that the proposed consolidation, merger, or conversion:
Is not inconsistent with the State health plan or the institution–specific plan developed by the Commission as appropriate;
Will result in the delivery of more efficient and effective health care services; and
Is in the public interest; and
Within 45 days of receiving notice, the Commission notifies the health care facility of its finding;
A capital expenditure by a nursing home for equipment, construction, or renovation that:
Is not directly related to patient care; and
Is not directly related to any change in patient charges or other rates;
A capital expenditure by a hospital, as defined in § 19–301 of this title, for equipment, construction, or renovation that:
Is not directly related to patient care; and
Does not increase patient charges or hospital rates;
A capital expenditure by a hospital, as defined in § 19–301 of this title, for a project in excess of the hospital capital threshold and is for construction or renovation that:
May be related to patient care;
Does not require, over the entire period or schedule of debt service associated with the project, a total cumulative increase in patient charges or hospital rates of more than $1,500,000 for the capital costs associated with the project as determined by the Commission, after consultation with the Health Services Cost Review Commission;
At least 45 days before the proposed expenditure is made, the hospital notifies the Commission;
Within 45 days of receipt of the relevant financial information, the Commission makes the financial determination required under item 2 of this item; or
The Commission has not made the financial determination required under item 2 of this item within 60 days of the receipt of the relevant financial information; and
The relevant financial information to be submitted by the hospital is defined in regulations adopted by the Commission, after consultation with the Health Services Cost Review Commission;
A plant donated to a hospital, as defined in § 19–301 of this title, that does not require a cumulative increase in patient charges or hospital rates of more than $1,500,000 for capital costs associated with the donated plant as determined by the Commission, after consultation with the Health Services Cost Review Commission, if:
At least 45 days before the proposed donation is made, the hospital notifies the Commission;
Within 45 days of receipt of the relevant financial information, the Commission makes the financial determination required under this item (ix) of this paragraph; or
The Commission has not made the financial determination required under this item (ix) of this paragraph within 60 days of the receipt of the relevant financial information; and
The relevant financial information to be submitted by the hospital is defined in regulations adopted by the Commission after consultation with the Health Services Cost Review Commission; or
A capital expenditure made as part of a conversion of a licensed general hospital to a freestanding medical facility in accordance with subsection (o)(3) of this section.
Paragraph (6)(vi), (vii), (viii), (ix), and (x) of this subsection may not be construed to permit a facility to offer a new health care service for which a certificate of need is otherwise required.
A certificate of need is not required to close any health care facility or part of a health care facility if at least 90 days before the closing or if at least 45 days before the partial closing of the health care facility, including a State hospital, a person proposing to close all or part of the health care facility files notice of the proposed closing or partial closing with the Commission.
A hospital shall hold a public informational hearing in the county where the hospital is located if the hospital:
Files a notice of the proposed closing of the hospital with the Commission;
Requests an exemption from the Commission under subsection (o)(3) of this section to convert to a freestanding medical facility; or
Is located in a county with fewer than three hospitals and files a notice of the partial closing of the hospital with the Commission.
The Commission may require a health care facility other than a hospital described in paragraph (2) of this subsection that files notice of its proposed closing or partial closing to hold a public informational hearing in the county where the health care facility is located.
A public informational hearing required under paragraph (2) or (3) of this subsection shall be held by the health care facility, in consultation with the Commission, within 30 days after:
The health care facility files with the Commission a notice of its proposed closing or partial closing; or
The hospital files with the Commission a notice of intent to convert to a freestanding medical facility.
The Commission shall establish by regulation requirements for a public informational hearing required under paragraph (2) or (3) of this subsection.
For a hospital proposing to close, partially close, or convert to a freestanding medical facility, the regulations shall require the hospital to address:
The reasons for the closure, partial closure, or conversion;
The plan for transitioning acute care services previously provided by the hospital to residents of the hospital service area;
The plan for addressing the health care needs of the residents of the hospital service area;
The plan for retraining and placing displaced employees;
The plan for the hospital’s physical plant and site; and
The proposed timeline for the closure, partial closure, or conversion to a freestanding medical facility.
Within 10 working days after a public informational hearing held by a hospital under this subsection, the hospital shall provide a written summary of the hearing to:
The Governor;
The Secretary;
The governing body of the county in which the hospital is located;
The local health department and the local board of health or similar body for the county in which the hospital is located;
The Commission; and
Subject to § 2–1257 of the State Government Article, the Senate Finance Committee, the House Health and Government Operations Committee, and the members of the General Assembly who represent the district in which the hospital is located.
Notwithstanding any other provision of this section, the Commission shall consider the special needs and circumstances of a county where a medical service, as defined in this section, does not exist; and
The Commission shall consider and may approve under this subsection a certificate of need application to establish, build, operate, or participate in a health care project to provide a new medical service in a county if the Commission, in its sole discretion, finds that:
The proposed medical service does not exist in the county that the project would be located;
The proposed medical service is necessary to meet the health care needs of the residents of that county;
The proposed medical service would have a positive impact on the existing health care system;
The proposed medical service would result in the delivery of more efficient and effective health care services to the residents of that county; and
The application meets any other standards or regulations established by the Commission to approve applications under this subsection.
The Commission may not issue a certificate of need or a determination with respect to an acquisition that authorizes a general hospice to provide home–based hospice services on a statewide basis.
Except as provided in paragraphs (2) and (3) of this subsection, a person shall have a certificate of need issued by the Commission before a person establishes or operates a freestanding medical facility.
A certificate of need is not required for the establishment or operation of a freestanding medical facility pilot project established under § 19–3A–07 of this title.
A certificate of need is not required to establish or operate a freestanding medical facility if:
The freestanding medical facility is established as the result of the conversion of a licensed general hospital;
Through the conversion, the licensed general hospital will eliminate the capability of the hospital to admit or retain patients for overnight hospitalization, except for observation stays;
Except as provided in subparagraph (ii) of this paragraph, the freestanding medical facility will remain on the site of, or on a site adjacent to, the licensed general hospital;
At least 60 days before the conversion, written notice of intent to convert the licensed general hospital to a freestanding medical facility is filed with the Commission;
The Commission in its sole discretion finds that the conversion:
Is consistent with the State health plan;
Will result in the delivery of more efficient and effective health care services;
Will maintain adequate and appropriate delivery of emergency care within the statewide emergency medical services system as determined by the State Emergency Medical Services Board; and
Is in the public interest; and
Within 60 days after receiving notice under item 4 of this subparagraph, the Commission notifies the licensed general hospital of the Commission’s findings.
The Commission may approve a site for a freestanding medical facility that is not on the site of, or on a site adjacent to, the licensed general hospital if:
The licensed general hospital is:
The only hospital in the county; or
One of two hospitals in the county that are part of the same merged asset system, and are the only two hospitals in the county; and
The site is within a 5–mile radius and in the primary service area of the licensed general hospital.
Notwithstanding subparagraph (i) of this paragraph, a licensed general hospital located in Kent County may not convert to a freestanding medical facility in accordance with subparagraph (i) of this paragraph before July 1, 2020.
A certificate of need is not required for the establishment or operation of an intermediate care facility that offers medically managed residential substance use disorder treatment services if:
Written notice of the intent to establish or operate the intermediate care facility is filed with the Commission at least 45 days before establishment; and
The Commission in its sole discretion finds that the proposed intermediate care facility:
Is not inconsistent with the State health plan;
Will result in the delivery of more efficient and effective health care services; and
Is in the public interest.
In this section the following words have the meanings indicated.
“Certificate of conformance” means an approval issued by the Commission that allows an acute general hospital to establish emergency PCI services or elective PCI services without a certificate of need.
“Certificate of ongoing performance” means an approval issued by the Commission that the cardiac surgery services, emergency PCI services, or elective PCI services provided by an acute general hospital meet standards evidencing continued quality.
“Elective PCI” (also known as “nonprimary PCI”) includes PCI provided to a patient who is not suffering from an acute coronary syndrome, but whose condition is appropriately treated with PCI based on regulations established by the Commission.
“Emergency PCI” (also known as “primary PCI”) includes PCI capable of relieving coronary vessel narrowing associated with STEMI or, as defined by the Commission in regulations, STEMI equivalent.
“PCI” means percutaneous coronary intervention.
“Percutaneous coronary intervention” means a procedure in which a catheter is inserted into a blood vessel and guided to the site of the narrowing of a coronary artery to relieve coronary narrowing.
“Percutaneous coronary intervention” includes a variety of catheter–based techniques, including balloon angioplasty.
“STEMI” (ST–segment–elevation myocardial infarction) means a type of heart attack or myocardial infarction that is caused by a prolonged period of blocked blood supply, which affects a large area of the heart muscle and causes changes on an electrocardiogram and in the blood levels of key chemical markers.
Beginning July 1, 2012, before an acute general hospital may establish emergency PCI services or elective PCI services, the hospital shall obtain a certificate of conformance from the Commission.
The Commission may not issue a certificate of conformance unless the Commission finds that the proposed emergency PCI services or proposed elective PCI services:
Are consistent with the State Health Plan for Facilities and Services;
Will result in the delivery of more efficient and effective health care services; and
Are in the public interest.
Notwithstanding subsection (b) of this section, a certificate of conformance is not required for an acute general hospital to establish emergency PCI services if:
The acute general hospital was providing emergency PCI services on January 1, 2012; and
The Commission determines that the emergency PCI services are consistent with the State Health Plan for Facilities and Services.
Notwithstanding subsection (b) of this section, a certificate of conformance is not required for an acute general hospital to establish elective PCI services if:
On January 1, 2012, the acute general hospital was providing elective PCI services through the C–PORT E registry under authority of a research waiver issued by the Commission;
The Commission finds that the C–PORT E study produced results that should guide public policy; and
The Commission determines that the elective PCI services provided by the acute general hospital continue to be consistent with:
The requirements of the C–PORT E registry; and
Except for the requirements under COMAR 10.24.05.05, the requirements for maintaining a research waiver under COMAR 10.24.05 and 10.24.17, Table A–1.
This subsection applies to an acute general hospital that provides cardiac surgery or PCI services under:
A certificate of need issued under § 19–120 of this subtitle;
A certificate of conformance issued under this section; or
An exception from the certificate of conformance requirements under subsection (c) or (d) of this section.
An acute general hospital shall obtain and maintain a certificate of ongoing performance to continue to provide:
Cardiac surgery services;
Emergency PCI services; or
Elective PCI services.
An acute general hospital that is providing elective PCI services under a research waiver issued by the Commission and does not meet the requirements of subsection (d) of this section shall obtain a certificate of conformance for its elective PCI services before the acute general hospital may obtain a certificate of ongoing performance to provide the elective PCI services.
The Commission shall adopt regulations through an update to the State Health Plan for Facilities and Services to implement this section.
The regulations shall:
Address quality, access, and cost;
Establish a process and minimum standards for obtaining a certificate of conformance;
Establish a process and minimum standards for obtaining and maintaining a certificate of ongoing performance;
Set an appropriate time period for the expiration of a certificate of ongoing performance;
Require, as a condition of the issuance of a certificate of conformance or a certificate of ongoing performance, that an acute general hospital agree to voluntarily relinquish its authority to provide cardiac surgery services, emergency PCI services, or elective PCI services if the hospital fails to meet the applicable standards established by the Commission;
Establish a process for an acute general hospital that is out of compliance with minimum standards for a certificate of ongoing performance to return to good standing;
Require that an acute general hospital, except for an acute general hospital located in a part of the State that does not have sufficient access to emergency PCI services, have provided emergency PCI services in accordance with established standards before seeking a certificate of conformance for elective PCI services;
Prohibit an acute general hospital from providing elective PCI services unless the acute general hospital also provides emergency PCI services;
Incorporate, to the extent appropriate, the standards for cardiac surgery services, emergency PCI services, and elective PCI services recommended by the clinical advisory group established under paragraph (3) of this subsection;
Include requirements for peer or independent review, consistent with the ACCF/AHA/SCAI Guidelines for Percutaneous Coronary Intervention (Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions), of difficult or complicated cases and for randomly selected cases; and
For a certificate of conformance for elective PCI services, give weight to the experience, performance, investment, and scope of interventional capabilities of an applicant hospital that was providing emergency PCI services on January 1, 2012.
The Commission shall establish a clinical advisory group to advise the Commission and recommend standards for cardiac surgery services, emergency PCI services, and elective PCI services for inclusion in regulations adopted under this subsection.
The clinical advisory group shall be composed of experts in cardiac surgery services and PCI services, including:
Clinicians and representatives from hospitals in the State with and without on–site cardiac surgery services and with and without PCI services;
At least one representative of an acute general hospital that is not part of a merged asset system and provides only emergency PCI services; and
Other persons with needed expertise from inside and outside the State.
On or before September 30, 2013, after obtaining advice from the clinical advisory group and other appropriate stakeholders, the Commission shall:
Develop recommended regulations under this subsection;
Post the recommended regulations on its website for public comment; and
Submit the recommended regulations to the Governor and, in accordance with § 2–1257 of the State Government Article, the Senate Finance Committee and the House Health and Government Operations Committee.
The Senate Finance Committee and the House Health and Government Operations Committee shall have 60 days from receipt of the recommended regulations for review and comment.
In this section the following words have the meanings indicated.
“Executive Director” means the Executive Director of the Commission.
“Nursing home” has the meaning stated in § 19–1401 of this title.
“Request for acquisition” means a request for the Commission to approve the acquisition of a nursing home.
A person shall provide notice to the Commission at least 30 days before the closing of a change of ownership of a nursing home that:
Involves at least a 5% transfer in ownership interest; and
Is not an acquisition that requires approval under subsection (c) of this section.
This subsection does not apply to an acquisition that involves only changes of ownership interests among existing owners of a nursing home.
At least 60 days before the closing date of the acquisition of a nursing home, a person shall:
Submit to the Commission a request for acquisition; and
Provide notice to the residents, resident representatives, and employees of the nursing home that:
The request for acquisition was submitted to the Commission; and
There will be an opportunity to submit comments in accordance with subsection (f) of this section.
The Executive Director shall review a completed request for acquisition within 45 days after receiving the completed request from the applicant.
The Executive Director, in consultation with the Secretary or the Secretary’s designee, may:
Approve the acquisition;
Approve the acquisition with conditions;
Deny the acquisition; or
Refer the request for acquisition to the Commission for a final decision.
To approve a request submitted under subsection (c) of this section, the Executive Director must find that the acquisition:
Is consistent with the State Health Plan; and
Subject to subsection (f) of this section, is in the public interest.
In determining whether an acquisition of a nursing home is in the public interest, the Executive Director shall:
Solicit and accept comments from individuals who:
Reside in the nursing home;
Have family members who reside in the nursing home; or
Are employees of the nursing home; and
Consult with the Attorney General on whether the acquisition raises public interest concerns.
If the Executive Director refers a request for acquisition to the Commission under subsection (d)(2)(iv) of this section, the Commission shall use the criteria specified in subsections (e) and (f) of this section and regulations adopted by the Commission to make a final decision within 60 days after receiving the completed request from the applicant.
If the Executive Director denies a request for acquisition or imposes a condition on the approval of the acquisition, a person that is a party to the acquisition may submit a written request for the Commission to review the decision in accordance with regulations adopted by the Commission.
A decision of the Commission under subsection (g) or (h) of this section shall be a final decision for the purpose of judicial review.
A person that is a party to the acquisition may take a direct judicial appeal within 30 days after the Commission makes the final decision.
The Commission shall send each final decision to the Secretary, the Secretary of Aging, the Office of Health Care Quality, the Office of the Attorney General, and the State Long–Term Care Ombudsman.
On or before July 1 immediately following the acquisition of a nursing home and each year for 3 years thereafter, the person that acquired the nursing home shall submit a report to the Commission in accordance with regulations adopted by the Commission.
The Commission shall provide the report required under paragraph (1) of this subsection to the Secretary, the Secretary of Aging, the Office of Health Care Quality, the Office of the Attorney General, and the State Long–Term Care Ombudsman.
The Commission shall adopt regulations through an update to the State Health Plan for Facilities and Services to carry out the provisions of this section.
The regulations adopted under this subsection shall:
Require the person that acquired ownership of a nursing home to:
Reduce the number of resident rooms in the nursing home that contain more than two beds in accordance with standards established by the Commission; or
Receive a waiver from the requirement established under item 1 of this item from the Executive Director in accordance with standards established by the Commission;
If necessary, allow the person that acquired ownership of a nursing home to temporarily delicense beds for at least 3 years immediately following the acquisition to reduce the number of resident rooms that contain more than two beds; and
Authorize the Commission to extend the period the beds are temporarily delicensed beyond 3 years for good cause shown, including demonstrated progress toward eliminating multibedded rooms by expanding the existing facility or transferring the beds to another facility within a merged asset system in the same jurisdiction;
Establish standards for the evaluation of the quality of the nursing homes currently or previously owned, whether in the State or outside the State, by the person that submitted a request for acquisition; and
Subject to paragraph (3) of this subsection, establish criteria for the Executive Director and the Commission to consider when making a decision regarding a request for acquisition.
The criteria established by the Commission under paragraph (2)(iv) of this subsection shall require that the Commission take into consideration whether any nursing home currently or previously owned, within or outside the State, by the person submitting the request, for the period of 3 years immediately preceding the submission of the request:
Maintained a quality assessment and assurance committee that met at least quarterly;
Was the subject of an enforcement action, a special focus facility designation, or a deficiency involving serious or immediate threat, actual harm, or immediate jeopardy to a resident; or
Was the subject of a lawsuit judgment, or an arbitration finding, following a complaint filed by a resident, resident representative, or a government agency.
In this section, “health maintenance organization” means a health maintenance organization under Subtitle 7 of this title.
A health maintenance organization or a health care facility that either controls, directly or indirectly, or is controlled by a health maintenance organization shall have a certificate of need before the health maintenance organization or health care facility builds, develops, operates, purchases, or participates in building, developing, operating, or establishing:
A hospital, as defined in § 19–301 of this title; and
Any other health care project for which a certificate of need is required under § 19–120 of this subtitle unless at least 90% of the patients who will receive health care services from the project will be individuals enrolled in that health maintenance organization.
Notwithstanding paragraph (1)(ii) of this subsection, a health maintenance organization or a health care facility that either controls, directly or indirectly, or is controlled by a health maintenance organization is not required to obtain a certificate of need before purchasing an existing ambulatory surgical facility or center, as defined in § 19–114(b) of this subtitle.
An application for a certificate of need by a health maintenance organization or by a health care facility that either controls, directly or indirectly, or is controlled by, a health maintenance organization shall be approved if the Commission finds that the application:
Documents that the project is necessary to meet the needs of enrolled members and reasonably anticipated new members for the services proposed to be provided by the applicant; and
Is not inconsistent with those sections of the State health plan or those sections of the institution–specific plan that govern hospitals, as defined in § 19–301 of this title, and ambulatory surgical facilities or centers, as defined in § 19–114(b) of this subtitle, or health care projects for which a certificate of need is required under subsection (b)(1)(ii) of this section.
A certificate of need is not required to delete, expand, develop, operate, or participate in a health care project for domiciliary care.
Notwithstanding the provisions of § 19-114(d)(2)(ii) of this subtitle, a continuing care community does not lose its exemption from certificate of need requirements when the continuing care community admits an individual directly to a nursing facility within the continuing care community if:
The admittee’s spouse or relative is admitted at the same time under a joint contract to an independent living unit or assisted living unit within the continuing care community; or
An individual having a long-term significant relationship with the admittee is admitted at the same time under a joint contract to an independent living unit or assisted living unit within the continuing care community.
Notwithstanding the provisions of § 19-114(d)(2)(ii) of this part, a continuing care community that qualifies for an exemption from a certificate of need under § 19-114(d)(2)(ii) of this part may admit a subscriber directly into a comprehensive care nursing bed only if, at the time of admission, the subscriber has the potential for an eventual transfer to an independent living unit or an assisted living unit, as determined by the subscriber’s personal physician who is not an owner or employee of the continuing care retirement community.
Notwithstanding the provisions of subsection (a) of this section and § 19-114(d)(2)(ii) of this part, the total number of comprehensive care nursing beds occupied by subscribers who have been directly admitted to a comprehensive care nursing bed may not exceed 20 percent of the total number of comprehensive care nursing beds that are available in the continuing care nursing facility.
Notwithstanding the provisions of subsections (a) and (b) of this section and § 19-114(d)(2)(ii) of this part, a continuing care retirement community that qualifies for an exemption from a certificate of need under § 19-114(d)(2)(ii) of this part may not admit a subscriber directly into a comprehensive care nursing bed if the direct admission would cause the occupancy of the comprehensive care nursing beds in the continuing care community to exceed 95 percent of full capacity.
A certificate of need is required before an ambulatory care facility:
Offers any health service:
Through a health care facility;
In space leased from a health care facility; or
In space on land leased from a health care facility;
To provide those services, makes an expenditure, if a certificate of need would be required under § 19-120(k) of this subtitle for the expenditure by or on behalf of a health care facility; or
Does anything else for which the federal act requires a certificate of need and that the Commission has not exempted from that requirement.
If the Commission receives an application for a certificate of need for a change in the bed capacity of a health care facility, as required under § 19–120 of this subtitle, or for a health care project that would create a new health care service or abolish an existing health care service, the Commission shall give notice of the filing by publication in the Maryland Register and give the following notice to:
Each member of the General Assembly in whose district the action is planned;
Each member of the governing body for the county where the action is planned;
The county executive, mayor, or chief executive officer, if any, in whose county or city the action is planned; and
Any health care provider, third party payor, local planning agency, or any other person the Commission knows has an interest in the application.
Failure to give notice shall not adversely affect the application.
All decisions of the Commission on an application for a certificate of need, except in emergency circumstances posing a threat to public health, shall be consistent with the State health plan and the standards for review established by the Commission.
The mere failure of the State health plan to address any particular project or health care service shall not alone be deemed to render the project inconsistent with the State health plan.
Unless the Commission finds that the facility or service for which the proposed expenditure is to be made is not needed or is not consistent with the State health plan, the Commission shall approve an application for a certificate of need required under § 19–120(k) of this subtitle to the extent that the expenditure is to be made to:
Eliminate or prevent an imminent safety hazard, as defined by federal, State, or local fire, building, or life safety codes or regulations;
Comply with State licensing standards; or
Comply with accreditation standards for reimbursement under Title XVIII of the Social Security Act or under the State Medical Assistance Program approved under Title XIX of the Social Security Act.
The Commission alone shall have final nondelegable authority to act upon an application for a certificate of need, except as provided in this subsection.
A majority of the full authorized membership of the Commission shall be a quorum to act on an application for a certificate of need.
After an application is filed, the staff of the Commission:
Shall review the application for completeness within 10 working days of the filing of the application; and
May request further information from the applicant.
The Commission may delegate to a reviewer the responsibility for review of an application for a certificate of need, including:
The holding of an evidentiary hearing if the Commission, in accordance with criteria it has adopted by regulation, considers an evidentiary hearing appropriate due to the magnitude of the impact the proposed project may have on the health care delivery system; and
Preparation of a recommended decision for consideration by the full Commission.
The Commission shall designate a single Commissioner to act as a reviewer for the application and any competing applications.
The Commission shall delegate to its staff the responsibility for an initial review of an application, including, in the event that no written comments on an application are submitted by any interested party other than the staff of the Commission, the preparation of a recommended decision for consideration by the full Commission.
Any “interested party” may submit written comments on the application in accordance with procedural regulations adopted by the Commission.
The Commission shall define the term “interested party” to include, at a minimum:
The staff of the Commission;
Any applicant who has submitted a competing application;
Any other person who can demonstrate that the person would be adversely affected by the decision of the Commission on the application;
A local health planning agency for a jurisdiction or region in which the proposed facility or service will be located; and
In the review of a replacement acute general hospital project proposed by or on behalf of a regional health system that serves multiple contiguous jurisdictions, a jurisdiction within the region served by the regional health system that does not contain the proposed replacement acute general hospital project.
The reviewer shall review the application, any written comments on the application, and any other materials permitted by this section or by the Commission’s regulations, and present a recommended decision on the application to the full Commission.
An applicant and any interested party may request the opportunity to present oral argument to the reviewer, in accordance with regulations adopted by the Commission, before the reviewer prepares a recommended decision on the application for consideration by the full Commission.
The reviewer may grant, deny, or impose limitations on an interested party’s request to present oral argument to the reviewer.
Any interested party who has submitted written comments under paragraph (7) of this subsection may submit written exceptions to the proposed decision and make oral argument to the Commission, in accordance with regulations adopted by the Commission, before the Commission takes final action on the application.
The Commission shall, after determining that the recommended decision is complete, vote to approve, approve with conditions, or deny the application on the basis of the recommended decision, the record before the staff or the reviewer, and exceptions and arguments, if any, before the Commission.
The decision of the Commission shall be by a majority of the quorum present and voting.
Where the State health plan identifies a need for additional hospital bed capacity in a region or subregion, in a comparative review of 2 or more applicants for hospital bed expansion projects, a certificate of need shall be granted to 1 or more applicants in that region or subregion that:
Have satisfactorily met all applicable standards;
Have within the preceding 10 years voluntarily delicensed the greater of 10 beds or 10 percent of total licensed bed capacity to the extent of the beds that are voluntarily delicensed; or
Have been previously granted a certificate of need which was not recertified by the Commission within the preceding 10 years; and
The Commission finds at least comparable to all other applicants.
If any party or interested person requests an evidentiary hearing with respect to a certificate of need application for any health care facility other than an ambulatory surgical facility and the Commission, in accordance with criteria it has adopted by regulation, considers an evidentiary hearing appropriate due to the magnitude of the impact that the proposed project may have on the health care delivery system, the Commission or a committee of the Commission shall hold the hearing in accordance with the contested case procedures of the Administrative Procedure Act.
Except as provided in this section or in regulations adopted by the Commission to implement the provisions of this section, the review of an application for a certificate of need for an ambulatory surgical facility is not subject to the contested case procedures of Title 10, Subtitle 2 of the State Government Article.
An application for a certificate of need shall be acted upon by the Commission no later than 150 days after the application was docketed.
If an evidentiary hearing is not requested, the Commission’s decision on an application shall be made no later than 90 days after the application was docketed.
The applicant or any aggrieved party, as defined in § 19–128(a) of this subtitle, may petition the Commission within 15 days for a reconsideration.
The Commission shall decide whether or not it will reconsider its decision within 30 days of receipt of the petition for reconsideration.
The Commission shall issue its reconsideration decision within 30 days of its decision on the petition.
Except as provided in paragraph (2) of this subsection, if the Commission does not act on an application within the required period, the applicant may file with a court of competent jurisdiction within 60 days after expiration of the period a petition to require the Commission to act on the application.
This paragraph does not apply to an application for a certificate of need involving:
The establishment of a health care facility;
The relocation of a health care facility; or
The introduction by a hospital of cardiac surgery or organ transplantation.
A certificate of need filed after October 1, 2019, shall be deemed approved if:
The certificate of need is uncontested; and
Final action by the Commission does not occur within 120 days after the application for the certificate of need was docketed.
The circuit court for the county where a health care project is being developed or operated in violation of this Part II of this subtitle may enjoin further development or operation.
In this section, “aggrieved party” means:
An interested party who presented written comments on the application to the Commission and who would be adversely affected by the decision of the Commission on the project; or
The Secretary.
The grounds for appeal by the Secretary shall be that the decision is inconsistent with the State health plan or adopted standards.
A decision of the Commission shall be the final decision for purposes of judicial review.
A request for a reconsideration will stay the final decision of the Commission for purposes of judicial review until a decision is made on the reconsideration.
An aggrieved party may take a direct judicial appeal within 30 days of the final decision of the Commission.
The Commission is a necessary party to an appeal at all levels of the appeal.
In the event of an adverse decision that affects its final decision, the Commission may apply within 30 days by writ of certiorari to the Court of Appeals for review where:
Review is necessary to secure uniformity of decision, as where the same statute has been construed differently by 2 or more judges; or
There are other special circumstances that render it desirable and in the public interest that the decision be reviewed.
Notwithstanding the fact that a merger or consolidation may limit free economic competition, the Commission may approve the merger or consolidation of 2 or more hospitals if the merger or consolidation:
Is not inconsistent with the State health plan or any institution-specific plan;
Will result in the delivery of more efficient and effective hospital services; and
Is in the public interest.
Notwithstanding the fact that a merger or consolidation or the joint ownership and operation of major medical equipment may limit free economic competition, a hospital may engage in a merger or consolidation or the joint ownership of major medical equipment that has been approved by the Commission under this section.
In this section the following words have the meanings indicated.
“Fund” means the Maryland Trauma Physician Services Fund.
“Maryland Trauma Specialty Referral Centers” means:
The Johns Hopkins Health System Burn Program;
The Eye Trauma Center at the Wilmer Eye Institute at The Johns Hopkins Hospital; and
The Curtis National Hand Center at Union Memorial Hospital.
“Reasonable compensation equivalent” means the limitation on the cost established by the Centers for Medicare and Medicaid Services that a provider may claim for compensation of services.
“Rehabilitation hospital” means a facility classified as a special rehabilitation hospital as described in § 19–307 of this title that is affiliated with a trauma center by common ownership.
“Trauma center” means a facility designated by the Maryland Institute for Emergency Medical Services Systems as:
The State primary adult resource center;
A Level I trauma center;
A Level II trauma center;
A Level III trauma center;
A pediatric trauma center; or
The Maryland Trauma Specialty Referral Centers.
“Trauma center” includes an out–of–state pediatric trauma center that has entered into an agreement with the Maryland Institute for Emergency Medical Services Systems.
“Trauma health care practitioner” means a health care practitioner licensed under the Health Occupations Article who provides care in a trauma center or in a rehabilitation hospital to trauma patients on the State trauma registry as defined by the Maryland Institute for Emergency Medical Services Systems.
“Trauma physician” means a physician who provides care in a trauma center or in a rehabilitation hospital to trauma patients on the State trauma registry as defined by the Maryland Institute for Emergency Medical Services Systems.
“Uncompensated care” means care provided by a trauma physician or a trauma health care practitioner to a trauma patient on the State trauma registry who:
Has no health insurance, including Medicare Part B coverage;
Is not eligible for medical assistance coverage; and
Has not paid the trauma physician or trauma health care practitioner for care provided by the trauma physician or trauma health care practitioner, after documented attempts by the trauma physician or trauma health care practitioner to collect payment.
There is a Maryland Trauma Physician Services Fund.
The purpose of the Fund is to subsidize the documented costs:
Of uncompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma care to a trauma patient on the State trauma registry;
Of undercompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma care to an enrollee of the Maryland Medical Assistance Program who is a trauma patient on the State trauma registry;
Incurred by a trauma center to maintain trauma physicians on–call as required by the Maryland Institute for Emergency Medical Services Systems;
Incurred by the State primary adult resource center to maintain trauma surgeons, orthopedic surgeons, neurosurgeons, and anesthesiologists on–call and on standby as required by the Maryland Institute for Emergency Medical Services Systems; and
Incurred by the Commission and the Health Services Cost Review Commission to administer the Fund and audit reimbursement requests to assure appropriate payments are made from the Fund.
The Commission and the Health Services Cost Review Commission shall administer the Fund.
The Fund is a special, nonlapsing fund that is not subject to § 7–302 of the State Finance and Procurement Article.
Interest on and other income from the Fund shall be separately accounted for and credited to the Fund, and are not subject to § 6–226(a) of the State Finance and Procurement Article.
The Fund consists of:
Motor vehicle registration surcharges paid into the Fund in accordance with § 13–954(b)(2) of the Transportation Article;
At least 20% of the fines collected under § 21–902(a)(1), (b)(2), (c)(2), and (d)(1) of the Transportation Article; and
Any other money transferred from the General Fund of the State.
Disbursements from the Fund shall be made in accordance with a methodology established jointly by the Commission and the Health Services Cost Review Commission to calculate costs incurred by trauma physicians and trauma centers that are eligible to receive reimbursement under subsection (b) of this section.
The Fund shall transfer to the Maryland Department of Health an amount sufficient to fully cover the State’s share of expenditures for the costs of undercompensated care incurred by a trauma physician in providing trauma care to an enrollee of the Maryland Medical Assistance Program who is a trauma patient on the State trauma registry.
The methodology developed under paragraph (1) of this subsection shall:
Take into account:
The amount of uncompensated care provided by trauma physicians;
The amount of undercompensated care attributable to the treatment of Medicaid enrollees in trauma centers;
The cost of maintaining trauma physicians on–call;
The number of patients served by trauma physicians in trauma centers;
The number of Maryland residents served by trauma physicians in trauma centers; and
The extent to which trauma–related costs are otherwise subsidized by hospitals, the federal government, and other sources; and
Include an incentive to encourage hospitals to continue to subsidize trauma–related costs not otherwise included in hospital rates.
The methodology developed under paragraph (1) of this subsection shall use the following parameters to determine the amount of reimbursement made to trauma physicians and trauma centers from the Fund:
The cost incurred by a Level II trauma center to maintain trauma surgeons, orthopedic surgeons, and neurosurgeons on–call shall be reimbursed:
At a rate of up to 60% of the reasonable compensation equivalent hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare economic index as designated by the Centers for Medicare and Medicaid Services; and
For the minimum number of trauma physicians required to be on–call, as specified by the Maryland Institute for Emergency Medical Services Systems in its criteria for Level II trauma centers;
The cost incurred by a Level III trauma center to maintain trauma surgeons, orthopedic surgeons, neurosurgeons, and anesthesiologists on–call shall be reimbursed:
At a rate of up to 60% of the reasonable compensation equivalent hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare economic index as designated by the Centers for Medicare and Medicaid Services; and
For the minimum number of trauma physicians required to be on–call, as specified by the Maryland Institute for Emergency Medical Services Systems in its criteria for Level III trauma centers;
The cost incurred by a Level I trauma center or pediatric trauma center to maintain trauma surgeons, orthopedic surgeons, and neurosurgeons on–call when a post–graduate resident is attending in the trauma center shall be reimbursed:
At a rate of up to 60% of the reasonable compensation equivalent hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare economic index as designated by the Centers for Medicare and Medicaid Services; and
When a post–graduate resident is authorized to be in the trauma center, as specified by the Maryland Institute for Emergency Medical Services Systems in its criteria for Level I trauma centers or pediatric trauma centers;
The cost incurred by a Maryland Trauma Specialty Referral Center to maintain trauma surgeons on–call in the specialty of the Center when a post–graduate resident is attending in the Center shall be reimbursed:
At a rate of up to 60% of the reasonable compensation equivalent hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare economic index as designated by the Centers for Medicare and Medicaid Services; and
When a post–graduate resident is authorized to be in the Center, as specified by the Maryland Institute for Emergency Medical Services Systems in its criteria for a Maryland Trauma Specialty Referral Center; and
A Level II trauma center is eligible for a maximum of 26,280 hours of trauma on–call per year;
A Level III trauma center is eligible for a maximum of 35,040 hours of trauma on–call per year;
A Level I trauma center shall be eligible for a maximum of 4,380 hours of trauma on–call per year;
A pediatric trauma center shall be eligible for a maximum of 4,380 hours of trauma on–call per year; and
A Maryland Trauma Specialty Referral Center shall be eligible for a maximum of 2,190 hours of trauma on–call per year;
The cost of undercompensated care incurred by a trauma physician in providing trauma care to enrollees of the Maryland Medical Assistance Program who are trauma patients on the State trauma registry shall be reimbursed at a rate of up to 100% of the Medicare payment for the service, minus any amount paid by the Maryland Medical Assistance Program;
The cost of uncompensated care incurred by a trauma physician in providing trauma care to trauma patients on the State trauma registry shall be reimbursed at a rate of 100% of the Medicare payment for the service, minus any recoveries made by the trauma physician for the care;
The Commission, in consultation with the Health Services Cost Review Commission, may establish a payment rate for uncompensated care incurred by a trauma physician in providing trauma care to trauma patients on the State trauma registry that is above 100% of the Medicare payment for the service if:
The Commission determines that increasing the payment rate above 100% of the Medicare payment for the service will address an unmet need in the State trauma system; and
The Commission reports on its intention to increase the payment rate to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, at least 60 days before any adjustment to the rate;
The Commission shall develop guidelines for the reimbursement of the documented costs of the State primary adult resource center under subsection (b)(2)(iv) of this section;
The Commission, in consultation with the Health Services Cost Review Commission, may change the percentage of the reasonable compensation equivalent paid to trauma hospitals if:
The Commission determines that the projected revenue to be collected in the Fund is adequate to support the proposed increase in the percentage of reasonable compensation equivalent inflated to the current year by the physician compensation component of the Medicare economic index; and
The Commission reports on its intention to change the percentage of reasonable compensation equivalent to be paid for on–call costs to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, at least 60 days before any adjustment to the allowable hours;
The Commission, in consultation with the Health Services Cost Review Commission, may change the number of allowable hours of trauma on–call each year if the Commission reports on its intention to change the number of allowable hours to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, at least 60 days before any adjustment to the allowable hours;
The Commission may modify the percentage paid of the reasonable compensation equivalent for on–call hours not more than once each year; and
The total reimbursement to emergency physicians from the Fund may not exceed $300,000 annually.
In order to receive reimbursement, a trauma physician or trauma health care practitioner in the case of costs of uncompensated care under subsection (b)(2)(i) of this section, or a trauma center in the case of on–call costs under subsection (b)(2)(iii) of this section, shall apply to the Fund on a form and in a manner approved by the Commission and the Health Services Cost Review Commission.
The Commission and the Health Services Cost Review Commission shall adopt regulations that specify the information that trauma physicians, trauma health care practitioners, and trauma centers must submit to receive money from the Fund.
The information required shall include:
The name and federal tax identification number of the trauma physician rendering the service;
The date of the service;
Appropriate codes describing the service;
Any amount recovered for the service rendered;
The name of the trauma patient;
The patient’s trauma registry number; and
Any other information the Commission and the Health Services Cost Review Commission consider necessary to disburse money from the Fund.
It is the intent of the General Assembly that trauma physicians and trauma centers shall cooperate with the Commission and the Health Services Cost Review Commission by providing information required under this paragraph in a timely and complete manner.
Except as provided in paragraph (2) of this subsection and notwithstanding any other provision of law, expenditures from the Fund for costs incurred in any fiscal year may not exceed revenues of the Fund.
The Commission, in consultation with the Health Services Cost Review Commission and the Maryland Institute for Emergency Medical Services Systems, shall develop a process for the award of grants to Level I, Level II, and Level III trauma centers in the delivery of trauma care.
The Commission shall issue grants under this paragraph from any balance carried over to the Fund from prior fiscal years.
The total amount of grants awarded under this paragraph in a fiscal year may not reduce the balance remaining in the Fund at the end of the fiscal year to less than 15% of the revenue collected in that fiscal year.
The process developed by the Commission for the award of grants under this paragraph shall include:
Grant applications and review and selection criteria for the award of grants;
Review by the Commission, if necessary, for any project that exceeds certificate of need thresholds; and
Any other procedure determined necessary by the Commission.
Before awarding grants under this subsection in a fiscal year, the Commission shall report to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with § 2–1257 of the State Government Article, on the process that the Commission has developed for awarding grants in that fiscal year.
On or before November 1 of each year, the Commission and the Health Services Cost Review Commission shall report to the General Assembly, in accordance with § 2–1257 of the State Government Article, on:
The amount of money in the Fund on the last day of the previous fiscal year;
The amount of money applied for by trauma physicians, trauma health care practitioners, and trauma centers during the previous fiscal year;
The amount of money distributed in the form of trauma physician, trauma health care practitioner, and trauma center reimbursements during the previous fiscal year;
Any recommendations for altering the manner in which trauma physicians, trauma health care practitioners, and trauma centers are reimbursed from the Fund;
The costs incurred in administering the Fund during the previous fiscal year;
The amount that each hospital that participates in the Maryland trauma system and that has a trauma center contributes toward the subsidization of trauma–related costs for its trauma center;
The costs that hospitals reported to the Health Services Cost Review Commission and are accounted for in the global budgets of the hospitals for each of the following:
Trauma standby;
Allowable trauma center costs for reimbursing the trauma director and trauma staff;
Maintaining Maryland Institute for Emergency Medical Services Systems trauma protocols;
Maintaining specialized trauma staff;
Procuring specialized trauma equipment; and
Providing trauma education and training; and
Any improvements made by trauma centers as a result of an increase in funding.
The Commission shall award an annual grant from the Fund in the amount up to $1,800,000 to Level I pediatric trauma centers as follows:
Up to $900,000 to Johns Hopkins Children’s Center; and
Up to $900,000 to Children’s National Medical Center.
In this Part III of this subtitle the following words have the meanings indicated.
“Ambulatory surgical facility” has the meaning stated in § 19–3B–01 of this title.
“Carrier” means:
An insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in the State in accordance with the Insurance Article; or
A health maintenance organization that holds a certificate of authority in the State.
“Comprehensive standard health benefit plan” means the comprehensive standard health benefit plan adopted in accordance with § 15–1207 of the Insurance Article.
“Health benefit plan” means a hospital or medical policy, contract, or certificate issued by a carrier.
“Health benefit plan” does not include:
Coverage for accident or disability income insurance;
Coverage issued as a supplement to liability insurance;
Liability insurance, including general liability insurance and automobile liability insurance;
Workers’ compensation or similar insurance;
Automobile or property medical payment insurance;
Credit–only insurance;
Coverage for on–site medical clinics;
Dental or vision insurance;
Long–term care insurance or benefits for nursing home care, home health care, community–based care, or any combination of these;
Coverage only for a specified disease or illness;
Hospital indemnity or other fixed indemnity insurance; or
The following benefits if offered as a separate insurance policy:
Medicare supplemental health insurance, as defined in § 1882(g)(1) of the Social Security Act;
Coverage supplemental to the coverage provided under Chapter 55 of Title 10 of the United States Code; or
Similar supplemental coverage provided to coverage under an employer sponsored plan.
“Health care practitioner” means any individual who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide health care services.
“Health care provider” means:
A person who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide health care in the ordinary course of business or practice of a profession or in an approved education or training program; or
A facility where health care is provided to patients or recipients, including:
A facility, as defined in § 10–101(g) of this article;
A hospital, as defined in § 19–301 of this title;
A related institution, as defined in § 19–301 of this title;
A health maintenance organization, as defined in § 19–701(g) of this title;
An outpatient clinic; and
A medical laboratory.
“Health care provider” includes the agents and employees of a facility who are licensed or otherwise authorized to provide health care, the officers and directors of a facility, and the agents and employees of a health care provider who are licensed or otherwise authorized to provide health care.
“Health care service” means any health or medical care procedure or service rendered by a health care practitioner that:
Provides testing, diagnosis, or treatment of human disease or dysfunction; or
Dispenses drugs, medical devices, medical appliances, or medical goods for the treatment of human disease or dysfunction.
“Hospital” has the meaning stated in § 19–301 of this title.
“Mandated health insurance service” means a legislative proposal or statute that would require a particular health care service to be provided or offered in a health benefit plan, by a carrier or other organization authorized to provide health benefit plans in the State.
“Mandated health insurance service”, as applicable to all carriers, does not include services enumerated to describe a health maintenance organization under § 19–701(g)(2) of this title.
“Nursing facility” has the meaning stated in § 19–1401 of this title.
“Office facility” means the office of one or more health care practitioners in which health care services are provided to individuals.
“Office facility” includes a facility that provides:
Ambulatory surgery;
Radiological or diagnostic imagery; or
Laboratory services.
“Office facility” does not include any office, facility, or service operated by a hospital and regulated under Part II of this subtitle.
“Payor” means:
A health insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in the State in accordance with this article or the Insurance Article;
A health maintenance organization that holds a certificate of authority in the State; or
For the purposes of this Part III of this subtitle only, a person that is registered as an administrator under Title 8, Subtitle 3 of the Insurance Article.
In this section, “code” means:
The applicable Current Procedural Terminology (CPT) code as adopted by the American Medical Association; or
If a CPT code is not available, the applicable code under an appropriate uniform coding scheme approved by the Commission.
The Commission shall establish a Maryland medical care data base to compile statewide data on health services rendered by health care practitioners and facilities selected by the Commission.
In addition to any other information the Commission may require by regulation, the medical care data base shall:
Collect for each type of patient encounter with a health care practitioner or facility designated by the Commission:
The demographic characteristics of the patient;
The principal diagnosis;
The procedure performed;
The date and location of where the procedure was performed;
The charge for the procedure;
If the bill for the procedure was submitted on an assigned or nonassigned basis;
If applicable, a health care practitioner’s universal identification number; and
If the health care practitioner rendering the service is a certified registered nurse anesthetist or certified nurse midwife, identification modifiers for the certified registered nurse anesthetist or certified nurse midwife;
Collect appropriate information relating to prescription drugs for each type of patient encounter with a pharmacist designated by the Commission; and
Collect appropriate information relating to health care costs, utilization, or resources from payors and governmental agencies.
The Commission shall adopt regulations governing the access and retrieval of all medical claims data and other information collected and stored in the medical care data base and any claims clearinghouse licensed by the Commission and may set reasonable fees covering the costs of accessing and retrieving the stored data.
These regulations shall ensure that confidential or privileged patient information is kept confidential.
Records or information protected by the privilege between a health care practitioner and a patient, or otherwise required by law to be held confidential, shall be filed in a manner that does not disclose the identity of the person protected.
To the extent practicable, when collecting the data required under subsection (c) of this section, the Commission shall utilize any standardized claim form or electronic transfer system being used by health care practitioners, facilities, and payors.
The Commission shall develop appropriate methods for collecting the data required under subsection (c) of this section on subscribers or enrollees of health maintenance organizations.
Until the provisions of § 19–134 of this subtitle are fully implemented, where appropriate, the Commission may limit the data collection under this section.
By October 1, 1995 and each year thereafter, the Commission shall publish an annual report on those health care services selected by the Commission that:
Describes the variation in fees charged by health care practitioners and facilities on a statewide basis and in each health service area for those health care services; and
Describes the geographic variation in the utilization of those health care services.
On an annual basis, the Commission shall publish:
The total reimbursement for all health care services over a 12–month period;
The total reimbursement for each health care specialty over a 12–month period;
The total reimbursement for each code over a 12–month period; and
The annual rate of change in reimbursement for health services by health care specialties and by code.
In addition to the information required under subparagraph (i) of this paragraph, the Commission may publish any other information that the Commission deems appropriate, including information on capitated health care services.
In developing the medical care data base, the Commission shall consult with representatives of the Health Services Cost Review Commission, health care practitioners, payors, and hospitals to ensure that the medical care data base is compatible with information collected by the Health Services Cost Review Commission.
The Commission, in consultation with the Insurance Commissioner, payors, health care practitioners, and hospitals, may adopt by regulation standards for the electronic submission of data and submission and transfer of the uniform claims forms established under § 15–1003 of the Insurance Article.
In order to more efficiently establish a medical care data base under § 19–133 of this subtitle, the Commission shall establish standards for the operation of one or more medical care electronic claims clearinghouses in Maryland and may license those clearinghouses meeting those standards.
In adopting regulations under this subsection, the Commission shall consider appropriate national standards.
The Commission may limit the number of licensed claims clearinghouses to assure maximum efficiency and cost effectiveness.
The Commission, by regulation, may charge a reasonable licensing fee to operate a licensed claims clearinghouse.
Health care practitioners in Maryland, as designated by the Commission, shall submit, and payors of health care services in Maryland as designated by the Commission shall receive claims for payment and any other information reasonably related to the medical care data base electronically in a standard format as required by the Commission whether by means of a claims clearinghouse or other method approved by the Commission.
The Commission shall establish reasonable deadlines for the phasing in of electronic transmittal of claims from those health care practitioners designated under paragraph (5) of this subsection.
As designated by the Commission, payors of health care services in Maryland and Medicaid and Medicare shall transmit explanations of benefits and any other information reasonably related to the medical care data base electronically in a standard format as required by the Commission whether by means of a claims clearinghouse or other method approved by the Commission.
The Commission may collect the medical care claims information submitted to any licensed claims clearinghouse for use in the data base established under § 19–133 of this subtitle.
The Commission shall:
Establish and implement a system to comparatively evaluate the quality of care and performance of categories of health benefit plans as determined by the Commission on an objective basis; and
Annually publish the summary findings of the evaluation.
The purpose of the evaluation system established under this subsection is to assist carriers to improve care by establishing a common set of quality and performance measurements and disseminating the findings to carriers and other interested parties.
The system, where appropriate, shall:
Solicit performance information from enrollees of health benefit plans;
Establish and incorporate a standard set of measures regarding racial and ethnic variations in quality and outcomes; and
Include information on the actions taken by carriers to track and reduce health disparities, including whether the health benefit plan provides culturally appropriate educational materials for its members.
The Commission shall adopt regulations to establish the system of evaluation provided under this subsection.
Before adopting regulations to implement an evaluation system under this subsection, the Commission shall consider recommendations of nationally recognized organizations that are involved in quality of care and performance measurement.
In implementing paragraph (3)(ii) and (iii) of this subsection, the Commission shall consult with appropriate stakeholders, including at least one representative of a carrier that does business predominantly in the State and a carrier that does business in the State and nationally, to determine national standards for evaluating the effectiveness of carriers in addressing health disparities and to fulfill the purposes of paragraph (3)(ii) and (iii) of this subsection in a manner that can be easily replicated in other states.
The Commission may contract with a private, nonprofit entity to implement the system required under this subsection provided that the entity is not an insurer.
The annual evaluation summary required under paragraph (1) of this subsection shall include to the extent feasible information on racial and ethnic variations.
The Commission, in consultation with the Maryland Department of Health and the Department of Aging, shall:
On or before July 1, 2001, develop and implement a system to comparatively evaluate the quality of care and performance of nursing facilities on an objective basis; and
Annually publish the summary findings of the evaluation.
The purpose of the comparative evaluation system established under this subsection is to improve the quality of care provided by nursing facilities by establishing a common set of performance measures and disseminating the findings of the comparative evaluation to nursing facilities, consumers, and other interested parties.
In developing the comparative evaluation system, the Commission shall consider the health status of the population served.
The system, as appropriate, shall solicit performance information from consumers and their families.
On or before October 1, 2007, to the extent feasible, the system shall incorporate racial and ethnic variations.
The Commission may adopt regulations to establish the comparative evaluation system provided under this subsection.
The Commission may:
On or before July 1, 2001, develop and implement a system to comparatively evaluate the quality of care outcomes and performance measurements of hospitals and ambulatory surgical facilities on an objective basis; and
Annually publish the summary findings of the evaluation.
The purpose of a comparable performance measurement system established under this subsection is to improve the quality of care provided by hospitals and ambulatory surgical facilities by establishing a common set of performance measurements and disseminating the findings of the performance measurements to hospitals, ambulatory surgical facilities, consumers, and interested parties.
In developing the performance measurement system, the Commission shall consider the geographic location, urban or rural orientation, and teaching or nonteaching status of the hospital and the ambulatory surgical facilities, and the health status of the population served.
The system, where appropriate, shall solicit performance information from consumers.
On or before October 1, 2007, to the extent feasible, the system shall incorporate racial and ethnic variations.
The Commission may adopt regulations to establish the system of evaluation provided under this subsection.
Before adopting regulations to implement an evaluation system under this subsection, the Commission shall:
Consider the performance measurements of appropriate accreditation organizations, State licensure regulations, Medicare certification regulations, the quality indicator project of the Association of Maryland Hospitals and Health Systems, and any other relevant performance measurements; and
Evaluate the desirability and feasibility of developing a consumer clearinghouse on health care information using existing available data.
The Commission may contract with a private entity to implement the system required under this subsection provided that the entity is not a hospital or an ambulatory surgical facility.
The comparable evaluation system established under this subsection shall include health care–associated infection information from hospitals.
The comparable evaluation system shall adhere, to the extent possible, to the current recommendations of the federal Centers for Disease Control and Prevention (CDC) and the CDC Healthcare Infection Control Practices Advisory Committee regarding public reporting of health care–associated infections.
The Commission shall compile data on:
Racial and ethnic disparities in insurance coverage for low–income, nonelderly individuals;
The racial and ethnic composition of the physician population compared to the racial and ethnic composition of the State’s population; and
Morbidity and mortality rates based on race and ethnicity for cardiovascular disease, cancer, diabetes, HIV/AIDS, infant mortality, asthma, and other diseases the Commission identifies.
The Commission shall:
Provide the racial and ethnic information compiled under this subsection to the Office of Minority Health and Health Disparities; and
Analyze the information jointly with the Office of Minority Health and Health Disparities for publication in the “Health Care Disparities Policy Report Card” required under § 20–1006(b)(2) of this article.
The Commission shall evaluate the feasibility of obtaining information from urban and rural populations in order to identify geographic disparities.
If the Commission is able to obtain the information described in subparagraph (i) of this paragraph, the Commission shall provide the information to the Office of Minority Health and Health Disparities.
For purposes of this section, the Commission shall collect racial and ethnic information and data that is reasonably collectable from any national, State, or county source that is reasonably available.
The Commission may implement a system to encourage health care practitioners to voluntarily control the costs of health care services.
The Commission may require health care practitioners of selected health care specialties to cooperate with licensed operators of clinical resource management systems that allow health care practitioners to critically analyze their charges and utilization of services in comparison to their peers.
If the Commission determines that clinical resource management systems are not available in the private sector, the Commission, in consultation with interested parties including payors, health care practitioners, and the Association of Maryland Hospitals and Health Systems, may develop a clinical resource management system.
The Commission may adopt regulations to govern the licensing of clinical resource management systems to ensure the accuracy and confidentiality of information provided by the system.
In any matter that relates to the utilization or cost of health care services rendered by health care practitioners or office facilities, the Commission may:
Hold a public hearing;
Conduct an investigation; or
Require the filing of any reasonable information.
If the Commission considers a further investigation necessary or desirable to authenticate information in a report that a health care practitioner or office facility files under this subtitle, the Commission may make necessary further examination of the records or accounts of the health care practitioner or office facility, in accordance with the regulations of the Commission.
In this Part IV of this subtitle the following words have the meanings indicated.
“Carrier” means:
An insurer;
A nonprofit health service plan;
A health maintenance organization; or
Any other person that provides health benefit plans subject to regulation by the State.
“Electronic health record” means an electronic record of health–related information on an individual that:
Includes patient demographic and clinical health information; and
Has the capacity to:
Provide clinical decision support;
Support physician order entry;
Capture and query information relevant to health care quality; and
Exchange electronic health information with and integrate the information from other sources.
“Health benefit plan” means a hospital or medical policy, contract, or certificate issued by a carrier.
“Health benefit plan” does not include:
Coverage for accident or disability income insurance;
Coverage issued as a supplement to liability insurance;
Liability insurance, including general liability insurance and automobile liability insurance;
Workers’ compensation or similar insurance;
Automobile or property medical payment insurance;
Credit–only insurance;
Coverage for on–site medical clinics;
Dental or vision insurance;
Long–term care insurance or benefits for nursing home care, home health care, community–based care, or any combination of these;
Coverage only for a specified disease or illness;
Hospital indemnity or other fixed indemnity insurance; or
The following benefits if offered as a separate insurance policy:
Medicare supplemental health insurance, as defined in § 1882(g)(1) of the Social Security Act;
Coverage supplemental to the coverage provided under Chapter 55 of Title 10, U.S.C.; or
Similar supplemental coverage provided to coverage under an employer–sponsored plan.
“Health care provider” means:
A person who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide health care in the ordinary course of business or practice of a profession or in an approved education or training program; or
A facility where health care is provided to patients or recipients, including:
A facility, as defined in § 10–101(g) of this article;
A hospital, as defined in § 19–301 of this title;
A related institution, as defined in § 19–301 of this title;
An outpatient clinic;
A freestanding medical facility, as defined in § 19–3A–01 of this title;
An ambulatory surgical facility, as defined in § 19–3B–01 of this title; and
A nursing home, as defined in § 19–1401 of this title.
“Health care provider” does not include a health maintenance organization as defined in § 19–701 of this title.
“Health information exchange” has the meaning stated in § 4–301 of this article.
“Management service organization” means an organization that offers one or more hosted electronic health record solutions and other management services to multiple health care providers.
“State–designated health information exchange” means the health information exchange designated by the Maryland Health Care Commission and the Health Services Cost Review Commission under § 19–143 of this subtitle.
“State–regulated payor” means a carrier issuing or delivering health benefit plans in the State.
“State–regulated payor” does not include a managed care organization as defined in Title 15, Subtitle 1 of this article.
On or before October 1, 2009, the Commission and the Health Services Cost Review Commission shall designate a health information exchange for the State.
The Secretary, to align funding opportunities with the purposes of this section and the development and effective operation of the State–designated health information exchange, may provide grants to the State–designated health information exchange.
On or before September 1, 2011, the Commission, in consultation with the Department, payors, and health care providers, shall adopt regulations that require State–regulated payors to provide incentives to health care providers to promote the adoption and meaningful use of electronic health records.
Incentives required under the regulations:
Shall have monetary value;
Shall facilitate the use of electronic health records by health care providers in the State;
To the extent feasible, shall recognize and be consistent with existing payor incentives that promote the adoption and meaningful use of electronic health records;
Shall take into account:
Incentives provided to health care providers under Medicare and Medicaid; and
Any grants or loans that are available to health care providers from the federal government;
May include:
Increased reimbursement for specific services;
Lump sum payments;
Gain–sharing arrangements;
Rewards for quality and efficiency;
In–kind payments; and
Other items or services to which a specific monetary value can be assigned; and
Shall be paid in cash, unless the State–regulated payor and the health care provider agree on an incentive of equivalent value.
The regulations need not require incentives for the adoption and meaningful use of electronic health records for each type of health care provider listed in § 19–142(e) of this subtitle.
If federal law is amended to allow the State to regulate payments made by entities that self–insure their health benefit plans, regulations adopted under this section shall apply to those entities to the same extent to which they apply to State–regulated payors.
Regulations adopted under this subsection:
May not require a group model health maintenance organization, as defined in § 19–713.6 of this title, to provide an incentive to a health care provider who is employed by the multispecialty group of physicians under contract with the group model health maintenance organization; and
Shall allow a State–regulated payor to:
Request information from a health care provider to validate the health care provider’s incentive claim; and
If the State–regulated payor determines that a duplicate incentive payment or an overpayment has been made, reduce the incentive amount.
The Commission may:
Audit the State–regulated payor or the health care provider for compliance with the regulations adopted under this subsection; and
If it finds noncompliance, request corrective action.
It is the intent of the General Assembly that the State Employee and Retiree Health and Welfare Benefits Program support the incentives provided under this subsection through contracts between the Program and the third party administrators arranging for the delivery of health care services to members covered under the Program.
The Health Services Cost Review Commission, in consultation with hospitals, payors, and the federal Centers for Medicare and Medicaid Services, shall take the actions necessary to:
Assure that hospitals in the State receive the payments provided under § 4102 of the federal American Recovery and Reinvestment Act of 2009 and any subsequent federal rules and regulations; and
Implement any changes in hospital rates required by the federal Centers for Medicare and Medicaid Services to ensure compliance with § 4102 of the federal American Recovery and Reinvestment Act of 2009 and any subsequent federal rules and regulations.
The Department, in consultation with the Commission, shall develop a mechanism to assure that health care providers that participate in the Maryland Medical Assistance Program receive the payments provided for adoption and use of electronic health records technology under § 4201 of the federal American Recovery and Reinvestment Act of 2009 and any subsequent federal rules and regulations.
On or before October 1, 2012, the Commission shall designate one or more management service organizations to offer services throughout the State.
The Commission may use federal grants and loans to help subsidize the use of the designated management service organizations by health care providers.
On and after the later of January 1, 2015, or the date established for the imposition of penalties under § 4102 of the federal American Recovery and Reinvestment Act of 2009:
Each health care provider using an electronic health record that seeks payment from a State–regulated payor shall use electronic health records that are:
Certified by a national certification organization designated by the Commission; and
Capable of connecting to and exchanging data with the State–designated health information exchange; and
The incentives required under subsection (b) of this section may include reductions in payments to a health care provider that does not use electronic health records that meet the requirements of paragraph (1) of this subsection.
To facilitate the use of Web–based technology for electronic advance directives, the Maryland Health Care Commission shall develop criteria for recognizing electronic advance directives services that are authorized to connect to the State–designated health information exchange.
To be authorized to connect to the State–designated health information exchange, an electronic advance directives service shall:
Be recognized by the Maryland Health Care Commission;
Be responsible for all costs associated with connecting to the State–designated health information exchange; and
Store electronic advance directives that are received by facsimile or other electronic means.
The State–designated health information exchange may charge electronic advance directives services recognized by the Maryland Health Care Commission a fee for connecting to the State–designated health information exchange.
The State–designated health information exchange shall ensure that electronic advance directives services do not have access to information stored on the State–designated health information exchange.
In this section the following words have the meanings indicated.
“Dispenser” means a person authorized by law to dispense, as defined in § 12–101 of the Health Occupations Article, a prescription drug to a patient or the patient’s agent in the State.
“Noncontrolled prescription drug” means a prescription drug, as defined in § 21–201 of this article, that is not a controlled dangerous substance designated under Title 5, Subtitle 4 of the Criminal Law Article.
“State–designated health information exchange” has the meaning stated in § 4–301 of this article.
The State–designated health information exchange shall operate as a health data utility for the State.
The purposes of the health data utility include:
The collection, aggregation, and analysis of clinical information, public health data, and health administrative and operations data to assist the Department, local health departments, the Commission, and the Health Services Cost Review Commission in the evaluation of public health interventions and health equity;
The communication of data between public health officials and health care providers to advance disease control and health equity; and
The enhancement and acceleration of the interoperability of health information throughout the State.
Dispensers shall provide data to the State–designated health information exchange.
The purpose of this subsection is to:
Authorize individuals and organizations involved in the treatment and care coordination of patients to access, as legally authorized, a patient’s medication history, including medications prescribed for the patient; and
Assist health care providers, care managers, the Department, and local health departments to understand and promote matters of health equity and treatment efficacy.
After dispensing a noncontrolled prescription drug, a dispenser shall submit prescription information to the State–designated health information exchange.
The prescription information shall be submitted:
By electronic means;
Without unduly increasing the workload and expense on a dispenser;
In a manner that minimizes burden and duplication by being as compatible as possible with existing federal standards for data submission practices, including technology software of dispensers; and
As otherwise required by regulations adopted by the Commission.
The State–designated health information exchange may not impose any fees or other assessments on dispensers to support the operation of the exchange.
The State–designated health information exchange shall make prescription information submitted under this subsection available for purposes of treatment and care coordination of a patient.
The State–designated health information exchange may provide data, as allowed by law, for public health purposes that may include:
Improving health equity through access to prescription medications, including for the treatment of infectious disease;
Assisting programs led by health care providers and the Department, local health departments, the Commission, and the Health Services Cost Review Commission to identify opportunities for quality improvement, including for stewardship of antibiotic medications; and
Conducting case investigations and related activities.
Information submitted to the State–designated health information exchange or provided by the State–designated health information exchange under this section shall be submitted or provided, to the extent practicable, in as near to real time as possible.
The Commission, in consultation with appropriate stakeholders, shall adopt regulations to carry out this section.
The regulations shall take into account consumer perspective and include:
The specific data required to be provided under subsection (d) of this section;
The specific prescription information required to be submitted under subsection (e) of this section;
The time frame for submitting prescription information under subsection (e) of this section;
The electronic means and manner by which prescription information is to be submitted under subsection (e) of this section;
Prescription information submission requirements that align with the data submission requirements on dispensers of monitored prescription drugs under Title 21, Subtitle 2A of this article; and
Identification and necessary suppression of information related to providers or medications that are determined to have significant potential to cause harm.
The State–designated health information exchange shall establish a consumer advisory council to bring the perspectives of individuals and organizations with an interest in protecting consumers into the delivery of services provided by the State–designated health information exchange.
In selecting members, the State–designated health information exchange shall consider diversity of experience.
The consumer advisory council established under paragraph (1) of this subsection shall:
Consist of a minimum of six members, including at least four consumer representatives and two staff representatives, and maintain a ratio of consumer representatives to nonconsumer representatives of at least two to one;
Identify and report consumer privacy concerns to senior leadership of the State–designated health information exchange;
Advise on efforts to educate consumers on data exchange policies, including options for consumers to opt out of disclosure of protected health information;
Meet at least 3 times each year; and
Adopt and maintain a charter to be posted online that includes the purpose, members, and meeting schedule of the consumer advisory council.
In this section the following words have the meanings indicated.
“Advance care planning document” means a document that indicates an individual’s preferences for the receipt of health care.
“Advance care planning document” includes:
An advance directive; and
A Medical Orders for Life–Sustaining Treatment form.
“Carrier” means:
An insurer;
A nonprofit health service plan; and
A health maintenance organization.
“Electronic advance care planning document” means an electronic version of an advance care planning document that is able to be uploaded or saved to the electronic platform developed under subsection (b)(2)(i) of this section.
“Health care provider” means:
A health care practitioner who is licensed or certified under the Health Occupations Article to provide health care in the ordinary course of business;
A set of health care practitioners, as defined in § 15–113 of this article;
A health care facility as defined in § 19–114 of this subtitle;
A nursing facility, as defined in § 19–301 of this title; or
An assisted living program, as defined in § 19–1801 of this title.
The Commission shall coordinate the accessibility of electronic advance care planning documents in the State.
The coordination provided by the Commission under this subsection shall include:
Collaboration with the State–designated health information exchange to develop an electronic platform through which:
Individuals can upload or save advance care planning documents;
Individuals can update electronic advance care planning documents; and
Health care providers can access electronic advance care planning documents as appropriate;
Identification of options meeting federal, State, and industry cybersecurity standards that may be taken by carriers, managed care organizations, and health care providers to:
Encourage members, enrollees, and patients to create, upload or save, and update advance care planning documents; and
Make tools, which may include electronic advance directives services recognized by the Commission under § 19–144 of this subtitle, accessible to members, enrollees, and patients that allow them to create, upload or save, and update electronic advance care planning documents;
Development and implementation of quality measures endorsed or designated for testing by a national quality measurement organization to measure the effectiveness of the options identified under item (ii) of this paragraph; and
Inclusion of a distinct tab on the State–designated health information exchange website that provides:
Access to the advance directive information sheet developed under § 5–615 of this article;
The electronic means to create, execute, and store an advance directive or health care designation; and
The capability to upload or save an advance care planning document to the electronic platform developed in accordance with item (i) of this paragraph and update existing electronic advance care planning documents.
As the Commission identifies options under paragraph (2)(ii) of this subsection, the Commission may explore whether carriers, managed care organizations, and health care providers with secure member authentication websites can link between the website of the carrier, managed care organization, or health care provider and the State–designated health information exchange website.
In developing the electronic platform in accordance with paragraph (2)(i) of this subsection, the Commission and the State–designated health information exchange:
Shall consult with other State agencies and stakeholders, as appropriate; and
Subject to available funds, may contract with a third–party vendor, as appropriate.
The electronic platform developed in accordance with paragraph (2)(i) of this subsection shall:
Provide an individual with disabilities with nonvisual access in a way that is fully and equally accessible to and independently usable by the individual with disabilities so that the individual is able to acquire the same information, engage in the same interactions, and enjoy the same services as users without disabilities, with substantially equivalent ease of use; and
Be consistent with the standards of § 508 of the federal Rehabilitation Act of 1973.
As an option under subsection (b)(2)(ii) of this section, a carrier, managed care organization, or health care provider may contract with an electronic advance directives service if the service:
Is approved by the Maryland Health Care Commission under § 19–144 of this subtitle; and
Meets the technology, security, and privacy standards set by the Commission.
The Commission may adopt regulations to carry out this section.
In this Part V of this subtitle the following words have the meanings indicated.
“Carrier” has the meaning stated in § 15–1301 of the Insurance Article.
“Enrollee” means an individual entitled to health benefits from a carrier.
“Physician rating system” has the meaning stated in § 15–1701 of the Insurance Article.
“Ratings examiner” means an independent entity that is approved by the Commission to review physician rating systems.
The Commission shall approve an entity that meets the requirements of this section to be a ratings examiner.
To be approved by the Commission as a ratings examiner, an entity examining a physician rating system shall require a physician rating system to:
Use only quality of performance and cost efficiency as measurement categories;
Calculate and disclose separately measures of cost efficiency and quality of performance;
Disclose clearly to physicians and enrollees the proportion of the component score for cost efficiency and quality of performance in each combined score;
In determining quality of performance, use measures:
That are based on nationally recognized, evidence–based or consensus–based clinical recommendations or guidelines; or
When available, that are endorsed by entities whose work in physician quality of performance is generally accepted in the health care system;
Disclose to physicians who are subject to the physician rating system:
The measurements for each criterion and the relative weight of each criterion and measurement in the overall rating of the physician;
The basis for the carrier’s quality of performance ratings;
The data used to determine the quality of performance ratings; and
The relative weight or relevance of quality of performance to the overall rating of a physician in the physician rating system;
The basis for determining whether there is a sufficient number of patients and episodes of care for a given disease state and specialty to generate reliable ratings for a physician; and
The methodology used to determine how data is attributed to a physician;
Use appropriate risk adjustments to account for the characteristics of the patient population seen by a physician in determining the quality of performance and cost efficiency of the physician;
In measuring the cost efficiency of the performance of a physician:
Compare physicians within the same specialty within the appropriate geographical market; and
Use appropriate and comprehensive episode of care computer software to evaluate the cost efficiency of the performance of a physician;
Include an appeals process that a physician subject to the physician rating system may use to appeal the rating received under the physician rating system; and
Based on the outcome of an appeal, make any necessary corrections to the data used to rate the physician in the physician rating system; and
Disclose to physicians and enrollees how the perspectives of enrollees, consumer advocates, employers, labor unions, and physicians were incorporated into the development of the physician rating system.
Notwithstanding subsection (b) of this section, an entity that has a physician performance rating certification program approved after August 1, 2008, by a national consortium of employer, consumer, and labor organizations working toward a common goal to ensure that all Americans have access to publicly reported health care performance information:
Is deemed to be a ratings examiner under this part; and
Is deemed to meet the requirements of subsection (b) of this section.