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2007 SESSION
077602472Be it enacted by the General Assembly of Virginia:
1. That §§ 32.1-102.1, 32.1-102.3, 32.1-102.6, 32.1-102.12, and 32.1-122.05 of the Code of Virginia are amended and reenacted as follows:
§ 32.1-102.1. Definitions.
As used in this article, unless the context indicates otherwise:
"Certificate" means a certificate of public need for a project required by this article.
"Clinical health service" means a single diagnostic, therapeutic, rehabilitative, preventive or palliative procedure or a series of such procedures that may be separately identified for billing and accounting purposes.
"Health planning region" means a contiguous geographical area of the Commonwealth with a population base of at least 500,000 persons which is characterized by the availability of multiple levels of medical care services, reasonable travel time for tertiary care, and congruence with planning districts.
"Medical care facility," as used in this title, means any institution, place, building or agency, whether or not licensed or required to be licensed by the Board or the State Mental Health, Mental Retardation and Substance Abuse Services Board, whether operated for profit or nonprofit and whether privately owned or privately operated or owned or operated by a local governmental unit, (i) by or in which health services are furnished, conducted, operated or offered for the prevention, diagnosis or treatment of human disease, pain, injury, deformity or physical condition, whether medical or surgical, of two or more nonrelated mentally or physically sick or injured persons, or for the care of two or more nonrelated persons requiring or receiving medical, surgical or nursing attention or services as acute, chronic, convalescent, aged, physically disabled or crippled or (ii) which is the recipient of reimbursements from third-party health insurance programs or prepaid medical service plans. For purposes of this article, only the following medical care facilities shall be subject to review:
1. General hospitals.
2. Sanitariums.
3. Nursing homes.
4. Intermediate care facilities, except those intermediate care facilities established for the mentally retarded that have no more than 12 beds and are in an area identified as in need of residential services for people with mental retardation in any plan of the Department of Mental Health, Mental Retardation and Substance Abuse Services.
5. Extended care facilities.
6. Mental hospitals.
7. Mental retardation facilities.
8. Psychiatric hospitals and intermediate care facilities established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts.
9. Specialized centers or clinics or that portion of a physician's office developed for the provision of outpatient or ambulatory surgery, cardiac catheterization, computed tomographic (CT) scanning, gamma knife surgery, lithotripsy, magnetic resonance imaging (MRI), magnetic source imaging (MSI), positron emission tomographic (PET) scanning, radiation therapy, nuclear medicine imaging, except for the purpose of nuclear cardiac imaging, or such other specialty services as may be designated by the Board by regulation.
10. Rehabilitation hospitals.
11. Any facility licensed as a hospital.
The term "medical care facility" shall not include any facility of (i) the Department of Mental Health, Mental Retardation and Substance Abuse Services; (ii) any nonhospital substance abuse residential treatment program operated by or contracted primarily for the use of a community services board under the Department of Mental Health, Mental Retardation and Substance Abuse Services' Comprehensive Plan; (iii) an intermediate care facility for the mentally retarded that has no more than 12 beds and is in an area identified as in need of residential services for people with mental retardation in any plan of the Department of Mental Health, Mental Retardation and Substance Abuse Services; (iv) a physician's office, except that portion of a physician's office described above in subdivision 9 of the definition of "medical care facility"; or (v) the Woodrow Wilson Rehabilitation Center of the Department of Rehabilitative Services. "Medical care facility" shall also not include that portion of a physician's office dedicated to providing nuclear cardiac imaging.
"Project" means:
1. Establishment of a medical care facility;
2. An increase in the total number of beds or operating rooms in an existing medical care facility;
3. Relocation at the same site of 10 beds or 10 percent of the beds, whichever is less, from one existing physical facility to another in any two-year period; however, a hospital shall not be required to obtain a certificate for the use of 10 percent of its beds as nursing home beds as provided in § 32.1-132;
4. Introduction into an existing medical care facility of any new nursing home service, such as intermediate care facility services, extended care facility services, or skilled nursing facility services, regardless of the type of medical care facility in which those services are provided;
5. Introduction into an existing medical care facility of any new cardiac catheterization, computed tomographic (CT) scanning, gamma knife surgery, lithotripsy, magnetic resonance imaging (MRI), magnetic source imaging (MSI), medical rehabilitation, neonatal special care, obstetrical, open heart surgery, positron emission tomographic (PET) scanning, psychiatric, organ or tissue transplant service, radiation therapy, nuclear medicine imaging, except for the purpose of nuclear cardiac imaging, substance abuse treatment, or such other specialty clinical services as may be designated by the Board by regulation, which the facility has never provided or has not provided in the previous 12 months;
6. Conversion of beds in an existing medical care facility to medical rehabilitation beds or psychiatric beds;
7. The addition by an existing medical care facility of any medical equipment for the provision of cardiac catheterization, computed tomographic (CT) scanning, gamma knife surgery, lithotripsy, magnetic resonance imaging (MRI), magnetic source imaging (MSI), open heart surgery, positron emission tomographic (PET) scanning, radiation therapy, or other specialized service designated by the Board by regulation. Replacement of existing equipment shall not require a certificate of public need; or
8. Any capital expenditure of $5 million or more, not defined as reviewable in subdivisions 1 through 7 of this definition, by or in behalf of a medical care facility. However, capital expenditures between $1 and $5 million shall be registered with the Commissioner pursuant to regulations developed by the Board.
"Regional health planning agency" means
the regional agency, including the regional health planning board, its staff
and any component thereof, designated by the Virginia Health Planning Board to
perform the health planning activities set forth in this chapter within a
health planning region.
"State Medical Facilities Plan" means the planning document adopted by the Board of Health which shall include, but not be limited to, (i) methodologies for projecting need for medical care facility beds and services; (ii) statistical information on the availability of medical care facilities and services; and (iii) procedures, criteria and standards for review of applications for projects for medical care facilities and services.
"Virginia Health Planning Board" means the statewide health planning body established pursuant to § 32.1-122.02 which serves as the analytical and technical resource to the Secretary of Health and Human Resources in matters requiring health analysis and planning.
§ 32.1-102.3. Certificate required; criteria for determining need.
A. No person shall commence any project without first obtaining a certificate issued by the Commissioner. No certificate may be issued unless the Commissioner has determined that a public need for the project has been demonstrated. If it is determined that a public need exists for only a portion of a project, a certificate may be issued for that portion and any appeal may be limited to the part of the decision with which the appellant disagrees without affecting the remainder of the decision. Any decision to issue or approve the issuance of a certificate shall be consistent with the most recent applicable provisions of the State Medical Facilities Plan; however, if the Commissioner finds, upon presentation of appropriate evidence, that the provisions of such plan are not relevant to a rural locality's needs, inaccurate, outdated, inadequate or otherwise inapplicable, the Commissioner, consistent with such finding, may issue or approve the issuance of a certificate and shall initiate procedures to make appropriate amendments to such plan.
B. In determining whether a public need for a project has been demonstrated, the Commissioner shall consider:
1. The recommendation and the reasons therefor of
the appropriate health planning agency.
21. The
relationship of the project to the applicable health plans of the Board and the health planning agency.
32. The
relationship of the project to the long-range development plan, if any, of the
person applying for a certificate.
43. The
need that the population served or to be served by the project has for the
project, including, but not limited to, the needs of rural populations in areas
having distinct and unique geographic, socioeconomic, cultural, transportation,
and other barriers to access to care.
54. The
extent to which the project will be accessible to all residents of the area
proposed to be served and the effects on accessibility of any proposed
relocation of an existing service or facility.
65. The
area, population, topography, highway facilities and availability of the
services to be provided by the project in the particular part of the health
service area in which the project is proposed, in particular, the distinct and
unique geographic, socioeconomic, cultural, transportation, and other barriers
to access to care.
76. Less
costly or more effective alternate methods of reasonably meeting identified
health service needs.
87. The
immediate and long-term financial feasibility of the project.
98. The
relationship of the project to the existing health care system of the area in
which the project is proposed; however, for projects proposed in rural areas,
the relationship of the project to the existing health care services in the
specific rural locality shall be considered.
109. The
availability of resources for the project.
1110. The
organizational relationship of the project to necessary ancillary and support
services.
1211. The
relationship of the project to the clinical needs of health professional
training programs in the area in which the project is proposed.
1312. The
special needs and circumstances of an applicant for a certificate, such as a
medical school, hospital, multidisciplinary clinic, specialty center or
regional health service provider, if a substantial portion of the applicant's
services or resources or both is provided to individuals not residing in the
health service area in which the project is to be located.
1413. The
special needs and circumstances of health maintenance organizations. When
considering the special needs and circumstances of health maintenance organizations,
the Commissioner may grant a certificate for a project if the Commissioner
finds that the project is needed by the enrolled or reasonably anticipated new
members of the health maintenance organization or the beds or services to be
provided are not available from providers which are not health maintenance
organizations or from other health maintenance organizations in a reasonable
and cost-effective manner.
1514. The
special needs and circumstances for biomedical and behavioral research projects
which are designed to meet a national need and for which local conditions offer
special advantages.
1615. In
the case of a construction project, the costs and benefits of the proposed
construction.
1716. The
probable impact of the project on the costs of and charges for providing health
services by the applicant for a certificate and on the costs and charges to the
public for providing health services by other persons in the area.
1817.
Improvements or innovations in the financing and delivery of health services
which foster competition and serve to promote quality assurance and cost
effectiveness.
1918. In
the case of health services or facilities proposed to be provided, the
efficiency and appropriateness of the use of existing services and facilities in
the area similar to those proposed, including, in the case of rural localities,
any distinct and unique geographic, socioeconomic, cultural, transportation,
and other barriers to access to care.
2019. The
need and the availability in the health service area for osteopathic and
allopathic services and facilities and the impact on existing and proposed
institutional training programs for doctors of osteopathy and medicine at the
student, internship, and residency training levels.
§ 32.1-102.6. Administrative procedures.
A. At least 30 calendar days before any person is contractually obligated to acquire an existing medical care facility, the cost of which is $600,000 or more, that person shall notify the Commissioner and the appropriate health planning agency of the intent, the services to be offered in the facility, the bed capacity in the facility, and the projected impact that the cost of the acquisition will have upon the charges for services to be provided. If clinical services or beds are proposed to be added as a result of the acquisition, the Commissioner may require the proposed new owner to obtain a certificate prior to the acquisition.
B. To obtain a certificate for a
project, the applicant shall file a completed application for a certificate with
the Department and the appropriate
health planning agency. In order to verify the date of the
Department's and the appropriate health planning agency's receipt
of the application, the applicant shall transmit the document by certified mail
or a delivery service, return receipt requested, or shall deliver the document
by hand, with signed receipt to be provided.
Within 10 calendar days of the date on which the document is
received, the Department and the appropriate health planning agency shall
determine whether the application is complete or not and the Department shall
notify the applicant, if the application is not complete, of the information
needed to complete the application.
At least 30 calendar days before any person is
contractually obligated to acquire an existing medical care facility, the cost
of which is $600,000 or more, that person shall notify the Commissioner and the
appropriate health planning agency of the intent, the services to be offered in
the facility, the bed capacity in the facility and the projected impact that
the cost of the acquisition will have upon the charges for services to be
provided. If clinical services or beds are proposed to be added as a result of
the acquisition, the Commissioner may require the proposed new owner to obtain
a certificate prior to the acquisition.
B. The appropriate health planning agency shall
review each completed application for a certificate within 60 calendar days of
the day which begins the appropriate batch review cycle as established by the Board
by regulation pursuant to subdivision A 1 of § 32.1-102.2, such cycle not to
exceed 190 days in duration. The health planning agency shall hold one public
hearing on each application in a location in the county or city in which the
project is proposed or a contiguous county or city. The health planning agency
shall cause notice of the public hearing to be published in a newspaper of
general circulation in the county or city where a project is proposed to be
located at least nine calendar days prior to the public hearing. Prior to the
public hearing, the health planning agency shall notify the local governing
bodies in the planning district. The health planning agency shall consider the
comments of such governing bodies and all other public comments in making its
decision. Such comments shall be part of the record provided to the Department.
In no case shall a health planning agency hold more than two meetings on any
application, one of which shall be the public hearing conducted by the board of
the health planning agency or a subcommittee of the board. The applicant shall
be given the opportunity, prior to the vote by the board of the health planning
agency or a committee of the agency, if acting for the board, on its
recommendation, to respond to any comments made about the project by the health
planning agency staff, any information in a staff report, or comments by those
voting; however, such opportunity shall not increase the 60-calendar-day period
designated herein for the health planning agency's review unless the applicant
or applicants request a specific extension of the health planning agency's
review period.
The health planning agency shall submit its
recommendations on each application and its reasons therefor to the Department
within 10 calendar days after the completion of its 60-calendar-day review or
such other period in accordance with the applicant's request for extension.
If the health planning agency has not completed its
review within the specified 60 calendar days or such other period in accordance
with the applicant's request for extension and submitted its recommendations on
the application and the reasons therefor within 10 calendar days after the
completion of its review, the Department shall, on the eleventh calendar day
after the expiration of the health planning agency's review period, proceed as
though the health planning agency has recommended project approval without
conditions or revision.
C. After commencement of any public hearing and
before a decision is made there shall be no ex parte contacts concerning the
subject certificate or its application between (i) any person acting on behalf
of the applicant or holder of a certificate or any person opposed to the
issuance or in favor of revocation of a certificate of public need and (ii) any
person in the Department who has authority to make a determination respecting
the issuance or revocation of a certificate of public need, unless the
Department has provided advance notice to all parties referred to in (i) of the
time and place of such proposed contact.
DC. The
Department shall commence the review of each completed application upon the day which that
begins the appropriate batch review cycle and
simultaneously with the review conducted by the health planning agency as established by
regulations promulgated pursuant to § 32.1-102.2. Such
review shall not exceed 120 calendar days.
A determination as to whether
a public need exists for a project shall be made by the Commissioner within 190 120
calendar days of the day which begins the appropriate batch cycle.
The 190-calendar-day 120-calendar-day
review period shall begin on the date upon which the application is determined
to be complete within the batching process specified in subdivision A 1 of §
32.1-102.2.
If the application is not determined to be complete within 40 calendar days from submission, the application shall be refiled in the next batch for like projects.
D. The Department shall hold one public hearing on each application in a location in the county or city in which the project is proposed or a contiguous county or city. The Department shall cause notice of the public hearing to be published in a newspaper of general circulation in the county or city where a project is proposed to be located at least nine calendar days prior to the public hearing. Prior to the public hearing, the Department shall notify the local governing bodies in the planning district. The Department shall consider the comments of such governing bodies and all other public comments in making its decision. Such comments shall be part of the record. In no case shall the Department hold more than two meetings on any application.
E. After commencement of any public hearing and before any decision is made there shall be no ex parte contact concerning the subject certificate or its application between (i) any person acting on behalf of the application or holder of a certificate or any person opposed to the issuance or in favor of revocation of a certificate of public need and (ii) any person in the Department who has authority to make a determination respecting the issuance or revocation of a certificate of public need, unless the Department has provided advance notice to all parties referred to in clause (i) of the time and place of the proposed contact.
F. The Commissioner shall make
determinations in accordance with the provisions of the Administrative Process
Act (§ 2.2-4000 et seq.) except for those parts of the determination process
for which timelines and specifications are delineated in subsection E G of this section. Further, if an informal fact-finding conference
is determined to be necessary by the Department or is requested by a person
seeking good cause standing, the parties to the case shall include only the
applicant, any person showing good cause, and any
third-party payor providing health care insurance or prepaid coverage to five
percent or more of the patients in the applicant's service area,
and the relevant health planning agency.
EG. Upon
entry of each completed application or applications into the appropriate batch
review cycle:
1. The Department shall establish, for every application, a
date between the eightieth tenth and
ninetieth twentieth calendar
days within the 190-calendar-day120-calendar-day
review period for holding an informal fact-finding conference, if such
conference is necessary.
2. The Department shall review every application at or before
the seventy-fifth fifth calendar
day within the 190-calendar-day120-calendar-day
review period to determine whether an informal fact-finding conference is
necessary.
3. Any person seeking to be made a party to the case for good
cause shall notify the Department of his request and the basis therefor on or
before the eightieth tenth calendar
day following the day which begins the appropriate batch review cycle.
4. In any case in which an informal fact-finding conference is held, a date shall be established for the closing of the record which shall not be more than 30 calendar days after the date for holding the informal fact-finding conference.
5. In any case in which an informal fact-finding conference is not held, the record shall be closed on the earlier of (i) the date established for holding the informal fact-finding conference or (ii) the date that the Department determines an informal fact-finding conference is not necessary.
6. The provisions of subsection D of § 2.2-4019
notwithstanding, if If a
determination whether a public need exists for a project is not made by the
Commissioner within 45 calendar days of the closing of the record, the
Commissioner shall notify the applicant or applicants and any persons seeking
to show good cause, in writing, that the application or the application of each
shall be deemed approved 25 calendar days after expiration of such 45-calendar-day
period, unless the receipt of recommendations from the person performing the
hearing officer functions permits the Commissioner to issue his case decision
within that 25-calendar-day period. The validity or timeliness of the
aforementioned notice shall not, in any event, prevent, delay or otherwise
impact the effectiveness of subdivision E 6 of § 32.1-102.6.
7. In any case when a determination as to whether a public need exists for a project is not made by the Commissioner within 70 calendar days after the closing of the record, the application shall be deemed to be approved and the certificate shall be granted.
8. If a determination as to whether a public need exists for a project is not made by the Commissioner within 45 calendar days of the closing of the record, any applicant who is competing in the relevant batch or who has filed an application in response to the relevant Request For Applications issued pursuant to § 32.1-102.3:2 may, prior to the application being deemed approved, petition for immediate injunctive relief pursuant to § 2.2-4030, naming as respondents the Commissioner and all parties to the case. During the pendency of the proceeding, no applications shall be deemed to be approved. In such a proceeding, the provisions of § 2.2-4030 shall apply.
FH.
Deemed approvals shall be construed as the Commissioner's case decision on the
application pursuant to the Administrative Process Act (§ 2.2-4000 et seq.) and
shall be subject to judicial review on appeal as the Commissioner's case decision
in accordance with such act.
Any person who has sought to participate in the Department's review of such deemed-to-be-approved application as a person showing good cause who has not received a final determination from the Commissioner concerning such attempt to show good cause shall be deemed to be a person showing good cause for purposes of appeal of the deemed approval of the certificate.
In any appeal of the Commissioner's case decision granting a certificate of public need pursuant to a Request for Applications issued pursuant to § 32.1-102.3:2, the court may require the appellant to file a bond pursuant to § 8.01-676.1, in such sum as shall be fixed by the court for protection of all parties interested in the case decision, conditioned on the payment of all damages and costs incurred in consequence of such appeal.
GI. For
purposes of this section, "good cause" shall mean that (i) there is
significant relevant information not previously presented at and not available
at the time of the public hearing, (ii) there have been significant changes in
factors or circumstances relating to the application subsequent to the public
hearing, or (iii) there is a substantial material mistake of fact or law in the
Department staff's report on the application or in the report
submitted by the health planning agency.
HJ. The
project review procedures shall provide for separation of the project review
manager functions from the hearing officer functions. No person serving in the
role of project review manager shall serve as a hearing officer.
IK. The
applicants, and only the applicants, shall have the authority to extend any of
the time periods specified in this section. If all applicants consent to
extending any time period in this section, the Commissioner, with the
concurrence of the applicants, shall establish a new schedule for the remaining
time periods.
§ 32.1-102.12. Report required.
The Commissioner shall annually report to the Governor and the General Assembly on the status of Virginia's certificate of public need program. The report shall be issued by October 1 of each year and shall include, but need not be limited to:
1. A summary of the Commissioner's actions during the previous fiscal year pursuant to this article;
2. A five-year schedule for analysis of all project categories which provides for analysis of at least three project categories per year;
3. An analysis of the appropriateness of continuing the certificate of public need program for at least three project categories in accordance with the five-year schedule for analysis of all project categories;
4. An analysis of the effectiveness of the application review
procedures used by the health systems agencies and the
Department required by § 32.1-102.6 which details the review time required during
the past year for various project categories, the number of contested or
opposed applications and the project categories of these contested or opposed
projects, the number of applications upon which the health
systems agencies have failed to act in accordance with the timelines of §
32.1-102.6 B, and the number of deemed approvals from the
Department because of their failure to comply with the timelines required by subsection G of § 32.1-102.6 E, and
any other data determined by the Commissioner to be relevant to the efficient
operation of the program;
5. An analysis of health care market reform in the Commonwealth and the extent, if any, to which such reform obviates the need for the certificate of public need program;
6. An analysis of the accessibility by the indigent to care provided by the medical care facilities regulated pursuant to this article and the relevance of this article to such access;
7. An analysis of the relevance of this article to the quality of care provided by medical care facilities regulated pursuant to this article; and
8. An analysis of equipment registrations required pursuant to § 32.1-102.1:1, including the type of equipment, whether an addition or replacement, and the equipment costs.
§ 32.1-122.05. Regional health planning agencies; boards; duties and responsibilities.
A. For the purpose of representing the interests of health planning regions and performing health planning activities at the regional level, there are hereby created such regional health planning agencies as may be designated by the Board of Health.
B. Each regional health planning agency shall be governed by a regional health planning board to be composed of not more than thirty residents of the region. The membership of the regional health planning boards shall include, but not be limited to, consumers, providers, a director of a local health department, a director of a local department of social services or welfare, a director of a community services board, a director of an area agency on aging and representatives of health care insurers, local governments, the business community and the academic community. The majority of the members of each regional health planning board shall be consumers. Consumer members shall be appointed in a manner that ensures the equitable geographic and demographic representation of the region. Provider members shall be solicited from professional organizations, service and educational institutions and associations of service providers and health care insurers in a manner that assures equitable representation of provider interest.
The members of the regional health planning boards shall be appointed for no more than two consecutive terms of four years or, when appointed to fill an unexpired term of less than four years, for three consecutive terms consisting of one term of less than four years and two terms of four years. The boards shall not be self-perpetuating. The Board of Health shall establish procedures requiring staggered terms. The composition and the method of appointment of the regional health planning boards shall be established in the regulations of the Board of Health. In addition, the Board of Health shall require, pursuant to regulations, each regional health planning board to report and maintain a record of its membership, including, but not limited to, the names, addresses, dates of appointment, years served, number of consecutive and nonconsecutive terms, and the group represented by each member. These membership reports and records shall be public information and shall be published in accordance with the regulations of the Board.
C. An agreement shall be executed between the Commissioner, in consultation with the Board of Health, and each regional health planning board to delineate the work plan and products to be developed with state funds. Funding for the regional health planning agencies shall be contingent upon meeting these obligations and complying with the Board's regulations.
D. Each regional health planning agency shall assist the Board
of Health by: (i) conducting data collection, research and analyses as required
by the Board; (ii) preparing reports and studies in consultation and
cooperation with the Board; (iii) reviewing and commenting on the components of
the State Health Plan; (iv) conducting needs assessments as appropriate and
serving as a technical resource to the Board; (v) identifying gaps in services,
inappropriate use of services or resources and assessing accessibility of
critical services; (vi) reviewing applications for certificates of public
need and making recommendations to the Department thereon as provided in §
32.1-102.6; and (viivi) conducting such other functions as
directed by the regional health planning board. All regional health planning
agencies shall demonstrate and document accountability for state funds through
annual budget projections and quarterly expenditure and activity reports that
shall be submitted to the Commissioner. A regional health planning agency may
designate membership and activities at subarea levels as deemed appropriate by
its regional health planning board. Each regional health planning board shall
adopt bylaws for its operation and for the election of its chairman and shall
maintain and publish a record of its membership and any subarea levels as required
by this section and the regulations of the Board of Health.