16106109D
Be it enacted by the General Assembly of Virginia: 1. That §§2.2-4006, 15.2-5307, 32.1-102.1, 32.1-102.1:1, 32.1-102.2, 32.1-102.2:1, 32.1-102.3, 32.1-102.4, 32.1-102.6, 32.1-122.01, 32.1-122.03, 32.1-122.04, and 32.1-122.07 of the Code of Virginia are amended and reenacted and that the Code of Virginia is amended by adding in Article 1.1 of Chapter 4 of Title 32.1 sections numbered 32.1-102.01, 32.1-102.2:2, and 32.1-102.14, by adding in Chapter 4 of Title 32.1 an article numbered 1.2, consisting of sections numbered 32.1-102.15 and 32.1-102.16, and by adding in Chapter 4 of Title 32.1 an article numbered 1.3, consisting of sections numbered 32.1-102.17 through 32.1-102.20, as follows: §2.2-4006. Exemptions from requirements of this article. A. The following agency actions otherwise subject to this chapter and §2.2-4103 of the Virginia Register Act shall be exempted from the operation of this article: 1. Agency orders or regulations fixing rates or prices. 2. Regulations that establish or prescribe agency organization, internal practice or procedures, including delegations of authority. 3. Regulations that consist only of changes in style or form or corrections of technical errors. Each promulgating agency shall review all references to sections of the Code of Virginia within their regulations each time a new supplement or replacement volume to the Code of Virginia is published to ensure the accuracy of each section or section subdivision identification listed. 4. Regulations that are: a. Necessary to conform to changes in Virginia statutory law or the appropriation act where no agency discretion is involved. However, such regulations shall be filed with the Registrar within 90 days of the law's effective date; b. Required by order of any state or federal court of competent jurisdiction where no agency discretion is involved; or c. Necessary to meet the requirements of federal law or regulations, provided such regulations do not differ materially from those required by federal law or regulation, and the Registrar has so determined in writing. Notice of the proposed adoption of these regulations and the Registrar's determination shall be published in the Virginia Register not less than 30 days prior to the effective date of the regulation. 5. Regulations of the Board of Agriculture and Consumer Services adopted pursuant to subsection B of §3.2-3929 or clause (v) or (vi) of subsection C of §3.2-3931 after having been considered at two or more Board meetings and one public hearing. 6. Regulations of the regulatory boards served by (i) the Department of Labor and Industry pursuant to Title 40.1 and (ii) the Department of Professional and Occupational Regulation or the Department of Health Professions pursuant to Title 54.1 that are limited to reducing fees charged to regulants and applicants. 7. The development and issuance of procedural policy relating to risk-based mine inspections by the Department of Mines, Minerals and Energy authorized pursuant to §§45.1-161.82 and 45.1-161.292:55. 8. General permits issued by the (a) State Air Pollution Control Board pursuant to Chapter 13 (§10.1-1300 et seq.) of Title 10.1 or (b) State Water Control Board pursuant to the State Water Control Law (§62.1-44.2 et seq.), Chapter 24 (§62.1-242 et seq.) of Title 62.1 and Chapter 25 (§ 62.1-254 et seq.) of Title 62.1, (c) Virginia Soil and Water Conservation Board pursuant to the Dam Safety Act (§10.1-604 et seq.), and (d) the development and issuance of general wetlands permits by the Marine Resources Commission pursuant to subsection B of §28.2-1307, if the respective Board or Commission (i) provides a Notice of Intended Regulatory Action in conformance with the provisions of §2.2-4007.01, (ii) following the passage of 30 days from the publication of the Notice of Intended Regulatory Action forms a technical advisory committee composed of relevant stakeholders, including potentially affected citizens groups, to assist in the development of the general permit, (iii) provides notice and receives oral and written comment as provided in § 2.2-4007.03, and (iv) conducts at least one public hearing on the proposed general permit. 9. The development and issuance by the Board of Education of guidelines on constitutional rights and restrictions relating to the recitation of the pledge of allegiance to the American flag in public schools pursuant to §22.1-202. 10. Regulations of the Board of the Virginia College Savings Plan adopted pursuant to §23-38.77. 11. Regulations of the Marine Resources Commission. 12. Regulations adopted by the Board of Housing and Community Development pursuant to (i) Statewide Fire Prevention Code (§27-94 et seq.), (ii) the Industrialized Building Safety Law (§36-70 et seq.), (iii) the Uniform Statewide Building Code (§36-97 et seq.), and (iv) §36-98.3, provided the Board (a) provides a Notice of Intended Regulatory Action in conformance with the provisions of §2.2-4007.01, (b) publishes the proposed regulation and provides an opportunity for oral and written comments as provided in § 2.2-4007.03, and (c) conducts at least one public hearing as provided in §§ 2.2-4009 and 36-100 prior to the publishing of the proposed regulations. Notwithstanding the provisions of this subdivision, any regulations promulgated by the Board shall remain subject to the provisions of §2.2-4007.06 concerning public petitions, and §§2.2-4013 and 2.2-4014 concerning review by the Governor and General Assembly. 13. Amendments to the list of drugs susceptible to counterfeiting adopted by the Board of Pharmacy pursuant to subsection B of § 54.1-3307 or amendments to regulations of the Board to schedule a substance in Schedule I or II pursuant to subsection D of §54.1-3443. 14. Waste load allocations adopted, amended, or repealed by the State Water Control Board pursuant to the State Water Control Law (§ 62.1-44.2 et seq.), including but not limited to Article 4.01 (§62.1-44.19:4 et seq.) of the State Water Control Law, if the Board (i) provides public notice in the Virginia Register; (ii) if requested by the public during the initial public notice 30-day comment period, forms an advisory group composed of relevant stakeholders; (iii) receives and provides summary response to written comments; and (iv) conducts at least one public meeting. Notwithstanding the provisions of this subdivision, any such waste load allocations adopted, amended, or repealed by the Board shall be subject to the provisions of §§2.2-4013 and 2.2-4014 concerning review by the Governor and General Assembly. 15. Amendments to the State Health Services Plan adopted by the State Board of Health following review by the State Health Services Advisory Council pursuant to §32.1-102.2:1 if the Board (i) provides a Notice of Intended Regulatory Action in accordance with the requirements of § 2.2-4007.01, (ii) provides notice and receives comment as provided in § 2.2-4007.03, and (iii) conducts at least one public hearing on the proposed amendments. B. Whenever regulations are adopted under this section, the agency shall state as part thereof that it will receive, consider and respond to petitions by any interested person at any time with respect to reconsideration or revision. The effective date of regulations adopted under this section shall be in accordance with the provisions of §2.2-4015, except in the case of emergency regulations, which shall become effective as provided in subsection B of §2.2-4012. C. A regulation for which an exemption is claimed under this section or §2.2-4002 or 2.2-4011 and that is placed before a board or commission for consideration shall be provided at least two days in advance of the board or commission meeting to members of the public that request a copy of that regulation. A copy of that regulation shall be made available to the public attending such meeting. §15.2-5307. Appointment, qualifications, tenure, and compensation of commissioners. An authority shall consist of not more than 15 commissioners
appointed by the mayor, and he shall designate the first chairman. No more than
three commissioners shall be practicing physicians. No officer or employee of
the city, with the exception of the director of a local health department,
shall be eligible for appointment; however, no director of a local health
department shall serve as chairman of the authority. One-third of the commissioners who are first appointed shall be designated by the mayor to serve for terms of two years, one-third to serve for terms of four years, and one-third to serve for terms of six years, respectively, from the date of their appointment. Thereafter, the term of office shall be six years. No person shall be appointed to succeed himself following four successive terms in office; no term of less than six years shall be deemed a term in office for the purposes of this sentence. A commissioner shall hold office until the earlier of the effective date of his resignation or the date on which his successor has been appointed and has qualified. Vacancies shall be filled for the unexpired term. In the event of a vacancy in the office of commissioner by expiration of term of office or otherwise, the remaining commissioners shall submit to the mayor nominations for appointments. The mayor may successively require additional nominations and shall have power to appoint any person so nominated. All such vacancies shall be filled from such nominations. A majority of the commissioners currently in office shall constitute a quorum. The mayor may file with the city clerk a certificate of the appointment or reappointment of any commissioner, and such certificate shall be conclusive evidence of the due and proper appointment of such commissioner. A commissioner shall receive no compensation for his services, but he shall be entitled to the necessary expenses including traveling expenses incurred in the discharge of his duties. §32.1-102.01. Certificate of public need program. The Board of Health shall establish a certificate of public need program and a permit program to (i) improve the health of all residents of the Commonwealth; (ii) meet the health care needs of all residents of the Commonwealth, including the indigent and uninsured; (iii) ensure availability of essential health care services in all areas of the Commonwealth; (iv) improve the patient experience in the delivery of health care; and (v) reduce the per capita cost of health care. §32.1-102.1. Definitions. As used in this article, unless the context indicates otherwise: "Advisory Council" means the State Health Services Plan Advisory Council established in §32.1-102.2:1. "Application" means a prescribed format for the presentation of data and information deemed necessary by the Board to determine a public need for a project. "Certificate" means a certificate of public need for a project required by this article. "Charity care" means health care services for which no compensation is expected provided to uninsured or underinsured individuals whose income is less than or equal to 200 percent of the federal poverty level for a household of that size. "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 "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 Department of Behavioral Health and Developmental Services, 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 persons who are injured or physically sick or have mental illness, 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.
"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 of beds from one existing facility to another,
provided that "project" does not include the relocation of up to 10
beds or 10 percent of the beds, whichever is less, (i) from one existing
facility to another existing facility at the same site in any two-year period 4. Introduction into an existing medical care facility of any
new nursing home service, such as intermediate care facility services 5. Introduction into an existing medical care facility of any
new cardiac catheterization, 6. Conversion of beds in an existing medical care facility to
medical rehabilitation beds 7. The addition by an existing medical care facility of any
medical equipment for the provision of cardiac catheterization, 8.
9. Establishment of any new rural medical care facility (i) for the provision of computed tomographic (CT) scanning, lithotripsy, magnetic resonance imaging (MRI), magnetic source imaging (MSI), or nuclear medicine imaging other than nuclear cardiac imaging service or (ii) as a psychiatric hospital; 10. Introduction into an existing rural medical care facility of any new computed tomographic (CT) scanning, lithotripsy, magnetic resonance imaging (MRI), magnetic source imaging (MSI), or nuclear medicine imaging other than nuclear cardiac imaging service that the medical care facility has not provided in the previous 12 months; or 11. The addition by an existing rural medical care facility of any medical equipment for the provision of computed tomographic (CT) scanning, lithotripsy, magnetic resonance imaging (MRI), or magnetic source imaging (MSI). Replacement of existing equipment shall not require a permit. 12. The addition of psychiatric beds, the relocation of psychiatric beds, or conversion into psychiatric beds at a rural medical care facility "Project" does not include those items listed under the definition of "permit-eligible project" in §32.1-102.15. "Rural medical care facility" means any medical care facility located (i) in Planning District 1, Planning District 2, or Planning District 3; or (iii) within 40 miles of any hospital located in Planning District 1, Planning District 2, or Planning District 3. "State §32.1-102.1:1. Equipment registration required. Within §32.1-102.2. Regulations. A. The Board shall promulgate regulations 1. Shall establish concise procedures for the prompt review of
applications for certificates consistent with the provisions of this article 2. May classify projects and may eliminate one or more or all of the procedures prescribed in §32.1-102.6 for different classifications; 3. May provide for exempting from the requirement of a certificate projects determined by the Commissioner, upon application for exemption, to be subject to the economic forces of a competitive market or to have no discernible impact on the cost or quality of health services; 4.
B. The Board shall promulgate regulations providing for time limitations for schedules for completion and limitations on the exceeding of the maximum capital expenditure amount for all reviewable projects. The Commissioner shall not approve any such extension or excess unless it complies with the Board's regulations. However, the Commissioner may approve a significant change in cost for an approved project that exceeds the authorized capital expenditure by more than 20 percent, provided the applicant has demonstrated that the cost increases are reasonable and necessary under all the circumstances and do not result from any material expansion of the project as approved. C. The Board shall also promulgate regulations authorizing the Commissioner to condition approval of a certificate on the agreement of the applicant to provide a level of care at a reduced rate to indigents or accept patients requiring specialized care. Such regulations shall set forth a methodology and formulas for uniform application of, active measuring and monitoring of compliance with, and approval of alternative plans for compliance in satisfaction of such conditions. In addition, the Board's licensure regulations shall direct the Commissioner to condition the issuing or renewing of any license for any applicant whose certificate was approved upon such condition on whether such applicant has complied with any agreement to provide a level of care at a reduced rate to indigents or accept patients requiring specialized care. §32.1-102.2:1. State Health Services Plan Advisory Council established.
A. There is hereby established in the executive branch of state government the State Health Services Plan Advisory Council for the purpose of advising the Board on the content of the State Health Services Plan. The Advisory Council shall provide recommendations related to (i) periodic revisions to the State Health Services Plan, (ii) the appropriateness of a certificate of public need review for certain projects, (iii) whether certain projects should be subject to expedited review rather than the full review process, and (iv) improvements in the certificate of public need process. All such recommendations shall be developed in accordance with an analytical framework established by the Commissioner for such purpose. B. The Advisory Council shall consist of the Commissioner and 13 nonlegislative citizen members appointed by the Commissioner as follows: two representatives each of the Virginia Hospital and Healthcare Association, the Medical Society of Virginia, and the Virginia Health Care Association and of physicians or administrators representing teaching hospitals affiliated with a public institution of higher education; one representative each of the Virginia Association of Health Plans, a company that is self-insured or full-insured for health coverage, a nonprofit organization located in the Commonwealth that engages in addressing access to health coverage for low-income individuals, and a rural locality recognized as a medically underserved area; and one individual with experience in health facilities planning. In making such appointments, the Commissioner shall, to the extent feasible, ensure that the membership of the Advisory Council is broadly representative of the interests of all residents of the Commonwealth and of the various geographic regions. The Commissioner shall serve a term coincident with his term in office. All other members of the Advisory Council shall serve two-year terms and may be reappointed. Appointments to fill vacancies, other than by expiration of a term, shall be made for the unexpired term. All vacancies shall be filled in the same manner as the original appointment. C. The Commissioner shall serve as chairman of the Advisory Council. A majority of the members appointed and serving shall constitute a quorum. Final action by the Advisory Council shall only be by affirmative vote of the majority of the members appointed and serving. D. The Advisory Council shall meet quarterly at places and dates fixed by the Commissioner. Special meetings may be called by the Commissioner, the Board, or at least three members of the Advisory Council. The Department shall make available the times and places of meetings of the Advisory Council and shall keep minutes of such meetings and a record of the actions of the Advisory Council and make a brief summary of such meetings and actions available to the public for review. E. Members of the Advisory Council shall receive no compensation but shall be reimbursed for all reasonable and necessary expenses incurred in the performance of their duties as provided in §§2.2-2813 and 2.2-2825. F. Staffing and administrative assistance shall be provided to the Advisory Council by the Department, which shall have charge of the Advisory Council's offices, records, and accounts. The Department shall provide such staff as may be necessary to allow the proper exercise of the powers and duties of the Advisory Council. §32.1-102.2:2. Powers and duties of the State Health Services Plan Advisory Council. A. The powers and duties of the Advisory Council shall be: 1. To develop, by July 1, 2019, recommendations for a comprehensive State Health Services Plan for adoption by the Board that includes (i) specific formulas for projecting need for medical care facilities and services subject to the requirement to obtain a certificate of public need; (ii) current statistical information on the availability of medical care facilities and services; (iii) objective criteria and standards for review of applications for projects for medical care facilities and services; and (iv) methodologies for integrating the goals and metrics of the State Health Services Plan established by the Commissioner into the criteria and standards for review. Criteria and standards for review included in the State Health Services Plan shall take into account current data on drive times, utilization, availability of competing services and patient choice within and among localities included in the health planning district or region, changes and availability of new technology, and other relevant factors identified by the Advisory Council. The State Health Services Plan shall also include specific criteria for determining need in rural areas, giving due consideration to distinct and unique geographic, socioeconomic, cultural, transportation, and other barriers to access to care in such areas and providing for weighted calculations of need based on the barriers to health care access in such rural areas in lieu of the determinations of need used for the particular proposed project within the relevant health planning district or region as a whole; 2. To engage the services of private consultants or request the Department to contract with any private organization for professional and technical assistance and advice or other services to assist the Advisory Council in carrying out its duties and functions pursuant to this section. The Advisory Council may also solicit the input of experts with professional competence in the subject matter of the State Health Services Plan, including representatives of licensed health care providers or health care provider organizations owning or operating licensed health facilities and representatives of organizations concerned with health care consumers and the purchasers and payers of health care services; and 3. To review annually and, if necessary, develop recommendations for revisions to each section of the State Health Services Plan on a rotating schedule defined by the Advisory Council at least every two years following the last date of adoption by the Board. B. The Advisory Council shall exercise its powers and carry out its duties to ensure: 1. The availability and accessibility of quality health services at a reasonable cost and within a reasonable geographic proximity for all people in the Commonwealth, competitive markets, and patient choice; 2. Appropriate differential consideration of the health care needs of residents in rural localities in ways that do not compromise the quality and affordability of health care services for those residents; 3. Elimination of barriers to access to care and introduction and availability of new technologies and care delivery models that result in greater integration and coordination of care, reduction in costs, and improvements in quality; and 4. Compliance with the goals of the State Health Services Plan and improvement in population health. C. Not less than 30 days prior to final action on any recommendation of the Advisory Council, the Advisory Council shall (i) submit the proposed action and a concise summary of the expected impact of the proposed action for comment to each member of the Board for review and comment and (ii) solicit public comment on such recommendation. All comments received by the Advisory Council shall be submitted to and reviewed by the Commissioner. If the Commissioner determines that a public hearing is necessary or appropriate to seek further input on a recommendation, the Commissioner may hold one public hearing. Any public hearing shall be conducted no more than 30 days after the close of the public comment period. Prior to such public hearing, the Commissioner shall notify the Board and shall cause notice of the public hearing to be published on the Department's website. Following completion of the public comment period, and if applicable, the public hearing, the Advisory Council shall either approve or disapprove of the proposed recommendation. All final recommendations shall be communicated to the Board for consideration at its next regularly scheduled meeting. No recommendation of the Advisory Council shall become effective until such time as it is approved by the Board. §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 B. In determining whether a public need for a project has been demonstrated, the Commissioner shall consider: 1. The extent to which the proposed service or facility will provide or increase access to needed services for residents of the area to be served, and the effects that the proposed service or facility will have on access to needed services in areas having distinct and unique geographic, socioeconomic, cultural, transportation, and other barriers to access to care; 2. The extent to which the project will meet the needs of the
residents of the area to be served, as demonstrated by each of the following:
(i) the level of community support for the project demonstrated by citizens,
businesses, and governmental leaders representing the area to be served; (ii)
the availability of reasonable alternatives to the proposed service or facility
that would meet the needs of the population in a less costly, more efficient,
or more effective manner; (iii) 3. The extent to which the application is consistent with the
State 4. The extent to which the proposed service or facility fosters institutional competition that benefits the area to be served while improving access to essential health care services for all persons in the area to be served; 5. The relationship of the project to the existing health care system of the area to be served, including the utilization and efficiency of existing services or facilities; 6. The feasibility of the project, including the financial benefits of the project to the applicant, the cost of construction, the availability of financial and human resources, and the cost of capital; 7. The extent to which the project provides improvements or innovations in the financing and delivery of health services, as demonstrated by: (i) the introduction of new technology that promotes quality, cost effectiveness, or both in the delivery of health care services; (ii) the potential for provision of services on an outpatient basis; (iii) any cooperative efforts to meet regional health care needs; and (iv) at the discretion of the Commissioner, any other factors as may be appropriate; and 8. In the case of a project proposed by or affecting a
teaching hospital associated with a public institution of higher education or a
medical school in the area to be served, (i) the unique research, training, and
clinical mission of the teaching hospital or medical school §32.1-102.4. Conditions of certificates; monitoring; revocation of certificates. A. A certificate shall be issued with a schedule for the
completion of the project B. The Commissioner shall monitor each project for which a
certificate is issued to determine its progress and compliance with the
schedule C. A certificate may be revoked when: 1. Substantial and continuing progress towards completion of the project in accordance with the schedule has not been made; 2.
D. Further, the Commissioner shall not approve an extension
for a schedule for completion of any project E. Any person willfully violating the Board's regulations
establishing limitations for schedules for completion F. The Commissioner may condition, pursuant to the regulations
of the Board, the approval of a certificate The certificate holder shall provide documentation to the
Department demonstrating that the certificate holder has satisfied the
conditions of the certificate. The Department shall establish a process for
auditing a certificate holder to ensure such satisfaction and shall require the
certificate holder to submit an audited financial statement demonstrating such
satisfaction. If the certificate holder is unable
G. Pursuant to regulations of the Board, the Commissioner may accept requests for and approve amendments to conditions of existing certificates related to the provision of care at reduced rates or to patients requiring specialized care or related to the development and operation of primary medical care services in designated medically underserved areas of the certificate holder's service area. H. For the purposes of this section, "completion" means conclusion of construction activities necessary for the substantial performance of the contract. §32.1-102.6. Administrative procedures. A. To obtain a certificate for a project, the applicant shall
file a completed application for a certificate with the Department In order to verify the date of the Department's Within 10 calendar days of the date on which the document is
received, the Department 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 B.
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 clause (i) of the time and place of such proposed contact. D. The Department shall commence the review of each completed
application upon the day A determination concerning whether a public need exists
for a project shall be made by the Commissioner within 190 calendar days of the
day The 190-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. 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 E. 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 and ninetieth calendar days within the 190-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 calendar day within the 190-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 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 C of §2.2-4021 notwithstanding, 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 this section. 7. In any case when a determination 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 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. F. 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. G. For purposes of this section, "good cause" H. 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. I. 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.
§32.1-102.14. Transparency. The Department shall develop a website to make information and materials related to the medical care facilities certificate of public need program and permit program available to the public in order to increase transparency. Such website shall include an automated mechanism for receiving, posting, and tracking letters of intent received by the Department so that information about such letters is available to the public upon receipt of such letters. §32.1-102.15. Definitions. As used in this article, unless the context requires a different meaning: "Charity care" has the same meaning as specified in §32.1-102.1. "Medical care facility" has the same meaning as specified in §32.1-102.1. "Permit-eligible project" means: 1. Establishment of any new medical care facility other than a rural medical care facility (i) for the provision of computed tomographic (CT) scanning, lithotripsy, magnetic resonance imaging (MRI), magnetic source imaging (MSI), or nuclear medicine imaging other than nuclear cardiac imaging service or (ii) as a psychiatric hospital; 2. Introduction into an existing medical care facility other than a rural medical care facility of any new computed tomographic (CT) scanning, lithotripsy, magnetic resonance imaging (MRI), magnetic source imaging (MSI), or nuclear medicine imaging other than nuclear cardiac imaging service that the medical care facility has not provided in the previous 12 months; 3. The addition by an existing medical care facility other than a rural medical care facility of any medical equipment for the provision of computed tomographic (CT) scanning, lithotripsy, magnetic resonance imaging (MRI), or magnetic source imaging (MSI). Replacement of existing equipment shall not require a permit; or 4. The addition of psychiatric beds, the relocation of psychiatric beds, or conversion into psychiatric beds at a medical care facility other than a rural medical care facility. "Rural medical care facility" has the same meaning as specified in §32.1-102.1. §32.1-102.16. Permit required; conditions on permits. A. No person shall commence any permit-eligible project without first obtaining a permit from the Commissioner. B. At least 90 days prior to initiating a permit-eligible project for which a permit is required, a person shall file with the Department an application for a permit, together with a fee determined by the Board. The Commissioner shall issue the permit within 30 days of receipt of the application. C. The Commissioner shall condition the issuance of a permit to undertake a permit-eligible project upon the agreement of the applicant to (i) provide a level of charity care in an amount that is equal to the average amount of charity care provided by holders of certificates of public need and permit holders in the applicant's health planning region or 10 percent of all services provided, whichever is less; (ii) accept patients requiring specialized care; or (iii) facilitate the development and operation of primary medical care services in designated medically underserved areas of the applicant's service area. The Commissioner shall also condition the issuance of a permit to undertake a permit-eligible project upon the agreement of the applicant to (a) reporting utilization and other data required by the Board to monitor and evaluate effects on health planning and availability of health care services in the Commonwealth; or (b) accept coverages, if the medical care facility is eligible, issued pursuant to Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (Medicare); Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (Medicaid), or Title XXI of the Social Security Act, 42 U.S.C. §1397aa et seq. (CHIP); or Chapter 55 of Title 10 of the United States Code, 10 U.S.C. §1071 et seq. (TRICARE). The value of charity care provided to individuals pursuant to this subsection shall be based on provider reimbursement methodology utilized by the Centers for Medicare and Medicaid Services for reimbursements under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. The holder of a permit that is subject to conditions pursuant to this subsection shall provide such documentation as may be required by the Commissioner to demonstrate compliance with the conditions imposed. The Commissioner shall monitor compliance with permit conditions pursuant to this subsection and may impose penalties on a permit holder that fails to comply with such permit conditions. If the permit holder is unable to comply with the conditions imposed by the Commissioner, the Commissioner may, upon request of the permit holder, approve a plan of compliance with alternate methods to satisfy the permit conditions. Such alternate methods may include (1) a direct payment by the permit holder to an organization authorized under a memorandum of understanding with the Department to receive contributions satisfying conditions of the permit; (2) a direct payment by the permit holder to a private nonprofit foundation that funds basic insurance coverage for indigents authorized under a memorandum of understanding with the Department to receive contributions satisfying conditions of a permit; (3) provision by the permit holder of on-call coverage at a hospital, including the emergency department of a hospital; or (4) such other methods for the provision of primary or specialized care to indigent patients or patients requiring specialized care as may be approved by the Commissioner. The Department shall establish a process for auditing a permit holder to ensure satisfaction of the conditions of a permit and shall require a permit holder to submit an audited financial statement demonstrating such satisfaction. Any permit holder that fails to satisfy the conditions of a permit or fails to comply with the plan of compliance shall be subject to a fine in an amount determined by the Board that shall be at least equal to the value of services the permit holder was required to deliver pursuant to its permit or plan of compliance. Such fines shall be deposited in the Virginia Charity Care Fund established in §32.1-102.18. The Commissioner may, pursuant to regulations of the Board, accept requests for and approve amendments to permit conditions pursuant to this subsection upon request of the permit holder. The Board shall adopt regulations governing the issuance and revocation of permits in accordance with the provisions of this subsection. D. The Commissioner shall condition the issuance of a permit to undertake a permit-eligible project upon the compliance of the applicant with quality of care standards established by the Board and may revoke a permit issued in accordance with this section in any case in which the permit holder fails to maintain compliance with such standards. The Board shall adopt regulations governing the issuance and revocation of permits in accordance with the provisions of this subsection, which shall include: 1. Quality of care standards for the specific specialty service that are consistent with nationally recognized standards for such specialty service; 2. A list of those national accrediting organizations having quality of care standards, compliance with which shall be deemed satisfactory to comply with quality of care standards adopted by the Board; 3. Equipment standards and standards for appropriate utilization of equipment and services; 4. Requirements for monitoring compliance with quality of care standards, including data reporting and periodic inspections; and 5. Procedures for the issuance and revocation of permits pursuant to this subsection. §32.1-102.17. Definitions. As used in this article, unless the context requires a different meaning: "Board" means the Board of Medical Assistance Services. "Department" means the Department of Medical Assistance Services. "Charity care" has the same meaning as specified in §32.1-102.1. "Fund" means the Virginia Charity Care Fund established in §32.1-102.18. "Medical care facility" means any licensed hospital except any public hospital, freestanding psychiatric or rehabilitation hospital, freestanding children's hospital, long-term care hospital, or critical access hospital. §32.1-102.18. Virginia Charity Care Fund. A. There is hereby created in the state treasury a special nonreverting fund to be known as the Virginia Charity Care Fund. The Fund shall be established on the books of the Comptroller. All funds appropriated for such purpose, contributions from medical care facilities in accordance with this article, any fines assessed in accordance with Article 1.1 (§32.1-102.01 et seq.) or Article 1.2 (§32.1-102.15 et seq.), and any gifts, donations, grants, bequests, and other funds received on its behalf shall be paid into the state treasury and credited to the Fund. Interest earned on moneys in the Fund shall remain in the Fund and be credited to it. Any moneys remaining in the Fund, including interest thereon, at the end of each fiscal year shall not revert to the general fund but shall remain in the Fund. Moneys in the Fund shall be used solely for the purposes of (i) administering the Fund and this article, (ii) compensating medical care facilities for losses incurred in the provision of care, and (iii) improving reimbursement rates for service provided under the Governor's Access Plan (GAP). Expenditures and disbursements from the Fund shall be made by the State Treasurer on warrants issued by the Comptroller upon written request signed by the Director. B. The Board shall promulgate regulations for the administration of the Fund and the implementation of this article. C. No money in the Fund shall be used to implement coverage for individuals described in 42 U.S.C. §1396a(a)(10)(A)(i)(VIII). D. No appropriations, contributions, or other sources of money shall be paid into the Fund and any contributions in the Fund shall be returned to its source if federal matching funds are not available. §32.1-102.19. Reporting. No later than 120 days following the end of each fiscal year, each medical care facility shall report to the Department a statement of charity care and any such other data as required by the Department. The Department may grant one 30-day extension to a medical care facility that is unable to meet the 120-day requirement. §32.1-102.20. Contributions; distributions. A. Contributions shall be made by medical care facilities on an quarterly basis. The Department shall develop the necessary contribution methodology based on the level of charity care provided by a medical care facility and the net operating revenues over operating expenditures of such medical care facility. The total of all medical care facility contributions shall not exceed $109 million in any given year. No one medical care facility shall contribute more than 25 percent of such total. B. Distributions shall be made to medical care facilities quarterly and in accordance with the appropriation act. C. For each permit granted by the Commissioner pursuant to Article 1.2 (§32.1-102.15 et seq.) for a permit-eligible project located in the city of Chesapeake, an annual distribution shall be made to any hospital located in the city of Chesapeake operated by a hospital authority established pursuant to Chapter 53 (§15.2-5300 et seq.) of Title 15.2, in an amount determined by the appropriation act. §32.1-122.01. Definitions. As used in this article unless the context requires a different meaning: "Board" means the State Board of Health. "Commissioner" means the State Health Commissioner. "Consumer" means a person who is not a provider of health care services. "Department" means the Virginia Department of Health.
"Provider" means a licensed or certified health care practitioner, a licensed health care facility or service administrator, or an individual who has a personal interest in a health care facility or service as defined in the Virginia Conflict of Interests Act (§2.2-3100 et seq.).
"Secretary" means the Secretary of Health and Human Resources of the Commonwealth of Virginia. "State Health Plan" means the document so designated by the Board, which may include analysis of priority health issues, policies, needs, methodologies for assessing statewide health care needs, and such other matters as the Board shall deem appropriate. "Tertiary care" means health care delivered by facilities that provide specialty acute care including, but not limited to, trauma care, neonatal intensive care, and cardiac services. §32.1-122.03. State Health Plan. A. The Board may develop, and revise as it deems necessary,
the State Health Plan with the support of the Department B. In order to develop and approve the State Health Plan, the
Board may conduct such studies as may be necessary of critical health issues as
identified by the Governor, the General Assembly, the Secretary,
or §32.1-122.04. Responsibilities of the Department. The Department shall have the following responsibilities as directed by the Board: 1. To conduct the research for the health planning activities of the Commonwealth. 2. To prepare, review and revise the State Health Plan when so directed by the Board. 3. To develop, under the direction of the Board 4.
§32.1-122.07. Authority of Commissioner for certain health planning activities; rural health plan; designation as a rural hospital. A. The Commissioner, with the approval of the Board, is authorized to make application for federal funding and to receive and expend such funds in accordance with state and federal regulations. B. The Commissioner shall administer C. In compliance with the provisions of the Balanced Budget Act of 1997, P.L. 105-33, and any amendments to such provisions, the Commissioner shall submit to the appropriate regional administrator of the Centers for Medicare & Medicaid Services (CMS) an application to establish a Medicare Rural Hospital Flexibility Program in Virginia. D. The Commissioner shall develop and the Board of Health
shall approve a rural health care plan for the Commonwealth to be included with
the application to establish a Medicare Rural Hospital Flexibility Program. In
cooperation and consultation with the Virginia Hospital and E. Notwithstanding any provisions of this chapter or the Board's regulations to the contrary, the Commissioner shall, in the rural health care plan, (i) use as minimum standards for critical access hospitals, the certification regulations for critical access hospitals promulgated by the Centers for Medicare & Medicaid Services (CMS) pursuant to Title XVIII of the Social Security Act, as amended; and (ii) authorize critical access hospitals to utilize a maximum of ten beds among their inpatient hospital beds as swing beds for the furnishing of services of the type which, if furnished by a nursing home or certified nursing facility, would constitute skilled care services without complying with nursing home licensure requirements or retaining the services of a licensed nursing home administrator. Such hospital shall include, within its plan of care, assurances for the overall well-being of patients occupying such beds. F. Nothing herein or set forth in Virginia's rural health care plan shall prohibit any hospital designated as a critical access hospital from leasing the unused portion of its facilities to other health care organizations or reorganizing its corporate structure to facilitate the continuation of the nursing home beds that were licensed to such hospital prior to the designation as a critical access hospital. The health care services delivered by such other health care organizations shall not be construed as part of the critical access hospital's services or license to operate. G. Any medical care facility licensed as a hospital shall be considered a rural hospital on and after September 30, 2004, pursuant to 42 U.S.C. §1395ww(d)(8)(E)(ii)(II), if (i) the hospital is located in an area defined as rural by federal statute or regulation; (ii) the Board of Health defines, in regulation, the area in which the hospital is located as a rural health area or the hospital as a rural hospital; or (iii) the hospital was designated, prior to October 1, 2004, as a Medicare-dependent small rural health hospital, as defined in 42 U.S.C. §1395ww(d)(5)(G)(iv). 2. That §§32.1-122.05 and 32.1-122.06 of the Code of Virginia are repealed. 3. That the provisions of the first, second and sixth enactments of this act shall become effective on January 1, 2019 if monies in the Virginia Charity Care Fund created by this act will be eligible for federal matching funds as determined by the Centers for Medicare & Medicaid Services. 4. That the Board of Health and the Board of Medical Assistance Services shall promulgate regulations to implement the provisions of this act to be effective within 280 days of its enactment. 5. That the Chairmen of the House Committee on Health, Welfare and Institutions and the Senate Committee on Education and Health shall form a task force, consisting of five members of the House of Delegates and four members of the Senate, to develop recommendations concerning the appropriateness of certificates of public need for specific medical care facilities and projects, or whether such projects should be subject to expedited review, and improvements in the certificate of public need process. The Commissioner of Health shall develop, by November 1, 2016, an analytical framework to assist such task force. The analytical framework shall include a specific evaluation of whether certificate of public need review is consistent with the goals of (i) meeting the health care needs of the indigent and uninsured citizens of the Commonwealth, (ii) protecting the public health and safety of the citizens of the Commonwealth, (iii) promoting the teaching missions of academic medical centers and private teaching hospitals, and (iv) ensuring the availability of essential health care services in the Commonwealth, and should be aligned with the goals and metrics of the Commonwealth's State Health Improvement Plan. The analytical framework shall also (a) take into consideration components of the approach utilized prior to 2012 in development of the Certificate of Public Need Annual Report; (b) include a recurrent three-year schedule for analysis of all project categories, with procedures for analysis of at least three project categories per year, which shall be developed in such a manner as to ensure that projects that are of relatively low complexity and low cost are analyzed first, and projects that are of relatively high complexity and high cost are analyzed subsequently; (c) include appropriate metrics to evaluate the impact of introducing a more competitive health care framework that could reduce costs and increase access to health care services; and (d) include a process for stakeholder involvement in review and public comment on any recommendations. 6. That, after July 1, 2019, the amount appropriated each year by the General Assembly for the purposes of health care services related to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (Medicaid) shall be at least equal to the average annual amount appropriated for such purposes between July 1, 2014 and July 1, 2019. 7. That nothing in this act shall be construed or interpreted in any way as an expansion of Medicaid pursuant to the Patient Protection and Affordable Care Act of 2010 or as authorizing the Department of Medical Assistance Services to amend the State Plan for Medicaid Assistance under Title XIX of the Social Security Act, and any waivers thereof, to implement coverage for individuals described in 42 U.S.C. §1396a(a)(10)(A)(i)(VIII). |