Regulatory Alert

Proposed Regulations Open to Public Comment:

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

18 VAC 5-21. Board of Accountancy Regulations (amending 18 VAC 5-21-10 through 18 VAC 5-21-40 and 18 VAC 5-21-170).

Pursuant to Chapter 291 of the 2003 Acts of Assembly, the Board of Accountancy (board) proposes to require continuing professional education (CPE) in ethics. The board also proposes to introduce language concerning the qualifications for, and implementation of the new computerized CPA exam.

A public hearing will be held on April 22, 2005, at 9 a.m. at the Board of Accountancy, Richmond.

Written public comment is being accepted by the Board of Accountancy and may be submitted until May 8, 2005.

For additional information contact: Mark D'Amato, Regulatory Coordinator, Board of Accountancy, (804) 367-8505, or e-mail mark.damato@boa.virginia.gov.

TITLE 9. ENVIRONMENT

STATE AIR POLLUTION CONTROL BOARD

9 VAC 5-230. Variance for International Paper Franklin Paper Mill (adding 9 VAC 5-230-10 through 9 VAC 5-230-120).

The regulation grants a variance that allows the International Paper Company to comply with the variance and an associated federally enforceable state operating permit as an alternate demonstration of compliance with provisions of the regulations of the board pertaining to new source review and new source control technology review for the Franklin Paper Mill. The variance establishes emission caps that limit the sitewide emissions of the Franklin Paper Mill for the duration of the variance. The localities particularly affected are the Cities of Franklin and Suffolk and the County of Isle of Wight.

A public hearing will be held on April 20, 2005, at 6:30 p.m. at the DEQ Central Office, Richmond.

Written public comment is being accepted by DEQ and may be submitted until 5 p.m. on May 5, 2005.

For additional information contact: Robert Mann, Director, Office of Air Regulatory Development, Department of Environmental Quality, (804) 698-4419, or e-mail ramann@deq.virginia.gov.

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

18 VAC 110-20. Regulations Governing the Practice of Pharmacy (adding 18 VAC 110-20-276 and 18 VAC 110-20-515).

The proposed amendments set out the requirements and conditions that must be met for a dispensing pharmacy (a retail pharmacy or within a hospital or long-term care facility) to outsource prescription order processing to a remote or centralized location. Regulations establish the aspects of the dispensing process that may be performed at the remote pharmacy, requirements for accountability and adherence to Virginia law and regulation, required content of a policy and procedure manual for outsourcing, and requirements for recordkeeping and confidentiality. The rules for retail pharmacies also include requirements for disclosure of the outsourcing arrangement to the public.

18 VAC 110-20-276. Central or remote processing.

A. Centralized or remote processing of a prescription does not include the dispensing of a drug, but does include any of the following activities related to the dispensing process:

1. Receiving, interpreting, analyzing, or clarifying prescriptions;
2. Entering prescription and patient data into a data processing system;
3. Transferring prescription information;
4. Performing a prospective drug review as set forth in § 54.1-3319 of the Code of Virginia;
5. Obtaining refill or substitution authorizations, or otherwise communicating with the prescriber concerning a patient's prescription;
6. Interpreting clinical data for prior authorization for dispensing;
7. Performing therapeutic interventions; or
8. Providing drug information or counseling concerning a patient's prescription to the patient or patient's agent.

B. A pharmacy may outsource certain prescription processing functions as described in subsection A of this section to another pharmacy in Virginia or a registered nonresident pharmacy under the following conditions:

1. The pharmacies shall either have the same owner or have a written contract describing the scope of services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with all federal and state laws and regulations related to the practice of pharmacy;
2. Any central or remote pharmacy shall comply with Virginia law with respect to duties that are restricted to pharmacists, and pharmacy technicians must be directly supervised by a pharmacist;
3. A pharmacist licensed in Virginia, whether at the remote pharmacy or the dispensing pharmacy, shall perform a check for accuracy on all processing done by the remote processor; and
4. The pharmacies shall share a common electronic file or have technology that allows sufficient information necessary to process a nondispensing function.

C. Any pharmacy that outsources prescription processing to another pharmacy shall provide notification of such to patients. A one-time written notification or a sign posted in the pharmacy in a location that is readily visible to the public will satisfy this notification requirement. The notice shall state the name of any contract pharmacy providing central or remote prescription processing. If the pharmacy uses a network of pharmacies under common ownership, this fact shall be disclosed in the notice.

D. A policy and procedure manual that relates to central or remote processing shall be maintained at each pharmacy involved in the processing of a prescription and available for inspection. The manual shall at a minimum include the following:

1. The responsibilities of each pharmacy;
2. A list of the name, address, telephone numbers, and permit/registration numbers of all pharmacies involved in central or remote processing;
3. Procedures for protecting the confidentiality and integrity of patient information;
4. Procedures for ensuring that pharmacists performing prospective drug reviews have access to appropriate drug information resources;
5. Procedures for maintaining required records;
6. Procedures for complying with all applicable laws and regulations to include counseling;
7. Procedures for objectively and systematically monitoring and evaluating the quality of the program to resolve problems and improve services; and
8. Procedures for annually reviewing the written policies and procedures for needed modifications and documenting such review.

E. In addition to any other required records, pharmacies engaged in central or remote processing shall maintain retrievable records that show, for each prescription processed, each individual processing function and identity of the pharmacist or pharmacy technician who performs a processing function and the pharmacist who checked the processing function, if applicable.
1. The records may be maintained separately by each pharmacy, or in a common electronic file shared by both pharmacies provided the system can produce a record showing each processing task, the identity of the person performing each task, and the location where each task was performed.
2. The record shall be readily retrievable for at least the past two years through the primary dispensing pharmacy, and shall be available for inspection by the board.
F. Nothing in this section shall prohibit an individual employee licensed as a pharmacist in Virginia from accessing the employer pharmacy's database from a remote location for the purpose of performing certain prescription processing functions as described in subsection A of this section, provided the pharmacy establishes controls to protect the privacy and security of confidential records.

18 VAC 110-20-515. Remote prescription order processing for hospitals and long-term care facilities.

A. Remote processing of a prescription does not include the dispensing of a drug, but does include any of the following activities related to the dispensing process:

1. Receiving, interpreting, analyzing, or clarifying prescriptions;
2. Entering prescription and patient data into a data processing system;
3. Transferring prescription information;
4. Performing a prospective drug review to include an evaluation of a prescription order and patient records for over- or under-utilization of medication, therapeutic duplication of medication, drug disease contraindications, drug interactions, incorrect drug dosage or duration of drug treatment, or clinical abuse or misuse of medication;
5. Obtaining substitution authorizations, or otherwise communicating with the prescriber concerning a patient's order;
6. Interpreting or acting on clinical data;
7. Performing therapeutic interventions;
8. Providing drug information to the medical or nursing staff of the hospital or long-term care facility; or
9. Authorizing the administration of the drug to the patient by appropriate hospital or long-term care facility staff.

B. The primary pharmacy providing pharmacy services to a hospital or long-term care facility may outsource certain order processing functions as described in subsection A of this section to another pharmacy in Virginia or a registered nonresident pharmacy under the following conditions:

1. The pharmacies shall either have the same owner or have a written contract describing the scope of services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with all federal and state laws and regulations related to the practice of pharmacy;
2. Any pharmacist participating in remote prescription order processing shall be a Virginia licensed pharmacist and the remote pharmacy shall comply with Virginia law with respect to duties that are restricted to pharmacists and supervision requirements for pharmacy technicians;
3. A pharmacist licensed in Virginia, whether at the remote pharmacy or the dispensing pharmacy, shall perform a check for accuracy on all processing done by the remote processor; and
4. The pharmacies shall share a common electronic file or have technology that allows sufficient information necessary to process a prescription order.

C. A policy and procedure manual that relates to remote processing shall be maintained at each pharmacy involved in the processing of a prescription and available for inspection. The manual shall at a minimum include the following:

1. The responsibilities of each pharmacy;
2. A list of the name, address, telephone numbers, and permit/registration numbers of all pharmacies involved in remote processing;
3. Procedures for protecting the confidentiality and integrity of patient information;
4. Procedures for ensuring that pharmacists performing prospective drug reviews have access to appropriate drug information resources;
5. Procedures for maintaining required records;
6. Procedures for complying with all applicable laws and regulations;
7. Procedures for objectively and systematically monitoring and evaluating the quality of the program to resolve problems and improve services; and
8. Procedures for annually reviewing the written policies and procedures for needed modifications and documenting such review.

D. A pharmacy involved in remote prescription order processing shall maintain a record that identifies each person who performed a processing function for every order.

1. The record shall be available by prescription order or by patient name.
2. The record may be maintained in a common electronic file if the record is maintained in such a manner that the data processing system can
produce a printout that identifies every person who performed a task involved in processing a prescription order and the location where the task was processed.
3. The record shall be readily retrievable for at least the past two years through the primary dispensing pharmacy, and shall be available for inspection by the board.

E. Nothing in this section shall prohibit an individual employee licensed as a pharmacist in Virginia from accessing the employer pharmacy's database from a remote location for the purpose of performing certain prescription processing functions as described in subsection A of this section provided the pharmacy establishes controls to protect the privacy and security of confidential records.

The Board of Pharmacy noticed a public comment period on the proposed Regulations Governing the Practice of Pharmacy (18 VAC 110-20) in the January 10, 2005, issue of the Virginia Register of Regulations (21:9 VA.R. 1068-1072 January 10, 2005). The purpose of the proposed action is to set requirements that must be met for a dispensing pharmacy to outsource prescription order processing to a remote or centralized pharmacy. The board has scheduled an additional public hearing and has extended the public comment period until May 18, 2005.

A public hearing will be held on April 25, 2005, at 10 a.m. at the Department of Health Professions, Richmond.

Public comments may be submitted until May 18, 2005, to Elizabeth Scott Russell, Executive Director, Board of Pharmacy, 6603 West Broad Street, Richmond, VA 23230.

For additional information contact: Elaine J. Yeatts, Agency Regulatory Coordinator, Department of Health Professions, (804) 662-9918, or e-mail elaine.yeatts@dhp.virginia.gov.

TITLE 12. HEALTH

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

12 VAC 30-80. Methods and Standards for Establishing Payment Rates; Other Types of Care (amending 12 VAC 30-80-190).

Pursuant to recommendations of the work group formed by the Governor's Executive Directive 2 issued on March 3, 2004, the proposed regulations increase Medicaid and Family Access to Medical Insurance Security reimbursements by 34% for obstetrical and gynecological (OB/GYN) physician services. Also, pursuant to Item 326 JJJ of the 2004 Acts of Assembly, the proposed regulations increase Medicaid reimbursement by 2.0% to physicians delivering services in hospital emergency rooms. Both of the proposed permanent changes have been in effect since September 2004 under emergency regulations.

The proposed amendments (i) increase Medicaid and Family Access to Medical Insurance Security reimbursements by 34% for obstetrical and gynecological physician services and (ii) increase Medicaid reimbursement by 2.0% to physicians delivering certain Medicaid services in hospital emergency rooms.

Written public comments will be accepted by the Department of Medical Assistance Services and may be submitted until June 3, 2005.

For additional information contact: Brian McCormick, Regulatory Coordinator, Policy Division, Department of Medical Assistance Services, (804) 786-7959, or e-mail brian.mccormick@dmas.virginia.gov.

TITLE 11. GAMING

CHARITABLE GAMING BOARD

11 VAC 15-31. Supplier Regulations (amending 11 VAC 15-31-10, 11 VAC 15-31-20, 11 VAC 15-31-30, 11 VAC 15-31-50, 11 VAC 15-31-60).

The proposed amendments (i) establish a uniform use-of-proceeds requirement of 10% for all organizations permitted or authorized to conduct charitable gaming and provides for additional flexibility to charitable gaming organizations in meeting this requirement; (ii) expand the definition of what constitutes a discount and specify that discounts provided by a charitable gaming organization in any given fiscal year not exceed 1.0% of the organization's previous year's gross receipts; (iii) reduce the maximum number of card faces that can be played per game on an electronic bingo machine from 72 to 54; (iv) increase the fee for tax exempt request reviews to $500; (v) require charities to only use reporting forms issued or approved by the department; (vi) modify recordkeeping requirements; (vii) change the fiscal year for reporting purposes from October 1 through September 30 to the calendar year; (viii) provide that unused gaming supplies must either be returned to the supplier or turned into the department for disposal; (ix) remove the option of paying rent from the organization's general fund so that rent is only paid out of the organization's charitable gaming account; (x) eliminate the requirement that the amount attributable to rent, equipment or services provided by the landlord be itemized in the lease or contract; (xi) establish rules for four new variations of bingo and raffle games (Decision Bingo, Lucky Seven, Treasure Chest, and Wingo); (xii) tighten requirements for the participation of minors in the operation, management, and conduct of charitable gaming; (xiii) increase the maximum value of complimentary food and beverages provided to volunteers working a bingo session from $8 to $15; (xiv) prohibit volunteers from playing bingo at any session they have worked once the session has begun; (xv) modify the notification requirements regarding the date, time, and location of charitable gaming events; and (xvi) make the regulation consistent with current practice and technology and with the Code of Virginia.

Written public comment will be accepted by the Charitable Gaming Board and may be submitted until June 3, 2005.

For additional information contact: Clyde E. Cristman, Director, Department of Charitable Gaming, (804) 371-0603, or e-mail clyde.cristman@dcg.virginia.gov.

TITLE 9. ENVIRONMENT

STATE WATER CONTROL BOARD

9 VAC 25-780. Local and Regional Water Supply Planning (adding 9 VAC 25-780-10 through 9 VAC 25-780-190).

Chapter 227 of the 2003 Acts of Assembly requires the State Water Control Board (board), with advice and guidance from the Commissioner of Health, local governments, public service authorities, and other interested parties, to establish a comprehensive water supply planning process for the development of local, regional, and state water supply plans that (i) ensure adequate and safe drinking water for all citizens of the Commonwealth, (ii) encourage, promote, and protect all other beneficial uses of the Commonwealth's water resources, and (iii) encourage, promote, and develop incentives for alternative water sources, including but not limited to desalinization.

The proposed regulation establishes a process for the development of local and regional water supply plans and criteria to be used by local governments in the development of these plans.

The proposed regulation establishes a planning process and criteria that all local governments will use in the development of local or regional water plans. These plans will be reviewed by the Department of Environmental Quality and a determination will be made by the State Water Control Board on whether the plans comply with this regulation. Within five years of a compliance determination by the board, the plans will be reviewed to assess adequacy and significant changes will require the submission of an amended plan and review by the board. All local programs will be reviewed, revised and resubmitted to the Department of Environmental Quality every 10 years after the last approval.

Public hearings will be held at various locations throughout the state beginning May 4, 2005 and ending May 17, 2005.

Written public comment will be accepted by DEQ until June 3, 2005.

For additional information contact: Scott Kudlas, Department of Environmental Quality, (804) 698-4456, or e-mail swkudlas@deq.virginia.gov.

TITLE 11. GAMING

CHARITABLE GAMING BOARD

11 VAC 15-31. Supplier Regulations (amending 11 VAC 15-31-10, 11 VAC 15-31-20, 11 VAC 15-31-30, 11 VAC 15-31-50, 11 VAC 15-31-60).

Summary of the proposed regulation. Section 18.2-340.15 of the Code of Virginia provides the Charitable Gaming Board (board) with the power to prescribe regulations and conditions under which gaming is conducted such that it is conducted in a manner consistent with the purpose for which it is permitted. It also vests the Department of Charitable Gaming (DCG) with control of all charitable gaming in the Commonwealth. Chapter 884 of the 2004 Acts of Assembly required that the board examine existing charitable gaming regulations and provide a report to the Governor and the 2004 Session of the General Assembly. The report was required to include the board's plan regarding any regulatory action and the anticipated timetable for such action. The report, which was submitted on December 2, 2003, concurred that a comprehensive revision to the Charitable Gaming Rules and Regulations and the Supplier Regulations was needed.

The proposed regulation (i) imposes additional testing requirements on manufacturers of pull tab and instant bingo machines, (ii) prohibits suppliers, supplier agents, and employees of the supplier from participating in gaming conducted by the supplier's customers, (iii) reduces the maximum number of card faces that can be played per game on an electronic bingo machine from 72 to 54, and (iv) includes a number of changes intended to improve enforcement and implementation of the regulation. In addition, the proposed regulation modifies some of the requirements relating to the manufacture of electronic bingo devices; eliminates the provision allowing for the issuance of provisional supplier certificates; establishes requirements for Lucky Seven, a new variation of bingo; and changes the fiscal year for reporting purposes from October 1 through September 30 to the calendar year.

The proposed regulation also adds new definitions, deletes unnecessary definitions, and modifies existing ones. According to DCG, these changes are not likely to significantly alter current practice. The proposed regulation also includes a number of changes that make the regulation consistent with current practice and technology. Other changes make the regulation consistent with federal requirements and with the Code of Virginia. Finally, the proposed regulation also includes a number of other changes that clarify aspects of the regulation, remove redundant language, and make it more streamlined.

The proposed amendments (i) impose additional testing requirements on manufacturers of pull-tab and instant bingo machines; (ii) prohibit suppliers, supplier agents, and employees of the supplier from participating in gaming conducted by the supplier's customers; (iii) reduce the maximum number of card faces that can be played per game on an electronic bingo machine from 72 to 54; (iv) clarify and add new definitions; (v) make technical adjustments to conform the regulation to federal requirements and the Code of Virginia; (vi) adjust requirements based on current law and industry standards; (vii) modify some of the requirements relating to the manufacture of electronic bingo devices; (viii) eliminate the provision allowing for the issuance of provisional supplier certificates; (ix) establish requirements for Lucky Seven, a new variation of bingo; (x) change the fiscal year for reporting purposes from October 1 through September 30 to the calendar year; and (xi) make other changes to conform the regulation to current practice and technology.

Written public comment will be accepted by the Charitable Gaming Board until June 3, 2005.

For additional information contact: Clyde E. Cristman, Director, Department of Charitable Gaming, (804) 371-0603, or e-mail clyde.cristman@dcg.virginia.gov.

TITLE 11. GAMING

CHARITABLE GAMING BOARD

11 VAC 15-22. Charitable Gaming Rules and Regulations (amending 11 VAC 15-22-10 through 11 VAC 15-22-120; adding 11 VAC 15-22-35).

Summary of the proposed regulation. Section 18.2-340.15 of the Code of Virginia provides the Charitable Gaming Board (board) with the power to prescribe regulations and conditions under which gaming is conducted such that it is conducted in a manner consistent with the purpose for which it is permitted. It also vests the Department of Charitable Gaming (DCG) with control of all charitable gaming in the Commonwealth. Chapter 884 of the 2004 Acts of Assembly required that the board examine regulations, including the computation and percentage of gross receipts that are required to be used for charitable purposes by qualified organizations, and provide a report to the Governor and the 2004 Session of the General Assembly. The report was required to include the board's plan regarding regulatory action on these issues and the anticipated timetable for such action. The report, which was submitted on December 2, 2003, concurred that a comprehensive revision to the Charitable Gaming Rules and Regulations and the Supplier Rules and Regulations was needed, including a review of the method for computation and the percentage of gross receipts required to be used for charitable purposes by qualified organizations.

The proposed amendments (i) establish a uniform use-of-proceeds requirement of 10% for all organizations permitted or authorized to conduct charitable gaming and provides for additional flexibility to charitable gaming organizations in meeting this requirement; (ii) expand the definition of what constitutes a discount and specify that discounts provided by a charitable gaming organization in any given fiscal year not exceed 1.0% of the organization's previous year's gross receipts; (iii) reduce the maximum number of card faces that can be played per game on an electronic bingo machine from 72 to 54; (iv) increase the fee for tax exempt request reviews to $500; (v) require charities to only use reporting forms issued or approved by the department; (vi) modify recordkeeping requirements; (vii) change the fiscal year for reporting purposes from October 1 through September 30 to the calendar year; (viii) provide that unused gaming supplies must either be returned to the supplier or turned into the department for disposal; (ix) remove the option of paying rent from the organization's general fund so that rent is only paid out of the organization's charitable gaming account; (x) eliminate the requirement that the amount attributable to rent, equipment or services provided by the landlord be itemized in the lease or contract; (xi) establish rules for four new variations of bingo and raffle games (Decision Bingo, Lucky Seven, Treasure Chest, and Wingo); (xii) tighten requirements for the participation of minors in the operation, management, and conduct of charitable gaming; (xiii) increase the maximum value of complimentary food and beverages provided to volunteers working a bingo session from $8 to $15; (xiv) prohibit volunteers from playing bingo at any session they have worked once the session has begun; (xv) modify the notification requirements regarding the date, time, and location of charitable gaming events; and (xvi) make the regulation consistent with current practice and technology and with the Code of Virginia.

Written public comment may be submitted to the Charitable Gaming Board until June 3, 2005.

For additional information contact: Clyde E. Cristman, Director, Department of Charitable Gaming, (804)371-0603, or e-mail clyde.cristman @dcg.virginia.gov.

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