2016 General Assembly Law Summary

Provided below is a summary of the legislation passed during the 2016 Virginia General Assembly session

Bills Effective July 1, 2016

HB313 – Immunizations – Adds Health Professionals Authorized to Sign Child Immunization Certificate

  • Adds physician assistants, nurse practitioners, and licensed practical nurses and pharmacists who administer pursuant to a valid prescription to the types of health professionals who may administer vaccinations to children and who may provide to the person who presents the child for immunizations a certificate stating that such immunizations have been administered.
  • The bill in its original form did not include pharmacists. VPhA requested that they be included.

HB629 – Voluntary Drug Disposal Programs

  • Adds liability protections to pharmacies that wish to provide voluntary drug takeback programs.
  • Board of Pharmacy will also be posting a list of collection sites.  Click here for the list.
  • Introduced at the request of VPhA

SB701 – Cannabidiol oil and THC-A oil; permitting of pharmaceutical processors to manufacture and provide.

  • Authorizes a pharmaceutical processor, after obtaining a permit from the Board of Pharmacy (Board) and under the supervision of a licensed pharmacist, to manufacture and provide cannabidiol oil and THC-A oil to be used for the treatment of intractable epilepsy.
  • Only a licensed practitioner of medicine or osteopathy who is a neurologist or who specializes in the treatment of epilepsy may issue a written certification to a patient for the use of cannabidiol oil or THC-A oil.
  • Provides an affirmative defense for agents and employees of pharmaceutical processors in a prosecution for the manufacture, possession, or distribution of marijuana.
  • An enactment clause provides that except for provisions requiring the Board to promulgate regulations, the provisions of the bill do not become effective unless reenacted by the 2017 Session of the General Assembly.

HB1077 & SB480 – Adding Synthetic Drugs to Schedule I

  • Schedules twelve synthetic compounds into Schedule I:
    • 4-BMC
    • 4-CMC
    • 25I-NBOH
    • alpha-PHP
    • PV8
    • Etizolam
    • Acetyl fentanyl
    • 5-fluoro-AMB
    • NM-2201
    • FUB-144
    • MAM-2201
  • Previously scheduled by Board of Pharmacy (for 18 months & thus needed permanent scheduling in Code)
  • These products are identified by the Virginia Department of Forensic Sciences. As with many designer drugs, chemical structures are modified frequently to avoid oversight by regulatory agencies.

HB1292 – Routine Scheduling Bill

  • Classifies eluxadoline as Schedule IV controlled substances.

HB293 & SB513 – PMP Program – Prescribers Accessing Program for Opioid Treatment Lasting More than 14 Days

  • Requires a prescriber to obtain information from the Prescription Monitoring Program at the time of initiating a new course of treatment that includes the prescribing of opioids anticipated to last more than 14 consecutive days.
  • Currently, a prescriber must request such information when a course of treatment for opioids or benzos is expected to last 90 days. Benzos requirement REMOVED.
  • EXEMPTIONS – A prescriber shall not be required to check the PMP program if:
    1. The opioid is prescribed to a patient currently receiving hospice or palliative care;
    2. The opioid is prescribed to a patient as part of treatment for a surgical or invasive procedure and such prescription is not refillable;
    3. The opioid is prescribed to a patient during an inpatient hospital admission or at discharge;
    4. The opioid is prescribed to a patient in a nursing home or a patient in an assisted living facility that uses a sole source pharmacy;
    5. The Prescription Monitoring Program is not operational or available due to temporary technological or electrical failure or natural disaster; or
    6. The prescriber is unable to access the Prescription Monitoring Program due to emergency or disaster and documents such circumstances in the patient’s medical record.
  • This bill also clarified that individuals delegated to have access to the PMP program by prescribers or dispensers must be:
    • individuals who are employed or engaged at the same facility and under the direct supervision of the prescriber or dispenser and
      1. are licensed, registered, or certified by a health regulatory board under the Department of Health Professions or in another jurisdiction or
      2. have routine access to confidential patient data and have signed a patient data confidentiality agreement.
  • Scheduled to sunset July 1, 2019

HB657 – Prescription Monitoring Program; indicators of misuse, disclosure of information.

  • Directs the Director of the Department of Health Professions to develop, in consultation with an advisory panel that shall include representatives of the Boards of Medicine and Pharmacy, criteria for indicators of unusual patterns of prescribing or dispensing of covered substances by prescribers or dispensers.
  • Authorizes the Director to disclose information about the unusual prescribing or dispensing of a covered substance by an individual prescriber or dispenser to the Enforcement Division of the Department of Health Professions.

 HB1044 & SB491 – PMP; Medicaid Managed Care PUMS Program Access

  • Director of the Department of Health Professions may disclose information in the possession of the PMP about a specific recipient who is a member of a Virginia Medicaid managed care program to a physician or pharmacist licensed in the Commonwealth and employed by the Virginia Medicaid managed care program.
  • Used only to determine eligibility for and to manage the care of the specific recipient in a Patient Utilization Management Safety or similar program.
  • The bill also requires the Prescription Monitoring Program advisory committee to provide guidance to the Director regarding such disclosures.
  • Originally contained language allowing Health Plans to report prescribers and dispensers for unusual prescribing or dispensing habits. This language was removed at the request of VPhA and the Medical Society of Virginia.

HB527 – Nonresident medical equipment suppliers; registration with Board of Pharmacy

  • Requires Medical Equipment Suppliers (MES) outside of Virginia but doing business with Virginia residents to register with the Board of Pharmacy.
  • Originally proposed by the Board of Pharmacy in 1999.
  • Resident MES have previously been registered with the Board.

HB312 – Increase Sharing of Electronic Health Records

  • Charges the Secretary of Health and Human Resources (SHHR) to work with stakeholder groups to:
    • evaluate interoperability of electronic health records systems between health systems and health care providers and the ability of health systems and health care providers to share patient records in electronic format and
    • develop recommendations for improving the ability of health systems and health care providers to share electronic health records with the goal of ensuring that all health care providers in the Commonwealth are able to share electronic health information to reduce the cost of health care and improve the efficiency of health care services.
  • Report to the chairman of the House’s and Senate’s health committees its recommendations and findings by December 1, 2016.

HB498 – TPA-certified Optometrists – Prescriptive Authority for Schedule II hydrocodone in combination with acetaminophen

  • Prior to the DEA reclassifying hydrocodone combination products from C-III to C-II, a TPA-certified optometrist could prescribe these products.
  • This bill expands the prescriptive authority to include Schedule II controlled substances consisting of hydrocodone in combination with acetaminophen.

HB528 – Track and Trace Requirements

  • Updates Virginia’s law to comply with new Federal “Track and Trace” requirements.
  • Removes Virginia’s pedigree requirements (as the Federal law voids all state pedigree and e-pedigree laws).

HB586 – Health regulatory boards; confidentiality of certain information obtained by boards.

  • Disciplinary actions involving allegations that a practitioner is or may be unable to practice with reasonable skill and safety to patients and the public because of a mental or physical disability, a health regulatory board shall consider whether to disclose and may decide not to disclose in its notice or order the practitioner’s health records or his health services, although such information may be considered by the board in a closed hearing and included in a confidential exhibit to a notice or order.
  • The public notice or order shall identify, if known, the practitioner’s mental or physical disability that is the basis of its determination.

HB829 – CE for Prescribers

  • Authorizes the Director of DHP to disclose information to the Board of Medicine about prescribers who meet a certain threshold for prescribing covered substances for the purpose of requiring relevant continuing education.
  • Threshold shall be determined by the Board of Medicine in consultation with the PMP.
  • Directs the Board of Medicine to require prescribers identified by DHP to complete two hours of CE in each biennium on topics related to pain management, the responsible prescribing of covered substances, and the diagnosis and management of addiction.
  • The provisions of the bill will expire on July 1, 2022.

SB556 – Opiate addiction treatment; nonmethadone opioid replacements.

  • Removes certain restrictions on licensure of providers who provide treatment for persons with opiate addiction using opioid replacements that have been approved by the U.S. Food and Drug Administration for the treatment of opioid addiction.
  • Such restrictions include the proximity of the provider to a school and community notice requirements.

HB825 & SB437 – Military medical personnel; pilot program for personnel to practice medicine.

  • Directs the Department of Veterans Services, in collaboration with the Department of Health Professions, to establish a pilot program in which military medical personnel may practice and perform certain delegated acts that constitute the practice of medicine under the supervision of a licensed physician or podiatrist.
  • Department of Veterans Services will establish general requirements for participating in the program.

HB815 – Compounding of Drugs for Executions

  • Bill originally would have made electrocution the preferred method of execution if lethal injection substances were unavailable
  • Governor amended the bill which authorizes the Director of the Department of Corrections to enter into contracts with a pharmacy or outsourcing facility to compound drugs necessary to carry out an execution.
  • Compounding of these drugs do not constitute the practice of pharmacy and is not under the jurisdiction of the Board of
  • Pharmacy, Board of Medicine, or DHP.
    The identities of those involved are exempt from the Freedom of Information Act (FOIA) and protected from civil liability

Bills with Parts Effective July 1, 2016 & January 1, 2017

SB287 – PMP 24 Hour Reporting & Increased Access to PMP

  • July 1, 2016 – Allows access to PMP program by:
    • a dispenser for the purpose of establishing a prescription history to assist the dispenser in providing clinical consultation on the care and treatment of the recipient
    • a prescriber for the purpose of establishing the treatment history of the specific recipient when the prescriber is consulting on the treatment of such recipient
  • January 1, 2017 – Reports by dispensers to the PMP shall be made within 24 hours or the dispenser’s next business day, whichever comes later.

Bills Effective January 1, 2017

HB319 – CE Credit for Volunteer Services

  • Requires health regulatory boards to promulgate regulations providing for the satisfaction of board-required CE for individuals registered, certified, licensed, or issued a multistate licensure privilege by a health regulatory board through delivery of health care services, without compensation, to low-income individuals receiving health services through a local health department or a free clinic organized in whole or primarily for the delivery of those health services.

Budget Items Effective July 1, 2016

Substance Use Disorder Treatment

  • $22 million over the biennium to implement a comprehensive Medicaid benefit package for substance abuse treatment.

Analysis of Pharmacy Claims Expenditures for State Employee Health Plan

  • The Director of the State Employee Plan shall analyze pharmacy claims data from the past biennium in order to assess the value of payments made to the state employee health program’s contracted third party administrators, and the value of payments made by the contracted third party administrators to their contracted prescription benefit managers (PBMs).
    The Director shall identify and report any difference in value in payments made to the contracted PBMs and payments made to the state employee health program’s contracted third party administrators and shall make recommendations to the Chairmen of the House Appropriations Committee and Senate Finance Committees by October 1, 2016.

Analysis of Pharmacy Claims Expenditures for Medicaid Managed Care Plans

  • DMAS Director shall analyze pharmacy claims data from the past biennium in order to assess the value of payments made to the Medicaid program’s contracted managed care plans, and the value of payments made by the contracted managed care plans to their contracted prescription benefit managers (PBMs).
  • Additionally, the Director shall request and, if made available, analyze the value of payments made by the Medicaid program’s managed care plans’ contracted PBMs to network pharmacies for the same set of pharmacy claims.
  • The Director shall identify and report any difference in value in payments made to the contracted PBMs, payments made to the contracted managed care plans, and if available, to network pharmacies and shall make recommendations to the Chairmen of the House Appropriations and Senate Finance Committees by October 1, 2016.