D.09 VHA Directive 1306 Querying State Prescription Drug Monitoring Programs (PDMP).pdf

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Department of Veterans Affairs Veterans Health Administration Washington, DC 20420

VHA DIRECTIVE 1306

Transmittal Sheet October 19, 2016

QUERYING STATE PRESCRIPTION DRUG MONITORING PROGRAMS (PDMP)

1. REASON FOR ISSUE: This Veterans Health Administration (VHA) Directive establishes policy requiring VHA health care provider participation in State Prescription Drug Monitoring Programs.

2. SUMMARY OF CONTENT: This directive establishes responsibilities requiring VHA health care providers to query State Prescription Drug Monitoring Programs (PDMPs) to support safe and effective prescribing of controlled substances. This directive does not establish policy regarding the disclosure of information to state PDMPs except to the extent required to query.

3. RELATED ISSUES: VHA Directive 1005, Informed Consent for Long-Term Opioid Therapy for Pain.

4. RESPONSIBLE OFFICE: The Office of Patient Care Services, Primary Care Services (10P4F) is responsible for the contents of this Directive. Questions may be referred to 202-461-4158 or VHA10P4FStaff@va.gov.

5. RESCISSIONS: None.

6. RECERTIFICATION: This VHA Directive is scheduled for recertification on or before the last working day of October 31, 2021. This VHA directive will continue to serve as national VHA policy until it is recertified or rescinded.

David J. Shulkin, M.D.

Under Secretary for Health

DISTRIBUTION: Emailed to the VHA Publication Distribution List on October 25, 2016.

October 19, 2016 VHA DIRECTIVE 1306 i

CONTENTS

QUERYING STATE PRESCRIPTION DRUG MONITORING PROGRAMS (PDMP)

1. PURPOSE: 1

2. BACKGROUND: 1

3. DEFINITIONS: 1

4. POLICY: 2

5. RESPONSIBILITES: 3

6. REFERENCES: 6

QUERYING STATE PRESCRIPTION DRUG MONITORING PROGRAMS (PDMP)

1. PURPOSE:

This Veterans Health Administration (VHA) Directive establishes policy requiring VHA health care providers to query State Prescription Drug Monitoring Programs (PDMPs) to support safe and effective prescribing of controlled substances. This Directive does not establish policy regarding the disclosure of information to state PDMPs except to the extent required to query. AUTHORITY: 38 U.S.C. §§ 7301(b), 5701(l), 7332(b)(2)(G); 38 CFR §§ 1.483, 1.515.

2. BACKGROUND:

a. VA is committed to improving clinical care and furthering the public health benefits offered by PDMPs nationwide.

b. A PDMP is a statewide database that collects designated data on controlled substances dispensed to patients within that state. Some PDMPs participate in sharing of prescription monitoring program data with authorized users across state lines and federal entities. This helps to promote safety of controlled substance use and to decrease drug diversion and substance use disorders among patients nationwide.

c. Used appropriately, controlled substances may improve patient health, function and quality of life. However, controlled substances can present serious health risks when they are not used in accordance with prescribed instructions. By querying the PDMP database, VA providers will be able to improve identification of patients receiving controlled substances from multiple prescribers. This information may assist in the prevention of accidental or intentional misuse or diversion of prescribed medication by Veterans and their dependents, as well as in the prevention and early treatment of substance use disorders.

d. Patient safety is enhanced when VA providers have complete information about a Veteran’s controlled substance prescriptions. PDMPs provide information regarding controlled substances that have been dispensed by non-VA pharmacies. The patient and provider can then discuss therapeutic effectiveness for the treatment of pain or other conditions and patient safety. Most importantly, the information can help VA providers prevent harm to VA patients that could occur because the provider was unaware the patient was prescribed a controlled substance medication by a non-VA provider. Increasingly PDMPs now also provide information on controlled substances prescribed and dispensed by the VA, thereby similarly benefiting the non-VA provider who is providing care for Veterans.

3. DEFINITIONS:

a. Controlled substance. A controlled substance is a drug or other substance, or immediate precursor, included in Schedule I, II, III, IV, or V (see 21 U.S.C. § 802.

b. Controlled Substance Prescriber. A controlled substance provider is a physician, dentist, pharmacist, advanced practice registered nurse, physician assistant, who is permitted to prescribe controlled substances in accordance with licensure and privileges, or licensure and scope of practice and may be either an employee or a contractor.

c. State Prescription Drug Monitoring Program. A state PDMP is a statewide electronic database which collects designated data on controlled substances dispensed in the state. The PDMP is administered by a specified statewide regulatory, administrative or law enforcement agency. The authorized agency distributes data from the database to individuals who are permitted under state law to receive the information for purposes of their profession.

d. Delegate. A delegate is a VA health care team member who is allowed to access and query state PDMPs on behalf of the controlled substance prescriber in accordance with state law.

e. State. As used in this Directive, the term “state” means each of the 50 States, Territories, and possessions of the United States, the District of Columbia, and the Commonwealth of Puerto Rico, as defined in 38 U.S.C. § 101(20).

4. POLICY: It is VHA policy that state PDMP databases are queried for VHA patients who are receiving prescriptions for controlled substances as outlined in this policy on a minimum of an annual basis and that the results of queries are documented in the VA medical record. State PDMP databases will be queried prior to initiating therapy with a controlled substance and more often when clinically indicated. The requirements to query set forth in this paragraph are subject to limitations imposed by states on VA’s access to such databases.

NOTE: This policy is the minimum requirement VA-wide. However, if there is variation between state laws for PDMPs (e.g. definition of a controlled substance, PDMP querying frequency, procedures for disclosing PDMP information, delivery format for the PDMP information, etc.), providers and prescribers must conform to the policies and recommendations of the state of their licensure. For, example, individual VA medical professionals may be required by their state licensing boards to query state PDMPs more frequently than the minimum required by this policy. Additionally, when clinical indications and patient safety concerns warrant more frequent PDMP queries for a particular patient, such queries should be done at the discretion of the prescriber.

Unless contrary to applicable state law, the following are excluded from the requirements in this Directive to perform PDMP queries:

a. Any patient whose only controlled substance prescription is for a 5-day supply or less without refills.

b. Any patient who is enrolled in Hospice care.

Local policies may suspend one or both of these exclusions in some or all cases;

however, local policies may not add exclusions.

5. RESPONSIBILITES:

a. Assistant Deputy Under Secretary for Health for Patient Care Services. The VHA Assistant Deputy Under Secretary for Health for Patient Care Services, or designee, is responsible for ensuring policy guidance is established and communicated across VHA.

b. Deputy Under Secretary for Health for Clinical Operations and Management. The VHA Deputy Under Secretary for Health for Clinical Operations and Management is responsible for ensuring implementation of this Directive across VHA.

c. Veterans Integrated Service Network Director. Each Veterans Integrated Service Network (VISN) Director is responsible for:

(1) Ensuring the implementation and compliance with this Directive at all VA medical facilities in their VISN.

(2) Ensuring that VA medical facilities within their VISN establish local PDMP policies consistent with this Directive.

(3) When appropriate, establishing a VISN policy to ensure processes are in place that are consistent with this Directive and applicable state law.

d. VA Medical Facility Director. The VA medical facility Director is responsible for:

(1) Providing leadership that endorses, supports, and promotes the use of results from queries of the PDMP as an essential element of comprehensive, coordinated, patient-centered care for Veterans.

(2) Ensuring implementation of this Directive at all sites of care that are administered by the facility.

(3) Ensuring a local policy and processes are in place that are consistent with this Directive and applicable state law and that address:

(a) Education and training on how to access and utilize information received through the PDMP database. Education should include appropriate non-clinical staff members who are likely to interact with patients whose care may be affected by this Directive.

(b) Requirements for providers who prescribe controlled substances, or their designees, to query the PDMP database in compliance with VHA policy set forth in paragraph 4. Local policies may require more frequent queries, but may not require less frequent queries than this VHA Directive. For example, local policies may require

PDMP queries every three (3) months for patients prescribed opioids for chronic pain while requiring a once a year PDMP query for non-opioid controlled substances. Local policies should also address querying more than one state PDMP where appropriate and consistent with applicable state law requirements.

NOTE: While this Directive guides VA policy regarding participation in state PDMPs, local state policies and requirements should be considered when developing local VA medical facility policies. For example, if a particular state requires PDMP queries for patients on chronic opioids twice a year, local VA medical facility policy could establish a more frequent querying practice. However, if the state requirements are more lenient, the VA medical facility is still required to meet the minimum requirements of this Directive.

(c) Guidance on who is expected to query the PDMP database and which team members may support this function as a delegate, per local resources and state law.

(d) Any potential conflicts between VA duties and state law and/or regulations.

Regarding any such issues, the VA Chief Counsel for the appropriate District should be consulted, and input from relevant state officials (for example, state licensing boards and state PDMPs) should be solicited, when drafting local policy in order to be consistent with applicable state and Federal law, and to ensure that clear guidance is issued for VA medical providers.

(4) Establishing a local pre-defined progress note titled, “State Prescription Drug Monitoring Program” that must be linked to the national standard note titled, “Accounting of Disclosure Note”. NOTE: It is strongly recommended that this note be templated for compliance with accounting of disclosures. Please see Handbook 1605.1, Privacy and Release of Information.

e. Facility Chief of Staff. The Facility Chief of Staff is responsible for:

(1) Requiring controlled substance prescribers and/or responsible team members to request and maintain access to appropriate state PDMPs, where permitted by state law.

(2) Ensuring that prescribing providers interpret the PDMP data to make safe and appropriate care decisions.

(3) Ensuring that all queries are appropriately documented in the local pre-defined progress note titled State Prescription Drug Monitoring Program.

(4) Training all VA and contract staff members regarding the requirements of this directive.

(5) Establishing local policy and procedures to identify delegates who are authorized to query the PDMP database on behalf of a controlled substance prescriber, where state laws permit the use of delegates.

f. Controlled Substance Prescribers. Controlled substance prescribers are responsible for:

(1) Recognizing which medications are controlled substances and thus covered by this Directive. In addition, the controlled substance prescriber must be knowledgeable in the laws and regulations that govern prescribing these medications. This includes:

(a) Federal laws

(b) VA regulations and policy

(c) The relevant laws of the states in which the individual prescriber is licensed to practice. In case of any perceived conflict between their VA duties and state laws or regulations, prescribers should seek guidance from their VA District Chief Counsel. For additional information on individual state PDMP laws and regulations see:

http://www.nascsa.org/stateprofiles.htm.

(2) Registering for the PDMP in the state where the prescriber is practicing, if permitted by the laws and guidelines of that state. Providers should consider registering for PDMPs in neighboring states, where permitted by state laws and regulations, if that prescriber is prescribing controlled substances for patients who reside in those states.

NOTE: Some state laws do not allow prescribers to register if the prescriber is not licensed in that state. VA does not require VA-employed controlled substance prescribers to obtain a license in the state of practice in order to query the PDMP in that state. By law, VA-employed prescribers need to only be licensed in “a” state.

(3) As permitted by applicable state law, querying the PDMP in the state where the service is provided prior to initiating therapy with controlled substance(s) to determine if the patient is currently receiving controlled substances from another provider.

NOTE: Based on relevant concerns, such as geographic location, providers may consider querying PDMP databases in additional states, consistent with applicable state law, to compile more complete information regarding a Veteran’s controlled substance prescriptions.

(4) As permitted by applicable state law, querying PDMP databases at least annually when renewing or issuing a new outpatient prescription to continue therapy with a controlled substance, or anytime such query is clinically indicated. Local policy may require more frequent querying of PDMP databases.

NOTE: Where permitted by state law, VA medical facilities are encouraged to consider using provider team support (delegates) to access information, when needed for clinical evaluations.

(5) As permitted by applicable state law, documenting relevant PDMP query results in the local pre-defined progress note titled State Prescription Drug Monitoring Program within the Computerized Patient Record System (CPRS), upon receipt of PDMP query results. This allows for an accounting of disclosure when individually identifiable information is submitted as part of the query. Only the portions of the PDMP query results that are relevant to the subject patient’s treatment within the VA Healthcare System should be documented within CPRS. Care should be taken not to include information irrelevant for VA treatment but creating potential risk for unlawful use. For example, license numbers of past prescribers and Drug Enforcement Agency numbers obtained from PDMP queries should generally not be included in CPRS.

NOTE: The Privacy Act (5 USC 552a) and the Health Insurance Portability and Accountability Act (HIPAA) have legal requirements for Federal agencies to maintain an accounting of all disclosures made to any outside entity of agency records. Please see Handbook 1605.1 Privacy and Release of Information.

(6) Reevaluating and updating the care plan with the patient if the patient is found to be receiving controlled substance prescriptions from both VA and non-VA prescribers.

The modification of the care plan should carefully consider whether continuing controlled substances is safe and clinically appropriate. If so, the VA provider should determine if the patient would prefer to receive their controlled substances prescription from the non-VA provider. If the patient elects to receive controlled substance prescriptions from the non-VA provider, this will be documented in the Non-VA Medications section of CPRS and in the progress note template.

6. REFERENCES:

a. Privacy Act of 1974, 5 USC 552a.

b. Confidentiality of Certain Medical Records, 38 U.S.C. § 7332.

c. Health Insurance Portability and Accountability Act Privacy Rule, 42 C.F.R. Parts 160 and 164.

d. VHA Handbook 1605.1, Privacy and Release of Information.

e. NABP PMP InterConnect, National Association of Boards of Pharmacy, 2015, available at: http://www.nabp.net/programs/pmp-interconnect/nabp-pmp-interconnect.

f. State PDMP Web sites, Prescription Drug Monitoring Program Training and Technical Assistance Center, available at: http://pdmpassist.org/content/state-pdmp-websites.