New PMP Check Requirement for Outpatient Prescribing and Dispensing of Controlled Substances to Medicaid Patients Effective October 1, 2021

 

Purpose
The purpose of this bulletin is to inform hospitals about the new prescription monitoring program (PMP) check requirement for outpatient prescribing and dispensing of controlled substances to Apple Health patients that takes effect October 1, 2021. This new requirement is being promulgated as a result of the federal Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) passed in 2018. Under new WAC 182-530-1080, prescribers must conduct a PMP check for controlled substances prescribed to Apple Health patients in an outpatient context. In addition, dispensing pharmacists must conduct a PMP check for controlled substances prescribed to Apple Health patients before dispensing from an outpatient pharmacy. According to the Health Care Authority’s bulletin, the PMP mandate applies to Schedule II through V controlled substances. WSHA sought feedback from our members and actively participated in the rulemaking process and successfully narrowed the rule to apply solely to outpatient settings. The initial draft would have included inpatient admissions.

Recommendations

1. Review this bulletin and new WAC 182-530-1080 to understand the PMP check requirement for Apple Health patients. The new rule requires a PMP check before prescribing controlled substances in an outpatient context and before dispensing from an outpatient pharmacy. This differs from the current opioid requirements from the Washington Medical Commission and the Nursing Care Quality Assurance Commission that requires a PMP check at first refill and during pain phase transitions. Those requirements continue to apply.
2. Educate prescribers and pharmacists about this new requirement for outpatient controlled substances prescriptions for Apple Health patients.
3. Update any internal controlled substances policies and procedures to reflect the rule.

Applicability/Scope
The PMP check rule in new WAC 182-530-1080 applies to:

• All prescribers who prescribe Schedule II through V controlled substances to Apple Health patients for outpatient use. “Prescriber” is defined in WAC 182-530-1050 as a “physician, osteopathic physician/surgeon, dentist, nurse, physician assistant, optometrist, pharmacist, or other person authorized by law or rule to prescribe drugs.” and
• All pharmacists who dispense Schedule II through V controlled substances to Apple Health patients from an outpatient pharmacy. “Pharmacists” is defined in WAC 182-530-1050 as a “person licensed in the practice of pharmacy by the state in which the prescription is filled.”

HCA’s August 30, 2021 bulletin on the new rule specifies the rule’s applicability to Schedule II through V controlled substances. Please see the U.S. Drug Enforcement Administration Drug Scheduling webpage for more information about drug scheduling.

The rule section is situated under chapter 182-530 WAC, which applies to outpatient prescription drugs. However, HCA has not been precise in communications about the applicability of the new rule. WSHA will request that HCA be more precise about the scope of the rule applying only to outpatient prescription drugs in the HCA October 1 Prescription Drug Program Billing Guide.

WAC 182-530-1080 does not apply to controlled substances prescribed and dispensed to patients who are not covered by Apple Health.

Overview
New WAC 182-530-1080 “identifies the steps prescribers must take before prescribing a controlled substance and the steps pharmacists must take when dispensing a controlled substance from an outpatient pharmacy to check an apple health client’s prescription drug history in the prescription monitoring program (PMP) described in chapter 246-470 WAC.”

The PMP check must be conducted in accordance with the provisions set forth in chapter 246-470 WAC that are authorized by chapter 70.225 RCW.

The rule requires that “a prescriber, before prescribing, and a pharmacist, when dispensing, must check all of a client’s current prescriptions in the PMP, including any prescriptions not paid for by apple health.” HCA announced in its August 30, 2021 bulletin that guidelines for determining appropriate reviews of the Washington PMP will be reflected in the October 1 Prescription Drug Program Billing Guide. According to HCA’s recent explanatory presentation the guidance will include the following information on the timing to conduct PMP checks under the new rule:

• Prescribers may conduct the check “no more than 10 days prior to writing the prescription”; and
• Pharmacists may conduct the check “no more than 48 hours prior to or after filling any controlled medication.”

Please see the October 1 Prescription Drug Program Billing Guide to confirm the specific requirements.

Prescribers and pharmacists may delegate the PMP check “to anyone in their practice setting with authorization to access the PMP, so long as the prescriber or pharmacist reviews all of the client’s current prescriptions in the PMP before prescribing or when dispensing a controlled substance.”

Both the prescriber and the pharmacist are required to document the PMP check in the patient’s PMP record. New WAC 182-530-1080 (3) states, “The prescriber and pharmacist must document in the client’s record the date and time of the: (a) Retrieval of information from the PMP; and (b) Review of information from the PMP.”

New WAC 182-530-1080 also contains a “good faith effort exemption” that allows prescribers and pharmacists to document their reason for not conducting the PMP check if they were unable to fulfill the requirement.

Below is the full text of WAC 182-530-1080:

Requirements for prescribing and dispensing controlled substances—Prescription monitoring program (PMP).
This section identifies the steps prescribers must take before prescribing a controlled substance and the steps pharmacists must take when dispensing a controlled substance from an outpatient pharmacy to check an apple health client’s prescription drug history in the prescription monitoring program (PMP) described in chapter 246-470 WAC.

1. PMP review required. Except as identified in subsection (4) of this section, a prescriber, before prescribing, and a pharmacist, when dispensing, must check all of a client’s current prescriptions in the PMP, including any prescriptions not paid for by apple health.
2. Retrieval by delegates allowed. A prescriber or pharmacist may delegate the retrieval of the client’s PMP information to anyone in their practice setting with authorization to access the PMP, so long as the prescriber or pharmacist reviews all of the client’s current prescriptions in the PMP before prescribing or when dispensing a controlled substance.
3. Documentation. The prescriber and pharmacist must document in the client’s record the date and time of the:
   1. Retrieval of information from the PMP; and
   2. Review of information from the PMP.
4. Good faith effort exception.
   1. If a prescriber, pharmacist, or their delegate is unable to access the client’s record in the PMP after a good faith effort, that attempt must be documented in the client’s record.
   2. A prescriber or pharmacist must document the reason or reasons they were unable to conduct the check.

Next Steps
By October 1, 2021, hospitals should update any policies and procedures concerning controlled substance prescriptions for outpatients to reflect the requirements in new WAC 182-530-1080.

According to its August 30, 2021 bulletin, HCA is “finalizing guidelines for determining appropriate reviews of the Washington PMP consistent with SUPPORT Act requirements. These will be reflected in the October 1 prescription drug program billing guide. The guidelines are designed to inform providers how HCA will measure appropriate reviews of the PMP for reporting to the Centers for Medicare and Medicaid Services (CMS).” To receive the latest information, sign up for HCA’s email list here. Specific questions about the rule may be sent via email to AppleHealthPharmacyPolicy@hca.wa.gov.

According to HCA’s presentation, HCA will monitor compliance by reconciling PMP check data with data from qualifying claims. HCA’s analysis will be reported to the Centers for Medicare and Medicaid Services in accordance with the requirements in the federal SUPPORT Act. HCA’s presentation on the new rule states, “HCA may send educational letters to prescribers and pharmacists who fall below a threshold for qualifying checks,” but does not specify what the quantitative check threshold will be or any penalties for not meeting the threshold. Please see HCA’s slide deck for more information about monitoring and compliance.

Background
The new rule is a federal mandate from the SUPPORT Act in 42 USC § 1396w-3a. The SUPPORT Act specifically requires prescribers to conduct the PMP check while giving states the discretion to subject pharmacists to the PMP check requirement. WSHA sought feedback from our members and actively participated in HCA’s rulemaking process by submitting comment letters and meeting with HCA staff. WSHA successfully advocated for HCA to apply the rule solely to outpatient prescriptions to avoid delays in patient care and unnecessary burdens on hospital staff. WSHA also joined the Washington State Pharmacy Association and Washington State Medical Association in recommending changes to HCA’s rule drafts that would align the rule with the SUPPORT Act’s explicit language.

WSHA’s 2021 New Law Implementation Guide
Please visit WSHA’s new law implementation guide online. The Government Affairs team is hard at work preparing resources and information on the high-priority bills that passed in 2021 to help members implement the new laws, as well as links to resources such as this bulletin. In addition, you will find the Government Affairs team’s schedule for the release of upcoming resources on other laws and additional resources for implementation.

References
WAC 182-530-1080

HCA SUPPORT Act PMP Rule Slide Deck

Chapter 246-470 WAC

Chapter 70.225 RCW

Federal SUPPORT Act

42 USC § 1396w-3a

HCA SUPPORT Act Webpage

HCA Bulletin – August 30, 2021

Drug Enforcement Administration Drug Scheduling Webpage