Pharmacy Industry Updates: July 2019
Every month, our Industry Relations Director, LeAnn Lewis provides an in-depth industry update to customers. Below, you will find the agenda for the industry update for July. If you have any questions regarding any of the points, contact us here.
- North Dakota – Changed Gabapentin to Schedule V on 04-11-2019
- District of Columbia – Changed Gabapentin to Drug of Concern. Must report as of 06-07-2019
- New Hampshire
- XDEA(PRE09) and Treatment Type (DSP24) are now only required for Opioid
- Updated Dispenser’s Guide
- Iowa — Require Prescription Origin Code to be reported (DSP 12) as of 05-15-2019
- Butalbital require reporting on 06-26-2019 per notice from IA BOP, final rule on 06-22
- New Data Submission Guide published which requires the DSP 12 change, but not the Butalbital change
- Oklahoma — Effective 09-01-2019, Requires Treatment Type (DSP24) but will not generate errors on Treatment Type until 01-01-2020.
- If an opioid prescription is not for pain, select 01.
- If an opioid prescription includes a notation for “Acute Pain,” select 07.
- If an opioid prescription includes a notation for “Chronic Pain,” select 09.
- If the prescription is not for an opioid drug, select 99.
- Oklahoma SB848 was recently enacted which requires
- Any prescription for acute pain shall have the words “acute pain” notated on the face of the prescription by the practitioner.
- Any prescription for chronic pain shall have the words “chronic pain” notated on the face of the prescription by the practitioner.
- Situational Reporting of
- DSP19 – RxNorm Code
- DSP20 – Electronic Prescription Reference Number
- DSP21 – Electronic Prescription Order Number
- AIR01 – State Issuing Rx Serial Number
- AIR02 – State Issued Rx Serial Number
- AIR03 – Issuing Jurisdiction
- Nebraska Sept 2019 (Likely 09-09-2019)
- Changing from Dr. First to a NIC’s RxGov Platform — details will be made available in July for signup.
- Will accept but not require ASAP 4.2A with no new fields required other than fields required by LB 556 on 05-02-2019 Including:
- Phone Number
- Patient ID
- Alabama – Gabapentin Schedule V as of 11-18-2019
- California– From various emails.
- AB 1753: Effective Jan. 1, 2019, this rule introduced, among other requirements, the concept of a uniquely serialized number – to be prescribed by the CA Dept. of Justice. The Dept. devised a 15 character serial number, and these are the forms primarily in circulation today. Dispenser reporting requirement: If the form possesses a serial number then dispensers report If the form does not possess a serial number, then they would not have one to report.
- New Memo at https://oag.ca.gov/sites/all/files/agweb/pdfs/security-printers/ab-149.pdf?
- All forms are valid until 01-01-2021.
- New forms by 01-01-2020 which will be
- Compliant with all state and federal requirements;
- Compliant with current NCPDP Standards
- Utilizable as a barcode that may be scanned by pharmacists
- Florida – ASAP V4.2A Accepted now, but required as of 12-19-2019
Potential PDMP Changes
- Utah – Will be moving to NIC’s RxGov in the
- Updated spreadsheets with zero reporting are
- Oregon HB 3315 –Introduced March 4, 2019, Adds to the reporting
- method of payment used to purchase the prescription drug
- diagnosis or other information related to a prescription
- Whether the patient is required to obtain prescriptions from a designated practitioner or prescription drugs from a designated pharmacy
Legislative/Regulatory Reminders for July 2019
- Indiana (SB 133) If the drug contains or is derived from opium, the label must contain a statement that the drug is an opioid.
- Maine (LD6 / SP 10) Prohibit Cost Share > Cost and Gag Orders
- Minnesota 113 pages of summary provided by the Board of Pharmacy including nuggets
- HF 400
- Various opiate and narcotic pain prescribing and dispensing limits
- Opioid Stewardship Council
- SF 12 and SB 278 – Updated PBM Rules
- HF 400
- SB 2996 – Require Medication Synchronization with prorated copay and full dispensing fee
- SB 2365 – Allow biosimilar substitution with 5 day notification to prescriber
- New Mexico (SB 394) Imposes new restrictions on PBM Audits
- Tennessee (HB 786) Adds additional protections to pharmacies during a PBM Audit
- HB 499 – Moves Tramadol to Schedule IV
- Requires e-Prescribing for all prescriptions containing opiates as of 07-01-2019 with some exceptions.
- HB 1743 – Requires that patient counseling includes proper disposal of medication
- West Virginia
- HB 2768 – New prescribing limits on initial prescriptions of opioids, and new lock-in requirements
New Legislative/Regulatory Highlights
- Hawaii and Florida – appear to have removed the requirement for textual representation of quantity on an electronic prescription
- Nevada, Texas, Florida, Washington – Electronic prescribing of controlled substances
- Delaware and Minnesota – Opioids Impact/Stewardship Funds
- Colorado – Limits on Patient Cost Share for Insulin
- Increased PBM Regulation – Louisiana, Minnesota, Oklahoma, Tennessee
Get Involved/Get Informed Spotlight
Contact your Congressman and Senator
Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
Drug Supply Chain and Security Act (DSCSA)
- November 27, 2019 Wholesaler Resaleable Returns
- FDA Poster: https://www.fda.gov/media/113114/download
Pharmacy Quality Measurement
PQA is developing Pharmacy Level quality measures and asking for volunteers to assist.
If interested, contact Jake Galdo, Director, Performance Measurement, at JGaldo@pqaalienace.org
Overview of USP 800 Part 2 – Handling of Hazardous Drugs – Handling in Healthcare Settings
December 1, 2019: USP General Chapter <800>
Contact us to ask questions or get more information about these updates.
The organizer of this call is not an attorney, and the presentation on this call does not constitute legal advice. It contains only the opinions and observations of the organizer and its participants. Any use of information contained in this presentation is at the user’s own risk. The organizer will not be available for depositions or testimony in case of litigation.