Pharmacy Industry Updates: August 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 August. If you have any questions regarding any of the points, contact us here.
- Pennsylvania – Effective immediately, dispensations of Epidiolex and any generic version of the same formulation approved in the future must be reported, it is now a federal Schedule V Drug
- Oregon – Effective no later than 08-12-2019 New likely effective 01-01-2020
- Require Gabapentin Reporting as a Drug of Concern
- Require Diagnosis Code and “reason for the prescription”
- Oklahoma – Effective 09-01-2019, Requires Treatment Type (DSP24) but will not generate errors on Treatment Type until 01-01-2020.
- Nebraska – Effective 09-03-2019
- Changing from to a NIC’s RxGov Platform
- Requires ASAP 4.2A with new fields of Gender, Phone Number, and Patient ID
- New Data Submission Guide is available
- Account Signup available as of 08-05-2019
- Looking for Early Adopters – Contact nehii.org
- Voluntary reporting of SIG and ICD-10 for NE to evaluate usefulness
- Alabama – Gabapentin becomes a Schedule V as of 11-18-2019
- California –Still waiting on new format of serial number and barcode required by 01-01-2020
- PDMP reporting – required now if serial number is on the form.
- 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 future
Legislative/Regulatory Reminders for August 2019
- New restrictions on PBMs
- Pharmacists can dispense lower cost generics and biologics and “shall” disclose, the amount of the savings at the patients request, requires notification to the prescriber within 5 days.
- Minnesota – New restrictions on PBMs including licensure.
- North Dakota – Increased prescriptive authority for pharmacists.
- Louisiana – Require a Medically necessary indication on a prescription for an opioid > 7 day supply.
- Texas – Increase requirements to check PDMP prior to dispensing.
New Legislative/Regulatory Highlights
- North Carolina (SB 556) — No Schedule II substance shall be dispensed pursuant to a written or electronic prescription more than six months after the date it was
- New Hampshire (HB 359) – Require new labeling on Opioids
- Electronic Prescribing of Controlled Substances
- Maryland – 01-01-2021
- Missouri – 01-01-2021
- North Carolina – 01-01-2021
- Washington – 01-01-2021
- Updated PBM Rules
- California – AB 1803
- Connecticut – HB 7363
- Delaware – HB 194
- Oregon – HB 2185
- Rhode Island – HB 2185 and SB 581
Get Involved/Get Informed Spotlight
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
Overview of USP 800 Handling of Hazardous Drugs – Handling in Healthcare Settings
Modified on June 1, 2019 with effective date of December 1, 2019: USP General Chapter <800> Some states still reviewing and are considering delayed enforcement.
2019 Legislative Season
A general overview of what occurred during the 2019 Legislative Season
The Prescription Drug Pricing Reduction Act of 2019 (NEW)
- Senate Finance Committee will markup the legislation on Thursday, July 25th
- Contact your Senator/Senate Finance
- Your Senators
- Chuck Grassley (Chairman)
- Ron Wyden (Ranking Member)
- NCPA Letter Link – https://www.ncpanet.org/advocacy/the-tools/grassroots-resources/action- center?vvsrc=%2fcampaigns%2f66933%2frespond
- NACDS Telephone Hotline – (866) DIR-RE4M
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.