Pharmacy Industry Updates: April 2019
View the video recap below:
- California – Require Serial Number to be reported
- Emergency Legislation signed which delays enforcement of the Serial Number requirements to at least 07-01-2019 and no later than 01-01-2020.
- Allows dispensing of prescriptions on old pads until 01-01-2021
- DOJ/BOP are still discussing the format of the serial number and barcode.
- It does not address the PDMP reporting aspect.
- Ohio — report Naltrexone Products to OARRS Effective 03-19-2019 (Notice on 01-16-19)
- Florida – ASAP V4.2 Accepted now, but required as of 12-19-2019
Potential PDMP Changes
- Utah — Finalized rule not yet published in the Utah Bulletin. Waiting on final details.
- Nebraska – Pending legislation to require ASAP V4.2A and add additional fields in Q3 of 2019. Including Gender, ID, Sold date. SIG requirement will likely be removed.
- 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
- Montana – Updated rules on checking PDMP data prior to prescribing or dispensing 10-01-2019
The following states have recently announced state-wide funding for Appriss Health’s PMP Gateway and/or NarxCare solutions:
- Alabama: Funding NarxCare
- Louisiana: Funding NarxCare
- Nevada: Funding NarxCare
- Washington D.C.: Funding Gateway
Legislative/Regulatory Reminders for March/April 2019
- Medicare Part D – Precluded Provider Implementation on 04-01-2019
- The affected providers (pharmacies and prescribers) should have been notified by CMS and should not be on the list until all appeals to this process were exhausted.
- The CMS Precluded Provider list is not publicly available.
- Any affected beneficiaries should have gotten at least a 60 day notice.
- This is NOT something that can be overridden during adjudication.
- Expect Reject Code 929- ID Submitted is associated with a precluded prescriber.
- Alabama – Updates regulations for:
- Supervising pharmacists
- Failing to complete Continuing Education
- Idaho – Myriad of Rules in April if Legislature Approves — See March BOP Newsletter for summary.
- Texas – Updated rules related to licensing and pharmacy practice
- Wyoming – Prohibit Gag Orders
New Legislative/Regulatory Highlights
- Arkansas – Require electronic prescribing on Schedule II through VI as of 01-01-2021
- Arizona – Delayed EPCS for Schedule II Opioids until 01-01-2020, with some exceptions.
- Nebraska – Requires coverage for filling prescriptions to synchronize the patient’s medications with prorated copays and full dispensing fees.
- South Dakota – Prohibit gag orders
- Virginia – Gabapentin has moved from a drug of concern to Schedule V (Immediate)
- Wyoming – Require EPCS as of 01-01-2021
Get Involved/Get Informed Spotlight
Monthly Opioid Updates
- New York Tax on Opioids — Link to NACDS position
- NCPDP Free Informational Webinar April 4, 2019 at Noon ET
- DEA Notice again warning of potential phone scams demanding money for penalties/violations.
PBM’s and Medicaid Updates
- Washington Medicaid and below cost dispensing fees
- NACDS and NAPB filed briefs requesting immediate action including retroactive payment back to April 1, 2017.
- More states taking on PBMS and spread pricing for Medicaid Managed Care
- Kentucky, Montana, New Jersey, New York, Ohio, South Dakota, Tennessee, Texas, West Virginia
Rules, Rules, and more Rules
- Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard
- This is to allow the Quantity Prescribed field to be submitted on a controlled substance claim
- Limited to Schedule II claims only.
- Comments due: April 1, 2019
- 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 (CMS)
- Requires that for Medicare Part D rebate to be considered for safe harbor, the rebate must demonstrate that it affects patient out of pocket and doesn’t affect pharmacy reimbursement.
- Complicated rule which needs clarification on what “transparency means”
- Impact to financials could include
- Process of claim response
- Processing for business analysis (e.g. Data warehouse)
- Processing of reimbursements (e.g. ACS X12 835 Remittance)
- Comments due: April 8, 2019
- Medicare and Medicaid Programs: Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers
- Requests feedback on Universal Patient Identifier
- Information Blocking / Access to data via API’s
- Privacy / HIPAA Concerns
- Comments Due: May 3, 2019
- ONC: 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
- Affects IT developers of ONC certified technology with an expansive definition of “Providers”
- Affects EHI – Electronic Protected Health Information
- Comments Due: May 3, 2019
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.