South Dakota State Regulatory Update April 2019
ARSD 20:51:32, 20:51:33, 20:51:34, 20:67 changes were approved by the Board and by the Interim Legislative Research Council on November 20, 2018. Effective on December 20, 2018.
These rules provide clarification regarding prescription drug monitoring program (PDMP) reporting and wholesale and other drug distributors licensing.
ARSD 20:51:33 and 20:51:34 provide a mechanism for managing complaints and discipline for licensees or registrants.
House Bill 1137 was signed into law on March 7, 2019.
Section 1. Prevents pharmacy benefit manager (PBM) claw backs.
No pharmacy benefit manager shall contractually require a pharmacy to charge or collect from an insured a cost share for a prescription or pharmacy service that exceeds the amount retained by the pharmacist or pharmacy from all payment sources for the filling of the prescription or providing the pharmacy service.
Section 2 and 3. Preventing retroactive direct and indirect remuneration (DIR) fees
No pharmacy benefit manager shall retroactively adjust a claim for reimbursement submitted by a pharmacy for a prescription drug unless the adjustment is a result of either a pharmacy audit or technical billing error.
Section 4. Establishes 340B Drug Discount Program protections.
No pharmacy benefit manager may discriminate against a pharmacy participating in a health plan as an entity authorized to participate under section 340B of the Public Health Service Act, as amended to January 1, 2019, or any pharmacy under contract with such an entity to provide prescriptions.
What does this mean for pharmacists practicing in the state of South Dakota?
- Pharmacists must be familiar with reporting requirements to the state PDMP and ensure that they are practicing within the guidance of this regulation.
- Pharmacists must be aware of their rights regarding insurer billing for claims; clawbacks are not allowed, but PBMs can retroactively adjust a claim for reimbursement if it's a result of a pharmacy audit or technical billing error. Ensure that recordkeeping and billing procedures are accurate, and staff are properly trained in prescription billing activities.
- If a pharmacist or pharmacy participates in a 340B program, they should be familiar with the protections provided to them.
South Dakota State Regulatory Summary- 2018
The following laws, summarized below, were enacted by the South Dakota legislature during the 2018 session.
SB 32 - Places certain substances on the controlled substances schedule and to declare an emergency; effective immediately.
SB 62 - Provide for the notification related to a breach of certain data and to provide a penalty; effective immediately.
SB 63 - Revises certain prohibitions regarding methamphetamines and to create a mandatory penalty; effective immediately.
SB 75 - Establishes certain provisions regarding the dispensing of biological products; effective immediately.
- No pharmacy may dispense an equivalent drug product or an interchangeable biological product if a brand name has been prescribed without informing the patient of the selection and the right to refuse the product selected either by telephone or in writing.
- A practitioner may prohibit a pharmacist from selecting an equivalent drug product or interchangeable biological product by handwriting on the prescription drug order the words brand necessary, or words of similar meaning.
- A pharmacist dispensing a prescription drug order for a biological product prescribed by its brand or proper name may select an interchangeable biological product of the prescribed product.
- Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer.
- Any entry into an electronic records system is presumed to provide notice to the practitioner.
SB 141 - Establishes certain provisions regarding pharmacy benefits management; effective immediately.
The following acts or practices by a pharmacy benefits manager are declared to be false, misleading, deceptive, or unfair:
- Penalizing a pharmacist or pharmacy for providing cost-sharing information on the amount that a covered individual may pay for a prescription drug by a pharmacist or pharmacy.
What do these new regulations mean for pharmacists practicing within the state of South Dakota?
- Pharmacists should make themselves aware of the methamphetamine guidelines for dispensing; specifically, the maximum limits for methamphetamine precursors.
- Pharmacists should review the regulations around the security and accidental sharing of protected information, specifically that information collected as part of the routine pharmacy business.
- Ensure that all employees are protecting this information and that policies are in place to reflect these new requirements.
- Pharmacists may, using the board of pharmacy FDA list of interchangeable biological products and their professional judgment, may provide an alternate product to a patient upon their request to provide cost effective alternatives that assists the patient in adherence and therapy outcomes.
- The prescriber must allow for interchangeable products through the prescription (no DAW or non-substitution indicators), and the pharmacist must notify the prescribing physician of the change within five days of dispensing. This can be done electronically or other means.
- Pharmacists can play a larger role in patient adherence to their medication regimen through cost savings solutions, ensuring the most affordable therapy for their patients.
- Pharmacists can also positively affect adherence through 90-day dispensing conversions, allowing the patient to save time and money, and ensuring that they have needed medication on hand.
For full regulatory language, refer to the South Dakota Board of Pharmacy.
