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Search Results: agency_names:"Office of Inspector General"

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2021-02132 — 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
February 02, 2021
Type:Rule
Citation:86 FR 7815
Reading Time:about 4 minutes
The U.S. Department of Health and Human Services' Office of Inspector General announced a temporary delay in the effective date of certain amendments to a rule about safe harbor protections for prescription drug rebates. This decision is in line with the "Regulatory Freeze Pending Review" memo from January 20, 2021, and is due to ongoing litigation challenging the rule. The effective date for these amendments, initially set for January 29, 2021, is postponed to March 22, 2021, to allow time for further review and consideration. Additionally, a correction was made to a technical error in the published amendatory instructions.
Simple Explanation
The government decided to hit the pause button on some new rules about how pharmacies and companies get special discounts on medicine because people are arguing about it in court, and they also found a tiny mistake they had to fix. They're hoping this short break will help everyone figure things out better.
2021-03167 — 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; Delayed Effective Date
February 19, 2021
Type:Rule
Citation:86 FR 10181
Reading Time:about 3 minutes
The Office of Inspector General under the Health and Human Services Department announced a delay in the effective date of certain changes to the regulations that protect against kickbacks in the pharmaceutical industry. These changes, initially set to take effect on January 1, 2022, involve the removal of safe harbor protection for certain rebates on prescription drugs, and the creation of new protections for reductions in prices at the point of sale and for fixed fees paid to pharmacy benefit managers. The new effective date for these amendments is now January 1, 2023, following a court order. This action was taken without public comment due to a court-ordered mandate.
Simple Explanation
The government is changing some rules about how money is handled with medicine rebates, but a judge said they need to wait a little longer before starting. Now, the new plan will start in 2023 instead of 2022.

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