Source: https://www.arnoldporter.com/en/perspectives/publications/2019/02/hhs-oigs-proposed-rule
Timestamp: 2019-04-22 14:27:52+00:00

Document:
Proposed Rule, Department of Health and Human Services Office of Inspector General, 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.
Sixty days after February 6 is Sunday, April 7; therefore, we presume that comments will be due on Monday, April 8, 2019.
Proposed Rule, at 4, n. 1.
Proposed Rule, at 19, n.36.
Proposed Rule, at 118–19 (stating proposed 42 C.F.R § 1001.952(h)(5)(viii)). See also Proposed Rule, at 38 (preamble discussion of proposal to narrow discount safe harbor protection). Note that HHS does not propose to delete or amend the discount safe harbor provision that protects certain discounts to Medicaid MCOs under Social Security Act § 1903(m)(42 C.F.R. § 952.1001(h)(2)(i)), but does not discuss this issue.
Proposed Rule, at 40. Rebates under the Medicaid Drug Rebate Program are paid to state Medicaid programs (not Part D plans, Medicaid MCOs, or their PBMs), so it is unclear why they need to be excluded from proposed 42 C.F.R. § 1001.952(h)(5)(viii).
Proposed 42 C.F.R. § 1001.952(h)(8).
Proposed Rule, at 44–49, 119–21.
42 C.F.R. § 1001.952(h)(4) (emphasis added).
Proposed Rule, at 47. The apparent requirement that the total payment to the pharmacy (i.e., the beneficiary cost-sharing, plan payment, plus manufacturer chargeback) equals a price agreed on by the manufacturer and the Part D plan sponsor/Medicaid MCO (or its PBM) is puzzling as it does not require that the total payment to the pharmacy make the pharmacy whole. Later in the Proposed Rule on page 48, HHS refers to "the use of chargebacks to make pharmacies whole for the difference between acquisition cost, plan payment, and beneficiary out-of-pocket payment," which suggests that the chargeback would equal the pharmacy's acquisition cost minus the plan payment minus the beneficiary out-of-pocket payment.
Proposed Rule, at 49–56, 121–22.

References: § 1001
 § 1903
 § 952
 § 1001
 § 1001
 § 1001