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[Official Guidance]

Text of Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen

"The Secretary of [HHS] shall complete the rulemaking process he commenced seeking to: [1] exclude from safe harbor protections under the anti-kickback statute ... certain retrospective reductions in price that are not applied at the point-of-sale or other remuneration that drug manufacturers provide to health plan sponsors, pharmacies, or PBMs in operating the Medicare Part D program; and [2] establish new safe harbors that would permit health plan sponsors, pharmacies, and PBMs to apply discounts at the patient's point-of-sale in order to lower the patient's out-of-pocket costs, and that would permit the use of certain bona fide PBM service fees.... Prior to taking [this] action ... the Secretary of [HHS] shall confirm -- and make public such confirmation -- that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients' total out-of-pocket costs."

The White House

[Official Guidance]

Text of Executive Order on Increasing Drug Importation to Lower Prices for American Patients

"The Secretary of [HHS] shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by: [1] facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients ... [2] authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care ... and [3] completing the rulemaking process ... to allow importation of certain prescription drugs from Canada."

The White House

[Official Guidance]

Text of Executive Order on Access to Affordable Life-Saving Medications

"To the extent permitted by law, the Secretary of [HHS] shall take action to ensure future grants available under section 330(e) of the Public Health Service Act ... are conditioned upon Federally Qualified Health Centers (FQHCs) having established practices to make insulin and injectable epinephrine available at the discounted price paid by the FQHC grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who: [1] have a high cost sharing requirement for either insulin or injectable epinephrine; [2] have a high unmet deductible; or [3] have no health care insurance."

The White House

President Trump Signs Executive Orders Aimed at Lowering Drug Prices

"The orders ... would move towards allowing states to develop plans to import cheaper drugs from Canada, eliminate a system of drug discounts known as rebates in a bid to simplify the system, and seek to make EpiPens and insulin more affordable for some patients of certain health providers. Trump also announced a fourth, more sweeping order, seeking to slash the price that Medicare pays for drugs to be in line with prices paid in other countries ... But in a surprise move, Trump said that order's implementation would be delayed until Aug. 25 to give pharmaceutical executives, who strongly oppose the idea, a chance to propose an alternative."

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David Rhett Baker, J.D., Editor and Publisher
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