# Plain Language Summary: Reduced Costs and Continued Cures Act of 2021

This bill is designed to lower prescription drug prices for people on Medicare and Medicaid by giving the government more power to negotiate drug prices and by increasing transparency about how much drugs actually cost. The main idea is that drug manufacturers have been charging very high prices, and this bill tries to bring those prices down, especially for older drugs that have been on the market for a while and no longer have patent protection.

The bill creates a system where the government can negotiate directly with drug manufacturers on prices for certain older drugs used in Medicare Part B (drugs given in doctors' offices and hospitals) and Part D (prescription drug plans). For drugs that have lost their patent protection and exclusivity periods, the government and manufacturers would negotiate a price that falls between 65 and 75 percent of what the drug currently costs. This could mean significant savings for Medicare, which would translate to lower costs for beneficiaries. The bill also addresses a common tactic where manufacturers offer coupons to patients to reduce their out-of-pocket costs—these coupon values would now be counted as part of the drug's official price, which could actually lower what Medicare pays overall.

For people with Medicare Part D coverage, the bill makes several changes to help with affordability. It caps how much insulin costs monthly, limits how much patients have to pay out-of-pocket before insurance kicks in more fully, and requires pharmacy benefit managers (the middlemen who manage drug plans) to be more transparent about discounts and rebates they receive. The bill also cracks down on practices like "pay-for-delay" agreements, where brand-name drug makers pay generic manufacturers to stay off the market longer, and "product hopping," where companies make minor changes to drugs to extend their patents and block cheaper alternatives.

For Medicaid (which covers lower-income people), the bill strengthens the existing rebate program that requires manufacturers to give the program discounts, and it improves oversight of the committees that decide which drugs Medicaid will cover. The bill also includes provisions to increase competition in the drug market by limiting how companies can use patents to block generic and biosimilar drugs from entering the market. Overall, the bill aims to save money for both government programs and individual patients while encouraging more competition and innovation in the pharmaceutical industry.

Reduced Costs and Continued Cures Act of 2021

Peters, Scott H.

Reduced Costs and Continued Cures Act of 2021 This bill establishes and alters several programs and requirements relating to the prices of prescription drugs. For example, the bill establishes and alters several requirements under Medicare and Medicaid, including <ul> <li>requiring drug manufacturers to issue rebates to the Centers for Medicare &amp; Medicaid Services for covered drugs under Medicare that cost $100 or more and for which the average manufacturer price increases faster than inflation,</li> <li>capping annual out-of-pocket spending under the Medicare prescription drug benefit, and</li> <li>increasing the maximum rebate amount under the Medicaid Drug Rebate Program.</li> </ul> The bill also makes changes relating to market exclusivities and manufacturer price concessions for prescription drugs, including <ul> <li>authorizing the Federal Trade Commission to initiate proceedings against parties to settlements of patent infringement claims that have anticompetitive effects with respect to drugs or biologics,</li> <li>limiting in certain instances the number of patents that the manufacturer of a biologic can assert in a lawsuit against a company seeking to sell a biosimilar version, and</li> <li>nullifying regulations relating to the treatment of certain Medicare prescription drug benefit rebates from drug manufacturers for purposes of federal anti-kickback laws.</li> </ul>