Rx Drugs

FDA is requiring changes to the prescribing information for all opioid analgesic medicines used in the outpatient setting to provide more information about how health care providers can safely decrease the dose in patients who are physically dependent on opioids, the agency announced Tuesday (April 9).

Lawmakers in Maryland passed a scaled-back bill late Monday (April 8) that would create a board to review the affordability of prescription drugs, and potentially set ceilings for government payment of certain high-cost drugs.

American Hospital Association Executive Vice President Tom Nickels urged 340B hospitals on Monday (April 8) to join the group’s voluntary 340B reporting initiative -- which more than 900 hospitals have already done -- as he said hospitals face a choice between voluntary reporting or legislation and regulation.

Congressional Medicare advisers on Friday (April 5) mulled a proposal to fundamentally restructure the Medicare Part D coverage gap and catastrophic phase to prepare the system for an impending influx of high-cost specialty drugs.

HHS’ proposed overhaul of drug rebates is expected to lead to higher Medicare Part D premiums, but CMS is helping insurers keep premiums artificially low by letting them choose to have taxpayers cover the cost of setting premiums too low for the first two years, sources say.

After his tenure ends Friday, FDA Commissioner Scott Gottlieb will return to the conservative American Enterprise Institute, a group that has been a favorite resource on drug-pricing issues for Republicans.

The overhaul of the Medicare and Medicaid drug rebate systems would be handled as a voluntary two-year pilot starting in 2020, according to CMS guidance.

The House Ways & Means Committee is expected to hold a hearing next week on four bipartisan bills aimed at lowering prices after the House Energy & Commerce Committee this week passed six separate bipartisan bills aimed at speeding generic drug competition.

The White House budget staff are reviewing CMS’ final rule to lower Part D drug costs, which might include eliminating coverage protections in six drug classes, according to the Office of Management and Budget website.