On Sunday, August 7th, the U.S. Senate passed the Inflation Reduction Act (IRA of 2022) – budget reconciliation legislation), marking success for the Democrats’ long-held objective to enable government to negotiate drug prices since enactment of the Medicare Modernization Act in 2003. In addition, the IRA would provide a $35 out-of-pocket (OOP)/month cap for Medicare patients for insulin, a three-year extension of the temporary enhanced ACA premiums, and a cap on Medicare Part D beneficiary annual Part D OOP costs at $2,000. This legislation passed with the support of all 50 Senate Democrats and Independents plus Vice President Harris placing the tie-breaking vote, and all 50 Republicans voting no.

Late last week, Senate Majority Leader Chuck Schumer (D-NY) and Senator Joe Manchin (D-WV) announced they reached an agreement on an expanded Build Back Better/reconciliation bill. See Inflation Reduction Act of 2022 – Text and Summaries. While the situation remains fluid, now is a good time to explain key points and timing of this major development/breakthrough.

Last week, after months of advocacy from AmerisourceBergen/Good Neighbor Pharmacy and pharmacy organizations such as NCPA, APhA and NACDS, the FDA revised the EUA for Paxlovid, authorizing state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations the FDA believes are necessary to ensure appropriate patient assessment and prescribing.

On May 24th, U.S. Senators Maria Cantwell (D-WA), Chair of the Senate Committee on Commerce, Science, and Transportation, and Chuck Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, introduced the Pharmacy Benefit Manager Transparency Act of 2022, which would empower the Federal Trade Commission (FTC) to increase drug pricing transparency and hold PBMs in both commercial and government sponsored/funded plans accountable for “unfair and deceptive practices that drive up the costs of prescription drugs at the expense of consumers.”

On May 5, the U.S. Senate Commerce, Science and Transportation Committee’s Subcommittee on Consumer Protection, Product Safety, and Data Security held a hearing titled, “Ensuring Fairness and Transparency in the Market for Prescription Drugs,” which “examine[d] steps Congress can take to increase transparency in drug prices, require PBMs to operate fairly, and ensure the FTC has the authority it needs to stop unfair practices in the prescription drug market.”

Late last Friday (April 29), CMS issued its Final Medicare Advantage and Part D rule, which includes changes to Part D plan contracting with pharmacies – though Part D contracts will not reflect the changes until CY 2024.

On February 23, 2022, Governor Gretchen Whitmer (D-MI) signed House Bill (HB) 4348 into law. This important legislation establishes much needed protections for community and independent pharmacists, as well as specialty physicians practicing in Michigan.

Early success in Texas: collaborating with TX community pharmacists & physicians to protect independent pharmacists, specialty community physicians, and patients

On March 25th the Senate passed legislation extending the Medicare Part B sequestration moratorium through the remainder of 2021. This timely policy victory, if approved by the House in early April, will prevent the 2% reimbursement cuts that would have otherwise gone back into effect April 1, 2021, helping providers remain viable throughout the pandemic.

The embattled interim final rule looms over the new year.