The cost of insulin has been kept artificially high for millions of Americans because drug manufacturers and middlemen work together to maximize their profits, a new bipartisan investigation shows.
This maneuvering around the growing price tag for medicine needed by diabetics to combat America s No. 7 killer represents a microcosm of the reasons prescription drugs cost so much in the U.S.
It also demonstrates one of the consequences of growing consolidation within American health care, a trend The Dispatch is investigating.
“Insulin is Exhibit A of why America’s drug pricing system is broken from top to bottom, said U.S. Sen. Ron Wyden in a statement to The Dispatch/USA TODAY Network. Our bipartisan report reveals how large corporations benefit from high prices while consumers and taxpayers foot the bill.”
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This week in Washington: President Joe Biden begins his term and Congress begins work to confirm cabinet secretaries.
Congress
Administration
HHS Delays Trump Administration Final Rule on Health Clinics’ 340B Drug Discounts
CMS Releases an Informational Bulletin on the Extension of Grace Period Related to the Four Walls Requirement for IHS/Tribal Facilities
CMS: Part D Senior Savings Model – CY 2022 Pharmaceutical Manufacturer RFA Released
CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1
Proposed Rules
Final Rules/Guidance
HHS: Final Rule Sets Term Limits for Agency Policy Directors
Rebate Rule Implementation Date Would Bring Chaos to Medicare Part D Program January 26, 2021 (Washington, D.C.) The Pharmaceutical Care Management Association (PCMA) has filed a motion for summary judgment to vacate the effective date of the Trump Administration’s rebate rule. The motion for summary judgment, filed in the U.S. District Court for the District of Columbia, seeks to vacate the January 1, 2022 effective date for the rebate rule with respect to Part D. The motion is vitally important to ensuring the stability of the Medicare Part D program as the Biden Administration reviews the Trump Administration’s “midnight regulations” and PCMA proceeds with litigation to revoke the rule in its entirety.
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On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to the federal Anti-Kickback Statute (“AKS”) for certain pharmaceutical rebates and creates two new safe harbors governing certain pharmaceutical manufacturer price reductions at the point of sale (“POS”) and certain pharmacy benefit manager (“PBM”) service fees.[1] While the new safe harbors become effective January 29, 2021, the removal of the discount safe harbor has a delayed effective date of January 1, 2022.[2] The Final Rule, if fully implemented, will have a significant impact on drug supply chain stakeholders operating under Medicare Part D, including health plans, PBMs, pharmaceutical manufacturers, drug wholesalers, and pharmacies.