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340B Drug Pricing Program Compliance
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Drug Pricing Initiatives During the Trump Presidency
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The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit...more
On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more
On Monday, March 9, 2020, the Centers for Medicare and Medicaid (CMS) released information on permissible flexibilities and obligations that are in effect during a disaster and emergency resulting from COVID-19....more
Concluding one of the longest merger reviews in history, on September 4, Judge Richard Leon, District Judge for the District of Columbia, issued his final ruling in United States v. CVS Health, approving the proposed...more
On June 4 – 5, 2019, Judge Richard J. Leon of the U.S. District Court for the District of Columbia held an extraordinary and unprecedented evidentiary hearing to decide whether to enter the proposed Final Judgment in U.S. v....more
Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts - As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a...more
Medicare Advantage and Part D Preclusion List - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more
On October 26, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released for viewing a proposed rule that includes significant changes for Medicare Advantage organizations (“MAOs”), Part D prescription drug plan...more
On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D). ...more
CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more
With the release of its 2017 draft call letter, CMS continues its push to curb opioid dependence, overdose and death among Medicare Part D enrollees. To that end, CMS proposes that Part D plan sponsors edit their benefit...more
Medicare Part D’s Medication Therapy Management (MTM) program intends to optimize clinical benefits and avoid drug-related problems among eligible beneficiaries. MTM services—involving pharmaceutical and clinical...more
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more
If you are a dentist who writes prescriptions to Medicare beneficiaries for drugs covered under Medicare Part D, this article contains important information for you and your patients regarding your new enrollment requirements...more
The Centers for Medicare & Medicaid Services (CMS) on May 6, 2015, published an interim final rule with comment period (Interim Rule) modifying the regulatory requirement that health care professionals enroll in or opt out of...more
Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more
The Advance Notice ("Advance Notice") of Methodological Changes for Calendar Year ("CY") 2015 for Medicare Advantage ("MA") Capitation Rates, Part C and Part D Payment Policies and 2015 Call Letter was released by the Centers...more