The U.S. Food and Drug Administration (FDA) issued a guidance document today outlining its procedures for conducting clinical trials of investigational products in view of the worldwide COVID-19 outbreak.
As the spread of COVID-19 accelerates across the United States, hospitals, health systems, and other providers face unique challenges. Arent Fox’s Health Care Group analyzes what you need to know about regulatory changes and guidance from the federal government.
The Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for insulin.
The First Circuit handed the generic pharmaceutical industry an early Valentine’s Day treat earlier this month by resuscitating an antitrust suit against Sanofi by direct purchasers of insulin glargine.
CMS issued an Interim Final Rule with comment period that further delays the inclusion of the US territories in the definitions of “States” and “United States” for purposes of the Medicaid Drug Rebate Program from April 1, 2020 until April 1, 2022.
Late Friday, September 27, 2019, President Trump signed the Fair and Accurate Medicaid Pricing Act into law as part of the Continuing Appropriations Act.
WASHINGTON — Arent Fox LLP is pleased to announce that Health Care Co-Leader Stephanie Trunk has once again been selected to the LMG Life Sciences Award List in the “Healthcare Pricing & Reimbursement” category.
FDA issued a Compliance Policy delaying enforcement of the DSCSA’s saleable returns verification requirement by one year. So now, instead of wholesale distributors having to comply by November 27, 2019, FDA will exercise enforcement discretion until November 27, 2020.
In a Notice of Intent FDA reminded pharmaceutical manufacturers that if their drugs were not appropriately updated, certified or associated with a registered establishment, they will be marked “inactive” by FDA and the date of inactivation added to the listing record.
The Medicaid Services Investment and Accountability Act of 2019 (the Act) became law on April 18, 2019. Of most relevance to pharmaceutical manufacturers are the provisions amending the Medicaid statute concerning the Medicaid Drug Rebate Program (MDRP).
On March 28, 2019 CMS issued the Final Rule and Interim Final Rule with Comment Period: Medicaid Program; Covered Outpatient Drug; Finalization of Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs.
On February 19, 2019, the Supreme Court of the United States denied a request from Maryland’s Attorney General to review the decision of the Fourth Circuit Court of Appeals, which held the state’s drug price gouging law to be unconstitutional.
The end of 2018 saw good news for hospitals affected by the lowered Medicare Part B reimbursement rates for certain outpatient drugs that went into effect January 1, 2018.
On November 30, HRSA announced that it is “notifying all stakeholders that the secure pricing component of the 340B Office of Pharmacy Affairs Information System (340B OPAIS) will be open for the submission of manufacturer pricing data in the first quarter of 2019.”
WASHINGTON — Arent Fox LLP is pleased to announce that Health Care Co-Leader Stephanie Trunk has been selected to the LMG Life Sciences Award List in the “Healthcare Pricing & Reimbursement” category.
On September 11, 2018, hospital advocacy groups and three individual hospitals filed a complaint in the United States District Court for the District of Columbia.
The Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019 Proposed Rule (the Proposed Rule) is scheduled to be published in the Federal Register on July 27, 2018.
