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.
On Friday, July 13, 2018, the California Office of Statewide Health Planning and Development (OSHPD) posted proposed regulations implementing California’s drug price transparency law.
As the most recent state to address the issue of what to do with unused medications, on July 10, 2018, New York Governor Andrew Cuomo signed the Drug Take Back Act (the Act).
On June 28, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) dropped their lawsuit challenging the constitutionality of Nevada’s recent drug price transparency law.
On June 20, 2018, the Centers for Medicare & Medicaid Services issued a Request for Information seeking input from the public on how to address the undue regulatory impact and burden imposed on health care providers under the Stark Law.
The California Office of Statewide Health Planning and Development (OSHPD) has posted a preliminary working draft of the regulations implementing California’s prescription drug price transparency law.
Connecticut and Maine recently joined the increasing number of states to enact drug price transparency laws. Maine’s drug price transparency law (the Maine Law) became effective on May 1, 2018.
Following delays and much build up, the White House and the Department of Health and Human Services (HHS) have released their plan to address rising pharmaceutical prices and out-of-pocket costs directly impacting patients.
