Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more
On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more
The Inflation Reduction Act of 2022 (IRA) establishes the Medicare Drug Price Negotiation Program (“Negotiation Program”), which permits the government to negotiate drug prices for certain high expenditure, single source...more
On 3 March 2020, the Spanish Council of Ministers, based on Article 3(3) of the Spanish Regulation on Medicinal Products (RDL 1/2015), agreed on a new economic regime for orphan medicinal products. ...more
The 340B Drug Pricing Program has been a hot topic in Congress lately. It seems like new legislation and/or Congressional hearings related to the 340B Program pop up almost daily. ...more
On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more
SHUTDOWN SHOWDOWN: CHIP, OTHER HEALTH PROVISIONS AT RISK AS DEADLINE NEARS - Renewal of the Children’s Health Insurance Program and a host of other healthcare provisions hang in the balance as congressional Republicans...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more
A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more
Big Pharma’s skyrocketing prices are finally in for some real scrutiny by the U.S. Government Accountability Office (GAO), as well as new initiatives in the Maryland and New York statehouses....more
Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more
Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more
On October 14, 2015, the United States District Court for the District of Columbia struck down an interpretive rule from HHS that limited the prices pharmaceutical manufacturers could charge for orphan drugs sold to certain...more
On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more
On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more
The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more