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Regulatory Agenda HRSA

McDermott+

McDermott+ Check-Up: September 13, 2024

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House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Polsinelli

Congress Takes Steps to Prioritize Youth Mental Health

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Recognizing the urgent need to increase access to mental health and substance use services for young people, Congress is taking significant legislative steps to strengthen the federal government’s response to the nationwide...more

Stevens & Lee

Bipartisan Mental Health Legislation Awaits House Vote

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Annual overdose deaths in the U.S. reached an all-time high of 100,000 last year and overdose remains the second-leading cause of death for people between the ages of 10 and 14. In an attempt to address the rising number of...more

Manatt, Phelps & Phillips, LLP

340B Roundup: Trump-Era Rule Rescinded, Motion to Dismiss Denied & HRSA Advisory Opinion Withdrawn

The last two weeks of June saw several key developments affecting the 340B Drug Pricing Program—a federal government program created in 1992 that requires pharmaceutical manufacturers to provide outpatient drugs to eligible...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Drug Pricing Executive Orders: How Will They Impact Pharma and Providers?

Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

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Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

Foley & Lardner LLP

Health Care Policy Happenings - September 2018

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Congress is back in session after the August recess and, as expected, a flurry of activity took place. Here are some key health care policy headlines from the past week that you may have missed....more

Foley & Lardner LLP

Medicare’s New Virtual Care Codes: A Monumental Change and Validation of Asynchronous Telemedicine

Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services just issued a proposed rule introducing monumental changes to the physician fee schedule, paving the way for asynchronous telemedicine and new technologies through a new set of...more

Polsinelli

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

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The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

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