Latest Publications


K&L Gates Triage: Opioid Epidemic: Update on Policy Issues in Washington, DC.

In the third episode of our series on the national opioid crisis, Amanda Makki and Corbin Santo provide an overview of how the Trump Administration and Congress may address the opioid epidemic this year....more

340B Update: Trump Administration’s 2019 Budget and White House Council of Economic Advisors Signal Further Changes to 340B...

On February 12, 2018, the Trump Administration released its fiscal year (“FY”) 2019 budget request to Congress outlining several proposals related to the 340B Drug Pricing Program (the “340B Program”) including a modification...more

Medicare Diabetes Prevention Program Enrollment is Now Open

As of January 1, 2018, the Centers for Medicare & Medicaid Services (“CMS”) began enrolling suppliers in its new Medicare Diabetes Prevention Program (“MDPP”). If successfully enrolled prior to April 1, 2018, MDPP suppliers...more

2/2/2018  /  CDC , CMMI , CMS , Health Care Providers , Medicare , MPFS

340B Update: Hospitals Appeal Ruling on OPPS Reimbursement Cut; House Committee Issues Report Recommending Changes to 340B Program

The beginning of 2018 has brought significant developments relating to the federal 340B Drug Pricing Program (“340B Program”). On January 1, reimbursement under the Medicare Part B hospital Outpatient Prospective Payment...more

President’s Opioid Commission Issues Final Recommendations: Implications for Health Care Stakeholders

In late October, President Trump declared the nation’s opioid addiction crisis a public health emergency. Less than a week later, the President’s Commission on Combating Drug Addiction and the Opioid Crisis (the “Commission”)...more

K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC [Audio]

In this episode of Triage, Amanda Makki and Corbin Santo of the K&L Gates Public Policy and Law practice group discuss several fundamental issues that are currently at the center of the health care debate in Washington, DC....more

Trump Administration Seeks Stakeholder Input on New Direction

On September 20, 2017, the Centers for Medicare and Medicaid Services (“CMS”) released an informal request for information (“RFI”) seeking stakeholder feedback on the future direction of the Center for Medicare and Medicaid...more

FDA Seeks Stakeholder Input on Regulatory Reform Efforts

On September 8, 2017, the Food and Drug Administration (“FDA”) became the latest in a line of federal departments and agencies to seek public input on approaches to modify regulations and reduce the burden on stakeholders....more

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