K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more
Welcome to the seventh issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. Iowa Governor Kim Reynolds signed Senate File 383 into law, placing new restrictions on pharmacy benefit...more
On May 22, 2025, after a marathon markup session, the U.S. House of Representatives passed a bill containing significant proposed changes to the Medicaid program....more
As discussed in last week’s Regs & Eggs blog post, the US Department of Health and Human Services (HHS) recently released additional budget documents to support the department’s fiscal year (FY) 2026 discretionary request....more
U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more
Following a year of significant regulatory changes and market realignments, the health care landscape in North and South Carolina continues to undergo significant transformation driven by federal policy shifts, state...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Earlier this week, Congress released the text of a continuing resolution that includes a more-robust-than-anticipated healthcare package. While the bill’s primary purpose is to keep the government open through March 14, 2025,...more
As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more
The comment period for the CMS CY 2025 Physician Fee Schedule (PFS) Proposed Rule recently closed on Monday, September 9th. Based on previous years, the Final Rule can be expected as soon as early November, taking effect...more
Employers must check its employees, contractors and vendors to see if an individual or organization is excluded from participating in federal and/or state programs. While there are a variety of exclusion programs at the...more
The New Jersey Department of Banking and Insurance (DOBI) issued Bulletin 24-05 on May 14, 2024 updating Bulletin 24-03 to expand the unwinding special enrollment period and clarify the guaranteed issue period for Medicare...more
House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
As part of its ongoing mission to modernize and improve the interoperability of the health care system, on January 17, 2024, the Centers for Medicare & Medicaid Services (CMS) finalized the CMS Interoperability and Prior...more
The Centers for Medicare & Medicaid Services (CMS) issued the CMS Interoperability and Prior Authorization Final Rule (Final Rule) on Jan. 17, 2024. The agency proposed the rule in December 2022 (See Holland & Knight's...more
Last week CMS issued its final rule “CMS Interoperability and Prior Authorization” (CMS-0057-F), unchanged from its proposed rule in 2022, which addresses prior authorizations. Prior authorization, a “utilization management”...more
On December 6, the Biden administration released its Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions. A unified agenda is issued in the spring and fall each year; it outlines federal agencies' areas of focus...more
NEXT UP: SPEAKER MIKE JOHNSON - The House officially has a speaker: Mike Johnson (R-LA). On October 25, Rep. Johnson became Speaker Johnson with a final vote on the first ballot of 220–209. Speaker Johnson, a...more
August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more
The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more