The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more
The Biden administration gave its stamp of approval last week to Colorado’s novel waiver under Section 1332 of the Affordable Care Act (ACA) to require premium reductions in a public option program, a first-of-its-kind plan...more
On November 1, 2020, CMS and the Department of the Treasury approved Georgia’s request for a 1332 State Relief and Empowerment waiver (1332 waiver), permitting the state to implement a new healthcare plan to address growing...more
CMS approved Georgia’s Section 1115 demonstration project to partially expand Medicaid coverage for adults not otherwise eligible for Medicaid coverage with incomes up to 95 percent of the Federal Poverty Line (FPL)—short of...more
Today's post is the last in our series on the 10-year anniversary of the Affordable Care Act (ACA). While the Congress that passed the ACA recognized that health care delivery reform was necessary, the law included few...more
Examine the Evolving Challenges That Lie Ahead for Healthcare Stakeholders and State Regulators—and What You Can Do Now to Prepare and Protect Your Organization—at a New Manatt Webinar. Effective health insurance...more
On March 22, 2020, CMS announced a suite of four new tools intended to help states combat the coronavirus by allowing states to streamline enrollment into long-term care and home-based services and by expediting application...more
High-deductible health plans may now cover testing and treatment for 2019 novel coronavirus (COVID-19) on a first-dollar basis without risking making participants ineligible to participate in health savings accounts (HSAs)....more
On December 12, 2019, CMS approved South Carolina’s proposal for a demonstration project that would add work, or community engagement, requirements as part of the eligibility determinations for the state’s Medicaid plan. ...more
On November 4, Georgia released two draft waiver applications for public comment—a Section 1332 State Relief and Empowerment Waiver (“1332 waiver”) to restructure the state’s individual insurance market and a Section 1115...more
On November 4, 2019, Georgia officials announced a proposed Section 1115 demonstration waiver, referred to as the “Georgia Pathways Health Waiver,” to expand Georgia’s Medicaid program eligibility for non-disabled adults. If...more
On July 15, 2019, CMS released new resources, which are available here, that are intended to support states as they apply for waivers under Section 1332 of the Affordable Care Act. These materials follow guidance issued by...more
Editor’s Note: While Democratic victories in the U.S. House have fueled national conversations about some variant of Medicare for all, most of the policy change in the near term is likely to continue to be at the state level....more
Health care issues will remain a central focus in Washington throughout 2019. Having gained control of the House following the 2018 mid-term elections, Democrats now have the ability to block President Trump's legislative...more
Massachusetts Waiver Amendment Requests Partial Expansion and Closed Formulary - On September 8, 2017, Massachusetts submitted a waiver amendment request to the Centers for Medicare & Medicaid Services (CMS) to modify its...more
This week, the debate over the Affordable Care Act (ACA) gained new momentum in two separate, but connected channels. As the fiscal year (FY) budget reconciliation window enabling expedited passage of an ACA repeal draws to a...more
Next Steps on Healthcare Reform - Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...more
Below is a summary of recent U.S. Senate action on healthcare legislation and our outlook regarding coming issues and possible actions. Holland & Knight's Healthcare & Life Sciences Team will follow up as developments...more
After weeks of secrecy, the Senate has released a discussion draft of legislation that is the counterpart of the American Health Care Act (AHCA) previously passed by the House. The Senate legislation, entitled the Better Care...more
On June 22, 2017, Senate Republicans released a draft of the Better Care Reconciliation Act (BCRA), their much-anticipated version of the legislation to "repeal and replace" the Affordable Care Act (ACA). Despite rumors of a...more
On May 4, 2017, the U.S. House of Representatives approved the American Health Care Act (AHCA) by a vote of 217 to 213 (with 20 Republicans voting against the bill), sending the AHCA to the Senate. As we have reported in...more
On May 4, 2017, the House passed by a 217-213 vote, the measure referred to as the American Health Care Act (“Trumpcare”), which is intended to repeal and replace the Patient Protection and Affordable Care Act (“Obamacare”)....more
The House of Representatives took the first affirmative step towards repeal and replacement of the Affordable Care Act (ACA) today. After a failed attempt to pass legislation earlier this year, the House gathered the needed...more
Today, the House of Representatives passed the American Health Care Act (the “AHCA”). The AHCA was previously introduced in March but supporters failed to muster sufficient support to bring the legislation to a vote....more
On April 19, 2017, Wisconsin released for public comment a proposed amendment to its BadgerCare Reform Section 1115 demonstration. BadgerCare Reform currently provides coverage to approximately 150,000 childless adults ages...more