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 September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more
The Centers for Medicare & Medicaid Services (CMS) used its emergency waiver authority to relax many aspects of health care delivery during the federal Public Health Emergency for COVID-19 (PHE) to allow health care...more
In a new webinar, Manatt Health, the American Medical Association (AMA) and a panel of stakeholders will share key lessons for states seeking to innovate and expand access to evidence-based care for pregnant people with a...more
The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...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
Editor’s Note: In a new expert perspective prepared for the Robert Wood Johnson Foundation’s State Health and Value Strategies program, reproduced below, Manatt Health outlines the time-limited targeted enrollment...more
Texas Makes Significant Strides to Expand Telehealth - On April 14, 2021, the Texas House passed House Bill 4 (the “Bill” or “HB4”), a telehealth bill seeking to make permanent the temporary waivers issued during the public...more
Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...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
The Program will guide disbursement of $200 million to health care providers for connected care services. Health care providers interested in receiving funds must complete a three-step process that requires advance planning....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 Monday, the Chairman of the Federal Communications Commission (FCC), Ajit Pai, circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a...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
On March 17, the New York State Department of Financial Services (DFS) announced the issuance of a new emergency regulation requiring insurance companies in the state to waive cost-sharing, including deductibles, copayments,...more
With the emergency declaration under the National Emergencies Act related to the coronavirus (COVID-19) on March 13, 2020, President Trump paved the way for CMS to temporarily waive certain Medicare, Medicaid, and Children's...more
On March 2, New York Gov. Andrew Cuomo announced new regulations on New York health insurers regarding coverage for coronavirus testing and related matters. The State Department of Financial Services (DFS) directive requires...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
On January 23, 2019, Massachusetts Governor Charlie Baker revealed his fiscal year 2020 budget for the Commonwealth of $42.7 billion. While the budget contains a number of new initiatives, one new initiative is particularly...more
Although all signs this morning pointed to a quiet day under the Gold Dome, the halls quickly became abuzz with news of a compromise on HB 159, the adoption bill authored by Rep. Bert Reeves (R-Marietta). The masses got their...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
The State of Wisconsin recently proposed a Medicaid waiver that includes a number of precedent-setting features, including a 48-month time limit on enrollment (with the limit paused for periods of employment or job training),...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