Medical Device Legal News with Sam Bernstein: Episode 19
Midyear Premium Increases and Cafeteria Plan Rules
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Collaborating Before The PTAB
On the afternoon of July 4, President Trump signed into law H.R. 1, the One Big Beautiful Bill Act – comprehensive budget reconciliation legislation that represents the core of President’s second-term domestic agenda and...more
Employer-sponsored health plans would be required to cover over-the-counter contraception, including condoms and emergency contraception, without a prescription and without cost sharing under newly proposed Affordable Care...more
Back in June of 2019, the United States Preventive Services Task Force (“USPSTF”) released an A-rated recommendation for HIV Preexposure Prophylaxis (“PrEP”). As a result, the Affordable Care Act’s preventive care rules...more
On March 10, 2021, the U.S. House of Representatives narrowly passed H.R. 1319, the American Rescue Plan Act of 2021, on a largely partisan basis by a 220-211 vote. Final passage came four days after the U.S. Senate amended...more
On November 15, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the “Agencies”) issued a proposed "Transparency in Coverage" rule that would require most...more
Employer-sponsored health plans and health insurers may be required to post online - and to provide participants upon request - a range of pricing and cost-sharing information beginning in 2021. Proposed Affordable Care...more
Upcoming Hearings - Tuesday, March 26, 2019 - Senate Committee on Health, Education, Labor and Pensions (HELP): “Implementing the 21st Century Cures Act: Making Electronic Health Information Available to Patients and...more
President Trump's fiscal year 2020 (FY20) budget proposal for the Department of Health and Human Services (HHS) reflects the Trump Administration's priorities to repeal and replace the Affordable Care Act (ACA), implement...more
Congress kicks off this week with three weeks to go before the March 23 omnibus spending deadline. At this point it’s still not entirely clear what will be tacked on to this spending package, but immigration, market...more
Note: All fiscal estimates cited over a ten-year budget window refer to the Fiscal Year 2019-2028 budget window. The President's fiscal year 2019 (FY19) budget proposal for the Department of Health and Human Services (HHS)...more
Lawmakers return to Capitol Hill this week ahead of more self-imposed deadlines to resolve a series of thorny healthcare policies, including funding for the Department of Health and Human Services (HHS) and the rest of the...more
Of particular focus in the coming year will be Medicaid, the federal/state health care program for low-income Americans. The program, which cost the federal government $334 billion in FY15, is a frequent target of...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more
On October 23, the U.S. Department of Labor, the Department of Health and Human Services, and the Department of the Treasury (collectively, the “Departments”) jointly issued answers to frequently asked questions regarding the...more
Final ACO Fraud Waiver Under OMB Review – The White House Office of Management and Budget (OMB) reported on September 9, 2015, that it began its review of the final rule (CMS-1439-F; RIN 0938-AR30), titled “Medicare Shared...more
This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more
The Departments issued FAQs clarifying prior guidance on the ACA’s cost-sharing limitations applicable to non-grandfathered plans, and restating their enforcement approach with respect to the ACA’s provider nondiscrimination...more