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Artificial Intelligence Briefing: White House Announces the Completion of Agency Actions Required by the AI Executive Order

A week before the EU’s AI Act comes into force on August 1, the White House announced that U.S. agencies have completed all actions required by President Biden’s AI Executive Order to date. Meanwhile, the Republican Party...more

Artificial Intelligence Briefing: White House Issues AI Progress Report

Regulatory, Legislative and Litigation Developments - Federal Agencies and the White House Issue Six Month Update on AI Activities Outlined in President Biden’s Executive Order on AI. Since President Biden issued his...more

Artificial Intelligence Briefing: House Launches Bipartisan AI Task Force

The House of Representatives aims to keep the U.S. at the leading edge of AI policy and innovation with a bipartisan task force while the FTC considers expanding a rule to crack down on AI impersonation. Meanwhile, a recent...more

Artificial Intelligence Briefing: NYDFS Releases Proposed Circular on AI Use in Insurance Underwriting, Pricing

New York’s Department of Financial Services releases proposed guidance on AI and other data sources in insurance underwriting and pricing — and you’ll note plenty of influence from Colorado’s governance regulation and the...more

Federal Health Care Legislative Agenda: Fall Updates

As Congress returns and summer turns to fall, the federal health care legislative agenda remains crowded. While much near-term energy is focused on September 30 and averting a shutdown of the federal government before the...more

What to Know Before Getting Back to the Business of Health Care: FY2023 Omnibus Spending Bill

In late December, Congress passed and President Biden signed into law a $1.7 trillion year-end omnibus spending bill to fund the federal government through FY2023. This alert summarizes the notable health policies and...more

The Congressional Review Act: A Tool Democrats May Use to Overturn Recently Promulgated HHS Regulations

With Democrats having slight majorities in the House and Senate and Joe Biden in the White House, the Congressional Review Act (CRA) becomes an available tool to potentially vacate certain regulations that the outgoing Trump...more

Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor

Providers have a new tool in their toolbox to promote population health. The Health and Human Services Office of Inspector General (OIG) has adopted a new, extremely broad safe harbor that allows certain providers to give...more

The Affordable Care Act at Risk: American Health Policy at a Crossroads

We are at a major crossroads in U.S. health policy. The direction for American health care in 2021 and beyond will depend in large part on events that are unfolding now, and that will come to fruition in the first half of...more

CMS Proposes Reopening MLR Filings to Account for Risk Corridor Payouts

The Centers for Medicare & Medicaid Services (CMS) has issued guidance on how health insurers must report and rebate recoveries obtained from the federal government under the Supreme Court’s 8-1 decision in Maine Community...more

Considerations for Entry or Reentry Into the Individual Health Insurance Market

Many health insurers and HMOs may be considering entering or reentering the individual health insurance market, either on or off a federal or state-based health insurance marketplace. Over the last two years, the individual...more

What Health Insurers Should Consider Before Implementing a Premium Discount

The period of reduced economic activity in the United States due to the novel coronavirus pandemic has resulted in fewer in-office health care visits and procedures and, therefore, reduced claims costs for health insurers....more

The CARES Act: Relief for Health Care Providers

The $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law on March 27, 2020, contains significant relief to assist health care providers faced with the double burden of an onslaught of...more

Regulatory Actions to Address Affordability of Coronavirus-Related Services

The federal government and many governors and state insurance regulators have taken recent actions in response to (or anticipation of) the spread of the coronavirus across communities in the United States. This document...more

New CMS Regulation Proposes Another Set of Plan-Friendly Tweaks to Medicare Advantage

On February 5, the Centers for Medicare and Medicaid Services (CMS) proposed several interesting tweaks to the Medicare Advantage (MA) and Medicare Part D programs through an 895-page proposed regulation, Contract Year 2021...more

Is There a ‘Z’ in SDOH? New Government Report on Social Determinants of Health

Over the last five years, clinicians, health plans and policymakers have ramped up their focus on the social determinants of health (SDOH). SDOH are non-medical factors (food security, housing security, reliable access to...more

Increasing the Advantage of Medicare Advantage: Decoding President Trump’s Medicare Executive Order

On October 3, President Donald Trump signed an executive order (EO) focused on the Medicare program, titled, “Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors.” The EO offers expected political...more

Executive Order on Health Care Prescribes Change Ahead for Providers and Insurers

President Trump signed an Executive Order (EO) aimed at improving health care price and quality transparency. While it requires few immediate changes, it foreshadows future requirements for health care providers and health...more

The Pronounced Importance of an Unpronounceable Acronym: New Guidance on SSBCI in Medicare Advantage

On April 24, Centers for Medicare and Medicaid Services (CMS) issued a memo to Medicare Advantage (MA) plan sponsors detailing the scope of Special Supplemental Benefits for the Chronically Ill (SSBCI). Established by the...more

CMS Announces Primary Cares Initiative: New Direction or New Messaging?

On April 22, The Center for Medicare and Medicaid Innovation (the Innovation Center) at the Centers for Medicare and Medicaid Services (CMS) announced a new Primary Cares Initiative, with two new payment models aimed at...more

Medicare Advantage Plan Adoption of New Flex Benefits in 2019

Medicare Advantage, the private plan option in the Medicare program, is growing rapidly. Currently, 22 million people choose Medicare Advantage — more than one third of people with Medicare — and that number is expected to...more

Federal Trial Court Strikes Down Entire Affordable Care Act

A federal district court in Fort Worth, Texas struck down the entire Affordable Care Act (ACA) last Friday in a ruling that’s prompting questions about whether its legal reasoning will withstand further scrutiny, and whether...more

Trick or Treat? Expected and Surprising Provisions in the New Medicare Advantage Regulation

On October 26, the Centers for Medicare and Medicaid Services (CMS) released a 362-page proposed regulation that makes changes to three expected areas: - New telehealth flexibilities for Medicare Advantage (MA) plans....more

Requiring a Price Tag in Drug Commercials: Furthering Consumer Transparency or Government Overreach?

The Trump Administration released a draft regulation published in the Federal Register on October 18, 2018, which proposes to require drug manufacturers to include a drug’s list price in its direct-to-consumer (DTC)...more

CMS Greenlights Indication-Based Formulary Design: What Do You Need to Know?

In its latest effort to implement the Trump administration’s plan to address concerns over the cost of drugs, the Centers for Medicare and Medicaid Services (CMS) announced that Part D drug plans can begin applying...more

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