Health Law Advisor Thought Leaders On Laws And Regulations Affecting Health Care And Life Sciences

Tag Archives: Affordable Care Act

Change Is Here – President Trump’s First Day Includes Addressing the Affordable Care Act and Freezing Regulations

On his first day in office, President Trump issued an Executive Order entitled “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal.” The Executive Order is, in effect, a policy statement by the new administration that it intends to repeal the Patient Protection and Affordable Care Act (the “ACA” or the “Act”) as promptly as possible. The Executive Order also directs the Secretary of Health and Human Services and the heads of all other executive departments and agencies that, pending repeal of the ACA, they are to exercise the full extent of their … Continue Reading

Stakeholder Agendas in the Washington Transition: 5 Takeaways for Converting Ideas into Technically Effective Proposals

As the transition in Washington moves into high gear this month, it’s not just the new Administration and Congress that are putting in place plans for policy and legislation; stakeholders are busy creating agendas, too.

Many stakeholder agendas will seek to affect how government addresses such prominent health care issues as the Affordable Care Act, Medicare entitlements, fraud-and-abuse policies, FDA user fees, and drug pricing. There will be a myriad of stakeholder ideas, cutting a variety of directions, all framed with an eye to the new political terrain.

But whatever policies a stakeholder advocates, ideas must be translated into a … Continue Reading

Court Issues Nationwide Injunction Prohibiting Enforcement of Section 1557 Provisions Relating to Gender Identity and Termination of Pregnancy – But Other Provisions Still Can Be Enforced

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical association, and eight states in which the plaintiffs allege, among other allegations, that … Continue Reading

If At First It Doesn’t Succeed—FTC Will Try, Try Again to Oppose Hospital Mergers

Recently, the Federal Trade Commission (“FTC”) faced major losses in challenging hospital mergers.  However, it is clear that the FTC is not backing down, especially given its tendency to conclude that proposed efficiencies do not outweigh the chance of lessening competition.

In July of this year, the FTC abandoned a challenge to the proposed merger of St. Mary’s Medical Center and Cabell Huntington Hospital in West Virginia after state authorities had changed West Virginia law and approved the merger despite the FTC’s objections. This year as well, the FTC failed to enjoin the Penn State Hershey Medical Center and PinnacleHealth … Continue Reading

Top Five Takeaways from MedPAC’s Meeting on Medicare Issues and Policy Developments — September 2016

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, DC, on September 8-9, 2016. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC’s meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC’s next report to Congress.

As thought leaders in health law, Epstein Becker Green monitors MedPAC developments to … Continue Reading

U.S. Supreme Court Rules in Favor of Liberty Mutual

Stuart Gerson

Stuart Gerson

Today, the U.S. Supreme Court decided (6-2, with Kennedy writing for the majority and  Ginsburg and Sotomayor dissenting) the case of Gobeille v. Liberty Mutual Insurance Co.  The matter before the Court involved Vermont law requiring certain entities, including health insurers, to report payments relating to health care claims and other information relating to health care services to a state agency for compilation in an all-inclusive health care database. 

In an important victory for pre-emption advocates, the Court held that this law was pre-empted by The Employee Retirement Income Security Act of 1974 (ERISA) which expressly pre-empts “any … Continue Reading

CMS Issues Long-Awaited Rule Regarding Reporting and Returning Overpayments

Epstein-Becker-Green-ClientAlertHCLS_gif_pagespeed_ce_KdBznDCAW4In February 2012, two years after the passage of the Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule, which was subject to significant public comment, concerning reporting and returning certain Medicare overpayments (“Proposed Rule”). On February 12, 2016, four years from the issuance of the Proposed Rule (and six years after passage of the ACA), CMS issued the final rule, which becomes effective on March 14, 2016 (“A and B Final Rule”).

The A and B Final Rule applies only to providers and suppliers under Medicare Parts A and B. The return … Continue Reading

Network Adequacy: A Multimarket Recap of 2015 and Looking Ahead

2016 is poised to be a major year in network adequacy developments across public and private insurance markets.  Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges.  The developing standards and enforcement will vary significantly across these markets.

Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act’s insurance exchanges (“Exchanges”).  Others reported on enrollees’ frustration with receipt of unexpected charges from out-of-network practitioners when receiving treatment at in-network facilities (often … Continue Reading

BNA Webinar: Opportunities and Obstacles: Accountable Care Organizations and Other Provider Risk Sharing Arrangements — a Legal and Regulatory Overview

Epstein Becker Green’s Lynn Shapiro Snyder, Senior Member of the Firm, and Tanya Vanderbilt Cramer, Of Counsel, will present “Accountable Care Organizations and Other Provider Risk Sharing Arrangements — a Legal and Regulatory Overview,” a webinar hosted by Bloomberg BNA.

While the federal government has encouraged the growth of accountable care organizations (ACOs) through the Affordable Care Act, the regulation of ACOs and other provider risk sharing arrangements remains a patchwork of federal and state requirements that span many different areas of law. This webinar will explore some of the regulatory issues faced by ACOs, integrated delivery systems, … Continue Reading

FDA Continues Its De-Regulatory Trend with the Release of the Wellness Guidance

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are “low risk” and are intended to:

  1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
  2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy lifestyle may reduce the risk
Continue Reading

DC Circuit Stays Halbig Action Pending SCOTUS Review of King, Upholds Accommodation for Contraceptive Coverage

Stuart M. GersonOnly last week, we informed you of the Supreme Court’s somewhat surprising grant of cert. in the Fourth Circuit case of King v. Burwell, in which the court of appeals had upheld the government’s view that the Affordable Care Act makes federal premium tax credits available to taxpayers in all states, even where the federal government, not the state, has set up an exchange.

The Administration has taken something of a PR buffeting in the week following, after its principal ACA technical advisor’s comments on this issue were made public.

In any event, we suggested that the scheduled DC Continue Reading

The Cost of Ebola Treatment

Everyone is talking about Ebola, including the risk of contracting it, treatment for those who do contract it, and protection for those who treat patients who have it.  There has been very little discussion, though, about how to pay for the costs of treating Ebola patients, including whether health insurance will cover the treatment and pay the providers.

Most health insurance coverage that complies with the ACA minimum essential coverage standards will cover the costs of medically necessary hospitalization and physician services.  However, many of those policies have significant out of pocket expenses that must be paid by the patient, … Continue Reading

Hobby Lobby Update

By Stuart Gerson

In the wake of the Hobby Lobby ruling with respect to the Affordable Care Act’s contraceptive coverage mandate, the Administration (which already has taken steps to fund contraception for employees affected by their employers’ exemption) is attempting also to deal with the issue by a recently-published DHHS regulation setting forth the procedures that “religious” employers might follow to gain exemption from having to provide contraceptive coverage in their sponsored health plans. The proposed rule covers both religious not-for-profits and closely held religious for-profits.

The not-for-profit element has been spawned by religious employers, particularly Notre Dame University and … Continue Reading

The ACA Still Has Its Day in Court, Now Over Subsidies, in Law360

Our colleagues Kara Maciel, a Member of the Firm in the Labor and Employment, Litigation, and Health Care and Life Sciences practices, in the Washington, DC, office, Mark Trapp, a Member of the Firm in the Labor and Employment and Litigation practices, in the Chicago office, and Adam Solander, an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled “The ACA Still Has Its Day in Court, Now Over Subsidies.” (Read the full version – subscription required.)

Following is an excerpt:

Challenges to the government’s health care reform … Continue Reading

Stuart Gerson on the Supreme Court’s Harris and Hobby Lobby Decisions

Our colleague Stuart Gerson of Epstein Becker Green has a new post on the Supreme Court’s recent decisions: Divided Supreme Court Issues Decisions on Harris and Hobby Lobby.”

Following is an excerpt:

As expected, the last day of the Supreme Court’s term proved to be an incendiary one with the recent spirit of Court unanimity broken by two 5-4 decisions in highly-controversial cases. The media and various interest groups already are reporting the results and, as often is the case in cause-oriented litigation, they are not entirely accurate in their analyses of either opinion.

In Harris v. QuinnContinue Reading

Webinar on the ACA Employer Mandate: Feb. 20

In a complimentary webinar on February 20 (1:00 p.m. ET), our colleagues Frank C. Morris, Jr., and Adam C. Solander will review the ongoing impact of the Affordable Care Act (ACA) on employers and their group health plans.

The Treasury Department and the Internal Revenue Service recently issued highly anticipated final regulations implementing the employer shared responsibility provisions of the ACA, also known as the employer mandate. The rules make several important changes in response to comments on the original proposed regulations issued in December 2012 and provide significant transition relief.

Objectives of the webinar are to:

  • Provide an overview
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ACA’s Employer “Pay or Play” Mandate Delayed – What Now for Employers?

A recent article in Bloomberg BNA’s Health Insurance Report will be of interest: "ACA’s Employer ‘Pay or Play’ Mandate Delayed – What Now for Employers?" by Frank C. Morris, Jr., and Adam C. Solander, colleagues of ours, based in Epstein Becker Green’s Washington, DC, office. Following is an excerpt:

The past few weeks have changed the way that most employers will prepare for the employer ‘‘shared responsibility” provisions of the Affordable Care Act (ACA). Over the past year or so, employers have scrambled to understand their obligations with respect to the shared responsibility rules and implement system changes, … Continue Reading

Affordable Care Act: Important Deadline for Employee Notices of the Health Insurance Marketplace (Exchange) Due October 1, 2013

By Gretchen Harders and Michelle Capezza

On May 8, 2013, the Employee Benefits Security Administration of the Department of Labor (the “DOL”) issued Technical Release 2013-02 (the “Release”) providing important guidance under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “Affordable Care Act”) with regard to the requirement that employers provide notices to their employees of the existence of the Health Insurance Marketplace, generally referred to previously as the Exchange. These employee notices must be provided to existing employees no later than October 1, 2013. This deadline is … Continue Reading

Affordable Care Act Webinar, January 9 – To Pay or To Play: An Analysis of the Shared Responsibility Rules

Please join Epstein Becker Green’s Health Care & Life Sciences and Labor & Employment practitioners as we continue to review the Affordable Care Act and its ongoing impact on employers and their group health plans.

In less than a year, employers employing at least 50 full-time employees will be subject to the Employer Shared Responsibility provisions. Under these provisions, if employers do not offer health coverage or do not offer affordable health coverage that provides a minimum level of value to their full-time employees, they may be subject to a tax penalty under the proposed regulations just issued by the … Continue Reading

Post-Election Health Reform Implementation

by Brandon C. Ge

In the months leading up to Election Day 2012, the pace of health reform implementation slowed considerably as the Obama administration held off on releasing regulations to avoid pre-election controversy. With the 2012 elections now in the books, health reform has scored two major victories: the re-election of President Barack Obama and the preservation of a Democratic majority in the Senate. Although the Affordable Care Act (ACA) is now safe from repeal, implementation still faces hurdles, such as state resistance, the fiscal cliff, and pending lawsuits challenging ACA’s contraception mandate.

Nonetheless, the administration has stormed ahead … Continue Reading

ACA Webinar, Dec. 18: What Employers Need to Know Now!

Please join Epstein Becker Green’s Health Care & Life Sciences, Employee Benefits, and Labor & Employment practitioners as we continue to review the Affordable Care Act and its ongoing impact on employers and their group health plans and programs.

Since the Presidential election, The U.S. Department of Health and Human Services is moving quickly to implement the Affordable Care Act. Rules have been released in the past few weeks concerning participation in federal exchanges, discrimination based on pre-existing conditions, essential health benefit requirements, and expanded employment-based wellness. During this program, Epstein Becker Green practitioners will:

  • Review the ACA implementation timeline
Continue Reading

State Progress Defining What It Means to Be an “Essential Health Benefit”

In addition to the work that states are doing (or purposefully not doing) to implement State Health Insurance Exchanges for operation in 2014, states have also been given the task of choosing a benchmark plan for purposes of defining the essential health benefits (“EHB”), a minimum package of benefits that must be offered by all insurance policies sold in the small group and individual markets beginning in 2014. 

Section 1302(b) of the Affordable Care Act directs the Secretary of Health and Human Services (the “Secretary”) to define the EHB. The scope of the EHB must equal the scope of benefits provided … Continue Reading

Key Factors That May Influence a State’s Decision on Whether to Expand Its Medicaid Population Under the Affordable Care Act

by Lynn Shapiro Snyder and Shawn M. Gilman

Speculation abounds with respect to the decision that states will make on the issue of whether to expand Medicaid coverage under the Affordable Care Act, now that the Supreme Court of the United States has made the option to abstain a meaningful one. This health reform alert highlights some key factors that may influence a state’s decision on whether to implement such an expansion.

Read the full alert here

Danielle Steele, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green’s Washington, DC, office, contributed significantly to the Continue Reading

Providers: Do Your Managed Care Participation Agreements Apply to New Insurance Exchange Products?

by Jackie Selby and Jane L. Kuesel

As enacted in the Patient Protection and Affordable Care Act, states are required to have established operational health benefit exchanges by January 1, 2014, or the federal government will implement one for them. These exchanges will allow individuals and small businesses to buy health care coverage and are expected to add approximately 30 million currently uninsured persons to the health insurance market. Most of the health plans that will be offered on such exchanges will be managed care plans with networks of participating providers. Thus, the resulting new business will be covered by … Continue Reading