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

Category Archives: Access to Health Care

Subscribe to Access to Health Care RSS Feed

Long-Awaited Accessibility Standards for Medical Diagnostic Equipment Are Released

Our colleagues Joshua A. Stein and Frank C. Morris, Jr., at Epstein Becker Green have a post on the Health Employment And Labor blog that will be of interest to many of our readers: “The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards.”

Following is an excerpt:

As part of a flurry of activity in the final days of the Obama Administration, the U.S. the Architectural and Transportation Barriers Compliance Board (the “Access Board”) has finally announced the release of its Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”).  Published in the Federal Register … Continue Reading

Replace Without Repeal?

On Monday, January 23rd, Senators Bill Cassidy (R-LA) and Susan Collins (R-ME) introduced the Patient Freedom Act of 2017 (“PFA”), the first of what may be many Republican Affordable Care Act (“ACA”) “replacement” alternatives. The PFA is notable for several reasons. It is the first replacement plan to be introduced in the 115th Congress, it is sponsored by Senators who are considered comparatively moderate on health issues, and thus its content may represent an opportunity for compromise in the future, and, perhaps most interestingly, does not actually repeal the ACA. The overarching feature of the PFA is … 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

50-State Survey on Telemental Health Laws in the United States

Telemental/telebehavioral Health SurveyEpstein Becker Green has just released the 50-State Survey of Telemental/Telebehavioral Health (2016), a groundbreaking, comprehensive survey on the laws, regulations, and regulatory policies impacting telemental health in all 50 states and the District of Columbia.

While other telehealth studies exist, this survey focuses solely on the remote delivery of behavioral health care.

Compiled by attorneys in Epstein Becker Green’s Telehealth practice, the survey details the rapid growth of telemental health—mental health care delivered via interactive audio or video, computer programs, or mobile applications—and the increasingly complex legal issues associated with this trend. Additionally, the survey provides one source … 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

Members of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency

On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee[1] (the “Subcommittee”) held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration (“HRSA”), the Director of the Office of Pharmacy Affairs (“OPA”) of HRSA,[2] the Director of Health Care of the Government Accountability Office (“GAO”), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”).

The purpose of the hearing was to assess the functionality of the 340B Program, and, in particular, HRSA’s … Continue Reading

Key Issues Facing Places of Public Accommodation at the 25th Anniversary of the ADA

Epstein Becker Green’s recent issue of its Take 5 newsletter focuses on the 25th Anniversary of the ADA and recent developments and future trends under Title III of the ADA.

  1. Website Accessibility
  2. Accessible Point-of-Sale Devices and Other Touchscreen Technology
  3. Movie Theater Captioning & Audio (Narrative) Description
  4. The Availability of Sign Language Interpreters at Health Care Facilities
  5. “Drive By” Design/Construction Lawsuits

Read the full newsletter here.… Continue Reading

Deadline Extended for Comments on Proposed Changes to Home Health Conditions of Participation

In response to multiple requests, the Centers for Medicare and Medicaid Services (“CMS”) have extended the deadline for comments on the proposed changes to the home health conditions of participation (“CoPs”).  Home health providers and other interested stakeholders now have until 5:00 p.m. EST on January 7, 2015 to submit comments to CMS.

The proposed changes to the CoPs were published on October 9, 2014[1] and represent the most significant changes to the home health CoPs in seventeen years.  According to CMS, the new CoPs are intended to better reflect modern home health practice by acknowledging … Continue Reading

Halbig v. Burwell – En banc oral argument scheduled for December 17

As you may recall, a DC Circuit panel held that the Affordable Care Act makes federal premium tax credits available to taxpayers only in States where the State has established an exchange – which is what the ACA literally provides. On the same day, the Fourth Circuit issued a contrary decision in King v. Burwell, accepting the government’s argument that where HHS sets up an exchange in a State, that is a State exchange. The same argument is being made by the appellant (the government lost in District Court) in Oklahoma ex rel. Scott Pruitt v. Burwell, which … Continue Reading

Medicare’s Proposed Home Health Rule for 2015: Face-to-Face Encounter Documentation Requirements

Our colleagues at Epstein Becker Green released a client alert: “Medicare’s Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation Requirements but Continued Compliance Burdens on Home Health Agencies,” by Emily E. Bajcsi and Serra J. Schlanger.

Following is an excerpt:

On July 7, 2014, the Centers for Medicare & Medicaid Services (“CMS”) published proposed changes to the Medicare Home Health Prospective Payment System (“HH PPS”) for calendar year 2015 (“Proposed Rule”). The Proposed Rule would update the HH PPS payment rates effective January 1, 2015, including continued implementation of the … Continue Reading

Complimentary Webinar to Focus on the Role of Patient Engagement Strategies

Epstein Becker Green and EBG Advisors, as part of their Thought Leaders in Population Health Speaker Series, will host a complimentary webinar in July on emerging trends in population health. The webinar—What Role Do Patient Engagement Strategies Play in Promoting Population Health?—will examine different approaches to target, engage, and modify individual behaviors to lead a healthier lifestyle. Key thought leaders in population health will share examples of ways to engage high-risk and chronically ill groups so as to achieve meaningful clinical and financial outcomes.

This webinar, scheduled for July 31, 2014, at 12:00 p.m. ET, will be led … 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

Client Alert: Federally Facilitated Exchanges Are Almost Ready

Health Reform - Epstein Becker Green

Our colleagues at Epstein Becker Green have issued a client alert: "Federally Facilitated Exchanges Are Almost Ready," by Linda V. Tiano.

Following is an excerpt:

On March 1, 2013, the Center for Consumer Information and Insurance Oversight ("CCIIO") and the Centers for Medicare & Medicaid Services ("CMS") released lengthy and detailed draft guidance regarding the federally facilitated exchanges ("FFEs") that will operate in the 26 states that have chosen not to establish their own exchange or partner with CMS. Although the guidance was issued in draft form, CCIIO and CMS allowed only two weeks for the public to

Continue Reading

Client Alert: New York Issues “Invitation to Participate in the New York Health Benefit Exchange”

Health Reform - Epstein Becker Green

Our Epstein Becker Green colleagues Jane L. Kuesel, Jackie Selby, and Linda V. Tiano have released a client alert titled "New York Issues ‘Invitation to Participate in the New York Health Benefit Exchange,’ Clarifying Application Process and State Requirements."

The alert describes a number of the more significant requirements by New York on applicants that want to become eligible for certification as a Qualified Health Plan and to participate in the New York Exchange, as well as applicable time frames and processes.

Following is an excerpt:

The New York Department of Health’s Office of the New

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

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

10 Things Providers Should Know About the Health Insurance Exchange Final Rule

by Lynn Shapiro Snyder and Philo D. Hall

On March 12, 2012, the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing the new Affordable Health Insurance Exchanges (“Exchanges”) authorized under the Patient Protection and Affordable Care Act. These Exchanges are intended to establish and operate a “one-stop marketplace” in each state for individuals and small employers to obtain health insurance. While states, health issuers, and related vendors pour over all the details of the Final Rule, we thought it would be helpful to highlight 10 issues related to these Exchanges that would be … Continue Reading

Medicare ACOs: Financial and Clinical Integration

Back in 1996, the Federal Trade Commission and Department of Justice, in providing antitrust guidance for multi-provider networks, considered financial integration and clinical integration as separate pathways for such networks to avoid per se violations of the antitrust laws and, instead, to be treated under the rule of reason, allowing for an assessment of their procompetitive vs. anticompetitive effects. With 65 organizations now participating in Medicare shared savings initiatives, including the 27 Medicare Shared Savings Program participants announced on April 10 (there are 32 Pioneer Accountable Care Organizations and 6 Physician Group Practice Transition Demonstration organizations), we can see, 16 years … Continue Reading

The Supreme Court Mulls Obamacare; the Health Care Industry Mulls the Supreme Court

By Stuart M. Gerson

The three days of arguments about the constitutionality of the Patient Protection and Affordable Care Act are complete. The Justices of the Supreme Court of the United States have conducted their post-argument conference and are now turning their attention to the drafting and the discussions that will lead to a majority opinion and, likely, several dissents and concurrences. The Court’s decision should be issued before the end of June. Health care companies and employers, like the rest of the population, await the ultimate decision. However, there are several matters that can be identified in the short … Continue Reading

Poorly Crafted Wellness Programs Could Make Employers Sick

Kara Maciel, Member of the Epstein Becker Green Labor and Employment, Litigation, and Health Care and Life Sciences Practices, was recently interviewed by Employment Law360 concerning employer wellness programs

According to the article, businesses are turning to wellness programs to curb health care expenses, but programs that aren’t carefully crafted can open employers up to costly privacy and discrimination litigation, attorneys say.  Wellness programs can lead to big savings for employers by targeting behaviors that can cause conditions that drive up their health care expenditures. But programs that give employers too much  information about their employees can leave employers vulnerable … Continue Reading

CCIIO Issues Bulletin on Plans to Define the Essential Health Benefits Package: Providing States with a Significant Role While Still Leaving Room for Public Input

by Lynn Shapiro Snyder and Lesley R. Yeung

On December 16, 2011, the Center for Consumer Information and Insurance Oversight ("CCIIO") within the Centers for Medicare & Medicaid Services ("CMS") released a "bulletin" to provide information and solicit comments on the regulatory approach that the Department of Health and Human Services plans to propose to define essential health benefits ("EHB") under section 1302 of the Affordable Care Act. The "bulletin" provides information to stakeholders (i.e., consumers, states, employers, and health insurance issuers) about what benefits are likely to be required under the EHB package. CCIIO is proposing to give … Continue Reading

Medicare Providers and Suppliers Continue in the Spotlight: Medicare Providers and Suppliers Continue in the Spotlight

Expansion of the DMEPOS Competitive Bidding Program; Legislative Inquiry Related to Fraud and Abuse Enforcement Actions; and Automated Pre-Enrollment Provider Screening

by George B. Breen, Amy F. Lerman, Emily E. Bajcsi, Deepa B. Selvam

In order to be prepared for upcoming changes and to respond to new initiatives, providers and suppliers participating in Medicare must be aware of recent Congressional activity that would hold the federal government accountable for its intended enforcement efforts designed to curb health care fraud, waste, and abuse, as well as an effort by the Centers for Medicare & Medicaid Services (“CMSContinue Reading