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Category Archives: Obama Administration

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FDA Adopts New Designation Process for Regenerative Advanced Therapies

On January 19, 2017, the United States Food and Drug Administration (“FDA”) unveiled a new drug designation process for regenerative advanced therapies, an important first step toward implementation of the regenerative medicine provisions of the 21st Century Cures Act.  Products for which a designation as a regenerative advanced therapy (“RAT”) is obtained are eligible for accelerated approval under the 21st Century Cures Act, which was signed into law by former President Obama on December 13, 2016 with sweeping bipartisan support.

The accelerated approval provisions for RATs under the 21st Century Cures Act are intended to facilitate expedited … Continue Reading

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

New Federal and State Initiatives Seek to Combat Antimicrobial Resistance

Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a 2014 study underscore the magnitude of the threat of so-called “superbugs,” estimating that the number of deaths worldwide attributable to antimicrobial resistance will reach 10 million by 2050.  By comparison, the same study projected 8.2 million deaths from cancer, and 1.2 million deaths from traffic … Continue Reading

District Court Invalidates Payment of Cost-Sharing Subsidies, Setting Up Additional Legal Tests for the Affordable Care Act

In its recent decision in U.S. House of Representatives v. Burwell,[1] the U.S. District Court for the District of Columbia ruled that the Obama administration’s payment of cost-sharing subsidies for enrollees in plans offered through the Affordable Care Act’s Exchanges is unauthorized for lack of Congressional appropriation. The decision would affect future cost-sharing subsidies, though the court immediately stayed the decision pending its outcome on appeal.[2]

In its decision, the court found in favor of the members of the House of Representatives, based upon its interpretation of the applicable law. Specifically, the court found that, when Congress passed … Continue Reading

Defend Trade Secrets Act Signed Into Law

On May 11, 2016, President Obama signed into law the Defend Trade Secrets Act (“DTSA”), which became effective immediately. The DTSA provides the first private federal cause of action for trade secret misappropriation, and it allows parties to sue in federal court for trade secret misappropriation—regardless of the dollar value of the trade secrets at issue.   Employers in the health care and life science industry may want to note that the DTSA

requires that employers provide certain notices of these whistleblower protections in employment-related agreements that govern trade secrets or other confidential information entered into or amended after May 11,

Continue Reading

Surprise Health Care Bill Protections Addressed in President Obama’s 2017 Budget for Health and Human Services

In its Fiscal Year 2017 Private Insurance Legislative Proposals, President Obama’s Budget contains a provision seeking to “eliminate surprise out-of-network healthcare charges for privately insured patients.” Described as an attempt to “promote transparency on price, cost, and billing for consumers,” this measure requires hospitals and physicians to collaborate so that patients receiving treatment at in‐network facilities do not face unexpected charges from out‐of‐network practitioners. This provision could have far-reaching effects, potentially impacting enrollees in traditional commercial plans, Exchange plans and government plans (such as Medicare Advantage plans).

A surprise bill situation arises when patients incur unexpected, out‐of‐network charges when … Continue Reading

Bipartisan Budget Act of 2015 – Potential Impact on Hospitals

House Republican leaders introduced legislation on Monday, finalizing a two-year budget agreement between Congressional leaders and the White House. This legislation is currently being considered and may be up for a vote as early as Wednesday on the bipartisan budget deal.

Hospitals should note the language in Section 603 (which is on pages 35-39 of the draft bill) codifies the definition of a “provider-based off-campus hospital outpatient department” (PBD HOPD) as a location that is not on the main campus of a hospital and is located more 250 yards from the main campus.  The section defines a “new” PBD HOPD … Continue Reading

SCOTUS Upholds Exchange Subsidies – King v. Burwell

firm_sgersonIn a split decision announced today, June 25, the U.S. Supreme Court, in King v. Burwell, ruled in upholding the tax credits to individuals in all states, including those with only a federal exchange.  In a 6-3 decision, Chief Justice Roberts delivered the opinion of the Court.

“Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter. Section 36B can fairly be read consistent with what we see as Congress’s plan, and Continue Reading

President Obama to Announce New Privacy Initiatives in SOTU

By Evan J. Nagler

The State of the Union Address, scheduled for January 20, 2015, will contain new initiatives related to privacy, White House officials say. The known initiatives are the introduction of a data breach reporting bill, a bill restricting the sale of student information, and a Consumer Privacy Bill of Rights.

SETTING A NATIONAL DATA BREACH REPORTING STANDARD

President Obama is planning on introducing a data breach bill that would standardize the reporting period nationwide at 30 days. The proposed Personal Data Notification and Protection Act would require direct customer notification. The law would also criminalize selling Continue Reading

Comment Period on Proposed QHP Certification Guidance and Proposed Rule That May Impact Health Insurance Issuers’ Offering of Private Health Insurance Products

Stakeholders received insight on the Obama administration’s expected approach to the certification and oversight of qualified health plans (“QHPs”) late Friday, December 19, 2014, with the release by the Centers for Medicare & Medicaid Services (“CMS”) of its Draft 2016 Letter to Issuers in the Federally-facilitated Marketplaces (“Draft Letter”). This annual release comes more than a month earlier than the release of the 2015 version of this document.

While the Draft Letter largely mirrors the provisions of its 2015 predecessor, or restates earlier proposals, CMS does include several significant changes in approach for the 2016 application cycle. These changes include … Continue Reading

Eye on Ebola: Latest Updates from the CDC

The 2014 outbreak of the Ebola Virus Disease (“Ebola”) is the largest in history and continues to affect multiple countries in West Africa. Although reports of new Ebola cases in the U.S. – potential or confirmed – have slowed down in recent weeks, the Centers for Disease Control and Prevention (“CDC”) and its various domestic and international partners continue their efforts to prevent further transmission of Ebola in the U.S. as well as abroad. Earlier this week, in fact, the CDC released two new pieces of guidance regarding treatment of Ebola that will be of particular … 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

ACA Tax Credits Under Review: Supreme Court Grants Certiorari in King v. Burwell

Stuart M. GersonIn something of a surprise, the Supreme Court today granted certiorari 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. In doing so, the Supreme Court rebuffed the Solicitor General’s request that the Court decline cert. as various cases worked their way through the Courts of Appeals.

It was only a few days ago that the government had filed a … Continue Reading

Decision of a United States District Judge for Eastern District of Oklahoma Continues the Debate Over Provisions in the ACA

By Stuart Gerson

The September 30, 2014 decision of a United States District Judge for Eastern District of Oklahoma in the case of State v. Burwell  adds an interesting wrinkle to the debate over whether the provision in the Affordable Care Act that authorizes federal subsidies (tax credits) applies to individuals who are covered by  a qualified health plan that is enrolled through an Exchange established by the Federal government, not a State.  An IRS Rule (26 C.F.R.§ 1.36B-1(k)) allows this, while the ACA itself bases eligibility on participation in a plan that was “enrolled in through an Exchange established … Continue Reading

Five ACA Issues that Employers Should Be Following

 

Our Epstein Becker Green colleagues have released a new Take 5 newsletter: “Five ACA Issues that Employers Should Be Following” by David W. Garland, Adam C. Solander, and  Brandon C. Ge.  Below is an excerpt:

Employers have about three months to finalize their employer mandate compliance plans under the Affordable Care Act (“ACA”). While most employers are in the final stages of planning, this month’s Take 5 will address five ACA issues that employers should be aware of as they move forward:

  1. ACA-related litigation
  2. Employer mandate reporting
  3. Section 510 liability
  4. Alternatives to traditional plan
Continue Reading

DC Circuit Will Rehear Halbig

By Stuart Gerson

As we noted in our various blogs and communications on the subject (HEAL Advisory and HEAL Blog), the United States Court of Appeals for the District of Columbia Circuit’s action today, to rehear in December the Halbig case (Halbig v. Burwell, D.C. Cir., No. 14-508 ), challenging  Obamacare subsidies in the federal health exchange, is not unexpected given the current makeup of the Court. This development now makes it more likely that the Supreme Court will not take action on the King cert petition (King v. Burwell, U.S. 4th Circuit … Continue Reading

In re Kellogg Brown & Root Update

By Stuart Gerson

In this blog and subsequently in an article on the subject under the aegis  of the American Health Lawyers Association that can be found at http://www.lexology.com/library/detail.aspx?g=b68c51ae-2bdb-490e-ac3d-02c351a19310 EBG analyzed the DC Circuit’s decision  in  In re Kellogg Brown & Root, 2014 U.S. App. LEXIS 12115 (D.C. Cir. 2014).  The DC Circuit’s holding reinforces the protections established by the Supreme Court 30 years ago in Upjohn Co. v. United States, 449 U.S. 383 (1981), that afford privilege to confidential employee communications made during a corporation’s internal investigation led by company lawyers. 

Given the fact that this case … Continue Reading

How Big Is Halbig? The Viability of the ACA’s Employer Mandate Hangs in the Balance

By Adam C. Solander, Kara M. Maciel, Mark M. Trapp, and Stuart M. Gerson

Yesterday, the U.S. Court of Appeals for the District of Columbia and the U.S. Court of Appeals for the Fourth Circuit sent shockwaves through the country when they issued conflicting opinions on a key aspect of the ACA.  The cases are Halbig v. Burwell, D.C. Cir., No. 14-508 and King v. Burwell, 4th Cir., No. 14-1158.  The question at issue in both cases was whether the IRS has the authority to administer subsidies in federally facilitated exchanges when the statute itself … Continue Reading

OIG’s Permissive Exclusion Criteria: Comment Before Sept. 9, 2014

The Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) is soliciting comments, recommendations, and other suggestions on the non-binding criteria used by OIG in assessing whether to impose a permissive exclusion, which were first published in 1997 (https://oig.hhs.gov/authorities/docs/2014/2014-16222.pdf).  The OIG’s permissive exclusion criteria currently are organized into four general categories, including: (1) the circumstances and seriousness of the underlying misconduct; (2) the defendant’s response to the allegations or determination of wrongdoing; (3) the likelihood of a future violation; and (4) the defendant’s financial ability to provide quality health care services.  … 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

CMS Gets the Message – Updated Governance Changes to the Medicare Conditions of Participation

By Arthur J. Fried

The Controversy – 2012 Rulemaking Attempts

Roughly two years ago, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services (“CMS”) published final regulations announcing two controversial rule changes addressing hospital governance.  The industry was taken by surprise, to say  the least, as neither of these requirements had been in the proposed rule.  The changes, promulgated as amendments to the Governing Body Condition of Participation (CoP) included (i) the requirement that a hospital’s board include at least one member of its medical staff; and (ii) a statement in the preamble interpreting … 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

The Timeline for Accountable Care

Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let’s look at the rollout of the accountable care provisions–i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in the BNA’s Health Law Reporter.  Click here to read the full article Continue Reading

Infrastructure for Health Care Reform

Barack Obama signed an executive order on April 8, 2009 to formally lay infrastructure in the executive branch to facilitate health care reform activities. The executive order officially creates the White House Office of Reform (the “Health Reform Office”) and lays out its principle functions, including coordination across executive departments and agencies, outreach activities with state and local policymakers, and working with Congress for the purpose of enacting and implementing health care reform. As we reported on March 6, 2009, Nancy Ann DeParle was selected to be the Director of the Health Reform Office. The order grants DeParle the … Continue Reading