Public Health Service Act

News & Analysis as of

Stand Alone, Fixed-Indemnity Plans Are Back, Maybe

In Central United Life Ins. Co. v. Burwell, D.C. Cir. No. 15-5310 (July 1, 2016), a D.C. Circuit panel affirmed, 3-0, a trial court injunction barring enforcement of the 2014 HHS regulation permitting individual...more

Can FDA Implement The BPCIA As The CAFC Suggested?

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

DC Circuit strikes down HHS regulation regarding fixed indemnity plans

On July 1, 2016, in the case of Central United Life Insurance Company v. Burwell (No. 15-5310), the US Court of Appeals for the District of Columbia Circuit ruled that the US Department of Health and Human Services (HHS)...more

Injunction Enjoining Enforcement of HHS Attestation Rule Affirmed

The Court of Appeals for the District of Columbia affirmed the District Court’s decision in Central United Life v. Burwell on July 1, 2016. This decision is very significant for those assessing the future strength of, and...more

Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price...more

The (suf)Fix is In: FDA Opens the Floor for Comments on Biologic Naming Guidance

On June 2, 2016, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name...more

“Deemed to be a License” Provision Poses Potential Issues for Biological Products

The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”)....more

Learning Something New – Limits To Human Tissue Liability

Every now and then even Bexis comes across a decision involving legal propositions he’d never heard of before. Such was the human tissue case Kennedy-McInnis v. Biomedical Tissue Services, Ltd., No. 13-CV-6545, slip op....more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

Health and Welfare Plans: Big Compliance Burdens, Big Penalty Exposures

Health and welfare have been around for a long time, and they are ubiquitous. Employees have come to expect medical, dental, life, and other insurance as part of their benefits packages. Employers offer coverage in order to...more

What Constitutes Interchangeability? AbbVie Submits Citizen Petition to Suggest Requirements

On December 16, 2015, AbbVie submitted a citizen petition regarding the requirements necessary to show interchangeability of a biosimilar product. This petition follow’s AbbVie previous citizen petition and supplement...more

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

The PACE Act – Changes to the Definition of Small Group for Purposes of ACA Market Reforms

On October 7, 2015, the Protecting Affordable Coverage for Employees Act ("PACE Act") was enacted, and on October 19, 2015, the Department of Health and Human Services released FAQs providing further guidance on the Act's...more

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

House Hearings to Focus on ACA Insurance Issues

On September 9, 2015, the House Energy and Commerce Committee is holding a hearing on H.R. 1624, Protecting Affordable Coverage for Employees Act of 2015. The legislation would amend the Public Health Service Act to redefine...more

FDA’s Proposed Naming Convention for Biologics

On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more

The ERISA Litigation Newsletter - July 2015

Editor's Overview - This month's article by Lindsey Chopin discusses Affordable Care Act ("ACA") litigation. Just five years old, the Supreme Court has considered issues related to the ACA numerous times. Two of those...more

Washington Healthcare Update

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

HRSA Issues 340B Drug Discount Program Civil Money Penalty Proposed Rule

On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the...more

Supplemental Excepted Benefits? “It depends.”

Last week, HHS, along with the Department of Labor and the Treasury, provided long overdue guidance regarding the third category of supplemental “excepted benefits” as defined by Section 2791 of the Public Health Services...more

ODAC Committee Votes to License Sandoz’s Zarxio®

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

The Affordable Care Act—Countdown to Compliance for Employers, Week 3: Group Health Plan, Cafeteria Plan and Health FSA...

As applicable large employers grapple with the Affordable Care Act’s (ACA) employer shared responsibility (pay-or-play) rules, two questions arise with notable frequency...more

Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions...

In our blog post of November 18, 2013 (“No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Before Biosimilars Application is Filed”), we discussed the decision of the U.S. District Court for the Northern...more

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