Administrative Agency Health

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.
News & Analysis as of

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

Highmark and UPMC Consent Decree

Highmark and UPMC took a major step toward resolving network participation issues June 27, 2014, by executing a Consent Decree with the Commonwealth of Pennsylvania Departments of Insurance and Health. The Consent...more

FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with...

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

Favorable Ruling: Taxability of HMOs Under New York City General Corporation Tax

A New York City Tax Appeals Tribunal Administrative Law Judge (ALJ) recently ruled in favor of Aetna, Inc. (Aetna) on whether a health maintenance organization (HMO) was “doing an insurance business” in New York State,...more

Court Slams Medicare Agency, Notes Reputation As “Unfeeling Bureaucracy”

The Department of Health & Human Services’ Provider Reimbursement Review Board (Board) came in for some withering criticism last Friday from the federal court hearing the appeal of University of Chicago Hospital from the...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

Shorts on Long Term Care - Summer 2014

In this issue: - Nursing Facility Survey Trends: Directed Plans of Correction, Privacy Violations and FTag 520 Quality Assurance Committee Citations - COBRA Meets ACA – Time to Update COBRA Notices -...more

Hospitals File Lawsuit Over Medicare ALJ Hearings Delays

Over 460,000 appeals requesting hearings before an administrative law judge (ALJ) were pending in the Office of Medicare Hearings and Appeals (OMHA) at the end of 2013, with 15,000 new appeals being submitted each week. At...more

New Washington Rule Clarifies Authority to Issue Penalties Against TPAs

The Washington State Department of Health has promulgated a new rule clarifying the Department's authority to issue civil penalties against health carriers and third-party administrators. This rule, which is outside the...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

The Future of Premium Subsidies under the Affordable Care Act: 'Halbig v. Burwell' and 'King v. Burwell'

Both decisions addressed whether tax credits are available for residents in states that have federally-facilitated health exchanges. The District of Columbia Court of Appeals said “no”; the Fourth Circuit Court of Appeals...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Health Update - July 2014

Avoiding the Regulatory Land Mines of Commercial ACOs - While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more

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

For employers with employees in the 36 states with a federally facilitated exchange, the question arises how the Halbig decision impacts their decision and strategy to provide health coverage to their employees when the...more

A Tale of Two Circuits: D.C. Circuit, Fourth Circuit Split on ACA Subsidies

It was the best of times for ACA subsidies, it was the worst of times for ACA subsidies. On Tuesday, the Court of Appeals for the D.C. Circuit (“D.C. Circuit”) and the Court of Appeals for the Fourth Circuit (“Fourth...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

Buckle Up—Unwinding Phoebe Putney’s Acquisition of Palmyra Down in Georgia May End Up Being Back on the Table

Almost one year ago, Federal Trade Commission (FTC) agreed to settle its antitrust challenge of Phoebe Putney Health System’s (Phoebe Putney) acquisition of Palmyra Medical Center (Palmyra) without requiring divesture or any...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

Health Care Reform Implementation Update - July 2014

Last week the Senate debated a bill to reverse the Supreme Court’s contraception mandate decision, a group of House Republicans introduced a bill to replace Affordable Care Act (ACA) cuts to the Medicare home health benefit...more

D.C. Circuit Says CMS Doesn’t Know What’s New

On Tuesday of last week the D.C. Circuit Court ruled that the Provider Review Reimbursement Board doesn’t know what’s new. It reversed the PRRB’s decision, along with the District Court’s decision that upheld it. In doing...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

D.C. Circuit Overturns PRRB’s Decision that Only Newly Built Hospitals Can Qualify for Favorable Capital Reimbursement Rates

In Select Specialty Hospital – Bloomington, Inc. v. Burwell, No. 15-5355 (D.C. Cir., Jul. 8, 2014), a group of long-term care hospitals (LTCHs) successfully challenged the Secretary’s determination that they were not “new...more

3,041 Results
|
View per page
Page: of 122

Follow Administrative Agency Updates on: