Administrative Agency Health

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

Health Canada releases revised guidance on the submission requirements for biosimilar biologic drugs

On December 2, 2016, Health Canada released the revised Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs. The Guidance is intended to assist biosimilar companies to navigate the...more

[Webinar] The “Risky Business” of the Federal False Claims Act: Strategic Thinking for 2017 - December 8th, 12:00pm ET

Calling in-house counsel and top executives at government and defense contractors, health care and long term care providers, and manufacturing companies. On December 8 at 11:30 am ET, join Williams Mullen attorneys at this...more

Manatt on Health Reform: Weekly Highlights - November 2016 #4

CMS releases a wave of new regulations and guidance for Medicaid and CHIP; Michigan receives CMS approval for a lead abatement initiative; and Utah continues to push for its limited expansion of Medicaid coverage....more

Promise to Repeal the ACA Poses Threat to MACRA Implementation

Most of the post-election discussion of the ACA has focused on how promises to repeal the law could impact the newly insured. But one priority area of the ACA that has received very little discussion is the federal...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Briefing Points for the Board: The Election and the 2017 Health Policy Agenda

It is vitally important for the health system board, as well as certain of its key committees, to receive an introductory briefing as soon as possible on the health policy implications of last week’s Presidential and...more

D.C. District Court Bucks the Trend and Rules for Hospital in Provider Tax Case

Many states assess taxes against hospitals and other providers as a means of funding their Medicaid and other healthcare-related programs. The revenue generated by the taxes is used, with CMS’s approval, to fund Medicaid...more

Software as a Medical Device: FDA Releases Draft Guidance

Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more

PA Department of Health Issues Temporary Regulations for Medical Marijuana Growers/Processors and Draft Temporary Regulations for...

The Pennsylvania Department of Health has posted suggested temporary regulations for Dispensaries under the Medical Marijuana Act. There is an open comment period on these proposed regulations until November 4, 2016. After...more

Supreme Court Implied False Certification Case Reargued to First Circuit

On Tuesday, October 25, 2016, a three-judge panel of the United States Court of Appeals for the First Circuit heard argument in United States ex rel. Escobar, et al. v. Universal Health Services, Inc. This case was sent back...more

The Ohio Department of Commerce Proposes “Factsheet” in Advance of Publishing Draft Cultivator Rules

On November 1, 2016, the Ohio Department of Commerce released its “Cultivator Rules” factsheet, which outlines the key elements of its initial draft rules for cultivation licenses under the Ohio Medical Marijuana Control...more

FDA Launches Website for Allegations Against Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

AHCA Sues to Enjoin Prohibition on Binding Arbitration

On October 4, 2016 CMS issued its Final Rule entitled “Reform of Requirements for Long Term Care Facilities” which updates the requirements for all SNFs and NFs participating in Medicare and Medicaid. Many of the changes...more

CMS Issues Sweeping Final Rule, Significantly Changing the Requirements for Long-Term Care Facilities Participating in the...

On September 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a final rule comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities...more

Genomics and FDA Regulation: A Work in Progress

It took over a decade to sequence the human genome the first time, at a cost between half a billion and a billion dollars. Now, however? An entire human genome can be sequenced for one or two thousand dollars, in a matter of...more

FDA Launches New Webpage to Report Regulatory Misconduct

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

The 2016 Election and Your Healthcare System: What’s at Stake?

Regardless of the 2016 general election outcome, a new administration will have to respond to pressing policy issues that will shape continued transformation of the U.S. healthcare system. What are the issues and where do...more

OSHA Issues Final Rule On Complaints Under Affordable Care Act's Anti-Retaliation Provision

The Affordable Care Act (ACA) added Section 18C to the Fair Labor Standards Act (FLSA) to prohibit retaliation against employees who engage in certain activities protected by the ACA. Responsibility for receiving and...more

OSHA Issues New Whistleblower Guidelines

The Occupational Safety and Health Administration (OSHA) has issued a final rule on the procedures, processes, and timeframes for handling whistleblower complaints under the Affordable Care Act (ACA), as well as for hearings...more

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

Affordable Care Act Whistleblower Complaint Procedures

On October 11, 2016, the Occupational Safety and Health Administration published a final rule that establishes procedures and time frames for handling whistleblower complaints under the Affordable Care Act (ACA); for hearings...more

Recent Developments in Litigation Challenging the Medicare Appeals Delays: Is Victory Likely for Medicare Providers?

On September 19, 2016, the U.S. District Court for the District of Columbia (D.D.C.) refused to stay a highly anticipated case seeking to force the government to comply with statutory deadlines governing the Medicare appeals...more

D.C. Circuit Precludes Review of DSH Uncompensated Care Data

On July 26, 2016, the United States Court of Appeals for the District of Columbia Circuit decided Fla. Health Sciences Ctr. v. Burwell. In that case, the Court analyzed a statutory bar against judicial review of estimates...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

3,527 Results
|
View per page
Page: of 142

Follow Administrative Agency Updates on:

JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×