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Administrative Agency Health

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

Court of Appeals Reverses D.D.C. Order Requiring HHS to Eliminate Medicare Appeals Backlog by December 31, 2020

by Baker Ober Health Law on

Hopes were dashed for sooner relief from the backlog of Administrative Law Judge (ALJ) appeals. With the backlog of Medicare reimbursement appeals steadily growing, a reversal by the U.S. Court of Appeals for the District of...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

Under the Dome: Inside the Maine State House

by Pierce Atwood LLP on

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Looking Ahead . . . While the First Regular Session of the 128th Legislature has adjourned sine...more

FDA Issues Final Guidance For Medical Device Exchange of Patient Information

The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist...more

FDA Recalls St. Jude Medical Pacemakers for Cybersecurity Patches

The Food and Drug Administration (FDA) has issued a recall of 465,000 St. Jude Medical pacemakers in order to push a mandatory firmware patch of vulnerabilities in six types of radio controlled cardiac pacemakers....more

Publication of Final Regulations on Patent Linkage and Term Restoration

by Smart & Biggar on

On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more

D.C. Circuit Finds District Court Abused Discretion by Implementing a 4 Year Deadline to Clear Backlogged Administrative Appeals

On August 11, 2017, the D.C. Circuit issued its decision on the District Court’s order in American Hospital Association v. Price in a 2-1 decision, holding that the District Court abused its discretion by ordering the...more

Congressional Preview - Fall 2017

Summer isn’t quite over yet, but the August recess is coming to an end and Congress returns next week to resume work on a number of outstanding issues, as the Trump Administration continues to aggressively implement the...more

Court Finds Provider Failed to Exhaust Administrative Remedies in Suit Against Government Contractor for Withheld Reimbursement

by King & Spalding on

On August 28, 2017, the United States District Court for the Eastern District of Michigan held that a provider must fully exhaust administrative remedies before it can seek a remedy in Federal court against a Medicare...more

Drones Delivering Medical Supplies in East Africa but not in U.S.

Residents in remote areas of Tanzania and Rwanda in East Africa are receiving medical supplies through the use of drones, far surpassing similar efforts in the U.S., according to Robert Graboyes, a senior research fellow at...more

Health Alert (Australia) 28 August 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland (QLD) 21 August 2017 - A Practitioner v The Health Ombudsman [2017] QCAT 265 - PROFESSIONS AND TRADES – HEALTH CARE...more

FDA Seizes Stem Cell Therapy—A First of Many?

by Hogan Lovells on

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the...more

Court Says HHS Must Justify Methodology for Outlier Payments

by King & Spalding on

On August 18, 2017, the United States Court of Appeals for the District of Columbia ruled that HHS had inadequately justified its inclusion of data from hospitals that allegedly “turbo-charged” their cost-to-charge ratio when...more

FDA Announces New Device User Fees with Significant Increases for Some Submissions

by Hogan Lovells on

On August 29, 2017, FDA published a Federal Register notice with the device user fees for the Agency’s Fiscal Year (FY) 2018, which begins on October 1, 2017. Due to statutory increases, inflation adjustments and target...more

Hospitals Plagued by HHS's 2012 Medicare DSH Calculation Obtain Relief from the D.C. Circuit

by Baker Ober Health Law on

Hospitals affected by HHS's 2014 decision to include Medicare Part C enrollees as part of the Medicare fraction of the disproportionate share calculation obtained relief late last month when that position was voided by the...more

Ministry of Justice regulates the medical and scientific use of cannabis

by Dentons on

Through Resolutions 577–579, issued on August 8, 2017, the Ministry of Justice has regulated matters relating to (i) the evaluation and monitoring of licenses for the seeding and cultivation of cannabis plants, (ii) the...more

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

by Knobbe Martens on

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

Ninth Circuit Raises Bar for Approving Changes in State Medicaid Reimbursement

by Perkins Coie on

The U.S. Court of Appeals for the Ninth Circuit Court raised the bar last week for what states must prove to establish that their Medicaid provider reimbursement rates are sufficient to ensure a robust network of providers...more

Minnesota Patent Litigation Wrap-Up – July 2017

by Fish & Richardson on

This post continues our monthly summary of patent litigation in the District of Minnesota, including short summaries of substantive orders issued in pending cases. In July 2017, there were three notable decisions for...more

Health Alert (Australia) 7 August 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 July 2017 - Spragg and Australian Health Practitioner Regulation Agency [2017] WASAT 103 - The applicant made a complaint to the...more

D.C. Circuit Decides Part C DSH Issue in Favor of Providers

by King & Spalding on

On July 25, 2017, the United States Court of Appeals for the District of Columbia Circuit held that HHS violated the terms of the Medicare statute by failing to undertake notice-and-comment rulemaking in implementing its...more

Baker Administration and Legislature Debate Range of Health Care Proposals

Massachusetts policymakers are currently engaged in a robust debate over several proposals aimed at lowering health care costs in the Commonwealth. The House of Representatives rejected a set of MassHealth reforms that the...more

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