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

Policy Management Lessons From the VHA

by NAVEX Global on

Corporate compliance officers can learn a lot from their counterparts in government agencies. Today we’re going to review lessons about successful policy management, or the lack thereof, from the Veterans Health...more

FDA Simplifies and Clarifies Expanded Access Program

by Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

by Foley & Lardner LLP on

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more

A Conversation on CMS’ Emergency Preparedness Compliance for Healthcare Providers

by Carlton Fields on

Hurricane Irma recently wreaked havoc on the Caribbean and much of the state of Florida. In the storm's aftermath, ten residents of a South Florida nursing facility died because the facility lost power, and did not have...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

FDA Launches New Tool For Accessing Drug Adverse Event Information

by Hogan Lovells on

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more

Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

Perspectives for the Professions Newsletter - September 2017: Importance of Clear Guidelines and Policies

by Field Law on

Silwin v College of Physicians and Surgeons, 2017 ONSC 1947, upholding a Discipline Committee’s decision to reject a defence of officially induced error on the basis that the professional unreasonably misinterpreted the...more

Medicare Appeals Backlog: A Setback and New Opportunities for Providers

by McDermott Will & Emery on

As of June 2017, the Office of Medicare, Hearing and Appeals (OMHA) had 607,402 appeals pending with a current estimated wait time of three years for an Administrative Law Judge to process a provider’s appeal. At this rate,...more

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

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