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HHS Finalizes Appeals Backlog Rule in Wake of Judicial Order

The U.S. Department of Health and Human Services (HHS) released a Final Rule aimed at reducing and eventually eliminating the backlog of more than 650,000 claims currently awaiting adjudication by an administrative law judge...more

Relocation of the EU Medicines Agency: Italy

The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more

WPI Insider Briefing: New President, New Congress, New Direction in Workplace Policy

President Donald J. Trump was sworn into office on January 20, 2017, ushering in a new balance of power in Washington and what is expected to be a dramatically different era of workplace policy. On his first day in office,...more

Mississippi CON Report

CON – Final Orders - CON Review: ESRD-ES-1116-023 – RCG Tunica, LLC d/b/a Tunica Dialysis – Expansion of ESRD Stations at Existing ESRD Facility – Capital Expenditure: $1,374,346.00 – Location: Tunica, Tunica County,...more

SAMHSA Continues to Update Rules Related to Substance Abuse Records

On January 13, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the Final Rule to revise 42 C.F.R. Part 2 (Part 2 Regulations) – the federal regulations that govern the confidentiality of...more

HHS Publishes Final Rule Overhauling the Medicare Appeals Process

The Department of Health and Human Services (HHS) published its final rule revamping the Medicare appeals process at the Administrative Law Judge (ALJ) level on January 17, 2017. The final rule extensively revises federal...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

One in, Two Out: Potential FDA Uncertainty for Medical Device and Pharmaceutical Companies

On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs”...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

OIG Expands Exclusionary Authority

The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more

FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating...more

Current good manufacturing practice requirements for combination products

On January 11, 2017, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products.”[1] This guidance describes and explains...more

Perspectives for the Professions: Case Summary: Third Party Accreditation

B.C. College of Optics Inc. v. The College of Opticians of British Columbia, 2016 BCCA 85, allowing an appeal of the lower Court’s finding that the regulator could not require a third-party assessment of a training program as...more

FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement...

On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement...more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

Health Care E-Note - January 2017

On October 4, 2016, The Centers for Medicare and Medicaid Services ("CMS") released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

Perspectives for the Professions - January 2017: Case Summary: Test for Interim Conditions

Scott v. College of Massage Therapists of BC, 2016 BCCA 180, allowing an appeal of the lower Court’s decision to quash an interim condition on practice. A massage therapist was the subject of a complaint that he had...more

FDA Issued Draft Guidance on Interchangeability

Today, the FDA announced the availability of a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product,” which is currently available on FDA’s...more

Birmingham Medical News: End in Sight for Medicare ALJ Backlog?

As providers who are currently undergoing a Medicare claims appeal know, there is a lengthy delay to having an appeal actually heard by an Administrative Law Judge (“ALJ”). Some estimates indicate that it will currently take...more

HHS Ordered To Eliminate Medicare Appeals Backlog By 2021

On January 4, 2017, the U.S. District Court for the District of Columbia rejected a request by the Secretary of HHS asking the court to reconsider its decision that requires HHS to eliminate the backlog of Medicare claims...more

Mississippi CON Report

Certificates of Need Approved and Staff Recommendations – December 2016 - 1. CON – Final Orders - a. CON Review Number: HG-A-0715-015 – Singing River Health System d/b/a Singing River Hospital – Amendment and Cost...more

U.S. Access Board Issues Standards for Medical Diagnostic Equipment

Seyfarth Synopsis: Many years in the making, today the Access Board issued design criteria and other standards for medical diagnostic equipment. Today, the U.S. Access Board issued new accessibility standards for medical...more

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more

U.S. District Court for District of Columbia Requires HHS to Eliminate Medicare Appeals Backlog by December 31, 2020

On December 5, 2016, a U.S. District Court for the District of Columbia granted summary judgment in American Hospital Association, et al., v. Burwell, in favor of the American Hospital Association (AHA) in its quest to reduce...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

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