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OIG Approves Free Lodging and Meals Under "Promotes Access to Care" Exception to Beneficiary Inducement CMP

In Advisory Opinion 17-01, published March 10, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) approved an academic medical center's proposal to provide free or reduced-cost lodging and...more

Certain Medical Devices Exempted from 510(k) Requirements

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Federal Health Care Leaders Write Governors About New Direction for Medicaid

While much of the attention related to health care this week is focused on our nation’s capital, all 50 state governors have received a letter from recently confirmed U.S. Health & Human Services Secretary Tom Price and...more

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

Proof by Proxy in FCA Suits? District Court Says It Depends

Admissibility of statistical sampling to prove liability in FCA suit is fact dependent. In a February 14, 2017 decision, the Fourth Circuit declined to rule on the question of whether statistical sampling can be used to...more

Fourth Circuit Takes a Pass on Statistical Sampling, Finds DOJ's Settlement Veto Authority Unreviewable

After granting the relators’ petition for an interlocutory review of the district court’s rejection of the use of statistical sampling to establish FCA liability, the Fourth Circuit ultimately declined to reach that issue in...more

Sportbrain Sues Smartwatch Manufacturers, PTAB institutes IPR against Patent-in-Suit

Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent...more

ERISA: Winning Tactic on Summary Judgment to Prove Claimant Received the Policy: Get Key Evidence into the Administrative Record

You know that to apply an exclusion in a policy, the claims administrator must show that the claimant received the policy. But what happens when the claimant submits a declaration disputing your proof that she received...more

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

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