Administrative Agency Health

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District Court Denies Stay in Litigation Over Medicare Appeals Backlog

On September 19, 2016, the U.S. District Court for the District of Columbia rejected a request by HHS to stay proceedings in litigation brought by the American Hospital Association and several providers seeking to compel the...more

BREAKING NEWS: FDA Expected to Approve Amgen’s Humira Biosimilar Today

According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab...more

Alabama CON Report

I. SHPDA Administrative Report - Contested Case - AL2016-022, Geneva County Health Care Authority, Inc., Geneva AL: Proposes to acquire, relocate and operate five (5) geriatric psychiatric inpatient beds as an...more

CMS's Payment Suspensions Wreak Havoc: Understanding the Risks

CMS payment suspensions can cripple any provider's or supplier's operations. Yet, CMS has the authority to impose a payment suspension upon the mere existence of "reliable information" that an overpayment or fraud may exist....more

FDA Announces Upcoming Public Meeting on Its Recommendations for Reauthorizing the Biosimilar User Fee Act

Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the...more

Massachusetts Regulatory Overhaul: Hospitals, Clinics, Dialysis Units, and Medical Marijuana – Oh My!

The Massachusetts Department of Public Health (DPH) has released proposed amended regulations for the licensure of hospitals, clinics, and out-of-hospital dialysis units, proposed the rescission of separate birth center...more

D.C. District Ct Applies Prohibition on Administrative and Judicial Review to IRF PPS Rates

On July 25, 2016, Judge John D. Bates of the United States District Court for the District of Columbia issued a memorandum opinion broadly construing 42 U.S.C. § 1395ww(j) to prohibit administrative or judicial review of a...more

Federal Agencies Forced to Implement Huge Increases in Civil Monetary Penalties for Health Care Fraud

Thanks to section 701 of the Bipartisan Budget Act of 2015, Public Law 114–74, federal agencies have been forced to implement huge increases in penalties intended to deter health care fraud. The Federal Civil Penalties...more

Top Ten Things To Know About Florida's Amendment 2

The Basics: Amendment 2 is a voter-initiated constitutional amendment legalizing medical marijuana possession and use. Amendment 2 establishes a caregiver-patient system for medical marijuana distribution. Caregivers must be...more

Off-Label Promotion —To Speak or Not To Speak?

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

Wash Your Hands Before You Eat? Maybe Not with Antibacterial Soap According to the FDA

In a final rule published on Sept. 6, 2016, the U.S. Food and Drug Administration (FDA) reassessed its risk-benefit analysis for consumer antiseptic washes (antibacterial hand and body washes) and found that the evidence in...more

FDA Call For Comments on Off-Label Communications

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

CMS Proposes ACA Marketplace Benefit and Payment Parameters for 2018

CMS has proposed its annual Notice of Benefit and Payment Parameters, which would apply to participation in Affordable Care Act (ACA) Health Insurance Marketplaces for 2018. In particular, the rule proposes revisions to the...more

Health Alert (Australia) August 29, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 23 August 2016 - Secretary, Department of Health (as successor to the Secretary, Department of Social Services) v DLW...more

China FDA Clarifies Legal Consequences of Clinical Trial Data Inspections

China’s recent drug regulatory reform has emphasized that clinical trial data must be authentic and reliable. However, the legal consequences for breaching data integrity requirements in clinical trials remain ambiguous. On...more

Hospital and Fixed Indemnity Policies; Excepted Benefits; Supplemental Coverage under Recently Proposed Treasury Regulations; and...

We reported in a recent post on proposed regulations dealing with, among other things, the treatment of hospital indemnity or other fixed indemnity insurance products in the group market. This post takes a closer look at the...more

HHS Wins Summary Judgment Against Hospitals Disputing CMS’s Treatment of Part C Days as Days “Entitled to Part A” for Purposes of...

On August 17, 2016 the United States District Court for the District of Columbia granted summary judgment in favor of HHS in a dispute over whether Part C days can be treated as “days entitled to benefits under Part A” for...more

Massachusetts Determination of Need Regulation Overhaul

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and, perhaps, long overdue overhaul of the DoN Program regulations....more

D.C. District Court Invalidates CMS’s “Protest” Requirement

On August 19, 2016, the United States District Court for the District of Columbia granted a group of hospitals’ motion for summary judgment against HHS in a challenge of the Provider Reimbursement Review Board’s (PRRB) denial...more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

HRSA Releases Proposed Rule Governing the Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more

FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

A Favorable, New Climate for Challenging Medicare Appeals

Over the past decade, health care providers seeking to challenge Medicare claim denials have faced increasing delays in reaching what many consider the most important step in the Medicare appeals process - a hearing before an...more

CMS Re-proposes Ban on Per-Click Fees for Space and Equipment Leases under Stark

In the CY 2017 Medicare Physician Fee Schedule (CY 2017 MPFS), the Centers for Medicare & Medicaid Services (CMS) issued proposed updates to the physician self-referral law (Stark law). The primary Stark law update focused on...more

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