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OSHA Issues New Whistleblower Guidelines

The Occupational Safety and Health Administration (OSHA) has issued a final rule on the procedures, processes, and timeframes for handling whistleblower complaints under the Affordable Care Act (ACA), as well as for hearings...more

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

Affordable Care Act Whistleblower Complaint Procedures

On October 11, 2016, the Occupational Safety and Health Administration published a final rule that establishes procedures and time frames for handling whistleblower complaints under the Affordable Care Act (ACA); for hearings...more

Recent Developments in Litigation Challenging the Medicare Appeals Delays: Is Victory Likely for Medicare Providers?

On September 19, 2016, the U.S. District Court for the District of Columbia (D.D.C.) refused to stay a highly anticipated case seeking to force the government to comply with statutory deadlines governing the Medicare appeals...more

D.C. Circuit Precludes Review of DSH Uncompensated Care Data

On July 26, 2016, the United States Court of Appeals for the District of Columbia Circuit decided Fla. Health Sciences Ctr. v. Burwell. In that case, the Court analyzed a statutory bar against judicial review of estimates...more

10 Key Takeaways from FDA’s Draft Guidance on 510(k) Modifications

The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens. The US Food and Drug Administration (FDA or the Agency) issued...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

Court Rules in Favor of Hospitals in Bad Debt Collection Effort

On July 25, 2016, the United States District Court for the District of Columbia issued an opinion favoring provider flexibility in the reasonable collection of Medicare bad debt. Winder HMA, LLC, et al. v. Sylvia Burwell. The...more

Court Upholds CMS's Inclusion of Part C Days in Medicare Fraction of DSH Calculation FYE 2012

On August 17, 2016, the United States District Court for the District of Columbia upheld the position of the Secretary of Health and Human Services (Secretary) that Part C patients were to be considered as “entitled to...more

D.C. District Court Strikes Down PRRB's Application of "Self-Disallowance" Jurisdictional

In Banner Heart Hospital, et al. v. Burwell, the United States District Court for the District of Columbia (Court) held on August 19, 2016, that the Provider Reimbursement Review Board (PRRB) incorrectly declined to hear an...more

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

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