Hospitals

News & Analysis as of

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

EPA Proposes RCRA Rules Easing Standards For Pharmaceutical Wastes And Revising Generator Standards

The U.S. Environmental Protection Agency (EPA) on August 31, 2015, proposed two rules under the Resource Conservation and Recovery Act (RCRA) that would alter fundamentally the hazardous waste regulatory program. One rule...more

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

St. Elizabeth’s Medical Center Pays $218,400 to Settle Alleged HIPAA Security Case Stemming from Use of Cloud-Based Document...

Alleged HIPAA Violations Resulted from Medical Center’s Failure to Risk Assess Internet-Based Document Sharing Application and Inadequate Breach Response. The US Department of Health and Human Services (HHS) Office for...more

Blue Cross of Northeastern Pennsylvania Denied Peer Review Protection

The Pennsylvania Superior Court has decided the Pennsylvania Peer Review Protection Act does not apply to alleged peer review activity conducted by Blue Cross of Northeastern Pennsylvania, because Blue Cross is not a...more

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Take 2: A lesson from the healthcare industry

There are certain mistakes made by doctors or other healthcare professionals that result in the need for further treatment. An example is sponge that is left behind during surgery, which generally necessitates further...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

Texas Hospital Strikes Back at Aetna

On February 23, 2015, Aetna filed suit in Texas federal court against Robert A. Behar, M.D. and North Cypress Medical Center (North Cypress), alleging that Dr. Behar, the CEO of North Cypress, offered impermissible ownership...more

Prepare the ground for effective contract administration: the UK’s Privy Council looks at termination risks and the employer’s...

Introductory remarks - The UK’s Privy Council recently considered the interpretation of two clauses in the FIDIC Red Book 1999, concerning the obligations of an employer to evidence financial arrangements and to notify...more

Comprehensive Care for Joint Replacement: CMS adopts mandatory approach to payment reform

On July 9, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that seeks to implement a mandatory episode-based payment model for lower extremity joint replacement (and reattachment) care in...more

Proposed Changes to Stark Rule Would Create New Hospital Exceptions and Lessen Burden of Self-Disclosures

In a development that is limited in scope but still welcomed by hospitals, the proposed 2016 Physician Fee Schedule proposes a number of new exceptions to the physician self-referral or Stark law and other refinements that...more

Court Rejects Claim that a Doctor’s Loss of Privileges is an Antitrust Injury

A federal appeals court held that a doctor who lost his privileges at a local hospital failed to establish an antitrust injury sufficient to confer standing under the Sherman Act. The United States Court of Appeals for the...more

When the Government Comes Knocking

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Tennessee Supreme Court Throws Out Applicant's Workers' Compensation Retaliation Claim Against Prospective Employer

On August 21, 2015, the Tennessee Supreme Court held that a job applicant does not have a cause of action under the Tennessee Workers' Compensation Act (TWCA) against a prospective employer for failure to hire based on the...more

CMS Publishes Corrections to Comprehensive Care for Joint Replacement Model Proposed Rule

On August 25, 2015, the Centers for Medicare & Medicaid Services (CMS) published technical and typographical corrections to its July 14, 2015 proposed rule to establish a Comprehensive Care for Joint Replacement Model. As...more

CMS Updates Inpatient Hospital “Two Midnight” Review Education/Enforcement Strategy

CMS recently provided an update on its education and enforcement strategies related to its “Two Midnight” policy, which addresses when surgical procedures, diagnostic tests and other treatments are generally considered...more

Conscience Clauses for Health Care Providers

There has been a lot of news lately about a person’s right to decline to provide a service to another for reasons of conscience. For example, after the U.S. Supreme Court decision regarding marriage equality, the N.C....more

Hospital Compliance Program Overview

?In the constantly evolving climate of health care enforcement, maintaining a comprehensive and effective internal compliance program has taken on added significance, especially in the past few years. While detailed coverage...more

The 60 Day Rule — Identification and Knowing Avoidance

On August 3, 2015, the United States District Court for the Southern District of New York issued an opinion and order in Kane v. Healthfirst, Inc., et al.[1] that provides the first judicial interpretation of the requirement...more

Corridors September 2015 - News for North Carolina Hospitals

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

The Health Law Guide to Hospital Operations

This operations guide provides a brief look at health law issues hospitals deal with on a daily basis. While a detailed coverage of the elements, drafting, implementation and continued governance of a hospital compliance...more

CMS's "At a Collection Agency" Bad Debt Policy - Confusion Continues

As we reported in previous Payment Matters articles, the United States District Court for the District of Columbia has issued inconsistent opinions regarding Medicare's policy not to allow bad debt when that bad debt is still...more

Applying for a Waiver From U.S. Manufacturing Requirements For Federally Funded Intellectual Property

Countless ideas and inventions are developed at U.S. universities every year, often with federal funding. Many of these important ideas could not be commercialized for the public’s benefit without the Bayh-Dole Act, which...more

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