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The Akorn Case – New Development in Delaware for Termination by Material Adverse Effect

In Akorn, Inc. v. Fresenius Kabi AG, C.A., No. 2018-0300-JTL Del. Ch. October 1, 2018, the Delaware Court of Chancery determined that the buyer (Fresenius) had validly terminated a merger agreement because (i) the seller’s...more

Medicare Proposes Revised Telehealth Services and Payments

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule, primarily intended to modify certain Medicare payment policies. The Proposed Rule contains several provisions that address the growing...more

Private Equity Firm Named As Defendant In False Claims Act Case Targeting A Portfolio Company

A recent complaint filed by the United States against a private equity firm regarding an alleged kickback further illustrates new concerns private equity should be aware of in the healthcare arena and working with counsel to...more

New York 13 Hour Rule

The New York State Department of Labor (DOL) adopted an emergency temporary regulation on October 6, 2017 to address home care aides who work shifts of 24 hours or more. This action comes amidst much anxiety in the industry...more

Draft Interpretive Guidelines for COPs for Home Health

The Centers for Medicare & Medicaid Services (CMS) has released a draft of interpretive guidelines (Guidelines) to the Home Health agency Conditions of Participation (the COPs). After having previously been delayed, the COPs...more

Public Act 17-241 — An Act Concerning Fairness in Pharmacy and Pharmacy Benefits Manager Contracts

Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and...more

Public Act 17-241 — An Act Concerning Fairness in Pharmacy and Pharmacy Benefits Manager Contracts

Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and...more

Connecticut Enacts Legislation Intended to Curb Opioid Drug Abuse

On June 30, 2017, Connecticut Governor Dannel P. Malloy signed into law An Act Preventing Prescription Opioid Diversion and Abuse (Public Act No. 17-131). This legislation addresses opioid drug abuse in Connecticut by...more

Senate Proposes Expanded Use of Telehealth

On May 18, 2017, the Senate Finance Committee voted to move forward a bill entitled the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S870), which would increase access to...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more

CMS Finalizes MACRA Rule and Continues Transition Toward Value-based Payments

On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released a final rule with comment period (Final Rule) implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Final Rule...more

Third Circuit Delivers Resounding Victory for FTC in Pennsylvania Hospital Merger Case

On September 27, 2016, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission (FTC) a significant antitrust victory by granting its request for a preliminary injunction to stay the pending merger...more

Health Law Pulse - September 2016

DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE - On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more

Health Law Pulse - July 2016

On June 14, 2016, a federal district court in the Northern District of Illinois denied a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger of Advocate Health Care...more

Connecticut Legislative Update: Public Act 16-77: An act concerning patient notices, designation of a health information...

This legislation (P.A. 16-77) makes substantive and technical changes related to Public Act 15-146, a major public health and health care bill passed by the Connecticut Legislature during its 2015 Legislative Session....more

Medicare Launches Home Health Pre-Claim Review Demonstration in Five States

The Centers for Medicare and Medicaid Services (CMS) recently announced it will implement a pre-claim review demonstration for home health services. The three-year demonstration will apply to home health services performed in...more

Health Law Pulse - June 2016

On May 9, 2016, a federal district court for the Middle District of Pennsylvania rejected a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger (Merger) between Penn...more

Connecticut Legislature Passes Bill Limiting Physician Non-Compete Agreements

The Connecticut legislature recently passed Public Act No. 16-95 (PA 16-95), which aims to increase competition among health care providers by, among other things, restricting physician non-compete agreements. Though passed...more

Internal Revenue Service Issues Proposed Regulations Affecting Type I and Type III Supporting Organizations

On February 19, 2016, the IRS issued proposed regulations regarding Type I and Type III supporting organizations (Proposed Regulations). The Proposed Regulations implement amendments to Section 509(a)(3) of the Internal...more

Connecticut Governor Dannel P. Malloy Establishes Certificate of Need Task Force and Places Temporary Moratorium on Certain...

On February 25, 2016, Connecticut Governor Dannel P. Malloy issued Executive Order No. 51 (Executive Order), which establishes a taskforce (Taskforce) to study and provide recommendations on the state’s certificate of need...more

CMS Finalizes 60-Day Rule Overpayment Regulations

On February 12, 2016, the Centers for Medicare & Medicaid Services (CMS) released a final rule (Final Rule) interpreting the application of Section 1128J(d) of the Social Security Act (the 60-Day Rule) to over payments...more

CMS Issues Final Rule Implementing Mandatory Bundled Payment Program for Lower Extremity Joint Procedures

The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule (Final Rule) that implements the Comprehensive Care for Joint Replacement model (CJR Model), a new bundled payment program covering certain...more

Health Law Pulse - January 2016

CHANGES TO STARK LAW, NEW ADVANCE CARE PAYMENTS INCLUDED IN 2016 PHYSICIAN FEE SCHEDULE - The Centers for Medicare & Medicaid Services (CMS) recently published a final rule (Final Rule) regarding physician payment...more

DOJ and OIG Launch Wave of Aggressive Prosecutions Targeting Entities and Individuals for Illegal Health Care Marketing Practices

In the last few months, the United States Department of Justice (DOJ) and the Office of Inspector General (OIG) have obtained over half a billion dollars in settlements and multiple criminal convictions arising from...more

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