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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Alabama CON Report

I. For Informational Purposes Only - Contested Case - AL 2017-024, The Troy Hospital Health Care Authority d/b/a Troy Regional Medical Center, Troy, Alabama: Proposes to acquire, relocate and operate 18 geriatric...more

The Tennessee Health Services and Facilities Report - August 2017

by Burr & Forman on

The Tennessee Health Services and Development Agency ("HSDA") is responsible for regulating the health care industry in Tennessee through the Certificate of Need Program. A Certificate of Need ("CON") is a permit for the...more

Federal Government Does About-Face on Enforcement of Arbitration Agreements in Employment Contracts

by Foley & Lardner LLP on

One of the changes in approach that the current administration has taken to the legal system—a change often overshadowed by other headlines—is the current administration’s willingness to enforce arbitration clauses. While...more

Pharmacyclics Receives FDA Approval for Imbruvica in Treatment for Chronic Graft Versus Host Disease

by Knobbe Martens on

On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...more

CMS Proposal Terminates and Revises Mandatory Bundled Payment Models

by Polsinelli on

On August 15, 2017, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule which would cancel the Episode Payment Models (EPMs) and the Cardiac Rehabilitation (CR) incentive payment model, each of which...more

Another Key to HIPAA Compliance – Have Policies and Procedures and Implement Them, Too

by Williams Mullen on

On this blog, we have discussed the criticality of risk analyses – the assessment required by the Security Rule of the “risks and vulnerabilities” that an organization faces with respect to all of its electronic protected...more

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

by Knobbe Martens on

Globus Medical announced early yesterday that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017....more

Recent 11th Circuit Decision Is a Victory for Health Care Providers Challenging Insurer Reimbursement Decisions and a Reminder of...

by K&L Gates LLP on

The existence and scope of assignments of benefits from patients to health care providers continues to be critically important to a provider’s ability to challenge an insurer’s reimbursement decision under the Employee...more

A Rose by Any Other Name: Drug Claims Make Your Cosmetic a Drug

by Arnall Golden Gregory LLP on

Last month, FDA district offices issued Warning Letters to two cosmetic companies for making claims that established their products as drugs. In finding that the products were new drugs requiring premarket approval, FDA...more

AGG Food and Drug Newsletter - August 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

The State AG Report Weekly Update

by Cozen O'Connor on

2018 AG Elections- Democrat Amy Padden Announces Bid for Colorado Attorney General- Democrat Amy Padden, former Executive Assistant U.S. Attorney and Law Enforcement Coordinator for the District of Colorado, announced...more

Massachusetts Employers Face $200 Million Increase in Health Care Costs under MassHealth Amendments

On August 1, Massachusetts Governor Charlie Baker signed into law H. 3822, “An Act Further Regulating Employer Contributions to Health Care” (the “Act”). The purpose of the Act is to shore up the finances of the...more

House Passes Bill Relaxing Reporting Requirements

by Knobbe Martens on

The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to...more

District Court Finds Hospital’s Joint Venture Not “Per Se” Unlawful

On the eve of trial, and after years of litigation (including an appeal to the Sixth Circuit), all claims by Dayton, Ohio hospital The Medical Center at Elizabeth Place (“MCEP”) against Premier Health Partners (“Premier”)...more

Blog: OIG Releases August Work Plan Items

by Cooley LLP on

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The August updates released this week include 4 new Work Plan items:...more

New York Appellate Court Curtails NY AG Investigatory Subpoena on Constitutional Grounds

by Jones Day on

On June 21, 2017, a New York appellate court curtailed on constitutional grounds an investigative subpoena issued by the New York Attorney General. In the Matter of Evergreen Assoc., Inc., 54 N.Y.S.2d. 135 (App. Div. 2017)....more

Medicare Secondary Payer Act Class Actions

There have been a substantial number of putative class actions filed recently against insurers involving the Medicare Secondary Payer Act (MSPA). These cases are typically filed by assignees of Medicare advantage...more

MACRA: Proposed Changes to the Merit-Based Incentive Payment System Track

by Polsinelli on

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on the Medicare Quality Payment Program (QPP) in the Federal Register1 on June 30, 2017. This rule proposes the QPP program requirements for...more

Healthcare & Life Sciences Private Equity Deal Tracker: Ares Management PE Group Invests $1.45 Billion in DuPage Medical Group

by McGuireWoods LLP on

DuPage Medical Group has closed a strategic partnership with funds managed by the private equity group of Ares Management, according to a press release. The $1.45 billion transaction closed August 15....more

Sign, Sign, Everywhere A Sign: Don’t Overlook What FDA Says and Writes

by Arnall Golden Gregory LLP on

In the 1971 song, “Signs,” the Canadian rock band, Five Man Electrical Band sang, “Sign, Sign, Everywhere a Sign … Can’t You Read the Sign?” The lyric resonates with us periodically as we discuss with a client a response from...more

Thank You Very Much, Mr. Roboto: FDA Announces New Digital Health Programs

by Arnall Golden Gregory LLP on

Scott Gottlieb, M.D., FDA's commissioner, recently announced new digital health initiatives that will aid in the agency's push to regulate and support digital healthcare in the medical device space. In a statement posted to...more

Need OSHA Action On Ammonium Nitrate And Healthcare Workplace Violence, Government Monitor Urges

by Jackson Lewis P.C. on

Focus is needed on two safety and health priorities: healthcare workplace violence and high-risk facilities that handle hazardous substances such as ammonium nitrate, chief of the Government Accountability Office Gene L....more

Lawyers, Drugs, and Money – The Opioid Crisis Makes for Strange Bedfellows

by Arnall Golden Gregory LLP on

It seems that almost every day there is a new development in the government’s response to the opioid crisis or opioid emergency. But it’s not only the government and healthcare providers that are considering novel approaches....more

Maintaining Privilege for Quality Assurance Performance Improvement (QAPI) Documents and Reports

The Affordable Care Act (ACA), which was passed in 2010, provides authority for the Centers for Medicare & Medicaid Services (CMS) to establish and implement a Quality Assurance and Performance Improvement program for nursing...more

CMS Proposes Cancellation of Medicare Cardiac/Hip Fracture Episode Payment Models, Scale-Back of Mandatory CJR Participation

by Reed Smith on

The Centers for Medicare & Medicaid Services (CMS) has just released a proposed rule to cancel a significant — but still-pending — Obama Administration program that would require certain hospitals to participate in Medicare...more

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