Health Care

Last week, federal regulators released a Proposed Rule outlining accommodations for religious employers that object to the Affordable Care Act’s contraception coverage mandate. The Proposed Rule expands the range of employers that qualify for the existing religious exemption and outlines promised accommodations for other religious employers.

Yesterday the Centers for Medicare & Medicaid Services (CMS) filed a proposed rule (the Proposed Rule) that would make significant changes to existing regulations governing the proficiency testing (PT) process mandated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). 

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register.

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register.  It amends key definitions and adds new terms; retains broad reporting provisions but includes new limitations; exempts certain continuing medical education (CME) payments from disclosure; and includes additional reporting guidance.

As described in a blog post earlier today, the Centers for Medicare & Medicaid Services (CMS) has released the Final Rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act).

In a set of Frequently Asked Questions1 (FAQs) posted to the Department of Labor’s website on January 24, the Departments of Health and Human Services, Labor, and Treasury (the “Departments”) put a stop to an approach to health plan design under which employers furnish employees with a pre-determined dollar amount (a “defined contribution”) that employees can apply toward the purchase of health insurance coverage in the individual health insurance market.

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug and Cosmetic Act (FDCA), I predicted in a previous post that the government would file a motion for rehearing and would eventually take the case to the U.S. Supreme Court.

On January 14, 2013, a group of stakeholders, including the AARP and the AFL-CIO, urged the Obama Administration to issue the long-awaited final rule (the "Final Rule") implementing the Physician Payments Sunshine Act (the "Sunshine Act").

Yesterday the Centers for Medicare & Medicaid Services formally announced the 106 new Accountable Care Organizations (ACOs) participating in the 2013 Medicare Shared Savings Program (MSSP) cycle. CMS also announced that 15 of the new ACOs qualified to participate in the Advance Payment ACO Model. 

In Advisory Opinion 12-21, the OIG concluded that a Federally qualified health center’s offer of grocery store gift cards to capitated managed care patients would not constitute grounds for the imposition of sanctions under the civil monetary penalty law’s beneficiary inducement prohibition or the Anti-Kickback Statute.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

The Federal Communications Commission (FCC) has created a new Healthcare Connect Fund (Fund), designed to expand health care provider (HCP) access to broadband technologies and to encourage the creation of broadband health care networks.

As was widely expected over the month of December, the Obama Administration and Congress scrambled in the late hours of 2012 and on New Year’s Day devising a legislative package to prevent the United States from going over the “Fiscal Cliff,” a series of across-the-board tax increases and spending cuts that would have automatically implemented without intervening legislative action.

The Department of Health and Human Services, Office for Civil Rights (OCR) reached its first settlement for a breach involving data regarding less than 500 individuals. Under the December 2012 settlement, the Hospice of North Idaho (HONI) will pay OCR a $50,000 penalty to resolve allegations that it violated the HIPAA Security Rule.

In OIG Advisory Opinion 12-20, the OIG determined that a proposed arrangement (the “Proposed Arrangement”) by a hospital (the “Requestor”) would not constitute grounds for the imposition of sanctions under the Anti-Kickback Statute (“AKS”).

A court has ruled that Merck’s production of documents to the government under a confidentiality agreement during the Vioxx investigation waived any confidentiality or privilege; documents that Merck had previously disclosed to the government under a confidentiality agreement must now be produced to private party plaintiffs in pending securities litigation.

Pitfalls in Healthcare Mergers and Acquisitions - Emerging Issues (The Health Lawyer, October 2012), is a must read for anyone contemplating, in the midst of, or even recovering from, a healthcare merger or acquisition.

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes where the pharmacy’s patients reside.

The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing. Given the number of off-label marketing cases pursued by the government in recent years, this decision could have major repercussions.