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.

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).

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.

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 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. 

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.

On November 26th, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) released guidance on the methods that covered entities and business associates can use to de-identify protected health information (PHI) in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.

On November 14th, the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) published A Resource Guide to the U.S. Foreign Corrupt Practices Act, their long-awaited, highly anticipated guidance on the FCPA.

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.