Health Care

As reported in a recent Privacy and Security Matters post, we have updated the “Mintz Matrix,” a summary of the U.S. state data breach notification laws. The Mintz Matrix is an invaluable tool for reviewing state breach notification requirements, which may apply in addition to HIPAA in the event of a data breach.

On December 22, 2014, a federal district court in New Jersey found that Mylan Pharmaceuticals, Inc. (“Mylan”) alleged facts sufficient to plead an antitrust claim under Section 2 of the Sherman Act.

Earlier this week the OIG released an advisory opinion stating that a nonprofit organization’s proposed arrangement to provide copayment assistance to financially needy patients would not result in civil monetary penalties or administrative sanctions, even though it could potentially generate prohibited remunerations under the anti-kickback statute.

The Supreme Court announced it will be hearing King v. Burwell – a case which could determine the future scope and reach of the Affordable Care Act (ACA) – on March 4, 2015. 

The Nonprofit Revitalization Act brought sweeping changes to the laws that govern not-for-profit corporations in New York. Our colleagues Anthony E. Hubbard and Daniel E. Wilcox have authored an Advisory that provides an in-depth summary of key provisions of the Act that have recently gone into effect.

Although health care reform implementation via the Affordable Care Act (ACA) has focused mostly on federal changes to the health care marketplace, individual States are getting some much needed help to design and implement their own efforts to improve quality and lower health system costs.

The Office for Human Research Protections (OHRP) is extending the comment period for its Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (Draft Guidance).

The American Telemedicine Association (ATA) is now accepting limited registrations for organizations that wish to gain ATA’s seal of approval for online medical services.

On December 4, 2014, CMS issued additional guidance regarding rewards and incentives programs (“RI Programs”). This guidance elaborates on whether an RI Program can target members with specific diseases, whether rewards can be tied to health outcomes, how to value rewards and incentives, and gives examples of appropriate and inappropriate rewards and incentives.

This year the Federal Trade Commission ("FTC") celebrated its centennial. Looking back on the FTC’s first 100 years, we have seen dramatic shifts in antitrust enforcement in the health care sector. 

A recently announced settlement between Anchorage Community Mental Health (“ACMHS”) and the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”) emphasizes, once again, the importance of compliance with the Security Rule and keeping IT infrastructure up to date.

A recent opinion from the Connecticut Supreme Court illustrates that HIPAA is not the only law that covered entities and business associates must worry about if an unauthorized disclosure of protected health information (PHI) happens on their watch.

On December 8th, the Centers for Medicare & Medicaid Services published its proposal for long-awaited changes to the Medicare Shared Savings Program (MSSP).  Our colleagues Daria Niewenhous, Andrew Shin, Lauren Moldawer *, and Stephanie Willis have authored an Advisory that provides an in-depth analysis of key provisions of the proposed changes and how they may impact current and future MSSP accountable care organizations created under the authority of the Affordable Care Act.

According to Federal Trade Commission Chairwoman Edith Ramirez, the healthcare sector will “remain a top agency priority.”  Thus, the FTC will undoubtedly continue to closely analyze combinations of providers in the industry. 

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. 

Last week, the Government Accountability Office (GAO) released a report examining group purchasing organization (GPO) practices. 

Yesterday both chambers of the Illinois legislature voted to override the Governor's amendatory veto and passed Public Act 098-1127, which prohibits a physician from charging a markup on anatomic pathology services if the physician orders but does not supervise or perform the service.

On November 24, 2014, the New Jersey Appellate Division affirmed a lower court’s decision to dismiss a physician’s lawsuit against a hospital based on federal and state statutory immunity provisions that shield hospitals and their peer review participants from monetary damages.

Our Health Care Enforcement Defense Practice has published its most recent Qui Tam Update analyzing 68 recently unsealed health care related whistleblower cases. In this issue, the team analyzes overall trends in the 68 cases, and looks more closely at three notable cases. 

The United States District Court for the Western District of Washington ruled recently that the state’s corporate practice of medicine doctrine does not provide a private right of action, either express or implied, and dismissed claims brought by State Farm Mutual Automobile Insurance Company and State Farm Fire and Casualty Company.