Articles and Blogs

The Food and Drug Administration (“FDA”) is seeking comments on a draft guidance entitled “Design Considerations for Devices Intended for Home Use.”  The draft guidance urges manufacturers to “design out” product risks and consider usability and training for medical devices intended for use in a home environment.  The deadline for submitting comments on the... READ MORE

In 2003, two fires in long-term care facilities resulted in 31 resident deaths. As a result of these two events, CMS analyzed the fire safety precautions in place in these facilities and determined that resident safety could be greatly improved by requiring that all long-term care facilities have automatic sprinkling systems installed throughout the... READ MORE

The Patient Protection and Affordable Care Act (PPACA) requires all skilled nursing facilities (SNFs) and nursing facilities (NFs) to have an effective compliance and ethics program in place by March 23, 2013.  Unfortunately, the Centers for Medicare & Medicaid Services (CMS) has failed to publish final regulations covering these programs, as required under PPACA, by... READ MORE

Under the Bundled Payments for Care Improvement initiative, organizations will enter into payment arrangements that include financial and performance accountability for episodes of care. The Centers for Medicare & Medicaid Services (CMS) hopes these models may lead to higher quality and more coordinated care at a lower cost to Medicare.   READ MORE

Today, the Centers for Medicare & Medicaid Services (CMS) announced that over 500 organizations will begin participating in the Bundled Payments for Care Improvement initiative. Through this new initiative, made possible by the Affordable Care Act (ACA), CMS will test how bundling payments for episodes of care can result in more coordinated care for... READ MORE

On January 30, 2012, the Centers for Medicare & Medicaid Services (“CMS”) announced the new, lower prices that will go into effect July 1, 2013 in the substantial expansion of the Durable Medical Equipment, Prosthetics, Orthotics and Supplier (“DMEPOS”) Competitive Bidding Program. The Competitive Bidding Program prices will replace Medicare’s existing fee schedule amounts... READ MORE

In a suit brought against an Ohio nursing facility related to improper medication administration, the U.S. Court of Appeals for the Sixth Circuit allowed the use of res ipsa loquitur in finding a facility responsible for lapses in a resident’s medication regime.   READ MORE

On January 2, 2013, the Department of Health and Human Services (“HHS”) announced that it had reached a settlement with a hospice provider (“Hospice”) arising from potential violations of the Security Rule under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  HHS learned of the circumstances giving rise to the enforcement action... READ MORE

On December 19, 2012 the Department of Justice announced the owners and operators of two Miami health care agencies pleaded guilty for their participation in a $48 million home health Medicare fraud scheme.  According to plea documents, the owners conspired with patient recruiters for the purpose of billing the Medicare program for unnecessary home... READ MORE

The Federal Communications Commission (FCC) has just issued a release detailing the establishment of the Healthcare Connect Fund (the “Fund”) to reform and modernize its universal service program for health care.  Recognizing the importance of high-speed data connectedness for quality patient care and burgeoning  health care practices such as telemedicine, the FCC is expanding and reforming its existing Rural Health... READ MORE