Articles and Blogs

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued Advisory Opinion 16-12, determining that a proposed arrangement for a laboratory to provide test tube and specimen collection container labeling to dialysis facilities had the potential to violate the Anti-Kickback Statute (“AKS”). Background The requesting laboratory (“Requestor”) provides certain laboratory testing…Read More

This is another article in a series discussing the complete overhaul of Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities (“Final Regulations”) by the Centers for Medicare & Medicaid Services (“CMS”). Background On September 28, 2016, CMS released a complete overhaul of Part 483…Read More

While the holidays are upon us and many are traveling over the valley and through the wood, the Wisconsin Department of Quality Assurance (“DQA”) has issued a notice reminding health care providers that there is no time off from the reporting requirements under Wisconsin Statutes §457.25(1). This statute, and several like it, apply to any…Read More

The 21st Century Cures Act passed the U.S. House of Representatives on November 30, 2016 with a 392 to 26 margin and passed the U.S. Senate on December 7, 2016 with an 85 to 13 margin. The $6.3 billion health care bill is expected to be signed by President Obama on December 13, 2016. Above…Read More

Congress Passes 21st Century Cures Bill On December 7, the Senate passed the sweeping 21st Century Cures bill (H.R. 34), clearing the way for it to be signed into law. The Senate vote comes a week after House passage of the $6.3 billion medical research funding bill that makes comprehensive mental health reforms and provides…Read More

On December 8, 2016, the Centers for Medicare & Medicaid Services (“CMS”) posted the final Office of Management and Budget (“OMB”) approved version of the Medicare Outpatient Observation Notice (“MOON”) on its Beneficiary Notices Initiative website. CMS indicated that hospitals and critical access hospitals (“CAHs”) are required to provide the MOON to applicable patients beginning…Read More

On December 7, 2016, the Senate passed the 21st Century Cures Act (H.R. 34) (“Cures Act”), which, among many other changes, revises Section 603 of the Bipartisan Budget Act of 2015 (“Section 603”) to provide an exception for off-campus provider-based departments (“PBDs”) that were mid-build or under development prior to November 2, 2015. The Cures…Read More

On December 6, 2016, the Michigan House unanimously passed Senate Bill 753, which incorporates provisions related to telehealth into the Michigan Public Health Code (the “Code”). The bill adds six sections to the Code to permit health professionals to provide telehealth services after obtaining informed consent from patients. Additionally, the bill sets standards for drug…Read More

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) released a final rule (“Final Rule”) codifying new safe harbors to the Anti-Kickback Statute (“AKS”) and new exceptions to the beneficiary inducement provisions of the Civil Monetary Penalties law (“CMP”). In the Final Rule, OIG focused its efforts on…Read More

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) published a final rule (“Final Rule”) clarifying several exceptions to the Civil Monetary Penalties law (“CMP”) dealing with beneficiary inducements. OIG has finalized all of the beneficiary inducement CMP exceptions proposed in the October 2014 proposed rule (“Proposed Rule”).1…Read More