Articles and Blogs

On July 25, 2017, the Food and Drug Administration (“FDA”) issued guidance (the “Guidance”) stating that it does not intend to object to an Institutional Review Board’s (“IRB”) wavier of the informed consent requirements for human subjects research involving no more than minimal risk. The Guidance, effective immediately, aligns the FDA’s policy on the waiver of…Read More

As we reported in a previous article, the Third Circuit recently decided in Doe v. Mercy[1] that: 1) the medical residency program of the facility being sued in that case was an “educational program or activity” under Title IX; and 2) the medical resident had standing to sue under Title IX even though the resident…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”). Hall Render published an overview of Final Regulations components as well as Parts 1, 2,…Read More

Amazon is taking strides to enter one of the most complex of industries: health care. In late 2016, Amazon began investigating the possibilities of leveraging its supply chain to meet health care consumers’ needs. Amazon Business, Amazon’s current supply chain platform, has already transformed the supply chain industry, generating over $1 billion in sales in…Read More

The single largest and most unexpected change proposed in the 2018 Proposed PPS Rule is the announcement that the Home Health Groupings Model (“HHGM”) will be implemented as of January 1, 2019. Although the Centers for Medicare & Medicaid Services (“CMS”) released a detailed technical report on the HHGM last fall, the industry did not anticipate…Read More

On August 15, 2017, CMS released for public inspection a proposed rule that would: Cancel the AMI, CABG and SHFFT episode payment models that are currently scheduled to begin on January 1, 2018. Cancel the cardiac rehabilitation incentive payment program that is currently scheduled to begin on January 1, 2018. Revise various aspects of the…Read More

The public disclosure bar remains one of the most important tools for disposing of False Claims Act (“FCA”) claims. The Seventh Circuit’s recent decision in United States ex rel. Bellevue v. United Health Services of Hartgrove, Inc. clarified the effect of the 2010 amendments to the public disclosure bar and affirmed the dismissal of whistleblower allegations…Read More

Just over half a year into the new administration, significant developments have occurred that may permanently alter the landscape of the 340B drug discount program (“340B Program”), developments so significant that the mainstream news media has started to take notice.[1] As 340B Program participating “Covered Entities” and their contract pharmacy partners work to develop their…Read More

NATIONAL 7 statistics on physician compensation — average sign on bonus is $18k Elderly may be blocked from suing nursing homes for neglect, abuse 25% of Physicians Dissatisfied with Provider Compensation Rates 9 hospitals, health systems opening or planning ASCs — July 2017 Non-physician providers, support staff a driving factor behind more profitable physician groups,…Read More

Recently, the Department of Justice (“DOJ”) announced it had entered into a $42 million settlement (“Settlement”)[1] with the owners of a California acute care hospital (“Parent Company”) to resolve allegations that the Parent Company had violated the False Claims Act by submitting false claims to Medicare and MediCal (California Medicaid) programs. The Parent Company is…Read More