12/23/2021 7:10:15 PM Future of discount safe harbor for prescription drugs remains uncertain By Ryan Pate In November 2020, four months after the Trump Administration issued a series of Executive Orders reiterating its policy goals on reducing...
11/22/2021 4:30:52 PM New and improved proposed national coverage determination on screening for lung cancer with low dose CT By Tom Greeson The Centers for Medicare and Medicaid Services (CMS) is proposing significant and important modifications to its National Coverage...
11/10/2021 8:28:18 PM SCOTUS to examine “good faith” defense in criminal opioid prescription cases By Alexandra Hussey On Nov. 5, 2021, the U.S. Supreme Court consolidated and granted certiorari to a pair of cases involving physicians who were criminally...
11/5/2021 4:35:53 PM CMS issues interim final rule on SARS-CoV-2 vaccination for health care workers By Matthew Loughran The Centers for Medicare and Medicaid Services (CMS) has published an interim final rule that changed the conditions of participation in...
10/27/2021 12:22:50 PM HHS-OIG approves uniform chiropractic discount program for federal beneficiaries By Andrew Hayes Quynh La Andrew and Quynh are law clerks at the firm and their work is supervised by licensed attorneys. Their admission to – respectively – the...
10/14/2021 1:24:04 PM FDA codifies requirements for the medical device De Novo classification process By Andrew Lu On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device...
9/28/2021 12:00:43 PM FTC warns non-HIPAA covered entities to comply with Health Breach Notification Rule By Ellen Pighini Catherine David In an increasingly digital and interconnected world, the privacy and security of personal information is a significant concern....
9/21/2021 5:55:48 PM Biden administration looks to centralize pandemic response in preparedness plan By Sebnem Dugmeoglu In a report released on September 2, 2021 the Biden administration announced its plan to help prepare the nation for future pandemic...
9/15/2021 3:09:09 PM DOJ revises approach to publication and enforcement of guidance documents By Andrew Sylora On July 1, 2021, the Department of Justice (DOJ) released a memorandum signed by Attorney General Merrick Garland regarding the issuance...
9/7/2021 12:00:18 PM Seventh Circuit adopts Safeco objective reasonableness standard in the context of false claims act cases By Kristin Parker On August 12, 2021, the Seventh Circuit joined the Third, Eighth, Ninth, and D.C. Circuits in holding that the “objective reasonableness”...
9/3/2021 11:00:01 AM No Surprises Act: Time to revisit balance billing prohibitions in hospital-based physician professional services agreements with hospitals? By Tom Greeson James Hennessy Effective January 1, 2022, common prohibitions against “balance billing” under hospital professional service contracts will likely become...
8/26/2021 12:30:14 PM FDA clarifies evidence and knowledge requirements in intended use final rule By Kevin Madagan Sung Park John Kendzior On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. §...
8/16/2021 11:00:26 AM HHS authorizes pharmacy technicians and interns to administer flu vaccines By Matthew Loughran The flurry of Covid-19 vaccine administration that marked the mid spring to early summer resulting in millions of doses administered...
8/4/2021 1:23:18 PM Health Care Provisions in the Infrastructure Investment and Jobs Act By Samantha Beck On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and...
7/27/2021 7:35:45 PM CMS Gives the IPO List the Godfather 3 Treatment By Matthew Loughran Just when the procedures thought they were out(patient), CMS pulls them back in(patient). Last year, in the final CY 2021 Outpatient PPS...
7/20/2021 4:06:03 PM Expansive enforcement of HIPAA Right of Access continues By Catherine David Christina Bowen Starting in 2019, the Department of Health and Human Services Office for Civil Rights (“OCR”) has taken an increased interest in...