Dorsey Health Law Blog

Stark Law Reform a Focus of Recent Regulatory and Legislative Initiatives; 2018 DHS Code List and CPI-U Updates

Stark Law Reform Initiatives The Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma recently identified federal physician self-referral law (or “Stark Law”) reform as a top policy priority and reported that an inter-agency group is being formed to review the law. Specifically, in a January 17 American Hospital Association Town Hall webcast focused...

Cap-Subject H-1B Visa Petitions to be filed on April 2, 2018

The annual H-1B cap season will be opening April 2, 2018.  As usual, the application window period is 5 business days.  65,000 H-1B visas are allotted every year. An additional 20,000 visas are set aside for individuals with a U.S. Master’s or higher degree. In general, first time H-1B visa applicants, such as foreign students...

Two Recent Justice Department Memoranda May Have Significant Consequences for Pending and Future False Claims Act Enforcement

In recent weeks, the United States Department of Justice (“DOJ”) issued two memoranda that might change the calculus of False Claims Act (“FCA”) cases.  The memoranda at a minimum provide organizations with new—or at least invigorated—defenses to qui tam actions and civil enforcement matters. First, on January 10, Michael Granston, Director of DOJ’s Civil Frauds section,...

Applying Escobar’s Materiality Standard, Florida Federal Court Reverses $350 Million False Claims Act Verdict against a Nursing Home Operator

If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a question being answered in the negative by courts across the country, who have concluded that the government (or a...

OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement

On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social Security Act (the “Gainsharing CMP”) and Section 1128B(b) of the Social Security Act (the “Anti-Kickback Statute”) with respect to a cost-reduction...

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to finalize guidance related to complex generic drugs, a broader issue that received specialized focus during coverage of EpiPen’s price...

VA Proposed Rule Would Expand Telemedicine and Override State Licensure Barriers

On October 2, the Veterans Administration (VA) proposed a new rule that would expand access to quality care and availability of mental health, specialty, and general clinical care for VA beneficiaries through the use of telemedicine. In their proposed rule, the VA explains the difficulty it has faced attracting a sufficient number of providers to...

CMS To Expand Use of TPE Audits Nationwide by End of 2017

Perhaps lost amid the healthcare news coverage of competing proposals regarding “Medicare for All” and the repeal of Obamacare, the Centers for Medicare & Medicaid Services (“CMS”) last month announced the expansion of its Targeted Probe and Educate (“TPE”) claims review program to the entire country by the end of the year. CMS’s announcement can...