On November 16, 2020, OIG issued a significant Special Fraud Alert that warns about certain “inherent” fraud and abuse risks raised by speaker programs sponsored by pharmaceutical and medical device companies. OIG expressed...more
CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more
12/1/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Cybersecurity ,
Digital Health ,
DMEPOS ,
Electronic Health Record Incentives ,
Fair Market Value ,
Final Rules ,
OIG ,
Proposed Rules ,
Remuneration ,
Risk Assessment ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On October 28, 2020, CMS released an interim final rule with comment period (IFC) that implements several CARES Act requirements to prepare for the availability of a COVID-19 vaccine. Among other changes, the IFC establishes...more
11/10/2020
/ ACIP ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Cost-Sharing ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Inpatient Prospective Payment System (IPPS) ,
Interim Final Rules (IFR) ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Public Health Emergency ,
Public Health Service (PHS) ,
Vaccinations
On September 1, 2020, CMS published a proposed rule that would define “reasonable and necessary” for purposes of coverage under Part A and Part B of the Medicare program, and that would establish a new expedited Medicare...more
On August 20, 2020, the Committee on Appropriations of the California State Assembly approved sending SB-977 to the Assembly for a final vote, ahead of an August 31, 2020 deadline to send bills to Governor Gavin Newsom. ...more
On August 4, 2020, the California State Assembly referred SB-977 to the Committee on Appropriations, ahead of an August 31 deadline to send bills to Governor Gavin Newsom. SB-977, titled “Health care system consolidation:...more
On May 11, 2020, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System Proposed Rule for FY 2021 (the Proposed Rule), which will affect...more
On March 30, 2020, CMS issued blanket waivers of sanctions under the Federal physician self-referral law (the Stark Law) for purposes of responding to the COVID-19 pandemic (Stark Waivers or Waivers). The Stark Waivers,...more
4/9/2020
/ 1135 Waivers ,
Affiliated-Business Arrangements ,
Business Interruption ,
CARES Act ,
Coronavirus/COVID-19 ,
Economic Injury Disaster Loans ,
Employee Retention ,
Federal Loans ,
Financial Stimulus ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Physicians ,
Relief Measures ,
SBA ,
SBA Lending Programs ,
Small Business ,
Stark Law ,
Tax Relief
As the number of coronavirus cases across the country continue to rise, CMS has issued several coronavirus-specific memorandums to healthcare providers and laboratories. In the past two weeks, CMS has issued disease-specific...more
3/20/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Cost-Sharing ,
Diagnostic Tests ,
Emergency Rooms ,
EMTALA ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medicare ,
Medicare Part C ,
Medicare Part D
On December 17, 2019, OIG published Advisory Opinion 19-06 approving a supermarket’s expansion of a loyalty program to allow customers to earn rewards points on out-of-pocket costs paid in connection with the purchase of...more
1/3/2020
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Customer-Loyalty Programs ,
Grocery Stores ,
Medicaid ,
Medicare ,
OIG ,
Pharmacies ,
Prescription Drugs ,
Retailers
On October 31, 2019, in the face of a federal lawsuit, the Indiana Family and Social Services Administration suspended its enforcement of work requirements under the state’s Medicaid waiver project, the Healthy Indiana Plan...more
Payers are increasingly establishing purported “site of service” policies and guidelines that restrict the circumstances under which members may obtain certain services at hospital outpatient departments (HOPDs). In the...more
In an opinion issued last Wednesday, the Eleventh Circuit affirmed the district court’s entry of final judgment in favor of a multi-state hospital system by dismissing the qui tam relator’s claims under the federal False...more
8/13/2019
/ Appeals ,
Commercial Leases ,
Development Agreements ,
Dismissals ,
False Claims Act (FCA) ,
Final Judgment ,
Healthcare Facilities ,
Hospitals ,
Medicare ,
Qui Tam ,
Stark Law
On July 15, 2019, CMS released new resources, which are available here, that are intended to support states as they apply for waivers under Section 1332 of the Affordable Care Act. These materials follow guidance issued by...more